Department of Health and Human Services May 18, 2023 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2023-10594
Type: Notice
Date: 2023-05-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2023-10648
Type: Notice
Date: 2023-05-18
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 2023-10646
Type: Notice
Date: 2023-05-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2023-10616
Type: Notice
Date: 2023-05-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2023-10615
Type: Notice
Date: 2023-05-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2023-10614
Type: Notice
Date: 2023-05-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2023-10613
Type: Notice
Date: 2023-05-18
Agency: Department of Health and Human Services, National Institutes of Health
Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Draft Guidance for Industry; Availability
Document Number: 2023-10611
Type: Notice
Date: 2023-05-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations.'' This draft guidance addresses selected clinical, scientific, and ethical issues involved in developing drugs, including biological products, for pediatric use when such drug products are subject to the Pediatric Research Equity Act (PREA) and/or the Best Pharmaceuticals for Children Act (BPCA). This draft guidance is intended to assist industry in obtaining the data and information necessary to support the approval of drug products in pediatric populations. This draft guidance does not address the clinical development of drug products that are not subject to either PREA or the BPCA.
Pediatric Drug Development: Regulatory Considerations-Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act; Draft Guidance for Industry; Availability
Document Number: 2023-10610
Type: Notice
Date: 2023-05-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Pediatric Drug Development: Regulatory ConsiderationsComplying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act.'' This draft guidance, when finalized, is intended to provide recommendations to industry on complying with the pediatric study requirements under the Pediatric Research Equity Act (PREA), and to describe the process for qualifying for pediatric exclusivity and the protections that pediatric exclusivity offers under the Best Pharmaceuticals for Children Act (BPCA). Combining discussion of PREA and the BPCA together in regulatory guidance emphasizes the sponsor's need to consider both laws when developing pediatric drugs and biological products.
Patient Engagement Advisory Committee; Notice of Meeting
Document Number: 2023-10609
Type: Notice
Date: 2023-05-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Center for Devices and Radiological Health (CDRH) Patient Engagement Advisory Committee (the Committee). The general function of the committee is to provide advice to the Commissioner of Food and Drugs, or designee, on complex scientific issues relating to medical devices, the regulation of devices, and their use by patients. The meeting will be open to the public.
International Dairy Foods Association: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard for Yogurt; Correction
Document Number: 2023-10606
Type: Rule
Date: 2023-05-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is correcting a final order that appeared in the Federal Register on April 14, 2023. The document responded to objections and requests for a public hearing on the final rule to revoke the standards for lowfat yogurt and nonfat yogurt and amend the standard for yogurt. The final order published with an inadvertent error. This document corrects that error.
Product-Specific Guidance for Ethinyl Estradiol; Segesterone Acetate; Draft Guidance for Industry; Availability
Document Number: 2023-10604
Type: Notice
Date: 2023-05-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Draft Guidance for Ethinyl Estradiol; Segesterone Acetate.'' The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for ethinyl estradiol; segesterone acetate vaginal ring.
21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page, 2021 and 2022 Updates; Request for Comments
Document Number: 2023-10603
Type: Notice
Date: 2023-05-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency's annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page with updates made in 2021 and 2022. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since establishment has provided updates to both the format of the web pages and to the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).
Meeting of the National Vaccine Advisory Committee
Document Number: 2023-10635
Type: Notice
Date: 2023-05-18
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold an in- person meeting. The meeting will be open to the public and public comment will be heard during the meeting.
Fiscal Year (FY) 2023 Notice of Supplemental Funding Opportunity
Document Number: 2023-10632
Type: Notice
Date: 2023-05-18
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting a supplement in scope of the original award for the one grant recipient, the Community Anti-Drug Coalitions of America (CADCA), funded in FY 2019 under the National Anti-Drug Coalitions Training and Workforce Development award, Notice of Funding Opportunity (NOFO) SP-19-002. The recipient may receive up to $175,000 and the project period will be extended by 12 months until November 30, 2024. The supplemental funding to CADCA will be used to continue the Voices of Youth Training Initiative. The Voices of Youth Training Initiative has shown positive results, and the continuation of the program will support finalizing the sustainability and scalability beyond the supplements. The supplement will continue to connect the Future Health Professionals (HOSA) national student organization with CADCA to support youth-led strategic planning for the prevention field and develop leadership skills for the future workforce. This supplement will also allow CADCA to provide HOSA students an opportunity to both learn about and provide valuable input into strategic initiatives for prevention.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2023-10655
Type: Notice
Date: 2023-05-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2023-10650
Type: Notice
Date: 2023-05-18
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Amended Notice of Meeting
Document Number: 2023-10649
Type: Notice
Date: 2023-05-18
Agency: Department of Health and Human Services, National Institutes of Health
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