[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 57002-57003]
[FR Doc No: 2015-23523]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3224]

Request for Nominations of Individuals and Consumer Organizations
for the Patient Engagement Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting that any
consumer organizations interested in participating in the selection of
a voting consumer representative to serve on the Patient Engagement
Advisory Committee (the Committee) notify FDA in writing. FDA is also
requesting nominations for a voting consumer representative to serve on
the Committee. Nominees recommended to serve as a voting consumer
representative may either be self-nominated or may be nominated by a
consumer organization. Nominations will be accepted for the current
vacancy effective with this notice.
    FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore encourages nominations of
appropriately qualified candidates from these groups.

DATES: Any consumer organization interested in participating in the
selection of an appropriate voting member to represent consumer
interests on the Committee may send a letter or email stating that
interest to FDA by October 21, 2015. Concurrently, nomination materials
for prospective candidates should be sent to FDA by October 21, 2015.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process should be sent
electronically to Kimberly Hamilton (see FOR FURTHER INFORMATION
CONTACT). All Consumer Representative nominations may be submitted
electronically by accessing the FDA Advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, by mail to Advisory Committee Oversight and
Management Staff, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, or FAX: 301-
847-8640. Information about becoming a member of an FDA advisory
committee can also be obtained by visiting FDA's Web site at http://
www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: For questions relating to
participation in the selection process: Kimberly Hamilton, Advisory
Committee Oversight and Management Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 5117, Silver Spring, MD 20993-
0002,<PHONE_NUMBER><EMAIL_ADDRESS>    For questions relating to the Committee: Letise Williams, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993-
0002,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for a voting
consumer representative on the Committee.
    Elsewhere in this issue of the Federal Register, FDA is publishing
separate documents regarding:
    1. Patient Engagement Advisory Committee; Notice of Establishment.
    2. Request for Nominations for Voting Members for the Patient
Engagement Advisory Committee.
    3. Request for Nominations of Individuals and Industry
Organizations for the Patient Engagement Advisory Committee.

I. General Description of the Committee's Duties

    The Committee provides advice on complex issues relating to medical
devices, the regulation of devices, and their use by patients. Agency
guidance and policies, clinical trial or registry design, patient
preference study design, benefit-risk determinations, device labeling,
unmet clinical needs, available alternatives, patient reported outcomes
and device-related quality of life or health status issues are among
the topics that may be considered by the Committee. Members are
knowledgeable in areas such as clinical research, primary care patient
experience, health care needs of patient groups in the

United States, or are experienced in the work of patient and health
professional organizations, methodologies for eliciting patient
preferences, and strategies for communicating benefits, risks, and
clinical outcomes to patients and research subjects.

II. Criteria for Members

    Persons nominated for membership as a consumer representative on
this Committee should meet the following criteria: (1) Demonstrate ties
to consumer and community-based organizations, (2) be able to analyze
technical data, (3) understand research design, (4) discuss benefits
and risks, and (5) evaluate the safety and efficacy of products under
review. The consumer representative should be able to represent the
consumer perspective on issues and actions before the Committee; serve
as a liaison between the Committee and interested consumers,
associations, coalitions, and consumer organizations; and facilitate
dialogue with the Committees on scientific issues that affect
consumers.

III. Selection Procedures

    Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
member to represent consumer interests must send a letter stating that
interest to FDA (see ADDRESSES) within 30 days of publication of this
document.
    Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing three to five
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
resume. Ballots are to be filled out and returned to FDA within 30
days. The nominee receiving the highest number of votes ordinarily will
be selected to serve as the member representing consumer interests for
that particular advisory committee.

IV. Nomination Procedures

    Any interested person or organization may nominate one or more
qualified individuals to represent consumer interests on the Committee.
Self-nominations are also accepted. Nominations should include a cover
letter; a current, complete resume or curriculum vitae for each
nominee, including a current business and/or home address, telephone
number, and email address if available; and a list of consumer or
community-based organizations for which the candidate can demonstrate
active participation. Nominations should also specify the advisory
committee for which the nominee is recommended. In addition,
nominations should also acknowledge that the nominee is aware of the
nomination, unless self-nominated. FDA will ask potential candidates to
provide detailed information concerning such matters related to
financial holdings, employment, and research grants and/or contracts to
permit evaluation of possible sources of conflicts of interest. Members
will be invited to serve for terms up to 4 years.
    FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of three to five
qualified nominees. Names not selected will remain on a list of
eligible nominees and be reviewed periodically by FDA to determine
continued interest. Upon selecting qualified nominees for the ballot,
FDA will provide those consumer organizations that are participating in
the selection process with the opportunity to vote on the listed
nominees. Only organizations vote in the selection process. Persons who
nominate themselves to serve as voting consumer representatives will
not participate in the selection process.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: September 15, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-23523 Filed 9-18-15; 8:45 am]
BILLING CODE 4164-01-P