National Institute on Drug Abuse; Notice of Closed Meeting, 1621-1622 [2018-00445]
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Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Notices
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.
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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 § 60.30 (21
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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
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 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.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel, Digital
Markers for Marijuana Intoxication (1218).
Date: January 30, 2018.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
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Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Notices
Contact Person: Julia Berzhanskaya, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, Division of
Extramural Research, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
Boulevard, Room 4234, MSC 9550, Bethesda,
MD 20892, 301–827–5840,
julia.berzhanskaya@nih.gov.
(Catalogue of Federal Domestic Assistance
Program No.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: January 9, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–00445 Filed 1–11–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
sradovich on DSK3GMQ082PROD with NOTICES
Fogarty International Center; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Fogarty International
Center Advisory Board.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications
and/or contract proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Fogarty
International Center Advisory Board.
Date: February 12–13, 2018.
Place: National Institutes of Health
Lawton L. Chiles International House
(Stone House), Building 16, Conference
Room, 16 Center Drive, Bethesda, MD
20892.
Closed Session: February 12, 2018,
2:00 p.m. to 5:00 p.m.
Agenda: Second level review of grant
applications.
Date: February 13, 2018.
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Place: National Institutes of Health.
Lawton L. Chiles International House
(Stone House), Building 16, Conference
Room, 16 Center Drive, Bethesda, MD
20892.
Open Session: February 13, 2018, 9:00
a.m. to 3:00 p.m.
Agenda: Update and discussion of
current and planned FIC activities.
Contact Person: Kristen Weymouth,
Executive Secretary, Fogarty
International Center, National Institutes
of Health, 31 Center Drive, Room
B2C02, Bethesda, MD 20892, (301) 496–
1415, kristen.weymouth@nih.gov.
Any interested person may file
written comments with the committee
by forwarding the statement to the
Contact Person listed on this notice. The
statement should include the name,
address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for
entrance onto the NIH campus. All
visitor vehicles, including taxicabs,
hotel, and airport shuttles will be
inspected before being allowed on
campus. Visitors will be asked to show
one form of identification (for example,
a government-issued photo ID, driver’s
license, or passport) and to state the
purpose of their visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.fic.nih.gov/About/Advisory/Pages/
default.aspx, where an agenda and any
additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic
Assistance Program Nos. 93.106,
Minority International Research
Training Grant in the Biomedical and
Behavioral Sciences; 93.154, Special
International Postdoctoral Research
Program in Acquired Immunodeficiency
Syndrome; 93.168, International
Cooperative Biodiversity Groups
Program; 93.934, Fogarty International
Research Collaboration Award; 93.989,
Senior International Fellowship Awards
Program, National Institutes of Health,
HHS)
Dated: January 9, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel,
Development of Portable Neuromodulatory
Devices for the Treatment of Substance Use
Disorders (8941).
Date: January 17, 2018.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Julia Berzhanskaya, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, Division of
Extramural Research, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
Boulevard, Room 4234, MSC 9550, Bethesda,
MD 20892, 301–827–5840,
julia.berzhanskaya@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program No.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: January 9, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
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[Federal Register Volume 83, Number 9 (Friday, January 12, 2018)]
[Notices]
[Pages 1621-1622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00445]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The contract proposals and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the contract proposals, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel, Digital Markers for Marijuana Intoxication (1218).
Date: January 30, 2018.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852, (Telephone Conference
Call).
[[Page 1622]]
Contact Person: Julia Berzhanskaya, Ph.D., Scientific Review
Officer, Office of Extramural Policy and Review, Division of
Extramural Research, National Institute on Drug Abuse, NIH, DHHS,
6001 Executive Boulevard, Room 4234, MSC 9550, Bethesda, MD 20892,
301-827-5840, [email protected].
(Catalogue of Federal Domestic Assistance Program No.: 93.279, Drug
Abuse and Addiction Research Programs, National Institutes of
Health, HHS)
Dated: January 9, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-00445 Filed 1-11-18; 8:45 am]
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