[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 57004-57005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23522]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3173]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting industry 
organizations interested in participating in the selection of a pool of 
nonvoting industry representatives to serve as temporary nonvoting 
members on the Patient Engagement Advisory Committee (the Committee) 
for the Center for Devices and Radiological Health notify FDA in 
writing. FDA is also requesting nominations for temporary nonvoting 
industry representatives to be included in a pool of individuals to 
serve on the Committee. Nominees recommended to serve as a temporary 
nonvoting industry representative may either be self-nominated or 
nominated by an industry organization. This position may be filled by 
representatives of different medical device areas based on areas of 
expertise relevant to the topics being considered by the Committee. 
Nominations will be accepted for current vacancies 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 industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interest, must send a letter stating that interest to FDA by October 
21, 2015, (see sections I and II of this document for details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by October 21, 2015.

ADDRESSES: All statements of interest from interested industry 
organizations interested in participating in the selection process 
should be sent electronically to Margaret Ames (see FOR FURTHER 
INFORMATION CONTACT). All nominations for nonvoting industry 
representatives 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 on 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: Margaret Ames, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 5234, Silver Spring, MD 20993-0002, 
301-796-5960, FAX: 301-847-8510, [email protected].
    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, [email protected].

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for a pool of 
nonvoting industry representatives for the Committee (this position may 
be filled by representatives of different medical device areas based on 
areas of expertise relevant to the topics being considered by 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 Consumer 
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,

[[Page 57005]]

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. The Commissioner of Food and Drugs (the Commissioner), or 
designee, shall have the authority to select from a group of 
individuals nominated by industry to serve temporarily as nonvoting 
members who are identified with industry interests. The number of 
temporary members selected for a particular meeting will depend on the 
meeting topic(s).

II. Selection Procedure

    Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interest must send a letter stating that interest to the FDA contact 
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of 
this document (see DATES). Within the subsequent 30 days, FDA will send 
a letter to each organization that has expressed an interest, attaching 
a complete list of all such organizations; and a list of all nominees 
along with their current resumes. The letter will also state that it is 
the responsibility of the interested organizations to confer with one 
another and to select a candidate or candidates (to serve in a pool of 
individuals, with varying areas of expertise), to represent industry 
interest for the Committee, within 60 days after the receipt of the FDA 
letter. The interested organizations are not bound by the list of 
nominees in selecting a candidate or candidates. However, if no 
individual is selected within 60 days, the Commissioner will select 
temporary nonvoting members (or pool of individuals) to represent 
industry interests.

III. Nomination Procedure

    Individuals may self nominate and/or an organization may nominate 
one or more individuals to serve as a temporary nonvoting industry 
representative. Nominations should include a cover letter and 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. Nominations should specify the advisory 
committee for which the nominee is recommended within 30 days of 
publication of this document (see DATES). In addition, nominations 
should also acknowledge that the nominee is aware of the nomination, 
unless self-nominated. FDA will forward all nominations to the 
organizations expressing interest in participating in the selection 
process for the Committee. Only interested industry organizations 
participate in the selection process. Persons who nominate themselves 
as nonvoting industry 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. 2015-23522 Filed 9-18-15; 8:45 am]
BILLING CODE 4164-01-P