Determination of Regulatory Review Period for Purposes of Patent Extension; OVIDREL, 13406-13407 [E6-3640]
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Federal Register / Vol. 71, No. 50 / Wednesday, March 15, 2006 / Notices
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[FR Doc. 06–2453 Filed 3–14–06; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
President’s Committee for People With
Intellectual Disabilities: Notice of
Meeting
AGENCY: President’s Committee for
People with Intellectual Disabilities
(PCPID), Administration for Children
and Families, HHS.
ACTION: Notice of meeting.
The meeting will be held on
Friday, March 24, 2006, from 3 p.m. to
5 p.m. Eastern Daylight Savings Time.
The full committee meeting of PCPID
will be conducted by telephone
conference call and will be open to the
public. Anyone interested in
participating in the conference call
should advise Ericka Alston at 202–
619–0634, no later than March 17, 2006.
ADDRESSES: The conference call may be
accessed by dialing, U.S. toll-free 1–
888–395–6878, and the passcode
‘‘March 2006’’ on the date and time
indicated.
SUMMARY: Pursuant to Section 10(a) of
the Federal Advisory Committee Act as
amended (5 U.S.C. Appendix 2) notice
is hereby given that the President’s
Committee for People with Intellectual
Disabilities will hold its first quarterly
meeting of 2006 by telephone
conference call. The conference call will
be open to the public to listen, with callins limited to the number of telephone
lines available. Individuals who plan to
call in and need special assistance, such
as TTY, assistive listening devices, or
materials in alternative format, should
inform Ericka Alston, Executive
Assistant, PCPID, Telephone—202–619–
0634, Fax—202–205–9519, E-mail:
ealston@acf.hhs.gov, no later than
March 10, 2006. Efforts will be made to
meet special requests received after that
sroberts on PROD1PC70 with NOTICES
DATES:
VerDate Aug<31>2005
17:27 Mar 14, 2006
Jkt 208001
date, but availability of special needs
accommodations to respond to these
requests cannot be guaranteed.
AGENDA: Committee members will be
briefed on the outcome of the March 22,
2006 Roundtable on Personal and
Economic Freedom for People with
Intellectual Disabilities: An Exploration
of Asset Development for People with
Intellectual Disabilities that will be
jointly sponsored by PCPID, the
Administration for Children and
Families’ Office of Community Services,
and the U.S. Department of Health and
Human Services’ Office of the Assistant
Secretary for Planning and Evaluation
(ASPE).
FOR FURTHER INFORMATION CONTACT:
Sally Atwater, Executive Director,
President’s Committee for People with
Intellectual Disabilities, Aerospace
Center Office Building, Suite 701, 901 D
Street, SW., Washington, DC 20447,
Telephone—202–619–0634, Fax—202–
205–9519, E-mail: satwater@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: PCPID
acts in an advisory capacity to the
President and the Secretary of Health
and Human Services on a broad range
of topics relating to programs, services
and supports for persons with
intellectual disabilities. The Committee,
by Executive Order, is responsible for
evaluating the adequacy of current
practices in programs, services and
supports for persons with intellectual
disabilities, and for reviewing legislative
proposals that impact the quality of life
experienced by citizens with
intellectual disabilities and their
families.
Dated: March 1, 2006.
Sally Atwater,
Executive Director, President’s Committee for
People with Intellectual Disabilities.
[FR Doc. E6–3642 Filed 3–14–06; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005E–0256]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; OVIDREL
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
OVIDREL and is publishing this notice
of that determination as required by
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
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:
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 OVIDREL
(choriogonadotropin alfa for injection).
OVIDREL is indicated for the induction
of final follicular maturation and early
luteinization in infertile women who
have undergone pituitary
desensitization and who have been
E:\FR\FM\15MRN1.SGM
15MRN1
sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 71, No. 50 / Wednesday, March 15, 2006 / Notices
appropriately treated with follicle
stimulating hormones as part of an
assisted reproductive technology
program such as in vitro fertilization
and embryo transfer. Ovidrel is also
indicated for the induction of ovulation
and pregnancy in anovulatory infertile
patients in whom the cause of infertility
is functional and not due to primary
ovarian failure. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for OVIDREL (U.S. Patent
No. 4,840,896) 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
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 OVIDREL 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
OVIDREL is 1,787 days. Of this time,
1,485 days occurred during the testing
phase of the regulatory review period,
while 302 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355) became effective: November 1,
1995. The applicant claims October 2,
1995, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was November 1,
1995, 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: November 24, 1999. The
applicant claims November 23, 1999, as
the date the new drug application
(NDA) for OVIDREL (NDA 21–149) was
initially submitted. However, FDA
records indicate that NDA 21–149 was
submitted on November 24, 1999.
3. The date the application was
approved: September 20, 2000. FDA has
verified the applicant’s claim that NDA
21–149 was approved on September 20,
2000.
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.
VerDate Aug<31>2005
17:27 Mar 14, 2006
Jkt 208001
In its application for patent extension,
this applicant seeks 1,054 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 May 15, 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
September 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 are to 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: February 13, 2006.
Jane Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–3640 Filed 3–14–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E–0039]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; CRESTOR
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
CRESTOR 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
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
13407
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 CRESTOR
(rosuvastatin calcium). CRESTOR is
indicated in the following ways: (1) As
an adjunct to diet to reduce elevated
total-C, LDL-C, ApoB, nonHDL-C, and
TG levels and to increase HDL-C in
patients with primary
hypercholesterolemia (heterozygous
familial and nonfamilial) and mixed
dyslipidemia (Frederickson Type IIa
and IIb); (2) as an adjunct to diet for the
treatment of patients with elevated
serum TG levels (Frederickson Type IV);
and (3) to reduce LDL-C, total-C, and
ApoB in patients with homozygous
E:\FR\FM\15MRN1.SGM
15MRN1
]]>Agencies
[Federal Register Volume 71, Number 50 (Wednesday, March 15, 2006)]
[Notices]
[Pages 13406-13407]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-3640]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005E-0256]
Determination of Regulatory Review Period for Purposes of Patent
Extension; OVIDREL
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for OVIDREL 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: 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 OVIDREL
(choriogonadotropin alfa for injection). OVIDREL is indicated for the
induction of final follicular maturation and early luteinization in
infertile women who have undergone pituitary desensitization and who
have been
[[Page 13407]]
appropriately treated with follicle stimulating hormones as part of an
assisted reproductive technology program such as in vitro fertilization
and embryo transfer. Ovidrel is also indicated for the induction of
ovulation and pregnancy in anovulatory infertile patients in whom the
cause of infertility is functional and not due to primary ovarian
failure. Subsequent to this approval, the Patent and Trademark Office
received a patent term restoration application for OVIDREL (U.S. Patent
No. 4,840,896) 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 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 OVIDREL
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
OVIDREL is 1,787 days. Of this time, 1,485 days occurred during the
testing phase of the regulatory review period, while 302 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 505 of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective:
November 1, 1995. The applicant claims October 2, 1995, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was November 1, 1995,
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: November 24, 1999.
The applicant claims November 23, 1999, as the date the new drug
application (NDA) for OVIDREL (NDA 21-149) was initially submitted.
However, FDA records indicate that NDA 21-149 was submitted on November
24, 1999.
3. The date the application was approved: September 20, 2000. FDA
has verified the applicant's claim that NDA 21-149 was approved on
September 20, 2000.
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 1,054 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 May 15, 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 September 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 are to 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: February 13, 2006.
Jane Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-3640 Filed 3-14-06; 8:45 am]
BILLING CODE 4160-01-S
