Center for Scientific Review; Notice of Closed Meetings, 17416 [2010-7342]
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Federal Register / Vol. 75, No. 65 / Tuesday, April 6, 2010 / Notices
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: September 27, 2007.
FDA has verified the applicant’s claim
that the new drug application (NDA)
22–192 was submitted on September 27,
2007.
3. The date the application was
approved: May 6, 2009. FDA has
verified the applicant’s claim that NDA
22–192 was approved on May 6, 2009.
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 June 7, 2010.
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
October 4, 2010. 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: March 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–7678 Filed 4–5–10; 8:45 am]
sroberts on DSKD5P82C1PROD with NOTICES
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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
VerDate Nov<24>2008
16:37 Apr 05, 2010
Jkt 220001
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: Neuronal Diseases, Cell Death and
Regeneration.
Date: April 20–21, 2010.
Time: 12 p.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: Deborah L Lewis, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4183,
MSC 7850, Bethesda, MD 20892, 301–408–
9129, lewisdeb@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Cancer Research.
Date: April 21, 2010.
Time: 3 p.m. to 5 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: Eun Ah Cho, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6202,
MSC 7804, Bethesda, MD 20892, (301) 451–
4467, choe@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, PAR 10–
073: Technology Development for HighThroughput Structural Biology Research
Review.
Date: May 5–6, 2010.
Time: 9 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: Raymond Jacobson, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5858,
MSC 7849, Bethesda, MD 20892, 301–996–
7702, jacobsonrh@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)
PO 00000
Frm 00049
Fmt 4703
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Dated: March 25, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–7342 Filed 4–5–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
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 meeting.
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; ‘‘In vitro Assessments for
Antimicrobial Activity—Parasites and
Vectors’’.
Date: April 29, 2010.
Time: 12 p.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6700B
Rockledge Drive, Room 3248, Bethesda, MD
20817.
Contact Person: Yong Gao, PhD, Scientific
Review Officer, Scientific Review Program,
DEA/NIAID/NIH/DHHS, Room 3246, 6700B
Rockledge Drive, Bethesda, MD 20892–7616,
301–443–8115, gaol2@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: March 31, 2010.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–7747 Filed 4–5–10; 8:45 am]
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[Federal Register Volume 75, Number 65 (Tuesday, April 6, 2010)]
[Notices]
[Page 17416]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7342]
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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: Neuronal Diseases, Cell Death and
Regeneration.
Date: April 20-21, 2010.
Time: 12 p.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: Deborah L Lewis, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4183, MSC 7850, Bethesda, MD 20892, 301-408-
9129, lewisdeb@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Member Conflict: Cancer Research.
Date: April 21, 2010.
Time: 3 p.m. to 5 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: Eun Ah Cho, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6202, MSC 7804, Bethesda, MD 20892, (301) 451-
4467, choe@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, PAR 10-073: Technology Development for High-Throughput
Structural Biology Research Review.
Date: May 5-6, 2010.
Time: 9 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: Raymond Jacobson, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5858, MSC 7849, Bethesda, MD
20892, 301-996-7702, jacobsonrh@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: March 25, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-7342 Filed 4-5-10; 8:45 am]
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