{"abstract":"The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of D&C Black No. 4 for coloring ultra-high molecular weight polyethylene (UHMWPE) non- absorbable sutures for use in general surgery. This action is in response to a color additive petition (CAP) submitted by DSM Biomedical.","action":"Final rule.","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/2018/06/07/2018-12218.html","cfr_references":[{"chapter":null,"citation_url":null,"part":74,"title":21}],"citation":"83 FR 26356","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective July 10, 2018. See section VIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing on the final rule by July 9, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-C-0935"],"dockets":[],"document_number":"2018-12218","effective_on":"2018-07-10","end_page":26359,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/06/07/2018-12218.xml","html_url":"https://www.federalregister.gov/documents/2018/06/07/2018-12218/listing-of-color-additives-subject-to-certification-dandc-black-no-4","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-12218?publication_date=2018-06-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-06-07/2018-12218/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":2817,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-06-07/pdf/2018-12218.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-12218.pdf?1528289125","publication_date":"2018-06-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/06/07/2018-12218.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 2 Choi et al. WHO guidelines for indoor air quality: selected pollutants","document_id":"FDA-2017-C-0935-0007"},{"title":"Reference 1 CAP 7C0310_C_Memo_redacted_Redacted","document_id":"FDA-2017-C-0935-0006"},{"title":"Reference 4 CAP 7C0310  CARBON BLACK SIGNED FINAL TOXICOLOGY MEMO 04.27.18_redacted _Redacted","document_id":"FDA-2017-C-0935-0005"},{"title":"Reference 3 Brune et al Investigation of the Tumorigenic Response\nto Benzo(a)pyrene in Aqueous Caffeine Solution Applied Orally to Sprague-Dawley Rats*","document_id":"FDA-2017-C-0935-0004"},{"title":"Reference 5 Anand to Henry Indirect additives memo 2016-05-09","document_id":"FDA-2017-C-0935-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2017-C-0935","supporting_documents_count":5,"docket_id":"FDA-2017-C-0935","regulation_id_number":null,"title":"DSM Biomedical; Filing of Color Additive Petition","checked_regulationsdotgov_at":"2018-08-14T09:03:25Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":26356,"subtype":null,"title":"Listing of Color Additives Subject to Certification; D&C Black No. 4","toc_doc":"Listing of Color Additives Subject to Certification; D and C Black No. 4","toc_subject":null,"topics":["Color additives","Cosmetics","Drugs"],"type":"Rule","volume":83}