Science Advisory Board to the National Center for Toxicological Research Notice of Meeting, 55564-55565 [E9-25941]
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Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Notices
TABLE 1.—ESTIMATED REPORTING BURDEN1
No. of
Respondents
Guidance
Draft Guidance for Industry and Reviewers on SPL Standard for
Content of Labeling Technical Qs
& As, Revision
1 There
450
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
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. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/cber/guidelines.htm, or
https://www.regulations.gov.
Dated: October 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25940 Filed 10–27–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Science Advisory Board to the
National Center for Toxicological
Research Notice of Meeting
Food and Drug Administration,
HHS.
erowe on DSK5CLS3C1PROD with NOTICES
ACTION:
Total
Responses
11.11
Hours per
Response
5,000
Total Hours
1.25
6,250
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
AGENCY:
Frequency per
Response
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Science
Advisory Board (SAB) to the National
Center for Toxicological Research
(NCTR).
General Function of the Committee:
To provide advice and
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15:34 Oct 27, 2009
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recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on November 17, 2009, from 8:15
a.m. to 5 p.m. and on November 18,
2009, from 8:15 a.m. to 2 p.m.
Location: NCTR SAB Conference
Room B–12, 3900 NCTR Dr., Jefferson,
AR 72079.
Contact Person: Margaret Miller,
Designated Federal Official (DFO),
National Center for Toxicological
Research (HFT–10), Food and Drug
Administration, 5600 Fishers Lane,
Room 9C–05, Rockville, MD 20857,
301–827–6693, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code 301–451–
2559. 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 November 17, 2009, the
NCTR Director will provide a Centerwide update on scientific endeavors and
discuss prioritization, alignment, and
the strategic focus of NCTR. The SAB
will be presented with responses to the
evaluations of the Division of Systems
Toxicology and the Division of Genetic
and Reproductive Toxicology. The
evaluations were the product of an onsite review of the Division of Systems
Toxicology in February 2009 and the
Division of Genetic and Reproductive
Toxicology in July 2009, and will
address the issues raised and
recommendations made by the site visit
teams. On November 18, 2009, the SAB
will be presented with the Division of
Personalized Nutrition and Medicine
site visit report. This report is the
product of a site review of the Division
of Personalized Nutrition and Medicine
in August 2009 and will address the
issues and recommendations made by
the site visit teams.
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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: On November 17, 2009,
from 8:15 a.m. to 5 p.m., and November
18, 2009, from 8:15 a.m. to 1 p.m., the
meeting is open to the public. 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 November 16, 2009.
Oral presentations from the public will
be scheduled November 17, 2009,
between approximately 12:30 p.m. to
1:30 p.m. Those desiring to make 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 November 12, 2009. 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
November 13, 2009.
Closed Committee Deliberations: On
November 18, 2009, from approximately
1 p.m. to 2 p.m., the meeting will be
closed to permit discussion where
disclosure would constitute a clearly
unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). This
portion of the meeting will be closed to
permit discussion of information
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Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Notices
concerning individuals associated with
the research programs at NCTR.
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 Margaret
Miller (Contact Person) 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/AboutAdvisory
Committees/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: October 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25941 Filed 10–27–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Amended
Notice of Meeting
erowe on DSK5CLS3C1PROD with NOTICES
Notice is hereby given of a change in
the meeting of the National Cancer
Institute Clinical Trials and
Translational Research Advisory
Committee, November 4, 2009, 8 a.m. to
November 4, 2009, 5 p.m., National
Institutes of Health, Building 31, 31
Center Drive, Bethesda, MD 20892,
which was published in the Federal
Register on August 31, 2009,
74FR44860.
This meeting is amended to adjust the
end time to 4 p.m. The meeting is open
to the public.
Dated: October 22, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–25907 Filed 10–27–09; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
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 meeting.
The meeting 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: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; ‘‘R13 Conference Grants.’’
Date: November 20, 2009.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817
(Virtual Meeting).
Contact Person: Yong Gao, PhD, Scientific
Review Officer, Scientific Review Program,
DEA/NIAID/NIH/DHHS, Room 2217, 6700B
Rockledge Drive, Bethesda, MD 20892–7616,
301–443–8115, gaol2@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: October 21, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–25902 Filed 10–27–09; 8:45 am]
BILLING CODE 4140–01–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
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting 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.,
PO 00000
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55565
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: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Biology of
Neuroendocrine Peptides.
Date: December 1, 2009.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Lakshmanan Sankaran,
PhD, Scientific Review Officer, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 755, 6707 Democracy
Boulevard, Bethesda, MD 20892–5452, (301)
594–7799, ls38z@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: October 21, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–25879 Filed 10–27–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
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 meeting.
The meeting 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: National Institute of
Allergy and Infectious Diseases Special
E:\FR\FM\28OCN1.SGM
28OCN1
]]>Agencies
[Federal Register Volume 74, Number 207 (Wednesday, October 28, 2009)]
[Notices]
[Pages 55564-55565]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25941]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Science Advisory Board to the National Center for Toxicological
Research 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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Science Advisory Board (SAB) to the National
Center for Toxicological Research (NCTR).
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 17, 2009, from
8:15 a.m. to 5 p.m. and on November 18, 2009, from 8:15 a.m. to 2 p.m.
Location: NCTR SAB Conference Room B-12, 3900 NCTR Dr., Jefferson,
AR 72079.
Contact Person: Margaret Miller, Designated Federal Official (DFO),
National Center for Toxicological Research (HFT-10), Food and Drug
Administration, 5600 Fishers Lane, Room 9C-05, Rockville, MD 20857,
301-827-6693, or FDA Advisory Committee Information Line, 1-800-741-
8138 (301-443-0572 in the Washington, DC area), code 301-451-2559.
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 November 17, 2009, the NCTR Director will provide a
Center-wide update on scientific endeavors and discuss prioritization,
alignment, and the strategic focus of NCTR. The SAB will be presented
with responses to the evaluations of the Division of Systems Toxicology
and the Division of Genetic and Reproductive Toxicology. The
evaluations were the product of an on-site review of the Division of
Systems Toxicology in February 2009 and the Division of Genetic and
Reproductive Toxicology in July 2009, and will address the issues
raised and recommendations made by the site visit teams. On November
18, 2009, the SAB will be presented with the Division of Personalized
Nutrition and Medicine site visit report. This report is the product of
a site review of the Division of Personalized Nutrition and Medicine in
August 2009 and will address the issues and recommendations made by the
site visit teams.
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: On November 17, 2009, from 8:15 a.m. to 5 p.m., and
November 18, 2009, from 8:15 a.m. to 1 p.m., the meeting is open to the
public. 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 November 16,
2009. Oral presentations from the public will be scheduled November 17,
2009, between approximately 12:30 p.m. to 1:30 p.m. Those desiring to
make 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 November 12, 2009. 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 November 13, 2009.
Closed Committee Deliberations: On November 18, 2009, from
approximately 1 p.m. to 2 p.m., the meeting will be closed to permit
discussion where disclosure would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C. 552b(c)(6)). This portion of the
meeting will be closed to permit discussion of information
[[Page 55565]]
concerning individuals associated with the research programs at NCTR.
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 Margaret Miller
(Contact Person) 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).
Dated: October 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25941 Filed 10-27-09; 8:45 am]
BILLING CODE 4160-01-S
