Center For Scientific Review; Notice of Closed Meetings, 62796 [E9-28732]
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Federal Register / Vol. 229, No. 74 / Tuesday, December 1, 2009 / Notices
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I. Background
In the Federal Register of November
3, 2009 (74 FR 56842), FDA announced
the availability of a draft guidance
document entitled ‘‘Listing of
Ingredients in Tobacco Products.’’ The
agency considered received comments
as it finalized this guidance. This
guidance document is designed to assist
tobacco product manufacturers and
importers with making tobacco product
ingredient submissions to FDA. Under
section 904(a)(1) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 387d(a)(1)), as amended by the
Tobacco Control Act, each tobacco
product manufacturer or importer, or
agent thereof, is required to submit ‘‘a
listing of all ingredients, including
tobacco, substances, compounds, and
additives that are * * * added by the
manufacturer to the tobacco, paper,
filter, or other part of each tobacco
product by brand and by quantity in
each brand and subbrand.’’ For tobacco
products on the market as of June 22,
2009, information must be submitted to
FDA by December 22, 2009, and include
the ingredients added as of the date of
submission. FDA does not, however,
intend to enforce the statutory deadline
of this subsection provided the
ingredient list is submitted on or before
June 22, 2010. For tobacco products not
on the market as of June 22, 2009,
section 904(c)(1) requires that the list of
ingredients be submitted at least 90 days
prior to delivery for introduction into
interstate commerce. Section 904(c) of
the act also requires submission of
information whenever additives, or the
quantities of additives, are changed.
FDA does not, however, intend to
enforce the statutory deadlines for
ingredient reporting under section
904(c) of the act for additive changes or
the initial introduction of products into
interstate commerce occurring between
June 22, 2009, and 90 days after the
section 904(a)(1) ingredient list is
submitted, provided that these report(s)
are submitted at the time of the section
904(a)(1) submission and the report(s)
include the date, or planned date, of
making the change to the additive or
introducing the product into interstate
commerce.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on ‘‘Listing of
Ingredients in Tobacco Products.’’ It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
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alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Paperwork Reduction Act of 1995
This guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collection of information in
this guidance was approved under OMB
control number 0910–0650.
V. Electronic Access
An electronic version of the guidance
document is available on the Internet at
https://www.regulations.gov and https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: November 25, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–28747 Filed 11–27–09; 11:15
am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Drug
Targeting.
Date: December 15, 2009.
Time: 1 p.m. to 2:30 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: Hungyi Shau, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6186,
MSC 7804, Bethesda, MD 20892, 301–435–
1720, shauhung@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: Center for Scientific
Review Special Emphasis Panel, OBT Review
Panel Member Applications.
Date: January 7–8, 2010.
Time: 9 a.m. to 10 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Nywana Sizemore, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6204,
MSC 7804, Bethesda, MD 20892, 301–435–
1718, sizemoren@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 24, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–28732 Filed 11–30–09; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Center For Scientific Review; Notice of
Closed Meetings
National Institutes of Health
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
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
Center for Scientific Review; Amended
Notice of Meeting
PO 00000
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Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Special Emphasis Panel,
November 24, 2009, 3 p.m. to November
24, 2009, 5 p.m., National Institutes of
Health, 6701 Rockledge Drive, Bethesda,
MD, 20892 which was published in the
Federal Register on November 18, 2009,
74 FR 59569.
The meeting will be held December 9,
2009, from 12 p.m. to 2 p.m. The
meeting location remains the same. The
meeting is closed to the public.
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[Federal Register Volume 74, Number 229 (Tuesday, December 1, 2009)]
[Notices]
[Page 62796]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28732]
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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 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, Drug Targeting.
Date: December 15, 2009.
Time: 1 p.m. to 2:30 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: Hungyi Shau, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6186, MSC 7804, Bethesda, MD 20892, 301-435-
1720, shauhung@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: Center for Scientific Review Special Emphasis
Panel, OBT Review Panel Member Applications.
Date: January 7-8, 2010.
Time: 9 a.m. to 10 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Nywana Sizemore, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6204, MSC 7804, Bethesda, MD 20892, 301-435-
1718, sizemoren@csr.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: November 24, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-28732 Filed 11-30-09; 8:45 am]
BILLING CODE 4140-01-P
