Determination of Regulatory Review Period for Purposes of Patent Extension; INCRELEX, 34135-34136 [E6-9138]
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Federal Register / Vol. 71, No. 113 / Tuesday, June 13, 2006 / Notices
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of the community in coping with this
event; and building support systems,
which will aid in preventing future
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Dated: June 2, 2006.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. E6–9136 Filed 6–12–06; 8:45 am]
[Docket No. 2006E–0025]
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Operations, toll-free at 877–922–9262.
SUPPLEMENTARY INFORMATION: This
award will be made pursuant to Section
803 of the Native American Programs
Act of 1974.
Dated: June 7, 2006.
Kimberly Romine,
Deputy Commissioner, Administration for
Native Americans.
[FR Doc. E6–9209 Filed 6–12–06; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Determination of Regulatory Review
Period for Purposes of Patent
Extension; INCRELEX
BILLING CODE 4140–01–P
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Administration for Children and
Families
Administration for Native Americans
jlentini on PROD1PC65 with NOTICES
AGENCY: Administration for Native
Americans, Administration for Children
and Families, HHS.
ACTION: Award announcement.
SUMMARY: The Administration for
Native Americans (ANA) herein
announces a Program Expansion
Supplement to the Red Lake Band of
Chippewa Indians, Red Lake,
Minnesota. This supplement for
$136,400 will extend funding for 11
youth volunteers through the second
year of the project. In FY 2005, ANA
provided an urgent grant award to the
Tribe to assist in mitigating the effects
of the tragic events of the school
shooting in March 2005 that resulted in
the death of students, faculty and staff.
The shooting marked the highest death
toll in U.S. school shootings since the
Columbine High School massacre in
April 1999.
Due to the devastation created by the
high school shooting, ANA is providing
urgent financial assistance for minor
renovations to the local community
centers to support positive community
development; funding to hire 11
VerDate Aug<31>2005
16:40 Jun 12, 2006
Jkt 208001
Food and Drug Administration,
HHS.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
INCRELEX 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
that 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
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,
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
34135
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 human drug
product 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 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 INCRELEX
(mecasermin [rDNA origin] injection).
INCRELEX is indicated for the long-term
treatment of growth failure in children
with severe primary IGF–1 deficiency
(Primary IGFD) or with growth hormone
gene deletion who have developed
neutralizing antibodies to growth
hormone. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for INCRELEX (U.S. Patent
No. 5,681,814) from Genentech, 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
February 24, 2006, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of INCRELEX represented the
first permitted commercial marketing or
use of the product. Shortly 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
INCRELEX is 4,828 days. Of this time,
4,644 days occurred during the testing
phase of the regulatory review period,
while 184 days occurred during the
approval phase. These periods of time
were derived from the following dates:
E:\FR\FM\13JNN1.SGM
13JNN1
jlentini on PROD1PC65 with NOTICES
34136
Federal Register / Vol. 71, No. 113 / Tuesday, June 13, 2006 / Notices
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: June 13, 1992.
The applicant claims June 16, 1992, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was June 13, 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(b) of the act: February 28, 2005.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
Increlex (NDA 21–839) was initially
submitted on February 28, 2005.
3. The date the application was
approved: August 30, 2005. FDA has
verified the applicant’s claim that NDA
21–839 was approved on August 30,
2005.
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 1,058 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 August 14, 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
December 11, 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.
VerDate Aug<31>2005
16:40 Jun 12, 2006
Jkt 208001
Dated: May 17, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–9138 Filed 6–12–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E–0026]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; LUVERIS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
LUVERIS 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–007), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
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 human drug
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
product 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 LUVERIS
(lutropin alfa). LUVERIS, concomitantly
administered with follitropin alfa for
injection, is indicated for stimulation of
follicular development in infertile
hypogonadotropic hypogonadal women
with profound luteinizing hormone
deficiency. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for LUVERIS (U.S. Patent
No. 5,639,639) from Genzyme Corp.,
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 24, 2006, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of LUVERIS represented the
first permitted commercial marketing or
use of the product. Shortly 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
LUVERIS is 3,927 days. Of this time,
2,670 days occurred during the testing
phase of the regulatory review period,
while 1,257 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 9,
1994. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on January 9, 1994.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: May 1, 2001. FDA has
verified the applicant’s claim that the
new drug application (NDA) for Luveris
E:\FR\FM\13JNN1.SGM
13JNN1
]]>Agencies
[Federal Register Volume 71, Number 113 (Tuesday, June 13, 2006)]
[Notices]
[Pages 34135-34136]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9138]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E-0025]
Determination of Regulatory Review Period for Purposes of Patent
Extension; INCRELEX
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for INCRELEX 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
that 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-594-2041.
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 human drug product 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 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 INCRELEX
(mecasermin [rDNA origin] injection). INCRELEX is indicated for the
long-term treatment of growth failure in children with severe primary
IGF-1 deficiency (Primary IGFD) or with growth hormone gene deletion
who have developed neutralizing antibodies to growth hormone.
Subsequent to this approval, the Patent and Trademark Office received a
patent term restoration application for INCRELEX (U.S. Patent No.
5,681,814) from Genentech, 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 February 24, 2006, FDA
advised the Patent and Trademark Office that this human drug product
had undergone a regulatory review period and that the approval of
INCRELEX represented the first permitted commercial marketing or use of
the product. Shortly 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
INCRELEX is 4,828 days. Of this time, 4,644 days occurred during the
testing phase of the regulatory review period, while 184 days occurred
during the approval phase. These periods of time were derived from the
following dates:
[[Page 34136]]
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:
June 13, 1992. The applicant claims June 16, 1992, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was June 13, 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(b) of the act: February 28,
2005. FDA has verified the applicant's claim that the new drug
application (NDA) for Increlex (NDA 21-839) was initially submitted on
February 28, 2005.
3. The date the application was approved: August 30, 2005. FDA has
verified the applicant's claim that NDA 21-839 was approved on August
30, 2005.
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 1,058 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 August 14, 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 December 11,
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: May 17, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-9138 Filed 6-12-06; 8:45 am]
BILLING CODE 4160-01-S
