2025-01151. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Experience Reporting

Table 1—Estimated Annual Reporting Burden  ^1 2 3

21 CFR section or guidance; activity	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
310.305(c)(5); AERs for prescription products not the subject of a marketing application	36	88.8	3,197	1	3,197
314.80(c)(1); 15-day alerts for approved products	682	1,832.84	1,250,000	1	1,250,000
314.80(c)(2); periodic reports for approved products	682	1,228.73	838,000	60	50,280,000
329.100; AERs for non-prescription drug products	312	62.522	19,507	6	117,042
ICH E2C(R2) Guidance; Periodic safety updates; Applicants w/waiver for an approved application (section III.A.)	471	8.885	4,185	1	4,185
ICH E2C(R2) Guidance; Periodic safety updates; Applicants w/no waiver for an approved application (section III.B.)	1,115	16.254	18,123	2	36,246
AER During Pandemic Guidance; notifying FDA when normal reporting is not feasible (section III.C.)	1	1	1	8	8
4.103, 4.104, 4.105, 310.305, 314.80, 314.98, 329.100(c); Waiver requests from electronic reporting requirements	1	1	1	24	24
Total	4  2,618		2,133,014		51,690,702
1  There are no capital costs associated with this collection. The operating and maintenance costs associated with this collection of information are approximately $25,000 annually.
2  The reporting burdens for § 310.305(c)(1), (2), and (3), and voluntary reports by healthcare providers received under § 314.80(c)(1)(i) and (ii) are covered under OMB control number 0910-0291.
3  Totals may not sum due to rounding.
4  Total of unique respondents.

Table 2—Estimated Annual Recordkeeping Burden  ^1 2

21 CFR section or guidance section; activity	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping	Total hours
310.305; AER records—prescription product not the subject of a marketing application	36	88.8	3,197	16	51,152
314.80(j); AER records—product associated w/marketing application	841	1,814.0606	1,525,625	16	24,410,000
Postmarket AER for Nonprescription Drug Products Guidance; (§ 329.100)	312	62.5224	19,507	8	156,056
AERs During Pandemic Guidance; Continuity of operations planning (section III.B.)	100	1	100	50	5,000
AERs During Pandemic Guidance; documenting conditions and resultant high absenteeism (section III.C.2)	350	1	350	8	2,800
AERs During Pandemic Guidance; documenting AER process (section III.C.1.)	350	1	350	8	2,800
4.105; Postmarketing safety recordkeeping for combination products and constituent parts	11	18	198	0.1 (6 minutes)	19.8
Total			1,549,327		24,627,827.8
1  There are no capital costs associated with this collection of information. There are operating and maintenance costs associated with this collection of information of approximately $22,000 annually.
2  Totals may not sum due to rounding.

( print page 5897)

Table 3—Estimated Annual Third-Party Disclosure Burden ¹

21 CFR section; activity	Number of respondents	Number of disclosures per respondent	Total annual disclosures	Average burden per disclosure	Total hours
4.103; Postmarketing Safety reporting for combination products—Sharing information with other constituent part applicants	11	18	198	0.35 (21 minutes)	69.3
1  There are no capital costs or operating and maintenance costs associated with this collection of information.