{"abstract":"The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (the Program). The Program is part of the FDA performance commitments under the proposed fifth authorization of the Prescription Drug User Fee Act (PDUFA), which, if enacted into law, will allow FDA to collect user fees for the review of human drug and biologics applications for fiscal years (FYs) 2013-2017. The Program is described in detail in section II.B of the document entitled \"PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017.\" \\1\\ The Program will be evaluated by an independent contractor in an interim and final assessment. As part of the FDA performance commitment, FDA is providing a period of 30 days for public comment on the statement of work before letting the contract for the assessment. ---------------------------------------------------------------------------","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/2012/07/06/2012-16529.html","cfr_references":[],"citation":"77 FR 40072","comment_url":null,"comments_close_on":"2012-08-06","correction_of":null,"corrections":[],"dates":"Submit electronic or written comments by August 6, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-0603"],"dockets":[],"document_number":"2012-16529","effective_on":null,"end_page":40073,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/07/06/2012-16529.xml","html_url":"https://www.federalregister.gov/documents/2012/07/06/2012-16529/assessment-of-the-program-for-enhanced-review-transparency-and-communication-for-new-molecular","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-16529?publication_date=2012-07-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-07-06/2012-16529/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":506,"last_updated":"2026-06-27 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-07-06/pdf/2012-16529.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-16529.pdf?1341492617","publication_date":"2012-07-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/07/06/2012-16529.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-N-0603","supporting_documents_count":0,"docket_id":"FDA-2012-N-0603","regulation_id_number":null,"title":"Assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in PDUFA V; Request for Comments","checked_regulationsdotgov_at":"2012-08-08T05:00:34Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":40072,"subtype":null,"title":"Assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act V; Request for Comments","toc_doc":"New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act","toc_subject":"Program Assessment for Enhanced Review Transparency and Communication:","topics":[],"type":"Notice","volume":77}