Center for Scientific Review; Notice of Closed Meetings, 65540 [E9-29487]
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65540
Federal Register / Vol. 74, No. 236 / Thursday, December 10, 2009 / Notices
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Skeletal
Biology.
Date: December 16, 2009.
Time: 5:30 p.m. to 7:30 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: Daniel F. McDonald, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4110,
MSC 7814, Bethesda, MD 20892. (301) 435–
1215. mcdonald@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, Urology
Business Applications.
Date: December 21, 2009.
Time: 8 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: Ryan G. Morris, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4205,
MSC 7814, Bethesda, MD 20892. 301–435–
1501. morrisr@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.
(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: December 4, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–29473 Filed 12–9–09; 8:45 am]
BILLING CODE 4140–01–P
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: Muscle and Skeletal Biology.
Date: January 8, 2010.
Time: 9 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: Yi-Hsin Liu, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4214,
MSC 7814, Bethesda, MD 20892, 301–451–
1327, liuyh@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RM09–009
and RM009–008: Development of New
Technologies Needed for Studying Human
Microbiome.
Date: January 25, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Fouad A. El-Zaatari, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3206,
MSC 7808, Bethesda, MD 20814–9692, (301)
435–1149, elzaataf@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: December 4, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–29487 Filed 12–9–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Food and Drug Administration
mstockstill on DSKH9S0YB1PROD with NOTICES
Center for Scientific Review; Notice of
Closed Meetings
[Docket No. FDA–2009–N–0561]
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
Electronic Margin of Safety and
NonClinical Toxicology Study Data
Submission; Notice of Pilot Project
VerDate Nov<24>2008
17:19 Dec 09, 2009
Jkt 220001
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration’s (FDA’s) Center for
Veterinary Medicine (CVM) is seeking
sponsors interested in participating in a
PO 00000
Frm 00033
Fmt 4703
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pilot project to test the electronic
submission of margin of safety and
nonclinical toxicology study data using
the Standard for Exchange of
Nonclinical Data (SEND), a new
electronic data standard format which is
used to support review activity. FDA
anticipates that a successful pilot will
enable CVM to accept margin of safety
and nonclinical toxicology study data
related to investigational new animal
drug (INAD) files and new animal drug
applications (NADA’s) electronically in
SEND format.
DATES: Submit electronic or written
requests to participate in the pilot
project by March 10, 2010. General
comments on the pilot project are
welcome at any time.
ADDRESSES: Submit electronic requests
to participate in the pilot and comments
regarding the project to https://www.
regulations.gov. Submit written requests
and comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments should 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.
FOR FURTHER INFORMATION CONTACT:
Janis Messenheimer, Food and Drug
Administration, Center for Veterinary
Medicine, Office of New Animal Drug
Evaluation (HFV–135), 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8348, e-mail: Janis.messenheimer
@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing an opportunity to
participate in a 3-year CVM pilot
project. This pilot involves FDA’s
ongoing testing of SEND, a data model
initially developed for non-clinical data
from animal toxicology studies
submitted in support of applications for
approval of human drugs. This pilot is
designed to test the ability of SEND to
support the review of margin of safety
and nonclinical toxicology study data
submitted to INAD files and as part of
NADA’s at CVM. CVM considers this
pilot to be the beginning of a phased
implementation of SEND that will
enable CVM to receive and evaluate data
from toxicology studies as part of the
human food safety evaluation and
margin of safety studies.
E:\FR\FM\10DEN1.SGM
10DEN1
Agencies
[Federal Register Volume 74, Number 236 (Thursday, December 10, 2009)]
[Notices]
[Page 65540]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-29487]
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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: Muscle and Skeletal Biology.
Date: January 8, 2010.
Time: 9 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: Yi-Hsin Liu, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892, 301-451-
1327, liuyh@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; RM09-009 and RM009-008: Development of New Technologies
Needed for Studying Human Microbiome.
Date: January 25, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Fouad A. El-Zaatari, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3206, MSC 7808, Bethesda, MD
20814-9692, (301) 435-1149, elzaataf@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: December 4, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-29487 Filed 12-9-09; 8:45 am]
BILLING CODE 4140-01-P