80 FR 57004 - Request for Nominations of Individuals and Industry Organizations for the Patient Engagement Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 182 (September 21, 2015)

Page Range		57004-57005
FR Document		2015-23522

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.

Federal Register, Volume 80 Issue 182 (Monday, September 21, 2015)

[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 57004-57005]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-23522]

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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.

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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, margaret.ames@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 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

57004 Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices

and policies, clinical trial or registry This notice is issued under the ADDRESSES: All statements of interest
design, patient preference study design, Federal Advisory Committee Act (5 from interested industry organizations
benefit-risk determinations, device U.S.C. app. 2) and 21 CFR part 14, interested in participating in the
labeling, unmet clinical needs, available relating to advisory committees. selection process should be sent
alternatives, patient reported outcomes Dated: September 15, 2015. electronically to Margaret Ames (see FOR
and device-related quality of life or Jill Hartzler Warner, FURTHER INFORMATION CONTACT). All
health status issues are among the topics nominations for nonvoting industry
Associate Commissioner for Special Medical
that may be considered by the Programs. representatives may be submitted
Committee. Members are knowledgeable electronically by accessing the FDA
[FR Doc. 2015–23524 Filed 9–18–15; 8:45 am]
in areas such as clinical research, Advisory Committee Membership
BILLING CODE P
primary care patient experience, Nomination Portal: https://
healthcare needs of patient groups in www.accessdata.fda.gov/scripts/
the United States, or are experienced in DEPARTMENT OF HEALTH AND FACTRSPortal/FACTRS/index.cfm, by
the work of patient and health HUMAN SERVICES mail to Advisory Committee Oversight
professional organizations, and Management Staff, Food and Drug
methodologies for eliciting patient Food and Drug Administration Administration, 10903 New Hampshire
preferences, and strategies for Ave., Bldg. 32, Rm. 5103, Silver Spring,
communicating benefits, risks, and [Docket No. FDA–2015–N–3173]
MD 20993–0002, or FAX: 301–847–
clinical outcomes to patients and 8640. Information about becoming a
Request for Nominations of Individuals
research subjects. member on an FDA advisory committee
and Industry Organizations for the
II. Criteria for Voting Members Patient Engagement Advisory can also be obtained by visiting FDA’s
Committee Web site at http://www.fda.gov/
The Committee consists of a core of AdvisoryCommittees/default.htm.
nine voting members including the AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: For
Chair. Members and the Chair are HHS.
selected by the Commissioner of Food questions relating to participation in the
ACTION: Notice. selection process: Margaret Ames,
and Drugs or designee from among
authorities who are knowledgeable in SUMMARY: The Food and Drug Center for Devices and Radiological
areas such as clinical research, primary Administration (FDA) is requesting Health, Food and Drug Administration,
care patient experience, healthcare industry organizations interested in 10903 New Hampshire Ave., Bldg. 66,
needs of patient groups in the United participating in the selection of a pool Rm. 5234, Silver Spring, MD 20993–
States, or are experienced in the work of of nonvoting industry representatives to 0002, 301–796–5960, FAX: 301–847–
patient and health professional serve as temporary nonvoting members 8510, margaret.ames@fda.hhs.gov.
organizations, methodologies for on the Patient Engagement Advisory For questions relating to the
eliciting patient preferences, and Committee (the Committee) for the Committee: Letise Williams, Center for
strategies for communicating benefits, Center for Devices and Radiological Devices and Radiological Health, Food
risks, and clinical outcomes to patients Health notify FDA in writing. FDA is and Drug Administration, 10903 New
and research subjects. Members will be also requesting nominations for Hampshire Ave., Bldg. 66, Rm. 5441,
invited to serve for overlapping terms of temporary nonvoting industry Silver Spring, MD 20993–0002, 301–
up to 4 years. Prospective members representatives to be included in a pool 796–8398, letise.williams@fda.hhs.gov.
should also have an understanding of of individuals to serve on the SUPPLEMENTARY INFORMATION: FDA is
the broad spectrum of patients in a Committee. Nominees recommended to requesting nominations for a pool of
particular disease area. Almost all non- serve as a temporary nonvoting industry nonvoting industry representatives for
Federal members of this Committee representative may either be self- the Committee (this position may be
serve as Special Government nominated or nominated by an industry filled by representatives of different
Employees. organization. This position may be filled medical device areas based on areas of
by representatives of different medical expertise relevant to the topics being
III. Nomination Procedures device areas based on areas of expertise considered by the Committee).
Any interested person may nominate relevant to the topics being considered Elsewhere in this issue of the Federal
one or more qualified individuals for by the Committee. Nominations will be Register, FDA is publishing separate
membership on the Committee. Self- accepted for current vacancies effective documents regarding:
nominations are also accepted. with this notice. 1. Patient Engagement Advisory
Nominations should include a cover FDA seeks to include the views of Committee; Notice of Establishment.
letter; a current, complete resume or women and men, members of all racial 2. Request for Nominations for Voting
curriculum vitae for each nominee, and ethnic groups, and individuals with Members for the Patient Engagement
including a current business and/or and without disabilities on its advisory Advisory Committee.
home address, telephone number, and committees and, therefore encourages 3. Request for Nominations of
email address if available; and should nominations of appropriately qualified Individuals and Consumer
specify the advisory committee for candidates from these groups. Organizations for the Patient
which the nominee is recommended. DATES: Any industry organization Engagement Advisory Committee.
Nominations should also acknowledge interested in participating in the
that the nominee is aware of the selection of an appropriate nonvoting I. General Description of the
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nomination, unless self-nominated. FDA member to represent industry interest, Committee’s Duties
will ask potential candidates to provide must send a letter stating that interest to The Committee provides advice on
detailed information concerning such FDA by October 21, 2015, (see sections complex issues relating to medical
matters related to financial holdings, I and II of this document for details). devices, the regulation of devices, and
employment, and research grants and/or Concurrently, nomination materials for their use by patients. Agency guidance
contracts to permit evaluation of prospective candidates should be sent to and policies, clinical trial or registry
possible sources of conflicts of interest. FDA by October 21, 2015. design, patient preference study design,

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Document Created: 2015-12-15 09:38:34
Document Modified: 2015-12-15 09:38:34

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
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]
FR Citation		80 FR 57004

80 FR 57004 - Request for Nominations of Individuals and Industry Organizations for the Patient Engagement Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 182 (September 21, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration