{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.'' This guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product that refers to a previously approved peptide drug product of Recombinant Deoxyribonucleic Acid (rDNA) origin should be submitted as an abbreviated new drug application (ANDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) rather than as a new drug application (NDA) under the FD&C Act. This guidance finalizes the draft guidance of the same title issued on October 3, 2017.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2021/05/20/2021-10603.html","cfr_references":[],"citation":"86 FR 27446","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 20, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-D-5767"],"dockets":[],"document_number":"2021-10603","effective_on":null,"end_page":27447,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/05/20/2021-10603.xml","html_url":"https://www.federalregister.gov/documents/2021/05/20/2021-10603/abbreviated-new-drug-applications-for-certain-highly-purified-synthetic-peptide-drug-products-that","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-10603?publication_date=2021-05-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-05-20/2021-10603/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1099,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-05-20/pdf/2021-10603.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-10603.pdf?1621428326","publication_date":"2021-05-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/05/20/2021-10603.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-2017-D-5767","supporting_documents_count":0,"docket_id":"FDA-2017-D-5767","document_id":"FDA-2017-D-5767-0028","regulation_id_number":null,"title":"ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin","checked_regulationsdotgov_at":"2021-05-26T03:30:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27446,"subtype":null,"title":"Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid; Guidance for Industry; Availability","toc_doc":"Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":86}