{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action.\" This draft document provides recommendations to applicants planning product quality studies to document bioavailability (BA) or bioequivalence (BE) in support of new drug applications (NDAs), or abbreviated new drug applications (ANDAs) for locally acting drugs in nasal aerosols (metered-dose inhalers) and nasal sprays (metered-dose spray pumps). The draft guidance was originally issued for comment on June 24, 1999. Since many substantive changes have been made to the guidance, it is being reissued for comment as a level 1 draft guidance.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2003/04/03/03-8010.html","cfr_references":[],"citation":"68 FR 16292","comment_url":null,"comments_close_on":"2003-07-02","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on the draft guidance by July 2, 2003. General comments on agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. 99D-1738"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2003-04-09","updated_at":"2025-06-04T10:56:45.433-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-1999-D-0050-0002","allow_late_comments":false,"id":"FDA-1999-D-0050-0002","comment_end_date":"2003-07-03","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-1999-D-0050","title":"Bioavilability & Bioequivalence Studies for Nasal Aerosols"}],"document_number":"03-8010","effective_on":null,"end_page":16293,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2003/04/03/03-8010.xml","html_url":"https://www.federalregister.gov/documents/2003/04/03/03-8010/draft-guidance-for-industry-bioavailability-and-bioequivalence-studies-for-nasal-aerosols-and-nasal","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/03-8010?publication_date=2003-04-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2003-04-03/03-8010/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1166,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2003-04-03/pdf/03-8010.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2003-04-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2003/04/03/03-8010.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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-0050","supporting_documents_count":0,"docket_id":"FDA-1999-D-0050","document_id":"FDA-1999-D-0050-0002","regulation_id_number":null,"title":"Bioavilability & Bioequivalence Studies for Nasal Aerosols","checked_regulationsdotgov_at":"2025-06-05T17:55:06Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":16292,"subtype":null,"title":"Draft Guidance for Industry: Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action; Availability","toc_doc":"Nasal aerosols and nasal sprays; bioavailability and bioequivalence studies","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":68}