{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Part 11, Electronic Records; Electronic Signatures--Scope and Application.\" This draft guidance explains FDA's current thinking regarding the requirements and application of part 11 (21 CFR part 11). As an outgrowth of its current good manufacturing practice (CGMP) initiative for human and animal drugs and biologics, FDA is embarking on a re- examination of part 11 as it applies to all FDA regulated products. We may revise provisions of part 11 as a result of that reexamination. The draft guidance explains that while this re-examination is under way, we intend to exercise enforcement discretion with respect to certain part 11 requirements. We are also announcing the withdrawal of Compliance Policy Guide (CPG) 7153.17 and previously published part 11 draft guidance documents on validation, glossary of terms, time stamps, and maintenance of electronic records.","action":"Notice; availability; withdrawal.","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/2003/02/25/03-4312.html","cfr_references":[],"citation":"68 FR 8775","comment_url":null,"comments_close_on":"2003-04-28","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on the draft guidance by April 28, 2003. General comments on agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket Nos. 03D-0060, 99D-1458, 00D-1538, 00D-1543, 00D-1542, and 00D-1539"],"dockets":[{"supporting_documents":[{"title":"Draft Guidance for Industry: Part 11, Electronic Records; Electronic Signatures--Scope and Application - [Draft Guidance for Industry on \"Part 11, Electronic Records, Electronic Signatures--Scope and Application;\" Availability of Draft Guidance and Withdrawal of Draft Part 11 Guidance Documents and a Compliance Policy Guide]","document_id":"FDA-1999-D-0012-0007"}],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2025-05-29T07:57:39.393-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-1999-D-0012-0004","allow_late_comments":false,"id":"FDA-1999-D-0012-0004","comment_end_date":null,"regulations_dot_gov_open_for_comment":false},{"comment_count":null,"comment_start_date":null,"updated_at":"2025-05-29T07:57:39.397-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-1999-D-0012-0001","allow_late_comments":false,"id":"FDA-1999-D-0012-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false},{"comment_count":null,"comment_start_date":null,"updated_at":"2025-05-29T07:57:39.401-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-1999-D-0012-0002","allow_late_comments":false,"id":"FDA-1999-D-0012-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false},{"comment_count":null,"comment_start_date":null,"updated_at":"2025-05-29T07:57:39.406-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-1999-D-0012-0003","allow_late_comments":false,"id":"FDA-1999-D-0012-0003","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-1999-D-0012","title":"Enforcement Policy for FDA Personnel/Electronic Records& Sig"}],"document_number":"03-4312","effective_on":null,"end_page":8776,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2003/02/25/03-4312.xml","html_url":"https://www.federalregister.gov/documents/2003/02/25/03-4312/draft-guidance-for-industry-on-part-11-electronic-records-electronic-signatures-scope-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/03-4312?publication_date=2003-02-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2003-02-25/03-4312/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":409,"last_updated":"2026-09-21 12:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2003-02-25/pdf/03-4312.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2003-02-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2003/02/25/03-4312.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Draft Guidance for Industry: Part 11, Electronic Records; Electronic Signatures--Scope and Application - [Draft Guidance for Industry on \"Part 11, Electronic Records, Electronic Signatures--Scope and Application;\" Availability of Draft Guidance and Withdrawal of Draft Part 11 Guidance Documents and a Compliance Policy Guide]","document_id":"FDA-1999-D-0012-0007"}],"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-D-0012","supporting_documents_count":1,"docket_id":"FDA-1999-D-0012","document_id":"FDA-1999-D-0012-0001","regulation_id_number":null,"title":"Enforcement Policy for FDA Personnel/Electronic Records& Sig","checked_regulationsdotgov_at":"2025-06-01T08:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":8775,"subtype":null,"title":"Draft Guidance for Industry on “Part 11, Electronic Records, Electronic Signatures-Scope and Application;” Availability of Draft Guidance and Withdrawal of Draft Part 11 Guidance Documents and a Compliance Policy Guide","toc_doc":"Part 11, electronic records, electronic signaturesscope and application","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":68}