Dockets

Recently active federal rulemakings, soonest-closing first.

• Patent Term Extension Application for JAYPIRCA (pirtobrutinib), Patent No. 10,342,780FDANonrulemaking
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• Patent Term Extension Application for LAMZEDE (velmanase alfa-tycv), Patent No. 10,159,718FDANonrulemaking
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• Patent Term Extension Application for SKYCLARYS (omaveloxolone), Patent No. 8,124,799FDANonrulemaking
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• Patent Term Extension Application for SKYCLARYS® (omaveloxolone), Patent No. 8,440,854FDANonrulemaking
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• Patent Term Extension Application for SKYCLARYS (omaveloxolone), Patent No. 8,993,640FDANonrulemaking
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• Patent Term Extension Application for SKYCLARYS (omaveloxolone), Patent No. 9,670,147FDANonrulemaking
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• Patent Term Extension Application for SKYCLARYS (omaveloxolone), Patent No. 9,701,709FDANonrulemaking
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• Patent Term Extension Application for SKYCLARYS (omaveloxolone), Patent No. 11,091,430FDANonrulemaking
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• Patent Term Extension Application for NAVITOR Transcatheter Aortic Valve Implantation System, Patent No. 9,220,594FDANonrulemaking
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• Patent Term Extension Application for NAVITOR Transcatheter Aortic Valve Implantation System, Patent No. 9,289,296FDANonrulemaking
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• Patent Term Extension Application for NAVITOR Transcatheter Aortic Valve Implantation System, Patent No. 9,351,828FDANonrulemaking
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• Patent Term Extension Application for NAVITOR Transcatheter Aortic Valve Implantation System, Patent No. 9,545,307FDANonrulemaking
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• Patent Term Extension Application for NAVITOR Transcatheter Aortic Valve Implantation System, Patent No. 9,681,949FDANonrulemaking
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• Patent Term Extension Application for NAVITOR Transcatheter Aortic Valve Implantation System, Patent No. 9,693,859FDANonrulemaking
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• Patent Term Extension Application for NAVITOR Transcatheter Aortic Valve Implantation System, Patent No. 9,820,851FDANonrulemaking
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• Patent Term Extension Application for NAVITOR Transcatheter Aortic Valve Implantation System, Patent No. 10,314,694FDANonrulemaking
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• Patent Term Extension Application for NAVITOR Transcatheter Aortic Valve Implantation System, Patent No. 11,007,053FDANonrulemaking
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• Filing of Food Additive Petition from Environmental Defense Fund, et al.; Request to Amend the Food Additive Regulations to Remove the Solvents Benzene, Ethylene Dichloride, Methylene Chloride, and TrichloroethyleneFDANonrulemaking
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• DAB Civil Money Penalty; S.V.S. Enterprises, LLC d/b/a La Tapatia 4; CLOSED 11/5/2025FDANonrulemaking
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• DAB Civil Money Penalty; JBA Enterprises, LLC d/b/a Puff The Magic Dragon; CLOSED 05/22/2026FDANonrulemaking
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• DAB Civil Money Penalty; Omaha Tobacco, LLC d/b/a Tobacco and Vapes; CLOSED 10/29/2025FDANonrulemaking
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• DAB Civil Money Penalty; Tobacco Outlet and Vape Outlet Plus Inc. d/b/a Smoke World Vape; CLOSED 11/6/2025FDANonrulemaking
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• DAB Civil Money Penalty; Bolla Operating L.I. Corp. d/b/a Mobil / Bolla Market; CLOSED 01/13/2026FDANonrulemaking
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• DAB Civil Money Penalty; Nur 4 Corp d/b/a Gulf; CLOSED 09/24/2025FDANonrulemaking
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• DAB Civil Money Penalty; 410 Greenwood Inc. d/b/a Delta; CLOSED 5/14/2026FDANonrulemaking
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• DAB Civil Money Penalty; Tennessee Market LLC d/b/a Cedar Market; CLOSED 2/19/2026FDANonrulemaking
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• DAB Civil Money Penalty; Baba Jawahardas Inc. d/b/a Texaco / Toledo Short Stop Grocery; CLOSED 09/02/2025FDANonrulemaking
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• DAB Civil Money Penalty; Sana Ventures LLC d/b/a Space City Food Mart / A and K Food Store; CLOSED 09/11/2025FDANonrulemaking
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• DAB Civil Money Penalty; ESAM Deli Corp d/b/a ESAM Deli Corp.; CLOSED 06/01/2026FDANonrulemaking
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• DAB Civil Money Penalty; Puff Smokeshop Number 1 Inc. d/b/a Puff Smoke Shop; CLOSED 09/30/2025FDANonrulemaking
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• Fiscal Year 2023 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for CommentsFDANonrulemaking
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• Filing of Color Additive Petition from Center for Science in the Public Interest, et al.; Request to Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs.FDANonrulemaking
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• Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; request for information and comments.FDANonrulemaking
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• Modernizing the Recall ProcessFDANonrulemaking
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• Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic ProductsFDARulemaking
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• Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for HearingFDANonrulemaking
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• FDA Rare Disease Day 2024FDANonrulemaking
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• Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation ProgramFDANonrulemaking
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• Keller and Heckman LLP submits a citizen petition on behalf of Lucy Goods, Inc; CLOSED 1/9/2026FDANonrulemaking
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• Requests that the FDA publish a notice in the Federal Register determining that erythritol is not GRAS and is a food additive subject to section 409 of the Federal Food, Drug, and Cosmetic Act, and that the Notice require discontinuation of the use of erythritol. CLOSEDFDANonrulemaking
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• Requests that the FDA either (1) determine that NMN is not excluded from the definition of a dietary supplement under section 21 U.S.C. S321(ff)(3)(B) of the Act or (2) commit to exercise enforcement discretion in connection with the marketing and selling NMN in or as a dietary supplementFDANonrulemaking
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• Request that the FDA take the following three actions described below: 1) To determine that the preclusion date referenced in the statute (i.e., the date on which the race to market between a drug and a supplement is adjudicated) is the date the existence of substantial clinical trials are made public, not the non-public date on which an investigational new drug (IND) application goes intoFDANonrulemaking
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• Requests that the FDA revise existing regulations and policies to require drug and dietary supplement manufacturers to clearly label whether ingredients used in their products are animal derived or contain animal byproducts.FDANonrulemaking
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• Request the Commissioner of Food and Drugs to take urgent action concerning the off-label use of GnRH agonists, a class of drugs also known as Puberty Blockers in Children.FDANonrulemaking
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• Requests that the FDA update the Agency’s public list of Paragraph IV Certifications to reflect the date of submission of Par’s ANDA 208217 as the date of the sole first-applicant ANDA referencing the Auryxia RLD.FDANonrulemaking
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• Requests that the FDA better protect more than 3.3 million Americans with Celiac by labeling Gluten (Wheat, Barley, Rye and Oats) as a Major Food Allergen on all packaged foods, just like labeling Gluten is required in more than 85 other countries.FDANonrulemaking
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• Requests that the FDA amend 2022 Food code 3-301.11 and 3-304.15 to read: 3-301 Preventing Contamination by Employees 3-301.11 Preventing Contamination from Hands. (B) Except when washing fruits and vegetables as specified under §3-302.15 or as specified in (D) and (E) of this section, FOOD EMPLOYEES may not contact exposed, READY-TO-EAT FOOD with their bare hands and shall use suitable UTENSILSFDANonrulemaking
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• Requests that the FDA declare that Oxycodone Hydrochloride and Acetaminophen Oral Solution, in strengths of 2.5 mg/325 mg per 5 mL, 7.5 mg/325 mg per 5 mL and 10 mg/325 mg per 5 mL strengths, are suitable for review under an Abbreviated New Drug Application (ANDA) supplement (PAS), pursuant to section 505(j) of the Federal Food, Drug and Cosmetic Act, as amended.; CLOSEDFDANonrulemaking
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• Requests that the FDA establish tolerances at the method detection limit MDL which is 0.05 ug/kg 0.05 ppb according to the data available as of November 2023 from the FDA, for residues of either twenty-six 26 or thirty 30 PFAS in a variety of foods.FDANonrulemaking
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• Requests that FDA amend 21 C.F.R. § 101.22 to eliminate use of the word “natural” in the terms “natural flavor” and “natural flavoring.”FDANonrulemaking
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