{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Drug Products, Including Biological Products, that Contain Nanomaterials.\" This draft guidance has been developed to provide industry with the Agency's current thinking for the development of human drug products, including those that are biological products, that contain nanomaterials. The draft guidance also includes recommendations for applicants and sponsors of investigational, premarket, and postmarket submissions for these products.","action":"Notice of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/2017/12/18/2017-27133.html","cfr_references":[],"citation":"82 FR 60019","comment_url":null,"comments_close_on":"2018-03-19","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by March 19, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-D-0759"],"dockets":[{"supporting_documents":[{"title":"Drug Products, Including Biological Products, that Contain Nanomaterials Guidance for Industry","document_id":"FDA-2017-D-0759-0017"},{"title":"Drug Products, Including Biological\nProducts, That Contain Nanomaterials;\nGuidance for Industry; Availability","document_id":"FDA-2017-D-0759-0016"},{"title":"Drug Products, Including Biological Products, that Contain Nanomaterials\nGuidance for Industry","document_id":"FDA-2017-D-0759-0002"},{"title":"Drug Products, Including Biological Products, That Contain Nanomaterials; Draft Guidance for Industry; Availability","document_id":"FDA-2017-D-0759-0001"}],"agency_name":null,"documents":[{"comment_count":4,"comment_start_date":"2017-12-18","updated_at":"2023-02-28T21:34:17.806-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-D-0759-0001","allow_late_comments":null,"id":"FDA-2017-D-0759-0001","comment_end_date":"2018-03-20","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":4,"id":"FDA-2017-D-0759","title":"Drug Products, Including Biological Products, that Contain Nanomaterials"}],"document_number":"2017-27133","effective_on":null,"end_page":60021,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/12/18/2017-27133.xml","html_url":"https://www.federalregister.gov/documents/2017/12/18/2017-27133/drug-products-including-biological-products-that-contain-nanomaterials-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-27133?publication_date=2017-12-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-12-18/2017-27133/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1603,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-12-18/pdf/2017-27133.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-27133.pdf?1513345538","publication_date":"2017-12-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/12/18/2017-27133.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Drug Products, Including Biological Products, that Contain Nanomaterials Guidance for Industry","document_id":"FDA-2017-D-0759-0017"},{"title":"Drug Products, Including Biological\nProducts, That Contain Nanomaterials;\nGuidance for Industry; Availability","document_id":"FDA-2017-D-0759-0016"},{"title":"Drug Products, Including Biological Products, that Contain Nanomaterials\nGuidance for Industry","document_id":"FDA-2017-D-0759-0002"},{"title":"Drug Products, Including Biological Products, That Contain Nanomaterials; Draft Guidance for Industry; Availability","document_id":"FDA-2017-D-0759-0001"}],"comments_count":4,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2017-D-0759","supporting_documents_count":4,"docket_id":"FDA-2017-D-0759","document_id":"FDA-2017-D-0759-0001","regulation_id_number":null,"title":"Drug Products, Including Biological Products, that Contain Nanomaterials","checked_regulationsdotgov_at":"2023-03-01T02:34:16Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":60019,"subtype":null,"title":"Drug Products, Including Biological Products, That Contain Nanomaterials; Draft Guidance for Industry; Availability","toc_doc":"Drug Products, Including Biological Products, that Contain Nanomaterials","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":82}