Document ID: FDA-2012-E-0595-0007
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent
Extension; ZACTRAN
Posted Date: 2014-05-29T04:00Z

[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Notices]
[Pages 30854-30855]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12350]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-0595]

Determination of Regulatory Review Period for Purposes of Patent 
Extension; ZACTRAN

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for ZACTRAN 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 animal drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written petitions (two copies are required) and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
Submit petitions electronically to http://www.regulations.gov at Docket 
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of 
Management, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver 
Spring, MD 20993-0002, 301-796-7900.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Pub. L. 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 animal drug products, the 
testing phase begins on the earlier date when either a major 
environmental effects test was initiated for the drug or when an 
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 360b(j)) became effective and runs until 
the approval phase begins. The approval phase starts with the initial 
submission of an application to market the animal 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 an animal drug product will include all of the testing phase 
and approval phase as specified in 35 U.S.C. 156(g)(4)(B).
    FDA has approved for marketing the animal drug product ZACTRAN 
(gamithromycin). ZACTRAN, an animal drug product, is indicated for the 
treatment of bovine respiratory disease (BRD) associated with 
Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in 
beef and non-lactating dairy cattle. ZACTRAN is also indicated for the 
control of respiratory disease in beef and non-lactating dairy cattle 
at high risk of developing BRD associated with M. haemolytica and P. 
multocida. Subsequent to this approval, the Patent and Trademark Office 
received a patent term restoration application for ZACTRAN (U.S. Patent 
No. 5,985,844) from Merck Sharp & Dohme 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 1, 2013, FDA advised the Patent and Trademark Office that this 
animal drug product had undergone a regulatory review period and that 
the approval of ZACTRAN represented the first permitted commercial 
marketing or use of the product. 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 
ZACTRAN is 2,990 days. Of this time, 2,930 days occurred during the 
testing phase of the regulatory review period, while 60 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 FD&C Act (21 
U.S.C. 355(i)) became effective: April 11, 2003. The applicant claims 
September 11, 1997, as the date the investigational new animal drug 
application (INAD) became effective. However, FDA records indicate that 
the INAD effective date was April 11, 2003, which was the date a major 
health or environmental effects test is begun or the date on which the 
Agency acknowledges the filing of a notice of claimed investigational 
exemption for a new animal drug, whichever is earlier.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512 of the FD&C Act (21 U.S.C. 
360b): April 18, 2011. The applicant claims April 15, 2011, as the date 
the new animal drug application (NADA) for ZACTRAN (NADA 141-328) was 
initially submitted. However, FDA records indicate that NADA 141-328 
was submitted on April 18, 2011.
    3. The date the application was approved: June 16, 2011. FDA has 
verified the applicant's claim that NADA 141-328 was approved on June 
16, 2011.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the 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 1,826 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) either electronic or written comments and ask for a 
redetermination by July 28, 2014. 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 25, 2014. 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.,

[[Page 30855]]

pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 
10.30.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments and written or 
electronic petitions. It is only necessary to send one set of comments. 
Identify comments with the docket number found in brackets in the 
heading of this document. If you submit a written petition, two copies 
are required. A petition submitted electronically must be submitted to 
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and 
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12350 Filed 5-28-14; 8:45 am]
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