Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee, 61083-61084 [2014-24074]
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Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / Notices
Mendrick at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Date: September 30, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2014–24039 Filed 10–8–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
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: Oncologic Drugs
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 6, 2014, from 8 a.m.
to 5 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.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Caleb Briggs, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31 Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, email:
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17:56 Oct 08, 2014
Jkt 235001
ODAC@fda.hhs.gov, 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: During the morning session,
the committee will discuss new drug
application (NDA) 205353, panobinostat
capsules, application submitted by
Novartis Pharmaceuticals Corporation.
The proposed indication (use) for this
product is in combination with
bortezomib and dexamethasone, for the
treatment of patients with multiple
myeloma who have received at least one
prior therapy.
During the afternoon session, the
committee will discuss NDA 206317,
ferric pyrophosphate solution, for
administration via hemodialysis
dialysate, application submitted by
Rockwell Medical, Inc. The proposed
indications (uses) for this product are
for the treatment of iron loss or iron
deficiency to maintain hemoglobin in
adult patients with hemodialysisdependent stage 5 chronic kidney
disease and to reduce the prescribed
dose of erythropoiesis stimulating agent
required to maintain desired
hemoglobin levels.
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 23, 2014.
Oral presentations from the public will
be scheduled between approximately
10:30 a.m. to 11 a.m., and 3:30 p.m. to
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61083
4 p.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
requested to make their presentation on
or before October 15, 2014. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
October 16, 2014.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Caleb Briggs
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
September 30, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2014–24038 Filed 10–8–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0394]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Tobacco Products
Scientific Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\09OCN1.SGM
Notice.
09OCN1
61084
Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / Notices
The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Tobacco Products Scientific
Advisory Committee, Office of Science,
Center for Tobacco Products.
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 December 8, 2014 will be given
first consideration for membership on
the Tobacco Products Scientific
Advisory Committee. Nominations
received after December 8, 2014 will be
considered for nomination to the
committee as later vacancies occur.
ADDRESSES: All nominations for
membership should be submitted
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 to 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:
Regarding all nomination questions for
membership, the primary contact is:
Caryn Cohen, Office of Science, Center
for Tobacco Products, Center for
Tobacco Products Document Control
Center, Food and Drug Administration,
10903 New Hampshire Avenue, Bldg.
71, rm. G335, Silver Spring, MD 20993–
0002, 1–877–287–1373 (choose Option
5), FAX: 240–276–3655, email:
TPSAC@fda.hhs.gov.:
SUMMARY:
FDA is
requesting nominations for voting
members on the Tobacco Products
Scientific Advisory Committee.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
I. General Description of the Committee
Duties
The Tobacco Products Scientific
Advisory Committee (the Committee)
advises the Commissioner of Food and
Drugs (the Commissioner) or designee in
discharging responsibilities related to
the regulation of tobacco products. The
Committee reviews and evaluates safety,
dependence, and health issues relating
to tobacco products and provides
VerDate Sep<11>2014
17:56 Oct 08, 2014
Jkt 235001
appropriate advice, information, and
recommendations to the Commissioner.
II. Criteria for Voting Members
The Committee consists of 12
members including the Chair. Members
and the Chair are selected by the
Commissioner or designee from among
individuals knowledgeable in the fields
of medicine, medical ethics, science, or
technology involving the manufacture,
evaluation, or use of tobacco products.
Members are invited to serve for
overlapping terms of up to 4 years.
Almost all non-Federal members of this
committee serve as Special Government
Employees. The Committee includes
nine technically qualified voting
members, selected by the Commissioner
or designee. The nine voting members
include seven members who are
physicians, dentists, scientists, or health
care professionals practicing in the area
of oncology, pulmonology, cardiology,
toxicology, pharmacology, addiction, or
any other relevant specialty. The nine
voting members also include one
member who is an officer or employee
of a state or local government or of the
Federal Government, and one member
who is a representative of the general
public.
In addition to the voting members, the
Committee includes three nonvoting
members who are identified with
industry interests. These members
include one representative of the
interests of the tobacco manufacturing
industry, one representative of the
interests of tobacco growers, and one
representative of the interests of the
small business tobacco manufacturing
industry, which position may be filled
on a rotating, sequential basis by
representatives of different small
business tobacco manufacturers based
on areas of expertise relevant to the
topics being considered by the
Committee.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the Committee. Selfnominations are also accepted.
Nominations must include a current,
´
´
complete resume or curriculum vitae for
each nominee, including current
business address and/or home address,
telephone number, and email address if
available. Nominations must also
specify the advisory committee for
which the nominee is recommended.
Nominations must 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 as financial holdings,
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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: October 3, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2014–24074 Filed 10–8–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Policy on Conferring With Urban Indian
Organizations; Correction
Indian Health Service, HHS.
Notice; correction.
AGENCY:
ACTION:
The Indian Health Service is
issuing this Notice to correct the
effective date from October 29, 2014 to
September 22, 2014 for the final Policy
for Conferring with Urban Indian
Organizations. The notice published at
79 FR 58359, September 29, 2014.
FOR FURTHER INFORMATION CONTACT:
Office of Management Services,
Management Policy and Internal Control
Staff, Indian Health Service, 801
Thompson Avenue, Suite 625A,
Rockville, MD 20852, Telephone (301)
443–2650. (This is not a toll-free
number.)
SUMMARY:
Correction
In the Federal Register of September
29, 2014, in FR Doc. 2014–23005, on
page 58359, in the third column,
following DATES the correct date should
read as follows:
This Policy is effective September 22,
2014.
Dated: October 3, 2014.
Yvette Roubideaux,
Acting Director, Indian Health Service.
[FR Doc. 2014–24154 Filed 10–8–14; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
E:\FR\FM\09OCN1.SGM
09OCN1
]]>Agencies
[Federal Register Volume 79, Number 196 (Thursday, October 9, 2014)]
[Notices]
[Pages 61083-61084]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24074]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0394]
Request for Nominations for Voting Members on a Public Advisory
Committee; Tobacco Products Scientific Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 61084]]
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Tobacco Products
Scientific Advisory Committee, Office of Science, Center for Tobacco
Products.
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 December 8, 2014 will be given
first consideration for membership on the Tobacco Products Scientific
Advisory Committee. Nominations received after December 8, 2014 will be
considered for nomination to the committee as later vacancies occur.
ADDRESSES: All nominations for membership should be submitted
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 to
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: Regarding all nomination questions for
membership, the primary contact is: Caryn Cohen, Office of Science,
Center for Tobacco Products, Center for Tobacco Products Document
Control Center, Food and Drug Administration, 10903 New Hampshire
Avenue, Bldg. 71, rm. G335, Silver Spring, MD 20993-0002, 1-877-287-
1373 (choose Option 5), FAX: 240-276-3655, email: TPSAC@fda.hhs.gov.:
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members on the Tobacco Products Scientific Advisory Committee.
I. General Description of the Committee Duties
The Tobacco Products Scientific Advisory Committee (the Committee)
advises the Commissioner of Food and Drugs (the Commissioner) or
designee in discharging responsibilities related to the regulation of
tobacco products. The Committee reviews and evaluates safety,
dependence, and health issues relating to tobacco products and provides
appropriate advice, information, and recommendations to the
Commissioner.
II. Criteria for Voting Members
The Committee consists of 12 members including the Chair. Members
and the Chair are selected by the Commissioner or designee from among
individuals knowledgeable in the fields of medicine, medical ethics,
science, or technology involving the manufacture, evaluation, or use of
tobacco products. Members are invited to serve for overlapping terms of
up to 4 years. Almost all non-Federal members of this committee serve
as Special Government Employees. The Committee includes nine
technically qualified voting members, selected by the Commissioner or
designee. The nine voting members include seven members who are
physicians, dentists, scientists, or health care professionals
practicing in the area of oncology, pulmonology, cardiology,
toxicology, pharmacology, addiction, or any other relevant specialty.
The nine voting members also include one member who is an officer or
employee of a state or local government or of the Federal Government,
and one member who is a representative of the general public.
In addition to the voting members, the Committee includes three
nonvoting members who are identified with industry interests. These
members include one representative of the interests of the tobacco
manufacturing industry, one representative of the interests of tobacco
growers, and one representative of the interests of the small business
tobacco manufacturing industry, which position may be filled on a
rotating, sequential basis by representatives of different small
business tobacco manufacturers based on areas of expertise relevant to
the topics being considered by the Committee.
III. Nomination Procedures
Any interested person may nominate one or more qualified
individuals for membership on the Committee. Self-nominations are also
accepted. Nominations must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business address and/or home address, telephone number, and
email address if available. Nominations must also specify the advisory
committee for which the nominee is recommended. Nominations must 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 as 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: October 3, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-24074 Filed 10-8-14; 8:45 am]
BILLING CODE 4164-01-P
