Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Disclosure - Postmarketing safety reporting for combination products New 198 69 0
Recordkeeping - AER and Records During Pandemic (COOP planning; documenting conditions and high absenteeism; documenting AER process) Modified 800 10600 0 Other-Agency Guidance
Recordkeeping - AER records for Rx products not subject of marketing application Modified 3197 51152 0
Recordkeeping - AER records under 314.80 (marketing applications) Modified 1525625 24410000 0
Recordkeeping - AER records under FFDCA 760(e)(1) (21 U.S.C. 379aa(e)(1)) Modified 19507 156056 0 Other-Agency Guidance
Recordkeeping - Postmarketing Safety Reporting for Combination Products Modified 198 20 0
Reporting - AER Rx products not subject of marketing application Modified 3197 3197 5000 Other-Agency Guidance
Reporting - AER for non-prescription drug products (21 CFR 329.100) Modified 19507 117042 5000 Other-Agency Guidance
Other-Agency Guidance
Other-Agency Guidance
Reporting - AER under 314.80 (marketing applications) - 15 day alerts Modified 1250000 1250000 5000 Other-Agency Guidance
Reporting - AER under 314.80 (marketing applications) - quarterly reports Modified 838000 50280000 5000 Other-Agency Guidance
Other-Agency Guidance
Reporting - ICH E2C(R2) Guidance: Providing periodic safety updates (applicants with and without waiver for an approved application) Modified 22308 40431 5000 Other-Agency Guidance
Other-Agency Guidance
Reporting - Pandemic Guidance; notifying FDA when normal reporting is not feasible New 1 8 0 Other-Agency Guidance
Other-Agency Guidance
Reporting - Waiver requests from electronic reporting New 1 24 0 Other-Agency Guidance
Total burden requested under this ICR: 3682539 76318599 25000  
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