2024-26801. Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug User Fee Program

Table 1—Estimated Annual Reporting Burden ¹

Prescription drug user fee activity	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Sections 735 and 736 of the FD&C Act (PDUFA waivers and exemptions, not including small business waiver requests)	99	1.828	181	17	3,077
Section 736(d)(1)(C) of the FD&C Act and Form FDA 3971 (small business waivers)	35	1	35	2	70
Reconsideration Requests	13	1.69	22	24	528
Appeal Requests	4	1.5	6	12	72
User Fee Cover Sheet Form FDA 3397 submission with original NDAs and BLAs	132	1.24	164	0.5 (30 minutes)	82
Total			408		3,829
1  There are no capital costs or operating and maintenance costs associated with this collection of information.