{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled \"Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.\" This guidance document is intended to clarify the regulations regarding ASRs and the role and responsibilities of ASR manufacturers.","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/2006/09/07/06-7500.html","cfr_references":[],"citation":"71 FR 52799","comment_url":null,"comments_close_on":"2006-12-06","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on this draft guidance by December 6, 2006.","disposition_notes":null,"docket_ids":["Docket No. 2006D-0336"],"dockets":[],"document_number":"06-7500","effective_on":null,"end_page":52800,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2006/09/07/06-7500.xml","html_url":"https://www.federalregister.gov/documents/2006/09/07/06-7500/draft-guidance-for-industry-and-food-and-drug-administration-staff-commercially-distributed-analyte","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/06-7500?publication_date=2006-09-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2006-09-07/06-7500/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":64,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2006-09-07/pdf/06-7500.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2006-09-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2006/09/07/06-7500.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T20:00:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":52799,"subtype":null,"title":"Draft Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions; Availability","toc_doc":"Commercially distributed analyte specific reagents; frequently asked questions","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":71}