Request for Nominations of Individuals and Industry Organizations for the Patient Engagement Advisory Committee, 57004-57005 [2015-23522]
Download as PDF
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
Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices
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.
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.
rmajette on DSK7SPTVN1PROD with NOTICES
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).
[FR Doc. 2015–23522 Filed 9–18–15; 8:45 am]
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
VerDate Sep<11>2014
15:14 Sep 18, 2015
Jkt 235001
Dated: September 15, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Vaccines and
Related Biological Products Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on November 13, 2015, from 8:45
a.m. to 4 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD, 20993–0002.
For those unable to attend in person, the
meeting will also be Webcast and will
be available at the following link
https://collaboration.fda.gov/
vrbpac1115/. Answers to commonly
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
57005
asked questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Sujata Vijh or Denise
Royster, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 6128, Silver Spring,
MD 20993–0002, 240–402–7107 or 240–
402–8158, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). A notice in the Federal Register
about last minute modifications that
impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s Web
site at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: On November 13, 2015, the
committee will meet in open session to
discuss considerations for evaluation of
the safety and effectiveness of vaccines
administered to pregnant women to
protect the infant. FDA intends to make
background material available to the
public no later than 2 business days
before the meeting. If FDA is unable to
post the background material on its Web
site prior to the meeting, the background
material will be made publicly available
at the location of the advisory
committee meeting, and the background
material will be posted on FDA’s Web
site after the meeting. Background
material is available at https://
www.fda.gov/AdvisoryCommittees/
Calendar/default.htm. Scroll down to
the appropriate advisory committee
meeting link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 29, 2015.
Oral presentations from the public will
be scheduled between approximately
10:45 a.m. to 11:45 a.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
E:\FR\FM\21SEN1.SGM
21SEN1
Agencies
[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 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.
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