{"description":"Documents matching 'traceability records certain foods compliance'","count":1426,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=traceability+records+certain+foods+compliance&format=json&page=2","results":[{"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 <span class=\"match\">Food</span> <span class=\"match\">Traceability</span> Rule \n \n The <span class=\"match\">Food</span> and Drug Administration (FDA, the Agency, or we) published the final rule, “Requirements for Additional <span class=\"match\">Traceability</span> <span class=\"match\">Records</span> for <span class=\"match\">Certain</span> <span class=\"match\">Foods</span>” (87 FR 70910) (<span class=\"match\">Food</span> <span class=\"match\">Traceability</span> Rule), on November 21, 2022. The final rule establishes additional recordkeeping requirements for persons who \n \n manufacture, process, pack, or hold <span class=\"match\">foods</span> the Agency has designated for inclusion on the <span class=\"match\">Food</span> <span class=\"match\">Traceability</span> List (FTL) based on risk. The final rule requires these entities to maintain <span class=\"match\">records</span> containing information"},{"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 <span class=\"match\">Food</span> and Drug Administration (FDA, the Agency, or we) is announcing that we are granting an exemption for <span class=\"match\">certain</span> cottage cheese products from the requirements of the rule titled “Requirements for Additional <span class=\"match\">Traceability</span> <span class=\"match\">Records</span> for <span class=\"match\">Certain</span> <span class=\"match\">Foods</span>” (the <span class=\"match\">Food</span> <span class=\"match\">Traceability</span> Rule). The Agency is taking this action in accordance with the FDA <span class=\"match\">Food</span> 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":"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 <span class=\"match\">foods</span> on FDA's <span class=\"match\">Food</span> <span class=\"match\">Traceability</span> List. The <span class=\"match\">Food</span> <span class=\"match\">Traceability</span> Rule requires lot-level tracking for <span class=\"match\">foods</span> on the <span class=\"match\">Food</span> <span class=\"match\">Traceability</span> List. Businesses that perform specific activities are required to assign unique codes, known as <span class=\"match\">Traceability</span> Lot Codes, that must be passed along unchanged (unless the <span class=\"match\">food</span> is transformed) as the <span class=\"match\">food</span> moves through the supply chain. Entities that handle <span class=\"match\">foods</span> on the <span class=\"match\">Food</span> <span class=\"match\">Traceability</span> List are required to <span class=\"match\">record</span> Key Data Elements (KDEs), such as the <span class=\"match\">Traceability</span> Lot Code, when they perform specific"},{"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. <span class=\"match\">Records</span> 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 <span class=\"match\">traceability</span> <span class=\"match\">records</span> for <span class=\"match\">certain</span> <span class=\"match\">foods</span> visit our website at \n https://www.fda.gov/<span class=\"match\">food</span>/<span class=\"match\">food</span>-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-<span class=\"match\">traceability</span>-<span class=\"match\">records</span>-<span class=\"match\">certain</span>-<span class=\"match\">foods</span>, \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 <span class=\"match\">records</span> required"},{"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 <span class=\"match\">Food</span> and Drug Administration (FDA, the Agency, or we) is proposing to grant an exemption for <span class=\"match\">certain</span> cottage cheese products from the requirements of the Requirements for Additional <span class=\"match\">Traceability</span> <span class=\"match\">Records</span> for <span class=\"match\">Certain</span> <span class=\"match\">Foods</span> rule (the <span class=\"match\">Food</span> <span class=\"match\">Traceability</span> Rule). The Agency is taking this action in accordance with the FDA <span class=\"match\">Food</span> 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: 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 <span class=\"match\">Food</span> and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled “Requirements for Additional <span class=\"match\">Traceability</span> <span class=\"match\">Records</span> for <span class=\"match\">Certain</span> <span class=\"match\">Foods</span>: What You Need to Know About the FDA Regulation: Guidance for Industry—Small Entity <span class=\"match\">Compliance</span> Guide.” The small entity <span class=\"match\">compliance</span> guide (SECG) is intended to help small entities comply with the final rule entitled “Requirements for Additional <span class=\"match\">Traceability</span> <span class=\"match\">Records</span> for <span class=\"match\">Certain</span> <span class=\"match\">Foods</span>.” \n \n \n DATES: \n \n The announcement of the"},{"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 <span class=\"match\">food</span> allergen statement (“Contains major <span class=\"match\">food</span> allergen(s)” followed by a colon and the name of the <span class=\"match\">food</span> source from which each major <span class=\"match\">food</span> 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 <span class=\"match\">food</span> source from which each major <span class=\"match\">food</span> allergen is derived; or \n • A heading such as “Major <span class=\"match\">Food</span> Allergen Information” followed by “Contains:” or other language and the name of the <span class=\"match\">food</span> source from which each major <span class=\"match\">food</span> allergen is derived"},{"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 <span class=\"match\">food</span> products falls under the purview of the <span class=\"match\">Food</span> Safety and Inspection Service (FSIS). APHIS does not have statutory authority to regulate for <span class=\"match\">food</span> safety. The EID eartag requirement is intended to facilitate animal disease <span class=\"match\">traceability</span>, thereby improving our ability to <span class=\"match\">trace</span> 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 <span class=\"match\">food</span> safety and animal disease, APHIS should increase"},{"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 <span class=\"match\">records</span> per \n recordkeeper \n \n \n Total \n annual \n <span class=\"match\">records</span> \n \n \n Average \n burden per \n recordkeeping \n \n \n Total \n hours \n \n \n \n <span class=\"match\">Records</span> regarding device adulteration or misbranding and <span class=\"match\">records</span> 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; 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 <span class=\"match\">records</span> per recordkeeper \n Total annual <span class=\"match\">records</span> \n \n Average\n burden per \n recordkeeping \n \n Total hours \n \n \n Maintenance of <span class=\"match\">records</span> (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 <span class=\"match\">records</span>, which are used to <span class=\"match\">trace</span> patients, and the organization and indexing of <span class=\"match\">records</span> into identifiable files to ensure a device's continued safety and effectiveness. These <span class=\"match\">records</span> are"},{"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 <span class=\"match\">records</span> per recordkeeper \n Total annual <span class=\"match\">records</span> \n \n Average\n burden per \n recordkeeping \n \n Total hours \n \n \n <span class=\"match\">Records</span> 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 <span class=\"match\">records</span> either electronically or on"},{"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":"US SHIP. \n Proposed § 148.4(a) would provide that participants must retain <span class=\"match\">records</span> necessary for demonstrating <span class=\"match\">compliance</span> with certification requirements. This provision is modeled on NPIP and the pilot program for US SHIP, and, as noted previously in this document, participant retention of <span class=\"match\">records</span> is necessary to demonstrate <span class=\"match\">compliance</span> and eligibility to participate in the Plan. \n Proposed § 148.4(b) would provide that a participant's animals, animal products, and <span class=\"match\">records</span> as needed to confirm certification requirements of swine or pork products"},{"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. <span class=\"match\">Food</span> <span class=\"match\">Traceability</span> 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. <span class=\"match\">Traceability</span> Plan (§ 1.1315) \n H. Assignment of <span class=\"match\">Traceability</span> Lot Codes (§ 1.1320) \n I. Critical Tracking Events Framework \n J. <span class=\"match\">Records</span> of Harvesting and Cooling (§ 1.1325) \n K. <span class=\"match\">Records</span> of Initial Packing (§ 1.1330) \n L. <span class=\"match\">Records</span> of First Land-Based Receiving of <span class=\"match\">Food</span> Obtained From a Fishing Vessel (§ 1.1335) \n M. <span class=\"match\">Records</span> of Shipping (§ 1.1340) \n N. <span class=\"match\">Records</span> of Receiving (§ 1.1345) \n O. <span class=\"match\">Records</span> 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":"products are in <span class=\"match\">compliance</span> with the proposed product standard. \n \n Second, proposed § 1160.32(b) provides <span class=\"match\">certain</span> specifications for these <span class=\"match\">records</span>. All <span class=\"match\">records</span> required under this part, regardless of storage medium, would need to be attributable (\n i.e., \n <span class=\"match\">traceable</span> to its source), legible (\n i.e., \n in a readable format), contemporaneously <span class=\"match\">recorded</span> (\n i.e., \n <span class=\"match\">recorded</span> 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 <span class=\"match\">records</span> would be"},{"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 <span class=\"match\">records</span> in electronic form satisfy the rule's <span class=\"match\">record</span>-keeping requirements. This change is consistent with ATF's enforcement practice in recent years. ATF is codifying the permission to use electronic <span class=\"match\">records</span> in this final rule because industry now almost exclusively uses electronic <span class=\"match\">records</span>. \n In addition, the final rule extends the current <span class=\"match\">record</span>-keeping requirement from three to five years. ATF estimates that there are no quantified costs associated with retaining <span class=\"match\">records</span> 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—<span class=\"match\">Records</span> \n \n § 213.180 \n \n \n (a) \n <span class=\"match\">Record</span> availability. \n All <span class=\"match\">records</span> required under this part, or copies of such <span class=\"match\">records</span>, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such <span class=\"match\">records</span> occurred and are subject to copying as part of such inspection. <span class=\"match\">Records</span> 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 <span class=\"match\">Record</span> requirements"},{"title":"Energy Conservation Program: Procedures, Interpretations, and Policies for Consideration of New or Revised Energy Conservation Standards and Test Procedures for Consumer Products and Certain Commercial/Industrial Equipment","type":"Proposed Rule","abstract":"The U.S. Department of Energy (\"DOE\" or \"the Department\") proposes to update the Department's current rulemaking methodology titled, \"Procedures, Interpretations, and Policies for Consideration of New or Revised Energy Conservation Standards and Test Procedures for Consumer Products and Certain Commercial/Industrial Equipment\" (\"Process Rule\"). Specifically, DOE proposes to: make Appendix A binding on DOE for certain actions; amend objectives and considerations consistent with recent Executive orders and Department policies; add a definition of \"significant energy savings\"; re-instate the comparative analysis requirement, described as a \"walk up\" approach; include certain economic thresholds; re-instate the description of clear and convincing evidence; and revert to language from the 2020 Process Rule text, with minor edits, in several sections. In addition to requesting written comments on its proposal, DOE will also hold a public meeting to discuss this proposal and obtain additional input.","document_number":"2026-13674","html_url":"https://www.federalregister.gov/documents/2026/07/07/2026-13674/energy-conservation-program-procedures-interpretations-and-policies-for-consideration-of-new-or","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-07/pdf/2026-13674.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13674.pdf?1783341912","publication_date":"2026-07-07","agencies":[{"raw_name":"DEPARTMENT OF ENERGY","name":"Energy Department","id":136,"url":"https://www.federalregister.gov/agencies/energy-department","json_url":"https://www.federalregister.gov/api/v1/agencies/136","parent_id":null,"slug":"energy-department"}],"excerpts":"U.S.C. 6295(p)(4)). The <span class=\"match\">compliance</span> date, on the other hand, is the specific date when manufacturers are required to use a new test procedure to make energy efficiency representations or to meet a new energy conservation standard. For test procedures, the <span class=\"match\">compliance</span> date is typically 180 days after publication in the \n Federal Register \n . (42 U.S.C. 6293(c)(2)). For standards, the <span class=\"match\">compliance</span> date is typically three or five years after publication in the \n Federal Register \n for covered products but can vary under <span class=\"match\">certain</span> circumstances. (42 U.SC"},{"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 <span class=\"match\">records</span> for at least 3 years after the date the <span class=\"match\">record</span> was created. We are proposing under 701(a) of the FD&amp;C Act to require that <span class=\"match\">records</span> 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 <span class=\"match\">food</span> <span class=\"match\">traceability</span> <span class=\"match\">records</span> requires <span class=\"match\">records</span> production"},{"title":"Phasedown of Hydrofluorocarbons: Management of Certain Hydrofluorocarbons and Substitutes Under the American Innovation and Manufacturing Act of 2020","type":"Rule","abstract":"The U.S. Environmental Protection Agency is issuing regulations to implement certain provisions of the American Innovation and Manufacturing Act of 2020. This rulemaking establishes an emissions reduction and reclamation program for the management of hydrofluorocarbons that includes requirements for leak repair and installation and use of automatic leak detection systems for certain equipment using refrigerants containing hydrofluorocarbons and certain substitutes; the servicing and/or repair of certain refrigerant- containing equipment to be done with reclaimed hydrofluorocarbons; the initial installation and servicing and/or repair of fire suppression equipment to be done with recycled hydrofluorocarbons, technician training, and recycling of hydrofluorocarbons prior to the disposal of fire suppression equipment containing hydrofluorocarbons; removal of hydrofluorocarbons from disposable cylinders before discarding them; and certain recordkeeping, reporting, and labeling requirements. In addition, EPA is establishing alternative Resource Conservation and Recovery Act standards for certain ignitable spent refrigerants being recycled for reuse.","document_number":"2024-21967","html_url":"https://www.federalregister.gov/documents/2024/10/11/2024-21967/phasedown-of-hydrofluorocarbons-management-of-certain-hydrofluorocarbons-and-substitutes-under-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-11/pdf/2024-21967.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-21967.pdf?1728564320","publication_date":"2024-10-11","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"excerpts":"establishing requirements for recordkeeping, the <span class=\"match\">record</span> must be maintained for three years in either paper or electronic format. An owner or operator may contract out the <span class=\"match\">record</span> generation responsibilities but retains ultimate liability for <span class=\"match\">compliance</span> and must be able to access these <span class=\"match\">records</span> electronically or in hard copy from the facility where the appliance is located. All recordkeeping requirements can be found in 40 CFR 84.106(l). These <span class=\"match\">records</span> are the primary means for the facility to demonstrate <span class=\"match\">compliance</span> with the leak repair requirements, and EPA"},{"title":"Waste Emissions Charge for Petroleum and Natural Gas Systems: Procedures for Facilitating Compliance, Including Netting and Exemptions","type":"Rule","abstract":"The Environmental Protection Agency (EPA) is promulgating a regulation to facilitate compliance with the requirements of the Waste Emissions Charge in the Clean Air Act's (CAA) Methane Emissions Reduction Program (MERP). Enacted as part of the Inflation Reduction Act (IRA), this program requires the EPA to impose and collect an annual charge on methane emissions that exceed waste emissions thresholds specified by Congress.","document_number":"2024-26643","html_url":"https://www.federalregister.gov/documents/2024/11/18/2024-26643/waste-emissions-charge-for-petroleum-and-natural-gas-systems-procedures-for-facilitating-compliance","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-18/pdf/2024-26643.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-26643.pdf?1731678322","publication_date":"2024-11-18","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"excerpts":"measure <span class=\"match\">compliance</span>, for example, until that <span class=\"match\">compliance</span> date arrives. Similarly, some “methane emission requirements pursuant to [section 111(b)],” have tiered <span class=\"match\">compliance</span> dates, meaning that the <span class=\"match\">compliance</span> dates vary between emissions sources. In such case, the WEC applicable facility is only eligible for the regulatory <span class=\"match\">compliance</span> exemption once the <span class=\"match\">compliance</span> dates for all CAA section 111(b) and (d) sources have occurred and the Administrator determinations have been made. In sum, the EPA concludes that the best reading of “in <span class=\"match\">compliance</span>” means that"}]}