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Federal Register / Vol. 72, No.

57 / Monday, March 26, 2007 / Notices 14119

Administration, 5630 Fishers Lane, rm. eligibility for patent term restoration. In pp. 41–42, 1984.) Petitions should be in
1061, Rockville, MD 20852. Submit a letter dated June 14, 2006, FDA the format specified in 21 CFR 10.30.
electronic comments to http:// advised the Patent and Trademark Comments and petitions should be
www.fda.gov/dockets/ecomments. Office that this human drug product had submitted to the Division of Dockets
FOR FURTHER INFORMATION CONTACT: undergone a regulatory review period Management. Three copies of any
Beverly Friedman, Office of Regulatory and that the approval of REVLIMID mailed information are to be submitted,
Policy (HFD–7), Food and Drug represented the first permitted except that individuals may submit one
Administration, 5600 Fishers Lane, commercial marketing or use of the copy. Comments are to be identified
Rockville, MD 20857, 301–594–2041. product. Shortly thereafter, the Patent with the docket number found in
SUPPLEMENTARY INFORMATION: The Drug
and Trademark Office requested that brackets in the heading of this
Price Competition and Patent Term FDA determine the product’s regulatory document.
review period. Comments and petitions may be seen
Restoration Act of 1984 (Public Law 98–
FDA has determined that the in the Division of Dockets Management
417) and the Generic Animal Drug and
applicable regulatory review period for between 9 a.m. and 4 p.m., Monday
Patent Term Restoration Act (Public
REVLIMID is 2,069 days. Of this time, through Friday.
Law 100–670) generally provide that a
1,804 days occurred during the testing Dated: March 12, 2007.
patent may be extended for a period of
phase of the regulatory review period,
up to 5 years so long as the patented Jane A. Axelrad,
while 265 days occurred during the
item (human drug product, animal drug approval phase. These periods of time Associate Director for Policy, Center for Drug
product, medical device, food additive, were derived from the following dates:
Evaluation and Research.
or color additive) was subject to 1. The date an exemption under [FR Doc. E7–5439 Filed 3–23–07; 8:45 am]
regulatory review by FDA before the section 505(i) of the Federal Food, Drug, BILLING CODE 4160–01–S
item was marketed. Under these acts, a and Cosmetic Act (the act) (21 U.S.C.
product’s regulatory review period 355(i)) became effective: April 30, 2000.
forms the basis for determining the The applicant claims May 1, 2000, as DEPARTMENT OF HEALTH AND
amount of extension an applicant may the date the investigational new drug HUMAN SERVICES
receive. application (IND) became effective.
A regulatory review period consists of Food and Drug Administration
However, FDA records indicate that the
two periods of time: A testing phase and IND effective date was April 30, 2000, [Docket No. 2006E–0034]
an approval phase. For human drug which was 30 days after FDA receipt of
products, the testing phase begins when the IND. Determination of Regulatory Review
the exemption to permit the clinical 2. The date the application was Period for Purposes of Patent
investigations of the human drug initially submitted with respect to the Extension; PREVICOX
product becomes effective and runs human drug product under section
until the approval phase begins. The AGENCY: Food and Drug Administration,
505(b) of the act: April 7, 2005. FDA has HHS.
approval phase starts with the initial verified the applicant’s claim that the
submission of an application to market ACTION: Notice.
new drug application (NDA) for
the human drug product and continues REVLIMID (NDA 21–880) was initially SUMMARY: The Food and Drug
until FDA grants permission to market submitted on April 7, 2005. Administration (FDA) has determined
the drug product. Although only a 3. The date the application was the regulatory review period for
portion of a regulatory review period approved: December 27, 2005. FDA has PREVICOX and is publishing this notice
may count toward the actual amount of verified the applicant’s claim that NDA of that determination as required by
extension that the Director of Patents 21–880 was approved on December 27, law. FDA has made the determination
and Trademarks may award (for 2005. because of the submission of an
example, half the testing phase must be This determination of the regulatory application to the Director of Patents
subtracted as well as any time that may review period establishes the maximum and Trademarks, Department of
have occurred before the patent was potential length of a patent extension. Commerce, for the extension of a patent
issued), FDA’s determination of the However, the U.S. Patent and which claims that animal drug product.
length of a regulatory review period for Trademark Office applies several
ADDRESSES: Submit written comments
a human drug product will include all statutory limitations in its calculations
and petitions to the Division of Dockets
of the testing phase and approval phase of the actual period for patent extension.
Management (HFA–305), Food and Drug
as specified in 35 U.S.C. 156(g)(1)(B). In its application for patent extension,
Administration, 5630 Fishers Lane, rm.
FDA recently approved for marketing this applicant seeks 1,166 days of patent
1061, Rockville, MD 20852. Submit
the human drug product REVLIMID term extension.
electronic comments to http://
(lenalidomide). REVLIMID is indicated Anyone with knowledge that any of
www.fda.gov/dockets/ecomments.
for treatment of patients with the dates as published are incorrect may
transfusion-dependent anemia due to submit to the Division of Dockets FOR FURTHER INFORMATION CONTACT:
Low- or Intermediate-1-risk Management (see ADDRESSES) written or Beverly Friedman, Office of Regulatory
myelodysplastic syndromes associated electronic comments and ask for a Policy (HFD–007), Center for Drug
with a deletion 5q cytogenetic redetermination by May 25, 2007. Evaluation and Research, Food and
abnormality with or without additional Furthermore, any interested person may Drug Administration, 5600 Fishers
cytogenetic abnormalities. Subsequent petition FDA for a determination Lane, Rockville, MD 20857, 301–594–
to this approval, the Patent and regarding whether the applicant for 2041.
cprice-sewell on PROD1PC66 with NOTICES

Trademark Office received a patent term extension acted with due diligence SUPPLEMENTARY INFORMATION: The Drug
restoration application for REVLIMID during the regulatory review period by Price Competition and Patent Term
(U.S. Patent No. 5,635,517) from September 24, 2007. To meet its burden, Restoration Act of 1984 (Public Law 98–
Celgene Corp., and the Patent and the petition must contain sufficient facts 417) and the Generic Animal Drug and
Trademark Office requested FDA’s to merit an FDA investigation. (See H. Patent Term Restoration Act (Public
assistance in determining this patent’s Rept. 857, part 1, 98th Cong., 2d sess., Law 100–670) generally provide that a

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14120 Federal Register / Vol. 72, No. 57 / Monday, March 26, 2007 / Notices

patent may be extended for a period of approval phase. These periods of time Dated: March 12, 2007.
up to 5 years so long as the patented were derived from the following dates: Jane A. Axelrad,
item (human drug product, animal drug 1. The date an exemption under Associate Director for Policy, Center for Drug
product, medical device, food additive, section 512(j) of the Federal Food, Drug, Evaluation and Research.
or color additive) was subject to [FR Doc. E7–5443 Filed 3–23–07; 8:45 am]
and Cosmetic Act (the act) (21 U.S.C.
regulatory review by FDA before the BILLING CODE 4160–01–S
360b(j)) involving this animal drug
item was marketed. Under these acts, a
product’s regulatory review period product became effective: June 29, 1998.
forms the basis for determining the FDA has verified the applicant’s claim
DEPARTMENT OF HEALTH AND
amount of extension an applicant may that the date the investigational new HUMAN SERVICES
receive. animal drug application (INAD) became
A regulatory review period consists of effective was on June 29, 1998. Food and Drug Administration
two periods of time: A testing phase and 2. The date the application was [Docket No. 2006E–0046]
an approval phase. For animal drug initially submitted with respect to the
products, the testing phase begins on animal drug product under section Determination of Regulatory Review
the earlier date when either a major 512(b) of the act: April 15, 2004. FDA Period for Purposes of Patent
environmental effects test was initiated has verified the applicant’s claim that Extension; ONYX LES
for the drug or when an exemption the new animal drug Application
under section 512(j) of the Federal Food, AGENCY: Food and Drug Administration,
(NADA) for PREVICOX (NADA 141– HHS.
Drug, and Cosmetic Act (21 U.S.C.
360b(j)) became effective and runs until 230) was initially submitted on April
ACTION: Notice.
the approval phase begins. The approval 15, 2004.
phase starts with the initial submission 3. The date the application was SUMMARY: The Food and Drug
of an application to market the animal approved: July 21, 2004. FDA has Administration (FDA) has determined
drug product and continues until FDA verified the applicant’s claim that the regulatory review period for ONYX
grants permission to market the drug NADA 141–230 was approved on July LES and is publishing this notice of that
product. Although only a portion of a 21, 2004. determination as required by law. FDA
regulatory review period may count has made the determination because of
This determination of the regulatory
toward the actual amount of extension the submission of an application to the
review period establishes the maximum Director of Patents and Trademarks,
that the Director of Patents and
Trademarks may award (for example, potential length of a patent extension. Department of Commerce, for the
half the testing phase must be However, the U.S. Patent and extension of a patent which claims that
subtracted as well as any time that may Trademark Office applies several medical device.
have occurred before the patent was statutory limitations in its calculations
ADDRESSES: Submit written comments
issued), FDA’s determination of the of the actual period for patent extension. and petitions to the Division of Dockets
length of a regulatory review period for In its application for patent extension, Management (HFA–305), Food and Drug
a animal drug product will include all this applicant seeks 650 days of patent Administration, 5630 Fishers Lane, rm.
of the testing phase and approval phase term extension. 1061, Rockville, MD 20852. Submit
as specified in 35 U.S.C. 156(g)(4)(B). Anyone with knowledge that any of electronic comments tohttp://
FDA approved for marketing the the dates as published are incorrect may www.fda.gov/dockets/ecomments.
animal drug product PREVICOX submit to the Division of Dockets FOR FURTHER INFORMATION CONTACT:
(firocoxib). PREVICOX is indicated for
Management (see ADDRESSES) written or Beverly Friedman, Office of Regulatory
control of pain and inflammation
electronic comments and ask for a Policy (HFD–007), Food and Drug
associated with osteoarthritis in dogs.
Subsequent to this approval, the Patent redetermination by May 25, 2007. Administration, 5600 Fishers Lane,
and Trademark Office received a patent Furthermore, any interested person may Rockville, MD 20857, 301–594–2041.
term restoration application for petition FDA for a determination SUPPLEMENTARY INFORMATION: The Drug
PREVICOX (U.S. Patent No. 5,981,576) regarding whether the applicant for Price Competition and Patent Term
from Merck Frosst Canada & Co., and extension acted with due diligence Restoration Act of 1984 (Public Law 98–
the Patent and Trademark Office during the regulatory review period by 417) and the Generic Animal Drug and
requested FDA’s assistance in September 24, 2007. To meet its burden, Patent Term Restoration Act (Public
determining this patent’s eligibility for the petition must contain sufficient facts Law 100–670) generally provide that a
patent term restoration. In a letter dated to merit an FDA investigation. (See H. patent may be extended for a period of
June 14, 2006, FDA advised the Patent Rept. 857, part 1, 98th Cong., 2d sess., up to 5 years so long as the patented
and Trademark Office that this animal pp. 41–42, 1984.) Petitions should be in item (human drug product, animal drug
drug product had undergone a the format specified in 21 CFR 10.30. product, medical device, food additive,
regulatory review period and that the or color additive) was subject to
Comments and petitions are to be regulatory review by FDA before the
approval of PREVICOX represented the
submitted to the Division of Dockets item was marketed. Under these acts, a
first permitted commercial marketing or
use of the product. Shortly thereafter, Management. Three copies of any product’s regulatory review period
the Patent and Trademark Office mailed information are to be submitted, forms the basis for determining the
requested that FDA determine the except that individuals may submit one amount of extension an applicant may
product’s regulatory review period. copy. Comments are to be identified receive.
cprice-sewell on PROD1PC66 with NOTICES

FDA has determined that the with the docket number found in A regulatory review period consists of
applicable regulatory review period for brackets in the heading of this two periods of time: A testing phase and
PREVICOX is 2,216 days. Of this time, document. Comments and petitions may an approval phase. For medical devices,
2,118 days occurred during the testing be seen in the Division of Dockets the testing phase begins with a clinical
phase of the regulatory review period, Management between 9 a.m. and 4 p.m., investigation of the device and runs
while 98 days occurred during the Monday through Friday. until the approval phase begins. The

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