Compliance Alert – April 2022
- May 5th, 2022
- in Newsletter, Regulations
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. 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: 2022-03-09 – 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. 16-36-60, 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
Occupational Exposure to COVID-19 in Healthcare Settings
OSHA is partially reopening the comment period to allow for additional public comment on specific topics and is scheduling an informal public hearing on its interim final rule establishing an Emergency Temporary Standard (ETS), “Occupational Exposure to COVID-19.” The public hearing will begin on April 27, 2022.
Federal Agency: Occupational Safety and Health Administration (OSHA), Labor
Affected Area: UMC
Comments Due: 4/22/2022
Additions of Entities to the Entity List
In response to the Russian Federation’s (Russia’s) further invasion of Ukraine on February 24, 2022, the Department of Commerce is amending the Export Administration Regulations (EAR) by adding 120 entities under 120 entries to the Entity List. These 120 entities have been determined by the U.S. Government to be acting contrary to the national security interests or foreign policy of the United States and will be listed on the Entity List under the destinations of Belarus and Russia.
Federal Agency: Bureau of Industry and Security, Commerce
Affected Area: ORED, Research Compliance
The U.S. Environmental Protection Agency (EPA or the Agency) is issuing a technical amendment to modify the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) list of hazardous substances, to be consistent with the statutory provisions that currently comprise this list. These modifications include adding the Clean Air Act (CAA) HAP 1-Bromopropane and removing the Resource Conservation and Recovery Act (RCRA) vacated K-Code Wastes: K064, K065, K066, K090, and K091. The Agency is also adding clarifying language, correcting a Chemical Abstract Service Registry Number (CASRN), and modifying the formatting of hazardous substance isomers and homologs that are listed with parent substances.
Federal Agency: Environmental Protection Agency (EPA)
Affected Area: EHS
Schedules of Controlled Substances: Placement of Daridorexant in Schedule IV
On January 7, 2022, the United States Food and Drug Administration approved a new drug application for QUIVIVIQ (daridorexant) tablets for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place daridorexant and its salts in schedule IV of the Controlled Substances Act (CSA). In accordance with the CSA, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing daridorexant in schedule IV, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of such isomers is possible within the specific chemical designation, thereby facilitating the commercial distribution of QUIVIVIQ as a lawful controlled substance.
Federal Agency: Drug Enforcement Administration, Department of Justice
Affected Area: EHS, UAPD
Comments Due: 5/9/2022
Notification of Interpretation of Section 188 of the Workforce Innovation and Opportunity Act
This Notification is to inform the public that, consistent with the Supreme Court’s 2020 decision in Bostock v. Clayton County and Title IX of the Education Amendments of 1972, the U.S. Department of Labor (DOL), beginning April 7, 2022, will interpret the prohibition on discrimination on the basis of sex that is codified in Section 188 of the Workforce Innovation and Opportunity Act to include discrimination on the basis of sexual orientation. DOL will continue to interpret and enforce Section 188’s prohibition on discrimination on the basis of sex to include discrimination on the basis of gender identity and transgender status. This interpretation will guide DOL’s Civil Rights Center in processing complaints and conducting investigations and compliance reviews, but does not determine the outcome in any particular case or set of facts.
Federal Agency: Office of the Secretary, Labor
Affected Area: Title IX, EEO, HR
Requiring Online Submission of Applications for and Renewals of DEA Registration
This rule mitigates issues created by paper applications by simplifying the process by which registrants submit new applications for registration, or renew current registrations. Previously, DEA regulations permitted the aforementioned DEA Registration Forms (224/224a, 225/225a, 363/363a, and 510/510a) to be submitted either through a secure online portal or via delivery to DEA Headquarters.[1] This rule amends DEA regulations by requiring all registration and renewal applications be submitted only through the secure online portal. The Administration believes this rule will mitigate some of the issues associated with paper applications by reducing inefficiencies and facilitating the application process. After careful consideration, DEA has determined that it is not necessary to amend the proposed regulations related to batch processing, because the regulations currently allow, and will continue to allow, the submission of batch applications. This rule is consistent with agency-wide efforts to reduce reliance on antiquated paper submissions and to facilitate electronic document processing.[2]
Federal Agency: Drug Enforcement Administration
Affected Area: Research, Research Compliance, CCHS, UMC
Proposed Rules
Pre-Enforcement Notice and Conciliation Procedures
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, HR
Proposed Deletion From the National Priorities List
The Environmental Protection Agency (EPA) is issuing a Notice of Intent to delete five sites and partially delete six sites from the National Priorities List (NPL) and requests public comments on this proposed action. The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the state, through its designated state agency, have determined that all appropriate response actions under CERCLA, other than operations and maintenance of the remedy, monitoring and five-year reviews, where applicable, have been completed. However, this deletion does not preclude future actions under Superfund.
Federal Agency: Environmental Protection Agency (EPA)
Affected Area: EHS
Comments Due: 4/21/2022
The Food and Drug Administration (FDA, we, or Agency) is extending the comment period for the notice of public hearing that appeared in the Federal Register of January 13, 2022. In the notice, FDA requested comments on scientific data and information related to the residue of carcinogenic concern for the new animal drug carbadox. 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: 6/10/2022
Improve Tracking of Workplace Injuries and Illnesses
OSHA is proposing to amend its occupational injury and illness recordkeeping regulation to require certain employers to electronically submit injury and illness information to OSHA that employers are already required to keep under the recordkeeping regulation. Specifically, OSHA proposes to amend its regulation to require establishments with 100 or more employees in certain designated industries to electronically submit information from their OSHA Forms 300, 301, and 300A to OSHA once a year. Establishments with 20 or more employees in certain industries would continue to be required to electronically submit information from their OSHA Form 300A annual summary to OSHA once a year. OSHA also proposes to update the classification system used to determine the list of industries covered by the electronic submission requirement. In addition, the proposed rule would remove the current requirement for establishments with 250 or more employees, not in a designated industry, to electronically submit information from their Form 300A to OSHA on an annual basis. OSHA intends to post the data from the proposed annual electronic submission requirement on a public website after identifying and removing information that reasonably identifies individuals directly, such as individuals’ names and contact information. Finally, OSHA is proposing to require establishments to include their company name when making electronic submissions to OSHA.
Federal Agency: Occupational Safety and Health Administration (OSHA), Labor
Affected Area: HR, Risk Management
Comments Due: 5/31/2022
Pre-Enforcement Notice and Conciliation Procedures
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: Office of Federal Contract Compliance Programs, Labor
Affected Area: EEO, HR
Comments Due: 4/21/2022
Energy Conservation Program: Energy Conservation Standards for Room Air Conditioners
The Energy Policy and Conservation Act, as amended (“EPCA”), prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including room air conditioners. EPCA also requires the U.S. Department of Energy (“DOE”) to periodically determine whether more-stringent standards would be technologically feasible and economically justified, and would result in significant energy savings. In this notice of proposed rulemaking (“NOPR”), DOE proposes amended energy conservation standards for room air conditioners, and also announces a webinar to receive comment on these proposed standards and associated analyses and results.
Federal Agency: Office of Energy Efficiency and Renewable Energy, Department of Energy
Affected Area: Facilities and Grounds
EPA proposes certain amendments to the electronic manifest (e-Manifest) regulations concerning the e-Manifest program and system. Specifically, EPA is proposing changes to manifest regulations for shipments of hazardous waste that are exported for treatment, storage, and disposal. These proposed changes follow EPA’s e-Manifest User Fee final rule, promulgated in January 2018, which stated that the scope of the e-Manifest requirements and system would not extend to U.S. export shipments of hazardous wastes until the Agency determined, through separate rulemaking, which entity in the export process would be responsible for submitting export manifests to the e-Manifest system and paying the associated user fees. EPA is also proposing regulatory changes to the RCRA hazardous waste export and import shipment international movement document-related requirements to more closely link the manifest data with the international movement document data. In addition, EPA is proposing regulatory amendments to three manifest-related reports (i.e., discrepancy, exception, and unmanifested waste reports) and is requesting public comment on changes to the manifest form. EPA is also requesting public comment with respect to how the Agency can begin to integrate biennial reporting requirements with e-Manifest data. Additionally, EPA is proposing conforming regulatory changes to the Toxic Substances Control Act (TSCA) manifest regulations for polychlorinated biphenyls (PCB) wastes. Finally, the Agency is proposing to make technical corrections to fix typographical errors in the e-Manifest and movement document regulations.
Federal Agency: Environmental Protection Agency (EPA)
Affected Area: EHS
Comments Due: 5/31/2022
The Office for Civil Rights (OCR) at the United States Department of Health and Human Services (HHS or the Department) is issuing this Request for Information (RFI) to solicit public comment on certain provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act, namely: The consideration of recognized security practices of covered entities and business associates when OCR makes determinations regarding fines, audits, and remedies to resolve potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule; and the distribution to harmed individuals of a percentage of civil money penalties (CMPs) or monetary settlements collected pursuant to the HITECH Act, which requires the Secretary of HHS (Secretary) to establish by regulation, and based upon recommendations from the Government Accountability Office (GAO), a methodology under which an individual who is harmed by an act that constitutes an offense under certain provisions of the HITECH Act or the Social Security Act relating to privacy or security may receive a percentage of any CMP or monetary settlement collected by OCR with respect to such offense.
Federal Agency: Office for Civil Rights, Office of the Secretary, Department of Health and Human Services
Affected Area: CERA, OIT
Comments Due: 6/6/2022
Affordability of Employer Coverage for Family Members of Employees
This document contains proposed regulations under section 36B of the Internal Revenue Code (the “Code”) that would amend the existing regulations regarding eligibility for the premium tax credit (“PTC”) to provide that affordability of employer-sponsored minimum essential coverage (employer coverage) for family members of an employee is determined based on the employee’s share of the cost of covering the employee and those family members, not the cost of covering only the employee. The proposed regulations also would add a minimum value rule for family members of employees based on the benefits provided to the family members. The proposed regulations would affect taxpayers who enroll, or enroll a family member, in individual health insurance coverage through a Health Insurance Exchange (“Exchange”) and who may be allowed a PTC for the coverage. This document also provides a notice of a public hearing on these proposed regulations.
Federal Agency: Internal Revenue Service
Affected Area: HR
Comments Due: 9/1/2022
The Drug Enforcement Administration proposes placing two phenethylamine hallucinogens, as identified in this proposed rule, in schedule I of the Controlled Substances Act. This action is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances for one of these substances. If finalized, this action would impose 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 these two specific controlled substances.
Federal Agency: Drug Enforcement Administration
Affected Area: UMC, ORED, UAPD
Comments Due: 6/10/2022
Schedules of Controlled Substances; Exempted Prescription Products
The Drug Enforcement Administration proposes to revoke the exempted prescription product status for all butalbital products previously granted exemptions. Upon publication of a final rule, these products shall become subject to all schedule III controls under the Controlled Substances Act. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule III controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess) or propose to handle butalbital products. This rulemaking also proposes to make changes to our regulations to clarify that DEA may revoke “(either individually or categorically)” any previously granted exemptions, and adds regulations to clarify that products exempted from application of all or any part of the Controlled Substances Act are listed in the Table of Exempted Prescription Products available on the DEA Diversion Control website (https://www.deadiversion.usdoj.gov/).
Federal Agency: Drug Enforcement Administration
Affected Area: UMC, UAPD
Comments Due: 5/12/2022
The Environmental Protection Agency (EPA) is proposing 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. TSCA requires that EPA address the unreasonable risks of injury to health and environment by rule and to apply requirements to the extent necessary so that chrysotile asbestos no longer presents such risks. Therefore, to address the unreasonable risk identified in the TSCA Risk Evaluation for Asbestos, Part 1 from chrysotile asbestos, EPA is proposing to prohibit manufacture (including import), processing, distribution in commerce and commercial use of chrysotile asbestos for chrysotile asbestos diaphragms for use in the chlor-alkali industry, chrysotile asbestos-containing sheet gaskets used in chemical production, chrysotile asbestos-containing brake blocks used in the oil industry, aftermarket automotive chrysotile asbestos-containing brakes/linings, other chrysotile asbestos-containing vehicle friction products, and other chrysotile asbestos-containing gaskets. EPA also is proposing to prohibit manufacture (including import), processing, and distribution in commerce of aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use, and other chrysotile asbestos-containing gaskets for consumer use. EPA is also proposing disposal and recordkeeping requirements for these conditions of use.
Federal Agency: Environmental Protection Agency
Affected Area: EHS
Comments Due: 6/13/2022
Submission for OMB Review; Certain Federal Acquisition Regulation Part 22 Labor 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 certain Federal Acquisition Regulation (FAR) part 22 labor requirements.
Federal Agency: Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA)
Affected Area: Procurement
Comments Due: 4/20/2022
Information Collection; Certain Federal Acquisition Regulation Part 32 Requirements
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 a revision concerning certain Federal Acquisition Regulation part 32 requirements.
Federal Agency: Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA)
Affected Area: ORED, Grant Accounting
Comments Due: 5/20/2022
The Coast Guard announces its intent to enter into a cooperative research and development agreement (CRADA) with companies to evaluate a detect and avoid (DAA) system to determine its potential use in a maritime environment to enable the Coast Guard to safely fly small UAS (SUAS) beyond visual line of sight (BVLOS). The Coast Guard will conduct flight testing and evaluations of SUAS DAA technology against CG mission scenarios. From our previous solicitations, the Coast Guard is currently considering partnering with AeroVironment (AV) Inc. and solicits public comment on the possible participation of other parties in the proposed CRADA, and the nature of that participation. The Coast Guard also invites other potential non-Federal participants, who have the interest and capability to bring similar contributions to this type of research, to consider submitting proposals for consideration in similar CRADAs.
Federal Agency: Coast Guard, DHS
Affected Area: CERA
Comments Due: 4/25/2022
This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0071, abstracted below to OMB for review and approval of an extension of the currently approved collection under the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. The collection involves the submission of information from former employees who are interested in a Law Enforcement Officers Safety Act (LEOSA) Identification (ID) Card, a retired badge, and/or a retired credential.
Federal Agency: Transportation Security Administration, DHS
Affected Area: UAPD
Comments Due: 4/25/2022
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 Occupational Exposure to Hazardous Chemicals in Laboratories.
Federal Agency: Occupational Safety and Health Administration (OSHA), Labor
Affected Area: EHS, ORED, HR
Comments Due: 5/27/2022
Privacy Act of 1974; System of Records
As required by the Privacy Act of 1974, and Office of Management and Budget (OMB) Circular No. A-108, this notice is a new Privacy Act System of Records titled Contractor and Visitor Public Health Emergency Records DOL/OASAM-38, which include information on contractor employees, special government employees and student volunteers who work in, as well as visitors to, Department of Labor (DOL) facilities during declared public health emergencies. The system contains information provided by the contractor’s employees including such information as their applicable vaccination or medical countermeasure status and whether they are experiencing symptoms associated with the public health emergency. Each contractor with employees who will work in DOL facilities (regardless of whether the contract is with DOL or another Federal agency such as GSA) will be asked to confirm if its employees have been vaccinated or have received appropriate medical countermeasures, in addition, the contractor will be required to ensure that its employees follow the guidelines specified for working in DOL facilities, for example, to mitigate the spread of COVID-19, not fully vaccinated employees are required to wear masks and maintain physical distancing. Visitors to DOL facilities will also be asked to provide information about their vaccination or medical countermeasure status and information about whether they are experiencing any symptoms associated with the public health emergency. Contractors, special government employees and student volunteers may also be asked to provide proof of their vaccination status.
Federal Agency: Department of Labor
Affected Area: CERA
Comments Due: 4/25/2022
In accordance with 29 CFR 1920.1003, 1915.1003, and 1926.1103, the 13 Carcinogens Standard protects workers from the adverse health effects that may result from their exposure to the specified carcinogens. The following is a brief description of the collection of information requirements contained in the 13 Carcinogens Standard: Establishing and implementing a medical surveillance program for workers assigned to enter regulated areas; informing workers of their medical examination results; and providing workers with access to their medical records. Further, employers must retain worker medical records for specified time periods and make them available upon request to OSHA and NIOSH. For additional substantive information about this ICR, see the related notice published in the Federal Register on December 15, 2021 (86 FR 71286).
Federal Agency: Department of Labor
Affected Area: HR, UMC
Comments Due: 4/22/2022
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).
Federal Agency: Department of Transportation
Affected Area: ORED, Grant Accounting, Construction Administration
Comments Due: 5/20/2022
The Secretary is authorized to require any “resident or citizen of the United States or a person in, and doing business in, the United States, to . . . keep records and file reports, when the resident, citizen, or person makes a transaction or maintains a relation for any person with a foreign financial agency.” The term “foreign financial agency” (FFA) means any person engaging in any activities outside the United States of a “financial agency,” which the statute defines as “a person acting for a person . . . as a financial institution, bailee, depository trustee, or agent, or acting in a similar way related to money, credit, securities, gold, or a transaction in money, credit, securities or gold, or a service provided with respect to money, securities, futures, precious metals, stones and jewels, or value that substitutes for currency.” The Secretary is also authorized to prescribe exemptions to the reporting requirement and to prescribe other matters the Secretary considers necessary to carry out 31 U.S.C. 5314. The regulations implementing reports of transactions with foreign financial agencies are found at 31 CFR 1010.360.
Federal Agency: Department of the Treasury
Affected Area: Procurement, CERA
Comments Due: 4/29/2022
Increase in Maximum Tuition and Fee Amounts Payable Under the Post-9/11 GI Bill
For the 2022-2023 AY, the Post-9/11 GI Bill allows the Department of Veterans Affairs (VA) to pay the actual net cost of tuition and fees not to exceed the in-state amounts for students pursuing training at public schools; $26,381.37 for students training at private and foreign schools; $26,381.37 for students training at non-degree granting schools; $15,075.05 for students training at vocational flight schools; and $12,813.78 for students training at correspondence schools. In addition, the entitlement charge for individuals receiving reimbursement of the costs associated with taking a licensing, certification, or national test is pro-rated based on the actual amount of the fee charged for the test relative to the rate of $2,200.96 for one month. The maximum reimbursable amount for licensing and certification tests is $2,000. There is no maximum reimbursable amount for national tests.
Federal Agency: Department of Veterans Affairs, Financial Aid
Affected Area: Student Financial Aid, Office of Veterans
Information Collection; Federal Acquisition Regulation Part 7 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
Comments Due: 6/3/2022
The U.S. Department of Education (Department) is issuing this notice regarding the automatic extension of HEERF grantees’ performance period. The performance period for all open HEERF grants with a balance greater than $1,000 is extended through June 30, 2023.
Federal Agency: Office of Postsecondary Education, Department of Education
Affected Area: OSP, Financial Aid
The Environmental Protection Agency is planning to submit an information collection request (ICR), “Prevention of Significant Deterioration and Nonattainment New Source Review” (EPA ICR No. 1230.34, OMB Control No. 2060-0003) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed renewal of the ICR, which is currently approved through January 31, 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.
This ICR is for activities related to the implementation of the EPA’s New Source Review (NSR) program, for the time period between January 1, 2022, and January 31, 2023, and renews the previous ICR. Title I, part C of the Clean Air Act (CAA or the Act)—“Prevention of Significant Deterioration,” and part D—“Plan Requirements for Nonattainment Areas,” require all states to adopt preconstruction review programs for new or modified stationary sources of air pollution. In addition, the provisions of section 110 of the Act include a requirement for states to have a preconstruction review program to manage the emissions from the construction and modification of any stationary source of air pollution to assure that the National Ambient Air Quality Standards are achieved and maintained. Tribes may choose to develop implementation plans to address these requirements.
Federal Agency: Environmental Protection Agency (EPA)
Affected Area: EHS
Comments Due: 6/7/2022
Section 6(e)(1) of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2605(e), directs EPA to regulate the marking and disposal of PCBs. Section 6(e)(2) bans the manufacturing, processing, distribution in commerce, and use of PCBs in other than a totally enclosed manner. TSCA section 6(e)(3) establishes a process for obtaining exemptions from the prohibitions on the manufacture, processing, and distribution in commerce of PCBs. Since 1978, EPA has promulgated numerous rules addressing all aspects of the life cycle of PCBs as required by the statute. The regulations are intended to prevent the improper handling and disposal of PCBs and to minimize the exposure of human beings or the environment to PCBs. These regulations have been codified in the various subparts of 40 CFR 761. There are approximately 100 specific reporting, third-party reporting, and recordkeeping requirements covered by 40 CFR 761. To meet its statutory obligations to regulate PCBs, EPA must obtain sufficient information to conclude that specified activities do not result in an unreasonable risk of injury to health or the environment. EPA uses the information collected under the 40 CFR 761 requirements to ensure that PCBs are managed in an environmentally safe manner and that activities are being conducted in compliance with the PCB regulations. The information collected by these requirements will update the Agency’s knowledge of ongoing PCB activities, ensure that individuals using or disposing of PCBs are held accountable for their activities, and demonstrate compliance with the PCB regulations. Specific uses of the information collected include determining the efficacy of a disposal technology; evaluating exemption requests and exclusion notices; targeting compliance inspections; and ensuring adequate storage capacity for PCB waste. This collection addresses the several information reporting requirements found in the PCB regulations.
Federal Agency: Environmental Protection Agency (EPA)
Affected Area: EHS
Comments Due: 6/6/2022
This notice announces the availability of EPA’s draft human health and ecological risk assessments for the registration review of anthraquinone for public comment. This notice also announces the availability of the anthraquinone Final Work Plan.
Federal Agency: Environmental Protection Agency (EPA)
Affected Area: EHS, Facilities and Grounds
Comments Due: 6/6/2022
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” As more medical devices are becoming interconnected, cybersecurity threats have become more numerous, more frequent, more severe, and more clinically impactful. As a result, ensuring medical device safety and effective includes adequate medical device cybersecurity, as well as its security as part of the larger system. In 2018, FDA proposed updates to the final guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” and issued a draft guidance of the same name. This draft guidance replaces the 2018 draft guidance. This draft guidance is intended to further emphasize the importance of ensuring that devices are designed securely, are designed to be capable of mitigating emerging cybersecurity risks throughout the Total Product Life Cycle, and to clearly outline FDA’s recommendations for premarket submission content to address cybersecurity concerns. This draft guidance is not final nor is it for implementation at this time.
Federal Agency: Food and Drug Administration, HHS
Affected Area: UMC
Comments Due: 7/7/2022
Section 2712 of the Public Health Service Act (PHS Act), as added by the Affordable Care Act, and the Departments’ final regulations (26 CFR 54.9815-2712, 29 CFR 2590.715-2712, 45 CFR 147.2712), provide rules regarding rescissions of health coverage for group health plans and health insurance issuers offering group or individual health insurance coverage. Under the statute and final regulations, a group health plan, or a health insurance issuer offering group or individual health insurance coverage, generally must not rescind coverage except in the case of fraud or an intentional misrepresentation of a material fact. The rescission notice will be used by health plans to provide advance notice to certain individuals that their coverage may be rescinded. For additional substantive information about this ICR, see the related notice published in the Federal Register on December 13, 2021 (86 FR 70866).
Federal Agency: Department of Labor
Affected Area: HR, EEO
Comments Due: 5/9/2022
The National Science Foundation (NSF) is announcing plans to renew this collection. In accordance with the requirements of the Paperwork Reduction Act of 1995, we are providing opportunity for public comment on this action. After obtaining and considering public comment, NSF will prepare the submission requesting Office of Management and Budget (OMB) clearance of this collection for no longer than 3 years.
Federal Agency: National Science Foundation
Affected Area: ORED
Comments Due: 6/13/2022
Compounding Animal Drugs From Bulk Drug Substances; Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #256 entitled “Compounding Animal Drugs from Bulk Drug Substances.” This guidance describes FDA’s current thinking about compounding animal drugs from bulk drug substances, identifies our enforcement priorities with respect to drugs compounded from bulk drug substances, and describes circumstances under which FDA generally does not intend to take action against veterinarians or pharmacists in either State-licensed pharmacies or Federal facilities, who compound animal drugs from bulk drug substances. We are also announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).
Federal Agency: Food and Drug Administration
Affected Area: Animal Care, ORED
Comments Due: 5/16/2022
Availability of the Draft IRIS Toxicological Review of Formaldehyde (Inhalation)
The Environmental Protection Agency (EPA) is announcing a 60-day public comment period associated with release of the draft Integrated Risk Information System (IRIS) Toxicological Review of Formaldehyde (Inhalation). The draft document was prepared by the Center for Public Health and Environmental Assessment (CPHEA) within EPA’s Office of Research and Development (ORD). EPA is releasing this draft IRIS assessment for public comment in advance of an external peer review conducted by the National Academy of Sciences, Engineering, and Medicine (NASEM). Public comments received will be provided to the external peer reviewers. NASEM, a contractor to EPA, will convene a public meeting to discuss the draft report with the public during Step 4 of the IRIS Process. The external peer reviewers will consider public comments submitted in response to this notice and provided at the public meeting when reviewing this document. EPA will consider all comments received when revising the document post-peer review. This draft assessment is not final as described in EPA’s information quality guidelines, and it does not represent, and should not be construed to represent Agency policy or views.
Federal Agency: Environmental Protection Agency
Affected Area: EHS
Comments Due: 4/13/2022
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: Department of Education
Affected Area: Student Financial Aid
Comments Due: 6/13/2022
Agency Information Collection Activities; Comment Request; Part 601 Preferred Lender Arrangements
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: Department of Education
Affected Area: Student Financial Aid
Comments Due: 6/13/2022
Funding Opportunity: Staff Sergeant Parker Gordon Fox Suicide Prevention Grant Program
The Department of Veterans Affairs (VA) is announcing the opportunity of funds for suicide prevention services grants under the Staff Sergeant Parker Gordon Fox Suicide Prevention Grant Program (SSG Fox SPGP). The SSG Fox SPGP enables the Office of Mental Health and Suicide Prevention (OMHSP) within the Veterans Health Administration (VHA) to provide financial assistance through a 3-year community-based grant program to eligible entities to provide, or coordinate the provision of, suicide prevention services to eligible Veterans and their families. Funding offered under this Notice of Funding Opportunity (NOFO) responds to the mounting need to reach Veterans at risk for suicide in their communities. This Notice contains information concerning the SSG Fox SPGP, the application process and the amount of funding available. Awards made for suicide prevention services grants will fund operations beginning on or around September 1, 2022.
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), Ethnicity, Race, Gender and Disability Self-Identification Form for nominees considered for appointment on federal advisory committees at the Environmental Protection Agency (EPA ICR Number 2717.01, OMB Control Number 2030-NEW) 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 request for approval of a new collection. 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.
Comments Due: 6/21/2022
Items of Interest
The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office requests public nominations of scientific experts to form a Panel to review the draft EPA document titled Cancer Risk Coefficients for Environmental Exposure to Radionuclides (Federal Guidance Report No. 16). This draft document is an update to Federal Guidance Report No. 13, and provides new radionuclide-specific cancer risk coefficients for incidence and mortality associated with internal radionuclide exposure from ingestion and inhalation, and external exposure to radionuclides distributed in air, water, and soil.
Comments Due: 4/11/2022
HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee). ACHDNC provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS (Secretary). HRSA is seeking nominations of qualified candidates for appointment to two positions on the Committee beginning in 2023, each serving a term of up-to 4 years.
Comments Due: 4/11/2022
HRSA is seeking nominations from organizations to send representatives to be a liaison to the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee). Selections will be based on a review of the organization’s subject area of expertise, mission, relevancy, and benefit provided relative to the Committee’s purpose. The organizational representatives are non-voting liaisons. The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS.
Comments Due: 5/2/2022
This notice seeks nominations for HUD’s Tribal Intergovernmental Advisory Committee (TIAC). It provides details on who is eligible to serve on TIAC and how Tribal governments can nominate persons to serve on TIAC on their behalf. Additionally, this notice announces the structure of the TIAC, informed by Tribal feedback.
Comments Due: 5/31/2022
Solicitation of Nominations for Appointment to the Advisory Committee on Homeless Veterans
The Department of Veterans Affairs (VA) is seeking nominations of qualified candidates to be considered for appointment to the Advisory Committee on Homeless Veterans (ACHV) (hereinafter in this section referred to as “the Committee”).
Comments Due: 4/8/2022
The Department of Veterans Affairs (VA) is seeking nominations of qualified candidates to be considered for appointment as a member of the Veterans and Community Oversight and Engagement Board (herein-after referred in this section to as “the Board”) for the VA West Los Angeles Campus in Los Angeles, CA (“Campus”) for the 2022 membership cycle.
Comments Due: 4/21/2022
The bill—sponsored by Sens. Dianne Feinstein (D-CA), Brian Schatz (D-HI) and Chuck Grassley (R-IA)—is titled the Cannabidiol and Marihuana Research Expansion Act. It cleared the full chamber unanimously, without debate. It would streamline the application process for researchers who want to study the plant and to encourage the Food and Drug Administration (FDA) to develop cannabis-derived medicines. It would also clarify that physicians are allowed to discuss the risks and benefits of marijuana with patients and require the U.S. Department of Health and Human Services (HHS) to submit a report on those potential health benefits, as well one on barriers to cannabis research and how to overcome those obstacles.
It’s Not a Grant…It’s Not a Contract…It’s an Other Transaction!
What does this mean? “Other Transactions” are not grants. They are neither contracts nor cooperative agreements. Other Transactions are a unique type of legal funding instrument. Generally, these awards are also not subject to the Federal Acquisition Regulation or grant regulations (unless otherwise noted for certain provisions in the terms and conditions of award). They are, however, subject to the Other Transactions Authority that governs the initiative, as well as applicable legislative mandates.
The Abject Failure of IRBs (The Chronicle)
Some of the degeneration of IRBs is a result of the usual suspects: fear of legal risk on the part of universities, petty bureaucrats with delusions of heroism and an infantilizing view of research subjects, generalized incompetence operating in an environment with little accountability, and genuine resource constraints. But some of it is also because of the Procrustean task of fitting research ethics into the machinery of university administration. When our completed research is peer reviewed before publication, that review is typically done by scholars who are not only within our discipline, but experts in our research niches. Most researchers would find it comical to imagine a sociologist reviewing an article by a biologist and vice versa. We would expect that the results of such a process would not be particularly informative and that such non-expert reviewers would very often disagree on their assessments of the research. We would be right.
As part of its enforcement efforts, OFCCP conducts compliance evaluations of federal contractors to ensure they are meeting their nondiscrimination and affirmative action obligations, and the notice requirements in Executive Order 13496. This directive explains OFCCP’s compliance evaluation policies and expectations for contractors. Specifically, this directive clarifies OFCCP’s policies regarding scheduling of contractors for compliance evaluations, including enhancing the agency’s neutral scheduling procedures to reach a broader universe of federal contractors and eliminating delays in scheduling. It also describes contractors’ obligations to provide timely submission of complete Affirmative Action Programs (AAPs) and support data, supplemental information, and access to employees, applicants, and other witnesses.
Voluntary Resolution Agreement: Rhode Island Department of Children, Youth, and Families
This matter was initiated by four complaints filed with HHS and the U. S. Attorney’s Office for the District of Rhode Island alleging that DCYF failed or was failing to provide parents with disabilities an equal opportunity to participate in and benefit from DCYF’s programs and services. Three complaints specifically allege that DCYF failed to provide sign language interpreter services necessary for effective communication with parents who are deaf, during DCYF child protection investigations or when DCYF removed their children from their homes. The fourth complaint alleges that DCYF based conclusions about the parental capacity on a parent’s disability (epilepsy and co-occurring intellectual disabilities) and failed to provide reasonable modifications to its treatment plan.
The National Institute of Standards and Technology (NIST or Institute) invites and requests nomination of individuals for appointment to seven existing Federal Advisory Committees (Committees): Advisory Committee on Earthquake Hazards Reduction; Board of Overseers of the Malcolm Baldrige National Quality Award; Information Security and Privacy Advisory Board; Judges Panel of the Malcolm Baldrige National Quality Award; Manufacturing Extension Partnership Advisory Board; National Construction Safety Team Advisory Committee; and Visiting Committee on Advanced Technology. NIST will consider nominations received in response to this notice for appointment to the Committees, in addition to nominations already received. Registered Federal lobbyists may not serve on NIST Federal Advisory Committees in an individual capacity.
Request for Nominations for a Science Advisory Board 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 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 value. BenMAP is a shorthand title referring to the EPA’s Environmental Benefits Mapping and Analysis Program, which has recently been updated to a new software platform built with Java code for the interface. The panel will review the latest available public release version of the BenMAP software.
Comments Due: 4/26/2022
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the HICPAC. The HICPAC consists of 14 experts in fields including but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related medical fields. 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 infectious diseases, infection prevention, healthcare epidemiology, nursing, environmental and clinical microbiology, surgery, internal medicine, and public health. Federal employees will not be considered for membership. Members may be invited to serve for four-year terms. Selection of members is based on candidates’ qualifications to contribute to the accomplishment of HICPAC objectives https://www.cdc.gov/hicpac/.
Comments Due: 9/17/2022
Advisory Board on Toxic Substances and Worker Health
The Secretary of Labor (Secretary) invites interested parties to submit nominations for individuals to serve on the Advisory Board on Toxic Substances and Worker Health for Part E of the Energy Employees Occupational Illness Compensation Program Act (EEOICPA).
Comments Due: 5/5/2022
United States Merchant Marine Academy Advisory Council
The Maritime Administration (MARAD) is seeking to solicit members for the United States Merchant Marine Academy Advisory Council (Council). The Council will provide advice and recommendations to the Secretary of Transportation, MARAD, and the United States Merchant Marine Academy (Academy) on matters related to the Academy.
Comments Due: 5/20/2022
Solicitation of Nominations for Membership on the Treasury Advisory Committee on Racial Equity
The Treasury Department is soliciting nominations for membership on the Treasury Advisory Committee on Racial Equity (TACRE). The TACRE is composed of up to 25 members who will provide information, advice and recommendations to the Department of the Treasury on matters relating to the advancement of racial equity. This notice provides expectations for Committee members and announces the process for applying for membership on the Committee.
Comments Due: 4/15/2022
Continuing To Strengthen Americans’ Access to Affordable, Quality Health Coverage
On January 28, 2021, I signed Executive Order 14009 (Strengthening Medicaid and the Affordable Care Act), establishing that it is the policy of my Administration to protect and strengthen Medicaid and the Affordable Care Act (ACA) and to make high-quality healthcare accessible and affordable for every American. It directs executive departments and agencies (agencies) with authorities and responsibilities related to Medicaid and the ACA to review existing regulations, orders, guidance documents, policies, and any other similar agency actions (collectively, agency actions) to determine whether such agency actions are inconsistent with this policy.
Technical Advisory Committees; Notice of Recruitment of Members
The Bureau of Industry and Security (BIS), Department of Commerce is announcing its recruitment of candidates to serve on one of its six Technical Advisory Committees (“TACs” or “Committees”). TAC members advise the Department of Commerce on the technical parameters for export controls applicable to dual-use items (commodities, software, and technology) and on the administration of those controls. The TACs are composed of representatives from industry, academia, and the U.S. Government and reflect diverse points of view on the concerns of the exporting community. Industry representatives are selected from firms producing a broad range of items currently controlled for national security, non-proliferation, foreign policy, and short supply reasons or that are proposed for such controls. Representation from the private sector is balanced to the extent possible among large and small firms.
Six TACs are responsible for advising the Department of Commerce on the technical parameters for export controls and the administration of those controls within specified areas: Information Systems TAC: Control List Categories 3 (electronics), 4 (computers), and 5 (telecommunications and information security); Materials and Equipment TAC: Control List Categories 1 (materials, chemicals, microorganisms, and toxins) and 2 (materials processing); Sensors and Instrumentation TAC: Control List Category 6 (sensors and lasers); Transportation and Related Equipment TAC: Control List Categories 7 (navigation and avionics), 8 (marine), and 9 (propulsion systems, space vehicles, and related equipment); and the Emerging Technology TAC (identification of emerging and foundational technologies that may be developed over a period of five to ten years with potential dual-use applications). The sixth TAC, the Regulations and Procedures TAC, focuses on the Export Administration Regulations (EAR) and procedures for implementing the EAR.
Request for Nominations for the Science Advisory Board IRIS Chloroform (Inhalation) 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 draft EPA Integrated Risk Information System (IRIS) Toxicological Review of Chloroform (Inhalation). The draft cancer and non-cancer assessment includes a hazard identification analysis, which summarizes the available evidence on health effects that may be associated with environmental or occupational exposure, and dose-response analysis, which characterizes the quantitative relationship between chloroform inhalation exposure and each credible health hazard. The SAB Chloroform Review Panel will consider whether the conclusions found in the EPA’s draft assessment are clearly presented and scientifically supported. The Panel will also be asked to provide recommendations on how the assessment may be strengthened.
Comments Due: 4/29/2022
Public Research Universities Have Spent $14.5B on COVID Relief
An analysis by the Association of Public and Land-grant Universities has found that public research universities had spent nearly $14.5 billion, or over 70 percent of the federal COVID-19 relief grant dollars they received, as of Dec. 31, 2021. This includes the nearly $10 billion from the first two pandemic relief bills—the Coronavirus Aid, Relief, and Economic Security Act and the Coronavirus Response and Relief Supplemental Appropriations Act, as well as a substantial portion of the third round of funding that came from the American Rescue Plan Act. Funds were used to meet students’ basic needs, mitigate the spread of COVID-19 and shift to digital then hybrid instruction formats with unprecedented speed. Spending has continued this year.
Washington, DC – Federal emergency pandemic relief funding provided critical support to students and public universities amid a global public health emergency, according to a new analysis from the Association of Public and Land-grant Universities (APLU) released today. The analysis finds public research universities have spent the vast majority of federal pandemic relief funding they received to meet students’ basic needs, mitigate the spread of COVID-19, and shift to digital then hybrid instruction formats with unprecedented speed. “The public research university community is extraordinarily grateful for emergency pandemic relief funding lawmakers provided the higher education community,” said APLU President Peter McPherson. “We’re very pleased to see that public research universities have wisely used these resources to meet critical needs facing their students and campuses while slowing the spread of COVID-19.”
Introducing NIH’s New Scientific Data Sharing Website
NIH has a long-standing commitment to making the research it funds available to the public. This commitment is demonstrated through a variety of sharing policies that function to increase the transparency and availability of scientific data and resources. NIH policies expect: The appropriate sharing of scientific data to be maximized;
Data from large scale genomic studies to be broadly and responsibly shared; Research tools developed with NIH funding to be made accessible to other researchers; Unique model organisms to be made available to the scientific community; Clinical trials to be registered and summary results reported in ClinicalTrials.gov; Peer reviewed manuscripts to be publicly available on PubMed Central. The new website will help you navigate these policies, providing you with step-by-step guides, infographics, tools and resources to help you on your way. In the case of clinical trials and public access policies, the site provides a central access point and visibility to these policies, and links out to existing NIH sites for more information. A key goal of the site is to serve as a central portal, providing information on both NIH-wide and NIH Institute and Center-specific sharing policies and data repositories in a way that is easily sortable and searchable
Upcoming Changes to the Federal Financial Report (FFR) Beginning April 1, 2022
Beginning April 1, 2022, recipients are no longer required to submit quarterly cash transaction reports 30 days after the end of each calendar quarter. Instead, PMS will pre-populate the cash transaction section (lines 10a through 10c) of the FFR using recipient real-time cash expenses information from PMS, and adjust recipient-reported disbursements to equal cash advance drawdowns on all non-closed sub-accounts (PMS type P). Recipients will be required to certify at the time of each drawdown whether the cash drawdown request is for reimbursement of actual expenditures or is an advance for immediate disbursement; recipients must assert that award funds are used in compliance with all award conditions and federal statutory requirements. For NIH recipients, the NIH Grants Policy Statement will be updated at the time of its next publication to incorporate the removal of this reporting requirement. These changes do not impact the standard reporting requirements and deadlines for financial expenditure data submitting in the SF-425, unless otherwise noted in the Notice of Award.
Top U.S. cancer institute in line for new leadership as director announces departure
The NCI director holds a position of unusual political prominence. Unlike the directors of NIH’s 26 other institutes, who are selected by the NIH director, the NCI chief must be hand-picked by the president. And whereas other institutes’ annual budgets go through the NIH director’s office, NCI submits an aspirational budget proposal directly to the president.
The Medical Marijuana Research Act, sponsored by the unlikely duo of pro-legalization Rep. Earl Blumenauer (D-OR) and prohibitionist Rep. Andy Harris (R-MD), passed the House in a 343-75 vote. “The cannabis laws in this country are broken, including those that deal with the medical research of marijuana,” Blumenauer said in a press release. “America’s growing cannabis industry operates without the benefit of a robust research program. Instead, we are outsourcing research to Israel, the United Kingdom, and Canada to our detriment.”
COGR appreciates the opportunity to provide feedback on the approaches NIH can take to
strengthen diversity, equity, inclusion, and accessibility (DEIA) across all NIH activities to achieve
the NIH mission. We also appreciate Dr. Maria Bernard’s recent participation at COGR’s March
1st meeting, where she shared NIH’s plans and activities in progress to strengthen DEIA. COGR
plays a vital role in advocating for change on this critical issue, and our member organizations are
moving in similar directions as the NIH.
Appeals court sees high bar to restoring federal contractor vaccine mandate
A federal appeals court in Atlanta acknowledges the Biden administration has felt the impact of contracting delays from the COVID-19 pandemic. But a three-judge panel from the U.S. Court of Appeals for the 11th Circuit says it remains unclear whether the Biden administration has the authority to impose a COVID-19 vaccine mandate on federal contractor employees. The administration told the court last Friday that federal contracting law gives the president broad authority to set the terms of the federal government’s contracts, including making sure contractors have enough healthy employees to complete their contracts with agencies on time. The judges, however, repeatedly said during oral arguments that the federal government has a high bar to clear, in order for the court to overturn a lower court’s injunction barring the administration from enforcing the mandate.
Another Look at Applications Submitted During the Pandemic: Part 4
In posts from October 2021, June 2021,and July 2020, we looked at the distributions of gender, race, and ethnicity of designated principal investigators (PI’s) of R01 and RPG applications submitted before and after the onset of the COVID-19 pandemic. Since that time, we have paid close attention to the well-being of the extramural biomedical research workforce, in part through our survey of institutional leaders and scientists. Others have followed preprint postings, manuscript submissions, and publications, finding evidence of disproportionate effects. Here we add to these earlier analyses and look at NIH R01 and RPG application patterns for calendar dates May 8 through September 7 and September 8 through Jan 7 over the past 5 years.
National Advisory Committee on Racial, Ethnic, and Other Populations; Charter Renewal
The Census Bureau is publishing this notice to announce the renewal of the National Advisory Committee on Racial, Ethnic, and Other Populations (Committee or NAC). The purpose of the Committee is to provide advice to the Director of the Census Bureau on the full range of Census Bureau programs and activities, including the decennial census, demographic and economic statistical programs, field operations, and information technology. Additional information concerning the Committee can be found by visiting the Committee’s website at: http://www.census.gov/cac.
The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office requests public nominations of scientific experts to form a Panel to review the draft EPA Integrated Risk Information System (IRIS) Toxicological Review of Hexavalent Chromium (Cr(VI)). EPA’s draft assessment includes a hazard identification analysis, which summarizes the chemical properties, toxicokinetics, and health effects associated exposure, and dose-response analysis, which characterizes the quantitative relationship between chemical exposure and each credible health hazard. These quantitative relationships are then used to derive cancer and non-cancer toxicity values (e.g., inhalation unit risk, oral slope factor, reference concentration, reference dose). The SAB Hexavalent Chromium Review Panel will consider whether the conclusions found in the EPA’s draft assessment are clearly presented and scientifically supported. The Panel will also be asked to provide recommendations on how the assessment may be strengthened.
Comments Due: 5/4/2022
Solicitation of Nominations for Membership on the Treasury Advisory Committee on Racial Equity
The Treasury Department is soliciting nominations for membership on the Treasury Advisory Committee on Racial Equity (TACRE). The TACRE is composed of up to 25 members who will provide information, advice and recommendations to the Department of the Treasury on matters relating to the advancement of racial equity. This notice extends the process for applying for membership on the Committee until April 25th, 2022.
Comments Due: 4/25/2022
Solicitation of Nominations for Appointment to the Advisory Committee on Former Prisoners of War
The Department of Veterans Affairs (VA) is seeking nominations of qualified candidates to be considered for appointment to the Advisory Committee (Committee) on Former Prisoners of War (FPOW).
Comments Due: 6/2/2022
2021 Compliance Supplement Addenda 1 & 2 and Technical Update
The 2021 Addendum 1 serves as a complement to the 2021 Compliance Supplement published on August 13, 2021 (FR Doc. 2021-17363) and applies to fiscal year audits beginning after June 30, 2020. It added two programs funded by the American Rescue Plan Act (ARP) to Part 4 of the Compliance Supplement: (1) Treasury’s Coronavirus State and Local Fiscal Recovery Funds (assistance listing number 21.027) and (2) Education’s Education Stabilization Fund (assistance listing number 84.425). For audits with report dates prior to the issuance of these guidance, auditors are not required to go back retroactively to review these two programs based on the newly issued guidance. The 2021 Addendum 2 serves as a complement to the 2021 Compliance Supplement published on August 13, 2021 (FR Doc. 2021-17363) and applies to fiscal year audits beginning after June 30, 2020. It includes 7 programs. The 2021 Compliance Supplement Technical Update document provides an update for two programs that were included with the 2021 Compliance Supplement (issued on August 13, 2021 – FR Doc. 2021-17363) and Addendum 1 (issued on December 3, 2021 – FR Doc. 2021-26238). The two programs are: (1) the Department of Health and Human Services Assistance Listing 93.498 – Provider Relief Fund and (2) Treasury Assistance Listing 21.027 – Coronavirus State and Local Fiscal Recovery Funds. It also provides an update to Part 8 Appendix VII to add the alternative compliance examination engagement in accordance with the Government Accountability Office’s Government Auditing Standards for eligible recipients of the SLFRF.
The four agencies GAO reviewed do not have procedures that define political interference in scientific decision-making or describe how it should be reported and addressed. These agencies within the Department of Health and Human Services (HHS) are: the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Office of the Assistant Secretary for Preparedness and Response (ASPR).
The 21st Century Cures Act called for NIH to collaborate with the U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) to reduce administrative burdens associated with laboratory animal research programs, while maintaining high standards of animal welfare as well as the integrity and credibility of the research. We jointly released a final report in 2019 outlining steps to accomplish this goal, and have since worked together to implement many of the recommendations. We wanted to take this opportunity today to share some of NIH’s progress and how you can remain involved.
New Resources on Fighting Sexual Harassment
The National Academies of Sciences, Engineering and Medicine’s Action Collaborative on Preventing Sexual Harassment in Higher Education on Wednesday released three reports regarding preventing sexual harassment and mitigating the damage it causes. The first paper, “Applying Procedural Justice to Sexual Harassment Policies, Processes, and Practice,” looks at how a procedural justice framework could help higher education better deal with harassment.
The other papers look at innovative policies that two institutions adopted to fight higher education’s “pass-the-harasser” problem. Those latter papers look at the University of California, Davis, and the University of Wisconsin system. (The Wisconsin system adopted information sharing between campuses and state agencies on potential hires in 2018.)