March 13, 2024 – Federal Register Recent Federal Regulation Documents

The Assistant Regional Administrator for Sustainable Fisheries, Greater Atlantic Region, NMFS, has made a preliminary determination that an Exempted Fishing Permit application contains all of the required information and warrants further consideration. The exempted fishing permit would allow federally permitted fishing vessels to fish outside fishery regulations in support of exempted fishing activities proposed by the Maine Department of Marine Resources. Regulations under the Magnuson-Stevens Fishery Conservation and Management Act and the Atlantic Coastal Fisheries Cooperative Management Act require publication of this notification to provide interested parties the opportunity to comment on applications for proposed exempted fishing permits (EFP).

The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning carryover of passive activity losses and credits and at-risk losses to bankruptcy estates of individuals.

The Food and Drug Administration (FDA or Agency) has determined that Romidepsin Injection, 10 milligrams (mg)/2 milliliters (mL) (5 mg/mL) and 27.5 mg/5.5 mL (5 mg/mL), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for romidepsin solution, 10 mg/2 mL (5 mg/mL) and 27.5 mg/5.5 mL (5 mg/mL), that refer to these drugs as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.'' This draft guidance proposes select updates to the final guidance ``Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.'' This draft guidance, when finalized, will identify the information FDA generally considers to be necessary for cyber devices to support obligations under the new amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) for ensuring cybersecurity of devices. This draft guidance is not final nor is it for implementation at this time.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products.'' This draft guidance provides recommendations to applicants of approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for nonprescription drug products on documenting minor labeling changes in the next annual report and provides examples of minor labeling changes that may be submitted in an annual report. The recommendations in this draft guidance address the types of minor labeling changes that may be appropriate to submit in an annual report to ensure that consumers have timely access to the most current labeling for a nonprescription drug product to ensure the product's safe and effective use. We anticipate that these recommendations may assist industry in understanding the circumstances in which it would be appropriate to document minor changes in the applicant's next annual report rather than submitting a prior approval supplement or ``changes being effected'' supplement, thereby reducing burden on industry and FDA.

The Department of Education (Department) is issuing a notice inviting applications for fiscal year (FY) 2024 for the Braille Training program, Assistance Listing Number 84.235E. This notice relates to the approved information collection under OMB control number 1894-0006.

The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

This final rule amends the Pension Benefit Guaranty Corporation's regulation on Allocation of Assets in Single-Employer Plans to prescribe interest assumptions under the asset allocation regulation for plans with valuation dates in the second quarter of 2024. These interest assumptions are used for valuing benefits under terminating single-employer plans and for other purposes.

The FAA is superseding Airworthiness Directive (AD) 2022-13-16 for all GE Aviation Czech s.r.o. (GEAC) (type certificate previously held by WALTER Engines a.s., Walter a.s., and MOTORLET a.s.) Model M601D-11 engines; and AD 2022-14-12, for certain GEAC Model M601D-11, M601E-11, M601E-11A, M601E-11AS, M601E-11S, and M601F engines. AD 2022- 13-16 required revising the airworthiness limitations section (ALS) of the existing engine maintenance manual (EMM) to incorporate a visual inspection of the centrifugal compressor case for cracks. AD 2022-14-12 required replacing the propeller shaft for Model M601F engines. AD 2022-14-12 also required calculating the accumulated life of the propeller shaft and replacing the propeller shaft, if necessary, for model M601D-11, M601E-11, M601E-11A, M601E-11AS, and M601E-11S engines. Since the FAA issued AD 2022-13-16 and AD 2022-14-12, the manufacturer revised the ALS of the existing EMM to introduce new and more restrictive tasks and limitations, expand the applicability to all Model M601 engines, and incorporate certain requirements addressed by AD 2021-13-07 and AD 2023-01-10, which prompted this AD. This AD requires revising the ALS of the existing EMM and the operator's existing approved engine maintenance or inspection program, as applicable, to incorporate new and more restrictive tasks and limitations, as specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.

The Office of Advanced Manufacturing within the National Institute of Standards and Technology, an agency of the U.S. Department of Commerce, intends to announce an open competition for a new Manufacturing USA institute. The expected competition will seek to establish a Manufacturing USA institute focused on the use of Artificial Intelligence to improve resilience of U.S. manufacturing. This NOI is provided to allow potential applicants sufficient time to develop meaningful collaborations among industry, academia, Federal laboratories and state/local government.

In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) and U.S. Department of Agriculture, Forest Service (USDA Forest Service), collectively ``the Agencies,'' have prepared a Draft Resource Management Plan (RMP) and Draft Environmental Impact Statement (EIS) for the Bears Ears National Monument (BENM or Monument), and by this notice are providing information announcing the opening of the comment period on the Draft RMP/EIS and the comment period on proposed areas of critical environmental concern (ACECs) on lands managed by the BLM and proposed recreational shooting closures. The BLM is leading the NEPA process in partnership with the USDA Forest Service, which will sign a decision for the USDA Forest Service-managed lands based on the analysis in the EIS. The Agencies have and will continue to meaningfully engage the Bears Ears Commission in the development of the RMP and EIS, as required by Proclamation 10285.

Notice is hereby given that the U.S. International Trade Commission (``Commission'') has found no violation of section 337 of the Tariff Act of 1930, as amended, in the above-captioned investigation. The investigation is terminated.

The Assistant Regional Administrator for Sustainable Fisheries, Greater Atlantic Region, NMFS, has made a preliminary determination that an Exempted Fishing Permit (EFP) application contains all of the required information and warrants further consideration. The EFP would allow federally permitted fishing vessels to fish outside fishery regulations in support of exempted fishing activities proposed by Coonamessett Farm Foundation. Regulations under the Magnuson-Stevens Fishery Conservation and Management Act require publication of this notification to provide interested parties the opportunity to comment on applications for proposed EFPs.

On March 22, 2022, PHMSA announced an initiative to convert historical letters of interpretation (LOI) applicable to the Hazardous Materials Regulations (HMR) that have been issued to specific stakeholders into broadly applicable frequently asked questions (FAQ). On December 9, 2022, PHMSA published the first set of FAQ regarding applicability of the HMR. On August 18, 2023, PHMSA published the second set of FAQ regarding incident reporting. Today's notice contains the third set of FAQ regarding training requirements.

The SBA is holding a webinar to educate the public on the new Reinvestor SBIC License introduced to the market as part of the SBIC Investment Diversification and Growth Final Rule that went into effect on August 17, 2023.

The Environmental Protection Agency is planning to submit an information collection request (ICR), ``Annual Public Water System Compliance Report'' (EPA ICR No. 1812.08, OMB Control No. 2020-0020) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through November 30, 2024. 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 rule provides for annual adjustments to the level of civil monetary penalties contained in Bureau of Indian Affairs (Bureau) regulations to account for inflation under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 and Office of Management and Budget (OMB) guidance.