[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)
[[Page 490]]
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.
[[Page 491]]
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