Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
314.101(a) Unchanged 1 1 0
314.107(c) Unchanged 230 115 0
314.107(e) Unchanged 98 49 0
314.107(f) Unchanged 230 115 0
314.110(a)(5) Unchanged 1 1 0
314.110(c) Unchanged 15 8 0
314.420 Unchanged 1038 63318 0
314.50 (a), (b), (c), (d), (e), (f), and (k) Modified 92 241542 0 Form and Instruction 3331 NDA-Field Alert Report
314.50(i) and 314.94(a)(12) Modified 923 1846 0
314.50(j) Modified 285 572 0
314.52 and 314.95 Modified 260 4160 0
314.60 Modified 7564 605120 0
314.65 Modified 12 24 0
314.70 and 314.71 Unchanged 3050 457500 0
314.72 Unchanged 310 620 0
314.81(b)(1) [3331] Unchanged 378 3024 0
314.81(b)(2) [2252] Unchanged 8149 362892 0
314.81(b)(3)(i) [2253] Unchanged 30130 60260 0
314.94(a)(1)-(11) and (d) Unchanged 862 413760 0
314.96 Unchanged 10461 836880 0
314.97 Unchanged 5169 413520 0
314.99(a) Unchanged 122 244 0
Guidance; Reports on the Status of Postmarketing Studies/Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 Unchanged 935 468 0
Total burden requested under this ICR: 70315 3466039 0  
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