Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
314.101(a) Modified 1 1 0
314.107(e) Removed 0 0 0
314.107(f) Removed 0 0 0
314.110(a)(5) Removed 0 0 0
314.110(c) Removed 0 0 0
314.420 Removed 0 0 0
314.420 Modified 1038 63318 0
314.50 (a), (b), (c), (d), (e), (f), and (k) Modified 151 290373 0 Form and Instruction 3331 NDA-Field Alert Report
Form 2252 Transmittal of Annual Report for Drug and Biologics for Human Use
Form 2253 Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use
Form 356 Application to Market a New or Abbreviated New Drug or Biologic for Human Use
314.52 Modified 21 336 0
314.550 Modified 140 16800 0
314.60 Modified 2418 193440 0
314.65 Modified 21 42 0
314.70 and 314.71 Modified 2854 428100 0
314.72 Modified 145 290 0
314.81(b)(1) [3331] Modified 4241 33928 0
314.81(b)(2) [2252] Modified 10490 419600 0
314.81(b)(3)(i) [2253] Modified 45464 90928 0
314.94(a) and (d) Modified 1187 569760 0
314.95 Modified 627 10032 0
314.96 Modified 10676 854080 0
314.97 Modified 5612 448960 0
314.99(a) Modified 659 1318 0
Guidance; Reports on the Status of Postmarketing Studies/Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 Removed 0 0 0
Total burden requested under this ICR: 85745 3421306 0  
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