October 2, 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research's (CBER) Office of Therapeutic Products (OTP) and Center for Drug Evaluation and Research's (CDER) Office of New Drugs are announcing the opportunity for a limited number of development programs to participate in the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program, with the goal of further accelerating the pace of development of certain CBER- and CDER-regulated products (novel drug and biological products) that are intended to treat a rare disease. Because each Center has identified specific needs concerning regulated products for rare diseases, the eligibility criteria for the pilot differ between CBER and CDER. This pilot would augment the currently available formal meetings between FDA and sponsors by addressing issues related to the development of individual products through more rapid, ad-hoc communication mechanisms. Sponsors, if selected for the pilot, would receive more frequent advice related to such specific issues through additional interactions to facilitate novel drug and biological product program development and generate high quality and reliable data intended to support a Biologics License Application (BLA) or New Drug Application (NDA). This notice outlines the eligibility criteria, what to submit in a request to participate in the pilot, selection criteria, process, and FDA-Sponsor interactions expected to occur for programs participating in the pilot.

The FAA is requesting public comment on the Iberia Parish Airport Authority's proposal to change 233 acres of airport property at Acadiana Regional Airport in New Iberia, Louisiana from aeronautical to non-aeronautical use. This acreage was federally conveyed through the Surplus Property Act of 1944.

The Federal Emergency Management Agency (FEMA) is accepting comments on the proposed FEMA policy, Federal Flood Risk Management Standard (FFRMS). This proposed policy would provide detail, consistent with applicable regulations, on applicability, processes, resources, and responsibilities for implementing the FFRMS as part of FEMA's 8- step decision making process for carrying out the directives of Executive Order 11988, Floodplain Management, as amended.

In accordance with the requirements of the Federal Advisory Committee Act, the Millennium Challenge Corporation (MCC) Advisory Council was established as a discretionary advisory committee on July 14, 2016. Its charter was most recently renewed for a fourth term on July 7, 2022. The MCC Advisory Council serves MCC solely in an advisory capacity and provides insight regarding innovations in infrastructure, technology, and sustainability; perceived risks and opportunities in MCC partner countries; new financing mechanisms for developing country contexts; and shared value approaches. The MCC Advisory Council provides a platform for systematic engagement with the private sector and other external stakeholders and contributes to MCC's missionto reduce poverty through sustainable economic growth.

In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Fish and Wildlife Service (Service), are proposing a new information collection.

The Office of Community Services (OCS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting to extend the currently approved Low Income Home Energy Assistance Program (LIHEAP) Model Plan Application (OMB #0970-0075, expiration 12/31/2023) through August 31, 2024, and then making significant revisions to the FY 2025 application to be effective September 1, 2024. This notice outlines the proposed revisions for FY 2025.

The Department of Labor (DOL) is submitting this Office of the Assistant Secretary for Administration and Management (OASAM)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

Under the Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, FRA seeks approval of the Information Collection Request (ICR) summarized below. Before submitting this ICR to the Office of Management and Budget (OMB) for approval, FRA is soliciting public comment on specific aspects of the activities identified in the ICR.

The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments 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.

This rule implements a recommendation from the Almond Board of California (Board) to change multiple provisions in the administrative requirements prescribed under the Federal marketing order regulating the handling of almonds grown in California (Order). This action amends administrative requirements regulating quality control, exempt dispositions, and interest and late charges provisions. In addition, the rule stays two sections of the administrative requirements that define almond butter and stipulate disposition in reserve outlets by handlers to facilitate the efficient administration of the Order.

New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities.

The purpose of this notice is to solicit public nominations for three positions on the Wild Horse and Burro Advisory Board (Board) that will become vacant on January 11, 2024. The Board provides advice concerning the management, protection, and control of wild free-roaming horses and burros on public lands administered by the Department of the Interior, through the Bureau of Land Management (BLM), and the Department of Agriculture, through the U.S. Forest Service.

In accordance with the Federal Advisory Committee Act, the Department of Health and Human Services is giving notice that the Advisory Committee on Infant and Maternal Mortality (ACIMM or Committee) is renewed. The effective date of the charter renewal is September 30, 2023.

In preparation for the 2023 International Commission for the Conservation of Atlantic Tunas (ICCAT) meeting, the Advisory Committee to the U.S. Section to ICCAT is announcing the convening of its fall meeting.

NMFS is transferring 25 metric tons (mt) of Atlantic bluefin tuna (BFT) quota from the Reserve category to the General category October through November time period resulting in an adjusted October through November time period subquota of 117.4 mt and a Reserve category quota of 87.2 mt. This action would affect Atlantic Tunas General category (commercial) permitted vessels and Highly Migratory Species (HMS) Charter/Headboat permitted vessels with a commercial sale endorsement when fishing commercially for BFT.

In accordance with the Paperwork Reduction Act of 1995 we, the National Park Service (NPS), are proposing to renew an information collection with revisions.

BOEM is announcing the availability of the Proposed Final Program (PFP) for the 2024-2029 National Outer Continental Shelf (OCS) Oil and Gas Leasing Program (2024-2029 Program, National OCS Program, or Program), as well as the Final Programmatic Environmental Impact Statement for the 2024-2029 Program (Final Programmatic EIS).

This notice announces that the date for the third public meeting of the Ground Ambulance and Patient Billing (GAPB) Advisory Committee is October 31, 2023 and November 1, 2023. The GAPB Advisory Committee will make recommendations with respect to the disclosure of charges and fees for ground ambulance services and insurance coverage, consumer protection and enforcement authorities of the Departments of Labor, Health and Human Services, and the Treasury (the Departments) and relevant States, and the prevention of balance billing to consumers. The recommendations shall address options, best practices, and identified standards to prevent instances of balance billing; steps that can be taken by State legislatures, State insurance regulators, State attorneys general, and other State officials as appropriate, consistent with current legal authorities regarding consumer protection; and legislative options for Congress to prevent balance billing.

The FAA is superseding Airworthiness Directive (AD) 2020-24- 04, which applied to all The Boeing Company Model 787-8, 787-9, and 787-10 airplanes. AD 2020-24-04 required revising the existing airplane flight manual (AFM) to incorporate procedures for an approach with a localizer-based navigation aid, monitoring localizer raw data, calling out any significant deviations, and performing an immediate go around under certain conditions. This AD was prompted by the development of a modification to address the previously identified unsafe condition, and the identification of a separate unsafe condition where misleading vertical flight director (FD) guidance can be presented to the flightcrew under certain conditions. This AD continues to require the actions specified in AD 2020-24-04 and requires installing applicable software updates to the flight control module (FCM). Using updated software terminates the retained AFM requirement in this AD. The FAA is issuing this AD to address the unsafe condition on these products.

HRSA provided additional award funds to the two Regional Pediatric Pandemic Network (RPPN) Program recipients in Maryland and Ohio with periods of performance ending in fiscal year 2024.

This document contains a notice of exemption issued by the Department of Labor (the Department) from certain prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974. The exemption permits: (1) the acquisition, on August 3, 2020, by the Occidental Petroleum Corporation Savings Plan (the Oxy Plan) and the Anadarko Employee Savings Plan (the Anadarko Plan; together, the Plans), of stock warrants (the Warrants) issued by Occidental Petroleum Company, a party in interest with respect to the Plans; and (2) the holding of the Warrants.