81 FR 23722 - Determination of Regulatory Review Period for Purposes of Patent Extension; LUZU

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 78 (April 22, 2016)

Page Range		23722-23723
FR Document		2016-09374

The Food and Drug Administration (FDA) has determined the regulatory review period for LUZU 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Federal Register, Volume 81 Issue 78 (Friday, April 22, 2016)

[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23722-23723]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-09374]

[[Page 23722]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-2329]

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

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 LUZU 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 the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by June
21, 2016. 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 October 19, 2016.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-E-2329, For Determination of Regulatory Review Period for
Purposes of Patent Extension; LUZU. Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background

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 human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug 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 USPTO 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 has approved for marketing the human drug product LUZU
(luliconazole). LUZU is indicated for topical treatment of interdigital
tinea pedis, tinea cruris, and tinea corporis caused by the organisms
Tricophyton

[[Page 23723]]

rubrum and Epidermophyton floccosum in patients 18 years of age and
older. Subsequent to this approval, the USPTO received a patent term
restoration application for LUZU (U.S. Patent No. 5,900,488) from Nihon
Nohyaku Co., Ltd., and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated May 11, 2015, FDA advised the USPTO that this human drug
product had undergone a regulatory review period and that the approval
of LUZU represented the first permitted commercial marketing or use of
the product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

FDA has determined that the applicable regulatory review period for
LUZU is 2,242 days. Of this time, 1,903 days occurred during the
testing phase of the regulatory review period, while 339 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 Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: September 27, 2007. FDA has verified the Nihon Nohyaku Co.,
Ltd. claim that September 27, 2007, is the date the investigational new
drug application (IND) became effective.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
11, 2012. FDA has verified the applicant's claim that the new drug
application (NDA) for LUZU (NDA 204153) was initially submitted on
December 11, 2012.
3. The date the application was approved: November 14, 2013. FDA
has verified the applicant's claim that NDA 204153 was approved on
November 14, 2013.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,289 days of patent term extension.

III. Petitions

Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). 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.
To meet its burden, the petition must be timely (see DATES) and 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.
Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Dated: April 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09374 Filed 4-21-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices 23723

rubrum and Epidermophyton floccosum determination regarding whether the vitro diagnostic tests for detection of
in patients 18 years of age and older. applicant for extension acted with due Zika virus and/or diagnosis of Zika
Subsequent to this approval, the USPTO diligence during the regulatory review virus infection subject to the terms of
received a patent term restoration period. To meet its burden, the petition any authorization issued under the
application for LUZU (U.S. Patent No. must be timely (see DATES) and contain FD&C Act. The Authorization, which
5,900,488) from Nihon Nohyaku Co., sufficient facts to merit an FDA includes an explanation of the reasons
Ltd., and the USPTO requested FDA’s investigation. (See H. Rept. 857, part 1, for issuance, is reprinted in this
assistance in determining this patent’s 98th Cong., 2d sess., pp. 41–42, 1984.) document.
eligibility for patent term restoration. In Petitions should be in the format DATES: The Authorization is effective as
a letter dated May 11, 2015, FDA specified in 21 CFR 10.30. of March 17, 2016.
advised the USPTO that this human Submit petitions electronically to
drug product had undergone a ADDRESSES: Submit written requests for
http://www.regulations.gov at Docket
regulatory review period and that the No. FDA–2013–S–0610. Submit written single copies of the EUA to the Office
approval of LUZU represented the first petitions (two copies are required) to the of Counterterrorism and Emerging
permitted commercial marketing or use Division of Dockets Management (HFA– Threats, Food and Drug Administration,
of the product. Thereafter, the USPTO 305), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1,
requested that FDA determine the 5630 Fishers Lane, Rm. 1061, Rockville, Rm. 4338, Silver Spring, MD 20993–
product’s regulatory review period. MD 20852. 0002. Send one self-addressed adhesive
label to assist that office in processing
II. Determination of Regulatory Review Dated: April 18, 2016. your request or include a fax number to
Period Leslie Kux, which the Authorization may be sent.
FDA has determined that the Associate Commissioner for Policy. See the SUPPLEMENTARY INFORMATION
applicable regulatory review period for [FR Doc. 2016–09374 Filed 4–21–16; 8:45 am] section for electronic access to the
LUZU is 2,242 days. Of this time, 1,903 BILLING CODE 4164–01–P Authorization.
days occurred during the testing phase FOR FURTHER INFORMATION CONTACT:
of the regulatory review period, while Carmen Maher, Office of
339 days occurred during the approval DEPARTMENT OF HEALTH AND Counterterrorism and Emerging Threats,
phase. These periods of time were HUMAN SERVICES Food and Drug Administration, 10903
derived from the following dates: New Hampshire Ave., Bldg. 1, Rm.
1. The date an exemption under Food and Drug Administration
4347, Silver Spring, MD 20993–0002,
section 505(i) of the Federal Food, Drug, [Docket No. FDA–2016–N–0969] 301–796–8510 (this is not a toll free
and Cosmetic Act (the FD&C Act) (21 number).
U.S.C. 355(i)) became effective: Authorization of Emergency Use of an
September 27, 2007. FDA has verified In Vitro Diagnostic Device for SUPPLEMENTARY INFORMATION:
the Nihon Nohyaku Co., Ltd. claim that Detection of Zika Virus; Availability I. Background
September 27, 2007, is the date the
investigational new drug application AGENCY: Food and Drug Administration, Section 564 of the FD&C Act (21
(IND) became effective. HHS. U.S.C. 360bbb–3) as amended by the
2. The date the application was ACTION: Notice. Project BioShield Act of 2004 (Pub. L.
initially submitted with respect to the 108–276) and the Pandemic and All-
human drug product under section SUMMARY: The Food and Drug Hazards Preparedness Reauthorization
505(b) of the FD&C Act: December 11, Administration (FDA) is announcing the Act of 2013 (Pub. L. 113–5) allows FDA
2012. FDA has verified the applicant’s issuance of an Emergency Use to strengthen the public health
claim that the new drug application Authorization (EUA) (the Authorization) protections against biological, chemical,
(NDA) for LUZU (NDA 204153) was for an in vitro diagnostic device for nuclear, and radiological agents. Among
initially submitted on December 11, detection of Zika virus in response to other things, section 564 of the FD&C
2012. the Zika virus outbreak in the Americas. Act allows FDA to authorize the use of
3. The date the application was FDA issued this Authorization under an unapproved medical product or an
approved: November 14, 2013. FDA has the Federal Food, Drug, and Cosmetic unapproved use of an approved medical
verified the applicant’s claim that NDA Act (the FD&C Act), as requested by the product in certain situations. With this
204153 was approved on November 14, U.S. Centers for Disease Control and EUA authority, FDA can help assure
2013. Prevention (CDC). The Authorization that medical countermeasures may be
This determination of the regulatory contains, among other things, used in emergencies to diagnose, treat,
review period establishes the maximum conditions on the emergency use of the or prevent serious or life-threatening
potential length of a patent extension. authorized in vitro diagnostic device. diseases or conditions caused by
However, the USPTO applies several The Authorization follows the February biological, chemical, nuclear, or
statutory limitations in its calculations 26, 2016, determination by the radiological agents when there are no
of the actual period for patent extension. Department of Health and Human adequate, approved, and available
In its application for patent extension, Services (HHS) Secretary that there is a alternatives.
this applicant seeks 1,289 days of patent significant potential for a public health Section 564(b)(1) of the FD&C Act
term extension. emergency that has a significant provides that, before an EUA may be
mstockstill on DSK4VPTVN1PROD with NOTICES

potential to affect national security or issued, the Secretary of HHS must
III. Petitions the health and security of U.S. citizens declare that circumstances exist
Anyone with knowledge that any of living abroad and that involves Zika justifying the authorization based on
the dates as published are incorrect may virus. On the basis of such one of the following grounds: (1) A
submit either electronic or written determination, the HHS Secretary determination by the Secretary of
comments and ask for a redetermination declared on February 26, 2016, that Homeland Security that there is a
(see DATES). Furthermore, any interested circumstances exist justifying the domestic emergency, or a significant
person may petition FDA for a authorization of emergency use of in potential for a domestic emergency,

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by June 21, 2016. 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 October 19, 2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
Contact		Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
FR Citation		81 FR 23722

81 FR 23722 - Determination of Regulatory Review Period for Purposes of Patent Extension; LUZU

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 78 (April 22, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration