Document ID: FDA-2015-N-3224-0002
Agency: fda
Document Type: Notice
Title: Request for Nominations of Individuals and Consumer Organizations for the Patient Engagement Advisory Committee
Posted Date: 2015-09-21T04:00Z

[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 57002-57003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23523]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, 301-796-6319, kimberly.hamilton@fda.hhs.gov.
    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, 301-796-8398, letise.williams@fda.hhs.gov.

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

[[Page 57003]]

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