{"abstract":"The Food and Drug Administration (FDA) is amending certain references in various medical device regulations. The amendments update the references in those regulations to various standards of the American Society for Testing and Materials (ASTM) to reflect the current standards designations. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedures for notice-and-comment, to provide a procedural framework to finalize the rule in the event that the agency receives any significant adverse comment and withdraws the direct final rule.","action":"Direct 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/2000/01/24/00-1404.html","cfr_references":[{"chapter":null,"citation_url":null,"part":801,"title":21}],"citation":"65 FR 3584","comment_url":null,"comments_close_on":"2000-04-10","correction_of":null,"corrections":[],"dates":"The rule is effective June 7, 2000. Submit written comments on or before April 10, 2000. If FDA receives no significant adverse comments within the specified comment period, the agency intends to publish in the Federal Register a document confirming the effective date of the direct final rule within 30 days after the comment period on this direct final rule ends. If the agency receives any adverse comments, FDA intends to withdraw this final rule by publication in the Federal Register of a document within 30 days after the comment period ends. The Director of the Office of the Federal Register approves the incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain publications in Sec. 801.410(d)(2) (21 CFR 801.410(d)(2)) and Sec. 801.430(f)(2) (21 CFR 801.430(f)(2), effective June 7, 2000.","disposition_notes":null,"docket_ids":["Docket No. 99N-4955"],"dockets":[{"supporting_documents":[{"title":"Attachment 2 Designation: D 412 - 98a Standard Test Methods for\nVulcanized Rubber and Thermoplastic Elastomers Tension re: Comment from American Society for Testing and Materials","document_id":"FDA-1999-N-0195-0005"},{"title":"Attachment 1 Designation: D 3492 - 97 Standard Specification for Rubber Contraceptives {Male Condoms) re: Comment from American Society for Testing and Materials","document_id":"FDA-1999-N-0195-0004"}],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2024-10-29T11:57:21.249-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-1999-N-0195-0002","allow_late_comments":false,"id":"FDA-1999-N-0195-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"FDA-1999-N-0195","title":"Amendment of Various Device Regulations - CLOSED"}],"document_number":"00-1404","effective_on":"2000-06-07","end_page":3586,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2000/01/24/00-1404.xml","html_url":"https://www.federalregister.gov/documents/2000/01/24/00-1404/amendment-of-various-device-regulations-to-reflect-current-american-society-for-testing-and-material","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/00-1404?publication_date=2000-01-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2000-01-24/00-1404/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":55,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2000-01-24/pdf/00-1404.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2000-01-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2000/01/24/00-1404.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 2 Designation: D 412 - 98a Standard Test Methods for\nVulcanized Rubber and Thermoplastic Elastomers Tension re: Comment from American Society for Testing and Materials","document_id":"FDA-1999-N-0195-0005"},{"title":"Attachment 1 Designation: D 3492 - 97 Standard Specification for Rubber Contraceptives {Male Condoms) re: Comment from American Society for Testing and Materials","document_id":"FDA-1999-N-0195-0004"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-1999-N-0195","supporting_documents_count":2,"docket_id":"FDA-1999-N-0195","document_id":"FDA-1999-N-0195-0002","regulation_id_number":null,"title":"Amendment of Various Device Regulations - CLOSED","checked_regulationsdotgov_at":"2024-10-30T15:00:23Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":3584,"subtype":null,"title":"Amendment of Various Device Regulations to Reflect Current American Society for Testing and Material Citations","toc_doc":null,"toc_subject":null,"topics":["Incorporation by reference","Medical devices"],"type":"Rule","volume":65}