Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
314.101(a) Unchanged 1 1 0
314.420 Unchanged 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 Unchanged 21 336 0
314.550 Unchanged 140 16800 0
314.60 Unchanged 2418 193440 0
314.65 Unchanged 21 42 0
314.70 and 314.71 Unchanged 2854 428100 0
314.72 Unchanged 145 290 0
314.81(b)(1) [3331] Unchanged 4241 33928 0
314.81(b)(2) [2252] Unchanged 10490 419600 0
314.81(b)(3)(i) [2253] Unchanged 45464 90928 0
314.94(a) and (d) Unchanged 1187 569760 0
314.95 Unchanged 627 10032 0
314.96 Unchanged 10676 854080 0
314.97 Unchanged 5612 448960 0
314.99(a) Unchanged 659 1318 0
Total burden requested under this ICR: 85745 3421306 0  
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