federal_register: 2012-26257
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 |
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| 2012-26257 | Generic Drug User Fee-Backlog Fee Rate for Fiscal Year 2013 | Notice | The Food and Drug Administration (FDA) is announcing the rate for the backlog fee related to generic drug user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), authorizes FDA to assess and collect user fees for certain applications and supplements associated with human generic drug products, on applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities, and on type II API drug master files (DMFs) to be made available for reference. GDUFA directs FDA to establish each year the Generic Drug User Fee rates for the upcoming year. In the first year of GDUFA (FY 2013), some rates will be published in separate Federal Register notices because of the timing specified in the statute. Each year thereafter the GDUFA fee rates will be published 60 days before the start of the FY. This document establishes the FY 2013 rate for the backlog fee ($17,434). This fee is effective on October 1, 2012. | 2012-10-25 | 2012 | 10 | https://www.federalregister.gov/documents/2012/10/25/2012-26257/generic-drug-user-fee-backlog-fee-rate-for-fiscal-year-2013 | https://www.govinfo.gov/content/pkg/FR-2012-10-25/pdf/2012-26257.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the rate for the backlog fee related to generic drug user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments... |