{"abstract":"The Food and Drug Administration (FDA) announces its intention to accept and consider a single source application for an award of a cooperative agreement to the World Health Organization (WHO) in support of collaborative efforts to advance innovative approaches to vaccine clinical trial design and to enhance the utilization of a range of pharmacovigilance tools as a means to further vaccine safety and potentially facilitate more rapid introduction of new vaccines. The goal of FDA's Center for Biologics Evaluation and Research (CBER) is to enhance technical collaboration and cooperation between FDA, WHO, and its Member States to facilitate strengthening regulatory capacity globally.","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/2012/05/16/2012-11932.html","cfr_references":[],"citation":"77 FR 28883","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Important dates are as follows:","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-0009"],"dockets":[],"document_number":"2012-11932","effective_on":null,"end_page":28886,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/05/16/2012-11932.xml","html_url":"https://www.federalregister.gov/documents/2012/05/16/2012-11932/cooperative-agreement-to-support-innovation-in-vaccine-clinical-trial-design-and-collaboration-in","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-11932?publication_date=2012-05-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-05-16/2012-11932/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":311,"last_updated":"2026-10-22 16:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-05-16/pdf/2012-11932.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-11932.pdf?1337086622","publication_date":"2012-05-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/05/16/2012-11932.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-0009","supporting_documents_count":0,"docket_id":"FDA-2012-N-0009","regulation_id_number":null,"title":"Cooperative Agreement","checked_regulationsdotgov_at":"2012-06-04T06:00:23Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":28883,"subtype":null,"title":"Cooperative Agreement To Support Innovation in Vaccine Clinical Trial Design and Collaboration in Pharmacovigilance To Advance Global Access to Safe and Effective Vaccines","toc_doc":"Pharmacovigilance to Advance Global Access to Safe and Effective Vaccines","toc_subject":"Cooperative Agreement to Support Innovation in Vaccine Clinical Trial Design and Collaboration:","topics":[],"type":"Notice","volume":77}