[Federal Register Volume 81, Number 3 (Wednesday, January 6, 2016)]
[Notices]
[Pages 489-491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-33261]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-4952]


Food and Drug Administration Safety and Innovation Act 907 Public 
Meeting: Progress on Enhancing the Collection, Analysis, and 
Availability of Demographic Subgroup Data; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Office of 
Minority Health (OMH), Office of Women's Health (OWH), the Center for 
Biologics Evaluation and Research (CBER), the Center for Drug 
Evaluation and Research (CDER), and the Center for Devices and 
Radiological Health (CDRH)

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are announcing a public meeting seeking feedback and recommendations 
from patient groups, consumer groups, regulated industry, academia, and 
other interested parties on FDA's progress in implementing the ``Action 
Plan to Enhance the Collection and Availability of Demographic Subgroup 
Data,'' required under the Food and Drug Administration Safety and 
Innovation Act (FDASIA).

DATES: The public meeting will be held on February 29, 2016, from 9 
a.m. to 4 p.m. The deadline for submitting comments regarding this 
meeting is April 29, 2016.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room 
(B & C), 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-4952 for ``FDASIA 907 Public Meeting: Progress on Enhancing 
the Collection, Analysis, and Availability of Demographic Subgroup 
Data; Request for Comments.'' Received 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.
    FDA will post the full agenda approximately 5 days before the 
meeting at: http://www.fda.gov/ForHealthProfessionals/LearningActivities/ucm470074.htm.

FOR FURTHER INFORMATION CONTACT: Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993-0002, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the President signed FDASIA (Pub. L. 112-144) into 
law. Section 907 of FDASIA directed FDA to publish and provide to 
Congress a report ``addressing the extent to which clinical trial 
participation and the inclusion of safety and effectiveness data by 
demographic subgroups, including sex, age, race, and ethnicity, is 
included in applications submitted to the Food and Drug 
Administration.'' Section 907 of FDASIA also directed that 1 year after 
the publication of the report FDA publish and provide to Congress an 
action plan outlining ``recommendations for improving the completeness 
and quality of analyses of data on demographic subgroups in summaries 
of product safety and effectiveness data and in labeling; on the 
inclusion of such data, or the lack of availability of such data, in 
labeling; and on improving the public availability of such data to 
patients, healthcare providers, and researchers'' and to indicate the 
applicability of these recommendations to the types of medical products 
addressed in section 907. To fulfill these directives, an FDA-wide 
steering committee with representatives from CBER, CDER, CDRH, and the 
Office of the Commissioner (OC) conducted a detailed assessment of the 
72 new drug, biologic, and medical device applications the Agency 
approved in 2011. In August 2013, FDA issued a report on the group's 
findings entitled ``Collection, Analysis, and Availability of 
Demographic Subgroup Data for FDA-Approved Medical Products.'' In 
August 2014, FDA followed up with a report entitled ``FDA Action Plan 
to Enhance the Collection and Availability of Demographic Subgroup 
Data,'' which contained 27 action items divided up into three 
overriding priorities: Data quality, subgroup participation, and data 
transparency.

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    The purpose of the public meeting is to report on FDA's progress 
implementing the Action Plan, to discuss how stakeholders have been 
affected by these changes, and to solicit feedback and recommendations 
for further implementation from interested parties and stakeholders.
    Some questions we would like the public to comment on during the 
meeting include:
    1. What approaches have been successful in addressing key barriers 
to recruiting diverse clinical trial populations?
    2. What are your key limitations to conducting meaningful data 
analysis of underrepresented groups?
    3. What have you learned about best practices for recruiting a 
broad representation of subjects for clinical trials? Which practices 
have been successful and why? Which have not and why?
    4. What communication strategies have you successfully used that 
were also sensitive to the needs of underrepresented populations?
    5. What are potential methods FDA should consider using to 
effectively communicate meaningful information on demographic analyses 
to a diverse public?
    6. What are some of the actual or potential unintended consequences 
of data transparency you have encountered related to reporting 
demographic subgroup analysis?
    Stakeholders are invited to provide brief comments on these topics 
during the public comment portion of the meeting, but are not limited 
to discussing only the previous topics. Since the day-long meeting may 
not provide enough time to fully address all of these issues, we 
encourage interested groups to submit longer explanations and comments 
to the docket.

II. Registration and Request for Oral Presentations

    FDA will try to accommodate all participant requests to speak; 
however, the duration of comments may be limited by time constraints. 
Those wishing to make oral presentations will be asked to send a brief 
summary of their comments and registration information (including name, 
title, firm name, address, telephone, email address, and fax number), 
and should register by February 1, 2016, by emailing 
[email protected].
    All other participants are asked to register online at: http://www.fda.gov/ForHealthProfessionals/LearningActivities/ucm470074.htm by 
February 13, 2016, whether they plan to attend in person or listen to 
the meeting on a live Webcast. Registration is free and will be on a 
first-come, first-served basis. Onsite registration on the day of the 
meeting will be based on space availability. Information on how to 
access the Webcast will be posted approximately 5 days before the 
meeting at: http://www.fda.gov/ForHealthProfessionals/LearningActivities/ucm470074.htm.
    If you need special accommodations due to a disability, please 
contact [email protected] at least 7 days in advance. Persons 
attending the public meeting are advised that FDA is not responsible 
for providing access to electrical outlets.

    Dated: December 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-33261 Filed 1-5-16; 8:45 am]
 BILLING CODE 4164-01-P