[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Notices]
[Pages 66909-66910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27728]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3805]
Clinical Trials--Assessing Safety and Efficacy for Diverse
Populations; Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA), in collaboration with
the Johns Hopkins Center of Excellence in Regulatory Science and
Innovation, is announcing a public workshop entitled ``Clinical
Trials--Assessing Safety and Efficacy in Diverse Populations.'' The
purpose of the meeting is to discuss approaches in clinical trial
design and subgroup analyses for therapeutic product development and
life-cycle management.
DATES: The meeting will be held on December 2, 2015, from 9 a.m. to 5
p.m.
ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993-0002. Entrance for the public meeting
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2015-N-3805 for Clinical Trials--Assessing Safety and Efficacy for
Diverse Populations; Public Meeting; Request for Comments. Received
[[Page 66910]]
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Martin Mendoza, Office of Minority
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 2306, Silver Spring, MD 20993-0002, [email protected].
SUPPLEMENTARY INFORMATION: The purpose of this public workshop is to
facilitate a unique opportunity for relevant stakeholders, including
industry, academia, patients, and FDA, to discuss the importance of
diversity in medical research and the incorporation of participant
diversity in the design, analysis, and regulation of medical
interventions. Medical interventions may have different benefits and
harms for subgroups within a population. If clinical trials do not
include an adequate number of participants who are representative of
people likely to use an approved intervention, then the average results
of clinical trials might not be replicated in practice. Even if
clinical trials include representative participants, important subgroup
differences might not be detectable if their representation is not
adequate. For these reasons, regulators might use a combination of
information from clinical trials and other data sources to address
questions about heterogeneity across large and diverse populations. The
use of data from patients in their usual care setting (``real-world''
data) may be particularly valuable for understanding this
heterogeneity.
Agenda: The agenda is located at: http://www.jhsph.edu/research/centers-and-institutes/center-of-excellence-in-regulatory-science-and-innovation/news-and-events/clinical-trials-assessing-safety-and-efficacy-for-diverse-population.html. (FDA has verified the Web site
addresses throughout this notice, but FDA is not responsible for
subsequent changes to the Web sites after this document publishes in
the Federal Register).
Registration: There is no registration fee to attend this meeting.
Seats are limited, and registration will be on a first-come, first-
served basis. To register, please complete registration online at
http://www.surveymonkey.com/r/ClinicalTrialsWorkshop120215. (FDA has
verified the Web address, but FDA is not responsible for subsequent
changes to the Web site after this document publishes in the Federal
Register.)
Accommodations: Attendees are responsible for their own hotel
accommodations. If you need special accommodations due to a disability,
please contact Jill Zung at [email protected] at least 7 days in
advance.
Dated: October 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27728 Filed 10-29-15; 8:45 am]
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