Category: Compliance

Compliance Alert – November 2022

Final Rules

Student Assistance General Provisions, Federal Family Education Loan Program, and William D. Ford Federal Direct Loan Program; Student Assistance General Provisions

The Department of Education (Department or we) corrects the text in regulations issued under the Higher Education Act of 1965, as amended (HEA) and published in the Federal Register on: September 23, 2019, for provisions relating to Borrower Defense to Repayment and Financial Responsibility; November 1, 2019, for provisions relating to Accreditation, State Authorization, and the Student Assistance General Provisions; and September 2, 2020, for provisions relating to Distance Education and Innovation, Institutional Eligibility, and the Student Assistance General Provisions.

Federal Agency: Office of Postsecondary Education, Department of Education

Affected Area: Student Financial Aid

Pell Grants for Prison Education Programs; Determining the Amount of Federal Education Assistance Funds Received by Institutions of Higher Education (90/10); Change in Ownership and Change in Control

The Secretary amends regulations for the Federal Pell Grant program (Pell Grants or Pell), institutional eligibility, and student assistance general provisions. First, we amend the regulations for Federal Pell Grants for prison education programs (PEPs), to implement new statutory requirements to establish Pell Grant eligibility for a confined or incarcerated individual enrolled in a PEP to implement the statutory change in the Consolidated Appropriations Act, 2021. Second, we amend the Title IV Revenue and Non-Federal Education Assistance Funds regulations (referred to as “90/10” or the “90/10 Rule”) to implement the statutory change in the American Rescue Plan Act of 2021 (ARP). We further amend which non-Federal funds can be counted when determining compliance with the 90/10 rule to align allowable non-Federal revenue more closely with statutory intent. Finally, we amend regulations to clarify the process for consideration of changes in ownership and control (CIO), to promote compliance with the Higher Education Act of 1965, as amended (HEA), and related regulations and reduce risk for students and taxpayers, as well as institutions contemplating or undergoing such a change.

Federal Agency: Office of Postsecondary Education, Department of Education

Affected Area: Student Financial Aid

National Emission Standards for Hazardous Air Pollutants: Paint Stripping and Miscellaneous Surface Coating Operations at Area Sources Technology Review

This action finalizes the technology review conducted for the paint stripping and miscellaneous surface coating operations area source categories regulated under national emission standards for hazardous air pollutants (NESHAP). These final amendments also address provisions regarding electronic reporting; make miscellaneous clarifying and technical corrections; simplify the petition for exemption process; and clarify requirements for emissions during periods of startup, shutdown, and malfunction (SSM). We are making no revisions to the numerical emission limits based on the technology review.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

Proposed Rules

Significant New Use Rules on Certain Chemical Substances (22-2.5e)

EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to Orders issued by EPA pursuant to TSCA. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

Comments Due: 11/30/2022

Protection of Human Subjects and Institutional Review Boards, and Institutional Review Boards; Cooperative Research; Extension of Comment Period

The Food and Drug Administration (FDA or the Agency) is extending the comment period for two proposed rules that appeared in the Federal Register of September 28, 2022. In the proposed rule entitled “Protection of Human Subjects and Institutional Review Boards,” FDA requested comments on proposed changes to its regulations regarding obtaining and documenting informed consent from research participants, and institutional review board membership and functions, including continuing review (Docket No. FDA-2021-N-0286). In the proposed rule entitled “Institutional Review Boards; Cooperative Research,” FDA requested comment on a change to its regulations that would require any institution located in the United States participating in FDA-regulated cooperative research to rely on approval by a single institutional review board (IRB) for that portion of the research that is conducted in the United States, with some exceptions (Docket No. FDA-2019-N-2175). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

Federal Agency: Food and Drug Administration, Department of Health and Human Services (HHS)

Affected Area: IRD, ORED, OSP

Comments Due: 12/28/2022

Notices

Real ID Applicant Information and Documentation

The REAL ID Act of 2005 (the Act) prohibits Federal agencies from accepting State-issued drivers’ licenses or identification cards for any official purpose—defined in the Act and regulations to include accessing federal facilities, boarding federally regulated commercial aircraft, and entering nuclear power plants—unless the license or card is issued by a State that meets the requirements set forth in the Act. The REAL ID regulations, which DHS issued in January 2008, establish the minimum standards that States must meet to comply with the Act. DHS has a separate collection of information related to DHS interaction with States, e.g., State certification (see OMB Control No. 1601-0005). By contrast to that collection of information, this collection of information relates to the States’ collection of information from driver’s license applicants.

Federal Agency: Department of Homeland Security (DHS)

Comments Due: 11/30/2022

FAFSA Simplification Act Changes for Implementation in the 2023-2024 Award Year

The U.S. Department of Education (Department) publishes this notice, as required by the Consolidated Appropriations Act, 2022, of the phased implementation of some elements of the FAFSA Simplification Act for the 2023-2024 award year. This notice also addresses other rules that will take effect for the 2023-2024 award year as part of the FAFSA Simplification Act.

Federal Agency: Office of Postsecondary Education, Department of Education

Affected Area: Student Financial Aid

Notice of Availability of Committee on Foreign Investment in the United States Enforcement and Penalty Guidelines

By this Notice, the Department of the Treasury (Treasury Department), announces the availability of the Committee on Foreign Investment in the United States (CFIUS) Enforcement and Penalty Guidelines. These guidelines provide the public with a summary of CFIUS’s practice regarding penalties and other remedies for violations of section 721 of the Defense Production Act of 1950 as amended (Section 721), the regulations promulgated thereunder, or mitigation agreements, conditions, or orders pursuant thereto (Violations).

Federal Agency: Office of Investment Security, Department of the Treasury

Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Generator Standards Applicable to Laboratories Owned by Eligible Academic Entities (Renewal)

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Generator Standards Applicable to Laboratories Owned by Eligible Academic Entities (EPA ICR Number 2317.04, OMB Control Number 2050-0204) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2022. Public comments were previously requested via the Federal Register on May 2, 2022 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is available by following the link above, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

Comments Due: 11/28/2022

Agency Information Collection Activities; Comment Request; Accrediting Agencies Reporting Activities for Institutions and Programs-Database of Accredited Postsecondary Institution and Programs (DAPIP)

Sections 496(a)(7), (a)(8), (c)(7), and (c)(8) of the Higher Education Act (HEA), and federal regulations at 34 CFR; 34 CFR 602.26 and 602.27 contain certain requirements for reporting by recognized accrediting agencies to the Department on the institutions and programs the agencies accredit. This collection specifies the required and requested reporting. It also discusses the channel for reporting this information, and reporting information the accrediting agency may wish to submit voluntarily to ensure that the Department’s Database of Accredited Postsecondary Institutions and Programs is accurate and comprehensive.

Federal Agency: Office of Postsecondary Education (OPE), Department of Education (ED)

Affected Area: OIRA, Institutional Effectiveness

Comments Due: 12/19/2022

Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2023

The Drug Enforcement Administration (DEA) proposes to establish the 2023 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

Federal Agency: Drug Enforcement Administration, Department of Justice

Affected Area: CCHS

Comments Due: 11/17/2022

Methylene Chloride; Revision to Toxic Substances Control Act (TSCA) Risk Determination; Notice of Availability

The Environmental Protection Agency (EPA) is announcing the availability of the final revision to the risk determination for the methylene chloride risk evaluation issued under the Toxic Substances Control Act (TSCA). The revision to the methylene chloride risk determination reflects the announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law. EPA determined that methylene chloride, as a whole chemical substance, presents an unreasonable risk of injury to health when evaluated under its conditions of use. In addition, this revised risk determination does not reflect an assumption that workers always appropriately wear personal protective equipment (PPE). EPA understands that there could be occupational safety protections in place at workplace locations; however, not assuming use of PPE reflects EPA’s recognition that unreasonable risk may exist for subpopulations of workers that may be highly exposed because they are not covered by Occupational Safety and Health Administration (OSHA) standards, or their employers are out of compliance with OSHA standards, or because many of OSHA’s chemical-specific permissible exposure limits largely adopted in the 1970’s are described by OSHA as being “outdated and inadequate for ensuring protection of worker health,” or because the OSHA permissible exposure limit (PEL) alone may be inadequate for ensuring protection of worker health, or because EPA finds unreasonable risk for purposes of TSCA notwithstanding OSHA requirements. This revision supersedes the condition of use-specific no unreasonable risk determinations in the June 2020 Methylene Chloride Risk Evaluation and withdraws the associated TSCA order included in the June 2020 Methylene Chloride Risk Evaluation.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

Standard for Welding, Cutting, and Brazing; Extension of the Office of Management and Budget’s (OMB) Approval of Information Collection (Paperwork) Requirements

OSHA solicits public comments concerning the proposal to extend the Office of Management and Budget’s (OMB) approval of the information collection requirements specified in the Standard for Welding, Cutting, and Brazing.

Federal Agency: Occupational Safety and Health Administration (OSHA), Labor

Comments Due: 1/9/2023

Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin; International Council for Harmonisation; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin.” The draft guidance was prepared under the auspices of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonization. The draft guidance updates the ICH guidance for industry “Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin” issued in September 1998 to reflect advances in scientific knowledge and regulatory expectations. The draft guidance is intended to describe risk-based principles and mitigation strategies to assure the viral safety of biotechnology products, including the data necessary to submit in a marketing application.

Federal Agency: Food and Drug Administration, HHS

Affected Area: ORED

Comments Due: 1/13/23

Notice That the Build America, Buy America Requirement for Construction Materials Applies Effective November 10, 2022, and Notice of Proposed Waiver of Buy America Requirements for De Minimis Costs, Small Grants, and Minor Components  and  Notice That the Build America, Buy America Requirement for Construction Materials Applies Effective November 10, 2022, and Notice of Proposed Waiver of That Requirement for a Narrow Category of Contracts and Solicitations

The Department of Transportation (DOT) seeks to maximize the use of American-made products and materials in all federally funded projects as part of the Biden-Harris Administration’s implementation of the Build America, Buy America Act (the Act), which was included in the historic Bipartisan Infrastructure Law (BIL). The implementation of this law will transform the Department’s approach to domestic procurement requirements. The Department is taking three concurrent actions: (1) DOT is not extending its temporary waiver for construction materials, making that requirement applicable effective November 10, 2022; (2) in a separate notice, DOT is proposing a waiver for narrow categories of contracts and solicitations; and (3) in this notice, DOT is proposing a narrow waiver to allow DOT and its assistance recipients to focus their domestic sourcing efforts on products that provide the greatest manufacturing opportunities for American workers and firms and reduce delays in the delivery of important transportation infrastructure projects that provide jobs and promote economic growth. DOT is seeking comments on whether a waiver of Buy America requirements under the Act and related domestic preference statutes administered by DOT and its Operating Administrations (OAs) should be granted in the public interest for de minimis costs, small grants, and minor components.

Federal Agency: Department of Transportation

Affected Area: Procurement, Campus Development, Facilities and Grounds

Comments Due: 11/20/2022

Items of Interest

Research, Engineering, and Development Advisory Committee (REDAC); Revitalization Membership Plan

Comments Due: 12/31/2022

DEA Again Boosts 2022 Production Goals For Psychedelics Like Psilocybin, MDMA and DMT

The Drug Enforcement Administration (DEA) has yet again increased its quota for the legal production of illegal controlled substances like psilocybin, MDMA and DMT for research purposes in 2022.

Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2023

The Drug Enforcement Administration (DEA) proposes to establish the 2023 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

Comments Due: 11/14/2022

Solicitation of Nominations To Serve on the BEA Advisory Committee

The Director of the Bureau of Economic Analysis (BEA) requests nominations of individuals to the Bureau of Economic Analysis Advisory Committee (BEAAC or Committee) to fill upcoming vacancies. The Director of BEA will consider nominations received in response to this notice, as well as from other sources.

Federal Economic Statistics Advisory Committee

The Under Secretary for Economic Affairs requests nominations of individuals to the Federal Economic Statistics Advisory Committee (FESAC or the Committee). The Under Secretary for Economic Affairs, in coordination with the Directors of the Bureau of Economic Analysis and the U.S. Census Bureau, as well as the Commissioner of the U.S. Department of Labor’s Bureau of Labor Statistics, will consider nominations received in response to this notice, as well as from other sources.

Solicitation of Nominations for Appointment to the Advisory Committee on Breast Cancer in Young Women (ACBCYW)

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ACBCYW. The ACBCYW consists of 15 experts in fields associated with breast cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and counseling, treatment, rehabilitation, palliative care, and survivorship in young women, or in related disciplines with a specific focus on young women.

Comments Due: 12/29/2022

Higher Ed’s Top 10 IT Issues

Educause, the association of higher ed technology officials, highlights a need to move from data insight to data action, develop learning-first strategies regardless of modality, and lead with humility.

Call for Nominations To Serve on the NIST Safety Commission

The Director of the National Institute of Standards and Technology (NIST) intends for a new federal advisory committee to be established, the NIST Safety Commission (Commission). The Commission would provide advice to the NIST Director on matters relating to NIST safety policies; safety management system, practices, and performance; and safety culture. NIST invites and requests nominations of individuals for appointment to the Commission. Registered federal lobbyists may not serve on NIST federal advisory committees in an individual capacity.

Comments Due: 11/17/2022

Science Advisory Committee on Chemicals (SACC); Request for Nominations

The Environmental Protection Agency (EPA) invites the public to nominate scientific experts from a diverse range of disciplines to be considered for appointment to the Science Advisory Committee on Chemicals (SACC), established pursuant to the Toxic Substances Control Act (TSCA). EPA anticipates appointing new SACC members by mid-2023 due to expiring membership terms. Sources in addition to this Federal Register notice may be utilized to solicit nominations and identify candidates. Any interested person or organization may nominate qualified individuals to be considered prospective candidates to the committee by following the instructions provided in this document. Individuals may also self-nominate.

Comments Due: 12/12/2022

Moving Forward on FAFSA Simplification

The U.S. Education Department is moving forward to carry out some parts of the FAFSA Simplification Act before unveiling a simplified Free Application for Federal Student Aid next fall. For colleges and universities, that means updating how the total cost of attendance is calculated—a key measure used to add up financial aid offers. Guidance released this week provides institutions with details on how to calculate a new cost-of-attendance figure, which will be used to calculate financial aid awards for the 2023–24 academic year.

Policy Update – September 2022

 Posting Date

Department

Contact

Name

Effective Date

Summary

New Policies

9/13/2022

Environmental Health and Safety

William Diltz, Environmental Safety Manager

Asbestos Policy

9/13/2022

The purpose of this policy is to ensure compliance with applicable state and federal regulations regarding asbestos-containing materials and to minimize the potential exposure to the University of Alabama (University) students, faculty, staff, visitors and contractors. 

7/27/2022

Environmental Health and Safety

Gene Holcomb, Assistant Director

Automated External Defibrillator (AED) Policy

7/27/2022

Automated External Defibrillators (AEDs) make it possible for laypersons to administer defibrillation during the critical minutes between the onset of sudden cardiac arrest and the arrival of emergency medical services personnel. The purpose of this policy is to assign responsibility for the purchase and management of AEDs, establish AED-user training options, and provide continuity and consistency across campus in AED installation, maintenance, and use.

9/13/2022

Environmental Health and Safety

Gene Holcomb, Assistant Director

Fireworks and Pyrotechnics Policy

9/13/2022 

The purpose of this policy is to define the authorities responsible for approving the use of fireworks displays or use of pyrotechnic special effects as part of a University of Alabama (University) activity, on University property, or within its buildings; and to establish approval processes and general precautions for such use. Displays include, but are not limited to, fireworks, flame effects, or other devices such as cold pyro (collectively, “fireworks”) that are regulated by the Alabama State Fire Marshal.

Revised Policies

9/13/2022

Research and Economic Development

Carpantanto Myles, Director, Office for Research Compliance

Export Controls Policy

1/1/2020

The export of certain items, technologies, software, and services is regulated for reasons of national security, foreign policy, prevention of the spread of weapons of mass destruction, and competitive trade reasons.  Export Control Laws restrict the shipment, transmission or transfer of certain items, software, information, technology and services from the United States to foreign countries. The Export Control Laws also apply to “deemed exports,” which are releases of controlled technology, source code, or technical data to a foreign person located within the United States.  Federal law may impose sanctions, embargos, as well as restrictions on travel and physical shipments to and financial transactions with, certain countries, individuals, and organizations, including certain foreign universities and research institutes.  Violations of Export Control Laws carry significant criminal and civil penalties for both the University and the individual researcher.  Criminal penalties include up to twenty (20) years incarceration and fines of up to $1,000,000 per violation.  Violations may also result in the University being prevented from receiving future federal funding.  The application of export control laws involves fact-specific analysis.  While most exports do not require specific approval from the federal government, certain exports require a license and others are strictly prohibited.   

Compliance Alert – September 2022

Final Rules

Cyber-Related Sanctions Regulations

The Department of the Treasury’s Office of Foreign Assets Control (OFAC) is amending the Cyber-Related Sanctions Regulations and reissuing them in their entirety to further implement an April 1, 2015 cyber-related Executive order, as amended by a December 28, 2016 cyber-related Executive order, as well as certain provisions of the Countering America’s Adversaries Through Sanctions Act. This final rule replaces the regulations that were published in abbreviated form on December 31, 2015, and includes additional interpretive guidance and definitions, general licenses, and other regulatory provisions that will provide further guidance to the public. Due to the number of regulatory sections being updated or added, OFAC is reissuing the Cyber-Related Sanctions Regulations in their entirety.

Federal Agency: Office of Foreign Assets Control, Treasury

Affected Area: OIT, Export Control

Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment

The Food and Drug Administration (FDA, the Agency, or we) is revising the “small number of animals” definition for dogs and cats in our existing regulation for new animal drugs for minor use or minor species. The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives to encourage animal drug sponsors to develop and seek FDA approval of drugs intended for use in minor animal species or for minor uses in major animal species. Congress provided a statutory definition of “minor use” that relies on the phrase “small number of animals” to characterize such use. We are revising the definition of “small number of animals” based on our most recent reassessment of the small numbers, which we conducted from 2018 to 2019.

Federal Agency: Food and Drug Administration, Department of Health and Human Services (HHS)

Affected Area: ORED

Comments Due: 11/14/2022

Proposed Rules

Schedules of Controlled Substances: Placement of 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) in Schedule I; Withdrawal of Proposed Rule

The Drug Enforcement Administration (DEA) is withdrawing a proposed rule that was published in the Federal Register on April 11, 2022, which proposed to place two phenethylamine hallucinogens in schedule I of the Controlled Substances Act. DEA is withdrawing the proposed rule, terminating all proceedings related thereto, and will be publishing a new proposed rule using an amended procedure.

Federl Agency: Drug Enforcement Administration, Department of Justice

Affected Area: EHS, UAPD

Accidental Release Prevention Requirements: Risk Management Programs Under the Clean Air Act; Safer Communities by Chemical Accident Prevention

The Environmental Protection Agency (EPA) is proposing to amend its Risk Management Program (RMP) regulations as a result of Agency review. The proposed revisions include several changes and amplifications to the accident prevention program requirements, enhancements to the emergency preparedness requirements, increased public availability of chemical hazard information, and several other changes to certain regulatory definitions or points of clarification. These proposed amendments seek to improve chemical process safety; assist in planning, preparedness, and responding to RMP-reportable accidents; and improve public awareness of chemical hazards at regulated sources.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

Comments Due: 10/31/2022

Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances

Under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended (“CERCLA” or “Superfund”), the Environmental Protection Agency (EPA or the Agency) is proposing to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, as hazardous substances. CERCLA authorizes the Administrator to promulgate regulations designating as hazardous substances such elements, compounds, mixtures, solutions, and substances which, when released into the environment, may present substantial danger to the public health or welfare or the environment. Such a designation would ultimately facilitate cleanup of contaminated sites and reduce human exposure to these “forever” chemicals.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

Comments Due: 11/7/2022

Modification of Significant New Uses of Certain Chemical Substances (21-1.M)

EPA is proposing to amend the significant new use rules (SNURs) for certain chemical substances identified herein, which were the subject of one or more premanufacture notices (PMNs) and in some cases significant new use notices (SNUNs). This action would amend the SNURs to allow certain new uses reported in the SNUNs or PMNs without additional notification requirements and modify the significant new use notification requirements based on the actions and determinations for the SNUN or PMN submissions or based on the examination of new test data or other information. EPA is proposing these amendments based on our review of new and existing data for the chemical substances.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

Comments Due: 10/17/2022

Workforce Innovation and Opportunity Act Effectiveness in Serving Employers Performance Indicator

The Workforce Innovation and Opportunity Act (WIOA) establishes six primary indicators of performance. Currently, the regulations contain definitions for five of the six performance indicators. However, in the final rule implementing WIOA, the U.S. Departments of Labor and Education (the Departments) indicated that they would initially implement the sixth indicator of performance—effectiveness in serving employers—in the form of a pilot program to test the feasibility and rigor of the three proposed approaches. With the pilot completed, the Departments are engaging in this rulemaking that proposes to define in a standardized way the performance indicator for effectiveness in serving employers for the regulations implementing the jointly administered requirements governing WIOA’s six core programs.

Federal Agency: Office of Career, Technical, and Adult Education (OCTAE), Rehabilitation Services Administration (RSA), Education; Employment and Training Administration (ETA), Labor.

Affected Area: HR

Comments Due: 11/14/2022

Notices
Annual Notice of Interest Rates for Variable-Rate Federal Student Loans Made Under the William D. Ford Federal Direct Loan Program

The Chief Operating Officer for Federal Student Aid announces the interest rates for Federal Direct Stafford/Ford Loans (Direct Subsidized Loans), Federal Direct Unsubsidized Stafford/Ford Loans (Direct Unsubsidized Loans), and Federal Direct PLUS Loans (Direct PLUS Loan), Assistance Listing Number 84.268, with first disbursement dates before July 1, 2006, and for Federal Direct Consolidation Loans (Direct Consolidation Loans) for which the application was received before February 1, 1999. The rates announced in this notice are in effect for the period July 1, 2022 through June 30, 2023.

Federal Agency: Federal Student Aid, Department of Education

Affected Area: Student Financial Aid

Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; FAFSA Form Demographic Survey

The U.S. Department of Education (the Department) is requesting a new information collection to gather demographic information in conjunction with the Free Application for Federal Student Aid (FAFSA) form. The FAFSA Simplification Act (FSAct) passed as part of the Consolidated Appropriations Act, 2021 (Pub. L. 116-260) amends the Higher Education Act of 1965, Title IV, Sec 483 (B)(ii)(VII) to add sex and race or ethnicity as information required to be provided by the applicant on the Free Application for Federal Student Aid (FAFSA) form. For the launch of the 2023-24 FAFSA on October 1, 2022, FSA will ask the demographic questions in a pilot, voluntary survey format in order to collect specific feedback on the new questions. This feedback will inform the development of the questions for full implementation within the FAFSA form for the 2024-2025 award year.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid

Comments Due: 9/23/2022

Publication of OIG Special Fraud Alerts

This Federal Register notice sets forth two Special Fraud Alerts previously published by OIG on its website. We are publishing these Special Fraud Alerts in the Federal Register to ensure widespread dissemination of the Special Fraud Alerts to the general public and to satisfy the Federal Register publication requirement.

Federal Agency: Office of Inspector General (OIG), HHS

Affected Area: UMC

Proposed Collection; 60-Day Comment Request; Application and Impact of Clinical Research Training on Healthcare Professionals in Academia and Clinical Research (Office of the Director)

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Office of Clinical Research (OCR), Office of the Director (OD), National Institutes of Health, will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Federal Agency: National Institutes of Health, HHS

Affected Area: ORED, OSP

Comments Due: 10/28/2022

Collection of Information – Accidental Release Prevention Requirements: Risk Management Programs Under Section 112(r) of the Clean Air Act, as Amended; Safer Communities by Chemical Accident Prevention, EPA ICR Number 2725.01, OMB Control Number 2050-NEW

The Environmental Protection Agency (EPA or Agency) is planning to submit an information collection request (ICR), Accidental Release Prevention Requirements: Risk Management Programs under the Clean Air Act, as amended; Safer Communities by Chemical Accident Prevention, (EPA ICR Number 2725.01, OMB Control Number 2050-NEW) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a new ICR. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Federal Agency: Environmental Protection Agency

Affected Area: EHS

Comments Due: 10/28/2022

Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Gathering Data on Results of Annual and Triennial Testing To Evaluate the Impacts of EPA’s 2015 Federal Underground Storage Tank Regulation

The Environmental Protection Agency has submitted an information collection request (ICR), Gathering Data on Results of Annual and Triennial Testing to Evaluate the Impacts of EPA’s 2015 Federal Underground Storage Tank Regulation (EPA ICR Number 2650.02, OMB Control Number 2050-NEW) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a request for approval of a new collection. Public comments were previously requested via the Federal Register on June 2, 2022 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

Comments Due: 10/11/2022

Agency Information Collection Activities; Comment Request; HEAL Program: Physician’s Certification of Borrower’s Total and Permanent Disability

This is a request for an extension of the OMB approval of the information collection associated with the form for the Health Education Assistance Loan (HEAL) Program, Physician’s Certification of Borrower’s Total and Permanent Disability, currently approved under OMB Control Number 1845-0124. The form is HEAL 539. A borrower and the borrower’s physician must complete this form. The borrower then submits the form and additional information to the lending institution (or current holder of the loan) who in turn forwards the form and additional information to the Secretary for consideration of discharge of the borrower’s HEAL loans. The form provides a uniform format for borrowers and lenders to use when submitting a disability claim.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid

Comments Due: 11/7/2022

Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; FFEL/Direct Loan/Perkins Military Service Deferment/Post-Active Duty Student Deferment Request

The Military Service/Post-Active Duty Student Deferment request form serves as the means by which a Federal Family Education Loan (FFEL), Perkins, or Direct Loan borrower requests a military service deferment and/or post-active duty student deferment and provides his or her loan holder with the information needed to determine whether the borrower meets the applicable deferment eligibility requirements. The form also serves as the means by which the U.S. Department of Education identifies Direct Loan borrowers who qualify for the Direct Loan Program’s no accrual of interest benefit for active duty service members.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid

Comments Due: 10/6/2022

Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Federal Family Education Loan (FFEL) Program Secured Overnight Financing Rate (SOFR) Election Form

The Department of Education (ED) is requesting approval of a new information collection for the Federal Family Education Loan (FFEL) Program Secured Overnight Financing Rate (SOFR) Election form. On March 15, 2022, the President signed the Adjustable Interest Rate (LIBOR) Act into law. Among other things, the law amended section 438(b)(2)(I) of the Higher Education Act of 1965, as amended (HEA). This provision of the law requires FFEL Program lenders or an entity that holds a beneficial ownership interest in a FFEL Program loan (beneficial holder) to transition away from LIBOR based Special Allowance Payments (SAP) to a new formula set by the law based on SOFR. The transition may occur any time on or before June 30, 2023. However, a FFEL Program lender or beneficial holder must transition to the SOFR based SAP calculation by July 1, 2023, as a condition of continued participation in FFEL Program.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid

Comments Due: 10/6/2022

Submission for OMB Review; Federal Acquisition Regulation Part 46 Requirements

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division has submitted to the Office of Management and Budget (OMB) a request to review and approve a revision of a previously approved information collection requirement regarding Federal Acquisition Regulation part 46 requirements.

Federal Agency: Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA)

Affected Area: Procurement

Comments Due: 10/14/2022

Agency Information Collection Activities; Comment Request; Federal Perkins Loan Program Regulations and General Provisions Regulations

This is a request by the Department of Education (Department) for continued approval of the reporting, disclosure and records maintenance requirements that are contained in the Student Assistance General Provisions regulations, the Federal Perkins Loan program, the Federal Work-Study program, and the Federal Supplemental Educational Opportunity Grant program. The Department is seeking an extension of the currently approved information collection 1845-0019. There has been no change to the regulatory or statutory requirements.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid

Comments Due: 11/15/2022

Privacy Act of 1974; System of Records

In accordance with the Privacy Act of 1974, as amended (Privacy Act) (5 U.S.C. 552a), the U.S. Department of Education (Department) publishes this notice of a new system of records titled “Enterprise Data Management and Analytics Platform Services (EDMAPS)” (18-11-22). The EDMAPS system is a data analytics platform that ingests data from multiple Federal Student Aid (FSA) systems of records to perform big-data analytics on FSA data in one common location, produce reports and statistical models, and serve as a centralized repository of information about FSA customers across the full student aid life cycle.

Federal Agency: Federal Student Aid, U.S. Department of Education

Affected Area: Student Financial Aid

Comments Due: 10/13/2022

Privacy Act of 1974; System of Records

In accordance with the Privacy Act of 1974, as amended (Privacy Act), the U.S. Department of Education (Department) publishes this notice of a new system of records entitled “Aid Awareness and Application Processing” (18-11-21) and of the rescindment of the system of records notices entitled “Federal Student Aid Application File” (18-11-01) and ”Customer Engagement Management System (CEMS)” (18-11-11). The Aid Awareness and Application Processing system of records consolidates the Federal Student Aid Application File and CEMS system of records notices to create a new system of records notice that combines customer information necessary for the Department to process customer applications for Federal student financial program assistance under title IV of the Higher Education Act of 1965, as amended (HEA); to perform the duties and responsibilities of the Federal Student Aid (FSA) Ombudsman; and, separately, to provide Federal student loan repayment relief including under the borrower defense to repayment regulations. The Department’s will use the new Digital and Customer Care (DCC) information technology (IT) system to accomplish these functions and duties. The Department will also use DCC IT to make customers aware of aid program opportunities and updates under title IV of the HEA via digital communication channels and establishes the StudentAid.gov website as the front end for assisting customers with all their Federal student financial aid needs throughout the student aid lifecycle.

Federal Agency: Federal Student Aid, U.S. Department of Education

Affected Area: Student Financial Aid

Comments Due: 10/13/2022

Privacy Act of 1974; System of Records

In accordance with the Privacy Act of 1974, as amended (Privacy Act), the U.S. Department of Education (Department) publishes this notice of a modified system of records entitled “Common Origination and Disbursement (COD) System” (18-11-02). The information contained in this system is maintained for various purposes relating to aid applicants and recipients including determining their eligibility for Federal student financial assistance under the programs authorized by title IV of the Higher Education Act of 1965, as amended (HEA); institutions of higher education participating in and administering title IV, HEA programs; and the Department’s oversight of title IV, HEA programs.

Federal Agency: Federal Student Aid, U.S. Department of Education

Affected Area: Student Financial Aid

Comments Due: 10/13/2022

Privacy Act of 1974; System of Records

In accordance with the Privacy Act of 1974, as amended (Privacy Act), the U.S. Department of Education (Department) publishes this notice of a modified system of records entitled “Common Services for Borrowers (CSB)” (18-11-16). The information contained in this system is maintained for various purposes relating to aid applicants and recipients, cosigners, and endorsers. These include: determining program benefit eligibility; originating, disbursing, servicing, collecting, assigning, adjusting, transferring, referring, discharge, and furnishing of credit information for title IV, Higher Education Act of 1965, as amended (HEA), obligations; enforcing conditions or terms of title IV, HEA obligations; and ensuring program and contractual requirements are met by education and financial institutions, guaranty agencies, and Department contractors including Federal Loan Servicers, Not-for-Profit (NFP) Federal Loan Servicers, the Federal Perkins Loan Servicer, and Private Collection Agencies (PCAs).

Federal Agency: Federal Student Aid, U.S. Department of Education

Affected Area: Student Financial Aid

Comments Due: 10/13/2022

Agency Information Collection Activities; Comment Request; Federal Direct Loan Program Regulations for Forbearance and Loan Rehabilitation

This information collection for the Direct Loan (DL) Program regulations is related to regulations for forbearance in § 685.205 and reasonable and affordable loan rehabilitation in § 685.211. The Department of Education is requesting an extension without change of the current burden calculated for this information collection. Due to the COVID-19 pandemic and loan payment pause, there is not sufficient information to estimate burden changes. These regulations provide additional flexibilities for DL borrowers and permit oral requests for forbearance, as well as allow a borrower to object to the initially established reasonable and affordable loan repayment amount. In addition, if a borrower incurs changes to his or her financial circumstances, the borrower can provide supporting documentation to change the amount of the reasonable and affordable loan monthly repayment amount. There has been no change to the regulatory language.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid

Comments Due: 11/14/2022

Proposed Information Collection Request; Comment Request; National Refrigerant Recycling and Emissions Reduction Program (Renewal)

The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), “National Refrigerant Recycling and Emissions Reduction Program” (EPA ICR No. 1626.18, OMB Control No. 2060-0256) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through April 30, 2023. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

Comments Due: 11/18/2022

Items of Interest

Request for Nominations of Candidates for the National Environmental Education Advisory Council (NEEAC)

The U.S. Environmental Protection Agency (EPA) or Agency Office of Public Engagement and Environmental Education is soliciting applications for environmental education professionals for consideration to serve on the National Environmental Education Advisory Council (NEEAC). There are multiple vacancies on the Advisory Council that must be filled. Additional avenues and resources may be utilized in the solicitation of applications. “In accordance with Executive Order 14035 (June 25, 2021), EPA values and welcomes opportunities to increase diversity, equity, inclusion and accessibility on its federal advisory committees. EPA’s federal advisory committees have a workforce that reflects the diversity of the American people.”

Comments Due: 9/19/2022

Request for Nominations for the Science Advisory Board Environmental Justice Screen (EJScreen) Review Panel

The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office requests public nominations of scientific experts to form a Panel to review the updated EJScreen methodology. EJScreen is an environmental justice mapping and screening tool that provides EPA with a nationwide consistent approach for combining environmental and demographic indicators to identify areas with potential environmental justice (EJ) concerns. The SAB EJScreen Review Panel will consider the EJScreen methodology and updated calculations for the EJ indexes released publicly in 2022, as well as other aspects of the calculations. The Panel will also be asked to provide recommendations and expert input on other components of the tool.

Comments Due: 9/20/2022

Solicitation of Nominations To Serve on the BEA Advisory Committee

The Director of the Bureau of Economic Analysis (BEA) requests nominations of individuals to the Bureau of Economic Analysis Advisory Committee (BEAAC) to fill upcoming vacancies. The Director will consider nominations received in response to this notice, as well as from other sources.

Solicitation of Nominations To Serve on the BEA Advisory Committee

Comments Due: 9/30/2022

Establishment of the Ocean Research Advisory Panel and Solicitation of Nominations for Membership

Pursuant to the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 Act and the Federal Advisory Committee Act (FACA), the NOAA Administrator and the Co-Chairs of the Ocean Policy Committee (OPC) announce the establishment of the Ocean Research Advisory Panel (ORAP). The ORAP shall advise the OPC on certain ocean science and research policies, procedures, priorities, and other appropriate matters. The ORAP charter shall terminate two years from the date of its filing with the appropriate U.S. Senate and House of Representatives Committees unless earlier terminated or renewed by proper authority. Notwithstanding section 14 of the Federal Advisory Committee Act, the Advisory Panel shall terminate on January 1, 2040. This notice also requests nominations for membership on the ORAP.

Comments Due: 9/30/2022

Compliance Alert – July 2022

Final Rules

Schedules of Controlled Substances: Placement of Serdexmethylphenidate in Schedule IV

This final rule refers to the single entity, serdexmethylphenidate. The chloride salt of serdexmethylphenidate is chemically known as 3-[[[(1S)-1-carboxy-2-hydroxyethyl]-amino]carbonyl]-1-[[[[(2R)-2-[(1R)-2-methoxy-2-oxo-1-phenylethyl]-1-piperidinyl]carbonyl]oxy]methyl]pyridinium chloride. This rule maintains the placement of serdexmethylphenidate, including its salts, isomers, and salts of isomers, in schedule IV of the Controlled Substances Act (CSA), thereby facilitating the commercial distribution of AZSTARYS as a controlled substance.

Federal Agency: Drug Enforcement Administration, Department of Justice

Affected Area: CCHS

Defense Federal Acquisition Regulation Supplement: Maximizing the Use of American-Made Goods, Products, and Materials (DFARS Case 2019-D045)

DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement an Executive order regarding maximizing the use of American-made goods, products, and materials.

Federal Agency: Defense Acquisition Regulations System, Department of Defense (DoD)

Affected Area: Procurement

Grants Regulation; Removal of Non-Discrimination Provisions and Repromulgation of Administrative Provisions Under the Uniform Grant Regulation

The U.S. District Court for the District of Columbia in Facing Foster Care et al. v. HHS, 21-cv-00308 (D.D.C. Feb. 2, 2021), has delayed the effective date of portions of the final rule making amendments to the Uniform Administrative Requirements promulgated on January 12, 2021.

Federal Agency: Assistant Secretary for Financial Resources (ASFR), Health and Human Services (HHS or the Department)

Affected Area: ORED, OSP

Safety and Health Regulations for Construction-Lead

OSHA is issuing a correcting amendment to the OSHA lead standard for construction to correct the inadvertent removal of regulatory text resulting from a notice of correcting amendments issued February 18, 2020.

Federal Agency: Occupational Safety and Health Administration (OSHA), Labor

Affected Area: Campus Development, EHS

Protection of Human Subjects

This rule is being published by the Office of the Federal Register to correct an editorial or technical error that appeared in the most recent annual revision of the Code of Federal Regulations.

Federal Agency: Department of Labor

Affected Area: ORC

Rules of Practice and Procedure for Administrative Hearings Before Administrative Law Judges in Cases Involving Allegations of Unlawful Employment of Aliens, Unfair Immigration-Related Employment Practices, and Document Fraud

This rule is being published by the Office of the Federal Register to correct an editorial or technical error that appeared in the most recent annual revision of the Code of Federal Regulations.

Federal Agency: Department of Justice

Affected Area: HR

Safety and Health Regulations for Construction

This rule is being published by the Office of the Federal Register to correct an editorial or technical error that appeared in the most recent annual revision of the Code of Federal Regulations.

Occupational Safety and Health Administration

Affected Area: Campus Development, EHS

Principle-Based Ethics Framework for Access to and Use of Veteran Data

The Department of Veterans Affairs (VA or Department) amends its regulations concerning the standards of ethical conduct and related responsibilities of its employees by adopting an overarching principle-based ethics framework for access to and use of veteran data. This framework is an important part of VA’s data governance strategy. A data ethics framework can ensure uniform ethics standards for data practices and address consumer protection and data stewardship concerns that are beyond traditional privacy and confidentiality practices. This framework is intended to be applied by all parties who oversee the access to, sharing of, or the use of veteran data, or who access, share, or use veteran data themselves in the context of all other specific clinical, technical, fiscal, regulatory, professional, industry, and other standards.

Federal Agency: Department of Veterans Affairs

Affected Area: Office of Veterans Affairs

Social Security Number Fraud Prevention Act of 2017 Implementation

The Department of the Interior (DOI) is publishing a direct final rule to promulgate regulations to implement the provisions of the Social Security Number Fraud Prevention Act of 2017. The new regulations will prohibit the inclusion of an individual’s Social Security account number (SSN) on any document sent through the mail unless the Secretary of the Interior deems it necessary and precautions are taken to protect the SSN. The regulations also include requirements for the safeguarding of SSNs sent through the mail by partially redacting SSNs where feasible and prohibiting the display of SSNs on the outside of any package or envelope sent by mail. This rule is being published as a direct final rule as DOI does not expect any adverse comments. If adverse comments are received, this direct final rule will be withdrawn and a proposed rule for comments will be published.

Federal Agency: Office of the Secretary, Interior

Affected Area: CERA, OIT, HR

Comments Due: 8/15/2022

Proposed Rules

Defense Federal Acquisition Regulation Supplement: Reporting Tax Information on Certain Foreign Procurements (DFARS Case 2021-D029)

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to allow for the efficient and accurate identification of contracts subject to excise tax withholding. DoD is also proposing to prohibit use of the Governmentwide commercial purchase card as a method of payment when the tax on certain foreign procurements applies. These changes will promote the efficient administration of the excise tax.

Federal Agency: Defense Acquisition Regulations System, Department of Defense (DoD)

Affected Area: Procurement, Tax Office, CERA

Comments Due: 8/22/2022

Defense Federal Acquisition Regulation Supplement: Prohibition on Award to Contractors That Require Certain Nondisclosure Agreements (DFARS Case 2021-D018)

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2021 that prohibits the award of any DoD contracts to an entity that requires its employees to sign internal confidentiality agreements or statements that would prohibit or otherwise restrict its employees from lawfully reporting waste, fraud, or abuse related to the performance of a DoD contract to a designated investigative or law enforcement representative of DoD authorized to receive such information.

Federal Agency: Defense Acquisition Regulations System, Department of Defense (DoD)

Affected Area: Procurement, HR, ORED

Comments Due: 8/22/2022

Nondiscrimination on the Basis of Sex in Education Programs or Activities Receiving Federal Financial Assistance

The U.S. Department of Education (Department) proposes to amend the regulations implementing Title IX of the Education Amendments of 1972 (Title IX). The purpose of the proposed regulations is to better align the Title IX regulatory requirements with Title IX’s nondiscrimination mandate, and to clarify the scope and application of Title IX and the obligation of all schools, including elementary schools, secondary schools, postsecondary institutions, and other recipients that receive Federal financial assistance from the Department (referred to below as recipients or schools) to provide an educational environment free from discrimination on the basis of sex, including through responding to incidents of sex discrimination. The Department recognizes that schools vary in size, student populations, and administrative structure. The proposed regulations would enable all schools to meet their obligations to comply fully with Title IX while providing them appropriate discretion and flexibility to account for these variations.

Federal Agency: Office for Civil Rights, Department of Education

Affected Area: Title IX

Comments Due: 9/12/2022

Student Assistance General Provisions, Federal Perkins Loan Program, Federal Family Education Loan Program, and William D. Ford Federal Direct Loan Program

This notice of proposed rulemaking (NPRM) covers student loans and affordability issues. This rulemaking specifically discusses issues involving loans under the William D. Ford Direct Loan (Direct Loan) Program, the Federal Perkins Loan (Perkins) Program, and the Federal Family Education Loan (FFEL) Program. The Secretary proposes to amend the regulations governing seven topics related to student loans administered by the U.S. Department of Education. First, we propose to amend the regulations governing the William D. Ford Federal Direct Loan (Direct Loan) Program to establish a new Federal standard and process for determining whether a borrower has a defense to repayment on a loan. We also propose to prohibit the use of certain contractual provisions regarding dispute resolution processes by participating institutions, and to require certain notifications and disclosures by institutions regarding their use of arbitration. Additionally, we propose to amend the Perkins, Direct Loan, and FFEL Program regulations to improve the process for granting total and permanent disability (TPD) discharges by eliminating the income monitoring period and expanding allowable documentation allowing additional health care professionals to provide a certification that a borrower is totally and permanently disabled. We further propose to amend the closed school discharge provisions in the Perkins Loan, Direct Loan, and FFEL programs to expand borrower eligibility for automatic discharges and eliminate provisions pertaining to reenrollment in a comparable program. We further propose to amend the Direct Loan and FFEL regulations to streamline the regulations governing false certification discharges. We propose to amend the Direct Loan regulations to eliminate interest capitalization in instances where it is not required by statute. Finally, we propose to amend regulations governing Public Service Loan Forgiveness (PSLF) in the Direct Loan program to improve the application process, and to clarify and expand definitions for full-time employment, qualifying employers, and qualifying monthly payments. The proposed changes would bring greater transparency and clarity and improve the administration of Federal student financial aid programs to assist and protect students, participating institutions, and taxpayers.

Federal Agency: Office of Postsecondary Education, Department of Education

Affected Area: Student Financial Aid

Comments Due: 8/12/2022

Nondiscrimination on the Basis of Disability: Accessibility of Web Information and Services of State and Local Governments

The Americans with Disabilities Act (ADA) states that: no qualified individual with a disability shall, by reason of such disability, be excluded from participation in or be denied the benefits of services, programs, or activities of a public entity, or be subjected to discrimination by any such entity 42 U.S.C. 12132. However, many websites from public entities (i.e., State and local governments) fail to incorporate or activate features that enable users with disabilities to access the public entity’s programs, activities, services, or information online.  The Department intends to publish a Notice of Proposed Rulemaking (NPRM) to amend its Title II ADA regulation to provide technical standards to assist public entities in complying with their existing obligations to make their websites accessible to individuals with disabilities.

Federal Agency: Department of Justice

Affected Area: Office of Disability Services

Notices

Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects and Institutional Review Boards

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with statutory and regulatory provisions governing human subject protection and institutional review boards.

Federal Agency: Food and Drug Administration, HHS

Affected Area: ORED, OSP, IRB

Comments Due: 8/23/2022

Agency Information Collection Activities: Requests for Comments; Clearance of a Renewed Approval of Information Collection: Small Unmanned Aircraft Registration System

In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. Aircraft registration is necessary to ensure personal accountability among all users of the National Airspace System (NAS). Aircraft registration also allows the FAA and law enforcement agencies to address non-compliance by providing the means for identifying an aircraft’s owner and operator. This collection also permits individuals to de-register or update their record in the registration database.

Federal Agency: Federal Aviation Administration (FAA), DOT

Affected Area: CERA, UAPD

Comments Due: 8/22/2022

Agency Information Collection Activities; OSHA Strategic Partnership Program (OSSP) for Worker Safety and Health

The Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et seq.) authorizes information collection by employers as necessary or appropriate for enforcement of the OSH Act or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain such information with a minimum burden upon employers, especially those operating small businesses, and to reduce to the maximum extent feasible unnecessary duplication of efforts in obtaining said information (29 U.S.C. 657). The OSPP allows OSHA to enter into an extended, voluntary, cooperative relationship with groups of employers, employees, and representatives (sometimes including other stakeholders, and sometimes involving only one employer) to encourage, assist, and recognize their efforts to eliminate serious hazards and to achieve a high level of worker safety and health that goes beyond what historically has been achieved from traditional enforcement methods. Each OSHA Strategic Partnership (OSP) determines what information will be needed, determining the best collection method, and clarifying how the information will be used. At a minimum, each OSP must identify baseline injury and illness data corresponding to all summary line items on the OSHA 300 logs and must track changes at either the worksite level or participant-aggregate level. An OSP may also include other measures of success, such as training activity, self-inspections, and/or workers’ compensation data. In this regard, the information collection requirements for the OSPP are used by the agency to gauge the effectiveness of programs, identify needed improvements, and ensure that resources are being used effectively and appropriately. For additional substantive information about this ICR, see the related notice published in the Federal Register on March 7, 2022 (87 FR 12735).

Federal Agency: Department of Labor

Affected Area: EHS, HR, Risk Management

Comments Due: 7/21/2022

Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and approval; Comment Request; William D. Ford Federal Direct Loan Program (Direct Loan Program) Promissory Notes and Related Forms

The Direct Subsidized Loan and Direct Unsubsidized Loan Master Promissory Note (Subsidized/Unsubsidized MPN) serves as the means by which an individual agrees to repay a Direct Subsidized Loan and/or Direct Unsubsidized Loan. The Direct PLUS Loan Master Promissory Note (PLUS Loan MPN) serves as the means by which an individual applies for and agrees to repay a Direct PLUS Loan. If a Direct PLUS Loan applicant is determined to have an adverse credit history, the applicant may qualify for a Direct PLUS Loan by obtaining an endorser who does not have an adverse credit history. The Endorser Addendum serves as the means by which an endorser agrees to repay the Direct PLUS Loan if the borrower does not repay it. An MPN is a promissory note under which a borrower may receive loans for a single or multiple academic years. The MPN explains the terms and conditions of the loans that are made under the MPN. The Direct Consolidation Loan Application and Promissory Note (Consolidation Note) serves as the means by which a borrower applies for a Direct Consolidation Loan and promises to repay the loan. It also explains the terms and conditions of the Direct Consolidation Loan. The Consolidation Note Instructions explain to the borrower how to complete the Consolidation Note. The Consolidation Additional Loan Listing Sheet provides additional space for a borrower to list loans that he or she wishes to consolidate. The Consolidation Request to Add Loans serves as the means by which a borrower may add other loans to an existing Direct Consolidation Loan within a specified time period. The Consolidation Loan Verification Certificate serves as the means by which the U.S. Department of Education obtains the information needed to pay off the holders of the loans that the borrower wants to consolidate. This revision updates the Subsidized/Unsubsidized MPN and the Consolidation Note by removing information related to the 150% Subsidized Usage Limit requirements. This previous statutory provision was repealed by the Free Application for Federal Student Aid (FAFSA) Simplification Act, part of the part of the Consolidated Appropriations Act, 2021 (Public Law 116-260), and no longer applies to borrowers of Direct Subsidized Loans and Direct Consolidation Loans. There are no proposed changes to the PLUS MPN or to any of the other forms included in this submission.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid

Comments Due: 7/21/2022

William D. Ford Federal Direct Loan Program (Direct Loan Program) Promissory Notes and Related Forms

This revision updates the Subsidized/Unsubsidized MPN and the Consolidation Note by removing information related to the 150% Subsidized Usage Limit requirements. This previous statutory provision was repealed by the Free Application for Federal Student Aid (FAFSA) Simplification Act, part of the part of the Consolidated Appropriations Act, 2021 (Public Law 116-260), and no longer applies to borrowers of Direct Subsidized Loans and Direct Consolidation Loans. There are no proposed changes to the PLUS MPN or to any of the other forms included in this submission.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid

Part 601 Preferred Lender Arrangements

34 CFR part 601—Institution and Lender Requirements Relating to Education Loans is a section of the regulations governing private education loans offered at covered institutions. These regulations assure the Secretary that the integrity of the program is protected from fraud and misuse of program funds and places requirements on institutions and lenders to ensure that borrowers receive additional disclosures about Title IV, HEA program assistance prior to obtaining a private education loan. The Department is submitting the unchanged Private Education Loan Applicant Self-Certification for OMB’s continued approval. While information about the applicant’s cost of attendance and estimated financial assistance must be provided to the student, if available, the student will provide the data to the private loan lender who must collect and maintain the self-certification form prior to disbursement of a Private Education Loan. The Department will not receive the Private Education Loan Applicant Self-Certification form and therefore will not be collecting and maintaining the form or its data.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid

Comments Due: 7/21/2022

Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Loan Cancellation in the Federal Perkins Loan Program

This is a request for an extension of the current OMB approval for the recordkeeping requirements contained in 34 CFR 674.53, 674.56, 674.57, 674.58 and 674.59. The information collections in these regulations are necessary to determine Federal Perkins Loan (Perkins Loan) Program borrower’s eligibility to receive program benefits and to prevent fraud and abuse of program funds. There has been no change to the regulatory requirements. Due to the effects of the COVID-19 pandemic and the suspension of the collection of loans, the Department lacks sufficient data to allow for more accurate updates to the usage of the regulations.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid

Comments Due: 7/21/2022

Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Diesel Emissions Reduction Act (DERA) and Clean School Bus (CSB) Rebate Programs

This is an extension of the current Information Collection Request (ICR) for the Diesel Emissions Reduction Act program (DERA) authorized by Title VII, Subtitle G (Sections 791 to 797) of the Energy Policy Act of 2005 (Pub. L. 109-58), as amended by the Diesel Emissions Reduction Act of 2010 (Pub. L. 111-364) and Division S (Section 101) of the Consolidated Appropriations Act, 2021 (Pub. L. 116-260), codified at 42 U.S.C. 16131 et seq. DERA provides the Environmental Protection Agency (EPA) with the authority to award grants, rebates or low-cost revolving loans on a competitive basis to eligible entities to fund the costs of projects that significantly reduce diesel emissions from mobile sources through implementation of a certified engine configuration, verified technology, or emerging technology. Eligible mobile sources include buses (including school buses), medium heavy-duty or heavy heavy-duty diesel trucks, marine engines, locomotives, or nonroad engines or diesel vehicles or equipment used in construction, handling of cargo (including at ports or airports), agriculture, mining, or energy production. In addition, eligible entities may also use funds awarded for programs or projects to reduce long-duration idling using verified technology involving a vehicle or equipment described above. The objective of the assistance under this program is to achieve significant reductions in diesel emissions in terms of tons of pollution produced and reductions in diesel emissions exposure, particularly from fleets operating in areas designated by the Administrator as poor air quality areas. EPA uses approved procedures and forms to collect necessary information to operate its grant and rebate programs. EPA has been providing rebates under DERA since Fiscal Year 2012. EPA is requesting an extension of the current ICR, which is approved through June 30, 2022, for forms needed to collect necessary information to operate a rebate program as authorized by Congress under the DERA program.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: Fleet Management, Campus Development, Facilities and Grounds

Comments Due: 7/28/2022

Asbestos Part 2 Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos; Final Scope of the Risk Evaluation To Be Conducted Under the Toxic Substances Control Act; Notice of Availability

In accordance with implementing regulations for the Toxic Substances Control Act (TSCA), EPA is announcing the availability of the final scope of the risk evaluation to be conducted for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos. In the Part 2 risk evaluation for asbestos, EPA will evaluate the conditions of use of asbestos (including other types of asbestos fibers in addition to chrysotile) that EPA had excluded from Part 1 as legacy uses and associated disposals, as well as any conditions of use of asbestos-containing talc. The final scope for this chemical substance includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk evaluation for this chemical substance.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Quanterix Corp. for the Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test and for the Simoa SARS-CoV-2 N Protein Antigen Test. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.

Food and Drug Administration, HHS

Affected Area: CCHS

Request for Information (RFI): HHS Initiative To Strengthen Primary Health Care

OASH invites input from members of the public representing all backgrounds and perspectives. In particular, OASH is interested in input from individuals; paid and unpaid caregivers; communities; community-based organizations; health care providers (please state discipline and specialty, as appropriate); professional societies; community health centers and Rural Health Clinics; state, local, tribal, and territorial governments and public

health departments; educators; academic researchers; global partners; health insurance payers and purchasers; health technology developers; and policy experts. Examples of health care providers include, but are not limited to: family medicine, internal medicine, pediatrics, and obstetrics and gynecology physicians; physician assistants; nurse practitioners; nurse midwives; nurses; behavioral health providers; oral health providers; medical/surgical specialists; community health workers; social workers; care coordinators; telehealth navigators; peer recovery specialists; provider practices; and health care systems.

Federal Agency: Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services

Affected Area: CCHS

Comments Due: 8/1/2022

Use of a Single Institutional Review Board for Cooperative Research Draft Guidance

OHRP is announcing the availability of a draft guidance document for public comment titled “Use of a Single Institutional Review Board for Cooperative Research.” The document is intended primarily for institutions, institutional review boards (IRBs), investigators, institutional officials, and other human research protection staff.

The draft guidance document applies to activities that are conducted or supported by HHS. It is intended primarily to help entities implement the requirement for use of a single IRB for cooperative research (subpart A of 45 CFR part 46.114). In particular, the draft guidance addresses the following topics: (1) What is cooperative research? (2) When must an institution rely on a single IRB for approval of cooperative research? (3) Who decides which IRB will be the IRB of record for the purposes of regulatory compliance? (4) Can an institution that is not required to comply with 45 CFR 46.114(b)(1) for a particular study still choose to rely on a single IRB for review of cooperative research? (5) Can an institution involved in cooperative research choose to conduct its own IRB review of the research even though review is required by a single IRB that is located elsewhere? (6) Are there documentation requirements for use of a single IRB in cooperative research? (7) What are some of the operational capacities an IRB should have in order to serve as a single IRB? (8) What are the responsibilities of the reviewing IRB with respect to information pertaining to sensitivity to community attitudes and the local context for proposed research? (9) What are the responsibilities of the reviewing IRB pertaining to applicable State and local laws?

Federal Agency: Department of Health and Human Services

Affected Area: ORED, ORC

Comments Due: 8/30/2022

Submission for OMB Review; Cost Accounting Standards Administration

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division has submitted to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding cost accounting standards administration.

Federal Agency: Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA)

Affected Area: Financial Accounting

Comments Due: 7/28/2022

Guidance on Development and Implementation of Railroad Capital Projects

FRA proposes guidance on the development and implementation of railroad capital projects that are funded, in whole or in part, by FRA. FRA seeks comment from the public on the content and application of the proposed guidance (“guidance”), which is available for review at https://regulations.gov under docket number FRA-2022-0035.

Federal Agency: Federal Railroad Administration (FRA), Department of Transportation (DOT)

Affected Area: Campus Development

Comments Due: 8/12/2022

Unmanned Aircraft Systems Beyond Visual Line of Sight Aviation Rulemaking Committee Final Report; Notice of Public Meeting

This action announces a public meeting of the UAS Beyond Visual Line of Sight (BVLOS) Aviation Rulemaking Committee (ARC) Final Report.

Federal Agency: Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT)

Affected Area: CERA, UAPD

Notice of Availability of State, Local, and Tribal Allocation Formulas for the Energy Efficiency and Conservation Block Grant Program

The Department of Energy (DOE or the Department) is publishing three allocation formulas that will be used to distribute funds to local governments, states, and Indian tribes through the Energy Efficiency and Conservation Block Grant Program (EECBG Program or Program), as required by the Program’s authorizing legislation, Title V, Subtitle E of the Energy Independence and Security Act of 2007. The purpose of the EECBG Program is to assist eligible entities in implementing strategies to reduce fossil fuel emissions, to reduce total energy use, and to improve energy efficiency. This notice provides the allocation formulas established by the Department to distribute funds to eligible entities.

Federal Agency: Office of Energy Efficiency and Renewable Energy, Department of Energy

Affected Area: Facilities and Grounds, Campus Development

Agency Information Collection Activities; Comment Request; FFEL/Direct Loan/Perkins Military Service Deferment/Post-Active Duty Student Deferment Request

The Military Service/Post-Active Duty Student Deferment request form serves as the means by which a Federal Family Education Loan (FFEL), Perkins, or Direct Loan borrower requests a military service deferment and/or post-active duty student deferment and provides his or her loan holder with the information needed to determine whether the borrower meets the applicable deferment eligibility requirements. The form also serves as the means by which the U.S. Department of Education identifies Direct Loan borrowers who qualify for the Direct Loan Program’s no accrual of interest benefit for active duty service members.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid, Veterans and Military Affairs

Comments Due: 8/29/2022

Agency Information Collection Activity: Yellow Ribbon Program Agreement and Principles of Excellence for Educational Institutions

These forms will be used to satisfy requirements as outlined. VA Form 22-0839, Yellow Ribbon Program Agreement, is sanctioned by Public Law 110-252 which authorized the Department of Veterans Affairs (VA) to administer an education benefit program known as the Post-9/11 GI Bill. Section 3317 of title 38, United States Code, established the Yellow Ribbon G.I. Enhancement Program, referred to as the “Yellow Ribbon Program”. The Yellow Ribbon Program allows institutions of higher Learning (IHLs) to voluntarily enter into an agreement with VA to commit to contributing towards the outstanding amount of tuition and fees not otherwise covered under the Post-9/11 GI Bill. VA will match the contribution made by the IHL not to exceed fifty percent of the total outstanding amount of tuition and fees. IHLs wishing to participate in the Yellow Ribbon Program are required to submit the Yellow Ribbon Program Agreement (VA Form 22-0839) indicating the maximum number of students that can receive this additional benefit under the program, the maximum contribution towards outstanding tuition and fees for each student based on student status (i.e., undergraduate, graduate, doctoral) or sub-element (i.e., college or professional school). Title 38 U.S.C 3317 necessitates this collection of information. VA Form 22-10275, Principles of Excellence for Educational Institution is authorized by Executive Order 13607. Participating schools commit to voluntarily follow the guidelines outlined in Executive Order 13607 intended to promote transparency and student success. Currently, the VA Form 22-0839 includes the Principles of Excellence (POE) application, but because only degree granting schools can participate in the Yellow Ribbon Program, non-degree granting schools are disadvantaged. Further the Yellow Ribbon Program Participation is only solicited during an annual `open season’ from March to May, POE participation is further restricted. VA Form 22-10275 will be made available year-round. Executive Order 13607 necessitates this collection of information.

Federal Agency: Veterans Benefits Administration, Department of Veterans Affairs

Affected Area: Office of Veterans Affairs

Comments Due: 8/29/2022

Information Collection; Federal Acquisition Regulation Part 46 Requirements

DoD, GSA, and NASA are combining OMB Control Nos. for the Federal Acquisition Regulation (FAR) by FAR part. This consolidation is expected to improve industry’s ability to easily and efficiently identify burdens associated with a given FAR part. The review of the information collections by FAR part allows improved oversight to ensure there is no redundant or unaccounted for burden placed on industry. Lastly, combining information collections in a given FAR part is also expected to reduce the administrative burden associated with processing multiple information collections.

Federal Agency: Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA)

Affected Area: Procurement, ORED, OSP

Comments Due: 9/6/2022

Submission for OMB Review; Bid Guarantees, Performance and Payment Bonds, and Alternative Payment Protection

This justification supports an extension of the expiration date of OMB Control No. 9000-0045. This clearance covers the information that offerors or contractors must submit to comply with the following Federal Acquisition Regulation (FAR) requirements:

Federal Agency: Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA)

Affected Area: Procurement, ORED, OSP

Comments Due: 8/5/2022

Free Application for Federal Student Aid (FAFSA®) Information to be Verified for the 2023-2024 Award Year

For each award year, the Secretary publishes in the Federal Register a notice announcing the FAFSA information that an institution and an applicant may be required to verify, as well as the acceptable documentation for verifying FAFSA information. This is the notice for the 2023-2024 award year, Assistance Listing Numbers 84.007, 84.033, 84.063, and 84.268.

Federal Agency: Office of Postsecondary Education, Department of Education

Affected Area: Student Financial Aid

2022-2023 Award Year Deadline Dates for Reports and Other Records… Correction

On June 1, 2022, the Department of Education (Department) published in the Federal Register

a notice announcing the 2022-2023 Award Year deadline dates for reports and other records associated with the Free Application for Federal Student Aid (FAFSA), the Federal Supplemental Educational Opportunity Grant Program (FSEOG) Program, the Federal Work-Study (FWS) Program, the Federal Pell Grant (Pell Grant) Program, the William D. Ford Federal Direct Loan (Direct Loan) Program, the Teacher Education Assistance for College and Higher Education (TEACH) Grant Program, and the Iraq and Afghanistan Service Grant Program (Deadline Dates notice). We correct the Deadline Dates notice by removing references to the Federal verification requirement of high school completion status. All other information in the Deadline Dates notice remains the same.

Federal Agency: Office of Federal Student Aid, Department of Education

Affected Area: Student Financial Aid

Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Campus Equity in Athletics Disclosure Act (EADA) Survey

The collection of information is necessary under section 485 of the Higher Education Act of 1965, as amended, with the goal of increasing transparency surrounding college athletics for students, prospective students, parents, employees and the general public. The survey is a collection tool to compile the annual data on college athletics. The data is collected from the individual institutions by ED and is made available to the public through the Equity in Athletics Data Analysis Cutting Tool as well as the College Navigator.

Federal Agency: Office of Postsecondary Education (OPE), Department of Education (ED)

Affected Area: Athletics

Comments Due: 8/12/2022

Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Application for Approval To Participate in Federal Student Aid Programs

Section 487(c) of the Higher Education Act (HEA) of 1965, as amended, requires that the Secretary of Education prescribe regulations to ensure that any funds postsecondary institutions receive under the HEA are used solely for the purposes specified in and in accordance with the provision of the applicable programs. The concept of this federal gatekeeping has a long history, originating in 1952. Part H, Subpart 3, Section 498 of the HEA of 1965, as amended, gives the Secretary the responsibility for determining qualifications of institutions of higher education to participate in programs under the HEA. To comply with this requirement Section 498(b) of the HEA specified that the Secretary prepare and prescribe a single application form. The Department of Education (the Department) developed the Application for Approval to Participate in the Federal Student Financial Aid Programs to comply with the statutory requirements of collecting necessary information under the HEA. An institution must use this Application to apply for approval to be determined to be eligible and if the institution wishes, to participate; to expand its eligibility; or to continue to participate in the Title IV programs. An institution must also use the Application to report certain required data as part of its recordkeeping requirements contained in the regulations under 34 CFR part 600 (Institutional Eligibility under the Higher Education Act of 1965, as amended). The Department uses the information reported on the Application in its determination of whether an institution meets the statutory and regulatory requirements. This request is for a revision of the current information collection. The Department is transitioning the current Application to an electronic webform housed within the FSA Partner Connect system (fsapartners.ed.gov).

Comments Due: 8/15/2022

Agency Information Collection Activities: Extension, Without Change, of a Currently Approved Collection: Notice to Student or Exchange Visitor

In accordance with the Paperwork Reductions Act (PRA) of 1995 the Department of Homeland Security (DHS), U.S. Immigration and Customs Enforcement (ICE) will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance. This information collection was previously published in the Federal Register on April 28, 2022, allowing for a 60-day comment period. The activity was labeled as a revision however ICE is not modifying the existing form or information received. The purpose of this notice is to allow an additional 30 days for public comments.

Federal Agency: U.S. Immigration and Customs Enforcement, Department of Homeland Security

Affected Area: Admissions, Capstone International

Comments Due: 8/17/2022

Items of Interest

US lawmakers unveil bipartisan American Data Privacy and Protection Act

Members of U.S. Congress appear to be full-steam ahead in their pursuit of finalizing comprehensive federal privacy legislation by year’s end. A day after revelations of a draft bill circulating, a bipartisan group of lawmakers published a discussion draft for the proposed American Data Privacy and Protection Act for full public consumption. The proposal has three thresholds for covered entities based on the size of a given business. There are provisions for enhanced children’s protections, limits on targeted advertising, preemption over facets of state laws, and a limited private right of action. The draft also proposes a chief privacy officer requirement and other organizational requirements related to data minimization and scaled-back data practices.

After Confucius Institutes China’s Enduring Influence on American Higher Education

In the last four years, Confucius Institutes have rapidly closed down across the United States. Amid pressure from the FBI, the Department of State, Congress, and state legislatures, colleges and universities have terminated their agreements for these Chinese language and culture centers sponsored by the Chinese government. Of 118 Confucius Institutes that once existed in the United States, 104 have closed or are in the process of doing so. The demise of Confucius Institutes (CIs), one of China’s most strategic beachheads in American higher education, has not deterred the Chinese government from seeking alternative means of influencing American colleges and universities. It has used an all-of-the-above approach to protecting its spheres of influence on American higher education, ranging from full-throated defenses of Confucius Institutes to threats. Among its most successful tactics, however, has been the effort to rebrand Confucius Institute-like programs under other names.

Bill to Create Biden’s Biomedical Agency Wins House Passage

House passage of legislation to shepherd biomedical breakthroughs through a new agency marks a critical step in shaping how the government entity will direct billions in health spending. The bill (H.R. 5585), which the House passed Wednesday on a 336-85 vote, would establish the Advanced Research Projects Agency for Health—modeled after a Pentagon entity for developing national security technologies. ARPA-H would fund applied research with short-term teams to solve major challenges, such as a vaccine to prevent most cancers.

U.S. universities fight Senate innovation bill targeting foreign gifts to faculty

The shape of U.S. research is at stake as Congress tries to reconcile competing versions of a massive bill, 2 years in the making, aimed at bolstering U.S. competitiveness with China in research and high-tech manufacturing.

The bills would not only authorize spending hundreds of billions of additional dollars on research, but also set out new policies on the government’s approach to supporting science. One controversial provision in the Senate version, the U.S. Innovation and Competition Act (USICA), would change how the National Science Foundation and the Department of Energy’s science office distribute their research dollars by geographic region.

New Rules on Title IX

The Biden administration released a proposed Title IX rule Thursday featuring major overhauls to how colleges should respond to cases of sexual assault. The proposed rule also expands protections for LGBTQ students. Title IX of the Education Amendments of 1972 is the law that protects students, faculty and staff from sex-based discrimination at education programs that receive federal aid. The proposed rule prohibits discrimination based on sexual orientation and gender identity, in addition to sex, on college campuses for the first time in history. That protection is expected to be attacked by many. During the Obama administration, LGBTQ students were protected under Title IX, but that was never added to the regulations. The proposed rule also eliminates many of the Trump administration’s requirements for investigations of cases of discrimination, including cross-examination of witnesses, which many critics of the 2020 regulations said imposed burdens on victims of harassment. It also gives colleges more flexibility to develop their own grievance procedures and policies.

Industrial Technology Innovation Advisory Committee

In accordance with the Federal Advisory Committee Act, the U.S. Department of Energy (DOE) is soliciting nomination for candidates to the Industrial Technology Innovation Advisory Committee (Committee).

Comments Due: 8/1/2022

50th Anniversary of the Federal Pell Grant Program

For 50 years, the Federal Pell Grant program has been the cornerstone of our Nation’s efforts to create a financial pathway for tens of millions of low- and middle-income students to attend college. Established by the Congress in 1972 and named after former United States Senator from Rhode Island Claiborne Pell, a champion of higher education with whom I served in the United States Senate, Pell Grants are awarded to students based exclusively on their financial need. Since the program’s creation, Pell Grants have helped more than 80 million students attend college and pursue their dreams. Today, Pell Grants form the foundation of many students’ financial assistance packages—especially for students of color. As the single largest source of grants for postsecondary education, Pell Grants were awarded to more than one-third of undergraduate students last academic year. On this 50th anniversary, our Nation pays tribute to the importance of Federal Pell Grants and the opportunities they afford millions of students across our Nation. Today, let us recommit to expanding access to quality education so that all of our citizens are empowered to achieve their professional goals and contribute to the success and prosperity of America.

COGR Submits Comment Letter to NIH on the Draft Supplemental Information for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data notice (hereafter “NOT-OD-22-131

COGR members appreciate the importance of data sharing to scientific advancement, as well as the need to provide appropriate protections for the data that is being shared, particularly with respect to guarding the privacy and confidentiality of human research participants. COGR appreciates NIH’s development of the draft operational principles, best practices, and points to consider outlined in NOT-OD-22-131, and below we provide our comments on these items for NIH’s consideration. In our comments, we include, for ready reference, the text of the draft principle, practice, or point for consideration, but with footnotes omitted.

U.S. Plans to Help Universities Protect Security of Research

The U.S. Department of Commerce on Tuesday announced a new effort aimed at working with universities to protect potentially sensitive research products from theft by foreign agents. The so-called Academic Outreach Initiative was announced by the Commerce Department’s assistant secretary for export enforcement, Matthew S. Axelrod, in a speech at the annual meeting of the National Association of College and University Attorneys. “The challenges of keeping our academic research environments thriving and our controlled information secure from improper foreign acquisition are significant,” Axelrod said in remarks prepared for delivery at the conference. “That’s why I’m announcing today a new Export Enforcement initiative to help academic research institutions protect themselves from these threats.” By working more closely with universities that conduct research with potential national security implications, the federal government “will empower colleges and universities to prevent unauthorized exports, including releases of controlled technology, and to make informed judgments about their future and ongoing partnerships with foreign universities and companies,” Axelrod said in remarks prepared for delivery at the conference.

Foreign Influence in NIH Research Gets Lawmakers’ Attention

https://news.bloomberglaw.com/pharma-and-life-sciences/foreign-influence-in-nih-research-gets-lawmakers-attention

Foreign interference in NIH-funded research remains a pervasive challenge, but some higher education advocates are cautioning that the latest legislative proposals could cause more headaches and compliance pitfalls for research institutions if the disclosure requirements are inconsistent across the government.

Diversity Push for Clinical Trials Prompts House Panel Look

Clinical trial diversity is garnering more attention from lawmakers as they seek to resolve a longstanding deficiency amid a larger national focus on health equity. The House Energy and Commerce Committee’s health panel Wednesday will consider a bill (H.R. 7845) that would require researchers to submit “clear and measurable goals” in their grant applications to recruit and retain clinical trial participants who reflect the race, ethnicity, age, and sex of the patient or general US population. The bill would apply to clinical trials funded by the National Institutes of Health.

Evolving Research Tech Spurs Plan to Revamp Integrity Rules

Research misconduct regulations at the HHS will undergo their first makeover under a plan by the Biden administration to account for changes in technology. Administered by the Health and Human Services Office of Research Integrity, the regulations define research misconduct as making up data, tampering with existing data, or plagiarism.

US Restricts Science Collaborations with Russia

The U.S. is sunsetting research collaborations with Russia in response to its war against Ukraine, joining a coalition of countries that have already moved to restrict ties with research institutions affiliated with the Russian government. The White House Office of Science and Technology Policy announced on June 11 that the U.S. will “wind down” research collaborations with Russia in response to its invasion of Ukraine. The policy applies to federally funded projects involving research institutions and individuals affiliated with the Russian government, and it permits non-government organizations in the U.S. to make their own decisions on whether to continue collaborations.

What Biden’s Title IX Rules Mean for Due Process

The long-awaited proposals for new Title IX regulations under the Biden administration were released last week, to mixed reactions. The proposals include changes to the way colleges investigate sexual assault, which has sparked concern and condemnation from civil liberties advocates. Some critics believe that changing the process for sexual assault investigations will roll back due process rights for the accused, returning higher education to a climate that allegedly favored the rights of accusers, which prompted a flurry of lawsuits from alleged perpetrators in recent years. Supporters of the changes argue that Biden’s Title IX regulations reverse rules established by the Trump administration that have silenced accusers and made victims less likely to come forward.

Do Colleges Need a Chief Data Officer?

Universities today recognize the importance of having access to meaningful, quality data. In fact, there is often an overabundance of data, with many departments equipped with specialized technology platforms to manage and report on their discrete programs and functions. The current world health crisis has served to emphasize how critical this capability is, as leaders have been thrust into a position of continuously modeling a variety of health-related, personnel-related and finance-related scenarios in real time. No institution has been immune from the ripple effects of the pandemic, but those who lack data-driven insights are at risk of more scrutiny. As an example, understanding how changes in the program portfolio make an impact on enrollment and research growth provides a line of sight well ahead of siloed analytics efforts.

Children’s Health Protection Advisory Committee

The U.S. Environmental Protection Agency (EPA) invites nominations from a range of qualified candidates for consideration for appointment to its Children’s Health Protection Advisory Committee (CHPAC). EPA anticipates filling vacancies by March 1, 2023.

Comments Due: 8/15/2022

Technical Mapping Advisory Council

The Federal Emergency Management Agency (FEMA) is requesting qualified individuals interested in serving on the Technical Mapping Advisory Council (TMAC) apply for appointment. As established in the Biggert-Waters Flood Insurance Reform Act of 2012, the TMAC makes recommendations to the FEMA Administrator on how to improve, in a cost-effective manner, the accuracy, general quality, ease of use, and distribution and dissemination of Flood Insurance Rate Maps (FIRMs) and risk data; and to define performance metrics and milestones required to effectively and efficiently map flood risk areas in the United States. The appointments are for 3 years each and applicants will be considered for four vacancies on the TMAC.

Comments Due: 8/8/2022

ED to Publish Proposed Regulations for Borrower Defense, PSLF, and More Targeted Relief Programs

The Department of Education (ED) on Wednesday announced that it will be publishing a highly anticipated Notice of Proposed Rulemaking (NPRM) on a number of regulations, including borrower defense, the Public Service Loan Forgiveness (PSLF) program, interest capitalization, total permanent disability discharges, closed school discharges, and false certification.

Higher Ed Funding Package Advanced by House Committee

The House Appropriations Committee approved a funding plan on June 30 that would increase funding for the Education Department by 13 percent for fiscal year 2023. The bill, approved by the committee in a vote of 32 to 24 along party lines, would allocate over $3.9 billion for higher education, a $968 million increase from fiscal year 2022, and $24.6 billion for federal student aid programs, a $59 million increase. The budget plan would set the stage to fulfill Biden’s proposal to expand the maximum Pell Grant by $2,175 to $8,670. It does this by providing an additional $500 increase to the discretionary funding for Pell Grant, the only portion of the funding that is controlled by the Appropriations Committee. In order to reach the president’s goal, the House and Senate must increase mandatory funding through legislation to change the Higher Education Act of 1965.

When should U.S. research be stamped ‘top secret’? NSF asks for a new look at the issue

The U.S. academic community is gearing up for a new effort to convince national policymakers that the benefits of keeping government-funded basic research out in the open—and not stamping it classified—far outweigh any threat to national security from sharing scientific findings. The National Science Foundation (NSF) has asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to hold a workshop on factors affecting the classification of federally funded research. Tentatively scheduled for the fall, the meeting is expected to revisit a Cold War-era policy that sets openness as the gold standard and says any classification of fundamental research should be kept to a minimum. “Openness is axiomatic for scientists. But its value has not been articulated in a convincing way to the outside community,” says John Mester, CEO of the Universities Research Association, a consortium that runs several government laboratories and research facilities.

Solicitation of Nominations for Appointment to the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC)

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the BSC, NCIPC. The BSC, NCIPC consists of 18 experts in fields associated with surveillance; basic epidemiologic research; intervention research; and implementation, dissemination, and evaluation of promising and evidence-based strategies for the prevention of injury, violence, and drug abuse. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the Committee’s objectives. Nominees will be selected based on expertise in the fields of pertinent disciplines involved in injury, violence, and drug overdose prevention, including, but not limited to, epidemiology, statistics, trauma surgery, rehabilitation medicine, behavioral science/psychology, health economics, program evaluation, political science, law, criminology, informatics, and other aspects of injury management. Federal employees will not be considered for membership. Members may be invited to serve for up to four-year terms. Selection of members is based on candidates’ qualifications to contribute to the accomplishment of BSC, NCIPC objectives (https://www.cdc.gov/​injury/​bsc/​).

Bills to Address Mental Health, Addiction on Campus Pass House

Two bipartisan bills targeting mental health and substance abuse passed the House. They would create new policies for campuses to carry out evidence-based programs to address the rising mental health crisis.

China: updates on international data transfers

Recent weeks have seen a flurry of activity in China’s regulation of international data transfers. Three principal data laws, the Cyber Security Law (“CSL”), the Data Security Law (“DSL”) and the Personal Information Protection Law (“PIPL”) regulate different aspects of the collection, use and transfer of data in China. One of the key areas of concern, for multi-national businesses in particular, is the treatment of international transfers from China. Since the introduction of the CSL, there have been ongoing concerns that personal data (and non-personal data considered “important”) would be localized to China, or at least subject to challenging regulatory restrictions that make international transfers difficult or practically impossible to implement. These concerns failed to fully materialize in the wake of the implementation of the CSL in June 2017, but the introduction of the DSL and PIPL in September and November 2021, respectively, has rekindled these concerns.

Federal Judge Blocks Title IX Guidance on Transgender Students

A Tennessee judge on Friday issued a temporary block on the Education Department’s Title IX guidance that prohibits discrimination based on gender identity and sexual orientation.

National Oceanic and Atmospheric Administration, Office of Education, Higher Education Scholarship, Fellowship and Internship Programs

The Administrator of NOAA is authorized by section 4002 of the America COMPETES Act, Public Law 110-69, to establish and administer a Graduate Sciences Program and two undergraduate scholarship programs to enhance understanding of ocean, coastal, Great Lakes, and atmospheric science and stewardship by the general public and other coastal stakeholders, including underrepresented groups in ocean and atmospheric science and policy careers. In addition, NOAA’s Administrator is authorized by section 214 of the Consolidated Appropriations Act, 2005, Public Law 108-447, to establish and administer the Ernest F. Hollings Undergraduate Scholarship Program to support undergraduate studies in oceanic and atmospheric science, research, technology, and education that support NOAA’s mission and programs.

National Oceanic and Atmospheric Administration

Solicitation of Nominations for Appointment to the Clinical Laboratory Improvement Advisory Committee (CLIAC)

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the Clinical Laboratory Improvement Advisory Committee (CLIAC). CLIAC, consisting of 20 members including the Chair, represents a diverse membership across laboratory specialties, professional roles (laboratory management, technical specialists, physicians, nurses) and practice settings (academic, clinical, public health), and includes a consumer representative.

Comments Due: 9/30/2022

Compliance Alert – June 2022

Legislative Updates

HB46: This bill establishes the State Seal of Biliteracy program to recognize graduates who have attained a high level of proficiency in speaking, reading, and writing in one or more languages in addition to English, and would provide for the seal to be awarded to the graduate by the State Department of Education, Including American sign language. Passed on 2022-29-03.

HB138: This bill makes supplemental appropriations from the Education Trust Fund totaling $1,283,283,616 to various agencies and entities for the fiscal year ending September 30, 2022; and to amend Section 3B of Act 2021-342 of the 2021 Regular Session, the Education Trust Fund Appropriations Act for the fiscal year ending September 30, 2022, to clarify the 9 intent regarding an appropriation to the Department of Education. Passed on: 2022-04-07. Conference Committee on HB138 2022RS first Substitute Offered.

HB267: Appropriations, supplemental appropriations for fiscal year ending September 30, 2022, from the Education Trust Fund Advancement and Technology Fund to various school systems and colleges and universities, and other entities. Passed on: 2022–04-06 – Delivered to Governor at 1:53 p.m.

HB312: Education and training, divisive concepts, prohibits teaching of the concepts under certain circumstances, allows teaching of the concepts in public institutions of higher education as long as assent to the concept is not compelled. Status: Engrossed on 2022-03-17 – 50% progression. Action: Pending third on day 28 Favorable from Governmental Affairs.

HB307: Education, issuance of professional educator certificate to individuals completing approved alternative teacher preparation programs, Sec. 16-23-3.01 added; Sec. 16-23-3 am’d. Passed on: 2022-03-29 – Delivered to Governor at 3:34 p.m.

HB395: Alcoholic beverage licenses, Hospitality Management Program license created at certain state universities, activities under license authorized. Passed on 2022-04-05 – Forwarded to Governor.

SB313: Colleges and universities, local boards of education, schools prohibited from using public funds to advocate for or against ballot measures. Passed on 2022-04-07 – 100% progression.

HB135: Education budget, appropriations for the support, maintenance, and development of public education. This bill makes appropriations for the support, maintenance and development of public education in Alabama, for debt service, and for capital outlay for the fiscal year ending September 30, 2023. Passed on: 2022-04-06. Forwarded to the Executive Department.

SB15: State Textbook Committee, publishers permitted to provide standards correlation evidence to State Dept. of Education, State Superintendent of Education to convene other instructional materials review committees to review and rate materials and to establish evaluation criteria, Sec. 16-36-73 added; Secs. 16-13B-2, 16-36-60, 16-36-60.1, 16-36-65 am’d. Passed on: 2022-03-03. Assigned Act No. 2022-80.

SB119: Colleges and Universities, Alabama G.I. and Dependents’ Educational Benefit Act, use of scholarship benefits at 2 year or 4 year public or private institutions of higher education physically located in state provided, Sec. 31-6-8 repealed; Secs. 31-6-2, 31-6-2.1, 31-6-3, 31-6-4, 31-6-5, 31-6-6, 31-6-9, 31-6-11, 31-6-12, 31-6-13, 31-6-14, 31-6-15, 31-6-15.1, 31-6-16 am’d.  Passed on 2022-03-01 – Assigned Act No. 2022-91.

Final Rules

Pyridate; Pesticide Tolerances

This regulation establishes tolerances for residues of pyridate in or on lentil, dry, seed and rapeseed subgroup 20A. Belchim Crop Production US Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Agency: Environmental Protection Agency

Affected Area: EHS, Facilities and Grounds

Health and Human Services Grants Regulation

The U.S. District Court for the District of Columbia in Facing Foster Care et al. v. HHS, 21-cv-00308 (DDC Feb. 2, 2021), has postponed the effective date of portions of the final rule making amendments to the Uniform Administrative Requirements promulgated on January 12, 2021. Specifically, the rule amended paragraph (c), which had stated, “It is a public policy requirement of HHS that no person otherwise eligible will be excluded from participation in, denied the benefits of, or subjected to discrimination in the administration of HHS programs and services based on non-merit factors such as age, disability, sex, race, color, national origin, religion, gender identity, or sexual orientation. Recipients must comply with this public policy requirement in the administration of programs supported by HHS awards. The rule amended paragraph (c) to state, “It is a public policy requirement of HHS that no person otherwise eligible will be excluded from participation in, denied the benefits of, or subjected to discrimination in the administration of HHS programs and services, to the extent doing so is prohibited by Federal statute.” Additionally, the rule amended paragraph (d), which had stated, “In accordance with the Supreme Court decisions in United States v. Windsor and in Obergefell v. Hodges, all recipients must treat as valid the marriages of same-sex couples. This does not apply to registered domestic partnerships, civil unions or similar formal relationships recognized under state law as something other than a marriage.” The rule amended paragraph (d) to state, “HHS will follow all applicable Supreme Court decisions in administering its award programs.”

Federal Agency: Department of Health and Human Services

Affected Area: ORED, OSP

Importation of Prescription Drugs Final Rule Questions and Answers; Guidance for Industry: Small Entity Compliance Guide; Availability

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled “Importation of Prescription Drugs Final Rule Questions and Answers.” The guidance is intended to help small entities comply with the final rule entitled “Importation of Prescription Drugs.” The final rule was issued to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada.

Federal Agency: Food and Drug Administration

Affected Area: UMC

Placement of N-Ethylhexedrone, alpha-Pyrrolidinohexanophenone, 4-Methyl-alpha-ethylaminopentiophenone, 4′-Methyl-alpha-pyrrolidinohexiophenone, alpha-Pyrrolidinoheptaphenone, and 4′-Chloro-alpha-pyrrolidinovalerophenone in Schedule I

By this rule, the Drug Enforcement Administration permanently places six synthetic cathinones, as identified in this rule, in schedule I of the Controlled Substances Act. These six substances are currently listed in schedule I pursuant to a temporary scheduling order. As a result of this rule, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess) or propose to handle these six specified controlled substances will continue to apply.

Federal Agency: Drug Enforcement Administration, Department of Justice

Affected Area: UMC, UAPD, ORED, EHS

Schedules of Controlled Substances: Placement of Methoxetamine (MXE) in Schedule I

With the issuance of this final rule, the Drug Enforcement Administration places 2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one (methoxetamine, MXE), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, in schedule I of the Controlled Substances Act to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle, methoxetamine.

Federal Agency: Drug Enforcement Administration, Department of Justice

Affected Area: UMC, UAPD, ORED, EHS

Proposed Rules

Integrating e-Manifest With Hazardous Waste Exports and Other Manifest-Related Reports, PCB Amendments and Technical Corrections; Extension of Comment Period

The Environmental Protection Agency (EPA) is extending the comment period for the proposed rule entitled “Integrating e-Manifest with Hazardous Waste Exports and Other Manifest-related Reports, PCB Amendments and Technical Corrections.” EPA published the proposed rule in the Federal Register on April 1, 2022 (87 FR 19290), and the public comment period was scheduled to end on May 31, 2022. However, EPA has received at least one request for additional time to develop and submit comments on the proposal. In response to the request for additional time, EPA is extending the comment period for an additional 61 days, through August 1, 2022.

Federal Agency: Environmental Protection Agency

Affected Area: EHS

Comments Due: 8/1/2022

Asbestos Part 1: Chrysotile Asbestos; Regulation of Certain Conditions of Use Under Section 6(a) of the Toxic Substances Control Act (TSCA); Extension of Comment Period

EPA proposed a rule under the Toxic Substances Control Act (TSCA) to address the unreasonable risk of injury to health it has identified for conditions of use of chrysotile asbestos following completion of the TSCA Risk Evaluation for Asbestos, Part 1: Chrysotile Asbestos.

Federal Agency: Environmental Protection Agency

Affected Area: EHS

Comments Due: 7/13/2022

Improve Tracking of Workplace Injuries and Illnesses

The Occupational Safety and Health Administration (OSHA) is extending the comment period on the proposed rule on Improve Tracking of Workplace Injuries and Illnesses for an additional 30 days, to June 30, 2022.

Federal Agency: Occupational Safety and Health Administration (OSHA), Labor

Affected Area: EHS, Risk Management

Comments Due: 6/30/2022

Clean Water Act Section 401 Water Quality Certification Improvement Rule

Following a careful reconsideration of the water quality certification rule promulgated in 2020, the Environmental Protection Agency (EPA or the Agency) is publishing for public comment a proposed rule revising and replacing the Agency’s 2020 regulatory requirements for water quality certification under Clean Water Act (CWA) section 401. This proposed rule would update the existing regulations to be more consistent with the statutory text of the 1972 CWA; to clarify, reinforce, and provide a measure of consistency with respect to elements of section 401 certification practice that have evolved over the 50 years since the 1971 Rule was promulgated; and to support an efficient and predictable certification process that is consistent with the water quality protection and cooperative federalism principles central to CWA section 401. This proposal is consistent with the Executive order signed on January 20, 2021, “Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis,” which directed the Agency to review the water quality certification rule EPA promulgated in 2020. The Agency is also proposing conforming amendments to the water quality certification regulations for EPA-issued National Pollutant Discharge Elimination System permits.

Federal Agency: Environmental Protection Agency

Affected Area: EHS, Water Institute

Comments Due: 8/8/2022

International Services Surveys: Renewal of and Changes to BE-120 Benchmark Survey of Transactions in Selected Services and Intellectual Property With Foreign Persons, and Clarifying When BE-140 and BE-180 Benchmark Surveys Are Conducted

This proposed rule would amend regulations of the Department of Commerce’s Bureau of Economic Analysis (BEA) to renew reporting requirements for the BE-120 Benchmark Survey of Transactions in Selected Services and Intellectual Property with Foreign Persons. This proposed rule would also amend the regulations for BEA’s two other international services benchmark surveys, the BE-140 Benchmark Survey of Insurance Transactions by U.S. Insurance Companies with Foreign Persons and the BE-180 Benchmark Survey of Financial Services Transactions between U.S. Financial Services Providers and Foreign Persons, to clarify when the surveys will be conducted.

Federal Agency: Bureau of Economic Analysis, Commerce

Affected Area: Tax Office, ORED

Comments Due: 8/15/2022

Notices

Applications for New Awards; Fund for the Improvement of Postsecondary Education-Open Textbooks Pilot Program

The Open Textbooks Pilot program supports projects at eligible institutions of higher education (IHEs) that create new open textbooks (as defined in this notice) and expand the use of open textbooks and course materials in courses that are part of a degree-granting program, particularly those with high enrollments. Applicants are encouraged to develop projects that demonstrate the greatest potential to achieve the highest level of savings for students through sustainable, expanded use of open educational resources in high-enrollment courses (as defined in this notice) or in programs that prepare individuals for in-demand fields.

Federal Agency: Department of Education

Affected Area: College Bookstore

Comments Due: 7/25/2022

Certain New Chemicals; Receipt and Status Information for April 2022

EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA Section 5, including notice of receipt of a Premanufacture notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. This document covers the period from 04/01/2022 to 04/30/2022.

Federal Agency: Environmental Protection Agency

Affected Area: EHS

Comments Due: 6/24/2022

Agency Information Collection Activities; Submission for OMB Review; Comment Request; Request for a Medical or Religious Exception or Delay to the COVID-19 Vaccination Requirement

Section 2 of Executive Order 14043, Requiring Coronavirus Disease 2019 Vaccination for Federal Employees, mandates that each agency “implement, to the extent consistent with applicable law, a program to require COVID-19 vaccination for all of its Federal employees, with exceptions only as required by law.” The Rehabilitation Act of 1973, as amended, requires federal agencies to provide reasonable accommodations to qualified employees with disabilities unless that reasonable accommodation would impose an undue hardship on the employee’s agency. The Department of Labor is proposing to add student volunteers as respondents who may be requesting a medical exception or delay to the COVID-19 vaccination requirement. Additionally, the Department is proposing to add the form, Request for a Religious Exception or Delay to the COVID-19 Vaccination Requirement, to the ICR. This religious exemption form is necessary for DOL to determine legal exemptions to the vaccine requirement from student volunteers under Title VII of the Civil Rights Act of 1964. As student volunteers are not considered to be Federal employees, the Department must account for the burden for student volunteers to complete the form. For additional substantive information about this ICR, see the related notice published in the Federal Register on March 8, 2022 (87 FR 13004).

Federal Agency: Department of Labor

Affected Area: HR, ODS, OAA

Comments Due: 6/27/2022

Temporary Waiver of Buy America Requirements for Construction Materials

As the Biden-Harris Administration implements the historic Bipartisan Infrastructure Law (BIL), we seek to maximize the use of American made products and materials in all federally funded projects while also successfully delivering a wide range of critical infrastructure projects for States, local communities, counties, Tribal nations and farms, factories and businesses across the U.S. In order to deliver projects and meaningful results while ensuring robust adoption of Buy America standards, the U.S. Department of Transportation (“DOT” or “Department”) is establishing a temporary public interest waiver for construction materials for a period of 180 days beginning on May 14, 2022 and expiring on November 10, 2022. DOT is establishing this transitional waiver to prepare for compliance with the new Made in America standards for construction materials. During this time period, DOT expects States, industry, and other partners to begin developing procedures to document compliance. DOT will continue its engagement through the waiver period to help facilitate the creation of robust enforcement and compliance mechanisms and to rapidly encourage domestic sourcing of construction materials for transportation infrastructure improvements.

Federal Agency: Department of Transportation

Affected Area: Campus Development, Procurement

Submission for OMB Review; Certain Federal Acquisition Regulation Part 32 Requirements

DoD, GSA, and NASA are combining OMB Control Nos. for the Federal Acquisition Regulation (FAR) by FAR part. This consolidation is expected to improve industry’s ability to easily and efficiently identify burdens associated with a given FAR part. The review of the information collections by FAR part allows improved oversight to ensure there is no redundant or unaccounted for burden placed on industry. Lastly, combining information collections in a given FAR part is also expected to reduce the administrative burden associated with processing multiple information collections.

Federal Agency: Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA)

Affected Area: Procurement, Contracts & Grants Accounting

Comments Due: 6/27/2022

Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments and for Grants and Cooperative Agreements With Institutions of Higher Education, and Other Nonprofit Organizations

The Department of Transportation (DOT) invites public comments about our intention to request the Office of Management and Budget (OMB) approval for a previously approved information collection. These forms include Application for Federal Assistance (SF-424), Federal Financial Report (SF-425), Request for Advance or Reimbursement (SF-270) and Outlay Report and Request for Reimbursement for Construction Programs (SF-271). We are required to publish this notice in the Federal Registerby the Paperwork Reduction Act of 1995. A Federal Register Notice with a 60-day comment period soliciting comments on the following information collection was published on March 30th, 2022, in the Federal Register. No comments were received.

Federal Agency: Department of Transportation

Affected Area: ORED, OSP, Contracts  and Grants Accounting

Comments Due: 7/5/2022

Agency Information Collection Activities; Construction Standards on Posting Emergency Telephone Numbers and Floor Load Limits

The Department of Labor (DOL) is submitting this Occupational Safety & Health Administration (OSHA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

Federal Agency: Department of Labor

Affected Area: EHS, Space Management, Campus Development

Comments Due: 7/5/2022

Proposed Information Collection Request; Comment Request; Recordkeeping for Institutional Dual Use Research of Concern (iDURC) Policy Compliance (Renewal)

The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), “Recordkeeping for Institutional Dual Use Research of Concern (iDURC) Policy Compliance” (EPA ICR No. 2530.03, OMB Control No. 2080-0082) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through January 1, 2023. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

Federal Agency: Environmental Protection Agency

Affected Area: ORED

Comments Due: 8/1/2022

Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Integrated Postsecondary Education Data System (IPEDS) 2022-23 Through 2024-25

The National Center for Education Statistics (NCES) seeks authorization from OMB to make a change to the Integrated Postsecondary Education Data System (IPEDS) data collection. Current authorization expires August 31, 2022 (OMB# 1850-0582 v.24-29). NCES is requesting a new clearance for the 2022-23, 2023-24, and 2024-25 data collections to enable us to make changes to the IPEDS data collection components, clarify definitions and instructions throughout the components, and to continue the IPEDS collection of postsecondary data over the next three years. IPEDS is a web-based data collection system designed to collect basic data from all postsecondary institutions in the United States and the other jurisdictions. IPEDS enables NCES to report on key dimensions of postsecondary education such as enrollments, degrees and other awards earned, tuition and fees, average net price, student financial aid, graduation rates, student outcomes, revenues and expenditures, faculty salaries, and staff employed. The IPEDS web-based data collection system was implemented in 2000-01. In 2020-21, IPEDS collected data from 6,063 postsecondary institutions in the United States and the other jurisdictions that are eligible to participate in Title IV Federal financial aid programs. All Title IV institutions are required to respond to IPEDS (Section 490 of the Higher Education Amendments of 1992 [Pub. L. 102-325]). IPEDS allows other (non-title IV) institutions to participate on a voluntary basis; approximately 300 non-title IV institutions elect to respond each year. Institution closures and mergers have led to a decrease in the number of institutions in the IPEDS universe over the past few years. Due to these fluctuations, combined with the addition of new institutions, NCES uses rounded estimates for the number of institutions in the respondent burden calculations for the upcoming years (estimated 6,100 Title IV institutions plus 300 non-title IV institutions for a total of 6,400 institutions estimated to submit IPEDS data during the 2022-23 through 2024-25 IPEDS data collections). IPEDS data are available to the public through the College Navigator and IPEDS Data Center websites. This clearance package includes a number of proposed changes to the data collection. As part of the public comment period review, NCES requests that IPEDS data submitters and other stakeholders respond to the directed questions found in Appendix D of this submission.

Federal Agency: Department of Education

Affected Area: OIRA

Comments Due: 7/1/2022

Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; 2023-2024 Free Application for Federal Student Aid (FAFSA)

Section 483, of the Higher Education Act of 1965, as amended (HEA), mandates that the Secretary of Education “. . . shall produce, distribute, and process free of charge common financial reporting forms as described in this subsection to be used for application and reapplication to determine the need and eligibility of a student for financial assistance . . .”. The determination of need and eligibility are for the following Title IV, HEA, federal student financial assistance programs: The Federal Pell Grant Program; the Campus-Based programs (Federal Supplemental Educational Opportunity Grant (FSEOG) and Federal Work-Study (FWS)),; the William D. Ford Federal Direct Loan (Direct Loan) Program; the Teacher Education Assistance for College and Higher Education (TEACH) Grant; the Children of Fallen Heroes Scholarship; and the Iraq and Afghanistan Service Grant.

Federal Agency: Department of Education

Affected Area: Student Financial Aid

Comments Due: 6/30/2022

Agency Information Collection Activity: Authorization To Disclose Personal Information to a Third Party-Education Benefits

VA Form 22-10278 is used to release information in its custody or control in the following circumstances: where the individual identifies the particular information and consents to its use; for the purpose for which it was collected or a consistent purpose (i.e., a purpose which the individual might have reasonably expected). By law, VA must have a claimants or beneficiary’s written permission (an “authorization”) to use or give out claim or benefit information for any purpose that is not contained in VA’s System of Records, 58VA21/22/28 Compensation, Pension, Education and Veteran Readiness and Employment Records—VA. The claimant or beneficiary may revoke the authorization at any time, except if VA has already acted based on the claimant’s permission.

Federal Agency: Department of Veteran’s Affairs

Affected Area: Office of Veteran Affairs

Comments Due: 8/5/2022

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drug Applications and Veterinary Master Files

This information collection supports implementation of section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b), which governs new animal drugs. Agency regulations in 21 CFR part 514 and associated regulations in 21 CFR part 558, establish format and content requirements regarding new animal drug application (NADA) submissions, as well as provide for preapplication submissions, amended applications, and application supplements. This information collection also supports implementation of section 571 of the FD&C Act (21 U.S.C. 360ccc) regarding application for conditional approval of new animal drug (CNADA) submissions. As set forth in the FD&C Act and Agency regulations, requisite elements include safety and effectiveness data, proposed labeling, product manufacturing information, and, where necessary, complete information on food safety (including microbial food safety) and any methods used to determine residues of drug chemicals in edible tissue from food producing animals. Applications must be prepared as appropriate to support the particular submission. Respondents to the information collection are persons developing, manufacturing, and/or researching new animal drugs.

Federal Agency: Food and Drug Administration, Health and Human Services (HHS)

Affected Area: ORED, Animal Care

Comments Due: 7/8/2022

Agency Information Collection Activities: Information Collection Renewal; Submission for OMB Review; Identity Theft Red Flags and Address Discrepancies Under the Fair and Accurate Credit Transactions Act of 2003

The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a continuing information collection as required by the Paperwork Reduction Act of 1995 (PRA). An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid OMB control number. The OCC is soliciting comment concerning the renewal of its information collection titled, “Identity Theft Red Flags and Address Discrepancies under the Fair and Accurate Credit Transactions Act of 2003.” The OCC also is giving notice that it has sent the collection to OMB for review.

Federal Agency: Office of the Comptroller of the Currency

Affected Area: CERA

Comments Due: 7/7/2022

Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Toxic Chemical Release Reporting (Revision)

Pursuant to section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), 42 U.S.C. 11001 et seq., certain facilities that manufacture, process, or otherwise use specified toxic chemicals in amounts above reporting threshold levels as provided in 40 CFR 372.25 must submit annually to EPA reporting forms to the Toxics Release Inventory (TRI). The revisions to this ICR covers the information collection activities associated with the submission of information to TRI pursuant to EPCRA section 313(b)(2), 42 U.S.C. 11023. Under EPCRA section 313(b)(2), the EPA Administrator has the authority to extend TRI reporting requirements to specific facilities that manufacture, process, or otherwise use a TRI-listed toxic chemical, but who are not currently covered by TRI reporting requirements as described at 40 CFR 372. The Administrator may determine a specific facility warrants TRI reporting on the basis of a chemical’s toxicity, the facility’s proximity to other facilities that release the chemical or to population centers, the facility’s history of releases of the chemical, or other factors that the Administrator deems appropriate. This ICR revision includes discussion of EPA’s discretionary authority under EPCRA section 313(b)(2) and outreach to potential stakeholders.

Federal Agency: Environmental Protection Agency

Affected Area: EHS

Comments Due: 7/15/2022

Agency Information Collection Activities; Comment Request; Report of Construction Contractor’s Wage Rates

The Department of Labor (the Department) is soliciting comments concerning a proposed revision of the information collection request (ICR) titled “Report of Construction Contractor’s Wage Rates,” which describes the WD-10 form and its use in wage surveys to implement the prevailing wage requirements of the Davis-Bacon and Related Acts. The Department is proposing to revise the WD-10 form and create a new WD-10A pre-survey form that will be used to identify potential respondents to the WD-10. This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA). The PRA process helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. A copy of the proposed information collection request can be obtained by contacting the office listed below in the FOR FURTHER INFORMATION CONTACT section of this Notice.

Federal Agency: Wage and Hour Division, Department of Labor

Affected Area: Campus Development, Procurement

Comments Due: 8/15/2022

Agency Information Collection Activities; Occupational Exposure to Hazardous Chemicals in Laboratories

The Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et seq.) authorizes information collection by employers as necessary or appropriate for enforcement of the OSH Act or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain such information with minimum burden upon employers, especially those operating small businesses, and to reduce to the maximum extent feasible unnecessary duplication of effort in obtaining information (29 U.S.C. 657).

Federal Agency: Department of Labor

Affected Area: EHS

Comments Due: 7/14/2022

Agency Information Collection Activities for Prevailing Wage Determination Information Collection

The Department of Labor’s (Department) Employment and Training Administration (ETA) is soliciting comments concerning a proposed revision to the information collection request (ICR) titled “Application for Prevailing Wage Determination” (OMB Control Number 1205-0508), which covers Forms ETA-9141 and ETA-9141 Appendix A, and the accompanying form instructions. This action seeks to incorporate into this ICR the Form ETA-9165, with revisions, which is currently approved under the ICR titled “H-2B Foreign Labor Certification Program” (OMB Control Number 1205-0509). This action proposes minor changes to the Forms ETA-9141, ETA-9141, Appendix A, and ETA-9165, and their accompanying instructions. This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).

Federal Agency: Employment and Training Administration, Department of Labor

Affected Area: HR, OAA, ORED

Comments Due: 8/15/2022

Announcement of Intent To Establish the 2025 Dietary Guidelines Advisory Committee and Solicitation of Nominations for Membership

Section 301 of the National Nutrition Monitoring and Related Research Act of 1990 (7 U.S.C. 5341) requires the Secretaries of HHS and USDA to publish the Dietary Guidelines for Americans (Dietary Guidelines) jointly at least every five years. The law instructs that this publication shall contain nutritional and dietary information and guidelines for the general public, shall be based on the preponderance of scientific and medical knowledge current at the time of publication, and shall be promoted by each federal agency in carrying out any federal food, nutrition, or health program. The current edition of the Dietary Guidelines (2020-2025) provides guidance on the entire life span, from birth to older adulthood, including pregnancy and lactation. The Dietary Guidelines for Americans, 2025-2030 will continue to provide food-based dietary guidance across the entire lifespan to help meet nutrient needs, promote health, and reduce the risk of chronic disease. The 2025 Dietary Guidelines Advisory Committee (Committee) shall be formed and governed under the provisions of the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C., App), which sets forth standards for the formation and use of advisory committees. The Committee is established to provide independent, evidence-based advice and recommendations to be considered by HHS and USDA in the Departments’ development of the Dietary Guidelines for Americans, 2025-2030. The Committee’s review and advice will focus on the scientific questions prioritized by HHS and USDA with the potential to inform nutrition guidance for Americans across the lifespan. Formation of the Committee is necessary to adequately review the science to inform the Dietary Guidelines and is in the public interest.

Federal Agency: U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Health; U.S. Department of Agriculture (USDA), Food, Nutrition, and Consumer Services

Affected Area: OAA, HR

Comments Due: 7/15/2022

Antimicrobial Drug Use in Companion Animals; Extension of Comment Period

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice that appeared in the Federal Register of February 16, 2022. In that notice, FDA requested comments on antimicrobial drug use practices in companion animals and the potential impacts of such uses on antimicrobial resistance in both humans and animals. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

Federal Agency: Food and Drug Administration, HHS

Affected Area: ORED

Comments Due: 9/14/2022

Agency Information Collection Activities; Comment Request; Federal Perkins Loan Program Regulations

The requirements of these regulations is necessary to monitor a school’s due diligence in its contact with the Perkins loan borrower regarding repayment, billing and collections, reimbursement to its Perkins loan revolving fund, rehabilitation of defaulted loans as well as institutions use of third party collections. There has been no change to the regulations. This is a request for an extension without change of the currently approved reporting and record-keeping requirements contained in the regulations related to the administrative requirements of the Perkins Loan Program. Due to the effects of the COVID-19 pandemic the Department lacks sufficient data to allow for more accurate updates to the burden estimates.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid

Comments Due: 8/15/2022

Agency Information Collection Activities; Comment Request; Federal Family Education Loan (FFEL) Program Secured Overnight Financing Rate (SOFR) Election Form

The Department of Education (ED) is requesting approval of a new information collection for the FFEL Program SOFR Election form. On March 15, 2022, the President signed the Adjustable Interest Rate (LIBOR) Act into law. Among other things, the law amended section 438(b)(2)(I) of the Higher Education Act of 1965, as amended (HEA). This provision of the law requires FFEL Program lenders or an entity that holds a beneficial ownership interest in a FFEL Program loan (beneficial holder) to transition away from LIBOR based Special Allowance Payments (SAP) to a new formula set by the law based on Secured Overnight Financing Rate (SOFR). The transition may occur any time on or before June 30, 2023. However, a FFEL Program lender or beneficial holder must transition to the SOFR based SAP calculation by July 1, 2023, as a condition of continued participation in FFEL Program.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid

Comments Due: 8/15/2022

Agency Information Collection Activities; Comment Request; FAFSA Form Demographic Survey

The U.S. Department of Education (the Department) is requesting a new information collection to gather demographic information in conjunction with the Free Application for Federal Student Aid (FAFSA) form. The FAFSA Simplification Act (FSAct) passed as part of the Consolidated Appropriations Act, 2021 (Pub. L. 116-260) amends the Higher Education Act of 1965, Title IV, Sec 483 (B)(ii)(VII) to add sex and race or ethnicity as information required to be provided by the applicant on the Free Application for Federal Student Aid (FAFSA) form. For the launch of the 2023-24 FAFSA on October 1, 2022, FSA will ask the demographic questions in a pilot, voluntary survey format in order to collect specific feedback on the new questions. This feedback will inform the development of the questions for full implementation within the FAFSA form for the 2024-2025 award year.

Federal Agency: Department of Education

Affected Area: Student Financial Aid

Comments Due: 8/12/2022

Items of Interest

Request for Public Nominations of Experts To Review the New Chemicals Collaborative Research Program

The U.S. Environmental Protection Agency (EPA) is seeking nominations for technical experts to serve as Special Government Employees (SGEs) to participate in the review of the New Chemicals Collaborative Research Program with the Board of Scientific Counselors (BOSC), a federal advisory committee to the Office of Research and Development (ORD). Submission of nominations will be made via the BOSC website at: https://www.epa.gov/​bosc.

Comments Due: 6/30/2022

NIH Seeking Input on Privacy When Research Data Is Shared

The National Institutes of Health (NIH) is requesting public comment on how best to protect the privacy of participants when federally funded research data is shared. NIH is seeking input on draft supplemental information to the NIH Data Management and Sharing (DMS) policy to address privacy.

Tackling the Challenges of Our Time Requires All of Us to Be at the Table’

“America’s science and technology ecosystem … must be a place of learning and curiosity, a place of research and development, a place of opportunity and innovation, and a place of constantly developing pathways for more people to be included,” she added. “But most of all, it must be cultivated such that all people can thrive.” To improve equity, she said, “We need to invite contributions from individuals and communities who have been historically excluded from federal decision-making, and include them in America’s science and technology ecosystem.”

Blind Review Is Blind to Discrimination

The blind peer-review process has long been a hallmark of academic research. Blind review ensures that research is evaluated based on the merits of the work, not the individuals who did the work. In theory, this results in better-quality research and mitigates the impacts of bias and gatekeeping in academic publishing. In reality, however, blind review can facilitate the perpetuation of institutional discrimination by turning a blind eye to the identities of those whose work is disseminated and the agendas of their institutions. It is time for academia to rethink the consequences of blind review and create processes to evaluate research that promote the sharing of high-quality work without the unintended consequence of reinforcing legacies of harm.

Patent and Trademark Public Advisory Committees

The United States Patent and Trademark Office (USPTO)—America’s Innovation Agency—is seeking nominations for up to three members of its Patent Public Advisory Committee (PPAC) to advise the Director of the USPTO on patent policy and for up to three members of its Trademark Public Advisory Committee (TPAC) to advise the Director on trademark policy. Each new member, who can serve remotely, will serve a three-year term. The members represent the interests of the public and the stakeholders of the USPTO.

Comments Due: 7/1/2022

Call for Review Editor Nominations for the Fifth National Climate Assessment (NCA5)

This notice seeks nominations for NCA5 Review Editors with pertinent subject matter expertise and scientific background. The Review Editor serves a critical role on the NCA, ensuring that each public and peer review comment has been considered by the author team. Review Editors do not provide additional comments on assigned draft chapters; rather they attest that the annotation is sufficiently responsive to the comment and indicates any revision made to the chapter(s), including the scientific or logical rationale for said action.

Securing the data ecosystem

Organizations are often pressured to choose how to prioritize what is essential in terms of data management. Equally as often, they make rash decisions to comply with industry and regulatory standards. Some prioritize concern with cybersecurity threats and data leaks rather than cost efficiency. Many do not know that data management can protect against cyberattacks while being cost-effective. The growth of big data in the digital world is extraordinary. Developing an efficient data management strategy is key to securing your organization’s data ecosystem.

Solicitation of Nominations for Appointment to the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT)

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT). The CHACHSPT consists of 18 experts in fields associated with public health; epidemiology; laboratory practice; immunology; infectious diseases; drug abuse; behavioral science; health education; healthcare delivery; state health programs; clinical care; preventive health; medical education; health services and clinical research; and healthcare financing, who are selected by the Secretary of the U.S. Department of Health and Human Services (HHS).

2022-2023 Award Year Deadline Dates for Reports and Other Records Associated with the Free Application for Federal Student Aid (FAFSA)

The Secretary announces deadline dates for the receipt of documents and other information from applicants and institutions participating in certain Federal student aid programs authorized under title IV of the Higher Education Act of 1965, as amended (HEA), for the 2022-2023 award year. These programs, administered by the Department of Education (Department), provide financial assistance to students attending eligible postsecondary educational institutions to help them pay their educational costs. The Federal student aid programs (title IV, HEA programs) covered by this deadline date notice are the Pell Grant, Direct Loan, TEACH Grant, Iraq and Afghanistan Service Grant, and campus-based (FSEOG and FWS) programs. Assistance Listing Numbers: 84.007 FSEOG Program; 84.033 FWS Program; 84.063 Pell Grant Program; 84.268 Direct Loan Program; 84.379 TEACH Grant Program; 84.408 Iraq and Afghanistan Service Grant Program.

A Gift or a Burden?

Every year, the Department of Education sends a checklist to colleges and universities reminding them of the various federal laws and regulations they have to comply with, including environmental standards, Title IX and FERPA, the Family Educational Rights and Privacy Act. For many years, that checklist did not mention any reporting requirements for foreign gifts and contracts. As a result, many higher education institutions were caught off guard in 2019 when the department began launching investigations of colleges and universities for noncompliance with the regulations. Now, three years later, lawmakers are attempting to strengthen and clarify the reporting mandates for donations that come from abroad. The Bipartisan Innovation Act, versions of which passed the House and Senate this spring, is meant to boost America’s competitiveness in the global economy, but it also includes language that would beef up foreign donation transparency laws for higher education institutions. The law would require individual faculty and staff members to report gifts from foreign entities and lower the current reporting threshold for institutions from $250,000 per gift to $50,000. President Biden has promised to sign the bill once the House and the Senate hash out their differences.

DOJ Revises CFAA Charging Policy to Provide Clarity for Cybersecurity Research and Terms of Use

On May 19, 2022, the Department of Justice (DOJ) issued revisions to its existing policy for charging offenses under the Computer Fraud and Abuse Act (CFAA) (2022 CFAA Policy). The revisions state that “good-faith” security research will not be charged as a criminal CFAA violation. Comments accompanying the revised policy statement also highlight the importance of technical barriers—in addition to contractual limits—to determinations of when access exceeds authorization. Although the announcement regarding security research made a splash in the press, it is unclear to what degree the policy represents a change in how DOJ will approach cases. Nor can security researchers rely on the guidance for concrete assurances against liability, because the policy revision has no effect on civil CFAA liability or state laws that provide for criminal or civil liability for unauthorized access to computer systems. The revision may also introduce uncertainty for system owners, who may be left wondering how the new policy will be applied, and how federal law enforcement will react to conduct viewed by some as good-faith research and by others as in a gray area.

 

Final priority-State Personnel Development Grants

The Department of Education (Department) announces a priority under the State Personnel Development Grants (SPDG), Assistance Listing Number 84.323A. The Department may use the priority for competitions in fiscal year (FY) 2022 and later years. We take this action to focus attention on the need to improve results for children with disabilities and their families by supporting a comprehensive system of personnel development (CSPD) for the Individuals with Disabilities Education Act (IDEA) Part C Grants for Infants and Families program.

DataWorks! Prize – Incentives for building a culture of data sharing and reuse

A $500,000 prize purse, rewarding data sharing and reuse in biomedical research, is a new, innovative strategy for supporting the research community. The DataWorks! Prize highlights the role of data sharing and reuse in scientific discovery while recognizing and rewarding researchers who engage in these practices. This prize, which launched on May 11, 2022, is a partnership between the NIH Office of Data Science Strategy and the Federation of American Societies for Experimental Biology (FASEB). The future of biological and biomedical research hinges on researchers’ ability to share and reuse data. Sharing and reuse had a sizable, catalytic impact on the development of COVID-19 vaccines and treatment protocols. The DataWorks! Prize is an opportunity for the research community to share their stories about the practices, big and small, that lead to scientific discovery.

Taking on ‘U.S. News’?

Since 1970, the Carnegie Classification system has helped make sense of the diversity of institutions that make up higher education in the U.S., grouping them based on the degrees they offer, their size and the research productivity of their faculty, among other measures. Earlier this year, the Carnegie Foundation and the American Council on Education announced that they would partner on the classifications and specifically described the need for the “Carnegie Classification system to reflect the nation’s pressing social, racial, and economic concerns and challenge higher education institutions and their public, social, and commercial sector partners to meaningfully address them.”

Researchers criticize Senate plan to steer more NSF funding to ‘have not’ states

Top research universities in just a handful of U.S. states conduct the majority of research funded by the National Science Foundation (NSF), while institutions in half the country receive only crumbs. The U.S. Senate wants NSF to correct that longstanding geographic imbalance. But its solution—to immediately allocate 20% of NSF’s budget to what is currently a small program serving those have-not states—is drawing fierce opposition from many universities and nearly 100 members of Congress.

Effective Biomedical Public-Private Partnerships Are About Innovation, Not Lower Drug Prices

There is fascination of late with the prospect of exercising Bayh-Dole Act “march-in rights,” primarily as a means of reducing the price of expensive drugs that have been discovered or developed with federal funds. In recently published pieces in Health Affairs Forefront and elsewhere, some contend that the intended public health benefits of biomedical public-private partnerships will be realized only if the drug prices paid by consumers are reduced prior to patent expiry.

AAU Sends Letter Expressing Concern Over Section 124 Reporting Requirements in USICA

AAU President Barbara R. Snyder sent a letter to the leadership of the House and Senate Education and Labor Committees expressing concern “with the potential adverse consequences of the new Higher Education Act (HEA) Section 124 reporting requirement created by Section 6124(b) of S. 1260, the U.S. Innovation and Competition Act (USICA).” The provision mandates university personnel to report any gifts from, or contracts with, any foreign source and requires the establishment of a new searchable database containing information about engagements with foreign scholars or entities.

A focus groups study on data sharing and research data management

Data sharing can accelerate scientific discovery while increasing return on investment beyond the researcher or group that produced them. Data repositories enable data sharing and preservation over the long term, but little is known about scientists’ perceptions of them and their perspectives on data management and sharing practices. Using focus groups with scientists from five disciplines (atmospheric and earth science, computer science, chemistry, ecology, and neuroscience), we asked questions about data management to lead into a discussion of what features they think are necessary to include in data repository systems and services to help them implement the data sharing and preservation parts of their data management plans. Participants identified metadata quality control and training as problem areas in data management. Additionally, participants discussed several desired repository features, including: metadata control, data traceability, security, stable infrastructure, and data use restrictions. We present their desired repository features as a rubric for the research community to encourage repository utilization. Future directions for research are discussed.

Request for Applicants for Appointment to the Surface Transportation Security Advisory Committee

The Transportation Security Administration (TSA) is requesting applications from individuals who are interested in being appointed to serve on the Surface Transportation Security Advisory Committee (STSAC). All applicants must represent one of the constituencies specified below in order to be eligible for appointment. STSAC’s mission is to provide advice, consultation, and recommendations to the TSA Administrator on improving surface transportation security matters, including developing, refining, and implementing policies, programs, initiatives, rulemakings, and security directives pertaining to surface transportation security, while adhering to sensitive security guidelines. The STSAC will consider risk-based approaches in the performance of its duties.

Comments Due: 7/18/2022

Voluntary Resolution Agreement Between the U.S. Department of Health and Human Services Office for Civil Rights and the University of Southern California

This Voluntary Resolution Agreement (“Agreement”) is entered into by the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS OCR”) and the University of Southern California (“USC”) and its medical enterprise, Keck Medicine of USC (“KMUSC”). The health care components of USC and KMUSC (hereinafter collectively referred to as “the KMUSC Entities”), are set forth in Appendix A, attached hereto and incorporated by reference. HHS OCR and the KMUSC Entities shall together be referred to as the “Parties.” The purpose of this Agreement is for KMUSC Entities to affirm their compliance with Title IX of the Education Amendments of 1972, as amended, 20 U.S.C. § 1681 et seq., and its implementing regulation at 45 C.F.R. Part 86 (“Title IX”). The scope of this Agreement is defined by the HHS Title IX implementing regulation, which states that “no person shall, on the basis of sex, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any academic, extracurricular, research, occupational training, or other education program or activityoperated by a recipient which receives Federal financial assistance.” 45 C.F.R. § 86.31(a). HHS OCR initiated a compliance review of KMUSC on June 10, 2019, to assess KMUSC’s compliance with Title IX in its handling of sexual harassment complaints. Pursuant to Title IX, this Agreement between the KMUSC Entities and HHS OCR resolves HHS OCR Transaction No. 18-308562, a compliance review of the KMUSC Entities’ policies and procedures for responding to sex discrimination complaints made by students, employees, or patients employed by, or participating in, any KMUSC programs or activities receiving Federal financial assistance from HHS.

Renewal of the Renewable Energy and Energy Efficiency Advisory Committee and Solicitation of Nominations for Membership

Pursuant to provisions of the Federal Advisory Committee Act, the Department of Commerce announces the renewal of the Renewable Energy and Energy Efficiency Advisory Committee (the Committee). The Committee shall advise the Secretary of Commerce regarding the development and administration of programs and policies to expand the competitiveness of U.S. exports of renewable energy and energy efficiency goods and services. The Committee’s work on renewable energy will focus on technologies, equipment, and services to generate electricity, produce heat, and power vehicles from renewable sources such as solar, wind, biomass, hydropower, geothermal, and hydrogen. The Committee’s work on energy efficiency will focus on technologies, services, and platforms that provide system-level energy efficiency to electricity generation, transmission, and distribution. These include smart grid technologies and services, as well as equipment and systems that increase the resiliency of power infrastructure such as energy storage. Climate solutions in the energy sector, such as low-carbon hydrogen production, clean energy transportation, and virtual power plants are also within the scope of the Committee. For the purposes of this Committee, covered goods and services will not include vehicles, feedstock for biofuels, or energy efficiency as it relates to consumer goods or buildings. Non-fossil fuels that reduce carbon consumption (e.g., liquid biofuels and pellets) are included. This notice also requests nominations for membership.

Comments Due: 7/22/2022

Research must do no harm: new guidance addresses all studies relating to people

Editors, authors and reviewers should together consider and discuss benefits and harms that might emerge from manuscripts dealing with human population groups, and discuss when potential harms warrant revisions. Ethical concerns need to be flagged about research that could fuel hate speech; about potentially denigrating images; about content that could be used to undermine the dignity or rights of a human group; and about content that could cause harm in other ways. Although cases are not always clear cut, if publication risks people being harmed, authors and editors need to consider those risks against any benefits that could arise from publication.

GAO Urges Better Analysis of Universities’ Risk of Foreign Threats

The GAO report relates to the issue of whether foreign governments like China’s are targeting sensitive research information at American universities—efforts that have intensified in recent years. The report focuses on the outreach by the Departments of Commerce and Homeland Security and other agencies to universities to help guard against possible breaches and the extent to which the agencies can target their efforts at the institutions most at risk. The review found that the agencies either don’t take risk into consideration or rate the institutions’ risk on too narrow a set of factors. The report lays out a set of recommendations to improve the information available to the agencies about institutional risk.

Electric Vehicle Working Group

In accordance with the Bipartisan Infrastructure Law (BIL), enacted as the Infrastructure Investment and Jobs Act (IIJA), and the Federal Advisory Committee Act, the U.S. Department of Energy and U.S. Department of Transportation are soliciting nominations for candidates to fill vacancies on the Electric Vehicle Working Group (Working Group).

Comments Due: 7/15/2022

Request for Nominations for a Science Advisory Board Panel on BenMAP and Benefits Methods

The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office is expanding its request for nominations previously announced on April 5, 2022. The EPA SAB Staff Office previously requested nominations of scientific experts to form a panel to review EPA’s new cloud-based Environmental Benefits and Mapping (BenMAP) tool, an open-source computer program that calculates estimated air pollution-related deaths and illnesses and their associated economic values. In that notice, the SAB Staff Office indicated its intention to announce a separate panel that would address the approach EPA takes for selecting and applying evidence in its PM2.5

and Ozone (O3) benefits assessments. Because the two panels would require substantially similar expertise, the SAB Staff Office has now determined that it is appropriate to combine them into a single panel with a more comprehensive charge. The Science Advisory Board Staff Office is soliciting additional candidates to complement those nominated for the review of BenMAP.

Comments Due: 6/27/2022

Tech accountability package: The way to kill privacy legislation

In recent months, the pressure from Congress on tech companies has grown with nebulous, and at times paradoxical, accountability proposals introduced on Capitol Hill. Bills have been proposed to change and regulate the way we protect freedom on the internet, privacy, and platform interoperability and competition.

US lawmakers unveil bipartisan American Data Privacy and Protection Act

Members of U.S. Congress appear to be full-steam ahead in their pursuit of finalizing comprehensive federal privacy legislation by year’s end. A day after revelations of a draft bill circulating, a bipartisan group of lawmakers published a discussion draft for the proposed American Data Privacy and Protection Act for full public consumption. The proposal has three thresholds for covered entities based on the size of a given business. There are provisions for enhanced children’s protections, limits on targeted advertising, preemption over facets of state laws, and a limited private right of action. The draft also proposes a chief privacy officer requirement and other organizational requirements related to data minimization and scaled-back data practices.

Please contact Compliance, Ethics, and Regulatory Affairs with any questions or concerns about compliance with a particular regulation and/or for suggestions to improve the newsletter.

Compliance Alert – May 2022

Legislative Updates

HB46: This bill establishes the State Seal of Biliteracy program to recognize graduates who have attained a high level of proficiency in speaking, reading, and writing in one or more languages in addition to English, and would provide for the seal to be awarded to the graduate by the State Department of Education. Including American sign language. Passed on 2022-29-03.

SB15: State Textbook Committee, publishers permitted to provide standards correlation evidence to State Dept. of Education, State Superintendent of Education to convene other instructional materials review committees to review and rate materials and to establish evaluation criteria, Sec. 16-36-73 added; Secs. 16-13B-2, 16-36-60, 16-36-60.1, 16-36-65 am’d. Passed on: 2022-02-10. Assigned Act No. 2022-80.

SB119: Colleges and Universities, Alabama G.I. and Dependents’ Educational Benefit Act, use of scholarship benefits at 2 year or 4 year public or private institutions of higher education physically located in state provided, Sec. 31-6-8 repealed; Secs. 31-6-2, 31-6-2.1, 31-6-3, 31-6-4, 31-6-5, 31-6-6, 31-6-9, 31-6-11, 31-6-12, 31-6-13, 31-6-14, 31-6-15, 31-6-15.1, 31-6-16 am’d.  Passed on 2022-03-01 – Assigned Act No. 2022-91.

Final Rules

Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, Participation by DBEs in U.S. EPA Programs, State and Local Assistance, Research and Demonstration Grants, National Environmental Education Act Grants

This regulatory action finalizes an interim final rule and revises certain provisions of other Environmental Protection Agency (EPA) financial assistance regulations to make non-substantive technical corrections to the text of the rules. Revisions to these rules are exempt from the notice and comment requirements of the Administrative Procedure Act (APA) because it is a matter relating to agency management concerning grants.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: ORED, OSP, EHS

Proposed Rules

Pesticides; Proposal To Add Chitosan to the List of Active Ingredients Permitted in Exempted Minimum Risk Pesticide Products; Notice of Data Availability on Chitosan and Chitosan Salts

As authorized by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 25(b), the EPA has exempted from the requirement of registration certain pesticide products if they are composed of specified ingredients (recognized active and inert substances which are listed in the regulations) and labeled according to the EPA’s regulations in 40 CFR 152.25(f). The EPA created the exemption for minimum risk pesticides to eliminate the need for the Agency to expend significant resources to regulate products that were deemed to be of minimum risk to human health and the environment. Prior to submission of these aquatic toxicity reports, the EPA received a petition from Tidal Vision Products, LLC, requesting that the substance commonly known as chitosan (also known by its chemical name poly-D-glucosamine) (CAS Reg. No. 9012-76-4) be added to the list of active ingredients allowed in exempted minimum risk pesticide products under 40 CFR 152.25(f)(1). This matter was the subject of a proposed regulation (85 FR 69307) (FRL-10009-24). The EPA is considering the information submitted by Tidal Vision in its decision regarding whether to finalize the proposal to add chitosan to the list of permitted active ingredients, and if so, whether and how to address chitosan salts in the exemption.

Federal Agency: Environmental Protection Agency

Affected Area: EHS, Facilities and Grounds

Comments Due: 6/6/2022

Asbestos; Reporting and Recordkeeping Requirements Under the Toxic Substances Control Act (TSCA)

The Environmental Protection Agency (EPA) is proposing reporting and recordkeeping requirements for asbestos under the Toxic Substances Control Act (TSCA). EPA proposes to require certain persons that manufactured (including imported) or processed asbestos and asbestos-containing articles (including as an impurity) in the four years prior to the date of publication of the final rule to electronically report certain exposure-related information. This action would result in a one-time reporting obligation. EPA emphasizes that this proposed requirement would include asbestos that is a component of a mixture. The information sought includes quantities of asbestos (including asbestos that is a component of a mixture) and asbestos-containing articles that were manufactured (including imported) or processed, types of use, and employee data. Reported information would be used by EPA and other Federal agencies in considering potential future actions, including risk evaluation and risk management activities. EPA is requesting public comment on all aspects of this proposed rule and has also identified items of particular interest for public input.

Federal Agency: Environmental Protection Agency

Affected Area: EHS

Comments Due: 7/5/2022

Air Plan Approval; Alabama; NOX

The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Alabama, through the Alabama Department of Environmental Management (ADEM), in a letter dated October 18, 2021. The revision includes corrections to deficiencies to Alabama’s regulation titled “NOX Budget Program Monitoring and Reporting” (AL NOX SIP Call Monitoring Rule), which EPA previously conditionally approved into the SIP. Specifically, the AL NOX SIP Call Monitoring Rule establishes monitoring and reporting requirements for units subject to the nitrogen oxides (NOX) SIP Call, including alternative monitoring options for certain sources of NOX. EPA is also proposing to convert the conditional approval to a full approval. In addition, EPA is proposing to approve other minor changes into the SIP.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

Comments Due: 6/15/2022

Notices

Forty-First Update of the Federal Agency Hazardous Waste Compliance Docket

Since 1988, the Environmental Protection Agency (EPA) has maintained a Federal Agency Hazardous Waste Compliance Docket (“Docket”) under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). CERCLA requires EPA to establish a Docket that contains certain information reported to EPA by Federal facilities that manage hazardous waste or from which a reportable quantity of hazardous substances has been released. This notice identifies the Federal facilities not previously listed on the Docket and identifies Federal facilities reported to EPA since the last update on October 27, 2021. In addition to the list of additions to the Docket, this notice includes a section with revisions of the previous Docket list and a section of Federal facilities that are to be deleted from the Docket. Thus, the revisions in this update include eleven additions, zero deletions, and zero corrections to the Docket since the previous update.

Federal Agency: Environmental Protection Agency

Affected Area: EHS

 

Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Asbestos (Renewal)

The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Asbestos (40 CFR part 61, subpart M) regulations apply to either the demolition and/or renovation of facilities; the disposal of asbestos waste; asbestos milling, manufacturing and fabricating; the use of asbestos on roadways; asbestos waste converting facilities; and the use of asbestos insulation and sprayed-on materials. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NESHAP.

Federal Agency: Environmental Protection Agency

Affected Area: EHS

Comments Due: 5/25/2022

Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects (Renewal)

EPA is responsible for the regulation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). The EPA regulations at 40 CFR part 26 protect subjects of “third-party” research (i.e., research that is not conducted or sponsored by EPA). In addition to other protections, the regulations require affected entities to submit information to EPA and an institutional review board (IRB) prior to initiating, and to the EPA upon the completion of, certain studies that involve human research participants. The information collection activity consists of activity-driven reporting and recordkeeping requirements for those who intend to conduct research for submission to EPA under the pesticide laws. If such research involves intentional exposure of human subjects, these individuals (respondents) are required to submit study protocols to the EPA and a cognizant local Human Subjects IRB before such research is initiated so that the scientific design and ethical standards that will be employed during the proposed study may be reviewed and approved. Also, respondents are required to submit information about the ethical conduct of completed research that involved human subjects when such research is submitted to the EPA. This renewal ICR estimates the third-party response burden from complying with the requirements in 40 CFR part 26.

Federal Agency: Environmental Protection Agency

Affected Area: EHS, ORED

Comments Due: 5/25/2022

Determination That FOLVITE (Folic Acid), Oral Tablets, 1 Milligram, and Other Drug Products, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

Federal Agency: Food and Drug Administration

Affected Area: UMC

Agency Information Collection Activities: Requests for Comments; Clearance of New Approval of Information Collection: Safety Statement Requirement for Manufacturers of Small Unmanned Aircraft

In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval new information collection. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on May 7, 2019. The collection involves manufacturers of small unmanned aircraft providing a safety statement to owners of the UAS they produce. This is a statutory requirement. To minimize the burden on small businesses, the FAA has developed an example safety statement that can be used to satisfy the requirement.

Federal Agency: Federal Aviation Administration (FAA), DOT

Affected Area: CERA

Comments Due: 5/27/2022

Information Collection; Bid Guarantees, Performance and Payment Bonds, and Alternative Payment Protection

In accordance with the Paperwork Reduction Act of 1995 and the Office of Management and Budget (OMB) regulations, DoD, GSA, and NASA invite the public to comment on an extension concerning bid guarantees, performance and payment bonds, and alternative payment protections. DoD, GSA, and NASA invite comments on: Whether the proposed collection of information is necessary for the proper performance of the functions of Federal Government acquisitions, including whether the information will have practical utility; the accuracy of the estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. OMB has approved this information collection for use through August 31, 2022. DoD, GSA, and NASA propose that OMB extend its approval for use for three additional years beyond the current expiration date.

Federal Agency: Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA)

Affected Area: Procurement, Construction Administration

Comments Due: 6/28/2022

Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Health Education Assistance Loan (HEAL)

This is a request for an extension of the Office of Management and Budget (OMB) approval of information collection requirements associated with the forms of the Health Education Assistance Loan (HEAL) Program, currently approved under OMB No. 1845-0126, which expires June 30, 2022. Clearance of this information collection is necessary to provide borrowers with information on the cost of their loan(s) including Truth in Lending information and to provide the Department with information to monitor the financial status of the HEAL program and to identify which lenders may have excessive delinquencies and defaulted loans. The information collection is essential for reporting and retaining information for sound and responsible program management.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid

Comments Due: 5/31/2022

Agency Information Collection Activities; Revision of a Currently Approved Collection: Notice to Student or Exchange Visitor

The Department of Homeland Security (DHS), U.S. Immigration and Customs Enforcement (ICE) invites the general public and other Federal agencies to comment on this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, this information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

Federal Agency: U.S. Immigration and Customs Enforcement, Department of Homeland Security

Affected Area: Admissions

Comments Due: 6/27/2022

Agency Information Collection Activities; Submission for OMB Review; Comment Request; National Safety Stand-Down To Prevent Falls in Construction

The Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et seq.) authorizes information collection by employers as necessary or appropriate for enforcement of the OSH Act or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain such information with minimum burden upon employers, especially those operating small businesses, and to reduce to the maximum extent feasible unnecessary duplication of effort in obtaining information (29 U.S.C. 657). Falls are a leading cause of death for employees. According to 2019 Bureau of Labor Statistics data, falls accounted for 418 of the 1,061 construction fatalities, and 880 of the 5,333 fatalities in all recorded industries. The National Fall Safety Stand-Down to Prevent Falls in Construction raises fall hazard awareness across the country in an effort to stop fall fatalities and injuries. The Stand-Down is the biggest safety outreach event ever conducted by the agency. OSHA has collaborated with countless industry leaders and employers over the last eight years to reach over 10 million workers during Stand-Downs. For additional substantive information about this ICR, see the related notice published in the Federal Register on 2/15/2022 (87 FR 8614). This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number. See 5 CFR 1320.5(a) and 1320.6. DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.

Federal Agency: Department of Labor

Affected Area: HR, Construction Administration, EHS

Comments Due: 5/31/2022

Submission for OMB Review; Federal Acquisition Regulation Part 23 Requirements

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division has submitted to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding Federal Acquisition Regulation (FAR) part 23 requirements.

Federal Agency: Federal Agency: Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA)

Affected Area: ORED, ORC

Comments Due: 6/1/2022

Agency Information Collection Activities; Proposed Collection; Comment Request; Generator Standards Applicable to Laboratories Owned by Eligible Academic Entities, EPA ICR No. 2317.05, OMB Control No. 2050-0204

Subpart K within 40 CFR part 262 provides a flexible and protective set of regulations that address the specific nature of hazardous waste generation and accumulation in laboratories owned by colleges and universities, including teaching hospitals and non-profit research institutes that are either owned by or formally affiliated with a college or university. In addition, eligible academic entities have the discretion to determine the most appropriate and effective method of compliance with these requirements—by allowing them the choice of either managing their hazardous wastes in accordance with the alternative regulations as set forth in Subpart K, or remaining subject to the existing generator regulations.

Federal Agency: Environmental Protection Agency

Affected Area: EHS

Comments Due: 7/1/2022

Agency Information Collection Activities; Comment Request; 2023-24 National Postsecondary Student Aid Study (NPSAS:24) Field Test-Institution Contacting and List Collection

This request is to conduct the 2023-24 National Postsecondary Student Aid Study Institution Contacting and List Collection Field Test (NPSAS:24 FT). This study is being conducted by the National Center for Education Statistics (NCES), within the Institute of Education Sciences (IES), part of the U.S. Department of Education. This submission covers materials and procedures related to institution sampling, enrollment list collection, and matching to administrative data files as part of the NPSAS:24 FT data collection, and includes details about the full-scale institution sampling and enrollment list data collection. NCES will submit a separate clearance package covering the student FT data collection, including the student record data abstraction and student surveys, in the summer of 2022. The materials and procedures for NPSAS:24 are based on those developed for previous institution-based data collections, including the 2019-20 National Postsecondary Student Aid Study (NPSAS:20) [OMB #1850-0666 v. 23], and the 2017-18 National Postsecondary Student Aid Study Administrative Collection (NPSAS:18-AC) [1850-0666 v.21]. The first NPSAS was implemented by NCES during the 1986-87 academic year to meet the need for national data about significant financial aid issues. Since 1987, NPSAS has been fielded every 2 to 4 years, most recently during the 2019-20 academic year (NPSAS:20). NPSAS:24 will be nationally-representative. The NPSAS:24 field test sample size will be 6,000 students, and the full-scale sample will include 137,000 nationally representative undergraduate and 25,000 nationally representative graduate students who will be asked to complete a survey and for whom we will collect student records and administrative data. If the full-scale budget allows, we will include state-representative sampling for the full-scale collection, and provide the budget for a state-representative sampling plan in the 30-day full-scale package, planned for 2023. Also, if exercised, NPSAS:24 will serve as the base year for the 2024 cohort of the Baccalaureate and Beyond (B&B) Longitudinal Study and will include a nationally representative sample of students who will complete requirements for the bachelor’s degree during the NPSAS year (i.e., completed at some point between July 1, 2022 and June 30, 2023 for the field test and July 1, 2023 to June 30, 2024 for the full-scale). Subsets of questions in the student survey will focus on describing aspects of the experience of students in their last year of postsecondary education, including student debt and education experiences. This submission is designed to adequately justify the need for and overall practical utility of the full study, presenting the overarching plan for all of the phases of the institution sampling and enrollment list data collection and providing as much detail about the measures to be used as is available at the time of this submission. As part of this submission, NCES is publishing a notice in the Federal Register allowing first a 60- and then a 30-day public comment period. Field test materials, procedures, and results will inform the full-scale study. After completion of this field test, NCES will publish a notice in the Federal Register allowing additional 30-day public comment period on the final details of the NPSAS:24 full-scale institution sampling and enrollment list study.

Federal Agency: Department of Education

Affected Area: Student Financial Aid

Comments Due: 7/5/2022

Accrediting Agencies Currently Undergoing Review for the Purposes of Recognition by the U.S. Secretary of Education

This request for written third-party comments concerning the performance of accrediting agencies under review by the Secretary of Education is required by 496(n)(1)(A) of the Higher Education Act (HEA) of 1965, as amended, and pertains to the summer 2023 meeting of the National Advisory Committee on Institutional Quality and Integrity (NACIQI). The meeting date and location have not been determined, but will be announced in a later Federal Register notice. In addition, a later Federal Register notice will describe how to register to provide oral comments at the meeting. Agencies Under Review and Evaluation: The Department requests written comments from the public on the following accrediting agencies, which are currently undergoing review and evaluation by the Accreditation Group, and which will be reviewed at the summer 2023 NACIQI meeting. The agencies are listed by the type of application each agency has submitted. Please note, each agency’s current scope of recognition is indicated below. If any agency requests a change to its scope of recognition, identified are both the current scope of recognition and the requested scope of recognition.

Federal Agency: Department of Education

Affected Area: Office of Institutional Effectiveness

 

Agency Information Collection Activities; Comment Request; Campus Equity in Athletics Disclosure Act (EADA) Survey

The collection of information is necessary under section 485 of the Higher Education Act of 1965, as amended, with the goal of increasing transparency surrounding college athletics for students, prospective students, parents, employees and the general public. The survey is a collection tool to compile the annual data on college athletics. The data is collected from the individual institutions by ED and is made available to the public through the Equity in Athletics Data Analysis Cutting Tool as well as the College Navigator.

Federal Agency: Department of Education

Affected Area: Athletics

Comments Due: 7/5/2022

Lead in Construction Standard; Extension of the Office of Management and Budget’s (OMB) Approval of Information Collection (Paperwork) Requirements

The purpose of the Lead in Construction Standard and its collection of information (paperwork) requirements is to reduce occupational lead exposure in the construction industry. Lead exposure can result in both acute and chronic effects and can be fatal in severe cases of lead toxicity. The major collection of information requirements of the Standard are: Conducting worker exposure assessments; notifying workers of their lead exposures; establishing, implementing and reviewing a written compliance program annually; labeling containers of contaminated protective clothing and equipment; providing medical surveillance to workers; providing examining physicians with specific information; ensuring that workers receive a copy of their medical surveillance results; posting warning signs; establishing and maintaining exposure monitoring, medical surveillance, medical removal and objective data records; and providing workers with access to these records. The records are used by employees, physicians, employers and OSHA to determine the effectiveness of the employer’s compliance efforts.

Federal Agency: Occupational Safety and Health Administration (OSHA), Labor

Affected Area: Campus Development, EHS

Comments Due: 7/5/2022

Requests to Approve Conformed Wage Classifications and Unconventional Fringe Benefit Plans Under the Davis-Bacon and Related Acts and Contract Work Hours and Safety Standards Act

The Wage and Hour Division of the Department of Labor administers the Davis-Bacon Act (DBA) and Davis-Bacon Related Acts (DBRA), 40 U.S.C. 3141 et seq., and the Contract Work Hours and Safety Standards Act (CWHSSA), 40 U.S.C. 3701 et seq. Regulations at 29 CFR part 5 prescribe labor standards for federally financed and federally assisted construction contracts subject to DBA, DBRA, and labor standards for all contracts subject to CWHSSA. The DBA and DBRA require payment of locally prevailing wages and fringe benefits, as determined by the Department, to laborers and mechanics on most federally financed or assisted construction projects. CWHSSA requires the payment of one and one-half times the basic rate of pay for hours worked over 40 in a week on most federal contracts involving the employment of laborers or mechanics. The requirements of this information collection consist of (1) reports of conformed classifications and wage rates, and (2) requests for approval of unfunded fringe benefit plans. For additional substantive information about this ICR, see the related notice published in the Federal Register on February 7, 2022 (87 FR 6894).

Federal Agency: Department of Labor

Affected Area: Construction Administration, Procurement

Comments Due: 6/13/2022

Agency Information Collection Activities; Comment Request; Foreign Schools Eligibility Criteria Apply To Participate in Title IV HEA Programs

This request is for an extension of the information collection of the requirements in the policies and procedures related to the eligibility of foreign schools to apply to participate in Title IV, HEA programs that were added by the Higher Education Opportunity Act of 2008 (HEOA). The information in 34 CFR 600.54, 600.55, 600.56, and 600.57 is used by the Department during the initial review for eligibility certification, recertification and annual evaluations. These regulations help to ensure that all foreign institutions participating in the Title IV, HEA programs are meeting the minimum participation standards.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid

Comments Due: 7/8/2022

Submission for OMB Review; Comment Request; Pilot Study and Prospective Analysis of the Draft Revised Form 33, Safety and Health Program Assessment Worksheet

The Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et seq.) authorizes information collection by employers as necessary or appropriate for enforcement of the OSH Act or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires OSHA to obtain such information with minimum burden upon employers, especially those operating small businesses, and to reduce to the maximum extent feasible unnecessary duplication of efforts in obtaining information (29 U.S.C. 657). OSHA is requesting approval from OMB pursuant to the Paperwork Reduction Act (PRA), to conduct validity and reliability analyses of a safety and health program (SHP) assessment worksheet, the Draft Revised Form 33 (DRF33), that will replace the current SHP Assessment Worksheet, OSHA Form 33, used by the OSHA On-Site Consultation Program (OMB #1218-0110). The studies that will be conducted on the DRF33 will enable OSHA to ensure that a valid, reliable, and efficient tool is provided to On-Site Consultation programs in the 50 states, the District of Columbia, and several United States territories to replace the current OSHA Form 33, thereby, enhancing the quality of consultative services. The studies for which OSHA is requesting approval will comprise a pretest, Pilot Study (consultation visits to assess the validity and reliability of the DRF33), a follow-up study (consultation visits to assess any updates to the DRF33 resulting from Pilot Study findings), and a Prospective Analysis (conducted after the Pilot Study to assess any impact of the DRF33 at workplaces that received consultation visits during the Pilot Study). After completing the Pilot Study OSHA will request OMB approval before implementing the DRF33 for use by state On-Site Consultation programs nationwide to replace the current Form 33. Similarly, OSHA will seek OMB approval if any additional updates are made to the approved worksheet, following the Prospective Analysis. For additional substantive information, see the submission at https://www.reginfo.gov, ICR Reference Number=202202-121002.

Federal Agency: Department of Labor

Affected Area: HR, Risk Management, Campus Development

Comments Due: 6/21/2022

Agency Information Collection Activities; Comment Request; Guaranty Agency Financial Report

The Department of Education (ED) is requesting renewal by extension of the information collection 1845-0026 for the Guaranty Agency Financial Report. There has been no change to the underlying statute or regulations. The Guaranty Agency Financial Report is used by a guaranty agency to request payments of reinsurance for defaulted student loans; make payments for amounts due ED, for collections on default and lender of last resort loan (default) claims on which reinsurance has been paid and for refunding amounts previously paid for reinsurance claims. The form is also used to determine required reserve levels for agencies; and to collect debt information as required for the “Report on Accounts and Loans Receivable Due from the Public,” SF 220-9 (Schedule 9 Report) as required by the U.S. Department of Treasury.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid

Comments Due: 7/18/2022

Agency Information Collection Activities; Comment Request; FERPA and PPRA E-Complaint Forms

The Student Privacy Policy Office (SPPO) reviews, investigates, and processes complaints of alleged violations of Family Education Rights and Privacy Act (FERPA) and Protection of Pupil Rights Amendment (PPRA) filed by parents and eligible students. SPPO’s authority to investigate, review, and process complaints extends to allegations of violations of FERPA by any recipient of United States Department of Education (Department) funds under a program administered by the Secretary (e.g., schools, school districts, postsecondary institutions, state educational agencies, and other third parties that receive Department funds).

Federal Agency: Office of Management (OM), Department of Education (ED)

Affected Area: CERA, Registrar

Comments Due: 7/18/2022

Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” The guidance focuses on safety aspects of the container label and carton labeling design for human prescription drug and biological products. The guidance provides sponsors of new drug applications (NDAs), biologics license applications (BLAs), abbreviated new drug applications (ANDAs), and prescription drugs marketed without an approved NDA or ANDA with a set of principles and recommendations for ensuring that critical elements of product container labels and carton labeling are designed to promote safe dispensing, administration, and use of the product. This guidance finalizes the draft guidance of the same title issued on April 24, 2013.

Federal Agency: Food and Drug Administration, HHS

Affected Area: UMC

 

Request for Information (RFI): 2022 HHS Environmental Justice Strategy and Implementation Plan Draft Outline; Comment Period Extended

On April 8, 2022, the Department of Health and Human Services (HHS) published into the Federal Register a Request for Information (RFI) which is located at 87 FR 20876 to receive input from the public on HHS’s draft outline to further the development of the 2022 Environmental Justice Strategy and Implementation Plan. Consistent with the policy of this administration directing HHS to make achieving environmental justice part of its mission, HHS would like to identify priority actions and strategies to best address environmental injustices and health inequities for people of color, disadvantaged, vulnerable, low-income, marginalized, and indigenous populations. With the engagement of and input from the public, the 2022 Environmental Justice Strategy and Implementation Plan will serve as a guide to confront environmental and health disparities and implement a multifaceted approach that will serve vulnerable populations and communities disproportionately impacted by environmental burdens.

Federal Agency: Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services (HHS)

Affected Area: UMC

Comments Due: 6/18/2022

Items of Interest

Notice of Solicitation for Nominations for Appointment to the Aviation Rulemaking Advisory Committee (ARAC)

ARAC was established on January 22, 1991, under the Federal Advisory Committee Act (FACA) pursuant to Title 5 of the United States Code, Appendix 2. The purpose of ARAC is to provide information, advice, and recommendations to the Secretary of Transportation, through the FAA Administrator, concerning rulemaking activities, such as aircraft operations, airman and air agency certification, airworthiness standards and certification, airports, maintenance, noise, and training.

Comments Due: 5/18/2022

Internal Revenue Service Advisory Council (IRSAC); Nominations

The Internal Revenue Service (IRS) is seeking new members to serve on the Internal Revenue Service Advisory Council (IRSAC). Applications are currently being accepted for appointments that will begin in January 2023. IRSAC members are drawn from substantially diverse backgrounds representing a cross-section of the taxpaying public with substantial, disparate experience in: Tax preparation for individuals, small businesses and large, multi-national corporations; tax-exempt and government entities; information reporting; and taxpayer or consumer advocacy. Nominations of qualified individuals may come from individuals or organizations; applications should describe and document the proposed member’s qualifications for IRSAC.

Comments Due: 6/3/2022

Haley signs letter demanding American universities divest from China

The letter, drafted by the Athenai Institute, requests university officials push their schools to divest entirely from their Chinese financial ties in protest of Chinese human rights abuses and international security threats. Haley’s signature is among the most prominent attached to the Athenai Letter. “American universities must ensure they’re not sending a single dollar to fund genocide,” Haley told Fox News Digital. “Communist China is imprisoning millions of Uyghurs, forcing them to work and subjecting them to rape, sterilization and torture.”

 

Medical regulators: look beyond animal tests

Within ten months of scientists identifying SARS-CoV-2, the European Commission and the US Food and Drug Administration (FDA) had authorized vaccines for emergency use, thus beginning immunization programmes that are saving many lives. Regulatory approval for vaccines usually takes ten years. Much of the speed was achieved by prioritizing COVID-19 programmes; another innovation was allowing human studies to begin before all standard animal tests had been concluded. Before clinical trials of the two messenger RNA vaccines began in 2020, pharmaceutical companies presented regulators with historical data from work on animal models, which studied similar technology in vaccines against diseases including rabies. Other data came from cell-based tests and computational assessments of the experimental vaccines. Non-animal techniques, including the use of monoclonal antibodies, cultured cells and physico-chemical analysis, were also used to ensure the quality of each vaccine batch.

 

FBI chief says espionage threat posed by China ‘unprecedented in history’

FBI Director Christopher Wray said on Sunday that the current scale of espionage and cybersecurity threats from China were “unprecedented in history.” “The biggest threat we face as a country from a counterintelligence perspective is from the People’s Republic of China and especially the Chinese Communist Party,“ Wray said during an interview on CBS News’s “60 Minutes.” “They are targeting our innovation, our trade secrets, our intellectual property, on a scale that’s unprecedented in history,” he added, noting that China’s hacking program is larger “than that of every other major nation combined.”

 

Congressional Researchers Highlight Growing Federal-State Marijuana ‘Policy Gap’ In New 100-Page Report

The gap between federal and state marijuana policies continues to widen and shows no signs of stopping, congressional researchers said in a new report that also lays out options for how lawmakers could address the growing schism. The Congressional Research Service (CRS) published the 101-page analysis just days after the U.S. House of Representatives approved a bill to federally legalize cannabis. It covers a wide range of policy implications caused by the ongoing prohibition of marijuana under federal law as more states move to legalize for medical and adult use.

New Biomed Unit Under Pressure to Use Untried Drug Patent Grabs

There’s been a push, particularly among progressives, for the NIH to exercise what’s known as march-in rights to temper drug prices—most recently on Astellas’ cancer drug Xtandi. Established under the 1980 Bayh-Dole Act, march-in allows the government to seize patents for inventions created with government funding and license them to other entities for commercialization.

 

Biden Wants to Attract Russian Scientists

President Biden has asked Congress to suspend, for four years, the requirement that Russian scientists applying for visas have a sponsoring employer, eliminating a major obstacle for many seeking to come to the United States, The New York Times reported. The measure would apply only to Russian citizens “with master’s or doctoral degrees in science or engineering fields like artificial intelligence, nuclear engineering or quantum physics,” the Times reported. The move comes at a time when many Russian scientists already want to leave their home country.

 

We Don’t Necessarily Need a Scientist at the Head of the Office of Science and Technology Policy

President Biden came into office promising to restore the role of science in government after the Trump administration’s rocky relationship with scientific advice. (You might remember an incident involving a hurricane forecast and a Sharpie.) A key tool for the White House to implement its ambitious science-related agenda is the Office of Science and Technology Policy, or OSTP—a relatively small outfit that oversees policies about science, including budget requests for agencies that conduct science and the coordination of major scientific endeavors across the federal government. Since Biden took office, OSTP has taken on a variety of sorely needed priorities, including reinvigorating government processes for scientific integrity, future pandemic preparedness, and exploring what artificial intelligence means for human rights. But these good causes have been overshadowed by controversies over OSTP’s leadership.

 

Request for Nominations of Experts to the EPA Office of Research and Development’s Human Studies Review Board Advisory Committee

The U.S. Environmental Protection Agency (EPA) invites nominations from a diverse range of qualified candidates with expertise in the areas of toxicology, bioethics, and statistics to be considered for appointment to its Human Studies Review Board (HSRB) federal advisory committee. Submission of nominations will be made via the HSRB website at:  https://www.epa.gov/​osa/​human-studies-review-board.

Comments Due: 5/31/2022

Solicitation of Nominations for Membership on the National Vaccine Advisory Committee

The Office of Infectious Disease and HIV/AIDS Policy (OIDP), a program office within the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), solicits nominations of qualified candidates to be considered for appointment to the National Vaccine Advisory Committee (NVAC). The activities of this committee are governed by the Federal Advisory Committee Act (FACA). The NVAC serves an advisory role, providing recommendations to the Assistant Secretary for Health in her capacity as the Director of the National Vaccine Program. The committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States, as well as research priorities and other measures to enhance the safety and efficacy of vaccines. The committee also advises the Assistant Secretary for Health on the implementation of sections 300aa-2, 300aa-3, and 300aa-4 of the Public Health Service (PHS) Act, including government and non-government cooperation. A copy of the NVAC charter that describes its structure and functions and lists of the current members can be reviewed on the NVAC website at: http://www.hhs.gov/​nvpo/​nvac/​index.html. Submission Process: Please email all submissions to nvac@hhs.gov. All nominations for membership on the committee must be received no later than 5:00 p.m. EDT on June 24, 2022.

Comments Due: 6/24/2022

Biden Orders Quantum Computing Push as China Challenge Grows

President Joe Biden will sign directives on Wednesday aimed at preparing the U.S for a new era of quantum computing, as Chinese agencies and companies pour billions of dollars into the next-generation technology…. Federal agencies will have to develop comprehensive plans to safeguard American intellectual property, research and other sensitive technology from acquisition by America’s adversaries, plus educate industry and academia on the threats they face, the White House said, without naming specific countries.

 

President Biden Announces Two Presidential Directives Advancing Quantum Technologies

Today, President Biden will sign two Presidential directives that will advance national initiatives in quantum information science (QIS), signaling the Biden-Harris Administration’s commitment to this critical and emerging technology. Together, the two directives lay the groundwork for continued American leadership in an enormously promising field of science and technology, while mitigating the risks that quantum computers pose to America’s national and economic security.

 

Risky ‘gain-of-function’ studies need stricter guidance, say US researchers

Researchers and biosecurity specialists are calling on the US government to issue clearer guidance about experiments it might fund that would make pathogens more transmissible or deadly. They made these pleas on 27 April, during the first of a series of public listening sessions organized by the US National Institutes of Health (NIH). The sessions are part of a months-long review, conducted by the National Science Advisory Board for Biosecurity (NSABB), of US policies governing risky pathogen research.

 

Duke’s Klotman is under consideration as the next NIH head

Mary Klotman, a Duke University scientist and senior leader, is a strong contender to be the next director of the National Institutes of Health, according to three people with knowledge of the selection. A physician known for her research into HIV, Klotman has served as dean of the Duke University School of Medicine since 2017. She has had conversations with several senior administration officials, said the three people, who spoke on the condition of anonymity because they were not authorized to discuss the selection. If selected by President Biden and confirmed by the Senate, she would replace Francis S. Collins, who stepped down as NIH director last year but returned to government this year to advise Biden on science policy. Lawrence A. Tabak, a longtime federal official, has served as the agency’s interim head since Collins’s departure.

 

Research universities are shortchanging their storytelling

Higher Ed unequivocally sits at the tip of the spear for ideation and invention. And research universities are its leading incubators, moving the world forward in every field. But on the whole, universities’ research stories aren’t being told well enough, broadly enough, or consistently enough. Universities often struggle to make the case for how research contributes to their educational mission when speaking to prospective students and their families, despite research, learning, and discovery being intrinsically linked. They’ve historically had a hard time translating research endeavors to alumni [and alumni donors], a presumably friendly audience when it comes to showcasing and celebrating university successes. And similarly, universities have fumbled efforts to powerfully convey research ROI to legislators. Yet each of these constituent groups are incredibly important to ensure ongoing support and investment.

Putin’s Failure to Hold on to the Educated Could Be the World’s Gain (New York Times, Opinion)

Russia has suffered from brain drain for at least a century, in part because it produces top-notch university graduates but usually hasn’t had an economy capable of putting their skills to good use….. The United States has been tougher to get into because visas are scarce. In March the Department of Homeland Security granted Ukrainians temporary protected status for 18 months, enabling them to stay and work in the United States without a visa — but it has not done so for Russians.  In a shift, however, the Biden administration asked Congress last week to suspend for four years the requirement that Russian scientists applying for H1-B visas have a sponsoring employer. The measure would apply only to Russian citizens with master’s or doctoral degrees in science or engineering fields such as artificial intelligence, nuclear engineering and quantum physics. They would have to undergo security vetting.

Request for nominations for Mobile Sources Technical Review Subcommittee

The U.S. Environmental Protection Agency (EPA) invites nominations from a diverse range of qualified candidates to be considered for appointment to its Mobile Sources Technical Review Subcommittee (MSTRS). Vacancies are anticipated to be filled by October 17, 2022. Sources in addition to this Federal Register Notice may also be utilized in the solicitation of nominees.

Comments Due: 7/11/2022

Stop squandering data: make units of measurement machine-readable

Humans struggle to interpret numbers with sloppy or missing units, and it is much more difficult when computers are involved. Most software packages, data-management tools and programming languages lack built-in support for associating units with numeric data (with the exception of the language F#). This means that information is essentially stored and managed as ‘unitless’ values. Disciplines including bioscience and aerospace engineering have adopted conventions for unit representation, such as the Unified Code for Units of Measure (UCUM) and the Quantities, Units, Dimensions, and Types (QUDT) Ontology. But there are no broadly agreed technical specifications for how to represent quantities and their associated units without confusing machines.

 

Gearing Up for 2023 Part II: Implementing the NIH Data Management and Sharing Policy

NIH has a long history of developing consent language and, as such, our team worked across the agency – and with you! – to develop a new resource that shares best practices for developing informed consents to facilitate data/biospecimen storage and sharing for future use.  It also provides modifiable sample language that investigators and IRBs can use to assist in the clear communication of potential risks and benefits associated with data/biospecimen storage and sharing.  In developing this resource, we engaged with key federal partners, as well as scientific societies and associations.  Importantly, we also considered the 102 comments from stakeholders in response to a RFI that we issued in 2021. As for our second resource, we are requesting public comment on protecting the privacy of research participants when data is shared. I think I need to be upfront and acknowledge that we have issued many of these types of requests over the last several months and NIH understands the effort that folks take to thoughtfully respond.  With that said, we think the research community will greatly benefit from this resource and we want to hear your thoughts on whether it hits the mark or needs adjustment.

 

NIH gains new power to police sexual harassment

Now, thanks to a provision Congress added to NIH’s 2022 spending legislation, reporting harassment will be mandatory. In addition, the trigger for reporting is not just a change in grant personnel, but any disciplinary action. As of 9 July, institutions must inform NIH within 30 days if key grant personnel “are removed from their position or are otherwise disciplined due to concerns about harassment, bullying, retaliation, or hostile working conditions,” the agency announced in a 10 May notice.

 

OIG report is critical of information security at academic and research contractors

The OIG report, “Audit of the Protection of Military Research Information and Technologies Developed by Department of Defense Academic and Research Contractors”, found that universities and research contractors omitted to consistently implement the necessary cybersecurity protocols to protect CUI stored on their networks from internal and external cyber threats. The OIG report made eight findings on research contractor protocols used to store, process, and transmit CUI. Out of the ten contractors reviewed, the OIG specifically found that:

One failed to create an incident response plan; One failed to monitor network traffic and scan its network for viruses; Two failed to implement physical security protocols (e.g., security guards, biometric readers, access card readers, and physical access control logs); Two failed to encrypt workstation hard drives to safeguard CUI from unauthorized disclosure or access; Three failed to identify and resolve system and network vulnerabilities in a timely fashion; Four failed to deactivate user accounts after prolonged periods of inactivity; Four failed to enforce the use of multifactor authentication or enforce the use of strong passwords to access their systems and networks; and Five failed to use automatic controls to restrict the use of removable media to protect CUI stored on removable media.

 

COMPLIANCE SUPPLEMENT

The 1,968 page 2022 Compliance Supplement was posted on May 11th (at least three months early compared to previous years) on the OMB, Office of Federal Financial Management (OFFM) website. Comments on the 2022 Compliance Supplement, as specified in the Federal Register Notice, are due to OMB by July 11, 2022 (late comments will be considered to the extent practicable). Comments will be addressed in the development of the 2023 Compliance Supplement––however, COGR’s view is that if significant, we will advocate for comments to be addressed sooner. Several items of note are:

•             Applicability of 2 CFR Part 200 FAQs (p. 28 and p. 1778) . As COGR requested upon the original release of 2 CFR 200, the FAQs applicable to 2 CFR Part 200 (the Uniform Guidance) are recognized in the Compliance Supplement.

•             Part V: R&D and SFA Clusters (p. 1776 and p. 1781). COGR reviews the Compliance Supplement for updates to the R&D Cluster––there appear to be no significant changes to the R&D Cluster.

•             Appendix IV: “Higher Risk” programs (p. 1931). This section updates the list of COVID-19 programs that have been determined as “higher risk.”

•             Appendix VII: Federal Audit Clearinghouse transition (p. 1959). This section provides the timing for the Federal Audit Clearinghouse transition from Census to GSA, effective October 1, 2022.

Solicitation of Nominations for Appointment to CDC’s Advisory Committee to the Director (ACD) Data and Surveillance Workgroup (DSW); Re-Opening of Solicitation Period

Notice is hereby given of a change in the solicitation of CDC’s Advisory Committee to the Director (ACD) Data and Surveillance Workgroup (DSW). In the Federal Register notice published on May 4, 2022, nominations for appointment to CDC’s ACD DSW workgroup were due May 16, 2022. Nominations are now due May 27, 2022.

Comments Due: 5/27/2022

Solicitation of Nominations for Membership to the Advisory Committee on Transportation Equity

Solicitation of nominations for membership to the Advisory Committee on Transportation Equity.

Comments Due: 6/16/2022

Revision of NSF Award Terms and Conditions (NSF)

The entire suite of NSF Award Terms and Conditions have been revised to implement the requirements of the Build America, Buy America provisions of the Infrastructure Investment and Jobs Act (P.L. 117-58).  The revised terms and conditions will apply to all new NSF awards and funding amendments to existing NSF awards made on or after May 13, 2022. All sets of award conditions are accompanied by a summary of changes made to that document.

Comments Due: June 2022

Updated eRA RPPR Module and Instruction Guide: Action Required for In-Progress Budget Forms

The Research Performance Progress Report (RPPR) Module in eRA Commons is moving to the new visual appearance being adopted by other eRA modules, because of a required technology upgrade that enhances the security and stability of the module. The upgrade includes adding the new unique entity identifier (UEI) fields where applicable and required FORMS-G changes, including updated budget forms. These upgrades are expected to be released on June 23, 2022.

Hot Off the Presses: Updated RPPR Instruction Guide Available (NIH Extramural Nexus)

An updated RPPR Instruction Guide is now available. The instruction guide reflects changes associated with recently issued guide notices on Other Support and Biosketch format pages, human subjects, Trainee Diversity Report and NRSA childcare costs reporting (see NOT-OD-22-130 for details).  Note that a final RPPR Instruction Guide will be published on June 23 to reflect the revised screenshots accompanying the new look and feel of the RPPR module.

 

Action Required for In-Progress RPPR Budget Forms By or Before June 22

The Research Performance Progress Report (RPPR) module in eRA Commons is moving June 23 to the new visual appearance of other eRA modules. This is part of a required technology upgrade that will enhance the security and stability of the module. The release will include the addition of the new unique entity identifiers (UEI) where applicable as well as required FORMS-G changes, including updated budget forms.

Compliance Alert – March 2022

Legislative Updates

HB46: This bill would establish the State Seal of Biliteracy program to recognize graduates who have attained a high level of proficiency in speaking, reading, and writing in one or more languages in addition to English, and would provide for the seal to be awarded to the graduate by the State Department of Education. Last Action:  2022-03-17 – Forwarded to Executive Department

HB138: Appropriations, supplemental appropriations, from the Education Trust Fund to various agencies and entities for the fiscal year ending September 30, 2022. Last Action: 2022-03-10 – Read for the first time and referred to the Senate committee on Finance and Taxation Education

HB267: Appropriations, supplemental appropriations for fiscal year ending September 30, 2022, from the Education Trust Fund Advancement and Technology Fund to various school systems and colleges and universities, and other entities. Last Action: 2022-03-10 – Read for the first time and referred to the Senate committee on Finance and Taxation Education.

HB312: Education and training, divisive concepts, prohibits teaching of the concepts under certain circumstances, allows teaching of the concepts in public institutions of higher education as long as assent to the concept is not compelled.  Last Action: 2022-03-17 – Read for the first time and referred to the Senate committee on Governmental Affairs

HB307: Education, issuance of professional educator certificate to individuals completing approved alternative teacher preparation programs, Sec. 16-23-3.01 added; Sec. 16-23-3 am’d. Last Action: 2022-03-17

HB395: Alcoholic beverage licenses, Hospitality Management Program license created at certain state universities, activities under license authorized. Last Action: 2022-03-17 – Pending third reading on day 24 Favorable from Judiciary

SB292: Education and training, divisive concepts, prohibits teaching of the concepts under certain circumstances, allows teaching of the concepts in public institutions of higher education as long as assent to the concept is not compelled. Last Action: Introduced on March 3, 2022

SB313: Colleges and universities, local boards of education, schools prohibited from using public funds to advocate for or against ballot measures. Status: Last Action: 2022-03-17 – Fiscal Responsibility and Economic Development first Substitute Offered

HB135: Education budget, appropriations for the support, maintenance, and development of public education. This bill makes appropriations for the support, maintenance, and development of public education in Alabama, for debt service, and for capital outlay for the fiscal year ending September 30, 2023. Last Action: 2022-03-08 – Engrossed

SB15: State Textbook Committee, publishers permitted to provide standards correlation evidence to State Dept. of Education, State Superintendent of Education to convene other instructional materials review committees to review and rate materials and to establish evaluation criteria, Sec. 16-36-73 added; Secs. 16-36-60, 16-36-60.1, 16-36-65 am’d. Last Action:  2022-03-03 – Assigned Act No. 2022-80.

SB119: Colleges and Universities, Alabama G.I. and Dependents’ Educational Benefit Act, use of scholarship benefits at 2 year or 4 year public or private institutions of higher education physically located in state provided, Sec. 31-6-8 repealed; Secs. 31-6-2, 31-6-2.1, 31-6-3, 31-6-4, 31-6-5, 31-6-6, 31-6-9, 31-6-11, 31-6-12, 31-6-13, 31-6-14, 31-6-15, 31-6-15.1, 31-6-16 am’d. Last Action: 2022-03-01 – Assigned Act No. 2022-91.

Final Rules

Defense Federal Acquisition Regulation Supplement: Exception to Competition for Certain Follow-On Production Contracts (DFARS Case 2019-D031)

DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2016 that modifies the criteria required to exempt from competition certain follow-on production contracts.

Federal Agency: Defense Acquisition Regulations System, Department of Defense (DoD)

Affected Area: Procurement

Chlorpyrifos; Final Order Denying Objections, Requests for Hearings, and Requests for a Stay of the August 2021 Tolerance Final Rule

In response to EPA’s August 2021 final rule revoking all tolerances for the insecticide chlorpyrifos under the Federal Food, Drug, and Cosmetic Act (FFDCA), several objections, hearing requests, and requests for stay were filed by numerous parties representing a wide variety of growers and pesticide users. In this Order, EPA denies all objections to, requests for hearing on those objections, as well as requests for stay of the final rule.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and a conditionally approved new animal drug application (cNADA) during July, August, and September 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy of the regulations.

Federal Agency: Food and Drug Administration, HHS

Affected Area: ORED, Animal Care

Russian Harmful Foreign Activities Sanctions Regulations

The Department of the Treasury’s Office of Foreign Assets Control (OFAC) is adding regulations to implement an April 15, 2021 Russia-related Executive order. OFAC intends to supplement these regulations with a more comprehensive set of regulations, which may include additional interpretive guidance and definitions, general licenses, and other regulatory provisions.

Federal Agency: Office of Foreign Assets Control, Treasury

Affected Area: ORED

Federal Acquisition Regulation: Amendments to the FAR Buy American Act Requirements

This rule increases the domestic content threshold initially from 55 percent to 60 percent, then to 65 percent in calendar year 2024 and to 75 percent in calendar year 2029. See FAR 25.101(a)(2)(i) and 25.201(b)(2)(i). The initial increase to 60 percent will occur several months from publication of the final rule, to allow industry time to plan for the new threshold and to provide workforce training on the new fallback threshold. The increase of the domestic content threshold ultimately to 75 percent is consistent with the Infrastructure Investment and Jobs Act (Pub. L. 117-58) (IIJA) which was enacted on November 15, 2021. Section 70921 of this statute includes a “sense of Congress” that the FAR be amended to increase the domestic content requirements for domestic end products and domestic construction material to 75 percent.

Federal Agency: Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA)

Affected Area: Procurement

Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1); Further Compliance Date Extension

The Environmental Protection Agency (EPA) is amending the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under the Toxic Substances Control Act (TSCA). Specifically, EPA is extending the compliance date applicable to the prohibition on processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, until October 31, 2024, along with the compliance date for the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles. This final rule follows issuance of a proposed rule for public comment on October 28, 2021; comments on the proposed rule are responded to in this action.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

Standards and Practices for All Appropriate Inquiries

EPA is taking direct final action to amend the Standards and Practices for All Appropriate Inquiries to reference a standard practice recently made available by ASTM International, a widely recognized standards developing organization. Specifically, this direct final rule amends the All Appropriate Inquiries Rule to reference ASTM International’s E1527-21 “Standard Practice for Environmental Site Assessments: Phase I Environmental Site Assessment Process” and allow for its use to satisfy the requirements for conducting all appropriate inquiries under the Comprehensive Environmental Response, Compensation and Liability Act.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS, Land Management

Comments Due: 4/13/2022

Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards

The Department of Energy (DOE) publishes a final rule to make technical and administrative changes as a result of the Office of Management and Budget (OMB) revisions to its regulations on Grants and Agreements. The changes are required in order to align DOE’s regulations with the revised OMB regulations and to remove reference to an expired statutory cost share pilot program. The final rule also makes technical changes to correct pre-existing numbering errors in the regulatory text.

Federal Agency: Office of Management, U.S. Department of Energy

Affected Area: Grant Accounting

Proposed Rules

Updating the Davis-Bacon and Related Acts Regulations

The Department of Labor (Department) proposes to amend regulations issued under the Davis-Bacon and Related Acts that set forth rules for the administration and enforcement of the Davis-Bacon labor standards that apply to Federal and federally assisted construction projects. As the first comprehensive regulatory review in nearly 40 years, the Department believes that revisions to these regulations are needed to provide greater clarity and enhance their usefulness in the modern economy.

Federal Agency: Wage and Hour Division, Department of Labor

Affected Area: Construction Administration, Procurement

Comments Due: 5/17/2022

National Priorities List

The Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA” or “the Act”), as amended, requires that the National Oil and Hazardous Substances Pollution Contingency Plan (“NCP”) include a list of national priorities among the known releases or threatened releases of hazardous substances, pollutants or contaminants throughout the United States. The National Priorities List (“NPL”) constitutes this list. The NPL is intended primarily to guide the Environmental Protection Agency (“EPA” or “the agency”) in determining which sites warrant further investigation. These further investigations will allow the EPA to assess the nature and extent of public health and environmental risks associated with the site and to determine what CERCLA-financed remedial action(s), if any, may be appropriate. This rule proposes to add five sites to the General Superfund section of the NPL. This document also withdraws a previous proposal for NPL addition.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

Comments Due: 5/17/2022

OFCCP Announces Proposed Rule for Modifying Procedures to Identify and Remedy Discrimination in Federal Contracting

To promote the efficient and effective enforcement of laws and regulations applicable to Federal contractors and subcontractors, the Office of Federal Contract Compliance Programs (OFCCP) proposes to modify regulations that delineate procedures and standards the agency follows when issuing pre-enforcement notices and securing compliance through conciliation. This proposal would support OFCCP in fulfilling its mission to ensure equal employment opportunity.

Federal Agency: Department of Labor

Affected Area: EEO, Compliance, Legal and HR

Comments Due: 4/21/2022

Notices

Agency Information Collection Activities; Comment Request; Transition and Postsecondary Programs for Students With Intellectual Disabilities (TPSID) Evaluation Protocol

In October 2020, the Institute for Community Inclusion (ICI), UMass Boston received a five-year cooperative agreement from the Office of Postsecondary Education to serve as the National Coordinating Center (NCC) for colleges and universities implementing inclusive higher education programs for students with intellectual disabilities, including 22 newly-funded model demonstration projects aimed at creating inclusive comprehensive transition and postsecondary programs for students with intellectual disabilities known as Transition and Postsecondary Programs for Students with Intellectual Disabilities (TPSIDs). To reduce respondent burden, the NCC has streamlined and simplified the previously approved evaluation system for the TPSID programs. The NCC will enhance the collection and analyses of longitudinal follow-up data from the new 22 TPSID model programs via an already developed and previously OMB approved evaluation system for the TPSID programs. The revised data collection system is part of an evaluation effort. The system will collect program data at the institutions from TPSID program staff via an online, secure data management system.

Federal Agency: Office of Postsecondary Education (OPE), Department of Education (ED)

Affected Area: Office of Disability Services

Comments Due: 5/3/2022

Agency Information Collection Activities; Comment Request; Transition and Postsecondary Programs for Students With Intellectual Disabilities (TPSID) Evaluation Protocol

In October 2020, the Institute for Community Inclusion (ICI), UMass Boston received a five-year cooperative agreement from the Office of Postsecondary Education to serve as the National Coordinating Center (NCC) for colleges and universities implementing inclusive higher education programs for students with intellectual disabilities, including 22 newly-funded model demonstration projects aimed at creating inclusive comprehensive transition and postsecondary programs for students with intellectual disabilities known as Transition and Postsecondary Programs for Students with Intellectual Disabilities (TPSIDs). To reduce respondent burden, the NCC has streamlined and simplified the previously approved evaluation system for the TPSID programs. The NCC will enhance the collection and analyses of longitudinal follow-up data from the new 22 TPSID model programs via an already developed and previously OMB approved evaluation system for the TPSID programs. The revised data collection system is part of an evaluation effort. The system will collect program data at the institutions from TPSID program staff via an online, secure data management system.

Federal Agency: Office of Postsecondary Education (OPE), Department of Education (ED)

Affected Area: Office of Disability Services

Comments Due: 5/3/2022

Certain New Chemicals; Receipt and Status Information for January 2022

EPA is required under the Toxic Substances Control Act (TSCA) to make certain information publicly available and to publish information in the Federal Register pertaining to submissions, including notice of receipt of a Premanufacture notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. This document covers the period from 01/01/2022 to 01/31/2022.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

Comments Due: 3/30/2022

Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Applications and Veterinary Master Files

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information associated with new animal drug applications and veterinary master files.

Federal Agency: Food and Drug Administration, HHS

Affected Area: ORED, Animal Care

Construction Standards on Posting Emergency Telephone Numbers and Floor Load Limits; Extension of the Office of Management and Budget’s (OMB) Approval of Information Collection (Paperwork) Requirements

OSHA solicits public comments concerning the proposal to extend the Office of Management and Budget’s (OMB) approval of the information collection requirements specified in the Construction Standards on Posting Emergency Telephone Numbers and Maximum Safe Floor Load Limits.

Federal Agency: Occupational Safety and Health Administration (OSHA), Labor

Affected Area: Campus Development, Construction Administration

Comments Due: 5/2/2022

Agency Information Collection Activities; Proposed Renewal and Request for Comment; Consolidation of Certain Reporting and Recordkeeping Under Section 8 of the Toxic Substances Control Act (TSCA)

In compliance with the Paperwork Reduction Act (PRA), this document announces that EPA is planning to submit a request to renew and consolidate existing approved Information Collection Requests (ICRs) to the Office of Management and Budget (OMB). Before submitting the consolidated ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection that is summarized in this document. The consolidated ICR is entitled: “Reporting and Recordkeeping Under Section 8 of the Toxic Substances Control Act (TSCA)” and is identified under EPA ICR No. 2703.01 and OMB Control No. 2070-[NEW]. EPA is consolidating several ICRs covering reporting and recordkeeping activities under TSCA Section 8 to streamline the presentation of the paperwork burden estimates for these various activities and eliminate any duplication, which will in turn is expected to reduce the administrative burden for both the public reviewers and the Agency. The ICR and accompanying materials are available in the docket for public review and comment.

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

Comments Due: 5/9/2022

Release of Volumes 1 and 2 of the Integrated Review Plan for the Lead National Ambient Air Quality Standards

On or about March 4, 2022, the Environmental Protection Agency (EPA) is making available to the public, Volumes 1 and 2 of the

Integrated Review Plan for the Lead National Ambient Air Quality Standards

(IRP). The national ambient air quality standards (NAAQS) for lead (Pb) are set to protect the public health and the public welfare from Pb in ambient air. Volume 1 of the IRP contains contextual background material and the anticipated schedule for the current review of the air quality criteria and NAAQS for Pb. Volume 2 identifies policy-relevant issues in the review and describes key considerations in EPA’s development of the Integrated Science Assessment (ISA). The ISA provides the scientific basis for the EPA’s decisions, in conjunction with additional technical and policy assessments, for the review of the NAAQS, as described in the Clean Air Act, section 108(a).

Federal Agency: Environmental Protection Agency (EPA)

Affected Area: EHS

Comments Due: 4/4/2022

Applications for New Awards; Fulbright-Hays Faculty Research Abroad (FRA) Fellowship Program

The Department of Education (Department) is issuing a notice inviting applications (NIA) for fiscal year (FY) 2022 for the Fulbright-Hays Faculty Research Abroad (FRA) Fellowship Program, Assistance Listing Number 84.019A. This notice relates to the approved information collection under OMB control number 1840-0005.

Federal Agency: Department of Education

Affected Area: OAA, ORED

Agency Information Collection Activities; Comment Request; William D. Ford Federal Direct Loan Program (Direct Loan Program) Promissory Notes and Related Forms

The Direct Subsidized Loan and Direct Unsubsidized Loan Master Promissory Note (Subsidized/Unsubsidized MPN) serves as the means by which an individual agrees to repay a Direct Subsidized Loan and/or Direct Unsubsidized Loan. The Direct PLUS Loan Master Promissory Note (PLUS Loan MPN) serves as the means by which an individual applies for and agrees to repay a Direct PLUS Loan. If a Direct PLUS Loan applicant is determined to have an adverse credit history, the applicant may qualify for a Direct PLUS Loan by obtaining an endorser who does not have an adverse credit history. The Endorser Addendum serves as the means by which an endorser agrees to repay the Direct PLUS Loan if the borrower does not repay it. An MPN is a promissory note under which a borrower may receive loans for a single or multiple academic years. The MPN explains the terms and conditions of the loans that are made under the MPN.

Federal Agency: Department of Education

Affected Area: Student Financial Aid

Comments Due: 5/16/2022

Agency Information Collection Activities; Comment Request; Public Service Loan Forgiveness Reconsideration Request

The Department of Education (Department) is requesting an emergency clearance for a new information collection at the same time requesting a 60-day public comment period. This collection will be used to obtain information from federal student loan borrowers to determine eligibility for reconsideration of their Public Service Loan Forgiveness (PSLF) or Temporary Expanded Public Service Loan Forgiveness (TEPSLF) denial notification on the basis of payment counts or employer eligibility determinations pursuant to a settlement agreement between the Department and the American Federation of Teachers (ATF) which was signed on October 12, 2021. The settlement between the Department and the AFT requires that “as soon as practicable but no later than April 30, 2022, the Department will establish an interim reconsideration process that will be available to any borrower whose application for PSLF or TEPSLF has been or is denied”. In order to meet the requirements of this settlement, the Department must gather the information needed from the borrowers to reconsider their denial. This collection will allow for the collection and review of such reconsideration requests.

Federal Agency: Federal Student Aid (FSA), Department of Education (ED)

Affected Area: Student Financial Aid

Comments Due: 3/29/2022

Items of Interest

Comments to Request for Information on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing (NOT-OD-22-029)

COGR appreciates the opportunity to respond to the Request for Information on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy (“GDS Policy”). COGR and its member institutions recognize the important role that timely and robust data sharing plays in both scientific advances and efforts to promote reproducibility and research integrity. Yet, we also appreciate that the sharing of data, particularly human genomic data, raises complex privacy and consent issues, and we commend NIH for seeing public input in this area.

Federal Agency: National Institutes of Health (NIH)

Affected Area: Privacy, Compliance OIT, ORED, UMC

Lawmakers plan March 8 vote on U.S. government funding

WASHINGTON, March 1 (Reuters) – Congress is expected to vote March 8 on a spending bill to fund U.S. government operations through the end of September, House Majority Leader Steny Hoyer said on Tuesday.

Biden Puts Biomedical Research at the Heart of His ‘Unity’ Plan

President Joe Biden’s spotlight on his cancer moonshot and a proposed new research entity in the State of the Union address Tuesday signals the White House’s reliance on biomedical innovation as a vehicle to advance bipartisan initiatives through Congress. Lawmakers told Bloomberg Government on Wednesday they’re hoping to fund a new medical research agency as part of a forthcoming FY 2022 spending bill, which must pass by March 11.

The Role Of Research At Universities: Why It Matters

Teaching and learning, research and discovery, synthesis and creativity, understanding and engagement, service and outreach. There are many “core elements” to the mission of a great university. Teaching would seem the most obvious, but for those outside of the university, “research” (taken to include scientific research, scholarship more broadly, as well as creative activity) may be the least well understood. This creates misunderstanding of how universities invest resources, especially those deriving from undergraduate tuition and state (or other public) support, and the misperception that those resources are being diverted away from what is believed should be the core (and sole) focus, teaching. This has led to a loss of trust, confidence, and willingness to continue to invest or otherwise support (especially our public) universities.

Inappropriate march-in actions would jeopardize public-private partnerships that make lifesaving medicines possible

For decades, partnerships among government-funded academic institutions and private companies in the United States have led to the discovery and development of innovative medicines that are improving, extending, and saving lives. My company’s treatment for advanced prostate cancer, Xtandi (enzalutamide), which emerged from a public-private collaboration, is an example of how this system works to benefit patients. Yet despite the clear health benefits and broad availability of Xtandi, some individuals and organizations want to use it as a test case for disrupting the technology transfer and medical innovation ecosystem that is the pathway to the treatments of tomorrow.

93 Academic Groups Oppose Measures Contrary to Academic Freedom

Ninety-three academic associations, led by the American Council on Education, have issued a joint statement opposing bills and other measures that would amount to “foreclosing evaluation of complex and challenging ideas.” The statement said, “Controversial and contentious topics deserve a place in the curriculum, but no matter how vigorous the classroom discussion, it should be respectful. Some campus speech is unacceptable, such as speech that violates the law, defames individuals, or threatens violence. Outside a few narrow exceptions, proposals to ban speech based on the idea expressed are not only constitutionally suspect but fundamentally at odds with the values of a free and open society.”

Cybersecurity for Government Contractors—2021 Update

The article looks at President Joe Biden’s May 12, 2021 Executive Order (EO), “Improving the Nation’s Cybersecurity,” which the authors note “seeks to harmonize, enhance, and extend existing cyber and supply chain security requirements across the government while operationalizing several new programs and frameworks to address existing and emerging threats.”

U of North Carolina’s Head of Research Cited for Research Misconduct

The vice chancellor for research at the University of North Carolina at Chapel Hill engaged in research misconduct when he plagiarized in his application for a federal grant for cancer research, according to a recent report from the federal Office of Research Integrity.

Congress poised to boost U.S. science funding, launch new health agency

U.S. research agencies would get budget boosts of roughly 5% this year under a final 2022 spending bill that congressional leaders unveiled early today and hope to pass in the next few days. But those amounts fall far short of aspirational funding levels for several science agencies that Congress is weighing under separate legislation now being negotiated.

Medical Research Funding Survives as Democrats Cut Covid Money

President Joe Biden’s proposed new biomedical research entity would receive $1 billion under the congressional spending plan released Wednesday. The research funding survived a last-minute cut of $15 billion for Covid testing and treatment supplies. The Senate expects to finalize the spending bill (H.R. 2471) next week. The current funding law expires Friday but the House is expected to pass a four-day stopgap to avoid a government shutdown and give the Senate time to deal with the omnibus legislation. The money for the Advanced Research Projects Agency for Health, or ARPA-H, comes almost a year after Biden first asked for $6.5 billion to fund the new entity over three years. The funding also comes about a week after Biden called on Congress to fund ARPA-H in his State of the Union address.

Everyone’ must prepare for university cyberattacks, says FBI agent

Colleges and universities, which manage federal research data in addition to the personal and financial information of students and staff, continue to face a barrage of ransomware and other cyberattacks, which often disrupt operations. Part of smoothing the response process involves determining an institution’s risk tolerance, which requires input from many offices and departments, said Kim Milford, executive director of the Research and Education Networks Information Sharing and Analysis Center. For example, chief financial officers should be involved in whether universities pay ransoms, she said.

Hunting and Wildlife Conservation Council; Call for Nominations; Extension

The Secretary of the Interior and the Director of the U.S. Fish and Wildlife Service seek nominations for membership on the Hunting and Wildlife Conservation Council (Council). This is a 15-day extension of the call for nominations published in the Federal Register on February 18, 2022.

Comments Due: 4/1/2022

Request for Nominations of Candidates for the National Environmental Education Advisory Council (NEEAC)

The U.S. Environmental Protection Agency (EPA or Agency Office of Public Engagement and Environmental Education is soliciting applications for environmental education professionals for consideration to serve on the National Environmental Education Advisory Council (NEEAC). There are multiple vacancies on the Advisory Council that must be filled. Additional avenues and resources may be utilized in the solicitation of applications. “In accordance with Executive Order 14035 (June 25, 2021), EPA values and welcomes opportunities to increase diversity, equity, inclusion and accessibility on its federal advisory committees. EPA’s federal advisory committees have a workforce that reflects the diversity of the American people.”

Comments Due: 4/13/2022

Ensuring Responsible Development of Digital Assets

While many activities involving digital assets are within the scope of existing domestic laws and regulations, an area where the United States has been a global leader, growing development and adoption of digital assets and related innovations, as well as inconsistent controls to defend against certain key risks, necessitate an evolution and alignment of the United States Government approach to digital assets. The United States has an interest in responsible financial innovation, expanding access to safe and affordable financial services, and reducing the cost of domestic and cross-border funds transfers and payments, including through the continued modernization of public payment systems. We must take strong steps to reduce the risks that digital assets could pose to consumers, investors, and business protections; financial stability and financial system integrity; combating and preventing crime and illicit finance; national security; the ability to exercise human rights; financial inclusion and equity; and climate change and pollution.

Rep. Jim Banks introduces bill to increase American universities’ transparency regarding foreign gifts

Rep. Jim Banks, R-Ind., introduced a bill Friday that would force American universities to be more transparent about foreign gifts and contracts. The Education Department in 2019 and 2020 began cracking down on schools’ acceptance of foreign gifts under Section 117 of the Higher Education Act in an effort to track the scope of money from countries like China and Qatar in the U.S. education system. That changed when President Biden took office. U.S. schools reported $1.6 billion in foreign gifts between July 1, 2020, and Jan. 20, 2021. Between Jan. 20, 2021 and November 2021, however, schools reported just $4.3 million in gifts over a longer time period, prompting questions from lawmakers about reporting requirements.

UA Compliance, Ethics, and Regulatory Affairs Office hires HIPAA Privacy Officer

The office of Compliance, Ethics, and Regulatory Affairs (CERA) is pleased to announce the hiring of a new Institutional HIPAA Privacy Officer, Ms. Ronda Lacey.  Ronda has over 25 years of experience in legal regulatory compliance with a concentration in health care compliance.  She has a JD, a BS and an MS in Pharmacy, and is current serving as the HIPAA Privacy Officer at Auburn University. 

With this hire, the institutional oversight and coordination of HIPAA Privacy will move to CERA, with Ronda serving as the primary HIPAA privacy contact for the covered entities on campus, and as a resource for researchers working with health care data.  Her knowledge, attitude, and experience will be invaluable to anyone working in these or other privacy areas.

Ronda will join CERA beginning March 1, 2022.  Please contact CERA with any privacy or HIPAA related questions at 205-348-2334 or privacy@ua.edu.