{"abstract":"The Food and Drug Administration (FDA) is revising the requirements for annual postmarketing status reports for approved human drug and biological products, and is requiring applicants to submit annual status reports for certain postmarketing studies of licensed biological products. This rule describes the types of postmarketing studies covered by these status reports, the information to be included in the reports, and the type of information that FDA would consider appropriate for public disclosure. This action will implement the Food and Drug Administration Modernization Act of 1997 (FDAMA).","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/2000/10/30/00-27731.html","cfr_references":[{"chapter":null,"citation_url":null,"part":314,"title":21},{"chapter":null,"citation_url":null,"part":601,"title":21}],"citation":"65 FR 64607","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective February 27, 2001.","disposition_notes":null,"docket_ids":["Docket No. 99N-1852"],"dockets":[],"document_number":"00-27731","effective_on":"2001-02-27","end_page":64619,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2000/10/30/00-27731.xml","html_url":"https://www.federalregister.gov/documents/2000/10/30/00-27731/postmarketing-studies-for-approved-human-drug-and-licensed-biological-products-status-reports","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/00-27731?publication_date=2000-10-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2000-10-30/00-27731/mods.xml","not_received_for_publication":null,"page_length":13,"page_views":{"count":689,"last_updated":"2026-10-23 02:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2000-10-30/pdf/00-27731.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2000-10-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2000/10/30/00-27731.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":64607,"subtype":null,"title":"Postmarketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports","toc_doc":"Postmarketing studies; status reports","toc_subject":"Human drugs and biological products:","topics":["Administrative practice and procedure","Biologics","Confidential business information","Drugs","Reporting and recordkeeping requirements"],"type":"Rule","volume":65}