21 CFR 514.6 - Amended applications

Cite as21 CFR 514.6
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1 practice notes
  • 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......

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