Request for Nominations for Voting Members on a Public Advisory Committee; Pharmacy Compounding Advisory Committee, 2179-2180 [2014-00318]
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2179
Federal Register / Vol. 79, No. 8 / Monday, January 13, 2014 / Notices
TABLE 1—COMMITTEE DESCRIPTION, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE NEEDED
Committee areas of expertise needed
Current vacancies
Pharmacy Compounding—Knowledgeable in the fields of pharmaceutical
compounding; pharmaceutical manufacturing; pharmacy, medicine, and related
specialties.
1—Voting .................................................
I. Pharmacy Compounding Drugs
Advisory Committee
The Committee provides advice on
scientific, technical, and medical issues
concerning drug compounding under
sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
353a and 353b), and, as required, any
other product for which FDA has
regulatory responsibility, and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
tkelley on DSK3SPTVN1PROD with NOTICES
II. Criteria for Members
Persons nominated for membership as
consumer representatives on
committees 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) be able to discuss benefits
and risks; and (5) be able to 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 advisory committee;
serve as a liaison between the
committee and interested consumers,
associations, coalitions, and consumer
organizations; and facilitate dialogue
with the advisory 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 consumer advocacy groups.
These organizations recommend
nominees for the Agency’s selection.
Representatives from the consumer
health branches of Federal, State, and
local governments may also participate
in the selection process. Any consumer
organization interested in participating
in the selection of an appropriate voting
member to represent consumer interests
should 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 at
least two qualified nominees selected by
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16:40 Jan 10, 2014
Jkt 232001
the Agency based on the nominations
received, along 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
persons to represent consumer interests
on the Agency’s advisory committees.
Self-nominations are also accepted.
Nominations should include a cover
´
´
letter and a current, complete resume or
curriculum vitae for each nominee,
including a current business address
and/or home address, telephone
number, email address if available, and
a list of consumer- or community-based
organizations for which the candidate
can demonstrate active participation.
Nominations also should specify the
advisory committee for which the
nominee is recommended. In addition,
nominations should include
confirmation that the nominee is aware
of the nomination, is willing to serve as
a member of the advisory committee if
selected, and appears to have no conflict
of interest. FDA will ask potential
candidates to provide detailed
information concerning such matters as
financial holdings, employment, and
research grants and/or contracts in order
to permit evaluation of possible sources
of conflicts of interest. Members will be
invited to serve for terms of up to 4
years.
FDA will review all nominations
received within the specified
timeframes and prepare a ballot
containing the names of qualified
nominees. Names not selected will
remain on a list of eligible nominees
and will 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
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Approximate
date needed
Immediately.
voting consumer representatives will
not participate in the selection process.
Elsewhere in this issue of the Federal
Register, FDA is publishing a notice
requesting nominations for voting
members of the Committee, a notice for
industry organizations to participate in
the nominations for and selection of the
industry representatives for the
Committee, and a final rule updating
information regarding the Committee.
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: January 7, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2014–00319 Filed 1–10–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Pharmacy Compounding
Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for 12 voting members to
serve on the Pharmacy Compounding
Advisory Committee, Center for Drug
Evaluation and Research.
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 on or
before March 14, 2014 will be given first
consideration for membership on the
Pharmacy Compounding Advisory
Committee. Nominations received after
March 14, 2014 will be considered for
nomination to the committee if
nominees are still needed.
SUMMARY:
E:\FR\FM\13JAN1.SGM
13JAN1
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Federal Register / Vol. 79, No. 8 / Monday, January 13, 2014 / Notices
All nominations for
membership should be sent
electronically to cv@oc.fda.gov, or by
mail to Advisory Committee Oversight
and Management Staff, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993–0002.
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:
Jayne E. Peterson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993, 301–796–
9001; FAX: 301–847–8533, email:
PCAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members on the Pharmacy
Compounding Advisory Committee (the
Committee).
ADDRESSES:
I. General Description of the
Committee’s Duties
The Committee provides advice on
scientific, technical, and medical issues
concerning drug compounding under
sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
353a and 353b), and as required, any
other product for which FDA has
regulatory responsibility. The
Committee also makes appropriate
recommendations to the Commissioner
of Food and Drugs.
tkelley on DSK3SPTVN1PROD with NOTICES
II. Criteria for Voting Members
Persons nominated for membership
must have adequately diversified
research and/or experience appropriate
to the work of the Committee in such
fields as pharmaceutical compounding,
pharmaceutical manufacturing,
pharmacy, medicine, and related
specialties. These members will include
representatives from the National
Association of Boards of Pharmacy, the
United States Pharmacopoeia,
pharmacists with current experience
and expertise in compounding,
physicians with background and
knowledge in compounding, and patient
and public health advocacy
organizations.
The specialized training and
experience necessary to qualify the
nominee as an expert suitable for
appointment is subject to review, but
may include experience in medical
practice, pharmacy practice, teaching,
research, and/or public service relevant
to the field of activity of the Committee.
Members will be invited to serve for
terms of up to 4 years.
VerDate Mar<15>2010
16:40 Jan 10, 2014
Jkt 232001
III. Nomination Procedure
Any interested person may nominate
one or more qualified persons for
membership on the Committee. Selfnominations are also accepted.
Nominations should include a cover
´
´
letter and a current, complete resume or
curriculum vitae for each nominee,
including a current business address
and/or home address, telephone
number, and email address if available.
Nominations should also specify the
advisory committee for which the
nominee is recommended. Nominations
should state that the nominee is aware
of the nomination unless selfnominated. Nominations should also
state that the nominee is willing to serve
as a member of the advisory committee
if selected and appears to have no
conflict of interest. FDA will ask
potential candidates to provide detailed
information concerning such matters as
financial holdings, employment, and
research grants and/or contracts in order
to permit evaluation of possible sources
of conflict of interest.
Elsewhere in this issue of the Federal
Register, FDA is publishing a notice for
industry organizations to participate in
the nominations for and selection of
industry representatives for the
Committee, a notice for consumer
organizations to participate in the
nominations for and selection of the
consumer representative for the
Committee, and a final rule updating
information regarding the Committee.
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: January 7, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2014–00318 Filed 1–10–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
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property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neurobiology of Memory
Formation.
Date: January 16, 2014.
Time: 3:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Wei-Qin Zhao, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5181
MSC 7846, Bethesda, MD 20892–7846, 301–
435–1236, zhaow@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Population Sciences
and Epidemiology Integrated Review Group;
Behavioral Genetics and Epidemiology Study
Section.
Date: February 3, 2014.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marines’ Memorial Club and Hotel,
609 Sutter Street, San Francisco, CA 94102.
Contact Person: George Vogler, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3140,
MSC 7770, Bethesda, MD 20892, (301) 237–
2693, voglergp@csr.nih.gov.
Name of Committee: Interdisciplinary
Molecular Sciences and Training Integrated
Review Group; Enabling Bioanalytical and
Imaging Technologies Study Section.
Date: February 5–6, 2014.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Alexandria Old Town, 1767
King Street, Alexandria, VA 22314.
Contact Person: Dennis Hlasta, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6185,
MSC, Bethesda, MD 20892, 301–435–1047,
dennis.hlasta@nih.gov.
Name of Committee: Cell Biology
Integrated Review Group; Cellular
Mechanisms in Aging and Development
Study Section.
Date: February 6–7, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: St. Gregory Hotel, 2033 M Street
NW., Washington, DC 20036.
Contact Person: John Burch, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 3213,
MSC 7808, Bethesda, MD 20892, 301–408–
9519, burchjb@csr.nih.gov.
E:\FR\FM\13JAN1.SGM
13JAN1
Agencies
[Federal Register Volume 79, Number 8 (Monday, January 13, 2014)]
[Notices]
[Pages 2179-2180]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00318]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Request for Nominations for Voting Members on a Public Advisory
Committee; Pharmacy Compounding Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for 12 voting members to serve on the Pharmacy Compounding
Advisory Committee, Center for Drug Evaluation and Research.
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 on or before March 14, 2014 will be given
first consideration for membership on the Pharmacy Compounding Advisory
Committee. Nominations received after March 14, 2014 will be considered
for nomination to the committee if nominees are still needed.
[[Page 2180]]
ADDRESSES: All nominations for membership should be sent electronically
to cv@oc.fda.gov, or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002. 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: Jayne E. Peterson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993, 301-796-
9001; FAX: 301-847-8533, email: PCAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members on the Pharmacy Compounding Advisory Committee (the Committee).
I. General Description of the Committee's Duties
The Committee provides advice on scientific, technical, and medical
issues concerning drug compounding under sections 503A and 503B of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a and 353b), and as
required, any other product for which FDA has regulatory
responsibility. The Committee also makes appropriate recommendations to
the Commissioner of Food and Drugs.
II. Criteria for Voting Members
Persons nominated for membership must have adequately diversified
research and/or experience appropriate to the work of the Committee in
such fields as pharmaceutical compounding, pharmaceutical
manufacturing, pharmacy, medicine, and related specialties. These
members will include representatives from the National Association of
Boards of Pharmacy, the United States Pharmacopoeia, pharmacists with
current experience and expertise in compounding, physicians with
background and knowledge in compounding, and patient and public health
advocacy organizations.
The specialized training and experience necessary to qualify the
nominee as an expert suitable for appointment is subject to review, but
may include experience in medical practice, pharmacy practice,
teaching, research, and/or public service relevant to the field of
activity of the Committee. Members will be invited to serve for terms
of up to 4 years.
III. Nomination Procedure
Any interested person may nominate one or more qualified persons
for membership on the Committee. Self-nominations are also accepted.
Nominations should include a cover letter and a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including a
current business address and/or home address, telephone number, and
email address if available. Nominations should also specify the
advisory committee for which the nominee is recommended. Nominations
should state that the nominee is aware of the nomination unless self-
nominated. Nominations should also state that the nominee is willing to
serve as a member of the advisory committee if selected and appears to
have no conflict of interest. FDA will ask potential candidates to
provide detailed information concerning such matters as financial
holdings, employment, and research grants and/or contracts in order to
permit evaluation of possible sources of conflict of interest.
Elsewhere in this issue of the Federal Register, FDA is publishing
a notice for industry organizations to participate in the nominations
for and selection of industry representatives for the Committee, a
notice for consumer organizations to participate in the nominations for
and selection of the consumer representative for the Committee, and a
final rule updating information regarding the Committee.
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: January 7, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-00318 Filed 1-10-14; 8:45 am]
BILLING CODE 4160-01-P