Determination of Regulatory Review Period for Purposes of Patent Extension; TAPENTADOL HYDROCHLORIDE, 45225-45226 [E9-21100]
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Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices
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invasion of personal privacy.
Name of Committee: National Advisory
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Date: September 21, 2009.
Open: 8 a.m. to 12:30 p.m.
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NICHD; (2) and annual review of the Division
of Intramural Research; (3) Intellectual and
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Dated: August 25, 2009.
Jennifer Spaeth,
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Committee Policy.
[FR Doc. E9–21045 Filed 8–31–09; 8:45 am]
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Food and Drug Administration
National Institute on Alcohol Abuse
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[Docket No. FDA–2009–E–0058]
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Jennifer Spaeth,
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Committee Policy.
[FR Doc. E9–20862 Filed 8–31–09; 8:45 am]
BILLING CODE 4140–01–M
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Determination of Regulatory Review
Period for Purposes of Patent
Extension; TAPENTADOL
HYDROCHLORIDE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
TAPENTADOL HYDROCHLORIDE and
is publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of a patent which claims 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
E:\FR\FM\01SEN1.SGM
01SEN1
mstockstill on DSKH9S0YB1PROD with NOTICES
45226
Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices
permission to market the drug product.
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 TAPENTADOL
HYDROCHLORIDE (tapentadol
hydrochloride). TAPENTADOL
HYDROCHLORIDE is indicated for the
relief of moderate to severe acute pain
in patients 18 years of age or older.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
TAPENTADOL HYDROCHLORIDE (U.S.
Patent No. RE 39,593) from Grunenthal
GmbH, 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 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 TAPENTADOL
HYDROCHLORIDE 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
TAPENTADOL HYDROCHLORIDE is
2,880 days. Of this time, 2,577 days
occurred during the testing phase of the
regulatory review period, while 303
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: January 3,
2001. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on January 3, 2001.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: January 23, 2008. FDA
has verified the applicant’s claim that
the new drug application (NDA) 22–304
was submitted on January 23, 2008, as
the date the NDA for TAPENTADOL
HYDROCHLORIDE (NDA 22–304) was
initially submitted.
VerDate Nov<24>2008
17:18 Aug 31, 2009
Jkt 217001
3. The date the application was
approved: November 20, 2008. FDA has
verified the applicant’s claim that NDA
22–304 was approved on November 20,
2008.
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 1,492 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 November 2, 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
March 1, 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 8, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–21100 Filed 8–31–09; 8:45 am]
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Inspections, LP, as a commercial gauger
and laboratory.
SUMMARY: Notice is hereby given that,
pursuant to 19 CFR 151.12 and 19 CFR
151.13, Chemical and Petrochemical
Inspections, LP, 5300 39th Street,
Groves, TX 77619, has been approved to
gauge and accredited to test petroleum
and petroleum products, organic
chemicals and vegetable oils for
customs purposes, in accordance with
the provisions of 19 CFR 151.12 and 19
CFR 151.13. Anyone wishing to employ
this entity to conduct laboratory
analyses and gauger services should
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Border Protection to conduct the
specific test or gauger service requested.
Alternatively, inquires regarding the
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may be directed to the U.S. Customs and
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of Chemical and Petrochemical
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and laboratory became effective on June
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Scientific Services, U.S. Customs and
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Avenue, NW., Suite 1500N,
Washington, DC 20229, 202–344–1060.
Dated: August 25, 2009.
Ira S. Reese,
Executive Director, Laboratories and
Scientific Services.
[FR Doc. E9–21106 Filed 8–31–09; 8:45 am]
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SECURITY
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U.S. Customs and Border Protection
DEPARTMENT OF HOMELAND
SECURITY
Accreditation and Approval of
Chemical and Petrochemical
Inspections, LP, as a Commercial
Gauger and Laboratory
AGENCY: U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Notice of accreditation and
approval of Chemical and Petrochemical
PO 00000
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U.S. Customs and Border Protection
Accreditation and Approval of SGS
North America, Inc., as a Commercial
Gauger and Laboratory
AGENCY: U.S. Customs and Border
Protection, Department of Homeland
Security.
E:\FR\FM\01SEN1.SGM
01SEN1
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[Federal Register Volume 74, Number 168 (Tuesday, September 1, 2009)]
[Notices]
[Pages 45225-45226]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21100]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-E-0058]
Determination of Regulatory Review Period for Purposes of Patent
Extension; TAPENTADOL HYDROCHLORIDE
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for TAPENTADOL HYDROCHLORIDE and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of Patents and Trademarks, Department of Commerce, for the
extension of a patent which claims 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
[[Page 45226]]
permission to market the drug product. 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
TAPENTADOL HYDROCHLORIDE (tapentadol hydrochloride). TAPENTADOL
HYDROCHLORIDE is indicated for the relief of moderate to severe acute
pain in patients 18 years of age or older. Subsequent to this approval,
the Patent and Trademark Office received a patent term restoration
application for TAPENTADOL HYDROCHLORIDE (U.S. Patent No. RE 39,593)
from Grunenthal GmbH, 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 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 TAPENTADOL
HYDROCHLORIDE 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
TAPENTADOL HYDROCHLORIDE is 2,880 days. Of this time, 2,577 days
occurred during the testing phase of the regulatory review period,
while 303 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:
January 3, 2001. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
January 3, 2001.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: January 23,
2008. FDA has verified the applicant's claim that the new drug
application (NDA) 22-304 was submitted on January 23, 2008, as the date
the NDA for TAPENTADOL HYDROCHLORIDE (NDA 22-304) was initially
submitted.
3. The date the application was approved: November 20, 2008. FDA
has verified the applicant's claim that NDA 22-304 was approved on
November 20, 2008.
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 1,492 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 November 2, 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 March
1, 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 8, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-21100 Filed 8-31-09; 8:45 am]
BILLING CODE 4160-01-S