{"description":"Documents matching 'traceability records certain foods which'","count":1728,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=traceability+records+certain+foods+which&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":"Outreach, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2122, \n Katherine.Vierk@fda.hhs.gov. \n \n \n \n \n SUPPLEMENTARY INFORMATION: \n I. Background \n \n On November 21, 2022, FDA published in the \n Federal Register \n (87 FR 70910) a final rule entitled “Requirements for Additional Traceability Records for Certain Foods” (the Food Traceability Rule), which established additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has"},{"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":"and accurate reading and recording of tag numbers and retrieval of traceability information.\n \n \n \n 3 \n See ADT Trace Performance Metric Report 2013-2022. \n https://www.aphis.usda.gov/traceability/downloads/adt-trace-perf-report-2013-2022.pdf. \n \n \n \n In support of greater efficiency in traceability and in furtherance of the above-listed program goals, on July 6, 2020, we published in the \n Federal Register \n (85 FR 40184-40185, Docket No. APHIS-2020-0022) a notice \n 4 \n \n in which we announced our proposal to approve only RFID tags as the official"},{"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":"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":"wording of the major food allergen statement (“Contains major food allergen(s)” followed by a colon and the name of the food source from which each major food allergen is derived)? Alternately, should TTB require or allow alternative formats, including the following: \n • “Contains” followed by a colon and the name of the food source from which each major food allergen is derived; or \n • A heading such as “Major Food Allergen Information” followed by “Contains:” or other language and the name of the food source from which each major food allergen is derived"},{"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":"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 required of all applicants who have an approved PMA. Currently there are 860 active PMAs that could be subject to these requirements, based on FDA data, and approximately 33 new PMAs are approved each year. We estimate our annual recordkeeping burden based on an average of 860 PMA holders. The applicant determines which records should be maintained"},{"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":"documentation of ownership if devices are detained at a place other than that of the appellant. Under § 800.55(k), the owner or other responsible person must supply records about how the devices may have become adulterated or misbranded, in addition to records of distribution of the detained devices. These recordkeeping requirements for administrative detentions permit FDA to trace devices \n \n for which the detention period expired before a seizure is accomplished or injunctive relief is obtained.\n \n FDA also has the statutory authority under section 516 of"},{"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":"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":"maintain certain records, including the results of batch testing and analyses conducted to determine conformance with the proposed product standard, records of sampling plans and sampling procedures, records related to manufacturing controls, and all records related to the analytical test method used to assess finished cigarettes and certain other finished combusted tobacco products for conformance with the proposed maximum nicotine level requirement. FDA is also proposing to require that manufacturers use a manufacturing code, from which the Agency"},{"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":"documentation of ownership if devices are detained at a place other than that of the appellant. Under § 800.55(k), the owner or other responsible person must supply records about how the devices may have become adulterated or misbranded, in addition to records of distribution of the detained devices. These recordkeeping requirements for administrative detentions permit FDA to trace devices for which the detention period expired before a seizure is accomplished or injunctive relief is obtained. \n FDA also has the statutory authority under section 516 of the"},{"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":"distributors' retention of required records. In general, existing § 646.150 provides that each distributor of cigarettes shall retain the records required by §§ 646.146 and 646.147 for three years following the close of the year in which the records are made and shall keep the required records on the distributor's business premises. 75 FR 44175. ATF stated it was considering extending the record retention requirement to five years, thus harmonizing the regulations with the applicable statute of limitations for CCTA violations, which is five years. \n See id"},{"title":"Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to require testing of talc-containing cosmetic products using standardized testing methods for detecting and identifying asbestos that may be present as a contaminant in talc. We are also proposing corresponding adulteration provisions. Asbestos is a potential contaminant in talc, which is used in certain cosmetic products, and is a known human carcinogen. This proposed rule, if finalized, will help protect users of talc-containing cosmetic products from harmful exposure to asbestos given the potential for contamination of these products.","document_number":"2024-30544","html_url":"https://www.federalregister.gov/documents/2024/12/27/2024-30544/testing-methods-for-detecting-and-identifying-asbestos-in-talc-containing-cosmetic-products","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-27/pdf/2024-30544.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-30544.pdf?1735220714","publication_date":"2024-12-27","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":"testing records for at least 3 years after the date the record was created. We are proposing under 701(a) of the FD&C Act to require that records be made available within 1 business day for inspection and copying upon request, either at the place of business of the manufacturer during inspection or remotely through electronic delivery. We chose 1 business day to be largely consistent with other FDA regulations that require production within 1 business day. As an example, 21 CFR 1.1455(c) regarding food traceability records requires records production"},{"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":"training. We estimate that 10 employees per firm will create 16,960 records (10 records per firm) and that it will take 5 minutes (0.083 hours) to prepare each record, for a total of 1,408 hours annually. \n Under § 213.34, records demonstrating that consultants have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained will be required. Based on available data, we estimate that 1,696 firms will maintain 571 records of consultants' education, training, and experience, or any combination"}]}