83 FR 1620 - Determination of Regulatory Review Period for Purposes of Patent Extension; PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 9 (January 12, 2018)

Page Range		1620-1621
FR Document		2018-00404

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

Federal Register, Volume 83 Issue 9 (Friday, January 12, 2018)

[Federal Register Volume 83, Number 9 (Friday, January 12, 2018)]
[Notices]
[Pages 1620-1621]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-00404]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-2516 and FDA-2016-E-2514]

Determination of Regulatory Review Period for Purposes of Patent
Extension; PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

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 PROACT ADJUSTABLE
CONTINENCE THERAPY FOR MEN and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of applications to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that medical device.

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 March
13, 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 July 11, 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 March 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of March 13, 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 Nos.
FDA-2016-E-2516 and FDA-2016-E-2514 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; PROACT ADJUSTABLE
CONTINENCE THERAPY FOR MEN.'' 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

[[Page 1621]]

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 medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (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 medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA has approved for marketing the medical device PROACT ADJUSTABLE
CONTINENCE THERAPY FOR MEN. PROACT ADJUSTABLE CONTINENCE THERAPY FOR
MEN is indicated for the treatment of adult men who have stress
incontinence arising from intrinsic sphincter deficiency of at least 12
months duration following radical prostatectomy or transurethral
resection of the prostate and who have failed to respond adequately to
conservative therapy. Subsequent to this approval, the USPTO received
patent term restoration applications for PROACT ADJUSTABLE CONTINENCE
THERAPY FOR MEN (U.S. Patent Nos. 7,014,606 and 7,828,716) from
Uromedica, Inc., and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated November 10, 2016, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN 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
PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN is 3,892 days. Of this
time, 3,179 days occurred during the testing phase of the regulatory
review period, while 713 days occurred during the approval phase. These
periods of time were derived from the following dates:
1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this
device became effective: March 31, 2005. The applicant claims that the
investigational device exemption (IDE) required under section 520(g) of
the FD&C Act for human tests to begin became effective on August 29,
2005. However, FDA records indicate that the IDE was determined
substantially complete for clinical studies to have begun on March 31,
2005, which represents the IDE effective date.
2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): December
12, 2013. The applicant claims June 19, 2013, as the date the premarket
approval application (PMA) for PROACT ADJUSTABLE CONTINENCE THERAPY FOR
MEN (PMA 130018) was initially submitted. However, FDA records indicate
that the PMA as submitted was not administratively complete for the
Agency to undertake a substantive review. FDA did not file this
application and notified the applicant of this fact by letter dated
September 13, 2013. The complete PMA was then submitted on December 12,
2013, which is considered to be the initially submitted date.
3. The date the application was approved: November 24, 2015. FDA
has verified the applicant's claim that PMA 130018 was approved on
November 24, 2015.
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 applications for patent extension,
this applicant seeks 1,827 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 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00404 Filed 1-11-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Notices 1621

Restoration Act (Pub. L. 100–670) II. Determination of Regulatory Review CFR 60.30), any interested person may
generally provide that a patent may be Period petition FDA for a determination
extended for a period of up to 5 years FDA has determined that the regarding whether the applicant for
so long as the patented item (human applicable regulatory review period for extension acted with due diligence
drug product, animal drug product, PROACT ADJUSTABLE CONTINENCE during the regulatory review period. To
medical device, food additive, or color THERAPY FOR MEN is 3,892 days. Of meet its burden, the petition must
additive) was subject to regulatory this time, 3,179 days occurred during comply with all the requirements of
review by FDA before the item was the testing phase of the regulatory § 60.30, including but not limited to:
marketed. Under these acts, a product’s review period, while 713 days occurred must be timely (see DATES), must be
regulatory review period forms the basis during the approval phase. These filed in accordance with § 10.20, must
for determining the amount of extension periods of time were derived from the contain sufficient facts to merit an FDA
an applicant may receive. following dates: investigation, and must certify that a
1. The date an exemption under true and complete copy of the petition
A regulatory review period consists of has been served upon the patent
two periods of time: A testing phase and section 520(g) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. applicant. (See H. Rept. 857, part 1, 98th
an approval phase. For medical devices, Cong., 2d sess., pp. 41–42, 1984.)
360j(g)) involving this device became
the testing phase begins with a clinical Petitions should be in the format
effective: March 31, 2005. The applicant
investigation of the device and runs specified in 21 CFR 10.30.
claims that the investigational device
until the approval phase begins. The exemption (IDE) required under section Submit petitions electronically to
approval phase starts with the initial 520(g) of the FD&C Act for human tests https://www.regulations.gov at Docket
submission of an application to market to begin became effective on August 29, No. FDA–2013–S–0610. Submit written
the device and continues until 2005. However, FDA records indicate petitions (two copies are required) to the
permission to market the device is that the IDE was determined Dockets Management Staff (HFA–305),
granted. Although only a portion of a substantially complete for clinical Food and Drug Administration, 5630
regulatory review period may count studies to have begun on March 31, Fishers Lane, Rm. 1061, Rockville, MD
toward the actual amount of extension 2005, which represents the IDE effective 20852.
that the Director of USPTO may award date. Dated: January 8, 2018.
(half the testing phase must be 2. The date an application was Leslie Kux,
subtracted as well as any time that may initially submitted with respect to the Associate Commissioner for Policy.
have occurred before the patent was device under section 515 of the FD&C [FR Doc. 2018–00404 Filed 1–11–18; 8:45 am]
issued), FDA’s determination of the Act (21 U.S.C. 360e): December 12, BILLING CODE 4164–01–P
length of a regulatory review period for 2013. The applicant claims June 19,
a medical device will include all of the 2013, as the date the premarket approval
testing phase and approval phase as application (PMA) for PROACT DEPARTMENT OF HEALTH AND
specified in 35 U.S.C. 156(g)(3)(B). ADJUSTABLE CONTINENCE THERAPY HUMAN SERVICES
FOR MEN (PMA 130018) was initially
FDA has approved for marketing the submitted. However, FDA records National Institutes of Health
medical device PROACT ADJUSTABLE indicate that the PMA as submitted was
CONTINENCE THERAPY FOR MEN. not administratively complete for the National Institute on Drug Abuse;
PROACT ADJUSTABLE CONTINENCE Agency to undertake a substantive Notice of Closed Meeting
THERAPY FOR MEN is indicated for review. FDA did not file this application
the treatment of adult men who have Pursuant to section 10(d) of the
and notified the applicant of this fact by
stress incontinence arising from Federal Advisory Committee Act, as
letter dated September 13, 2013. The
intrinsic sphincter deficiency of at least amended, notice is hereby given of the
complete PMA was then submitted on
12 months duration following radical following meeting.
December 12, 2013, which is considered
prostatectomy or transurethral resection The meeting will be closed to the
to be the initially submitted date.
of the prostate and who have failed to 3. The date the application was public in accordance with the
approved: November 24, 2015. FDA has provisions set forth in sections
respond adequately to conservative
verified the applicant’s claim that PMA 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
therapy. Subsequent to this approval,
130018 was approved on November 24, as amended. The contract proposals and
the USPTO received patent term the discussions could disclose
restoration applications for PROACT 2015.
This determination of the regulatory confidential trade secrets or commercial
ADJUSTABLE CONTINENCE THERAPY property such as patentable material,
FOR MEN (U.S. Patent Nos. 7,014,606 review period establishes the maximum
potential length of a patent extension. and personal information concerning
and 7,828,716) from Uromedica, Inc., individuals associated with the contract
and the USPTO requested FDA’s However, the USPTO applies several
statutory limitations in its calculations proposals, the disclosure of which
assistance in determining this patent’s would constitute a clearly unwarranted
eligibility for patent term restoration. In of the actual period for patent extension.
In its applications for patent extension, invasion of personal privacy.
a letter dated November 10, 2016, FDA Name of Committee: National Institute on
this applicant seeks 1,827 days of patent
advised the USPTO that this medical Drug Abuse Special Emphasis Panel, Digital
term extension.
device had undergone a regulatory Markers for Marijuana Intoxication (1218).
sradovich on DSK3GMQ082PROD with NOTICES

review period and that the approval of III. Petitions Date: January 30, 2018.
PROACT ADJUSTABLE CONTINENCE Time: 11:00 a.m. to 4:00 p.m.
Anyone with knowledge that any of
THERAPY FOR MEN represented the Agenda: To review and evaluate contract
the dates as published are incorrect may proposals.
first permitted commercial marketing or submit either electronic or written Place: National Institutes of Health,
use of the product. Thereafter, the comments and, under 21 CFR 60.24, ask Neuroscience Center, 6001 Executive
USPTO requested that FDA determine for a redetermination (see DATES). Boulevard, Rockville, MD 20852, (Telephone
the product’s regulatory review period. Furthermore, as specified in § 60.30 (21 Conference Call).

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Document Created: 2018-10-26 09:52:36
Document Modified: 2018-10-26 09:52:36

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 March 13, 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 July 11, 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 1620

83 FR 1620 - Determination of Regulatory Review Period for Purposes of Patent Extension; PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 9 (January 12, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration