{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Development and Submission of Near Infrared Analytical Procedures.\" This draft guidance provides recommendations to applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the development and submission of near infrared (NIR) analytical procedures used during the manufacture and analysis of pharmaceuticals. This draft guidance only pertains to the development and validation of NIR analytical procedures and does not provide recommendations concerning the set up and qualification of NIR instruments or their maintenance and calibration.","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/2015/03/31/2015-07266.html","cfr_references":[],"citation":"80 FR 17057","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 1, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-0868"],"dockets":[],"document_number":"2015-07266","effective_on":null,"end_page":17058,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/03/31/2015-07266.xml","html_url":"https://www.federalregister.gov/documents/2015/03/31/2015-07266/development-and-submission-of-near-infrared-analytical-procedures-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-07266?publication_date=2015-03-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-03-31/2015-07266/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":613,"last_updated":"2026-08-26 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-03-31/pdf/2015-07266.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-07266.pdf?1427719546","publication_date":"2015-03-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/03/31/2015-07266.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-D-0868","supporting_documents_count":0,"docket_id":"FDA-2015-D-0868","regulation_id_number":null,"title":"Development and Submission of Near Infrared Analytical Procedures","checked_regulationsdotgov_at":"2015-06-02T05:00:40Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":17057,"subtype":null,"title":"Development and Submission of Near Infrared Analytical Procedures; Draft Guidance for Industry; Availability","toc_doc":"Development and Submission of Near Infrared Analytical Procedures","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}