83 FR 5633 - Determination of Regulatory Review Period for Purposes of Patent Extension; JUBLIA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 27 (February 8, 2018)

Page Range		5633-5634
FR Document		2018-02522

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for JUBLIA 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 83 Issue 27 (Thursday, February 8, 2018)

[Federal Register Volume 83, Number 27 (Thursday, February 8, 2018)]
[Notices]
[Pages 5633-5634]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-02522]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-1664]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for JUBLIA 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 April
9, 2018. 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 August 7, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 9, 2018. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2015-E-1664 for ''Determination of Regulatory Review Period for
Purposes of Patent Extension; JUBLIA.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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 Sec. 10.20 (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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 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.

[[Page 5634]]

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 JUBLIA
(efinaconazole). JUBLIA is indicated for the topical treatment of
onychomycosis of the toenails due to Tricophyton rubrum and
Trichophyton mentagrophytes. Subsequent to this approval, the USPTO
received a patent term restoration application for JUBLIA (U.S. Patent
No. 7,214,506) from Kaken Pharmaceutical Co., Ltd., and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated November 4, 2015, FDA
advised the USPTO that this human drug product had undergone a
regulatory review period and that the approval of JUBLIA 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
JUBLIA is 2,521 days. Of this time, 1,840 days occurred during the
testing phase of the regulatory review period, while 681 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: July 14, 2007. FDA has verified the applicant's claim that
the date the investigational new drug application (IND) became
effective was on July 14, 2007.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: July 26,
2012. FDA has verified the applicant's claim that the new drug
application (NDA) for JUBLIA (NDA 203567) was initially submitted on
July 26, 2012.
3. The date the application was approved: June 6, 2014. FDA has
verified the applicant's claim that NDA 203567 was approved on June 6,
2014.
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 1,601 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, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec. 60.30 (21 CFR 60.30), 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 comply with all the requirements
of Sec. 60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec. 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (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 https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Dated: January 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02522 Filed 2-7-18; 8:45 am]
BILLING CODE 4164-01-P

5634 Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Notices

A regulatory review period consists of 505(b) of the FD&C Act: July 26, 2012. ACTION: Notice.
two periods of time: A testing phase and FDA has verified the applicant’s claim
an approval phase. For human drug that the new drug application (NDA) for SUMMARY: In compliance with the
products, the testing phase begins when JUBLIA (NDA 203567) was initially requirement of the Paperwork
the exemption to permit the clinical submitted on July 26, 2012. Reduction Act of 1995, the Office of the
investigations of the drug becomes 3. The date the application was Secretary (OS), Department of Health
effective and runs until the approval approved: June 6, 2014. FDA has and Human Services, is publishing the
phase begins. The approval phase starts verified the applicant’s claim that NDA following summary of a proposed
with the initial submission of an 203567 was approved on June 6, 2014. collection for public comment.
application to market the human drug This determination of the regulatory DATES: Comments on the ICR must be
product and continues until FDA grants review period establishes the maximum received on or before March 12, 2018.
permission to market the drug product. potential length of a patent extension. ADDRESSES: Submit your comments to
Although only a portion of a regulatory However, the USPTO applies several OIRA_submission@omb.eop.gov or via
review period may count toward the statutory limitations in its calculations facsimile to (202) 395–5806.
actual amount of extension that the of the actual period for patent extension. FOR FURTHER INFORMATION CONTACT:
Director of USPTO may award (for In its application for patent extension, Sherrette Funn, Sherrette.Funn@hhs.gov
example, half the testing phase must be this applicant seeks 1,601 days of patent or (202) 795–7714. When requesting
subtracted as well as any time that may term extension. information, please include the
have occurred before the patent was document identifier 0937–0191–30D
issued), FDA’s determination of the III. Petitions
and project title for reference.
length of a regulatory review period for Anyone with knowledge that any of
SUPPLEMENTARY INFORMATION: Interested
a human drug product will include all the dates as published are incorrect may
persons are invited to send comments
of the testing phase and approval phase submit either electronic or written
as specified in 35 U.S.C. 156(g)(1)(B). regarding this burden estimate or any
comments and, under 21 CFR 60.24, ask
FDA has approved for marketing the other aspect of this collection of
for a redetermination (see DATES).
human drug product JUBLIA information, including any of the
Furthermore, as specified in § 60.30 (21
(efinaconazole). JUBLIA is indicated for following subjects: (1) The necessity and
CFR 60.30), any interested person may
the topical treatment of onychomycosis utility of the proposed information
petition FDA for a determination
of the toenails due to Tricophyton collection for the proper performance of
regarding whether the applicant for
rubrum and Trichophyton the agency’s functions; (2) the accuracy
extension acted with due diligence
mentagrophytes. Subsequent to this of the estimated burden; (3) ways to
during the regulatory review period. To
approval, the USPTO received a patent enhance the quality, utility, and clarity
meet its burden, the petition must
term restoration application for JUBLIA of the information to be collected; and
comply with all the requirements of
(U.S. Patent No. 7,214,506) from Kaken (4) the use of automated collection
§ 60.30, including but not limited to:
Pharmaceutical Co., Ltd., and the techniques or other forms of information
Must be timely (see DATES), must be
USPTO requested FDA’s assistance in technology to minimize the information
filed in accordance with § 10.20, must
determining this patent’s eligibility for collection burden.
contain sufficient facts to merit an FDA Title of the Collection: Application
patent term restoration. In a letter dated investigation, and must certify that a
November 4, 2015, FDA advised the packets for Real Property for Public
true and complete copy of the petition Health Purposes.
USPTO that this human drug product has been served upon the patent
had undergone a regulatory review Type of Collection: Revision.
applicant. (See H. Rept. 857, part 1, 98th OMB No.: 0937–0191–30D—Office
period and that the approval of JUBLIA Cong., 2d sess., pp. 41–42, 1984.)
represented the first permitted within OS—Office of Assistant
Petitions should be in the format Secretary for Administration, Program
commercial marketing or use of the specified in 21 CFR 10.30.
product. Thereafter, the USPTO Support Center, Real Estate, Logistics
Submit petitions electronically to and Operations Support, Federal
requested that FDA determine the https://www.regulations.gov at Docket
product’s regulatory review period. Property Assistance Program.
No. FDA–2013–S–0610. Submit written Abstract: The Office of Assistant
II. Determination of Regulatory Review petitions (two copies are required) to the Secretary for Administration, Program
Period Dockets Management Staff (HFA–305), Support Center Federal Property
Food and Drug Administration, 5630 Assistance Program is requesting
FDA has determined that the
Fishers Lane, Rm. 1061, Rockville, MD approval by OMB on a revision. Cited,
applicable regulatory review period for
20852. 40 U.S.C. 550, as amended, provides
JUBLIA is 2,521 days. Of this time,
1,840 days occurred during the testing Dated: January 31, 2018. authority to the Secretary of Health and
phase of the regulatory review period, Leslie Kux, Human Services to convey or lease
while 681 days occurred during the Associate Commissioner for Policy. surplus real property to States and their
approval phase. These periods of time [FR Doc. 2018–02522 Filed 2–7–18; 8:45 am] political subdivisions and
were derived from the following dates: BILLING CODE 4164–01–P
instrumentalities, to tax-supported
1. The date an exemption under institutions, and to nonprofit
section 505(i) of the Federal Food, Drug, institutions which, (except for
and Cosmetic Act (the FD&C Act) (21 DEPARTMENT OF HEALTH AND institutions which lease property to
U.S.C. 355(i)) became effective: July 14, HUMAN SERVICES assist the homeless) have been held
daltland on DSKBBV9HB2PROD with NOTICES

2007. FDA has verified the applicant’s exempt from taxation under Section
[Document Identifier: 0937–0191–30D] 501(c)(3) of the 1954 Internal Revenue
claim that the date the investigational
new drug application (IND) became Agency Information Collection Code, and 501(c)(19) for veterans
effective was on July 14, 2007. Request. 30-Day Public Comment organizations, for public health
2. The date the application was Request purposes. Title V of the McKinney-
initially submitted with respect to the Vento Homeless Assistance Act (Title V)
human drug product under section AGENCY: Office of the Secretary, HHS. extended the Secretary’s authority to

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Document Created: 2018-02-08 00:16:17
Document Modified: 2018-02-08 00:16:17

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 April 9, 2018. 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 August 7, 2018. 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		83 FR 5633

83 FR 5633 - Determination of Regulatory Review Period for Purposes of Patent Extension; JUBLIA

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 27 (February 8, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration