Center for Scientific Review; Amended Notice of Meeting, 37717 [E9-18023]
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Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Notices
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 DUREZOL
(difluprednate ophthalmic emulsion).
DUREZOL is indicated for the treatment
of inflammation and pain associated
with ocular surgery. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for DUREZOL (U.S. Patent
No. 6,114,319) from Senju
Pharmaceutical Co. Ltd., and the Patent
and Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated February 18, 2009, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of DUREZOL
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
DUREZOL is 560 days. Of this time, 369
days occurred during the testing phase
of the regulatory review period, while
181 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: December 13,
2006. FDA has verified the applicant’s
claim that the investigational new drug
application became effective on
December 13, 2006.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: December 26, 2007.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
DUREZOL (NDA 22–212) was initially
submitted on December 26, 2007.
3. The date the application was
approved: June 23, 2008. FDA has
verified the applicant’s claim that NDA
22–212 was approved on June 23, 2008.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
VerDate Nov<24>2008
18:30 Jul 28, 2009
Jkt 217001
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 369 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) written or
electronic comments and ask for a
redetermination by September 28, 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
January 25, 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: June 23, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–18034 Filed 7–28–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Special Emphasis Panel, July 27,
2009, 9 a.m. to July 28, 2009, 6 p.m.,
National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
which was published in the Federal
Register on July 1, 2009, 74 FR 31453–
31454.
The meeting will be held August 3,
2009 to August 4, 2009. The meeting
time and location remain the same. The
meeting is closed to the public.
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37717
Dated: July 23, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–18023 Filed 7–28–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; 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
Neurological Disorders and Stroke Special
Emphasis Panel; Go Applications.
Date: August 5, 2009.
Time: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call)
Contact Person: Raul A Saavedra, Ph.D.,
Scientific Review Administrator, Scientific
Review Branch, Division of Extramural
Research, NINDS/NIH/DHHS, NSC; 6001
Executive Blvd., Ste. 3208, Bethesda, MD
20892–9529, 301–496–9223,
saavedrr@ninds.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Go Applications.
Date: August 6, 2009.
Time: 10 a.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call)
Contact Person: Ernest W Lyons, Ph.D.
Scientific Review Administrator, Scientific
Review Branch, NINDS/NIH/DHHS,
Neuroscience Center, 6001 Executive Blvd.,
Suite 3208, MSC 952, Bethesda, MD 20892–
9529, 301–496–4056, lyonse@ninds.nih.gov.
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29JYN1
Agencies
[Federal Register Volume 74, Number 144 (Wednesday, July 29, 2009)]
[Notices]
[Page 37717]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18023]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Notice is hereby given of a change in the meeting of the Center for
Scientific Review Special Emphasis Panel, July 27, 2009, 9 a.m. to July
28, 2009, 6 p.m., National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 which was published in the Federal Register on July
1, 2009, 74 FR 31453-31454.
The meeting will be held August 3, 2009 to August 4, 2009. The
meeting time and location remain the same. The meeting is closed to the
public.
Dated: July 23, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-18023 Filed 7-28-09; 8:45 am]
BILLING CODE 4140-01-P