{"description":"Documents matching 'traceability records certain foods'","count":1736,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=traceability+records+certain+foods&format=json&page=2","results":[{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods","type":"Notice","abstract":"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 the information collection provisions of our recordkeeping and records access requirements for food facilities.","document_number":"2025-22277","html_url":"https://www.federalregister.gov/documents/2025/12/09/2025-22277/agency-information-collection-activities-proposed-collection-comment-request-establishment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-09/pdf/2025-22277.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-22277.pdf?1765201510","publication_date":"2025-12-09","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"market. Records required under this subpart must be maintained for 2 years from the date they were created or obtained. For more information about requirements for additional traceability records for certain foods visit our website at \n https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods, \n which also includes a guide that provides key data elements for recordkeeping (\n https://www.fda.gov/media/163132/download?attachment \n ).\n \n \n The information and records required"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods","type":"Notice","abstract":"The Food and Drug Administration (FDA) 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.","document_number":"2026-11760","html_url":"https://www.federalregister.gov/documents/2026/06/11/2026-11760/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-11/pdf/2026-11760.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11760.pdf?1781095523","publication_date":"2026-06-11","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"market. Records required under this subpart must be maintained for 2 years from the date they were created or obtained. For more information about requirements for additional traceability records for certain foods visit our website at \n https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods, \n which also includes a guide that provides key data elements for recordkeeping (\n https://www.fda.gov/media/163132/download?attachment \n ).\n \n \n The information and records required"},{"title":"Questions and Answers About Requirements for Additional Traceability Records for Certain Foods; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled \"Questions and Answers About Requirements for Additional Traceability Records for Certain Foods.\" The draft guidance answers questions about the final rule entitled \"Requirements for Additional Traceability Records for Certain Foods,\" which established additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. The draft guidance is intended to answer questions to facilitate industry's understanding of the final rule.","document_number":"2026-03363","html_url":"https://www.federalregister.gov/documents/2026/02/20/2026-03363/questions-and-answers-about-requirements-for-additional-traceability-records-for-certain-foods-draft","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-20/pdf/2026-03363.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03363.pdf?1771508713","publication_date":"2026-02-20","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":" The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled “Questions and Answers About Requirements for Additional Traceability Records for Certain Foods.” The draft guidance answers questions about the final rule entitled “Requirements for Additional Traceability Records for Certain Foods,” which established additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List"},{"title":"Requirements for Additional Traceability Records for Certain Foods; Exemption for Cottage Cheese Regulated by the National Conference on Interstate Milk Shipments Grade “A” Pasteurized Milk Ordinance","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing that we are granting an exemption for certain cottage cheese products from the requirements of the rule titled \"Requirements for Additional Traceability Records for Certain Foods\" (the Food Traceability Rule). The Agency is taking this action in accordance with the FDA Food Safety Modernization Act and FDA's implementing regulations.","document_number":"2026-03362","html_url":"https://www.federalregister.gov/documents/2026/02/20/2026-03362/requirements-for-additional-traceability-records-for-certain-foods-exemption-for-cottage-cheese","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-20/pdf/2026-03362.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03362.pdf?1771508713","publication_date":"2026-02-20","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"ACTION: \n Notification of exemption. \n \n \n SUMMARY: \n The Food and Drug Administration (FDA, the Agency, or we) is announcing that we are granting an exemption for certain cottage cheese products from the requirements of the rule titled “Requirements for Additional Traceability Records for Certain Foods” (the Food Traceability Rule). The Agency is taking this action in accordance with the FDA Food Safety Modernization Act and FDA's implementing regulations. \n \n \n DATES: \n This exemption is effective on February 20, 2026. \n \n \n ADDRESSES: \n \n For"},{"title":"Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension","type":"Proposed Rule","abstract":"The Food and Drug Administration is proposing to extend the compliance date for the final rule, \"Requirements for Additional Traceability Records for Certain Foods,\" due to concerns about the amount of time affected entities will need to implement the requirements of the rule. If finalized, this rule would extend the compliance date by 30 months from January 20, 2026, to July 20, 2028.","document_number":"2025-14967","html_url":"https://www.federalregister.gov/documents/2025/08/07/2025-14967/requirements-for-additional-traceability-records-for-certain-foods-compliance-date-extension","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-07/pdf/2025-14967.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14967.pdf?1754484340","publication_date":"2025-08-07","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Background \n A. The Food Traceability Rule \n \n The Food and Drug Administration (FDA, the Agency, or we) published the final rule, “Requirements for Additional Traceability Records for Certain Foods” (87 FR 70910) (Food Traceability Rule), on November 21, 2022. The final rule establishes additional recordkeeping requirements for persons who \n \n manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List (FTL) based on risk. The final rule requires these entities to maintain records containing information"},{"title":"Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments","type":"Notice","abstract":"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 Food Traceability Rule and areas of concern, especially as they relate to lot-level tracking, and identify potential flexibilities to support compliance. In addition, FDA has developed a discussion paper titled \"Identifying Additional Flexibilities for Satisfying the Food Traceability Rule's Lot-Level Tracking Requirement\" that includes potential flexibilities for lot-level food traceability and questions we have regarding those flexibilities. This discussion paper may be helpful to speakers as they develop remarks for the public meeting. We are also providing an opportunity for all stakeholders to submit feedback on the discussion paper.","document_number":"2026-10603","html_url":"https://www.federalregister.gov/documents/2026/05/28/2026-10603/challenges-and-solutions-in-lot-level-food-traceability-public-meeting-and-request-for-comments","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-28/pdf/2026-10603.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10603.pdf?1779885915","publication_date":"2026-05-28","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"manufacture, process, pack, or hold foods on FDA's Food Traceability List. The Food Traceability Rule requires lot-level tracking for foods on the Food Traceability List. Businesses that perform specific activities are required to assign unique codes, known as Traceability Lot Codes, that must be passed along unchanged (unless the food is transformed) as the food moves through the supply chain. Entities that handle foods on the Food Traceability List are required to record Key Data Elements (KDEs), such as the Traceability Lot Code, when they perform specific"},{"title":"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 Ordinance","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to grant an exemption for certain cottage cheese products from the requirements of the Requirements for Additional Traceability Records for Certain Foods rule (the Food Traceability Rule). The Agency is taking this action in accordance with the FDA Food Safety Modernization Act and FDA's implementing regulations.","document_number":"2024-13236","html_url":"https://www.federalregister.gov/documents/2024/06/17/2024-13236/requirements-for-additional-traceability-records-for-certain-foods-proposed-exemption-for-cottage","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-17/pdf/2024-13236.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-13236.pdf?1718369121","publication_date":"2024-06-17","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"ACTION: \n Proposed exemption. \n \n \n SUMMARY: \n The Food and Drug Administration (FDA, the Agency, or we) is proposing to grant an exemption for certain cottage cheese products from the requirements of the Requirements for Additional Traceability Records for Certain Foods rule (the Food Traceability Rule). The Agency is taking this action in accordance with the FDA Food Safety Modernization Act and FDA's implementing regulations. \n \n \n DATES: \n Submit either electronic or written comments on the notice by September 16, 2024 to ensure that the Agency"},{"title":"Requirements for Additional Traceability Records for Certain Foods; Technical Amendment","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is correcting the final rule on requirements for additional traceability records for certain foods that published in the Federal Register of November 21, 2022. The final rule published with some editorial and inadvertent errors. This document corrects those errors.","document_number":"2023-20746","html_url":"https://www.federalregister.gov/documents/2023/09/26/2023-20746/requirements-for-additional-traceability-records-for-certain-foods-technical-amendment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-09-26/pdf/2023-20746.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-20746.pdf?1695645940","publication_date":"2023-09-26","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"2. In § 1.1305, revise paragraph (d)(4) to read as follows: \n \n § 1.1305 \n \n \n (d) * * * \n \n (4) Food that you change such that the food is no longer on the Food Traceability List, provided that you maintain records containing the information specified in § 1.1345 for your receipt of the food you change (unless you have entered into a written agreement concerning your changing of the food such that the food is no longer \n \n on the Food Traceability List in accordance with paragraph (d)(6) of this section);\n \n \n \n \n \n Dated: September 20, 2023. "},{"title":"Requirements for Additional Traceability Records for Certain Foods: What You Need To Know About the Food and Drug Administration Regulation: Guidance for Industry; Small Entity Compliance Guide; Availability","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled \"Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation: Guidance for Industry-- Small Entity Compliance Guide.\" The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled \"Requirements for Additional Traceability Records for Certain Foods.\"","document_number":"2023-10666","html_url":"https://www.federalregister.gov/documents/2023/05/19/2023-10666/requirements-for-additional-traceability-records-for-certain-foods-what-you-need-to-know-about-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-05-19/pdf/2023-10666.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-10666.pdf?1684413927","publication_date":"2023-05-19","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Notification of availability. \n \n \n SUMMARY: \n The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled “Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation: Guidance for Industry—Small Entity Compliance Guide.” The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled “Requirements for Additional Traceability Records for Certain Foods.” \n \n \n DATES: \n \n The announcement of the"},{"title":"Use of Electronic Identification Eartags as Official Identification in Cattle and Bison","type":"Rule","abstract":"We are amending the animal disease traceability regulations to require that eartags applied on or after a date 180 days after publication in the Federal Register of this final rule be both visually and electronically readable in order to be recognized for use as official eartags for interstate movement of cattle and bison covered under the regulations. We are also clarifying certain record retention and record access requirements and revising some requirements pertaining to slaughter cattle. These changes will enhance the ability of Tribal, State and Federal officials, private veterinarians, and livestock producers to quickly respond to high-impact diseases currently existing in the United States, as well as foreign animal diseases that threaten the viability of the U.S. cattle and bison industries.","document_number":"2024-09717","html_url":"https://www.federalregister.gov/documents/2024/05/09/2024-09717/use-of-electronic-identification-eartags-as-official-identification-in-cattle-and-bison","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-09/pdf/2024-09717.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-09717.pdf?1715172315","publication_date":"2024-05-09","agencies":[{"raw_name":"DEPARTMENT OF AGRICULTURE","name":"Agriculture Department","id":12,"url":"https://www.federalregister.gov/agencies/agriculture-department","json_url":"https://www.federalregister.gov/api/v1/agencies/12","parent_id":null,"slug":"agriculture-department"},{"raw_name":"Animal and Plant Health Inspection Service","name":"Animal and Plant Health Inspection Service","id":22,"url":"https://www.federalregister.gov/agencies/animal-and-plant-health-inspection-service","json_url":"https://www.federalregister.gov/api/v1/agencies/22","parent_id":12,"slug":"animal-and-plant-health-inspection-service"}],"excerpts":"meat and meat food products falls under the purview of the Food Safety and Inspection Service (FSIS). APHIS does not have statutory authority to regulate for food safety. The EID eartag requirement is intended to facilitate animal disease traceability, thereby improving our ability to trace outbreaks of diseases of livestock in live animals and more efficiently control or eradicate these diseases. This is consistent with our statutory authority under the AHPA. \n It was further stated that, to address food safety and animal disease, APHIS should increase"},{"title":"Major Food Allergen Labeling for Wines, Distilled Spirits, and Malt Beverages","type":"Proposed Rule","abstract":"The Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to require a labeling disclosure of all major food allergens used in the production of alcohol beverages subject to TTB's regulatory authority under the Federal Alcohol Administration Act. Under the proposed regulations, unless an exception applies, labels must declare milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame, as well as ingredients that contain protein derived from these foods, if used in the production of the alcohol beverage. TTB proposes a compliance date of 5 years from the date that a final rule resulting from this proposal is published in the Federal Register.","document_number":"2025-00955","html_url":"https://www.federalregister.gov/documents/2025/01/17/2025-00955/major-food-allergen-labeling-for-wines-distilled-spirits-and-malt-beverages","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-17/pdf/2025-00955.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-00955.pdf?1737035117","publication_date":"2025-01-17","agencies":[{"raw_name":"DEPARTMENT OF THE TREASURY","name":"Treasury Department","id":497,"url":"https://www.federalregister.gov/agencies/treasury-department","json_url":"https://www.federalregister.gov/api/v1/agencies/497","parent_id":null,"slug":"treasury-department"},{"raw_name":"Alcohol and Tobacco Tax and Trade Bureau","name":"Alcohol and Tobacco Tax and Trade Bureau","id":18,"url":"https://www.federalregister.gov/agencies/alcohol-and-tobacco-tax-and-trade-bureau","json_url":"https://www.federalregister.gov/api/v1/agencies/18","parent_id":497,"slug":"alcohol-and-tobacco-tax-and-trade-bureau"}],"excerpts":"FDA, food allergies and other food hypersensitivities affect millions of Americans.\n 25 \n \n A food allergy is an immune response to certain proteins in food, which may cause mild symptoms, but may also result in a severe, life-threatening allergic reaction called anaphylaxis. Because food allergies currently cannot be cured, early recognition of which foods cause individuals to have an allergic reaction, and learning how to avoid such foods, are important ways to prevent serious health risks.\n \n \n \n 25 \n See \n https://www.fda.gov/food/food-labe"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices","type":"Notice","abstract":"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 premarket approval of medical devices.","document_number":"2026-06906","html_url":"https://www.federalregister.gov/documents/2026/04/10/2026-06906/agency-information-collection-activities-proposed-collection-comment-request-premarket-approval-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-10/pdf/2026-06906.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06906.pdf?1775738707","publication_date":"2026-04-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Number of records per recordkeeper \n Total annual records \n \n Average\n burden per \n recordkeeping \n \n Total hours \n \n \n Maintenance of records (814.82(a)(5) and (a)(6)) \n 860 \n 2 \n 1,720 \n 17 \n 29,240 \n \n \n 1 \n There are no capital costs or operating and maintenance costs associated with this collection of information.\n \n \n The regulations require the maintenance of records, which are used to trace patients, and the organization and indexing of records into identifiable files to ensure a device's continued safety and effectiveness. These records are"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices","type":"Notice","abstract":"The Food and Drug Administration (FDA) 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.","document_number":"2025-10888","html_url":"https://www.federalregister.gov/documents/2025/06/16/2025-10888/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-16/pdf/2025-10888.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-10888.pdf?1749818716","publication_date":"2025-06-16","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"costs associated with this collection of information.\n \n \n \n \n Table 2—Estimated Annual Recordkeeping Burden \n 1 \n \n \n 21 CFR section \n \n Number of \n recordkeepers \n \n \n Number of \n records per \n recordkeeper \n \n \n Total \n annual \n records \n \n \n Average \n burden per \n recordkeeping \n \n \n Total \n hours \n \n \n \n Records regarding device adulteration or misbranding and records of distribution of detained devices—800.55(k) \n 1 \n 1 \n 1 \n 20 \n 20 \n \n \n 1 \n There are no capital costs or operating and maintenance costs associated with this collection of information"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Small Dispensers Assessment Under the Drug Supply Chain Security Act","type":"Notice","abstract":"The Food and Drug Administration (FDA) 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.","document_number":"2025-20643","html_url":"https://www.federalregister.gov/documents/2025/11/21/2025-20643/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-21/pdf/2025-20643.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-20643.pdf?1763646326","publication_date":"2025-11-21","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"recordkeepers \n Number of records per recordkeeper \n Total annual records \n \n Average\n burden per \n recordkeeping \n \n Total hours \n \n \n Records related to assessment questions response \n 922 \n 1 \n 922 \n 0.5 \n 461 \n \n \n 1 \n There are no capital costs or operating and maintenance costs associated with this collection of information.\n \n \n We expect that companies will compile information needed to respond to the questions in the assessment questionnaire and that they will keep copies of that information in their records either electronically or on"},{"title":"Requirements for Additional Traceability Records for Certain Foods","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule establishing additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List (FTL). The final rule adopts provisions requiring these entities to maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initially packing, shipping, receiving, and transforming these foods. The requirements established in the final rule will help the Agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded. We are issuing this regulation in accordance with the FDA Food Safety Modernization Act (FSMA).","document_number":"2022-24417","html_url":"https://www.federalregister.gov/documents/2022/11/21/2022-24417/requirements-for-additional-traceability-records-for-certain-foods","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-11-21/pdf/2022-24417.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-24417.pdf?1668528919","publication_date":"2022-11-21","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Introduction \n B. Food Traceability List \n C. General Comments on the Proposal \n D. Scope (§ 1.1300) \n E. Exemptions (§ 1.1305) \n F. Definitions (§ 1.1310) \n G. Traceability Plan (§ 1.1315) \n H. Assignment of Traceability Lot Codes (§ 1.1320) \n I. Critical Tracking Events Framework \n J. Records of Harvesting and Cooling (§ 1.1325) \n K. Records of Initial Packing (§ 1.1330) \n L. Records of First Land-Based Receiving of Food Obtained From a Fishing Vessel (§ 1.1335) \n M. Records of Shipping (§ 1.1340) \n N. Records of Receiving (§ 1.1345) \n O. Records of Transformation"},{"title":"US Swine Health Improvement Plan","type":"Proposed Rule","abstract":"We are proposing the creation of regulations governing the US Swine Health Improvement Plan (US SHIP). US SHIP would be a voluntary livestock improvement program aimed at improving biosecurity, traceability, and disease surveillance for swine health. The swine industry has requested the establishment of US SHIP, which builds on an existing pilot program initiated by industry. We propose to codify US SHIP as a Federal regulatory program and allow participating sites to obtain certifications of disease-monitored status for African swine fever and classical swine fever. Establishment of US SHIP would allow participating sites to market their products with the relevant certification status, which could limit disruptions to international and interstate commerce during outbreaks.","document_number":"2024-31386","html_url":"https://www.federalregister.gov/documents/2024/12/31/2024-31386/us-swine-health-improvement-plan","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-31/pdf/2024-31386.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31386.pdf?1735566320","publication_date":"2024-12-31","agencies":[{"raw_name":"DEPARTMENT OF AGRICULTURE","name":"Agriculture Department","id":12,"url":"https://www.federalregister.gov/agencies/agriculture-department","json_url":"https://www.federalregister.gov/api/v1/agencies/12","parent_id":null,"slug":"agriculture-department"},{"raw_name":"Animal and Plant Health Inspection Service","name":"Animal and Plant Health Inspection Service","id":22,"url":"https://www.federalregister.gov/agencies/animal-and-plant-health-inspection-service","json_url":"https://www.federalregister.gov/api/v1/agencies/22","parent_id":12,"slug":"animal-and-plant-health-inspection-service"}],"excerpts":"requirements of the regulations, without having to update the regulations each time a new mechanism is identified. The paragraph also requires each OSA to maintain enrollment records for 5 years and inspection records for at least 3 years from the date of inspection. We are proposing that the OSA would have to maintain initial enrollment records for 5 years because these records are foundational in documenting the OSA's decision to allow the facility to participate in US SHIP. \n The paragraph also would allow OSAs to arrange on-site inspections of"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices","type":"Notice","abstract":"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 administrative detention and banned medical devices.","document_number":"2024-28044","html_url":"https://www.federalregister.gov/documents/2024/11/29/2024-28044/agency-information-collection-activities-proposed-collection-comment-request-administrative","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-29/pdf/2024-28044.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-28044.pdf?1732715150","publication_date":"2024-11-29","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"operating and maintenance costs associated with this collection of information.\n \n \n \n Table 2—Estimated Annual Recordkeeping Burden1 \n \n 21 CFR section \n Number of recordkeepers \n Number of records per recordkeepers \n Total annual records \n \n Average \n burden per \n recordkeeping \n \n Total hours \n \n \n Records regarding device adulteration or misbranding and records of distribution of detained devices—800.55(k) \n 1 \n 1 \n 1 \n 20 \n 20 \n \n \n 1 \n There are no capital costs or operating and maintenance costs associated with this collection of information"},{"title":"Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing a tobacco product standard that would regulate nicotine yield by establishing a maximum nicotine level in cigarettes and certain other combusted tobacco products. FDA is proposing this action to reduce the addictiveness of these products, thus giving people who are addicted and wish to quit the ability to do so more easily. The proposed product standard is anticipated to benefit the population as a whole. For example, it would help to prevent people who experiment with cigarettes and cigars from developing addiction and using combusted tobacco products regularly.","document_number":"2025-00397","html_url":"https://www.federalregister.gov/documents/2025/01/16/2025-00397/tobacco-product-standard-for-nicotine-yield-of-cigarettes-and-certain-other-combusted-tobacco","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-16/pdf/2025-00397.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-00397.pdf?1736948724","publication_date":"2025-01-16","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"standard. \n \n Second, proposed § 1160.32(b) provides certain specifications for these records. All records required under this part, regardless of storage medium, would need to be attributable (\n i.e., \n traceable to its source), legible (\n i.e., \n in a readable format), contemporaneously recorded (\n i.e., \n recorded at the time of performance), original (\n i.e., \n first capture of the data), and accurate (\n i.e., \n correct, truthful, complete, valid, and reliable). In addition, these records would be required to be written in English; alternatively"},{"title":"Implementing PATRIOT Act Improvements: Contraband Cigarettes and Smokeless Tobacco","type":"Rule","abstract":"The Bureau of Alcohol, Tobacco, Firearms, and Explosives (\"ATF\") is amending Department of Justice (\"Department\") regulations to implement certain provisions of the USA PATRIOT Improvement and Reauthorization Act of 2005 (\"PATRIOT Improvement Act\") relating to trafficking in contraband cigarettes or smokeless tobacco. This act amended the Contraband Cigarette Trafficking Act (\"CCTA\") by, among other things, reducing the threshold amount of cigarettes necessary to trigger jurisdiction under the CCTA from a quantity in excess of 60,000 to a quantity in excess of 10,000; extending the provisions of the CCTA to cover contraband smokeless tobacco; expanding record-keeping requirements; and imposing reporting requirements.","document_number":"2026-09160","html_url":"https://www.federalregister.gov/documents/2026/05/08/2026-09160/implementing-patriot-act-improvements-contraband-cigarettes-and-smokeless-tobacco","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-08/pdf/2026-09160.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09160.pdf?1778157915","publication_date":"2026-05-08","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Bureau of Alcohol, Tobacco, Firearms, and Explosives","name":"Alcohol, Tobacco, Firearms, and Explosives Bureau","id":19,"url":"https://www.federalregister.gov/agencies/alcohol-tobacco-firearms-and-explosives-bureau","json_url":"https://www.federalregister.gov/api/v1/agencies/19","parent_id":268,"slug":"alcohol-tobacco-firearms-and-explosives-bureau"}],"excerpts":"proposed in the NPRM to provide that records in electronic form satisfy the rule's record-keeping requirements. This change is consistent with ATF's enforcement practice in recent years. ATF is codifying the permission to use electronic records in this final rule because industry now almost exclusively uses electronic records. \n In addition, the final rule extends the current record-keeping requirement from three to five years. ATF estimates that there are no quantified costs associated with retaining records beyond the existing three-year requirement"},{"title":"Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule revising the requirements concerning current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling that apply to certain medical gases. This final rule also establishes regulations regarding certification of designated medical gases. This final rule satisfies the medical gas rulemaking requirements of the Consolidated Appropriations Act, 2017.","document_number":"2024-13190","html_url":"https://www.federalregister.gov/documents/2024/06/18/2024-13190/current-good-manufacturing-practice-certification-postmarketing-safety-reporting-and-labeling","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-18/pdf/2024-13190.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-13190.pdf?1718628314","publication_date":"2024-06-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"\n Subpart J—Records \n \n § 213.180 \n \n \n (a) \n Record availability. \n All records required under this part, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred and are subject to copying as part of such inspection. Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting the requirements of this paragraph (a).\n \n \n (b) \n Record requirements"}]}