Determination of Regulatory Review Period for Purposes of Patent Extension; SENSIPAR, 22750-22751 [E9-11219]
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Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Notices
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[FR Doc. E9–11149 Filed 5–13–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2004–E–0266 (formerly
2004E–0446), FDA–2004–E–0270 (formerly
2004E–0391), and FDA–2004–E–0332
(formerly 2004E–0399)]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SENSIPAR
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SENSIPAR 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
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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 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 SENSIPAR
(cinacalcet hydrochloride). SENSIPAR
is indicated for the treatment of
secondary hyperparathyroidism in
patients with chronic kidney disease on
dialysis and for the treatment of
hypercalcemia in patients with
parathyroid carcinoma. Subsequent to
this approval, the Patent and Trademark
Office received patent term restoration
applications for SENSIPAR (U.S. Patent
Nos. 6,011,068; 6,211,244; and
6,313,146) from NPS Pharmaceuticals,
Inc., and the Patent and Trademark
Office requested FDA’s assistance in
determining the patents’ eligibilities for
patent term restoration. In a letter dated
October 19, 2004, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of SENSIPAR 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
SENSIPAR is 2,089 days. Of this time,
1,906 days occurred during the testing
phase of the regulatory review period,
while 183 days occurred during the
approval phase. These periods of time
were derived from the following dates:
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Federal Register / Vol. 74, No. 92 / Thursday, May 14, 2009 / Notices
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.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that the 10 drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Olivia Pritzlaff, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6308,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors must, with certain exceptions,
show that the drug for which they are
seeking approval contains the same
active ingredient in the same strength
and dosage form as the ‘‘listed drug,’’
which is a version of the drug that was
previously approved. Sponsors of
ANDAs do not have to repeat the
extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 355(j)(7)), which requires
FDA to publish a list of all approved
drugs. FDA publishes this list as part of
the ‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is withdrawn from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness, or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR
314.161(a)), the agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved; (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved; and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for reasons of
safety or effectiveness, the agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA has become aware that the drug
products listed in the table in this
document are no longer being marketed.
(As requested by the applicant, FDA
withdrew approval of NDA 18–821 for
REGLAN (metoclopramide) Oral
Solution in the Federal Register of
October 10, 2002 (67 FR 63107).)
Drug
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 21, 1998.
The applicant claims June 19, 1998, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was June 21, 1998,
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: September 8, 2003.
The applicant claims September 5,
2003, as the date the new drug
application (NDA) for SENSIPAR (NDA
21–688) was initially submitted.
However, FDA records indicate that
NDA 21–688 was submitted on
September 8, 2003, which is considered
to be the initially submitted date.
3. The date the application was
approved: March 8, 2004. FDA has
verified the applicant’s claim that NDA
21–688 was approved on March 8, 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 449 days of patent
term extension for U.S. Patent Nos.
6,011,068 and 6,313,146, and 627 days
of patent term extension for U.S. Patent
No. 6,211,244.
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 July 13, 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
November 10, 2009. 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,
Applicant
Dated: April 6, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research
[FR Doc. E9–11219 Filed 5–13–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0188]
Determination That DECADRON
Tablets and Nine Other Drug Products
Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Application No.
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22751
NDA 11–664
DECADRON (dexamethasone) Tablets, 0.5
milligram (mg) and 0.75 mg
Merck & Co., P.O. Box 4, BLA–20, West
Point, PA 19486
NDA 15–229
AMICAR (aminocaproic acid) Injection, 250
mg/milliliter (mL)
Xanodyne Pharmaceuticals, Inc., One Riverfront Pl., Newport, KY 41071–4563
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]]>Agencies
[Federal Register Volume 74, Number 92 (Thursday, May 14, 2009)]
[Notices]
[Pages 22750-22751]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-11219]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2004-E-0266 (formerly 2004E-0446), FDA-2004-E-0270
(formerly 2004E-0391), and FDA-2004-E-0332 (formerly 2004E-0399)]
Determination of Regulatory Review Period for Purposes of Patent
Extension; SENSIPAR
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for SENSIPAR 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 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 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 SENSIPAR
(cinacalcet hydrochloride). SENSIPAR is indicated for the treatment of
secondary hyperparathyroidism in patients with chronic kidney disease
on dialysis and for the treatment of hypercalcemia in patients with
parathyroid carcinoma. Subsequent to this approval, the Patent and
Trademark Office received patent term restoration applications for
SENSIPAR (U.S. Patent Nos. 6,011,068; 6,211,244; and 6,313,146) from
NPS Pharmaceuticals, Inc., and the Patent and Trademark Office
requested FDA's assistance in determining the patents' eligibilities
for patent term restoration. In a letter dated October 19, 2004, FDA
advised the Patent and Trademark Office that this human drug product
had undergone a regulatory review period and that the approval of
SENSIPAR 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
SENSIPAR is 2,089 days. Of this time, 1,906 days occurred during the
testing phase of the regulatory review period, while 183 days occurred
during the approval phase. These periods of time were derived from the
following dates:
[[Page 22751]]
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 21, 1998. The applicant claims June 19, 1998, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was June 21, 1998,
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: September 8,
2003. The applicant claims September 5, 2003, as the date the new drug
application (NDA) for SENSIPAR (NDA 21-688) was initially submitted.
However, FDA records indicate that NDA 21-688 was submitted on
September 8, 2003, which is considered to be the initially submitted
date.
3. The date the application was approved: March 8, 2004. FDA has
verified the applicant's claim that NDA 21-688 was approved on March 8,
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 449 days of
patent term extension for U.S. Patent Nos. 6,011,068 and 6,313,146, and
627 days of patent term extension for U.S. Patent No. 6,211,244.
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 July 13, 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 November 10,
2009. 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: April 6, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research
[FR Doc. E9-11219 Filed 5-13-09; 8:45 am]
BILLING CODE 4160-01-S
