2024-31308. Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug and Veterinary Master Files

Table 1—Estimated Annual Reporting Burden ^{1  2}

21 CFR part, activity	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
§ 514; applications and amendments, pre-submission conference requests, evidence to establish safety and effectiveness, manufacturing, labeling, and other changes, submission of data studies and other changes	254	2.8	711	42.25	30,040
§ 558.5(i); requirements for liquid medicated feed	254	.01	2.5	5	13
Applications for conditional approval submitted under section 571 of the FD&C Act	3	1	3	1	3
Form FDA 356V	254	30.8	7,823	0.75 (45 minutes)	5,867
VMF submissions	16	1	16	20	320
Total			8,556		36,243
1  There are no capital costs or operating and maintenance costs associated with this collection of information.
2  Totals may not sum due to rounding.