2024-24721. Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Sales and Distribution

Table 1—Estimated Annual Reporting Burden ¹

21 CFR section	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
514.87(a)-(e)—Annual Reports for Sponsors With Active Applications—Paper Submission	1	1	1	62	62
514.87(a)-(e)—Annual Reports for Sponsors With Active Applications—Electronic Submission	15	10.1	152	52	7,904
514.87(a)-(e)—Annual Reports for Sponsors With Inactive Applications—Paper Submission	2	3.5	7	2	14
514.87(a)-(e)—Annual Reports for Sponsors With Inactive Applications—Electronic Submission	10	17.9	179	2	358
Total					8,338
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

We base our estimate of the average burden per response on our recent experience with the existing antimicrobial animal drug distribution reports program. We base our estimate of the number of affected respondents reported in tables 1 and 2 and the average number of responses per respondent in table 1 on a review of our records of sponsors with active and inactive applications. We estimate sponsors with active applications, who submit an annual antimicrobial annual drug sales and distribution report on paper, will spend 62 hours to assemble the necessary information, prepare, and submit to FDA. We estimate sponsors with active applications, who submit an annual antimicrobial animal drug sales and distribution report electronically, will spend 52 hours to assemble the ( print page 84889) necessary information, prepare, and submit to FDA. We estimate that sponsors with inactive applications will spend 2 hours preparing their annual antimicrobial animal drug sales and distribution reports, whether electronically or on paper.

Table 2—Estimated Annual Recordkeeping Burden ¹

Activity	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping	Total hours
Recordkeeping required by section 512(l)(3) of the FD&C Act	23	1	23	2	46
1  There are no capital costs or operating and maintenance costs associated with this collection of information.