2024-15988. Agency Information Collection Activities; Proposed Collection; Comment Request; Diversity Action Plans for Clinical Studies

Table 1—Estimated One-Time Recordkeeping Burden ¹

Review guidance to comply with FDORA sections 3601/3602	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
CDER (sec. 505(z)(3) of the FD & C Act)	200	1	200	1	200
CBER (sec. 505(z)(3) of the FD & C Act)	40	1	40	1	40
CDRH (sec. 520(g)(9) of the FD & C Act)	488	1	488	1	488
Total			728		728
1  There are no operating and maintenance costs associated with this collection of information.

We are expanding the scope of our currently approved collection inventory to acknowledge the establishment of DAP requirements under FDORA and to account for burden that may be attendant to the submission of a DAP or for requesting a waiver. As explained in the draft guidance document Section VII (Procedures for Submitting the Diversity Action Plan and Receiving Feedback), the submission process will vary depending on the medical product type.

As reflected in table 1, we estimate a one-time burden of 728 hours and 728 responses, cumulatively, with regard to reviewing the guidance and to any necessary adjustment respondents may need to make in complying with applicable requirements.

Table 2—Estimated Annual Recordkeeping Burden ¹

Information collection activity; statutory authority	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
CDER DAP Submission—sec. 505(z)(3) of the FD & C Act	146	1.37	200	100	20,000
CBER DAP Submission—sec. 505(z)(3) of the FD & C Act	35	1.14	40	100	4,000
CDRH—sec. 520(g)(9)(A) of the FD & C Act	488	1	488	40	19,520
Waiver request CDER—sec. 505(z)(4) of the FD & C Act	4	1	4	16	72
Waiver request CBER—sec. 505(z)(4) of the FD & C Act	1	1	1	16	16
Waiver request CDRH—sec. 520(g)(9)(C) of the FD & C Act	5	1	5	16	80
Total			738		43,688
1  There are no operating and maintenance costs associated with this collection of information.