Center for Scientific Review; Notice of Closed Meetings, 9824-9825 [E9-4622]
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9824
Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices
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approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355(i)) became effective: June 7, 1994.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on June 7, 1994.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: April 29, 2005. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
Arranon (NDA 21–877) was initially
submitted on April 29, 2005.
3. The date the application was
approved: October 28, 2005. FDA has
verified the applicant’s claim that NDA
21–877 was approved on October 28,
2005.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 5 years of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by May 5, 2009.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
September 2, 2009. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: February 17, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–4770 Filed 3–5–09; 8:45 am]
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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. Appendix 2), 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, FIRCA and
GRIP in Behavioral and Social Sciences.
Date: March 24, 2009.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: One Washington Circle Hotel, One
Washington Circle Conference Room,
Washington, DC 20037.
Contact Person: Manana Sukhareva, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3214,
MSC 7808, Bethesda, MD 20892. 301–435–
1116, sukharem@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, PAR–08–1
60: Metabolic Effects Psychotropic
Medications.
Date: March 25–26, 2009.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Reed A. Graves, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6166,
MSC 7892, Bethesda, MD 20892. (301) 402–
6297, gravesr@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Millennium
Promise Awards: Non-communicable
Disease.
Date: March 25, 2009.
Time: 8 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Admiral Fell Inn, 888 South
Broadway, Baltimore, MD 21231.
Contact Person: Cathy Wedeen, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3213,
PO 00000
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MSC 7808, Bethesda, MD 20892. 301–435–
1191, wedeenc@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, ICBG
Review.
Date: March 25–26, 2009.
Time: 8:30 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda, 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Dan D. Gerendasy, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5132,
MSC 7843, Bethesda, MD 20892. 301–594–
6830, gerendad@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Tools for
Zebrafish Research.
Date: March 27, 2009.
Time: 8 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications, Place: The River Inn, 924
Twenty-Fifth Street, NW. Conference,
Washington, DC 20037.
Contact Person: Neelakanta Ravindranath,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5140,
MSC 7843, Bethesda, MD 20892. 301–435–
1034, ravindrn@csr.nih.gov.
Name of Committee: Center for Scientific
Review, Special Emphasis Panel, Zebrafish
Genetic Screens.
Date: March 27, 2009.
Time: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: The River Inn, 924 Twenty-Fifth
Street, NW. Conference, Washington, DC
20037.
Contact Person: Neelakanta Ravindranath,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5140,
MSC 7843, Bethesda, MD 20892. 301–435–
1034, ravindrn@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Enzyme
Specificity Program Project.
Date: April 1–2, 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: David R. Jollie, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4150,
MSC 7806, Bethesda, MD 20892. (301) 435–
1722, jollieda@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel,
Epigenomics of Human Health and Disease.
Date: April 2–3, 2009.
Time: 8 a.m. to 4:30 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: Michael K. Schmidt, PhD,
Scientific Review Officer, Center for
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Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2214,
MSC 7890, Bethesda, MD 20892. (301) 435–
1147, mschmidt@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Assays,
Detectors, and Devices.
Date: April 2–3, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda, 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Alexander Gubin, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Rm 5144, MSC
7812, Bethesda, MD 20892. 301–435–2902,
gubina@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflicts in Biological Chemistry and
Macromolecular Biophysics.
Date: April 2–3, 2009.
Time: 11 a.m. to 10 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Donald L. Schneider, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5160,
MSC 7842, Bethesda, MD 20892. (301) 435–
1727, schneidd@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: February 26, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–4622 Filed 3–5–09; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2009–0114]
National Boating Safety Advisory
Council
Coast Guard, DHS.
Committee Management; notice
of meeting.
AGENCY:
mstockstill on PROD1PC66 with NOTICES
ACTION:
SUMMARY: The National Boating Safety
Advisory Council (NBSAC) and its
subcommittees will meet on April 4, 5,
and 6, 2009, in Orlando, FL. The
meetings will be open to the public.
DATES: NBSAC will meet April 4, 2009,
from 8:30 a.m. to 12 noon, and on April
6, 2009, from 8:30 a.m. to 5 p.m. The
Boats and Associated Equipment
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Subcommittee will meet on April 4, and
the Prevention through People
Subcommittee and the Recreational
Boating Safety Strategic Planning
Subcommittee will meet on April 5,
2009. Please note that the meetings may
conclude early if the council has
completed it business.
All written materials, comments, and
requests to make oral presentations at
the meetings should reach Mr. Jeff
Ludwig by March 13, 2009, via one of
the methods described in ADDRESSES.
Requests to have a copy of your material
distributed to each member of the
committee prior to the meeting should
reach Mr. Ludwig by March 13, 2009.
ADDRESSES: The meeting will be held at
the Grand Bohemian Hotel,325 S.
Orange Ave, Orlando, FL 32801.
Please send written material,
comments, and requests to make oral
presentations to Mr. Jeff Ludwig by one
of the submission methods described
below. All materials, comments, and
requests must be identified by docket
number USCG–2009–0114.
Submission Methods: Please use only
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• E-mail: jeffrey.a.ludwig@uscg.mil.
Include the docket number in the
subject line of the message.
• Fax: (202) 372–1932.
• Mail: Mr. Jeff Ludwig, COMDT
(CG–54221), 2100 2nd Street, SW.,
Washington, DC 20593.
Instructions: All submissions received
must include the words ‘‘U.S. Coast
Guard’’ and docket number USCG–
2009–0114. All submissions received
will be posted without alteration at
https://www.regulations.gov, including
any personal information provided.
Anyone can search the electronic form
of comments received into any of our
dockets by the name of the individual
submitting the comment (or signing the
comment, if submitted on behalf of an
association, business, labor union, etc.).
You may review a Privacy Act notice
regarding our public dockets in the
January 17, 2008 issue of the Federal
Register (73 FR 3316).
Docket: For access to the docket to
read background documents or
submissions received by the NBSAC, go
to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Mr.
Jeff Ludwig, COMDT (CG–54221), 2100
2nd Street, SW., Washington, DC 20593;
(202) 372–1061;
Jeffrey.a.ludwig@uscg.mil.
Notice of
this meeting is given under the Federal
Advisory Committee Act, 5 U.S.C. App.
SUPPLEMENTARY INFORMATION:
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(Pub. L. 92–463). NBSAC was
established by the Federal Boat Safety
Act of 1971. That law requires the
Secretary of Homeland Security, and the
Commandant of the Coast Guard by
delegation, to consult with NBSAC in
prescribing Federal regulations, and on
other major matters regarding boating
safety. See 46 U.S.C. 4302(c) and
13110(c).
NBSAC will meet for the purpose of
discussing issues related to recreational
boating safety.
A. Tentative Agendas of Meetings
National Boating Safety Advisory
Council (NBSAC):
Saturday, April 4, 2009:
(1) Remarks—Mr. James P. Muldoon,
NBSAC Chairman;
(2) Chief, Office of Auxiliary and
Boating Safety Update on NBSAC
Resolutions and Recreational Boating
Safety Program report.
(3) Executive Secretary’s report.
(4) Chairman’s session.
(5) TSAC Liaison’s report.
(6) NAVSAC Liaison’s report.
(7) National Association of State
Boating Law Administrators report.
(8) Boats and Associated Equipment
Subcommittee meeting.
Sunday, April 5, 2009:
(9) Prevention through People
Subcommittee meeting.
(10) Recreational Boating Safety
Strategic Planning Subcommittee
meeting.
Monday, April 6, 2009:
(11) Prevention through People
Subcommittee report.
(12) Boats and Associated Equipment
Subcommittee report.
(13) Recreational Boating Safety
Strategic Planning Subcommittee report.
A more detailed agenda can be found
at: https://www.uscgboating.org/nbsac/
nbsac.htm, after March 27, 2009.
B. NBSAC Subcommittees
Prevention Through People
Subcommittee: Discuss current
regulatory projects, grants, contracts,
and new issues affecting the prevention
of boating accidents through outreach
and education of boaters.
Boats and Associated Equipment
Subcommittee: Discuss current
regulatory projects, grants, contracts,
and new issues affecting boats and
associated equipment.
Recreational Boating Safety Strategic
Planning Subcommittee: Discuss current
status of the strategic planning process
and any new issues or factors that could
impact, or contribute to, the
development of the strategic plan for the
recreational boating safety program.
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[Federal Register Volume 74, Number 43 (Friday, March 6, 2009)]
[Notices]
[Pages 9824-9825]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4622]
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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. Appendix 2), 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, FIRCA and GRIP in Behavioral and Social Sciences.
Date: March 24, 2009.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant applications.
Place: One Washington Circle Hotel, One Washington Circle
Conference Room, Washington, DC 20037.
Contact Person: Manana Sukhareva, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD
20892. 301-435-1116, sukharem@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, PAR-08-1 60: Metabolic Effects Psychotropic Medications.
Date: March 25-26, 2009.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Reed A. Graves, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6166, MSC 7892, Bethesda, MD 20892. (301) 402-
6297, gravesr@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Millennium Promise Awards: Non-communicable Disease.
Date: March 25, 2009.
Time: 8 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant applications.
Place: Admiral Fell Inn, 888 South Broadway, Baltimore, MD
21231.
Contact Person: Cathy Wedeen, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3213, MSC 7808, Bethesda, MD 20892. 301-435-
1191, wedeenc@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, ICBG Review.
Date: March 25-26, 2009.
Time: 8:30 a.m. to 6 p.m.
Agenda: To review and evaluate grant applications.
Place: Doubletree Hotel Bethesda, 8120 Wisconsin Avenue,
Bethesda, MD 20814.
Contact Person: Dan D. Gerendasy, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5132, MSC 7843, Bethesda, MD
20892. 301-594-6830, gerendad@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Tools for Zebrafish Research.
Date: March 27, 2009.
Time: 8 a.m. to 2 p.m.
Agenda: To review and evaluate grant applications, Place: The
River Inn, 924 Twenty-Fifth Street, NW. Conference, Washington, DC
20037.
Contact Person: Neelakanta Ravindranath, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5140, MSC 7843, Bethesda, MD
20892. 301-435-1034, ravindrn@csr.nih.gov.
Name of Committee: Center for Scientific Review, Special
Emphasis Panel, Zebrafish Genetic Screens.
Date: March 27, 2009.
Time: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: The River Inn, 924 Twenty-Fifth Street, NW. Conference,
Washington, DC 20037.
Contact Person: Neelakanta Ravindranath, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5140, MSC 7843, Bethesda, MD
20892. 301-435-1034, ravindrn@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Enzyme Specificity Program Project.
Date: April 1-2, 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: David R. Jollie, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4150, MSC 7806, Bethesda, MD 20892. (301) 435-
1722, jollieda@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Epigenomics of Human Health and Disease.
Date: April 2-3, 2009.
Time: 8 a.m. to 4:30 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: Michael K. Schmidt, PhD, Scientific Review
Officer, Center for
[[Page 9825]]
Scientific Review, National Institutes of Health, 6701 Rockledge
Drive, Room 2214, MSC 7890, Bethesda, MD 20892. (301) 435-1147,
mschmidt@mail.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Assays, Detectors, and Devices.
Date: April 2-3, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Doubletree Hotel Bethesda, 8120 Wisconsin Avenue,
Bethesda, MD 20814.
Contact Person: Alexander Gubin, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Rm 5144, MSC 7812, Bethesda, MD 20892. 301-435-
2902, gubina@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Member Conflicts in Biological Chemistry and Macromolecular
Biophysics.
Date: April 2-3, 2009.
Time: 11 a.m. to 10 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Donald L. Schneider, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5160, MSC 7842, Bethesda, MD
20892. (301) 435-1727, schneidd@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: February 26, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-4622 Filed 3-5-09; 8:45 am]
BILLING CODE 4140-01-M
