{"abstract":"The Food and Drug Administration (FDA) is amending its regulations governing the content and format of labeling for human prescription drug products, including biological products, to include information pertinent to the appropriate use of drugs in the elderly (persons aged 65 years and over) and to facilitate access to this information by establishing a ``Geriatric use'' subsection in the labeling. The final rule is one of several measures FDA has taken in response to the special concerns associated with prescription drug use in elderly patients. FDA believes that improving access to information that is important to the elderly will facilitate the safe and effective use of prescription drugs in older populations.","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/1997/08/27/97-22701.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"201","title":21}],"citation":"62 FR 45313","comment_url":null,"comments_close_on":"1997-10-27","correction_of":null,"corrections":[],"dates":"This final rule becomes effective on August 27, 1998. Submit written comments on the collection of information provisions by October 27, 1997. See section IV of this document for the implementation dates of this final rule for drug classes and drug products.","disposition_notes":null,"docket_ids":["Docket No. 89N-0474"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":57,"comment_start_date":"1997-08-28","updated_at":"2024-01-17T00:01:40.888-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-1989-N-0019-0001","allow_late_comments":null,"id":"FDA-1989-N-0019-0001","comment_end_date":"1997-10-30","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-1989-N-0019","title":"Prescription Labeling for Geriatric Use"}],"document_number":"97-22701","effective_on":"1998-08-27","end_page":45326,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1997/08/27/97-22701/specific-requirements-on-content-and-format-of-labeling-for-human-prescription-drugs-addition-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/97-22701?publication_date=1997-08-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1997-08-27/97-22701/mods.xml","not_received_for_publication":null,"page_length":14,"page_views":{"count":237,"last_updated":"2026-10-25 02:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1997-08-27/pdf/97-22701.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1997-08-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1997/08/27/97-22701.txt","regulation_id_number_info":{"0910-AA25":{"issue":"199704","html_url":"https://www.federalregister.gov/regulations/0910-AA25/specific-requirements-on-content-and-format-of-labeling-for-human-prescription-drugs-addition-of-ger","title":"Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Addition of \"Geriatric Use\" Subsection in the Labeling","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=199704&RIN=0910-AA25&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AA25"],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":57,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-1989-N-0019","supporting_documents_count":0,"docket_id":"FDA-1989-N-0019","document_id":"FDA-1989-N-0019-0001","regulation_id_number":null,"title":"Prescription Labeling for Geriatric Use","checked_regulationsdotgov_at":"2024-01-18T02:00:07Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":45313,"subtype":null,"title":"Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Addition of ``Geriatric Use'' Subsection in the Labeling","toc_doc":null,"toc_subject":null,"topics":[],"type":"Rule","volume":62}