Notice2023-18149
Workshop To Enhance Clinical Study Diversity; Public Workshop; Request for Comments
Primary source
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Published
August 23, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 162 (Wednesday, August 23, 2023)</title>
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[Federal Register Volume 88, Number 162 (Wednesday, August 23, 2023)]
[Notices]
[Pages 57462-57464]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet<ls-thn-eq> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#a3e7c2d78de7ccc2cde3c5c7c28dcbcbd08dc4ccd5"><span class="__cf_email__" data-cfemail="8cc8edf8a2c8e3ede2cceae8eda2e4e4ffa2ebe3fa">[email protected]</span></a>.
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.
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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: <a href="https://duke.zoom.us/meeting/register/tJcrceuhqjgvE9zGjDNOURONoJZvxrpK4Rvi#/registration">https://duke.zoom.us/meeting/register/tJcrceuhqjgvE9zGjDNOURONoJZvxrpK4Rvi#/registration</a>. 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, <a href="/cdn-cgi/l/email-protection#cdbeacafbfa8a3ace3a0a8bfbba4a3e0afa1aca6a88da9b8a6a8e3a8a9b8"><span class="__cf_email__" data-cfemail="6615070414030807480b0314100f084b040a070d032602130d0348030213">[email protected]</span></a> 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
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