National Cancer Institute; Notice of Meeting, 22753 [E9-11236]
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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]
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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.
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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]
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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
Agencies
[Federal Register Volume 74, Number 92 (Thursday, May 14, 2009)]
[Notices]
[Page 22753]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-11236]
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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.
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]
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