[Federal Register Volume 88, Number 162 (Wednesday, August 23, 2023)]
[Notices]
[Pages 57462-57464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18149]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2462]


Workshop To Enhance Clinical Study Diversity; Public Workshop; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing a public workshop entitled ``Workshop To Enhance Clinical 
Study Diversity.'' This public workshop will satisfy a mandate of the 
Food and Drug Omnibus Reform Act of 2022 (FDORA) for FDA to convene one 
or more public workshops to solicit input from various stakeholders on 
enhancing diversity in clinical studies.The public workshop will be 
convened and supported by a cooperative agreement between FDA and the 
Clinical Trials Transformation Initiative and will solicit input from 
interested parties on increasing the enrollment of historically 
underrepresented populations in clinical studies and encouraging 
clinical study participation that reflects the prevalence or incidence 
of the disease or condition among demographic subgroups, where 
appropriate.

DATES: The public workshop will be held virtually on November 29, 2023, 
from 10 a.m. to 2 p.m., Eastern Time and November 30, 2023, from 10 
a.m. to 2 p.m., Eastern Time. Following the workshop, a public comment 
period will be established to receive comments related to the topics 
addressed during the public workshop. Either electronic or written 
comments on this public workshop must be submitted by January 29, 2024. 
See the SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public workshop will be held virtually using the Zoom 
platform. The link for the public workshop will be sent to registrants 
upon registration.
    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 on January 29, 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-2023-N-2462 for ``Workshop To Enhance Clinical Study Diversity.'' 
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.

FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 3334, Silver Spring, MD 20993, 240-402-8962, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 3603 of the FDORA requires FDA to convene one or more 
public workshops to solicit input from various stakeholders on 
increasing diversity in clinical studies. To meet the FDORA 
requirement, FDA will convene a workshop with key participants, 
including drug and device sponsors, clinical research organizations, 
academia, patients and patient advocates, study site investigators, and 
the public, to gather input on how to enhance clinical study diversity 
by discussing ways to (1) increase enrollment of historically 
underrepresented populations in clinical studies and (2) encourage 
clinical study participation that reflects the prevalence of the 
disease or condition among demographic subgroups, where appropriate. 
The public workshop scheduled for November 29, 2023, and November 30, 
2023, will fulfill the requirement to convene a public workshop no 
later than 1 year after the date of the enactment of FDORA.

II. Topics for Discussion at the Public Workshop

    At the public workshop, FDA plans to solicit input from 
participants on increasing the enrollment of historically 
underrepresented populations in clinical studies and encouraging 
clinical study participation that reflects disease prevalence or 
incidence data, including but not limited to:
    1. The collection and presentation of disease prevalence and 
incidence data by demographic group.

[[Page 57464]]

    2. The dissemination of information to the public on clinical study 
enrollment demographic data.
    3. The establishment of goals for clinical study enrollment, 
including the relevance of disease prevalence and incidence.
    4. The approaches to include underrepresented populations and 
encourage participation that reflects the population expected to use 
the drug or device, if approved, including:
    A. The establishment of inclusion and exclusion criteria for 
certain subgroups, such as pregnant and lactating women and individuals 
with disabilities, including intellectual or developmental disabilities 
or mental illness.
    B. The considerations regarding informed consent with respect to 
individuals with intellectual or developmental disabilities or mental 
illness, including ethical and scientific considerations.
    C. The appropriate use of decentralized trials or digital health 
tools, clinical endpoints, biomarker selection, and studying analysis.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website: https://duke.zoom.us/meeting/register/tJcrceuhqjgvE9zGjDNOURONoJZvxrpK4Rvi#/registration. Please provide 
complete contact information for each attendee, including name, title, 
affiliation, address, email, and telephone.
    Registration is free, and persons interested in attending this 
public workshop must register to receive a link to the meeting. 
Registrants will receive a confirmation email after they register.
    If you need special accommodations due to a disability, please 
contact Sabrena Mervin-Blake, 919-724-0715, [email protected] no later than November 15, 2023. Please note, closed 
captioning and American Sign Language will be available automatically.

    Dated: August 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18149 Filed 8-22-23; 8:45 am]
BILLING CODE 4164-01-P