{"abstract":"The Food and Drug Administration (FDA or Agency) is requesting comment on the draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements and terminologies for the electronic submission of PQ/CMC data. The establishment of standardized pharmaceutical quality data elements and terminologies will provide opportunities for FDA and industry to transform PQ/CMC submission data into a readily useable electronic format. As a result, these established data elements and terminologies will improve the efficiency and quality of the drug review process. The Agency is seeking comment on the accuracy, suitability, and appropriateness of these data elements and terminologies for submission of PQ/CMC data. FDA is considering implementing PQ/CMC requirements as a Health Level 7 (HL7) Structured Product Labeling (SPL) document. The proposed data elements and terminologies can be obtained on https:// www.regulations.gov in Docket No. FDA-2017-N-2166.","action":"Notice; request for comments.","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/2017/07/11/2017-14456.html","cfr_references":[],"citation":"82 FR 32003","comment_url":null,"comments_close_on":"2017-09-11","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by September 11, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 11, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 11, 2017. Comments received by mail/hand delivery/ courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-N-2166"],"dockets":[{"supporting_documents":[{"title":"Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Terminologies","document_id":"FDA-2017-N-2166-0002"}],"agency_name":"FDA","documents":[{"comment_count":12,"comment_start_date":"2017-07-11","updated_at":"2023-03-01T01:49:55.692-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-N-2166-0001","allow_late_comments":null,"id":"FDA-2017-N-2166-0001","comment_end_date":"2017-09-12","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2017-N-2166","title":"Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies; Request for Comments"}],"document_number":"2017-14456","effective_on":null,"end_page":32004,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/07/11/2017-14456.xml","html_url":"https://www.federalregister.gov/documents/2017/07/11/2017-14456/draft-standardization-of-pharmaceutical-qualitychemistry-manufacturing-and-control-data-elements-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-14456?publication_date=2017-07-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-07-11/2017-14456/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":4186,"last_updated":"2026-04-24 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-07-11/pdf/2017-14456.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-14456.pdf?1499690756","publication_date":"2017-07-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/07/11/2017-14456.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Terminologies","document_id":"FDA-2017-N-2166-0002"}],"comments_count":12,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2017-N-2166","supporting_documents_count":1,"docket_id":"FDA-2017-N-2166","document_id":"FDA-2017-N-2166-0001","regulation_id_number":null,"title":"Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies; Request for Comments","checked_regulationsdotgov_at":"2023-03-01T06:49:54Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":32003,"subtype":null,"title":"Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies; Request for Comments","toc_doc":"Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies","toc_subject":null,"topics":[],"type":"Notice","volume":82}