Center for Scientific Review; Notice of Closed Meetings, 42678-42679 [E9-20329]
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42678
Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2009–E–0048 and FDA
2009–E–0047]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; LEXISCAN
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
LEXISCAN and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of
applications to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of patents
which claim that human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
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Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human drug product LEXISCAN
(regadenoson monohydrate). LEXISCAN
is indicated for radionuclide myocardial
perfusion imaging in patients unable to
undergo adequate exercise stress.
Subsequent to this approval, the Patent
and Trademark Office received patent
term restoration applications for
LEXISCAN (U.S. Patent Nos. 6,403,567
and 6,642,210) from CV Therapeutics,
Inc., and the Patent and Trademark
Office requested FDA’s assistance in
determining the patents’ eligibilities for
patent term restoration. In a letter dated
February 26, 2009, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of LEXISCAN represented the
first permitted commercial marketing or
use of the product. Thereafter, the
Patent and Trademark Office requested
that FDA determine the product’s
regulatory review period.
FDA has determined that the
applicable regulatory review period for
LEXISCAN is 2,446 days. Of this time,
2,113 days occurred during the testing
phase of the regulatory review period,
while 333 days occurred during the
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: August 1, 2001.
The applicant claims August 2, 2001, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was August 1, 2001,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: May 14, 2007. FDA has
verified the applicant’s claim that the
new drug application (NDA) 22–161
was submitted on May 14, 2007.
3. The date the application was
approved: April 10, 2008. FDA has
verified the applicant’s claim that NDA
22–161 was approved on April 10, 2008.
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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 applications for patent extension,
this applicant seeks 1,024 days and 977
days of patent term extension,
respectively.
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 October 23, 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
February 22, 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: July 31, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–20307 Filed 8–21–09; 8:45 am]
BILLING CODE 4160–01–S
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
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Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices
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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; Diabetes
and Lipids.
Date: September 15–16, 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: David Weinberg, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6170,
MSC 7892, Bethesda, MD 20892. 301–435–
1044. David.Weinberg@nih.gov.
Name of Committee: Oncology 1—Basic
Translational Integrated Review Group;
Cancer Molecular Pathobiology Study
Section.
Date: September 17–18, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Alexandria Old Town, 1767
King Street, Alexandria, VA 22314.
Contact Person: Elaine Sierra-Rivera, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6184,
MSC 7804, Bethesda, MD 20892. 301–435–
1779. riverase@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Microbiology and Epidemiology.
Date: September 18, 2009.
Time: 1 p.m. to 3 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: Liangbiao Zheng, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3214,
MSC 7808, Bethesda, MD 20892. 301–402–
5671. zhengli@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Alcohol and Toxicology.
Date: September 22–23, 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: Christine L. Melchior,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5176,
MSC 7844, Bethesda, MD 20892. (301) 435–
1713. melchioc@csr.nih.gov.
Name of Committee: Oncology 2—
Translational Clinical Integrated Review
Group; Cancer Immunopathology and
Immunotherapy Study Section.
Date: September 23–24, 2009.
Time: 8 a.m. to 5 p.m.
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Agenda: To review and evaluate grant
applications.
Place: Mayflower Park Hotel, 405 Olive
Way, Seattle, WA 98101.
Contact Person: Denise R. Shaw, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6158,
MSC 7804, Bethesda, MD 20892. 301–435–
0198. shawdeni@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Cell Death in Neurodegeneration
Study Section.
Date: September 24–25, 2009.
Time: 8:30 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites Hotel, 1250 22nd
Street, NW., Washington, DC 20037.
Contact Person: Boris P. Sokolov, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217A,
MSC 7846, Bethesda, MD 20892. 301–435–
1197. bsokolov@csr.nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Biological Rhythms
and Sleep Study Section.
Date: September 29, 2009.
Time: 8 a.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: Michael Selmanoff, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1208,
MSC 7844, Bethesda, MD 20892. 301–435–
1119. mselmanoff@csr.nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group;
Neuroendocrinology, Neuroimmunology, and
Behavior Study Section.
Date: September 30–October 1, 2009.
Time: 8 a.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: Michael Selmanoff, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3134,
MSC 7844, Bethesda, MD 20892. 301–435–
1119. mselmanoff@csr.nih.gov.
Name of Committee: Genes, Genomes, and
Genetics Integrated Review Group; Molecular
Genetics B Study Section.
Date: September 30–October 1, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Mark Hopkins San Francisco, One
Nob Hill, San Francisco, CA 94108.
Contact Person: Richard A. Currie, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5128,
MSC 7840, Bethesda, MD 20892. (301) 435–
1219. currieri@csr.nih.gov.
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42679
(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: August 17, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–20329 Filed 8–21–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, National
Human Genome Research Institute.
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. The meeting
will be closed to the public as indicated
below in accordance with the provisions
set forth in section 552b(c)(6), Title 5
U.S.C., as amended for the review,
discussion, and evaluation of individual
intramural programs and projects
conducted by the National Human
Genome Research Institute, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, National Human Genome
Research Institute.
Date: November 16–18, 2009.
Open: November 16, 2009, 5:45 p.m. to 7
p.m.
Agenda: To discuss matters of program
relevance.
Place: Eisenhower Hotels, Conference
Center and Resort, 2634 Emmitsburg Road,
Gettysburg, PA 17325.
Closed: November 16, 2009, 7 p.m. to 9:30
p.m.
Agenda: To review and evaluate personal
qualifications and performance and
competence of individual investigators.
Place: Eisenhower Hotels, Conference
Center and Resort, 2634 Emmitsburg Road,
Gettysburg, PA 17325.
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[Federal Register Volume 74, Number 162 (Monday, August 24, 2009)]
[Notices]
[Pages 42678-42679]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20329]
-----------------------------------------------------------------------
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
[[Page 42679]]
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; Diabetes and Lipids.
Date: September 15-16, 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: David Weinberg, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6170, MSC 7892, Bethesda, MD 20892. 301-435-
1044. David.Weinberg@nih.gov.
Name of Committee: Oncology 1--Basic Translational Integrated
Review Group; Cancer Molecular Pathobiology Study Section.
Date: September 17-18, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Alexandria Old Town, 1767 King Street, Alexandria,
VA 22314.
Contact Person: Elaine Sierra-Rivera, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6184, MSC 7804, Bethesda, MD
20892. 301-435-1779. riverase@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Microbiology and Epidemiology.
Date: September 18, 2009.
Time: 1 p.m. to 3 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: Liangbiao Zheng, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD 20892. 301-402-
5671. zhengli@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Alcohol and Toxicology.
Date: September 22-23, 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: Christine L. Melchior, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5176, MSC 7844, Bethesda, MD
20892. (301) 435-1713. melchioc@csr.nih.gov.
Name of Committee: Oncology 2--Translational Clinical Integrated
Review Group; Cancer Immunopathology and Immunotherapy Study
Section.
Date: September 23-24, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Mayflower Park Hotel, 405 Olive Way, Seattle, WA 98101.
Contact Person: Denise R. Shaw, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6158, MSC 7804, Bethesda, MD 20892. 301-435-
0198. shawdeni@csr.nih.gov.
Name of Committee: Brain Disorders and Clinical Neuroscience
Integrated Review Group; Cell Death in Neurodegeneration Study
Section.
Date: September 24-25, 2009.
Time: 8:30 a.m. to 6 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites Hotel, 1250 22nd Street, NW., Washington,
DC 20037.
Contact Person: Boris P. Sokolov, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217A, MSC 7846, Bethesda, MD
20892. 301-435-1197. bsokolov@csr.nih.gov.
Name of Committee: Integrative, Functional and Cognitive
Neuroscience Integrated Review Group; Biological Rhythms and Sleep
Study Section.
Date: September 29, 2009.
Time: 8 a.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: Michael Selmanoff, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1208, MSC 7844, Bethesda, MD
20892. 301-435-1119. mselmanoff@csr.nih.gov.
Name of Committee: Integrative, Functional and Cognitive
Neuroscience Integrated Review Group; Neuroendocrinology,
Neuroimmunology, and Behavior Study Section.
Date: September 30-October 1, 2009.
Time: 8 a.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: Michael Selmanoff, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3134, MSC 7844, Bethesda, MD
20892. 301-435-1119. mselmanoff@csr.nih.gov.
Name of Committee: Genes, Genomes, and Genetics Integrated
Review Group; Molecular Genetics B Study Section.
Date: September 30-October 1, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Mark Hopkins San Francisco, One Nob Hill, San Francisco,
CA 94108.
Contact Person: Richard A. Currie, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5128, MSC 7840, Bethesda, MD
20892. (301) 435-1219. currieri@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: August 17, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-20329 Filed 8-21-09; 8:45 am]
BILLING CODE 4140-01-P
