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Federal Register / Vol. 71, No.

56 / Thursday, March 23, 2006 / Notices 14709

DEPARTMENT OF HEALTH AND review period may count toward the verified the applicant’s claim that NDA
HUMAN SERVICES actual amount of extension that the 21–754 was approved on March 16,
Director of Patents and Trademarks may 2005.
Food and Drug Administration award (for example, half the testing This determination of the regulatory
[Docket No. 2005E–0252] phase must be subtracted, as well as any review period establishes the maximum
time that may have occurred before the potential length of a patent extension.
Determination of Regulatory Review patent was issued), FDA’s determination However, the U.S. Patent and
Period for Purposes of Patent of the length of a regulatory review Trademark Office applies several
Extension; MYCAMINE period for a human drug product will statutory limitations in its calculations
include all of the testing phase and of the actual period for patent extension.
AGENCY: Food and Drug Administration, approval phase as specified in 35 U.S.C.
HHS. In its application for patent extension,
156(g)(1)(B). this applicant seeks 476 days of patent
ACTION: Notice. FDA recently approved for marketing
term extension.
the human drug product MYCAMINE
SUMMARY: The Food and Drug (micafungin sodium). MYCAMINE is Anyone with knowledge that any of
Administration (FDA) has determined indicated for treatement of patients with the dates as published are incorrect may
the regulatory review period for esophageal candidiasis and prophylaxis submit to the Division of Dockets
MYCAMINE and is publishing this of Candida infections in patients Management (see ADDRESSES) written or
notice of that determination as required undergoing hematopoietic stem cell electronic comments and ask for a
by law. FDA has made the transplantation. Subsequent to this redetermination by May 22, 2006.
determination because of the approval, the Patent and Trademark Furthermore, any interested person may
submission of an application to the Office received a patent term restoration petition FDA for a determination
Director of Patents and Trademarks, application for MYCAMINE (U.S. Patent regarding whether the applicant for
Department of Commerce, for the No. 5,376,634) from Astellas Pharma, extension acted with due diligence
extension of a patent that claims that Inc., and the Patent and Trademark during the regulatory review period by
human drug product. Office requested FDA’s assistance in September 19, 2006. To meet its burden,
ADDRESSES: Submit written comments determining this patent’s eligibility for the petition must contain sufficient facts
and petitions to the Division of Dockets patent term restoration. In a letter dated to merit an FDA investigation. (See H.
Management (HFA–305), Food and Drug July 8, 2005, FDA advised the Patent Rept. 857, part 1, 98th Cong., 2d sess.,
Administration, 5630 Fishers Lane, rm. and Trademark Office that this human pp. 41–42, 1984.) Petitions should be in
1061, Rockville, MD 20852. Submit drug product had undergone a the format specified in 21 CFR 10.30.
electronic comments to http:// regulatory review period and that the Comments and petitions should be
www.fda.gov/dockets/ecomments. approval of MYCAMINE represented the submitted to the Division of Dockets
FOR FURTHER INFORMATION CONTACT:
first permitted commercial marketing or Management. Three copies of any
Claudia V. Grillo, Office of Regulatory use of the product. Shortly thereafter, mailed information are to be submitted,
Policy (HFD–013), Food and Drug the Patent and Trademark Office except that individuals may submit one
requested that FDA determine the copy. Comments are to be identified
Administration, 5600 Fishers Lane,
product’s regulatory review period. with the docket number found in
Rockville, MD 20857, 240–453–6681.
FDA has determined that the
SUPPLEMENTARY INFORMATION: The Drug brackets in the heading of this
applicable regulatory review period for
Price Competition and Patent Term document. Comments and petitions may
MYCAMINE is 2,546 days. Of this time,
Restoration Act of 1984 (Public Law 98– be seen in the Division of Dockets
2,221 days occurred during the testing
417) and the Generic Animal Drug and Management between 9 a.m. and 4 p.m.,
phase of the regulatory review period,
Patent Term Restoration Act (Public Monday through Friday.
while 325 days occurred during the
Law 100–670) generally provide that a approval phase. These periods of time Dated: February 13, 2006.
patent may be extended for a period of were derived from the following dates: Jane A. Axelrad,
up to 5 years so long as the patented 1. The date an exemption under Associate Director for Policy, Center for Drug
item (human drug product, animal drug section 505 of the Federal Food, Drug, Evaluation and Research.
product, medical device, food additive, and Cosmetic Act (the act) (21 U.S.C. [FR Doc. E6–4165 Filed 3–22–06; 8:45 am]
or color additive) was subject to 355) became effective: March 29, 1998. BILLING CODE 4160–01–S
regulatory review by FDA before the The applicant claims June 30, 2003, as
item was marketed. Under these acts, a the date the investigational new drug
product’s regulatory review period application (IND) became effective. DEPARTMENT OF HEALTH AND
forms the basis for determining the However, FDA records indicate that the HUMAN SERVICES
amount of extension an applicant may IND effective date was March 29, 1998,
receive. which was 30 days after FDA receipt of Health Resources and Services
A regulatory review period consists of the IND. Administration
two periods of time: A testing phase and 2. The date the application was
an approval phase. For human drug initially submitted with respect to the National Advisory Council on Nurse
products, the testing phase begins when human drug product under section 505 Education and Practice; Notice of
the exemption to permit the clinical of the act: April 26, 2004. The applicant Meeting
investigations of the drug becomes claims April 23, 2004, as the date the
effective and runs until the approval new drug application (NDA) for In accordance with section 10(a)(2) of
phase begins. The approval phase starts MYCAMINE (NDA 21–754) was initially the Federal Advisory Committee Act
wwhite on PROD1PC61 with NOTICES

with the initial submission of an submitted. However, FDA records (Public Law 92–463), notice is hereby
application to market the human drug indicate that NDA 21–754 was given of the following meeting:
product and continues until FDA grants submitted on April 26, 2004. Name: National Advisory Council on
permission to market the drug product. 3. The date the application was Nurse Education and Practice
Although only a portion of a regulatory approved: March 16, 2005. FDA has (NACNEP).

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