[Federal Register Volume 89, Number 140 (Monday, July 22, 2024)]
[Notices]
[Pages 59117-59121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15988]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-1298]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Diversity Action Plans for Clinical Studies

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each

[[Page 59118]]

proposed collection of information, and to allow 60 days for public 
comment in response to the notice. This notice solicits comments on the 
collections of information related to Diversity Action Plans for 
Clinical Studies.

DATES: Either electronic or written comments on the collection of 
information must be submitted by September 20, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 20, 2024. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2024-N-1298 for ``Diversity Action Plans To Improve Enrollment of 
Participants from Underrepresented Populations in Clinical Studies.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or Office 
of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or 
Office of the Center Director, Guidance and Policy Development, Center 
for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing this notice of the proposed collections 
of information as set forth in the draft guidance for industry 
``Diversity Action Plans To Improve Enrollment of Participants from 
Underrepresented Populations in Clinical Studies.''
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use

[[Page 59119]]

of automated collection techniques, when appropriate, and other forms 
of information technology.

Diversity Action Plans (DAPs) for Clinical Studies

OMB Control No. 0910-NEW

    This information collection supports the implementation of sections 
3601 and 3602 of the Food and Drug Omnibus Reform Act of 2022 (FDORA) 
included as part of the Consolidated Appropriations Act, 2023 (Pub. L. 
117-328). In the Federal Register of June 28, 2024 (89 FR 54010), FDA 
announced the availability of a draft guidance for industry entitled 
``Diversity Action Plans To Improve Enrollment of Participants from 
Underrepresented Populations in Clinical Studies,'' as required under 
FDORA. The guidance is available from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-action-plans-improve-enrollment-participants-underrepresented-populations-clinical-studies. Statutory requirements 
in sections 505(z) and 520(g) of the FD & C Act (21 U.S.C. 355(z) and 
360j(g)) are discussed in the draft guidance document, including the 
content of a DAP (guidance Section V), applicable timelines (guidance 
Section VI), procedures for submitting a DAP and receiving feedback 
(guidance Section VII), and requesting a DAP waiver (guidance Section 
VIII).
    A DAP must include the sponsor's goals for enrollment in the 
clinical study disaggregated by race, ethnicity, sex, and age group of 
clinically relevant study populations, the sponsor's rationale for 
those goals, including sufficient information and analysis to explain 
how the goals were determined, and an explanation of how the sponsor 
intends to meet such goals. The appropriate submission for a medical 
product type (investigational new drug application (IND) for drugs and 
biological products, and investigational device exemptions (IDE), 
premarket notification (510(k)), premarket approval application (PMA), 
and de novo classification request (De Novo) for devices) should 
include a cover letter identifying the submission as a DAP and whether 
the DAP submission is for an initial or a revised plan.
    DAP Waiver Requests should be submitted with a cover letter 
identifying the submission as a Diversity Action Plan--Waiver request. 
The waiver request should also identify the submission number, 
applicable clinical study name or identification number, and a 
justification for the waiver request, including relevant data and 
information. DAP submission and waiver requests should be submitted 
electronically.
    DAP submissions and waiver requests are processed through FDA's 
Center for Drug Evaluation and Research (CDER), Center for Biologics 
Evaluation and Research (CBER), and Center for Devices and Radiological 
Health (CDRH) according to product type.
    We estimate the burden of this collection of information as 
follows:

                              Table 1--Estimated One-Time Recordkeeping Burden \1\
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                                                     Number of
 Review guidance to comply with      Number of     responses per   Total annual   Average burden    Total hours
    FDORA sections 3601/3602        respondents     respondent       responses     per response
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CDER (sec. 505(z)(3) of the FD &             200               1             200               1             200
 C Act).........................
CBER (sec. 505(z)(3) of the FD &              40               1              40               1              40
 C Act).........................
CDRH (sec. 520(g)(9) of the FD &             488               1             488               1             488
 C Act).........................
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    Total.......................  ..............  ..............             728  ..............             728
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\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\
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                                                     Number of
Information collection activity;     Number of     responses per   Total annual   Average burden    Total hours
       statutory authority          respondents     respondent       responses     per response
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CDER DAP Submission--sec.                    146            1.37             200             100          20,000
 505(z)(3) of the FD & C Act....
CBER DAP Submission--sec.                     35            1.14              40             100           4,000
 505(z)(3) of the FD & C Act....
CDRH--sec. 520(g)(9)(A) of the               488               1             488              40          19,520
 FD & C Act.....................
Waiver request CDER--sec.                      4               1               4              16              72
 505(z)(4) of the FD & C Act....
Waiver request CBER--sec.                      1               1               1              16              16
 505(z)(4) of the FD & C Act....
Waiver request CDRH--sec.                      5               1               5              16              80
 520(g)(9)(C) of the FD & C Act.
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    Total.......................  ..............  ..............             738  ..............          43,688
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\1\ There are no operating and maintenance costs associated with this collection of information.

    As reflected in table 2, we assume recurring activities to include 
the preparation, submission, and retention of information consistent 
with statutory requirements and discussed in the draft guidance and, 
therefore, estimate an

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annual recordkeeping burden of 738 responses and 43,688 hours, 
including the submission of DAPs and waiver requests to FDA. We discuss 
these revisions and adjustments with regard to drugs and devices, 
respectively.

A. Section 505(z)(1) of the FD & C Act (21 U.S.C. 355(z)(1))--Drugs and 
Biological Products

    Regulations establishing procedures and requirements governing 
clinical investigations for investigational new drugs and biological 
products are found in part 312 (21 CFR part 312). Specifically, 
regulations in part 312, subpart D, establish responsibilities for 
sponsors and investigators of new drugs, including requirements 
applicable to the investigational plans. Relatedly, regulations in 21 
CFR 312.2(e) and 312.145 provide for the issuance of Agency guidance to 
assist respondents who must comply with part 312 and other requirements 
applicable to the clinical investigation of new drugs and biological 
products. The intent of the current draft guidance is to increase 
enrollment of participants who are members of historically 
underrepresented populations in clinical studies to help improve the 
strength and generalizability of the evidence for the intended use 
population. We have developed and issued other guidance documents also 
intended to enhance the representativeness of clinical trial 
populations and to improve enrollment of participants from 
underrepresented populations in clinical trials.\1\
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    \1\ ``Enhancing the Diversity of Clinical Trial Populations--
Eligibility Criteria, Enrollment Practices, and Trial Designs 
Guidance for Industry,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial.
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    As outlined in Section VII of the guidance, DAPs for drug and 
biological products must be submitted to the IND under which the 
applicable clinical study is to be conducted and, for applicable 
submissions, must be submitted in eCTD format through FDA's Electronic 
Submissions Gateways (ESG and ESG-NextGen). Based on our experience 
with current IND submissions, we estimate receipt of 240 DAPs annually, 
for FDA's drug and biological product programs. We assume an average of 
100 hours are necessary to prepare and submit a DAP.
    As noted in Section VIII of the guidance, the appropriateness of a 
DAP waiver is case-specific and depends on factors relevant to a 
specific development program. Sponsors should submit their DAP waiver 
requests electronically to the applicable IND for consideration by FDA. 
We estimate receipt of 5 waiver requests annually for CDER and CBER 
combined and estimate that each waiver request would require 16 hours 
to prepare and submit.
    Related information collection activities are currently approved 
under OMB control number 0910-0014. We intend to revise the scope of 
the information collection to account for DAP submissions and waiver 
requests and to adjust our estimated burden for the activities in the 
relevant information collection after evaluating DAP submissions 
received.

B. Section 520(g)(9) of the FD & C Act (21 U.S.C. 360j(g))--Devices

    Regulations that govern the clinical investigation of medical 
devices are found in part 812 (21 CFR part 812) (investigational device 
exemptions (IDE)), where regulations in subpart B set forth content 
elements, and 21 CFR 812.20 specifically requires the submission of an 
investigational plan. Consistent with Section VII of the draft 
guidance, a DAP submission should be accompanied by a cover letter and 
submitted as part of the IDE application for clinical studies of 
significant risk devices, or for device studies that require 
development of a Diversity Action Plan but do not require an IDE (see 
Section III of the guidance), the DAP must be submitted as part of a 
510(k), PMA, or De Novo. Currently, CDRH maintains dedicated IT systems 
intended to facilitate the uniform submission of information by 
respondents (CDRH Customer Collaboration Portal, https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-medical-device-premarket-submissions-online-cdrh-portal). Although electronic 
submission is not mandatory for all device submissions, most forms are 
completed and submitted electronically.
    In estimating the burden per response for a DAP submitted to CDRH, 
we considered the differences in requirements for the specific 
development programs (i.e., IDE, IND, PMA, De Novo, and 510(k)) and the 
content and number of clinical studies that may be included in a 
submission. The burden to submit a DAP for a device may vary to the 
extent that submitters have already considered the enrollment of 
participants from underrepresented populations, as recommended in 
existing guidance documents related to improving clinical studies.\2\ 
We assume a range of 16 to 40 hours is necessary to prepare and submit 
a DAP to CDRH. Based on our experience with current submissions, we 
estimate 488 DAP submissions annually.
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    \2\ See e.g., ``Evaluation and Reporting of Age-, Race-, and 
Ethnicity-Specific Data in Medical Device Clinical Studies,'' 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-and-reporting-age-race-and-ethnicity-specific-data-medical-device-clinical-studies, and ``Evaluation of Sex-
Specific Data in Medical Device Clinical Studies,'' https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-sex-specific-data-medical-device-clinical-studies-guidance-industry-and-food-and-drug.
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    Similarly, requests for waivers from any requirement in part 812 
are provided for in Sec.  812.10, and requests for waivers from 
applicable requirements under Sec.  812.28(a)(1) and (b) are provided 
for in Sec.  812.28(c). As discussed in Section VIII of the draft 
guidance, requests to waive the requirement to submit a DAP should be 
submitted electronically as a stand-alone submission for consideration 
by FDA. Further, the appropriateness of a waiver is case-specific and 
depends on factors relevant to a specific development program. We 
assume a range of 8 to 16 hours is necessary to prepare and submit a 
DAP waiver, and we assume 5 DAP waiver requests annually.
    Under section 520(g)(9)(A)(ii) of the FD & C Act, the sponsor of a 
device for which submission of an application for an IDE is not 
required must develop a diversity action plan for any clinical study 
with respect to the device, except for a device being studied as 
described in Sec.  812.2(c). Such diversity action plan must be 
submitted in any 510(k), De Novo, or PMA for such device. Regulations 
that govern 510(k), De Novo, and PMA are found in 21 CFR parts 807 
subpart E, 860 subpart D, and 814 subparts A through E, respectively. 
Related information collection activities are currently approved under 
OMB control numbers 0910-0078 (IDE), 0910-0231 (PMA), 0910-0844 (De 
Novo), and 0910-0120 (510(k)), respectively. We intend to revise the 
scope of the information collections to account for DAP submissions and 
waiver requests. We will adjust our estimated burden in these 
information collections after evaluating the DAP submissions we 
receive.
    The draft guidance also refers to previously approved FDA 
collections of information. The collections of information in 21 CFR 
part 314 relating to new drug marketing applications have been approved 
under OMB control number 0910-0001. The collections of information in 
21 CFR part 601 relating to biological product development and 
marketing applications have been

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approved under OMB control number 0910-0338. The collections of 
information pertaining to submission of a biologics license application 
under section 351(k) of the Public Health Service Act (42 U.S.C. 
262(k)) have been approved under OMB control number 0910-0718. The 
collections of information in 21 CFR part 50 for protection of human 
subjects have been approved under OMB control number 0910-0130. The 
collections of information pertaining to the Q-Submission program for 
medical devices have been approved under OMB control number 0910-0756.

    Dated: July 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15988 Filed 7-19-24; 8:45 am]
BILLING CODE 4164-01-P