Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
AER Rx products not subject of marketing application Unchanged 3 3 0
AER records for Rx products not subject of marketing application Unchanged 25 400 0
AER records under 314.80 (marketing applications) Unchanged 658240 10531840 0
AER records under FFDCA 760(e)(1) (21 U.S.C. 379aa(e)(1)) Unchanged 265700 2125600 0 Other-Agency Guidance
AER under 314.80 (marketing applications) - 15 day alerts Unchanged 5 5 0
AER under 314.80 (marketing applications) - quarterly reports Unchanged 14202 852120 0 Other-Agency Guidance
AER under FFDCA sec. 760 - nonprescription drug products Unchanged 196650 1179900 0 Other-Agency Guidance
Other-Agency Guidance
GFI: AER and Records During Pandemic Unchanged 1150 13400 0 Other-Agency Guidance
GFI: Providing PSURs Unchanged 254 321 0 Other-Agency Guidance
Postmarketing Safety Reporting for Combination Products New 198 89 0
Total burden requested under this ICR: 1136427 14703678 0  
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