October 2022 – Federal Register Recent Federal Regulation Documents

On behalf of the United States, the National Park Service has relinquished jurisdiction to the State of Washington in order to establish concurrent legislative jurisdiction over certain lands owned and administered by the National Park Service, known as the East and South Barracks, at Fort Vancouver National Historic Site.

The U.S. Nuclear Regulatory Commission (NRC) is considering an exemption request from Holtec Decommissioning International, LLC (HDI) for the Indian Point Energy Center Independent Spent Fuel Storage Installation. This exemption would, if granted, allow HDI to load up to three MPC-32Ms, using Amendment No. 15 for Certificate of Compliance (CoC) No. 1014 for the HI-STORM 100 storage system, with either up to thirty-two fuel assemblies having either Californium (Cf-252) or Antimony-Beryllium (Sb-Be) neutron source assemblies (NSAs) with sufficient cooling time, or a combination of up to five fuel assemblies having primary Plutonium Beryllium (Pu-Be) NSAs and the remaining basket locations with fuel assemblies having either Cf-252 or Sb-Be NSAs with sufficient cooling time. As discussed further, the proposed exemption would permit HDI to load the fuel assemblies having either Cf-252 or Sb-Be NSAs in any location in the basket and the fuel assemblies having Pu-Be NSAs such that one is located in the center of the basket and one is located in each of the four basket quadrants. The NRC prepared an environmental assessment (EA) and concluded that the proposed action would have no significant environmental impact. Accordingly, the NRC staff is issuing a finding of no significant impact (FONSI) associated with the proposed exemption.

NMFS solicits nominations for the Atlantic Highly Migratory Species (HMS) Advisory Panel (AP). NMFS consults with and considers the comments and views of the HMS AP when preparing and implementing Fishery Management Plans (FMPs) or FMP amendments for Atlantic tunas, swordfish, sharks, and billfish. Nominations are being sought to fill approximately one-third (10) of the seats on the HMS AP for 3-year appointments. Individuals with definable interests in the recreational and commercial fishing and related industries, environmental community, academia, and non-governmental organizations are considered for membership on the HMS AP.

Public Meeting: U.S. Election Assistance Commission.

The U.S. Agency for International Development (USAID) seeks Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, USAID requests public comment on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.

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.

The Bureau of Land Management (BLM) hereby provides constructive notice that it will issue an appealable decision approving conveyance of the surface estate in certain lands to Calista Corporation, an Alaska Native regional corporation, pursuant to the Alaska Native Claims Settlement Act of 1971 (ANCSA). The lands approved for conveyance lie entirely within Clarence Rhode National Wildlife Range, now known as the Yukon Delta National Wildlife Refuge. As provided by ANCSA, ownership of the subsurface estate in the same lands will be retained by the United States.

The Food and Drug Administration (FDA or we) is announcing the effective date for requirements related to establishing and implementing supply-chain programs, records documenting supply-chain programs, and onsite audits in two final rules, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, that appeared in the Federal Register of September 17, 2015.

The Coast Guard is establishing a temporary safety zone for all navigable waters of the Upper Mississippi River extending from mile marker (MM) 125 to MM 126 near Sainte Genevieve, MO. The safety zone is needed to protect personnel and vessels from potential hazards due to shoaling in the area. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Upper Mississippi River or a designated representative.

The FAA proposes to supersede Airworthiness Directive (AD) 2021-08-02, which applies to all Safran Helicopter Engines, S.A. (Safran) Arriel 2D and Arriel 2E model turboshaft engines. AD 2021-08- 02 requires replacing certain critical parts before reaching their published in-service life limits, performing scheduled maintenance tasks before reaching their published periodicity, and performing unscheduled maintenance tasks when the engine meets certain conditions. Since the FAA issued AD 2021-08-02, Safran has revised the airworthiness limitation section (ALS) of the existing maintenance and overhaul manuals, introducing new and more restrictive instructions and maintenance tasks. This proposed AD would require revisions to the ALS of the operator's existing approved aircraft maintenance program (AMP), as applicable, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference (IBR). The FAA is proposing this AD to address the unsafe condition on these products.

This action proposes to remove Colored Federal airway A-9 due to the planned decommissioning of the Evansville, AK (EAV), Non- Directional Beacon (NDB), which provides navigation guidance for the affected route. The Evansville, AK (EAV), NDB is scheduled to be decommissioned effective on June 15, 2023.

In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA), as amended, notification is hereby given that NMFS has issued a renewal IHA to the U.S. Navy (Navy) to incidentally harass marine mammals incidental to the Naval Base San Diego Pier 6 Replacement Project in San Diego, California.

The New England Fishery Management Council (Council) is scheduling a public joint meeting of its Habitat Advisory Panel and Committee via webinar to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

Noramco has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

Curia New York, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

The Food and Drug Administration (FDA or Agency) is announcing the opportunity for a limited number of applicants to participate in a Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program, to facilitate the expedited CMC development of products under an investigational new drug (IND) application, where warranted, based upon the anticipated clinical benefit of earlier patient access to the products. FDA is implementing this pilot program to facilitate CMC readiness for selected Center for Biologics Evaluation and Research (CBER)- and Center for Drug Evaluation and Research (CDER)-regulated products with accelerated clinical development timelines. To accelerate CMC development and facilitate CMC readiness, the pilot features increased communication between FDA and sponsors and explores the use of science- and risk-based regulatory approaches, such as those described in FDA guidance, as applicable. This notice outlines the eligibility criteria and process for submitting a request to participate in the pilot.

The U.S. Nuclear Regulatory Commission (NRC) is granting exemptions from certain portions of the acceptance criteria for emergency core cooling, and the general design criteria for emergency core cooling, containment heat removal, and atmosphere cleanup to allow the use of a risk-informed analysis to evaluate the effects of debris in containment following a loss-of-coolant accident for the Callaway Plant, Unit No. 1 (Callaway) located in Callaway County, Missouri. The exemptions are in response to a request dated March 31, 2021, from Union Electric Company, doing business as Ameren Missouri (the licensee) related to the licensee's proposed approach to resolve a generic safety concern for pressurized water reactors associated with potential clogging of emergency core cooling and containment spray system strainers during certain design basis events.

NMFS publishes Fraser River salmon inseason orders to regulate tribal treaty (treaty Indian) and non-tribal (all citizen) commercial salmon fisheries in United States (U.S.) waters. The orders were issued by the Fraser River Panel (Panel) of the Pacific Salmon Commission (Commission) and subsequently approved and issued by NMFS during 2022 for sockeye salmon fisheries within the U.S. Fraser River Panel Area. These orders established fishing dates, times, and areas for the gear types of U.S. treaty Indian and all citizen commercial fisheries during the period the Panel exercised jurisdiction over these fisheries.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other federal agencies to comment on the proposed information collections listed below, in accordance with the Paperwork Reduction Act of 1995.