Department of Health and Human Services October 31, 2024 – Federal Register Recent Federal Regulation Documents

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the proposed new information collection requirements relating to the State Annual Long- Term Care Ombudsman Report (OMB Control Number 0985-0005).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms" and the supplemental document entitled "M13A Bioequivalence for Immediate- Release Solid Oral Dosage Forms: Questions and Answers." The guidance and supplemental questions and answers document were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) assessment of orally administered immediate-release solid oral dosage forms of pharmaceutical drugs, such as tablets, capsules, and granules/powders for oral suspension. The supplemental questions and answers document provides clarity to concepts covered in the guidance and rationales behind to facilitate implementation. The guidance is intended to provide globally harmonized scientific recommendations for conducting BE studies during both the development and postapproval phases of immediate-release solid oral dosage forms. The guidance replaces the draft guidance "M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms" issued on February 1, 2023.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Department of Health and Human Services is correcting a final rule that appeared in the Federal Register on August 21, 2024. The effective date of that final rule was listed in the preamble as the date of publication, August 21, 2024, when it should have had the required 60-day delay to comply with the Congressional Review Act. The effective date should have been October 21, 2024. Additionally, the final rule inadvertently included an incorrect citation in the requirements for family partnership services, and failed to include the compliance date for the requirements for staff benefits (August 1, 2028) in the regulatory text.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Department of Health and Human Services (HHS) (Department) has created the Interagency Pain Research Coordinating Committee (IPRCC) and is seeking nominations for this committee.