Compliance Alert – February 2023
- February 22nd, 2023
- in Newsletter
Final Rules
Revised Definition of “Waters of the United States”
The Environmental Protection Agency (EPA) and the Department of the Army (“the agencies”) are finalizing a rule defining the scope of waters protected under the Clean Water Act. In developing this rule, the agencies considered the text of the relevant provisions of the Clean Water Act and the statute as a whole, the scientific record, relevant Supreme Court case law, and the agencies’ experience and technical expertise after more than 45 years of implementing the longstanding pre-2015 regulations defining “waters of the United States.”
This final rule advances the objective of the Clean Water Act and ensures critical protections for the nation’s vital water resources, which support public health, environmental protection, agricultural activity, and economic growth across the United States.
Federal Agency: Environmental Protection Agency
Affected Area: EHS, Water Center
Freedom of Information Act and the Privacy Act
The Office of the Intellectual Property Enforcement Coordinator (IPEC) is issuing its implementing regulations for the Freedom of Information Act (FOIA) and the Privacy Act. The final rule describes how to make a FOIA request with IPEC and how IPEC processes requests for records. The final rule also states IPEC’s Privacy Act Policies and Procedures. The final rule describes how individuals can find out if an IPEC system of records contains information about them and, if so, how to access or amend a record.
Federal Agency: Office of the Intellectual Property Enforcement Coordinator, Executive Office of the President
Affected Area: Privacy, ORED
Proposed Rules
Coverage of Certain Preventive Services Under the Affordable Care Act
These proposed rules would amend regulations regarding coverage of certain preventive services under the Patient Protection and Affordable Care Act, which requires non-grandfathered group health plans and non-grandfathered group or individual health insurance coverage to cover certain contraceptive services without cost sharing. Current regulations include exemptions and optional accommodations for entities and individuals with religious or moral objections to coverage of contraceptive services. These rules propose rescinding the moral exemption rule. These proposed rules also would establish a new individual contraceptive arrangement that individuals enrolled in plans or coverage sponsored, arranged, or provided by objecting entities may use to obtain contraceptive services at no cost directly from a provider or facility that furnishes contraceptive services. Contraceptive services would be available through the proposed individual contraceptive arrangement without any involvement on the part of an objecting entity. Under these proposed rules, a provider or facility that furnishes contraceptive services in accordance with the individual contraceptive arrangement for eligible individuals would be able to be reimbursed for its costs by entering into an arrangement with an issuer on a Federally facilitated Exchange or State Exchange on the Federal platform, which in turn may seek a user fee adjustment.
Federal Agency: Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; Centers for Medicare & Medicaid Services, Department of Health and Human Services
Affected Area: CCHS, HR
Comments Due: 4/3/2023
Education Acquisition Regulation
The Secretary of Education proposes to modify the Department of Education Acquisition Regulation (EDAR) to revise aspects of those regulations that are out-of-date or redundant with other U.S. Department of Education (Department) policies and procedures and to accurately implement the current Federal Acquisition Regulation (FAR) and Department policies.
Federal Agency: Department of Education
Affected Area: Procurement
Comments Due: 4/3/2023
Notices
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing an extension without change of a currently approved information collection request (ICR).
Federal Agency: Department of Education
Affected Area: OIE
Comments Due: 2/17/2023
The Secretary announces the 2023-24 award year deadline dates for the submission of requests and documents from postsecondary institutions for the Federal Perkins Loan (Perkins Loan) Program, Federal Work-Study (FWS), and Federal Supplemental Educational Opportunity Grant (FSEOG) programs (collectively, the “Campus-Based programs”), Assistance Listing Numbers 84.038, 84.033, and 84.007.
Federal Agency: Department of Education
Affected Area: Student Financial Aid
This information collection supports Agency regulations pertaining to the protection of human subjects, informed consent, and responsibilities of institutional review boards (IRBs) as set forth in parts 50 and 56 (21 CFR parts 50 and 56). Parts 50 and 56 apply to all clinical investigations regulated by FDA under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i) and 360j(g), respectively), as well as clinical investigations that support applications for research or marketing permits for products regulated by FDA. The regulations in parts 50 and 56 are intended to protect the rights and safety of subjects involved in such investigations. The regulations also contain the standards for composition, operation, and responsibilities of IRBs that review clinical investigations regulated by FDA.
Federal Agency: Food and Drug Administration, HHS
Affected Area: ORED
Comments Due: 2/21/2023
Agency Information Collection Activities; Comment Request; Cash Management Contract URL Collection
The Department of Education (the Department) is seeking an extension of OMB control number 1845-0147 for the collection of URLs hosting institutional contracts and contract data relating to campus banking agreements. The regulatory sections for this collection include 34 CFR 668.164(e)(2)(viii) and 34 CFR 668.164(f)(4)(iii)(B), are unchanged. The Department and the public have a strong interest in knowing the terms of marketing contracts of the millions of students receiving millions of dollars in Federal student aid. The Higher Education Act of 1965, as amended (HEA) strongly supports providing important consumer information to students and the public, as evidenced in several parts of the law. The increased transparency will help ensure accountability and encourage institutional practices that are in the interest of students.
Federal Agency: Department of Education
Affected Area: Student Financial Aid, Student Account Services
Comments Due: 3/21/2023
This request is for an extension of the information collection supporting the policies and reporting requirements contained in subpart E of part 668—Verification and Updating of Student Aid Application Information. Sections 668.53, 668.54, 668.55, 668.56, 668.57, 668.59 and 668.61 contain information collection requirements (OMB control number 1845-0041). This subpart governs the verification and updating of information provided on the Free Application for Federal Student Aid (FAFSA) which is used to calculate an applicant’s Expected Family Contribution (EFC) for purposes of determining an applicant’s need for student financial assistance under Title IV of Higher Education Act of 1965, as amended (HEA). The collection of this documentation helps ensure that students (and parents in the case of PLUS loans) receive the correct amount of Title IV program assistance by providing accurate information to calculate an applicant’s expected family contribution. There has been no change to the regulatory language since the prior information collection filing.
Federal Agency: Department of Education
Affected Area: Student Financial Aid
Comments Due: 3/31/2023
To address undue foreign influence in NASA-supported research and ensure responsible stewardship of taxpayer dollars, NASA has developed a new conflict of interest (COI) and conflict of commitment (COC) disclosure policy and an associated term and condition applicable to entities implementing NASA financial assistance awards ( i.e., grants or cooperative agreements). Grants Policy and Compliance (GPC) in NASA’s Office of Procurement is soliciting public comment on the Agency’s proposed policy and term and condition. After obtaining and considering public comment, it is NASA’s intention to implement the new policy and term and condition through a revision to the NASA Grant and Cooperative Agreement Manual (GCAM).
Federal Agency: National Aeronautics and Space Administration (NASA)
Affected Area: CERA, ORED
Comments Due: 3/1/2023
The Department of Education (the Department) amends the William D. Ford Federal Direct Loan (Direct Loan) Program regulations issued under the Higher Education Act of 1965, as amended (HEA), to implement a new regulation in § 685.400 et seq. —Borrower Defense to Repayment. These final regulations are a result of negotiated rulemaking and will add new requirements to the current regulations. These final regulations require the collection of this information from borrowers who believe they qualify for a borrower defense to repayment discharge, as permitted under Section 455(h) of the HEA. This request is to revise the currently approved information collection 1845-0163 to incorporate the new regulatory requirements and forms.
Federal Agency: Department of Education
Affected Area: Student Financial Aid
Comments Due: 4/3/2023
This notice announces the Secretary of Commerce’s approval of Federal Information Processing Standard (FIPS) 186-5, Digital Signature Standard (DSS). FIPS 186-5 specifies three techniques for the generation and verification of digital signatures that can be used for the protection of data: the Rivest-Shamir-Adleman (RSA) Algorithm, the Elliptic Curve Digital Signature Algorithm (ECDSA), and the Edwards Curve Digital Signature Algorithm (EdDSA). The Digital Signature Algorithm (DSA), specified in prior versions of this standard, is retained only for the purposes of verifying existing signatures.
Federal Agency: National Institute of Standards and Technology (NIST), Commerce
Affected Area: CERA, Procurement, ORED, OIT
The Department of Education (the Department) is requesting an extension of the current approval of the policies and procedures for determining satisfactory academic progress (SAP) as required in Section 484 of the Higher Education Act of 1965, as amended (HEA). A link to the Satisfactory Academic Progress regulations is provided at 34 CFR 668.34 and 34 CFR 600.55.
These regulations identify the policies and procedures to ensure that students are making satisfactory academic progress in their program at a pace and a level to receive or continue to receive Title IV, HEA program funds. If there is lapse in progress, the policy must identify how the student will be notified and what steps are available to a student not making satisfactory academic progress toward the completion of their program, and under what conditions a student who is not making satisfactory academic progress may continue to receive Title IV, HEA program funds. There have been minor changes to the regulatory language since the last information collection update.
Federal Agency: Federal Student Aid (FSA), Department of Education (ED)
Affected Area: Student Financial Aid, CERA
Comments Due:4/3/2023
The Higher Education Act of 1965, as amended, requires participating Title IV institutions to apply for funds and report expenditures for the Federal Perkins Loan (Perkins), the Federal Supplemental Educational Opportunity Grant (FSEOG) and the Federal Work-Study (FWS) Programs on an annual basis. The data submitted electronically in the Fiscal Operations Report and Application to Participate (FISAP) is used by the Department of Education to determine the institution’s funding need for the award year and monitor program effectiveness and accountability of fund expenditures. The data is used in conjunction with institutional program reviews to assess the administrative capability and compliance of the applicant. There are no other resources for collecting this data.
Federal Agency: Department of Education
Affected Area: Student Financial Aid
Comments Due: 3/9/2023
FEMA’s Grant Programs Directorate (GPD) awards thousands of grants each year through various grant programs. These programs award funds for projects used to improve homeland security and emergency preparedness. The National Environmental Policy Act of 1969 (NEPA) (Pub. L. 91-190, sec. 102 (B) and (C), 42 U.S.C. 4332), the National Historic Preservation Act of 1966 (NHPA) (Pub. L. 89-665, 16 U.S.C. 470f), the Endangered Species Act of 1973 (Pub. L. 93-205, 16 U.S.C. 1531, et seq.), and a variety of other environmental and historic preservation laws and Executive Orders (E.O.) require the Federal Government to examine the potential environmental impacts of its proposed actions on communities, public health and safety, and cultural, historic, and natural resources including endangered and threatened species prior to implementing those actions. The GPD process of considering these potential impacts is called an environmental and historic preservation (EHP) review which is employed to achieve compliance with multiple EHP authorities through one consolidated process.
Federal Agency: Federal Emergency Management Agency, Department of Homeland Security
Affected Area: ORED
Comments Due: 3/9/2023
Request for Comments Regarding Artificial Intelligence and Inventorship
The United States Patent and Trademark Office (USPTO) plays an important role in incentivizing and protecting innovation, including innovation enabled by artificial intelligence (AI), to ensure continued U.S. leadership in AI and other emerging technologies (ET). In June 2022, the USPTO announced the formation of the AI/ET Partnership, which provides an opportunity to bring stakeholders together through a series of engagements to share ideas, feedback, experiences, and insights on the intersection of intellectual property and AI/ET. To build on the AI/ET Partnership efforts, the USPTO is seeking stakeholder input on the current state of AI technologies and inventorship issues that may arise in view of the advancement of such technologies, especially as AI plays a greater role in the innovation process. As outlined in sections II to IV below, the USPTO is pursuing three main avenues of engagement with stakeholders to inform its future efforts on inventorship and promoting AI-enabled innovation: a series of stakeholder engagement sessions; collaboration with academia through scholarly research; and a request for written comments to the questions identified in section IV. The USPTO encourages stakeholder engagement through one or more of these avenues.
Federal Agency: United States Patent and Trademark Office, Department of Commerce
Affected Area: ORED
Comments Due: 5/15/2023
Items of Interest
Institutional and Organizational Research Data Retention Policies Questionnaire
To develop a compendium of research data retention requirements, the University of California is gathering information on institutional and organizational research data retention policies. Once developed, UC intends to provide it to the research community for its ongoing use. Interested parties are invited to complete a brief questionnaire by February 24, 2023. The estimated time to complete is 2-3 minutes. For more background and information, please read the Dear Colleague Letter here. If you have any questions, please contact Agnes Balla, Director, Research Analysis and Coordination, University of California Office of the President at RPAC@UCOP.edu.
NSF has published a revised version of the NSF Grants.gov Application Guide (NSF 23-006). Overall, the Guide has been updated to align with the revisions to NSF’s Proposal & Award Policies & Procedures Guide (PAPPG) (NSF 23-1). A by-chapter summary of changes is provided at the beginning of the document. The Guide will be effective for applications submitted (via Grants.gov) or due, on or after January 30, 2023.
White House releases new scientific integrity guidelines (Chemical & Engineering News)
Every US funding agency will be required to designate a scientific integrity official, and agencies that fund, conduct, or oversee research will have to establish the position of chief science officer under new guidelines released Jan. 12 by the White House Office of Science and Technology Policy (OSTP). The guidelines create a single definition of scientific integrity and provide a model policy to help agencies as they update and revise their existing integrity plans…The guidelines follow a January 2022 OSTP report that set out five scientific integrity principles to guide science in government, including scientists’ right to dissent, speak freely, and hold people responsible for integrity violations.
Request for Nominations to the EPA Clean Air Scientific Advisory Committee (CASAC)
The U.S. Environmental Protection Agency (EPA) invites nominations of scientific experts to be considered for appointment to the Clean Air Scientific Advisory Committee (CASAC).
Through this Request for Information (RFI), the National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) is seeking input on updates to the current Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals (NOT-OD-05-034). The updated guidance seeks to reduce administrative burden by clarifying the reporting requirements, without negatively impacting the accountability and transparency of the process.
Request for Nominations to the EPA Science Advisory Board
The U.S. Environmental Protection Agency (EPA) invites nominations of scientific experts from a diverse range of disciplines to be considered for appointment to the EPA Science Advisory Board (SAB). Appointments will be announced by the Administrator.
Request for Nominations for the Preservation Technology and Training Board
The National Park Service (NPS), U.S. Department of the Interior, is requesting nominations for qualified persons to serve as members of the Preservation Technology and Training Board (Board).
Comments Due: 3/6/2023
Request for Public Nominations of Experts to Serve on a Review Panel
The U.S. Environmental Protection Agency (EPA) is seeking nominations for technical experts to serve as Special Government Employees (SGEs) on a review panel under the authority of the Board of Scientific Counselors (BOSC), a federal advisory committee to the Office of Research and Development (ORD). Selected experts will participate in the review of the ORD’s draft report on a case study that uses value of information (VOI) analysis to weigh the public health and economic trade-offs associated with the timeliness, uncertainty, and costs of the draft EPA Transcriptomic Assessment Product (ETAP). The ETAP is a proposed ORD assessment product that utilizes a standardized short-term in vivo study design and data analysis procedures to develop transcriptomic-based toxicity values for data poor chemicals. The review will take place between April and July 2023. Submission of nominations should be made via the BOSC website.
Request for Public Nominations of Experts To Serve on a Review Panel
The U.S. Environmental Protection Agency (EPA) is seeking nominations for technical experts to serve as Special Government Employees (SGEs) on a review panel under the authority of the Board of Scientific Counselors (BOSC), a federal advisory committee to the Office of Research and Development (ORD). Selected experts will review ORD’s draft documents detailing scientific studies supporting the development of transcriptomic-based toxicity values and their implementation as a new EPA Transcriptomic Assessment Product (ETAP). The ETAP is a proposed ORD assessment product that utilizes a standardized short-term in vivo study design and data analysis procedures to develop transcriptomic-based toxicity values for data poor chemicals. The review will take place between April and July 2023. Submission of nominations should be made via the BOSC website.