Compliance Alert – November 2022
- November 21st, 2022
- in Compliance, Newsletter, Regulations
Final RulesThe Department of Education (Department or we) corrects the text in regulations issued under the Higher Education Act of 1965, as amended (HEA) and published in the Federal Register on: September 23, 2019, for provisions relating to Borrower Defense to Repayment and Financial Responsibility; November 1, 2019, for provisions relating to Accreditation, State Authorization, and the Student Assistance General Provisions; and September 2, 2020, for provisions relating to Distance Education and Innovation, Institutional Eligibility, and the Student Assistance General Provisions. Federal Agency: Office of Postsecondary Education, Department of Education Affected Area: Student Financial Aid The Secretary amends regulations for the Federal Pell Grant program (Pell Grants or Pell), institutional eligibility, and student assistance general provisions. First, we amend the regulations for Federal Pell Grants for prison education programs (PEPs), to implement new statutory requirements to establish Pell Grant eligibility for a confined or incarcerated individual enrolled in a PEP to implement the statutory change in the Consolidated Appropriations Act, 2021. Second, we amend the Title IV Revenue and Non-Federal Education Assistance Funds regulations (referred to as “90/10” or the “90/10 Rule”) to implement the statutory change in the American Rescue Plan Act of 2021 (ARP). We further amend which non-Federal funds can be counted when determining compliance with the 90/10 rule to align allowable non-Federal revenue more closely with statutory intent. Finally, we amend regulations to clarify the process for consideration of changes in ownership and control (CIO), to promote compliance with the Higher Education Act of 1965, as amended (HEA), and related regulations and reduce risk for students and taxpayers, as well as institutions contemplating or undergoing such a change. Federal Agency: Office of Postsecondary Education, Department of Education Affected Area: Student Financial Aid This action finalizes the technology review conducted for the paint stripping and miscellaneous surface coating operations area source categories regulated under national emission standards for hazardous air pollutants (NESHAP). These final amendments also address provisions regarding electronic reporting; make miscellaneous clarifying and technical corrections; simplify the petition for exemption process; and clarify requirements for emissions during periods of startup, shutdown, and malfunction (SSM). We are making no revisions to the numerical emission limits based on the technology review. Federal Agency: Environmental Protection Agency (EPA) Affected Area: EHS Proposed RulesSignificant New Use Rules on Certain Chemical Substances (22-2.5e) EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to Orders issued by EPA pursuant to TSCA. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination. Federal Agency: Environmental Protection Agency (EPA) Affected Area: EHS Comments Due: 11/30/2022 The Food and Drug Administration (FDA or the Agency) is extending the comment period for two proposed rules that appeared in the Federal Register of September 28, 2022. In the proposed rule entitled “Protection of Human Subjects and Institutional Review Boards,” FDA requested comments on proposed changes to its regulations regarding obtaining and documenting informed consent from research participants, and institutional review board membership and functions, including continuing review (Docket No. FDA-2021-N-0286). In the proposed rule entitled “Institutional Review Boards; Cooperative Research,” FDA requested comment on a change to its regulations that would require any institution located in the United States participating in FDA-regulated cooperative research to rely on approval by a single institutional review board (IRB) for that portion of the research that is conducted in the United States, with some exceptions (Docket No. FDA-2019-N-2175). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. Federal Agency: Food and Drug Administration, Department of Health and Human Services (HHS) Affected Area: IRD, ORED, OSP Comments Due: 12/28/2022 |
Notices
Real ID Applicant Information and Documentation
The REAL ID Act of 2005 (the Act) prohibits Federal agencies from accepting State-issued drivers’ licenses or identification cards for any official purpose—defined in the Act and regulations to include accessing federal facilities, boarding federally regulated commercial aircraft, and entering nuclear power plants—unless the license or card is issued by a State that meets the requirements set forth in the Act. The REAL ID regulations, which DHS issued in January 2008, establish the minimum standards that States must meet to comply with the Act. DHS has a separate collection of information related to DHS interaction with States, e.g., State certification (see OMB Control No. 1601-0005). By contrast to that collection of information, this collection of information relates to the States’ collection of information from driver’s license applicants.
Federal Agency: Department of Homeland Security (DHS)
Comments Due: 11/30/2022
FAFSA Simplification Act Changes for Implementation in the 2023-2024 Award Year
The U.S. Department of Education (Department) publishes this notice, as required by the Consolidated Appropriations Act, 2022, of the phased implementation of some elements of the FAFSA Simplification Act for the 2023-2024 award year. This notice also addresses other rules that will take effect for the 2023-2024 award year as part of the FAFSA Simplification Act.
Federal Agency: Office of Postsecondary Education, Department of Education
Affected Area: Student Financial Aid
By this Notice, the Department of the Treasury (Treasury Department), announces the availability of the Committee on Foreign Investment in the United States (CFIUS) Enforcement and Penalty Guidelines. These guidelines provide the public with a summary of CFIUS’s practice regarding penalties and other remedies for violations of section 721 of the Defense Production Act of 1950 as amended (Section 721), the regulations promulgated thereunder, or mitigation agreements, conditions, or orders pursuant thereto (Violations).
Federal Agency: Office of Investment Security, Department of the Treasury
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Generator Standards Applicable to Laboratories Owned by Eligible Academic Entities (EPA ICR Number 2317.04, OMB Control Number 2050-0204) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2022. Public comments were previously requested via the Federal Register on May 2, 2022 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is available by following the link above, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Federal Agency: Environmental Protection Agency (EPA)
Affected Area: EHS
Comments Due: 11/28/2022
Sections 496(a)(7), (a)(8), (c)(7), and (c)(8) of the Higher Education Act (HEA), and federal regulations at 34 CFR; 34 CFR 602.26 and 602.27 contain certain requirements for reporting by recognized accrediting agencies to the Department on the institutions and programs the agencies accredit. This collection specifies the required and requested reporting. It also discusses the channel for reporting this information, and reporting information the accrediting agency may wish to submit voluntarily to ensure that the Department’s Database of Accredited Postsecondary Institutions and Programs is accurate and comprehensive.
Federal Agency: Office of Postsecondary Education (OPE), Department of Education (ED)
Affected Area: OIRA, Institutional Effectiveness
Comments Due: 12/19/2022
The Drug Enforcement Administration (DEA) proposes to establish the 2023 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Federal Agency: Drug Enforcement Administration, Department of Justice
Affected Area: CCHS
Comments Due: 11/17/2022
The Environmental Protection Agency (EPA) is announcing the availability of the final revision to the risk determination for the methylene chloride risk evaluation issued under the Toxic Substances Control Act (TSCA). The revision to the methylene chloride risk determination reflects the announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law. EPA determined that methylene chloride, as a whole chemical substance, presents an unreasonable risk of injury to health when evaluated under its conditions of use. In addition, this revised risk determination does not reflect an assumption that workers always appropriately wear personal protective equipment (PPE). EPA understands that there could be occupational safety protections in place at workplace locations; however, not assuming use of PPE reflects EPA’s recognition that unreasonable risk may exist for subpopulations of workers that may be highly exposed because they are not covered by Occupational Safety and Health Administration (OSHA) standards, or their employers are out of compliance with OSHA standards, or because many of OSHA’s chemical-specific permissible exposure limits largely adopted in the 1970’s are described by OSHA as being “outdated and inadequate for ensuring protection of worker health,” or because the OSHA permissible exposure limit (PEL) alone may be inadequate for ensuring protection of worker health, or because EPA finds unreasonable risk for purposes of TSCA notwithstanding OSHA requirements. This revision supersedes the condition of use-specific no unreasonable risk determinations in the June 2020 Methylene Chloride Risk Evaluation and withdraws the associated TSCA order included in the June 2020 Methylene Chloride Risk Evaluation.
Federal Agency: Environmental Protection Agency (EPA)
Affected Area: EHS
OSHA solicits public comments concerning the proposal to extend the Office of Management and Budget’s (OMB) approval of the information collection requirements specified in the Standard for Welding, Cutting, and Brazing.
Federal Agency: Occupational Safety and Health Administration (OSHA), Labor
Comments Due: 1/9/2023
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin.” The draft guidance was prepared under the auspices of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonization. The draft guidance updates the ICH guidance for industry “Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin” issued in September 1998 to reflect advances in scientific knowledge and regulatory expectations. The draft guidance is intended to describe risk-based principles and mitigation strategies to assure the viral safety of biotechnology products, including the data necessary to submit in a marketing application.
Federal Agency: Food and Drug Administration, HHS
Affected Area: ORED
Comments Due: 1/13/23
Notice That the Build America, Buy America Requirement for Construction Materials Applies Effective November 10, 2022, and Notice of Proposed Waiver of Buy America Requirements for De Minimis Costs, Small Grants, and Minor Components and Notice That the Build America, Buy America Requirement for Construction Materials Applies Effective November 10, 2022, and Notice of Proposed Waiver of That Requirement for a Narrow Category of Contracts and Solicitations
The Department of Transportation (DOT) seeks to maximize the use of American-made products and materials in all federally funded projects as part of the Biden-Harris Administration’s implementation of the Build America, Buy America Act (the Act), which was included in the historic Bipartisan Infrastructure Law (BIL). The implementation of this law will transform the Department’s approach to domestic procurement requirements. The Department is taking three concurrent actions: (1) DOT is not extending its temporary waiver for construction materials, making that requirement applicable effective November 10, 2022; (2) in a separate notice, DOT is proposing a waiver for narrow categories of contracts and solicitations; and (3) in this notice, DOT is proposing a narrow waiver to allow DOT and its assistance recipients to focus their domestic sourcing efforts on products that provide the greatest manufacturing opportunities for American workers and firms and reduce delays in the delivery of important transportation infrastructure projects that provide jobs and promote economic growth. DOT is seeking comments on whether a waiver of Buy America requirements under the Act and related domestic preference statutes administered by DOT and its Operating Administrations (OAs) should be granted in the public interest for de minimis costs, small grants, and minor components.
Federal Agency: Department of Transportation
Affected Area: Procurement, Campus Development, Facilities and Grounds
Comments Due: 11/20/2022
Items of Interest
Research, Engineering, and Development Advisory Committee (REDAC); Revitalization Membership Plan
Comments Due: 12/31/2022
DEA Again Boosts 2022 Production Goals For Psychedelics Like Psilocybin, MDMA and DMT
The Drug Enforcement Administration (DEA) has yet again increased its quota for the legal production of illegal controlled substances like psilocybin, MDMA and DMT for research purposes in 2022.
The Drug Enforcement Administration (DEA) proposes to establish the 2023 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Comments Due: 11/14/2022
Solicitation of Nominations To Serve on the BEA Advisory Committee
The Director of the Bureau of Economic Analysis (BEA) requests nominations of individuals to the Bureau of Economic Analysis Advisory Committee (BEAAC or Committee) to fill upcoming vacancies. The Director of BEA will consider nominations received in response to this notice, as well as from other sources.
Federal Economic Statistics Advisory Committee
The Under Secretary for Economic Affairs requests nominations of individuals to the Federal Economic Statistics Advisory Committee (FESAC or the Committee). The Under Secretary for Economic Affairs, in coordination with the Directors of the Bureau of Economic Analysis and the U.S. Census Bureau, as well as the Commissioner of the U.S. Department of Labor’s Bureau of Labor Statistics, will consider nominations received in response to this notice, as well as from other sources.
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ACBCYW. The ACBCYW consists of 15 experts in fields associated with breast cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and counseling, treatment, rehabilitation, palliative care, and survivorship in young women, or in related disciplines with a specific focus on young women.
Comments Due: 12/29/2022
Educause, the association of higher ed technology officials, highlights a need to move from data insight to data action, develop learning-first strategies regardless of modality, and lead with humility.
Call for Nominations To Serve on the NIST Safety Commission
The Director of the National Institute of Standards and Technology (NIST) intends for a new federal advisory committee to be established, the NIST Safety Commission (Commission). The Commission would provide advice to the NIST Director on matters relating to NIST safety policies; safety management system, practices, and performance; and safety culture. NIST invites and requests nominations of individuals for appointment to the Commission. Registered federal lobbyists may not serve on NIST federal advisory committees in an individual capacity.
Comments Due: 11/17/2022
Science Advisory Committee on Chemicals (SACC); Request for Nominations
The Environmental Protection Agency (EPA) invites the public to nominate scientific experts from a diverse range of disciplines to be considered for appointment to the Science Advisory Committee on Chemicals (SACC), established pursuant to the Toxic Substances Control Act (TSCA). EPA anticipates appointing new SACC members by mid-2023 due to expiring membership terms. Sources in addition to this Federal Register notice may be utilized to solicit nominations and identify candidates. Any interested person or organization may nominate qualified individuals to be considered prospective candidates to the committee by following the instructions provided in this document. Individuals may also self-nominate.
Comments Due: 12/12/2022
Moving Forward on FAFSA Simplification
The U.S. Education Department is moving forward to carry out some parts of the FAFSA Simplification Act before unveiling a simplified Free Application for Federal Student Aid next fall. For colleges and universities, that means updating how the total cost of attendance is calculated—a key measure used to add up financial aid offers. Guidance released this week provides institutions with details on how to calculate a new cost-of-attendance figure, which will be used to calculate financial aid awards for the 2023–24 academic year.