Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
601.12(a)(5) - Changes to an Approved Application New 13059 13059 0 Form and Instruction 2567 Transmittal of Labels and Circulars
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application New 698 55840 0 Form and Instruction 2567 Transmittal of Labels and Circulars
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(c)(1) and (c)(3) - Changes to an Approved Application New 538 26900 0 Form and Instruction 2567 Transmittal of Labels and Circulars
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(c)(5) - Changes to an Approved Application New 29 1450 0 Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
Form and Instruction 2567 Transmittal of Labels and Circulars
601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application New 742 17808 0 Form and Instruction 2567 Transmittal of Labels and Circulars
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(f)(1) - Changes to an Approved Application New 166 6640 0 Form and Instruction 2567 Transmittal of Labels and Circulars
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(f)(2) - Changes to an Approved Application New 128 2560 0 Form and Instruction 2567 Transmittal of Labels and Circulars
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(f)(4)/601.45 - Changes to an Approved Application New 10578 105780 0 Form and Instruction 2567 Transmittal of Labels and Circulars
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.2(a) - Applications for Biologics Licenses; procedures for filing and 610.60 through 610.65 - Container Label Modified 45 38700 0 Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
Form and Instruction 2567 Transmittal of Labels and Circulars
601.26(f) - Additional Studies and Labeling New 1 1 0 Form and Instruction 2567 Transmittal of Labels and Circulars
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.27(b) - Pediatric Studies - Deferred Submission New 4 96 0 Form and Instruction 2567 Transmittal of Labels and Circulars
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.27(c) - Pediatric Studies New 6 48 0 Form and Instruction 2568 Transmittal of Labels and Circulars
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.5(a) - Revocation of License Modified 8 3 0 Form and Instruction 2567 Transmittal of Labels and Circulars
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.6(a) - Suspension of License Modified 1 0 0 Form and Instruction 2567 Transmittal of Labels and Circulars
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.6(a) - Suspension of License New 20 7 0 Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.70(b) and (d)/601.28 - Annual Progress Reports of Postmarketing Studies and Annual reports of postmarketing pediatric studies New 107 2568 0 Form and Instruction 2567 Transmittal of Labels and Circulars
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
610.15(d) - Constituent Materials New 1 1 0 Form and Instruction 2567 Transmittal of Labels and Circulars
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
680.1(b)(3)(iv) - Allergenic Products New 1 2 0 Form and Instruction 2567 Transmittal of Labels and Circulars
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
680.1(c) - Allergenic Products New 9 18 0 Form and Instruction 2567 Transmittal of Labels and Circulars
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
Amendments/Resubmissions New 2664 53280 0 Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
Total burden requested under this ICR: 28805 324761 0  
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