National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings, 3472-3473 [2010-1052]
Download as PDF
<![CDATA[
jlentini on DSKJ8SOYB1PROD with NOTICES
3472
Federal Register / Vol. 75, No. 13 / Thursday, January 21, 2010 / Notices
regions: The European Union, Japan,
and the United States. The six ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labour,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
In the Federal Register of September
3, 2008 (73 FR 51491), FDA published
a notice announcing the availability of
a draft guidance entitled ‘‘M3(R2)
Nonclinical Safety Studies for the
Conduct of Human Clinical Trials and
Marketing Authorization for
Pharmaceuticals.’’ The notice gave
interested persons an opportunity to
submit comments by October 20, 2008.
After consideration of the comments
received and revisions to the guidance,
a final draft of the guidance was
submitted to the ICH Steering
Committee and endorsed by the three
participating regulatory agencies in June
2009.
Guidance is provided on the various
nonclinical studies recommended to
support conduct of clinical trials and
marketing. The guidance further
harmonizes the recommendations in a
number of areas and includes a new
section on exploratory clinical trials.
The recommendations should promote
safe and ethical development and
availability of new pharmaceuticals.
The guidance reflects revisions made
in response to comments received on
the draft guidance. The revisions
include more detailed discussions of
some types of nonclinical studies and
editorial changes to provide further
clarification in a number of areas.
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 this topic. 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 statutes and regulations.
VerDate Nov<24>2008
16:17 Jan 20, 2010
Jkt 220001
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments on the guidance. 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
Dated: January 15, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–1027 Filed 1–20–10; 8:45 am]
BILLING CODE 4160–01–S
Place: Holiday Inn Chevy Chase, 5520
Wisconsin Avenue, Chevy Chase, MD 20815.
Contact Person: Gary S. Madonna, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIAID, National Institutes of Health, 6700B
Rockledge Drive, MSC 7616, Bethesda, MD
20892, 301–496–3528, gm12w@nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Clinical Trial
Planning (R34) Grants and Implementation
(U01) Cooperative Agreements.
Date: February 12, 2010.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crowne Plaza Hotel—Silver Spring,
8777 Georgia Avenue, Silver Spring, MD
20910.
Contact Person: B. Duane Price, PhD,
Scientific Review Officer, Scientific Review
Program, HHS/NIH/NIAID/DEA, Room 3139,
6700B Rockledge Drive, MSC 7616, Bethesda,
MD 20892, (301) 451–2592,
pricebd@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: January 14, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–1050 Filed 1–20–10; 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
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: Microbiology,
Infectious Diseases and AIDS Initial Review
Group; Microbiology and Infectious Diseases
B Subcommittee.
Date: February 11–12, 2010.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; 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: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, NIDDK KUHFellowship Review.
Date: February 19, 2010.
Time: 8 a.m. to 5 p.m.
E:\FR\FM\21JAN1.SGM
21JAN1
jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 13 / Thursday, January 21, 2010 / Notices
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Xiaodu Guo, MD, PhD,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 761, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–4719,
guox@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, R13 Conference.
Date: February 19, 2010.
Time: 2 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: D.G. Patel, PhD, Scientific
Review Officer, Review Branch, DEA,
NIDDK, National Institutes of Health, Room
756, 6707 Democracy Boulevard, Bethesda,
MD 20892–5452, (301) 594–7682,
pateldg@niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, Fellowships in
Digestive Diseases and Nutrition.
Date: February 22, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites Washington DC,
1250 22nd Street NW., Washington, DC
20037.
Contact Person: Thomas A. Tatham, PhD,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 760, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–3993,
tathamt@mail.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, NIDDK–BCBC U01
Review.
Date: March 2, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Xiaodu Guo, MD, PhD,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 761, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–4719,
guox@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, Obesity Centers
Review.
Date: March 10–11, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Churchill Hotel, 1914 Connecticut
Avenue, NW., Washington, DC 20009.
Contact Person: Thomas A. Tatham, PhD,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 760, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–3993,
tathamt@mail.nih.gov.
VerDate Nov<24>2008
16:17 Jan 20, 2010
Jkt 220001
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, Digestive Diseases
Core Centers.
Date: March 25–26, 2010.
Time: 5 p.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: Maria E. Davila-Bloom,
PhD, Scientific Review Officer, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 758, 6707 Democracy
Boulevard, Bethesda, MD 20892–5452, (301)
594–7637, davilabloomm@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, Energy Balance
Program Projects.
Date: March 31, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Ritz-Carlton Hotel, 1150 22nd
Street, NW., Washington, DC.
Contact Person: Paul A. Rushing, PhD,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 747, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8895,
rushingp@extra.niddk.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: January 14, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–1052 Filed 1–20–10; 8:45 am]
BILLING CODE 4140–01–P
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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
3473
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Child Psychopathology.
Date: January 27, 2010.
Time: 9 a.m. to 8 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting)
Contact Person: Melissa Gerald, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3172,
MSC 7848, Bethesda, MD 20892, (301) 408–
9107, geraldmel@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; Member
Conflict: CASE and KNOD.
Date: January 27, 2010.
Time: 12 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting)
Contact Person: Jose Fernando Arena, PhD,
MD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3135,
MSC 7770, Bethesda, MD 20892, 301–408–
9072, arenaj@mail.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; Study of
Osteoporotic Fractures Clinical Centers.
Date: February 4–5, 2010.
Time: 8 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel, 1515 Rhode Island
Avenue, Washington, DC 20005.
Contact Person: Heidi B. Friedman, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1012A,
MSC 7770, Bethesda, MD 20892, 301–435–
0906, hfriedman@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Sensory,
Motor, and Cognitive Neuroscience
Fellowship Study Section.
Date: February 19, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Circle Hotel, One
Washington Circle, NW., Washington, DC
20037.
Contact Person: John Bishop, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5182,
MSC 7844, Bethesda, MD 20892, (301) 408–
9664, bishopj@csr.nih.gov.
E:\FR\FM\21JAN1.SGM
21JAN1
]]>Agencies
[Federal Register Volume 75, Number 13 (Thursday, January 21, 2010)]
[Notices]
[Pages 3472-3473]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1052]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases;
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: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel, NIDDK KUH-Fellowship
Review.
Date: February 19, 2010.
Time: 8 a.m. to 5 p.m.
[[Page 3473]]
Agenda: To review and evaluate grant applications.
Place: Hilton Washington/Rockville, 1750 Rockville Pike,
Rockville, MD 20852.
Contact Person: Xiaodu Guo, MD, PhD, Scientific Review Officer,
Review Branch, DEA, NIDDK, National Institutes of Health, Room 761,
6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-4719,
guox@extra.niddk.nih.gov.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel, R13 Conference.
Date: February 19, 2010.
Time: 2 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: D.G. Patel, PhD, Scientific Review Officer,
Review Branch, DEA, NIDDK, National Institutes of Health, Room 756,
6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-7682,
pateldg@niddk.nih.gov.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel, Fellowships in Digestive
Diseases and Nutrition.
Date: February 22, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites Washington DC, 1250 22nd Street NW.,
Washington, DC 20037.
Contact Person: Thomas A. Tatham, PhD, Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes of Health,
Room 760, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301)
594-3993, tathamt@mail.nih.gov.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel, NIDDK-BCBC U01 Review.
Date: March 2, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Washington/Rockville, 1750 Rockville Pike,
Rockville, MD 20852.
Contact Person: Xiaodu Guo, MD, PhD, Scientific Review Officer,
Review Branch, DEA, NIDDK, National Institutes of Health, Room 761,
6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-4719,
guox@extra.niddk.nih.gov.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel, Obesity Centers Review.
Date: March 10-11, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Churchill Hotel, 1914 Connecticut Avenue, NW.,
Washington, DC 20009.
Contact Person: Thomas A. Tatham, PhD, Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes of Health,
Room 760, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301)
594-3993, tathamt@mail.nih.gov.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel, Digestive Diseases Core
Centers.
Date: March 25-26, 2010.
Time: 5 p.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: Maria E. Davila-Bloom, PhD, Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes of Health,
Room 758, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301)
594-7637, davila-bloomm@extra.niddk.nih.gov.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel, Energy Balance Program
Projects.
Date: March 31, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: The Ritz-Carlton Hotel, 1150 22nd Street, NW.,
Washington, DC.
Contact Person: Paul A. Rushing, PhD, Scientific Review Officer,
Review Branch, DEA, NIDDK, National Institutes of Health, Room 747,
6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-8895,
rushingp@extra.niddk.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: January 14, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-1052 Filed 1-20-10; 8:45 am]
BILLING CODE 4140-01-P
