Request for Nominations of Individuals and Consumer Organizations for the Patient Engagement Advisory Committee, 57002-57003 [2015-23523]
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Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices
Identify comments with the docket
number found in brackets in the
heading of this document. The
guidances, notices, and received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
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approval expires on August 31, 2018. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: September 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
V. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
[FR Doc. 2015–23566 Filed 9–18–15; 8:45 am]
Dated: September 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[Docket No. FDA–2015–N–3224]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Request for Nominations of Individuals
and Consumer Organizations for the
Patient Engagement Advisory
Committee
[FR Doc. 2015–23571 Filed 9–18–15; 8:45 am]
BILLING CODE 4164–01–P
AGENCY:
Food and Drug Administration,
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Food and Drug Administration
SUMMARY:
[Docket No. FDA–2009–N–0025]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Animal Food Labeling; Declaration of
Certifiable Color Additives
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Animal Food Labeling; Declaration of
Certifiable Color Additives’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On July
16, 2015, the Agency submitted a
proposed collection of information
entitled ‘‘Animal Food Labeling;
Declaration of Certifiable Color
Additives’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
rmajette on DSK7SPTVN1PROD with NOTICES
SUMMARY:
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15:14 Sep 18, 2015
Jkt 235001
Notice.
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 selfnominated 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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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
https://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
E:\FR\FM\21SEN1.SGM
21SEN1
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
]]>Agencies
[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 https://
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
