[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Notices]
[Pages 30854-30855]
From the Federal Register Online via the Government Publishing 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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