Request for Nominations for Voting Members for the Patient Engagement Advisory Committee, 57003-57004 [2015-23524]
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Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices
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.
rmajette on DSK7SPTVN1PROD with NOTICES
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-
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15:14 Sep 18, 2015
Jkt 235001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3224]
Request for Nominations for Voting
Members for the Patient Engagement
Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00044
Fmt 4703
Sfmt 4703
57003
The Food and Drug
Administration (FDA) is requesting
nominations for members to serve on
the Patient Engagement Advisory
Committee (the Committee), Office of
the Center Director, Center for Devices
and Radiological Health.
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: Nominations received by
November 20, 2015, will be given first
consideration for membership on the
Committee. Nominations received after
November 20, 2015, will be considered
for nomination to the Committee as later
vacancies occur.
ADDRESSES: All nominations for
membership should be sent
electronically by logging into 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 by 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 https://www.fda.gov/
AdvisoryCommittees/default.htm
FOR FURTHER INFORMATION CONTACT:
Letise Williams, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5441, 301–796–
8398, FAX: 301–847–8510,
Letise.Williams@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members for 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 of
Individuals and Industry Organizations
for the Patient Engagement Advisory
Committee.
3. Request for Nominations of
Individuals and Consumer
Organizations for the Patient
Engagement Advisory Committee.
SUMMARY:
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
E:\FR\FM\21SEN1.SGM
21SEN1
57004
Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices
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,
healthcare 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.
rmajette on DSK7SPTVN1PROD with NOTICES
II. Criteria for Voting Members
The Committee consists of a core of
nine voting members including the
Chair. Members and the Chair are
selected by the Commissioner of Food
and Drugs or designee from among
authorities who are knowledgeable in
areas such as clinical research, primary
care patient experience, healthcare
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. Members will be
invited to serve for overlapping terms of
up to 4 years. Prospective members
should also have an understanding of
the broad spectrum of patients in a
particular disease area. Almost all nonFederal members of this Committee
serve as Special Government
Employees.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the Committee. Selfnominations 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 should
specify the advisory committee for
which the nominee is recommended.
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.
VerDate Sep<11>2014
15:14 Sep 18, 2015
Jkt 235001
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. 2015–23524 Filed 9–18–15; 8:45 am]
BILLING CODE P
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.
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 selfnominated 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.
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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 https://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.
ADDRESSES:
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,
E:\FR\FM\21SEN1.SGM
21SEN1
]]>Agencies
[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 57003-57004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23524]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3224]
Request for Nominations for Voting Members for the Patient
Engagement Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for members to serve on the Patient Engagement Advisory
Committee (the Committee), Office of the Center Director, Center for
Devices and Radiological Health.
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: Nominations received by November 20, 2015, will be given first
consideration for membership on the Committee. Nominations received
after November 20, 2015, will be considered for nomination to the
Committee as later vacancies occur.
ADDRESSES: All nominations for membership should be sent electronically
by logging into 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 by 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 https://www.fda.gov/AdvisoryCommittees/default.htm
FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5441, 301-796-8398, FAX: 301-847-8510,
Letise.Williams@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members for 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 of Individuals and Industry
Organizations 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
[[Page 57004]]
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, healthcare 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 Voting Members
The Committee consists of a core of nine voting members including
the Chair. Members and the Chair are selected by the Commissioner of
Food and Drugs or designee from among authorities who are knowledgeable
in areas such as clinical research, primary care patient experience,
healthcare 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. Members will be invited to serve for
overlapping terms of up to 4 years. Prospective members should also
have an understanding of the broad spectrum of patients in a particular
disease area. Almost all non-Federal members of this Committee serve as
Special Government Employees.
III. Nomination Procedures
Any interested person may nominate one or more qualified
individuals for membership 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 should specify the advisory committee for
which the nominee is recommended. 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.
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. 2015-23524 Filed 9-18-15; 8:45 am]
BILLING CODE P
