2025-00564. Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Program

Table 1—Estimated Annual Reporting Burden ¹

Information collection activity	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Submission of Generic Drug User Fee Cover Sheet	500	7.616	3,808	0.5 (30 minutes)	1,904
Submission of Controlled Correspondence as Discussed in Agency Topic-Specific Guidance Documents	400	12.5	5000	5	25,000
Total			8,808		26,904
1 There are no capital costs or operating and maintenance costs associated with this collection of information.