April 6, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the publication of a report providing options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the human drug and biosimilar biologic review programs. FDA, in both the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and Biosimilar User Fee Amendments of 2017 (BsUFA II) committed to obtaining this report through a contract with an independent accounting or consulting firm and publishing it before September 30, 2020. This was also codified in the respective authorizing statutory language. FDA is announcing publication of this report and the opening of a docket to receive public comment on this report. Per the respective statutory sections, after review of this report and receipt and review of public comment thereon, FDA will establish a capacity planning methodology for adjusting the annual fee revenue amounts for the PDUFA and BsUFA programs.

The Food and Drug Administration (FDA or we) is extending for a second time the comment period for the proposed rule, and for the information collection related to the proposed rule, entitled ``Laboratory Accreditation for Analyses of Foods'' that appeared in the Federal Register of November 4, 2019. We are taking this action in response to a request from several food industry associations to extend open comment periods while their members focus on continuity of critical infrastructure operations due to the recent COVID-19 public health declaration. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.

The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

This notice announces a Virtual Meeting of the State Energy Advisory Board (STEAB). The Federal Advisory Committee Act requires that public notice of these meetings be announced in the Federal Register.

The Department of Commerce (Commerce) preliminarily determines that certain steel nails from Taiwan were sold in the United States at less than normal value during the period of review (POR), July 1, 2018 to June 30, 2019. Interested parties are invited to comment on these preliminary results.

As a result of this sunset review, the Department of Commerce (Commerce) finds that revocation of the antidumping duty (AD) order on carbon and certain alloy steel wire rod (wire rod) from the People's Republic of China (China) would be likely to lead to continuation or recurrence of dumping at the levels indicated in the ``Final Results of Review'' section of this notice.

The Council on Graduate Medical Education (COGME) meeting previously announced as in-person and webinar/conference call on Tuesday, April 28, 2020, and Wednesday, April 29, 2020, has changed its format, date, and time. The meeting will now be a one-day webinar and conference call only on Wednesday, April 29, 2020, from 12:00 p.m.-5:00 p.m. Eastern Time. The webinar link, conference dial-in number, meeting materials, and agenda will be available on the COGME website: https:// www.hrsa.gov/advisory-committees/graduate-medical-edu/meeting s/ index.html.

This notice provides information regarding FHWA's finding that it is appropriate to grant a Buy America waiver to the Inter-Island Ferry Authority (IFA) of Alaska for procurement of foreign iron and steel components for refurbishment of two ferry vessels, specifically including (i) two sets of reduction gear replacement parts, one for the M/V Stikine ferry and the other for the M/V Prince of Wales ferry; and (ii) one set of pitch control units for the M/V Prince of Wales ferry.

The FAA is adopting a new airworthiness directive (AD) for Airbus Helicopters Model AS332C, AS332C1, AS332L, and AS332L1 helicopters. This AD requires determining the accumulated hours time- in-service (TIS) of certain part-numbered main gearbox (MGB) suspension bar attachment fittings (fittings) and bolts, and establishes new life limits. This AD was prompted by the outcome of tests and analyses performed by Airbus Helicopters. The actions of this AD are intended to address an unsafe condition on these products.

This notice announces the availability of EPA's progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year 2017. This progress report also presents the total number of products registered under the ``fast- track'' provisions of the Federal Insecticide Fungicide and Rodenticide Act (FIFRA).

The Groundfish and Coastal Pelagic Species (CPS) Subcommittees of the Pacific Fishery Management Council's (Pacific Council's) Scientific and Statistical Committee (SSC) will hold a meeting to review proposed revisions to the Terms of Reference for the Groundfish and Coastal Pelagic Species Stock Assessment Review Process for 2021 and 2022. The meeting is open to the public.

The FHWA, on behalf of UDOT, is issuing this notice to announce actions taken by UDOT that are final Federal agency actions. The final agency actions relate to a proposed highway project, improvements to Interstate 15 (I-15), at milepost (MP) 11 in Washington City, Washington County, State of Utah. Those actions grant licenses, permits and/or approvals for the project. The UDOT's Record of Decision (ROD) provides details on the Selected Alternative for the proposed improvements.

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

FMCSA announces its decision to renew exemptions for 27 individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these hard of hearing and deaf individuals to continue to operate CMVs in interstate commerce.