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- Title 21. Food and Drugs
- Chapter I. Food and Drug Administration, Department of Health and Human Services
- Subchapter E. Animal Drugs, Feeds, and Related Products
- Part 514. New Animal Drug Applications
- Subpart A. General Provisions
21 CFR 514.6 - Amended applications
| Cite as | 21 CFR 514.6 |
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Agency information collection activities; proposals, submissions, and approvals,
- United States
- Federal Register July 09, 2007
- July 9, 2007
...approximately 50 hours. Thus, the total burden hours for presubmission conferences is estimated to be 4,650 hours. NADA (Sec. 514.1 and 21 CFR 514.6). Over the past 5 fiscal years, FDA has received an average of 19 NADAs per year. FDA estimates that preparing the paperwork required for an N......