2024-21435. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form 3601a

Table 1—Estimated Annual Reporting Burden ¹

FDA form or activity	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
User Fee Cover Sheet
Form FDA 3601 (Medical Device User Fee Cover Sheet)	6,182	1	6,182	0.30 (18 minutes)	1,855
Form FDA 3601a (Device Facility User Fee Cover Sheet)	24,086	1	24,086	0.17 (10 minutes)	4,095
Subtotal			30,268		5,950
Inspection by Accredited Persons Program Under Section 704 of the FD&C Act
Request for accreditation	1	1	1	80	80
Notification of the intent to use an Accredited Person	10	1	10	15	150
Subtotal			11		230
Request for Information Under Section 513(g) of the FD&C Act
Sections IV and V of Guidance; CDRH 513(g) requests	114	1	114	12	1,368
Sections IV and V of Guidance; CBER 513(g) requests	4	1	4	12	48
Subtotal			118		1,416
Total					7,596
1  There are no capital costs or operating and maintenance costs associated with this collection of information.