
[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, Martin.Mendoza@fda.hhs.gov.

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 Jill.Zung@fda.hhs.gov 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]
BILLING CODE 4164-01-P


