National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings, 22753-22754 [E9-11238]
Download as PDF
Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Notices
available, what information FDA
recommends you submit in support of a
request for a fee waiver or reduction,
how to submit such a request, and
FDA’s process for reviewing requests.
FDA is issuing this level 1 final
guidance document for immediate
implementation consistent with FDA’s
GGPs regulation (21 CFR 10.115). Prior
public participation is not feasible
because the guidance concerns statutory
requirements that FDA must implement
immediately. AGDUFA’s user fee
provisions are already in effect, and it
is essential for the agency to provide
guidance on how to request fee waivers
and reductions as quickly as possible. If
FDA receives comments on this final
guidance, it will review the comments
and revise the guidance if appropriate.
II. Significance of Guidance
This level 1 guidance is being issued
consistent with FDA’s GGPs regulation
(21 CFR 10.115). The guidance
represents the agency’s current thinking
on the fee waiver provisions of
AGDUFA. It does not create or confer
any rights for or on any person and will
not operate to bind FDA or the public.
Alternative methods may be used as
long as they satisfy the requirements of
the applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
FDA concludes that there are no
collections of information under the
Paperwork Reduction Act of 1995.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this 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. A copy of the
guidance and received comments are
available for public examination in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
V. Electronic Access
pwalker on PROD1PC71 with NOTICES
Persons with access to the internet
may obtain the guidance at either https://
www.fda.gov/cvm or https://
www.regulations.gov.
Dated: May 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–11218 Filed 5–13–09; 8:45 am]
BILLING CODE 4160–01–S
VerDate Nov<24>2008
17:37 May 13, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the meeting of the
National Cancer Advisory Board.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
A portion of 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 Cancer
Advisory Board Subcommittee on Cancer
Centers.
Open: June 10, 2009, 6 p.m. to 7:30 p.m.
Agenda: Discussion on Cancer Centers.
Place: Bethesda Hyatt Regency Hotel, One
Metro Center, Bethesda, MD 20814.
Contact Person: Dr. Linda K. Weiss,
Executive Secretary, NCAB Subcommittee on
Cancer Centers, National Cancer Institute,
National Institutes of Health, 6116 Executive
Boulevard, Suite 700, Bethesda, MD 20892–
8345, (301) 496–8531.
Name of Committee: National Cancer
Advisory Board.
Open: June 11, 2009, 8 a.m. to 4 p.m.
Agenda: Program reports and
presentations; business of the Board.
Place: National Institutes of Health, 9000
Rockville Pike, Building 31, C Wing, 6th
Floor, Conference Room 10, Bethesda, MD
20892.
Contact Person: Dr. Paulette S. Gray,
Executive Secretary, National Cancer
Institute, National Institutes of Health, 6116
Executive Boulevard, 8th Floor, Room 8001,
Bethesda, MD 20892–8327. (301) 496–5147.
Name of Committee: National Cancer
Advisory Board.
Closed: June 11, 2009, 4 p.m. to
adjournment.
Agenda: Review of grant applications.
Place: National Institutes of Health, 9000
Rockville Pike, Building 31, C Wing, 6th
Floor, Conference Room 10, Bethesda, MD
20892.
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
22753
Contact Person: Dr. Paulette S. Gray,
Executive Secretary, National Cancer
Institute, National Institutes of Health, 6116
Executive Boulevard, 8th Floor, Room 8001,
Bethesda, MD 20892–8327, (301) 496–5147.
Name of Committee: National Cancer
Advisory Board.
Open: June 12, 2009, 8:30 a.m. to 12 p.m.
Agenda: Program reports and
presentations; business of the Board.
Place: National Institutes of Health, 9000
Rockville Pike, Building 31, C Wing, 6th
Floor, Conference Room 10, Bethesda, MD
20892.
Contact Person: Dr. Paulette S. Gray,
Executive Secretary, National Cancer
Institute, National Institutes of Health, 6116
Executive Boulevard, 8th Floor, Room 8001,
Bethesda, MD 20892–8327, (301) 496–5147.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page:
deainfo.nci.nih.gov/advisory/ncab.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: May 5, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–11236 Filed 5–13–09; 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 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.
E:\FR\FM\14MYN1.SGM
14MYN1
22754
Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Notices
pwalker on PROD1PC71 with NOTICES
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; Cellular Signaling
and Kidney Function.
Date: June 17, 2009.
Time: 1 p.m. to 5 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: Atul Sahai, PhD, Scientific
Review Officer, Review Branch, DEA,
NIDDK, National Institutes of Health, Room
759, 6707 Democracy Boulevard, Bethesda,
MD 20892–5452, (301) 594–2242,
sahaia@niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Diabetes,
Endocrinology, and Metabolic Disease
Fellowships.
Date: June 17–18, 2009.
Time: 6 p.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Gaithersburg Marriott
Washingtonian Center, 9751 Washingtonian
Boulevard, Gaithersburg, MD 20878.
Contact Person: Robert Wellner, PhD,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 757, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–4721,
rw175w@nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; DP3 Reviews.
Date: July 15–16, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
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.
(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)
VerDate Nov<24>2008
17:37 May 13, 2009
Jkt 217001
Dated: May 6, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–11238 Filed 5–13–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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 on
Aging Special Emphasis Panel, Life Course
and Cognitive Impairment in Mexican
Americans.
Date: June 25, 2009.
Time: 12 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
2C212, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Jeannette L. Johnson, PhD,
Scientific Review Officer, National Institute
on Aging, National Institutes of Health, 7201
Wisconsin Avenue, Suite 2C212, Bethesda,
MD 20892. 301–402–7705.
JOHNSONJ9@NIA.NIH.GOV.
Name of Committee: National Institute on
Aging Special Emphasis Panel,
Proteinopathies in ALS–Dementia.
Date: June 29, 2009.
Time: 10:30 a.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
2C212, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: William Cruce, PhD,
Scientific Review Officer, National Institute
on Aging, Scientific Review Branch, Gateway
Building 2C–212, 7201 Wisconsin Ave.,
Bethesda, MD 20814. 301–402–7704.
crucew@nia.nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel, US–UK
Collaborations in the Biology of Aging.
Date: July 9–10, 2009.
Time: 8 a.m. to 1 p.m.
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites Hotel, Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Elaine Lewis, PhD,
Scientific Review Officer, Scientific Review
Branch, National Institute on Aging, Gateway
Building, Suite 2C212, MSC–9205, 7201
Wisconsin Avenue, Bethesda, MD 20892.
301–402–7707. elainelewis@nia.nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel, Gene Therapy
for AD.
Date: July 9, 2009.
Time: 1:15 p.m. to 4:15 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
2C212, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person:
Alexander Parsadanian, PhD, Scientific
Review Officer, National Institute on Aging,
Gateway Building 2C/212, 7201 Wisconsin
Avenue, Bethesda, MD 20892. 301–402–
7703. PARSADANIANA@NIA.NIH.GOV.
Name of Committee: National Institute on
Aging Special Emphasis Panel, Aging
Disease.
Date: July 28, 2009.
Time: 11 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
2C212, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Alexander Parsadanian,
PhD, Scientific Review Officer, National
Institute on Aging, Gateway Building 2C/212,
7201 Wisconsin Avenue, Bethesda, MD
20892. 301–402–7703.
PARSADANIANA@NIA.NIH.GOV.
Name of Committee: National Institute on
Aging Special Emphasis Panel, Pathways to
Health and Illness.
Date: July 28, 2009.
Time: 12 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
2C212, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Jeannette L. Johnson,
Ph.D., Scientific Review Officer, National
Institute on Aging, National Institutes of
Health, 7201 Wisconsin Avenue, Suite
2C212, Bethesda, MD 20892. 301–402–7705.
JOHNSONJ9@NIA.NIH.GOV.
Name of Committee: National Institute on
Aging Special Emphasis Panel, Mobility
Biology and Intervention Study.
Date: August 13, 2009.
Time: 12 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
2C212, Bethesda, MD 20892 (Telephone
Conference Call).
Contact: Jeannette L. Johnson, PhD,
Scientific Review Officer, National Institutes
E:\FR\FM\14MYN1.SGM
14MYN1
Agencies
[Federal Register Volume 74, Number 92 (Thursday, May 14, 2009)]
[Notices]
[Pages 22753-22754]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-11238]
-----------------------------------------------------------------------
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.
[[Page 22754]]
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; Cellular Signaling and
Kidney Function.
Date: June 17, 2009.
Time: 1 p.m. to 5 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: Atul Sahai, PhD, Scientific Review Officer,
Review Branch, DEA, NIDDK, National Institutes of Health, Room 759,
6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-2242,
sahaia@niddk.nih.gov.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; Diabetes, Endocrinology,
and Metabolic Disease Fellowships.
Date: June 17-18, 2009.
Time: 6 p.m. to 6 p.m.
Agenda: To review and evaluate grant applications.
Place: Gaithersburg Marriott Washingtonian Center, 9751
Washingtonian Boulevard, Gaithersburg, MD 20878.
Contact Person: Robert Wellner, PhD, Scientific Review Officer,
Review Branch, DEA, NIDDK, National Institutes of Health, Room 757,
6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-4721,
rw175w@nih.gov.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; DP3 Reviews.
Date: July 15-16, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda Marriott Suites, 6711 Democracy Boulevard,
Bethesda, MD 20817.
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.
(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: May 6, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-11238 Filed 5-13-09; 8:45 am]
BILLING CODE 4140-01-P