Department of Health and Human Services June 2023 – 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 the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the Proposed Revision and solicits comments on the information collection requirements related to the ``National SHIP- SMP Beneficiary Survey of Group Outreach and Education Events.''

Notice is provided of the persons who will serve on the Indian Health Service Senior Executive Service Performance Review Board.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the development of drugs or biological products for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Specifically, this guidance addresses FDA's current thinking regarding trial population and design, effectiveness, statistical analysis, and safety for drugs being developed for the treatment of CRSwNP. This guidance finalizes the draft guidance of the same title issued on December 10, 2021.

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with our Voluntary National Retail Food Regulatory Program (VNRFRP) Standards.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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.

Findings of research misconduct have been made against Yiorgos (Georgios) I. Laliotis, M.D. (Respondent), who was a Postdoctoral Fellow, Department of Cancer Biology and Genetics, College of Medicine, The Ohio State University (OSU), and Postdoctoral Fellow, Department of Oncology, Johns Hopkins University (JHU). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Cancer Institute (NCI), National Institutes of Health (NIH), grants R01 CA186729, R01 CA198117, P30 CA016058, K22 CA245487, and R21 CA252530 and included in grant applications submitted for PHS funds, specifically R01 CA186729-07 and R01 CA198117-05 submitted to NCI, NIH. The administrative actions, including supervision for a period of three (3) years, were implemented beginning on June 12, 2023, and are detailed below.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

Pursuant to the Head Start Act, notice is hereby given of two tribal consultation sessions to be held between HHS/ACF OHS leadership and the leadership of tribal governments operating Head Start and Early Head Start programs. The purpose of these consultation sessions is to discuss ways to better meet the needs of American Indian and Alaska Native (AI/AN) children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations. Two tribal consultations will be held as part of HHS/ACF or ACF Tribal Consultation Sessions.

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

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.