Dockets

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DAB Civil Money Penalty; Hokie Mart, Ltd. d/b/a Nick’s Convenience & More Ltd; CLOSED 11/14/2025FDANonrulemaking
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DAB Civil Money Penalty; Jarnail Singh Mann d/b/a Kingpin Smoke and Vape; CLOSED 09/25/2025FDANonrulemaking
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DAB Civil Money Penalty; The Vape Lounge, Inc. d/b/a The Vape Lounge; CLOSED 2/17/2026FDANonrulemaking
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DAB Civil Money Penalty; Grill and Chill Corp d/b/a Lukoil / Mini-Mart; CLOSED 4/17/2026FDANonrulemaking
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DAB Civil Money Penalty; Sunset Food, Corp. d/b/a 5 Brothers Gourmet Market; CLOSED 1/26/2026FDANonrulemaking
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DAB Civil Money Penalty; Winona Petroleum LLC d/b/a Mobil / Cube Express Stop; CLOSED 3/6/2026FDANonrulemaking
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DAB Civil Money Penalty; Zeigler Petro Inc. d/b/a Marathon; CLOSED 04/09/2026FDANonrulemaking
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DAB Civil Money Penalty; NAKV Enterprises Inc. d/b/a Fat Puff Wholesale; CLOSED 11/17/2025FDANonrulemaking
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DAB Civil Money Penalty; Deli Cioso LLC d/b/a Discount Vape Pen; CLOSED 09/11/2025FDANonrulemaking
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DAB Civil Money Penalty; The Vaping Dragon, LLC, d/b/a The Vaping DragonFDANonrulemaking
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DAB Civil Money Penalty; Gold Conda Ltd d/b/a Gold Conda; CLOSED 9/16/2025FDANonrulemaking
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DAB Civil Money Penalty; Carniceria Sonora 1, Inc. d/b/a Carniceria Sonora 1; CLOSED 9/4/2025FDANonrulemaking
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Proposal to Debar Yong Sheng JiaoFDANonrulemaking
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Agency Information Collection Activities; Proposed Collection; Comment Request; Proposed Small Dispensers Assessment under the Drug Supply Chain Security ActFDANonrulemaking
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Agency Information Collection Activities; Proposed Collection; Comment Request; Data to Support Social and Behavioral Research as Used by the Food and Drug AdministrationFDANonrulemaking
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NOOH Proposal to Debar William GoldsmithFDANonrulemaking
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Requirements for Additional Traceability Records for Certain Foods; Proposed Exemption for Cottage Cheese Regulated by the National Conference on Interstate Milk Shipments Grade A Pasteurized Milk OrdinanceFDANonrulemaking
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First Annual Animal Drug User Fee Educational Conference; Public MeetingFDANonrulemaking
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Food Labeling: Front-of-Package Nutrition InformationFDARulemaking
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NOOH Proposal to Debar Miguel Angel Montalvo VillaFDANonrulemaking
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Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biological ProductsFDANonrulemaking
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Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay DeviceFDANonrulemaking
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Agency Information Collection Activities; Proposed Collection; Comment Request; Pharmaceutical Distribution Supply Chain; Drug Supply Chain SecurityFDANonrulemaking
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Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Related Collections of InformationFDANonrulemaking
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FDA’s Strategy Document on Innovative Manufacturing TechnologiesFDANonrulemaking
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Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European CommunityFDARulemaking
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Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee ProgramFDANonrulemaking
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Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling Requirements for Prescription DrugsFDANonrulemaking
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Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical DevicesFDANonrulemaking
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Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human UseFDANonrulemaking
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Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical InvestigatorsFDANonrulemaking
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Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling: Notification Procedures for Statements on Dietary SupplementsFDANonrulemaking
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Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealer’s Certificate and Participation in the National Shellfish Sanitation ProgramFDANonrulemaking
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FDA Office of the Chief Medical Officer Guidance AgendaFDANonrulemaking
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Agency Information Collection Activities; Proposed Collection; Comment Request; FDA’s Adverse Event and Product Experience Reporting ProgramFDANonrulemaking
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Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other CombustedFDARulemaking
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Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and Issue CertificationsFDANonrulemaking
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Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug and Veterinary Master FilesFDANonrulemaking
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Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity ActFDANonrulemaking
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Proposal To Refuse To Approve a New Drug Application for TRADIPITANT; Opportunity for a HearingFDANonrulemaking
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Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Product Establishment Registration and ListingFDANonrulemaking
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Agency Information Collection Activities; Proposed Collection; Comment Request; Sanitary Transportation of Human and Animal FoodFDANonrulemaking
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Requests that the FDA declare that Pimavanserin Tablets, 34 mg is suitable for submission as an ANDA.FDANonrulemaking
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Requests that the FDA issue a guidance document, as outlined in 21 CFR 10.115, pertaining to third-party companies that partner with employer-sponsored health plans to import prescription drugs from outside the United States, also known as alternative funding programs.FDANonrulemaking
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Requests that the FDA issue a guidance stating that OTC vaginal suppositories containing boric acid, that are marketed solely with deodorant claims, or claims to reduce vaginal odor, are “cosmetics” and not also “drugs.”FDANonrulemaking
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Requests the Commissioner to ensure that applications submitted under 505(j) and 505(b)(2) that rely on Lutathera include data necessary to show that a proposed product is pharmaceutically equivalent, bioequivalent, and can be expected to have the same clinical effect and safety profile as Lutathera when administered to patients under the conditions specified in the labelingFDANonrulemaking
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Requests that the Commissioner take action consistent with Congress' enactment of the Federal Food, Drug, and Cosmetic Act ("FDCA") and the Food and Drug Omnibus Reform Act of 2022 ("FDORA") and amend its regulations and guidance documents to clarify the requirements for approval of drugs for the benefit of the regulated community, including the acceptance of data from new alternative methodsFDANonrulemaking
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Request that the FDA take the following three actions described below: 1Initiate proceedings to reclassify aging from a natural process to a disease for the purposes of regulation and research. 2) Review and consider the scientific and medical evidence presented in support of this reclassification. 3) Amend relevant FDA policies and regulations to reflect the reclassification of aging as a diseaseFDANonrulemaking
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Requests the Commissioner to take administrative action, specifically a determination whether the listed drug (Lunelle) that has been voluntarily withdrawn from sale was withdrawn for safety or effectiveness reasonsFDANonrulemaking
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Petition for Reclassification of next-generation sequencing oncology panels used for somatic or germline variant detection that include one or more companion diagnostic indications from class III to class IIFDANonrulemaking
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