Center for Scientific Review; Notice of Closed Meetings, 20607-20608 [2010-9095]
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Federal Register / Vol. 75, No. 75 / Tuesday, April 20, 2010 / Notices
behavioral, or physiologic effects of
current or future tobacco products, their
constituents (including smoke
constituents), ingredients, components,
and additives.’’ Information required
under section 904(a)(4) of the act must
be submitted to FDA beginning
December 22, 2009. FDA recognizes the
challenges associated with the
collection, review, organization, and
production of documents. We also
recognize that additional time may be
necessary for the production of
documents in a digital format, which
FDA strongly encourages in order to
improve the management and
accessibility of submitted documents.
Therefore, FDA does not intend to
enforce the December 22, 2009, deadline
provided you submit by April 30, 2010,
all documents described in section
904(a)(4) of the act developed between
June 22, 2009 and December 31, 2009.
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 ‘‘Tobacco Health
Document Submission.’’ It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
erowe on DSK5CLS3C1PROD with NOTICES
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. The guidance
document and 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(s) of information
in this guidance was approved under
OMB control number 0910–0654.
V. Electronic Access
An electronic version of the guidance
document is available on the Internet at
https://www.regulations.gov and https://
VerDate Nov<24>2008
14:55 Apr 19, 2010
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www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: April 15, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–9134 Filed 4–16–10; 11:15 am]
BILLING CODE 4160–01–S
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; Member
Conflict: Sensory.
Date: May 4–5, 2010.
Time: 7 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Bernard F. Driscoll, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5184,
MSC 7844, Bethesda, MD 20892, (301) 435–
1242, driscolb@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; PAR–BST
Consolidated: Member Conflict.
Date: May 6, 2010.
Time: 11 a.m. to 1 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: Ping Fan, MD, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5154,
MSC 7840, Bethesda, MD 20892, 301–408–
9971, fanp@csr.nih.gov.
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20607
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts: Bioengineering Sciences and
Technologies.
Date: May 7, 2010.
Time: 1 p.m. to 3 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: Ping Fan, MD, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5154,
MSC 7840, Bethesda, MD 20892, 301–408–
9971, fanp@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts: Clinical and Health Services
Research.
Date: May 18, 2010.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sheraton Sand Key Resort, 1160
Gulf Boulevard, Clearwater Beach, FL 33767.
Contact Person: Jacinta Bronte-Tinkew,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3164,
MSC 7770, Bethesda, MD 20892, (301) 435–
1503, brontetinkewjm@csr.nih.gov.
Name of Committee: Risk, Prevention and
Health Behavior Integrated Review Group;
Psychosocial Risk and Disease Prevention
Study Section.
Date: May 24–25, 2010.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott, 1960–A
Chain Bridge Road, Mclean, VA 22102.
Contact Person: Martha Faraday, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3110,
MSC 7808, Bethesda, MD 20892, 301–435–
3575, faradaym@csr.nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Neurobiology of
Learning and Memory Study Section.
Date: May 26, 2010.
Time: 8:30 .a.m to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Plaza Hotel, 10 Thomas
Circle, NW., Washington, DC 20005.
Contact Person: Bernard F. Driscoll, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5184,
MSC 7844, Bethesda, MD 20892, (301) 435–
1242, driscolb@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Neural Basis of Psychopathology,
Addictions and Sleep Disorders Study
Section.
Date: May 27–28, 2010.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites Hotel, 1250 22nd
Street, NW., Washington, DC 20037.
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Federal Register / Vol. 75, No. 75 / Tuesday, April 20, 2010 / Notices
Contact Person: Julius Cinque, MS,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5186,
MSC 7846, Bethesda, MD 20892, (301) 435–
1252, cinquej@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: April 13, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–9095 Filed 4–19–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Risk Communication Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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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: Risk
Communication 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 May 6, 2010, from 8 a.m. to 5
p.m. and May 7, 2010, from 8 a.m. to 2
p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Conference Center (rm. 1503), Silver
Spring, MD 20993. Please note that all
visitors must park in the visitors’
parking lot near Building 22 (for a
campus map, see https://www.fda.gov/
AboutFDA/WorkingatFDA/Buildings
andFacilities/WhiteOak
CampusInformation/default.htm). The
Campus is also served by several bus
lines connecting to metro rail (see
https://www.wmata.com/).
Contact Person: Lee L. Zwanziger,
Office of the Commissioner, Office of
Policy, Planning and Preparedness,
Office of Planning, Food and Drug
Administration, 5600 Fishers Lane, rm.
14–90, Rockville, MD 20857, 301–827–
2895, FAX: 301–827–4050, e-mail:
RCAC@fda.hhs.gov , or FDA Advisory
Committee Information Line, 1–800–
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741–8138 (301–443–0572 in the
Washington, DC area), code
8732112560. Please call the Information
Line for up-to-date information on this
meeting. 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 and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On May 6 and 7, 2010, the
Committee will review the state of
current research in a range of fields
relevant to improving risk
communication at FDA, and discuss
applications or gaps for strategic
planning of risk communication at FDA.
For more specific agenda information,
please visit the following Web site and
scroll down to the appropriate advisory
committee link (https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm), or call FDA Advisory
Committee Information Line as listed
above in the Contact Person section of
the notice. FDA intends to make agenda
information available at both these
locations no later than 15 days before
the meeting.
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 link.
Procedure: Visitors to the White Oak
Campus must have a valid driver’s
license or other picture ID, and must
enter through Building 1. In order to
help speed entrance through security,
we request that attendees send an email
giving their full names to
RCAC@fda.hhs.gov with the word
‘‘registration’’ in the subject line, or
telephone Lee Zwanziger (see Contact
Person), by April 27, 2010.
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
May 3, 2010. Oral presentations from
the public will be scheduled between
approximately 3:15 p.m. and 4:15 p.m.
on May 6, 2010, and between 1 p.m. and
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1:30 p.m. on May 7, 2010. Those
desiring to make formal oral
presentations should notify Lee
Zwanziger 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 April 27,
2010. 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 April 28, 2010.
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 Lee
Zwanziger 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/Advisory
Committees/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).
Dated: April 14, 2010.
Jill H. Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–9056 Filed 4–19–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Notice of Re-Designation of the
Service Delivery Area for the Cowlitz
Indian Tribe
Indian Health Service, HHS.
Notice.
AGENCY:
ACTION:
SUMMARY: This Notice advises the public
that the Indian Health Service (IHS)
proposes to expand the geographic
boundaries of the Service Delivery Area
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[Federal Register Volume 75, Number 75 (Tuesday, April 20, 2010)]
[Notices]
[Pages 20607-20608]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9095]
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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; Member Conflict: Sensory.
Date: May 4-5, 2010.
Time: 7 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Bernard F. Driscoll, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5184, MSC 7844, Bethesda, MD
20892, (301) 435-1242, driscolb@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; PAR-BST Consolidated: Member Conflict.
Date: May 6, 2010.
Time: 11 a.m. to 1 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: Ping Fan, MD, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5154, MSC 7840, Bethesda, MD 20892, 301-408-
9971, fanp@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflicts: Bioengineering Sciences and Technologies.
Date: May 7, 2010.
Time: 1 p.m. to 3 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: Ping Fan, MD, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5154, MSC 7840, Bethesda, MD 20892, 301-408-
9971, fanp@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflicts: Clinical and Health Services Research.
Date: May 18, 2010.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant applications.
Place: Sheraton Sand Key Resort, 1160 Gulf Boulevard, Clearwater
Beach, FL 33767.
Contact Person: Jacinta Bronte-Tinkew, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3164, MSC 7770, Bethesda, MD
20892, (301) 435-1503, brontetinkewjm@csr.nih.gov.
Name of Committee: Risk, Prevention and Health Behavior
Integrated Review Group; Psychosocial Risk and Disease Prevention
Study Section.
Date: May 24-25, 2010.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant applications.
Place: Courtyard by Marriott, 1960-A Chain Bridge Road, Mclean,
VA 22102.
Contact Person: Martha Faraday, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3110, MSC 7808, Bethesda, MD 20892, 301-435-
3575, faradaym@csr.nih.gov.
Name of Committee: Integrative, Functional and Cognitive
Neuroscience Integrated Review Group; Neurobiology of Learning and
Memory Study Section.
Date: May 26, 2010.
Time: 8:30 .a.m to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Washington Plaza Hotel, 10 Thomas Circle, NW.,
Washington, DC 20005.
Contact Person: Bernard F. Driscoll, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5184, MSC 7844, Bethesda, MD
20892, (301) 435-1242, driscolb@csr.nih.gov.
Name of Committee: Brain Disorders and Clinical Neuroscience
Integrated Review Group; Neural Basis of Psychopathology, Addictions
and Sleep Disorders Study Section.
Date: May 27-28, 2010.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites Hotel, 1250 22nd Street, NW., Washington,
DC 20037.
[[Page 20608]]
Contact Person: Julius Cinque, MS, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5186, MSC 7846, Bethesda, MD 20892, (301) 435-
1252, cinquej@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: April 13, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-9095 Filed 4-19-10; 8:45 am]
BILLING CODE 4140-01-P
