2025-01149. Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program

Table 1—Estimated Annual Reporting Burden ¹

FDA center or 21 CFR section and/or FDA form	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
CBER/CDER, FDA 3500 (voluntary reporting)	58,711	1	58,711	0.66 (40 minutes)	38,749
CBER, FDA 3500A; 600.80; 1271.350 (mandatory reporting)	599	98	58,702	1.21	71,029
CBER, FDA 3500B	13,750	1	13,750	0.46 (28 minutes)	6,325
CDER, FDA 3500B	18,961	1	18,961	0.46 (28 minutes)	8,722
CDRH, FDA 3500 and FDA 3500B	15,304	1	15,304	0.46 (28 minutes)	7,040
CTP, FDA 3500	39	1	39	0.66 (40 minutes)	26
HFP, FDA 3500	7,442	1.061	7,895	0.66 (40 minutes)	5,211
HFP, FDA 3500A	1,659	1	1,659	1.21	2,007
Written requests for temporary waiver under § 329.100(c)(2)	1	1	1	1	1
Total					139,110
1  There are no capital costs or operating and maintenance costs associated with this collection of information.
CBER = Center for Biologics Evaluation and Research
CDER = Center for Drug Evaluation and Research
CDRH = Center for Devices and Radiological Health
HFP = Human Foods Program
CTP = Center for Tobacco Products

The estimates in table 1 are based on current Agency data and our experience with the information collection. ( print page 5909)

Table 2—Estimated Annual Reporting Burden E-Submissions Including via SRP ¹

FDA form 3800	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Reportable Foods Registry (mandatory reports)	875	1	875	0.6 (36 minutes)	525
Reportable Foods Registry (voluntary reports)	5	1	5	0.6 (36 minutes)	3
Food, Infant Formula, and Cosmetic Adverse Event Reports	1,165	1.2	1,398	0.6 (36 minutes)	839
Voluntary Dietary Supplement Adverse Event Reports	360	1.2	432	0.6 (36 minutes)	259
Mandatory Dietary Supplement Adverse Event Reports	80	12	960	1	960
Animal Food: Voluntary Pet Food Reports	1,401	1	1,401	0.6 (36 minutes)	841
Animal Food: Voluntary Livestock Food Reports	23	1	23	0.6 (36 minutes)	14
Voluntary Tobacco Product Health Problem or Product Problem (i.e., adverse experience) Reports to SRP (both questionnaires)	176	1	176	0.6 (36 minutes)	106
Mandatory Tobacco Product Health Problem or Product Problem (i.e., adverse experience) Reports 1114.41(a)(2)	3	6	18	0.6 (36 minutes)	11
Total			5,924		3,961
1  There are no capital costs or operating and maintenance costs associated with this collection of information.