{"abstract":"The Food and Drug Administration (FDA or Agency) is extending the comment period in the notice of availability that appeared in the Federal Register of February 19, 2015. In that notice of availability, FDA requested comments on a draft standard memorandum of understanding (MOU) entitled \"Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State of [insert State] and the U.S. Food and Drug Administration.\" The draft standard MOU describes the responsibilities of any State that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the State and in addressing the interstate distribution of inordinate amounts of compounded human drug products. The Agency is taking this action to allow interested persons additional time to submit comments.","action":"Notice of availability; extension of comment period.","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/2015/06/03/2015-13466.html","cfr_references":[],"citation":"80 FR 31604","comment_url":null,"comments_close_on":"2015-07-20","correction_of":null,"corrections":[],"dates":"FDA is extending the comment period in the notice of availability published on February 19, 2015 (80 FR 8874) which includes comment on information collection issues under the Paperwork Reduction Act of 1995 (the PRA). Submit either electronic or written comments on the draft standard MOU or on information collection issues under the PRA by July 20, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-1459"],"dockets":[{"supporting_documents":[],"agency_name":null,"documents":[{"comment_count":1,"comment_start_date":"2015-06-03","updated_at":"2023-02-28T22:23:43.811-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2014-N-1459-0029","allow_late_comments":null,"id":"FDA-2014-N-1459-0029","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2014-N-1459","title":"Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the States and the Food and Drug Administration"}],"document_number":"2015-13466","effective_on":null,"end_page":31604,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/06/03/2015-13466.xml","html_url":"https://www.federalregister.gov/documents/2015/06/03/2015-13466/memorandum-of-understanding-addressing-certain-distributions-of-compounded-human-drug-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-13466?publication_date=2015-06-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-06-03/2015-13466/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":891,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-06-03/pdf/2015-13466.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-13466.pdf?1433249171","publication_date":"2015-06-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/06/03/2015-13466.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":1,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-N-1459","supporting_documents_count":0,"docket_id":"FDA-2014-N-1459","document_id":"FDA-2014-N-1459-0029","regulation_id_number":null,"title":"Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the States and the Food and Drug Administration","checked_regulationsdotgov_at":"2023-03-01T03:23:42Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":31604,"subtype":null,"title":"Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the States and the Food and Drug Administration; Extension of Comment Period","toc_doc":"Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the States and the Food and Drug Administration","toc_subject":"Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":80}