{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Pre-Launch Activities Importation Requests (PLAIR).\" This draft guidance describes FDA's policy regarding requests for the importation of unapproved finished dosage form drug products by applicants preparing products for market launch based on anticipated approval of a pending new drug application (NDA) or an abbreviated new drug application (ANDA). This draft guidance also applies to biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research. This draft guidance further describes the procedures for making these requests and the criteria that FDA will consider in granting such requests.","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/2013/07/24/2013-17768.html","cfr_references":[],"citation":"78 FR 44572","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 23, 2013. Submit either electronic or written comments concerning the proposed collection of information by September 23, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0836"],"dockets":[],"document_number":"2013-17768","effective_on":null,"end_page":44573,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/07/24/2013-17768.xml","html_url":"https://www.federalregister.gov/documents/2013/07/24/2013-17768/draft-guidance-for-industry-on-pre-launch-activities-importation-requests-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-17768?publication_date=2013-07-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-07-24/2013-17768/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1328,"last_updated":"2026-07-26 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-07-24/pdf/2013-17768.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-17768.pdf?1374584079","publication_date":"2013-07-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/07/24/2013-17768.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Pre-Launch Activities Importation Requests (PLAIR); Guidance for Industry","document_id":"FDA-2013-D-0836-0012"},{"title":"Pre-Launch Activities Importation Requests; Guidance for Industry; Availability","document_id":"FDA-2013-D-0836-0011"},{"title":"Draft Guidance for Industry on Pre-Launch Activities Importation Requests","document_id":"FDA-2013-D-0836-0002"},{"title":"Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability","document_id":"FDA-2013-D-0836-0001"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-0836","supporting_documents_count":4,"docket_id":"FDA-2013-D-0836","regulation_id_number":null,"title":"Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability","checked_regulationsdotgov_at":"2020-05-03T03:30:17Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":44572,"subtype":null,"title":"Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability","toc_doc":"Pre-Launch Activities Importation Requests","toc_subject":"Draft Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":78}