Determination of Regulatory Review Period for Purposes of Patent Extension; OMACOR, 5669-5670 [E6-1365]
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Federal Register / Vol. 71, No. 22 / Thursday, February 2, 2006 / Notices
hsrobinson on PROD1PC71 with NOTICES
indicate that the IND effective date was
December 24, 1992, 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
of the act: September 27, 2002. FDA has
verified the applicant’s claim that the
new drug application (NDA) for ALOXI
(NDA 21–372) was initially submitted
on September 27, 2002.
3. The date the application was
approved: July 25, 2003. FDA has
verified the applicant’s claim that NDA
21–372 was approved on July 25, 2003.
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 1,827 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 April 3, 2006.
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
August 1, 2006. 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: January 5, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 06–903 Filed 2–1–06; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
15:26 Feb 01, 2006
Jkt 208001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2005E–0258, 2005E–0247, and
2005E–0233]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; OMACOR
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
OMACOR and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of three
applications to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of three
patents that claim that human drug
product.
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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Claudia V. Grillo, Office of Regulatory
Policy (HFD–013), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 240–453–6681.
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.
ADDRESSES:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
5669
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 OMACOR
(omega–3–acid ethyl esters). OMACOR
is indicated as an adjunct to diet to
reduce very high (= 500 milligrams per
deciliter) triglyceride levels in adult
patients. Subsequent to this approval,
the Patent and Trademark Office
received three patent term restoration
applications for OMACOR (U.S. Patent
Nos. 5,656,667, 5,698,594, and
5,502,077) from Pronova Biocare AS,
and the Patent and Trademark Office
requested FDA’s assistance in
determining these patents’ eligibility for
patent term restoration. In a letter dated
July 8, 2005, FDA advised the Patent
and Trademark Office that this human
drug product had undergone a
regulatory review period and that the
approval of OMACOR 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
OMACOR is 3,712 days. Of this time,
3,408 days occurred during the testing
phase of the regulatory review period,
while 304 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: September 14,
1994. The applicant claims August 15,
1994, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was September 14,
1994, 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
of the act: January 12, 2004. FDA has
verified the applicant’s claim that the
new drug application (NDA) for
OMACOR (NDA 21–654) was initially
submitted on January 12, 2004.
3. The date the application was
approved: November 10, 2004. FDA has
verified the applicant’s claim that NDA
E:\FR\FM\02FEN1.SGM
02FEN1
5670
Federal Register / Vol. 71, No. 22 / Thursday, February 2, 2006 / Notices
21–654 was approved on November 10,
2004.
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 1,477 (U.S. Patent
No. 5,656,667), 1,413 (U.S. Patent No.
5,698,594), and 1,728 (U.S. Patent No.
5,502,077) days of patent term
extension.
Anyone with knowledge that any of
the dates as published is incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by April 3, 2006.
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
August 1, 2006. 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: January 5, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–1365 Filed 2–1–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Emerging Infectious Diseases
Laboratories Record of Decision
hsrobinson on PROD1PC71 with NOTICES
ACTION:
Notice.
SUMMARY: The Department of Health and
Human Services, the National Institutes
of Health (NIH), has decided, after
completion of a Final Environmental
Impact Statement (FEIS) and a thorough
consideration of the public comments
on the Draft EIS and Supplemental EIS,
VerDate Aug<31>2005
15:26 Feb 01, 2006
Jkt 208001
to implement the Proposed Action,
which is identified as the Preferred
Alternative in the Final EIS. This action
is to partially fund the construction of
a state-of-the-art National
Biocontainment Laboratory (NBL), to be
called the National Emerging Infectious
Diseases Laboratories (NEIDL), at the
Boston University Medical Center
(BUMC) Campus in Boston,
Massachusetts.
FOR FURTHER INFORMATION CONTACT:
Valerie Nottingham, Chief of the
Environmental Quality Branch, Division
of Environmental Protection, Office of
Research Facilities Development and
Operations, NIH, Building 13, Room
2W64, 9000 Rockville Pike, Bethesda,
MD 20892, Fax 301–480–8056, e-mail
nihnepa@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
Decision
After careful review of the
environmental consequences in the
Final Environmental Impact Statement
for the National Emerging Infectious
Diseases Laboratories (Final NEIDL EIS),
and consideration of public comment
throughout the NEPA process, the NIH
has decided to implement the Proposed
Action described below as the Selected
Alternative.
Selected Alternative
The NIH plans to partially fund the
construction of a state-of the art
National Biocontainment Laboratory,
which will be known as the National
Emerging Infectious Diseases
Laboratories (NEIDL), on the Boston
University Medical Center Campus in
Boston, Massachusetts. The NIH will
fund approximately $128 million
dollars. The proposed NEIDL will
enhance national security through the
development and evaluation of
improved diagnostics, therapeutics, and
vaccines for the protection against
naturally emerging and re-emerging
diseases, including those that have the
potential for bioterrorism. The proposed
NEIDL will not conduct research to
develop biological weapons.
The proposed NEIDL facility will be
a new steel and reinforced concrete
seven-story building that will be
constructed within the BioSquare
Research Park, with a total assignable
area of 84,100 square feet, and will
house Biosafety Level (BSL)–4, BSL–3,
and BSL–2 facilities, BSL–4 and BSL–3
animal facilities, an Arthropod
Containment Level (ACL)–3 insectary,
offices, conference rooms, and support
facilities including an effluent treatment
room, secure loading dock, and
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
dedicated mechanical floors to enhance
containment features of the building.
The proposed NEIDL facility will be
designed to safely support all the
superimposed loads applied to the
building and will be constructed to the
requirements of Seismic Performance
Category C, which assures that the
building structure stays functional after
a seismic event. In addition to standby
generators to provide power in the event
of a power outage, the NEIDL facility
will have a distributed on-line
uninterruptible power supply to power
the BSL–4 laboratory biosafety cabinets,
critical building control panels and
alarms. The four biosafety levels have
increasingly stringent design, security,
and containment requirements. The
safety levels are determined based on
the biological materials used in research
and the ways they affect the human
population. BSL–1 facilities have no
requirements for safety equipment,
while BSL–4 facilities have extensive
and multiple requirements for safety
equipment and facility design such as
isolation, buffer zones, airflow and
pressure requirements, and high
efficiency particulate air (HEPA)
filtration.
The building also will be provided
with an environmental monitoring
system to assess room pressure
differentials (to ensure negative pressure
in the biocontainment areas), smoke
detection, and the pressure drop
condition HEPA filters. Visual
indicators (such as pressure gauges) and
audible or strobic alarms will alert
NEIDL personnel in the event of an
emergency or situation that requires
corrective action or other response. The
NEIDL will have fire protection systems
that meet or exceed requirements
specified by the National Fire Protection
Association and all applicable local,
state, Federal, and BUMC requirements.
The design of the proposed NEIDL
facility’s BSL–4, –3, and –2 laboratories
will comply with the recommendations
and requirements of the Centers for
Disease Control (CDC) and the NIH joint
publication addressing biosafety in
laboratories, the current edition
Biosafety in Microbiological and
Biomedical Laboratories, as well as
NIH’s Design Policies and Guidelines
for Biomedical Research Laboratories.
The BSL–4, –3, –2 animal laboratories
will further comply with the
recommendations and requirements of
the latest edition of Guide for Care and
Use of Laboratory Animals, published
by the National Research Council.
The BSL–4 laboratory environment
employs the concept of a ‘‘box-withina-box’’ principle, whereby the
laboratory is built within a pressure-
E:\FR\FM\02FEN1.SGM
02FEN1
Agencies
[Federal Register Volume 71, Number 22 (Thursday, February 2, 2006)]
[Notices]
[Pages 5669-5670]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1365]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2005E-0258, 2005E-0247, and 2005E-0233]
Determination of Regulatory Review Period for Purposes of Patent
Extension; OMACOR
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for OMACOR and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of three applications to the Director of
Patents and Trademarks, Department of Commerce, for the extension of
three patents that 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of
Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 240-453-6681.
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.
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 OMACOR
(omega-3-acid ethyl esters). OMACOR is indicated as an adjunct to diet
to reduce very high (= 500 milligrams per deciliter) triglyceride
levels in adult patients. Subsequent to this approval, the Patent and
Trademark Office received three patent term restoration applications
for OMACOR (U.S. Patent Nos. 5,656,667, 5,698,594, and 5,502,077) from
Pronova Biocare AS, and the Patent and Trademark Office requested FDA's
assistance in determining these patents' eligibility for patent term
restoration. In a letter dated July 8, 2005, FDA advised the Patent and
Trademark Office that this human drug product had undergone a
regulatory review period and that the approval of OMACOR 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
OMACOR is 3,712 days. Of this time, 3,408 days occurred during the
testing phase of the regulatory review period, while 304 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:
September 14, 1994. The applicant claims August 15, 1994, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was September
14, 1994, 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 of the act: January 12, 2004.
FDA has verified the applicant's claim that the new drug application
(NDA) for OMACOR (NDA 21-654) was initially submitted on January 12,
2004.
3. The date the application was approved: November 10, 2004. FDA
has verified the applicant's claim that NDA
[[Page 5670]]
21-654 was approved on November 10, 2004.
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 1,477 (U.S.
Patent No. 5,656,667), 1,413 (U.S. Patent No. 5,698,594), and 1,728
(U.S. Patent No. 5,502,077) days of patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by April 3, 2006. 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 August 1,
2006. 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: January 5, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-1365 Filed 2-1-06; 8:45 am]
BILLING CODE 4160-01-S