Department of Health and Human Services June 28, 2023 – Federal Register Recent Federal Regulation Documents

AHRQ coordinates the development of sets of standardized definitions and formats (Common Formats) that make it possible to collect, aggregate, and analyze uniformly structured information about health care quality and patient safety for local, regional, and national learning. The Common Formats include technical specifications to facilitate the collection of electronically comparable data by Patient Safety Organizations (PSOs) and other entities. Additional information about the Common Formats can be obtained through AHRQ's PSO website at https://pso.ahrq.gov/common-formats and the PSO Privacy Protection Center's website at https://www.psoppc.org/psoppc_web/ publicpages/commonFormatsOverview. The purpose of this notice is to announce a meeting to discuss implementation of the Common Formats with software developers and other interested parties. This meeting is designed as an interactive forum where software developers can provide input on use of the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ's technical specifications and implemented, or plan to implement, the Common Formats electronically.

The Administration for Children and Families (ACF) is requesting an extension without changes of the form ACF-118: Child Care and Development Fund Plan Preprint for States/Territories for FFY 2022- 2024 (OMB #0970-0114, expiration 02/29/2024), and an additional 3-year extension of the form ACF-118: Child Care and Development Fund Plan Preprint for States/Territories for FFY 2025-2027. There are changes requested to the form ACF-118: Child Care and Development Fund Plan Preprint for States/Territories for FFY 2025-2027 to improve formatting, collect additional information about program implementation, and streamline questions.

The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH) hereby gives notice that the All of Us Research Program will be hosting a virtual Tribal Consultation with American Indian and Alaska Native (AI/AN) Federally Recognized Tribes. The consultation will include an update on our approach to Tribal engagement, discussion about integrating data from self-identified AI/ AN participants in the program's data platform, the All of Us Research Hub at https://www.researchallofus.org, and program planning.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Patient-Matched Guides to Orthopedic Implants.'' This draft guidance document provides recommendations regarding information that should be included in regulatory submissions for patient-matched guides to orthopedic implants. This draft guidance also provides recommendations that manufacturers should consider when developing their design process for these device types. This draft guidance is intended to promote clarity and transparency as to expectations regarding submission recommendations for orthopedic patient-matched guides. Following such recommendations may increase efficiency and consistency in review. This draft guidance is not final nor is it for implementation at this time.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.'' This guidance provides recommendations for presenting quantitative efficacy and risk information in DTC promotional labeling and advertisements for prescription human drug and biological products and prescription animal drugs and in DTC promotional labeling for over-the-counter (OTC) animal drugs (collectively, ``promotional communications''). FDA is issuing this guidance to describe the Agency's recommendations for how manufacturers, distributors, and packers (collectively, ``firms'') that include quantitative efficacy or risk information about their drugs in DTC promotional communications can make the language and presentation more consumer-friendly. This guidance finalizes the draft guidance of the same title issued in October 2018.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.