National Institute of General Medical Sciences; Notice of Closed Meeting, 14672 [2011-6262]
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14672
Federal Register / Vol. 76, No. 52 / Thursday, March 17, 2011 / Notices
to this approval, the Patent and
Trademark Office received a patent term
restoration application for ISTODAX
(U.S. Patent No. 4,977,138) from
Gloucester Pharmaceuticals, Inc., and
the Patent and Trademark Office
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
September 30, 2010, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of ISTODAX 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
ISTODAX is 2,717 days. Of this time,
2,419 days occurred during the testing
phase of the regulatory review period,
while 298 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 FD&C Act) (21
U.S.C. 355(i)) became effective: May 31,
2002. The applicant claims April 30,
2002, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was May 31, 2002,
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 FD&C Act: January 12,
2009. FDA has verified the applicant’s
claim that the new drug application
(NDA) for ISTODAX (NDA 22–393) was
initially submitted on January 12, 2009.
3. The date the application was
approved: November 5, 2009. FDA has
verified the applicant’s claim that NDA
22–393 was approved on November 5,
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 1,523 days 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) either
electronic or written comments and ask
for a redetermination by May 16, 2011.
Furthermore, any interested person may
petition FDA for a determination
VerDate Mar<15>2010
15:48 Mar 16, 2011
Jkt 223001
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
September 13, 2011. 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.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
of the petition. Identify comments with
the docket number found in brackets in
the heading of this document.
Comments and petitions that have not
been made publicly available on
regulations.gov may be viewed in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: February 14, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2011–6162 Filed 3–16–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; 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 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
General Medical Sciences Special Emphasis
Panel; Eureka Applications.
Date: April 7–8, 2011.
Time: 9 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Room
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
3AN18, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Lisa A. Dunbar, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN12, Bethesda, MD
20892, 301–594–2849, dunbarl@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: March 11, 2011.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–6262 Filed 3–16–11; 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.
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; PAR09–247
Ancillary Clinical Studies: Nephropathy and
Urinary Incontinence.
Date: April 4, 2011.
Time: 1 p.m. to 4:30 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: Ann A. Jerkins, PhD,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 759, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, 301–594–2242,
jerkinsa@niddk.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
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[Federal Register Volume 76, Number 52 (Thursday, March 17, 2011)]
[Notices]
[Page 14672]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6262]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of General Medical Sciences; 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 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 General Medical
Sciences Special Emphasis Panel; Eureka Applications.
Date: April 7-8, 2011.
Time: 9 a.m. to 4 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Natcher Building, 45
Center Drive, Room 3AN18, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Lisa A. Dunbar, PhD, Scientific Review Officer,
Office of Scientific Review, National Institute of General Medical
Sciences, National Institutes of Health, 45 Center Drive, Room
3AN12, Bethesda, MD 20892, 301-594-2849, dunbarl@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.375,
Minority Biomedical Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology, Physiology, and
Biological Chemistry Research; 93.862, Genetics and Developmental
Biology Research; 93.88, Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National Institutes of Health, HHS)
Dated: March 11, 2011.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-6262 Filed 3-16-11; 8:45 am]
BILLING CODE 4140-01-P
