{"abstract":"The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for FDA staff and stakeholders entitled \"Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act.\" This draft guidance, when finalized, will explain our current thinking on the approach we generally intend to take when we evaluate the public health importance of a food allergen other than milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybean, and sesame (non-listed food allergen). (In April 2021, the Food Allergy Safety, Treatment, Education, and Research Act of 2021 amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add sesame to the definition of \"major food allergen.\" This statutory requirement goes into effect on January 1, 2023). We are also announcing an opportunity for public comment on our proposed collection of information. This draft guidance is not final nor is it in effect at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2022/04/19/2022-08303.html","cfr_references":[],"citation":"87 FR 23181","comment_url":null,"comments_close_on":"2022-08-17","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by August 17, 2022 to ensure that we consider your comment on this draft guidance before we begin work on the final version of the guidance. Submit electronic or written comments on the proposed collection of information in the draft guidance by August 17, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0553"],"dockets":[{"supporting_documents":[{"title":"FG-Ref 40 - Taylor-2014-Establishment Reference Doses COPYRIGHT","document_id":"FDA-2021-N-0553-2004"},{"title":"FG-Ref 39-Allen-2014-Allergen reference doses for precautionary labeling COPYRIGHT","document_id":"FDA-2021-N-0553-2003"},{"title":"FG-Ref 37-Zhu 2015 COPYRIGHT","document_id":"FDA-2021-N-0553-2001"},{"title":"FG-Ref 36-GRADE Working Group welcome COPYRIGHT","document_id":"FDA-2021-N-0553-2000"},{"title":"FG-Ref 29-Chung 2012 COPYRIGHT","document_id":"FDA-2021-N-0553-1993"},{"title":"FG-Ref 24-FDA Sesame-Allergen-Draft-Guidance-November-2020","document_id":"FDA-2021-N-0553-1988"},{"title":"FG-Ref 21-FDA-Citizen Petition LabelGarlic","document_id":"FDA-2021-N-0553-1985"},{"title":"FG-Ref 19-FDA CPG-Sec.-555.250","document_id":"FDA-2021-N-0553-1983"},{"title":"FG-Ref 15-FDA-Guidance-Jan2025-AllergenLabelingQA-12292024","document_id":"FDA-2021-N-0553-1979"},{"title":"FG-Ref 2-NASEM Report COPYRIGHT","document_id":"FDA-2021-N-0553-1966"}],"agency_name":"FDA","documents":[{"comment_count":1748,"comment_start_date":"2022-04-19","updated_at":"2023-02-28T17:13:50.000-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-N-0553-0005","allow_late_comments":null,"id":"FDA-2021-N-0553-0005","comment_end_date":"2022-08-18","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":96,"id":"FDA-2021-N-0553","title":"Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Defined in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability"}],"document_number":"2022-08303","effective_on":null,"end_page":23184,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/04/19/2022-08303.xml","html_url":"https://www.federalregister.gov/documents/2022/04/19/2022-08303/evaluating-the-public-health-importance-of-food-allergens-other-than-the-major-food-allergens-listed","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-08303?publication_date=2022-04-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-04-19/2022-08303/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":1585,"last_updated":"2026-07-28 12:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-04-19/pdf/2022-08303.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-08303.pdf?1650285923","publication_date":"2022-04-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/04/19/2022-08303.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FG-Ref 40 - Taylor-2014-Establishment Reference Doses COPYRIGHT","document_id":"FDA-2021-N-0553-2004"},{"title":"FG-Ref 39-Allen-2014-Allergen reference doses for precautionary labeling COPYRIGHT","document_id":"FDA-2021-N-0553-2003"},{"title":"FG-Ref 37-Zhu 2015 COPYRIGHT","document_id":"FDA-2021-N-0553-2001"},{"title":"FG-Ref 36-GRADE Working Group welcome COPYRIGHT","document_id":"FDA-2021-N-0553-2000"},{"title":"FG-Ref 29-Chung 2012 COPYRIGHT","document_id":"FDA-2021-N-0553-1993"},{"title":"FG-Ref 24-FDA Sesame-Allergen-Draft-Guidance-November-2020","document_id":"FDA-2021-N-0553-1988"},{"title":"FG-Ref 21-FDA-Citizen Petition LabelGarlic","document_id":"FDA-2021-N-0553-1985"},{"title":"FG-Ref 19-FDA CPG-Sec.-555.250","document_id":"FDA-2021-N-0553-1983"},{"title":"FG-Ref 15-FDA-Guidance-Jan2025-AllergenLabelingQA-12292024","document_id":"FDA-2021-N-0553-1979"},{"title":"FG-Ref 2-NASEM Report COPYRIGHT","document_id":"FDA-2021-N-0553-1966"}],"comments_count":1748,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2021-N-0553","supporting_documents_count":96,"docket_id":"FDA-2021-N-0553","document_id":"FDA-2021-N-0553-0005","regulation_id_number":null,"title":"Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Defined in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-02-28T22:13:49Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":23181,"subtype":null,"title":"Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","toc_doc":"Evaluating the Public Health Importance of Food Allergens other than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act","toc_subject":"Guidance","topics":[],"type":"Notice","volume":87}