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