Department of Health and Human Services May 15, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2024. The animal drug regulations are also being amended to improve their accuracy and readability.
Gina Acosta: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Gina Acosta from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Acosta was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Ms. Acosta was given notice of the proposed debarment and an opportunity to request a hearing to show why she should not be debarred. As of March 6, 2024 (30 days after receipt of the notice), Ms. Acosta has not responded. Ms. Acosta's failure to respond and request a hearing constitutes a waiver of Ms. Acosta's right to a hearing concerning this matter.
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
The Food and Drug Administration (FDA, the Agency, or we) is amending the animal drug regulations for labeling of new animal drugs included on FDA's Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (indexed products) to reflect the 2018 statutory changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This amendment is intended to ensure accuracy and clarity in the Agency's regulations. This amendment is nonsubstantive.
Meeting of the Advisory Committee on Training and Primary Care Medicine and Dentistry
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD or Committee) will hold public meetings for the 2024 calendar year (CY). This notice supersedes the information about ACTPCMD's 2024 meetings found in the Federal Register notice dated December 15, 2023, Meeting of the Advisory Committee on Training and Primary Care Medicine and Dentistry.
Agency Information Collection Request; 60-Day Public Comment Request
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 ICR is for extending the use of the approved information collection assigned OMB control number 0937-0191, which expires on June 30, 2024. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Cosmetic Export Certificate Application Process
The Food and Drug Administration (FDA or Agency) 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 export certificate applications for FDA-regulated human food and cosmetic products.
Request for Information on the Development of the Fiscal Years 2026-2030 NIH-Wide Strategic Plan for Sexual & Gender Minority Health Research; Correction
The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on May 9, 2024. That Notice requires a correction in the DATES section.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; OJEMDA (tovorafenib)
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that OJEMDA (tovorafenib), approved on April 23, 2024, manufactured by Day One Biopharmaceuticals, Inc., meets the criteria for a priority review voucher.
Submission for Office of Management and Budget Review; Head Start REACH: Strengthening Outreach, Recruitment, and Engagement Approaches With Families-Mixed Methods Study (New Collection)
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is proposing to collect data on different approaches that Head Start programs use to recruit, select, and enroll families, and the ways in which such practices reflect programs' community contexts. We are not attempting to recruit a nationally representative sample. Instead, the study will aim to obtain a variety of eligibility, recruitment, selection, enrollment, and attendance (ERSEA) practices and experiences to explore how these practices and experiences intersect with different adversities, demographic characteristics, and community contexts.
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