2023 – Federal Register Recent Federal Regulation Documents

The DoD has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

In compliance with the Paperwork Reduction Act of 1995, the Office of Local Defense Community Cooperation announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

The FAA has accepted for review the application for Avon Park Executive Airport's (AVO) participation in the Airport Investment Partnership Program (AIPP), under the terms and conditions of the AIPP and the FAA's Notice of AIPP Application Procedures. The filing date for AVO's application is noted as July 7, 2023. The City of Avon Park, the airport sponsor, selected Florida Airport Management as the private operator and negotiated a draft agreement for FAA review. The FAA has determined that the final application is substantially complete and accepted for review. The determination that the application is substantially complete results in the commencement of the FAA's review and is not an approval or disapproval of the proposed privatization application. The FAA is seeking information and comments from interested parties on the final application. The FAA will review the application, public comments, and any other relevant additional submission by the applicant or the public and issue a decision approving or disapproving the application. The AVO application is available for public review at https://www.regulations.gov. The docket number is FAA Docket Number 2023-1724.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.'' This draft guidance outlines the recommendations to industry on formal meetings between the FDA and sponsors or applicants relating to the development and review of new drug or biological drug products. This draft guidance replaces the guidance ``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products'' issued on December 29, 2017.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications.'' This draft guidance provides information to applicants on how FDA intends to use alternative tools to assess manufacturing facilities identified in a marketing application (i.e., a new drug application (NDA), an abbreviated new drug application (ANDA), a biologics license application (BLA), or a supplement to any of these types of applications). As part of the negotiations relating to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA), as described in ``PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027'' (PDUFA VII commitment letter) and ``Biosimilar Biological Product Reauthorization Performance Goals and Procedures for Fiscal Years 2023 Through 2027'' (BsUFA III commitment letter), FDA agreed to issue guidance on the use of alternative tools to assess manufacturing facilities named in pending applications and to incorporate best practices from the use of such tools during the Coronavirus Disease 2019 (COVID-19) pandemic. This draft guidance, within the context of approval and licensure decisions by FDA, describes the use of alternative tools to assess manufacturing facilities identified in an NDA, an ANDA, or a BLA to establish that these facilities meet the applicable requirements, including under the Federal Food, Drug, and Cosmetic (FD&C Act) or the Public Health Service Act (PHS Act).

In accordance with the Federal Advisory Committee Act (FACA) of 1972, the U.S. Geological Survey (USGS) is publishing this notice to announce that a Federal Advisory Committee meeting of the National Geospatial Advisory Committee (NGAC) will take place and is open to members of the public.

In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing an extension without change of a currently approved information collection request (ICR).

This notice announces a meeting of the Electricity Advisory Committee (EAC). The Federal Advisory Committee Act (FACA) requires that public notice of these meetings be announced in the Federal Register.

The DoD has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

The DoD has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

The Department of Labor (DOL) is submitting this Occupational Safety & Health Administration (OSHA)-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.

This document denies a petition for rulemaking submitted by Mr. Eddie L. Fray on behalf of the Parent Advocacy Group on November 27, 2015. The petitioner requested that the Secretary of Transportation mandate installation of specific products and systems as well other complementary safety features intended to prevent pediatric heatstroke in vehicles. NHTSA is denying the petition because the Agency does not initiate rulemaking to require installation of specific products.

The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on November 16, 2023. The topic for this meeting will be ``The Application of Digital Health Technology to Type 2 Diabetes Management: Current Status, Research Gaps, and Opportunities''. The meeting is open to the public.

In February 2023, as required by Reese's Law, the U.S. Consumer Product Safety Commission (CPSC or Commission) issued a notice of proposed rulemaking (NPR) to establish performance and labeling requirements for consumer products containing button cell or coin batteries, and requirements for labeling of button cell or coin battery packages, to eliminate or adequately reduce the risk of injury from ingestion of button cell or coin batteries by children six years old and younger. Elsewhere in this issue of the Federal Register, the Commission is publishing a direct final rule to incorporate by reference a voluntary standard as the mandatory standard for consumer products containing button cell or coin batteries. The Commission issues this final rule to complete Reese's Law requirements for warning labels on the packaging of button cell or coin batteries. Button cell or coin battery packaging subject to this final rule must be certified as compliant with these warning label requirements.

NMFS issues regulations to implement Amendment 53 to the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic (FMP), as prepared and submitted by the South Atlantic Fishery Management Council (Council). For gag, this final rule revises the sector annual catch limits (ACLs), commercial trip limits, recreational bag, vessel, and possession limits, and recreational accountability measures (AMs). For black grouper, this final rule revises the recreational bag, vessel, and possession limits. In addition, Amendment 53 establishes a rebuilding plan, and revises the overfishing levels, acceptable biological catch (ABC), annual optimum yield (OY), and sector allocations for gag. The purpose of this final rule and Amendment 53 is to end overfishing of gag, rebuild the stock, and achieve OY while minimizing, to the extent practicable, adverse social and economic effects.

The Chugach National Forest is proposing to establish a new recreation fee site. Recreation fee revenues collected at the new recreation fee site would be used for operation, maintenance, and improvement of the site. An analysis of nearby recreation fee sites with similar amenities shows the new recreation fee that would be charged at the new recreation fee site is reasonable and typical of similar recreation fee sites in the area.