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Food and Drug Administration

154 documents across 43 days of the archive, 25 of them final rules. The five most recent days are below.

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Comment deadlines and effective dates from anything this agency published in the archive, still ahead of 19 October 2026.

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  1. today Comments close Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability Health and Human Services Department · Food and Drug Administration
  2. +2d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs Health and Human Services Department · Food and Drug Administration
  3. +4d Comments close Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Health and Human Services Department · Food and Drug Administration
  4. +7d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health Health and Human Services Department · Food and Drug Administration
  5. +7d Comments close Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast Health and Human Services Department · Food and Drug Administration
  6. +8d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service Delivery Health and Human Services Department · Food and Drug Administration
  7. +8d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers Health and Human Services Department · Food and Drug Administration
  8. +8d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration Health and Human Services Department · Food and Drug Administration
  9. +10d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503 Health and Human Services Department · Food and Drug Administration
  10. +11d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees Health and Human Services Department · Food and Drug Administration
  11. +11d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections Health and Human Services Department · Food and Drug Administration
  12. +14d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Improvement Program Health and Human Services Department · Food and Drug Administration
  13. +15d Comments close Advancing Development of Botanical Drug Products; Request for Information Health and Human Services Department · Food and Drug Administration
  14. +21d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products Health and Human Services Department · Food and Drug Administration
  15. +21d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications Health and Human Services Department · Food and Drug Administration
  16. +21d Comments close Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information Health and Human Services Department · Food and Drug Administration · Health Resources and Services Administration
  17. +21d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun)) Health and Human Services Department · Food and Drug Administration
  18. +21d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications, Procedures and Requirements Health and Human Services Department · Food and Drug Administration
  19. +21d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use Health and Human Services Department · Food and Drug Administration
  20. +22d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking Health and Human Services Department · Food and Drug Administration
  21. +25d Comments close Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments Health and Human Services Department · Food and Drug Administration
  22. +25d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Cosmetic Products Health and Human Services Department · Food and Drug Administration
  23. +25d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards Health and Human Services Department · Food and Drug Administration
  24. +25d Comments close Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements Health and Human Services Department · Food and Drug Administration
  25. +25d Comments close Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate Health and Human Services Department · Food and Drug Administration
  26. +29d Comments close Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability Health and Human Services Department · Food and Drug Administration
  27. +29d Comments close Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document Health and Human Services Department · Food and Drug Administration
  28. +29d Comments close Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Draft Guidance for Industry; Availability Health and Human Services Department · Food and Drug Administration
  29. +30d Comments close Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability Health and Human Services Department · Food and Drug Administration
  30. +32d Comments close Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications Health and Human Services Department · Food and Drug Administration

23 more beyond these.

16 October 2026 3 documents

Machine-written from the fields above · claude-haiku-4-5-20251001

The Food and Drug Administration published three notices on electronic submissions standards and a rare disease framework initiative.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Electronic Common Technical Document (eCTD); Data Standards; Supporting Forward Compatibility for eCTD 4.0

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing support for Forward Compatibility for Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)-based electronic submissions.

91 FR 65752FR Doc. 2026-21197official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 3.2.2 and Version 4.0

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing the date FDA will begin rejecting electronic submissions that fail new Electronic Common Technical Document (eCTD) Version 3.22 (v3.22) and Version 4.0 (v4.0) based validations. The new eCTD v3.2.2 validations are 2024 and 2025, which are high-severity validation errors as described in the Specifications for eCTD Validation Criteria. The new eCTD v4.0 validations are eCTD4-084, eCTD4-085, US-eCTD4-561, US-eCTD4-562, US-eCTD4-563, and US-eCTD4-564, which are high-severity validation errors as described in the Specifications for eCTD v4.0 Validation Criteria.

91 FR 65749FR Doc. 2026-21195official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled "Fit-for-Purpose Rare Disease Framework Initiative". Convened by the Reagan-Udall Foundation for, and in collaboration with FDA, the meeting will focus on developing a fit-for-purpose framework for the development and regulatory review of rare disease therapies. There will be an opportunity to request to provide public comments at the meeting. In addition, FDA is establishing a public docket to collect feedback on and input related to its Rare Disease Framework Initiative.

  • Comments close in 53 days

91 FR 65750FR Doc. 2026-21142official PDFfederalregister.gov

15 October 2026 2 documents

Machine-written from the fields above · claude-haiku-4-5-20251001

The Food and Drug Administration issued four Emergency Use Authorizations for animal drugs to prevent and treat New World screwworm infestations in livestock, wildlife, and pets.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Authorization of Emergency Use for Four Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability

The Food and Drug Administration (FDA or the Agency) is announcing the issuance of four Emergency Use Authorizations (EUA or Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for new animal products. FDA has issued one EUA for an animal product as requested by Elanco US Inc. for application on or around wounds for the prevention of infestations caused by New World screwworm (Cochliomyia hominivorax; NWS) larvae (myiasis) in sheep, cattle, goats, swine, camelids, and the following captive and captured wildlife species: cervids, American bison, bighorn sheep, and Sonoran pronghorn. FDA has issued one EUA for an animal product as requested by Zoetis Inc. for the treatment of infestations caused by NWS (myiasis) in dogs and puppies. FDA has issued one EUA for an animal product as requested by Bimeda Animal Health Ltd. for the prevention of infestations caused by NWS (myiasis) in cattle. FDA has issued one EUA for an animal product as requested by Sergeant's Pet Care Products LLC for the treatment and prevention of infestations caused by NWS (myiasis) in dogs, puppies, cats and kittens 2 pounds of body weight or greater and 4 weeks of age and older. The Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the August 18, 2025, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves NWS. On the basis of such determination, the Secretary of HHS declared on August 18, 2025, that circumstances exist justifying the authorization of emergency use of animal drugs to treat or prevent NWS myiasis in animals. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.

  • Takes effect 73 days ago

91 FR 65562FR Doc. 2026-21084official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee (TPSAC)

The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee (TPSAC), in the Center for Tobacco Products. FDA seeks to include the views of qualified individuals on its advisory committees and therefore encourages nominations of appropriately qualified candidates. Specifically, TPSAC is seeking to fill 2 voting member vacancies with physicians, dentists, scientists, or health care professionals practicing in the areas of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, engineering, or any other relevant specialty.

91 FR 65592FR Doc. 2026-21027official PDFfederalregister.gov

14 October 2026 5 documents

Machine-written from the fields above · claude-haiku-4-5-20251001

The Food and Drug Administration published a final rule permitting chromium propionate as a food additive for laying hens and breeder chickens.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Cosmetic Products

The Food and Drug Administration (FDA, Agency, or we) 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.

  • Comments close in 25 days

91 FR 65219FR Doc. 2026-20990official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Advisory Committee; Cellular, Tissue, and Gene Therapies Advisory Committee; Renewal

The Food and Drug Administration (FDA) is announcing the renewal of the Cellular, Tissue, and Gene Therapies Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Cellular, Tissue, and Gene Therapies Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the October 28, 2028, expiration date.

91 FR 65223FR Doc. 2026-20989official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards

The Food and Drug Administration (FDA or we) 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.

  • Comments close in 25 days

91 FR 65221FR Doc. 2026-20981official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements

The Food and Drug Administration (FDA, Agency, or we) 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.

  • Comments close in 25 days

91 FR 65225FR Doc. 2026-20980official PDFfederalregister.gov

RuleHealth and Human Services DepartmentFood and Drug Administration

Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate

The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate as a source of chromium in food for laying hens and breeder chickens. This action is in response to a food additive petition filed by Kemin Industries, Inc.

  • Comments close in 25 days
  • Takes effect 5 days ago

91 FR 65109FR Doc. 2026-20979official PDFfederalregister.gov

13 October 2026 2 documents

Machine-written from the fields above · claude-haiku-4-5-20251001

The FDA issued a final rule permitting salt substitutes in standardized foods to reduce sodium content, effective December 14, 2026, and released final guidance on postapproval manufacturing changes to biosimilar products.

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RuleSIGNIFICANT · E.O. 12866Health and Human Services DepartmentFood and Drug Administration

Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods

The Food and Drug Administration (FDA or we) is issuing a final rule to amend our standard of identity regulations that specify salt (sodium chloride) as a required or optional ingredient to permit the use of salt substitutes in standardized foods, to reduce the sodium content. Reducing sodium may help reduce the risk of hypertension, a major risk factor for heart disease and stroke. The rule will help support a healthier food supply by providing flexibility to facilitate industry innovation in the production of standardized foods lower in sodium while maintaining the basic nature and essential characteristics of the foods.

  • Takes effect in 56 days

91 FR 65040FR Doc. 2026-20848official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers." This guidance provides answers to commonly asked questions from applicants and other interested parties regarding postapproval manufacturing changes made to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act). This guidance finalizes the draft guidance of the same title issued on July 23, 2024.

91 FR 64931FR Doc. 2026-20817official PDFfederalregister.gov

9 October 2026 13 documents

Machine-written from the fields above · claude-haiku-4-5-20251001

The Food and Drug Administration published nine notices, three rules, and one proposed rule on October 9, 2026.

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NoticeHealth and Human Services DepartmentFood and Drug Administration

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZANVASTRO (Zilganersen)

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 ZANVASTRO (zilganersen), approved September 3, 2026, manufactured by Ionis Pharmaceuticals, Inc., meets the criteria for a priority review voucher.

91 FR 64663FR Doc. 2026-20769official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications, Procedures and Requirements

The Food and Drug Administration (FDA, Agency, or we) 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.

  • Comments close in 21 days

91 FR 64654FR Doc. 2026-20768official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MONOFERRIC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

  • Comments close in 50 days

91 FR 64660FR Doc. 2026-20766official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use

The Food and Drug Administration (FDA, Agency, or we) 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.

  • Comments close in 21 days

91 FR 64659FR Doc. 2026-20765official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Determination That LASIX (Furosemide) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA, Agency, or we) has determined that LASIX (furosemide) oral solution, 10 milligrams (mg)/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

91 FR 64662FR Doc. 2026-20764official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 37 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

91 FR 64652FR Doc. 2026-20762official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams

The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 208833 for Celecoxib capsules, 50 milligrams (mg), 100 mg, 200 mg, and 400 mg, held by Amneal Pharmaceuticals of New York, LLC, 50 Horseblock Rd., Brookhaven, NY 11719 (Amneal). Amneal requested withdrawal of approval of this application and has waived its opportunity for a hearing.

91 FR 64658FR Doc. 2026-20758official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on June 3, 2026. The document announced the withdrawal of approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of July 6, 2026. The document indicated that FDA was withdrawing approval of ANDA 207366 for ribavirin solution, 6 grams/vial, held by Navinta LLC, 1499 Lower Ferry Rd., Ewing, NJ 08618; ANDA 212957 for fosaprepitant dimeglumine powder, Equivalent to (EQ) 150 milligrams (mg) base/vial, held by Navinta LLC; and ANDA 218638 for nicardipine hydrochloride (HCl) capsule, 20 mg and 30 mg, held by Navinta LLC. Before FDA withdrew the approval of these ANDAs, Navinta LLC informed FDA that they did not want the approval of the ANDAs withdrawn. Because Navinta LLC timely requested that approval of the ANDAs not be withdrawn, the approval is still in effect. This notice removes the entries for ANDA 207366, ANDA 212957, and ANDA 218638.

91 FR 64652FR Doc. 2026-20730official PDFfederalregister.gov

RuleHealth and Human Services DepartmentFood and Drug Administration

Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens

The Food and Drug Administration (FDA) is classifying the system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  • Takes effect 10 days ago

91 FR 64611FR Doc. 2026-20727official PDFfederalregister.gov

RuleHealth and Human Services DepartmentFood and Drug Administration

Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use

The Food and Drug Administration (FDA) is classifying the infant pulse rate and oxygen saturation monitor for over-the-counter use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the infant pulse rate and oxygen saturation monitor for over-the-counter use. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  • Takes effect 10 days ago

91 FR 64615FR Doc. 2026-20726official PDFfederalregister.gov

RuleHealth and Human Services DepartmentFood and Drug Administration

Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit

The Food and Drug Administration (FDA) is classifying the hematopoietic cell enrichment kit into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the hematopoietic cell enrichment kit. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  • Takes effect 10 days ago

91 FR 64609FR Doc. 2026-20725official PDFfederalregister.gov

Proposed RuleHealth and Human Services DepartmentFood and Drug Administration

Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry titled "Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants." The draft guidance states that, at this time and based on our current understanding of the risks, FDA does not intend to enforce certain regulatory requirements as they apply to certain entities and/or activities. The applicable requirements are established in our regulation titled "Requirements for Additional Traceability Records for Certain Foods."

  • Comments close in 35 days

91 FR 64629FR Doc. 2026-20721official PDFfederalregister.gov

NoticeHealth and Human Services DepartmentFood and Drug Administration

Challenges and Solutions in Lot-Level Food Traceability; Public Meeting

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting titled "Challenges and Solutions in Lot- Level Food Traceability." The purpose of the meeting is to provide a forum for the public to share information on continued implementation of the "Requirements for Additional Traceability Records for Certain Foods" final rule and areas of concern, especially as they relate to lot-level tracking, and identify potential flexibilities to support compliance.

  • Comments close in 48 days

91 FR 64656FR Doc. 2026-20720official PDFfederalregister.gov

Earlier

38 further days of this agency's activity are in the long-form archive, oldest to newest, on one page.

Everything Food and Drug Administration has published, 2026-08-10 to 2026-10-16 →

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