September 23, 2020 – Federal Register Recent Federal Regulation Documents
Results 101 - 109 of 109
Regulations Regarding “Intended Uses”
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its medical product ``intended use'' regulations. This action, if finalized, will amend FDA's regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and FDA's implementing regulations, including whether an approved or cleared medical product is intended for a new use. This action will also repeal and replace the portions of a final rule issued on January 9, 2017, that never became effective. This action is intended to provide direction and clarity to regulated industry and other stakeholders.
Endangered and Threatened Wildlife and Plants; Removal of the Nashville Crayfish From the Federal List of Endangered and Threatened Wildlife
We, the U.S. Fish and Wildlife Service (Service), proposed to remove the Nashville crayfish (Orconectes shoupi) from the Federal List of Endangered and Threatened Wildlife (List). This determination is based on the best available scientific and commercial data, which indicate that the threats to the species have been eliminated or reduced to the point that the species has recovered and no longer meets the definition of an endangered species or a threatened species under the Endangered Species Act of 1973, as amended (Act). We announced a 60-day public comment period on the proposed rule, ending January 27, 2020. We now reopen the public comment period on the proposed rule to allow all interested parties additional time to comment on the proposed rule. Comments previously submitted need not be resubmitted and will be fully considered in preparation of the final rule. We also announce a public informational meeting and public hearing on the proposed rule.
Direct Grant Programs, State-Administered Formula Grant Programs, Non Discrimination on the Basis of Sex in Education Programs or Activities Receiving Federal Financial Assistance, Developing Hispanic-Serving Institutions Program, Strengthening Institutions Program, Strengthening Historically Black Colleges and Universities Program, and Strengthening Historically Black Graduate Institutions Program
In response to Executive Order 13864 (Improving Free Inquiry, Transparency, and Accountability at Colleges and Universities), the Department of Education revises its current regulations to encourage institutions of higher education to foster environments that promote open, intellectually engaging, and diverse debate, including through compliance with the First Amendment to the U.S. Constitution for public institutions and compliance with stated institutional policies regarding freedom of speech, including academic freedom, for private institutions. These regulations also require a public institution to not deny a religious student organization any of the rights, benefits, or privileges that are otherwise afforded to other student organizations. In response to recent decisions from United States Supreme Court's decisions, the Department revises its current regulations regarding grant programs authorized under titles III and V of the Higher Education Act of 1965, as amended (HEA), and the eligibility of students to obtain certain benefits under those programs. The Department also revises its current regulations to clarify how educational institutions may demonstrate that they are controlled by a religious organization to qualify for the exemption provided under Title IX, 20 U.S.C. 1681(a)(3), to the extent Title IX or its implementing regulations would not be consistent with the religious tenets of such organization.
Requirements for Additional Traceability Records for Certain Foods
The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish additional traceability recordkeeping requirements for persons that manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. The proposed rule would require these entities to establish and maintain records containing information on critical tracking events in the supply chain for these designated foods, such as growing, shipping, receiving, creating, and transforming the foods. The proposed requirements are intended to help the Agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded. We are issuing this proposed rule in accordance with the FDA Food Safety Modernization Act (FSMA).
Assessment and Collection of Regulatory Fees for Fiscal Year 2020
In this document, the Commission revises its Schedule of Regulatory Fees to recover an amount of $339,000,000 that Congress has required the Commission to collect for fiscal year 2020. Section 9 of the Communications Act of 1934, as amended, provides for the annual assessment and collection of regulatory fees under sections 9(b)(2) and 9(b)(3), respectively.
Air Quality Implementation Plan; California; Northern Sierra Air Quality Management District; Stationary Source Permits
The Environmental Protection Agency (EPA) is proposing to approve a revision to the Northern Sierra Air Quality Management District (NSAQMD or ``District'') portion of the California State Implementation Plan (SIP). In this action, we are proposing to approve a rule submitted by the NSAQMD that governs the issuance of permits for stationary sources, which focuses on the preconstruction review and permitting of major sources and major modifications under part D of title I of the Clean Air Act (CAA or ``the Act''). We are taking comments on this proposal and a final action will follow.
Project Management Oversight
This final rule amends FTA regulations implementing project management oversight. FTA is modifying the regulation to make it consistent with statutory changes and to modify the scope and applicability of project management oversight.
Margin Requirements for Uncleared Swaps for Swap Dealers and Major Swap Participants
The Commodity Futures Trading Commission (``Commission'' or ``CFTC'') is proposing to amend the margin requirements for uncleared swaps for swap dealers (``SDs'') and major swap participants (``MSPs'') for which there is no prudential regulator (``CFTC Margin Rule''). In particular, the Commission is proposing to revise the calculation method for determining whether certain entities come within the scope of the initial margin (``IM'') requirements under the CFTC Margin Rule beginning on September 1, 2021, and the timing for compliance with the IM requirements after the end of the phased compliance schedule. The proposed amendment would align certain aspects of the CFTC Margin Rule with the Basel Committee on Banking Supervision and Board of the International Organization of Securities Commissions' (``BSBS/IOSCO'') Framework for margin requirements for non-centrally cleared derivatives (``BCBS/IOSCO Framework''). The Commission is also proposing to allow SDs and MSPs subject to the CFTC Margin Rule to use the risk-based model calculation of IM of a counterparty that is a CFTC-registered SD or MSP to determine the amount of IM to be collected from the counterparty and to determine whether the IM threshold amount for the exchange of IM has been exceeded such that documentation concerning the collection, posting, and custody of IM would be required.
Rental Assistance and Asset Management for the Multi-Family Housing Direct Loan Programs
The Rural Housing Service (RHS or the Agency) is proposing to amend its regulation to implement changes related to the development of a sustainable plan for the Rental Assistance (RA) program, including new Agency flexibilities in the managing of the RA distribution and integrate new asset management policies. The regulation changes are designed to provide flexibility, more economically utilize the RA, and to improve the efficiency in managing the assets in the Direct Loan portfolio.
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