federal_register: 2012-6707
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2012-6707 | Medical Device User Fee Act; Public Meeting | Notice | The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Act (MDUFA) for fiscal years (FYs) 2013 through 2017. MDUFA authorizes FDA to collect user fees and use them for the process for the review of medical device applications. The current legislative authority for MDUFA expires on October 1, 2012. New legislation will be required for FDA to collect medical device user fees for future FYs. Following discussions with the device industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary. | 2012-03-20 | 2012 | 3 | https://www.federalregister.gov/documents/2012/03/20/2012-6707/medical-device-user-fee-act-public-meeting | https://www.govinfo.gov/content/pkg/FR-2012-03-20/pdf/2012-6707.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Act (MDUFA) for fiscal years (FYs) 2013 through 2017. MDUFA authorizes FDA to collect user... |