National Institute of Neurological Disorders and Stroke; Notice of Meetings, 12742-12743 [2016-05335]
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12742
Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices
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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 OPSUMIT
(macitentan). OPSUMIT is indicated for
the treatment of pulmonary arterial
hypertension to delay disease
progression. Subsequent to this
approval, the USPTO received a patent
term restoration application for
OPSUMIT (U.S. Patent No. 7,094,781)
from Actelion Pharmaceuticals 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
OPSUMIT 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
OPSUMIT is 1,935 days. Of this time,
1,570 days occurred during the testing
phase of the regulatory review period,
while 365 days occurred during the
approval phase. These periods of time
were derived from the following dates:
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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 3,
2008. The applicant claims July 2, 2008,
as the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was July 3, 2008,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: October 19,
2012. FDA has verified the applicant’s
claim that the new drug application
(NDA) for OPSUMIT (NDA 204410) was
initially submitted on October 19, 2012.
3. The date the application was
approved: October 18, 2013. FDA has
verified the applicant’s claim that NDA
204410 was approved on October 18,
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 1,151 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
https://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. Petitions that have not been
made publicly available on https://
www.regulations.gov may be viewed in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
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Dated: March 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05389 Filed 3–9–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Neurological
Disorders and Stroke Council.
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
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Neurological Disorders and Stroke Council.
Date: May 26–27, 2016.
Open: May 26, 2016, 8:00 a.m. to 2:30 p.m.
Agenda: Report by the Director, NINDS;
Report by the Associate Director for
Extramural Research; Administrative and
Program Developments; and an Overview of
the NINDS Intramural Program.
Place: National Institutes of Health,
Building 31, 31 Center Drive, 6th Floor,
Conference Room 10, Bethesda, MD 20892.
Closed: May 26, 2016, 2:30 p.m. to 4:45
p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, 6th Floor,
Conference Room 10, Bethesda, MD 20892.
Closed: May 26, 2016, 4:45 p.m. to 5:15
p.m.
Agenda: To review and evaluate the
Division of Intramural Research Board of
Scientific Counselors’ Reports.
Place: National Institutes of Health,
Building 31, 31 Center Drive, 6th Floor,
Conference Room 10, Bethesda, MD 20892.
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Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices
Closed: May 27, 2016, 8:00 a.m. to 11:00
a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, 6th Floor,
Conference Room 10, Bethesda, MD 20892.
Contact Person: Robert Finkelstein, Ph.D.,
Director of Extramural Research, National
Institute of Neurological Disorders and
Stroke, NIH, 6001 Executive Blvd., Suite
3309, MSC 9531, Bethesda, MD 20892, (301)
496–9248.
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.ninds.nih.gov, where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS).
Dated: March 3, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–05335 Filed 3–9–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK4VPTVN1PROD with NOTICES
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Cancer Institute Council of
Research Advocates.
The meeting will be open to the
public, 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.
Name of Committee: National Cancer
Institute Council of Research Advocates.
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Date: April 11, 2016.
Time: 8:30 a.m. to 4:30 p.m.
Agenda: Advocacy Community
Engagement in Future National Cancer
Research Initiatives.
Place: National Institutes of Health, 50
South Drive, Building 50, Conference Rooms
1328/1334, Bethesda, MD 20892.
Contact Person: Amy Williams, NCI Office
of Advocacy Relations, National Cancer
Institute, NIH, 31 Center Drive, Building 31,
Room 10A28, Bethesda, MD 20892, 301–594–
3194, williaam@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: March 4, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–05334 Filed 3–9–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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 Cancer
Institute Special Emphasis Panel; Cognitive
Assessment of Cancer.
Date: March 16–17, 2016.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Cancer Institute, 9609
Medical Center Drive, Room 7W266,
Rockville, MD 20850 (Telephone Conference
Call).
Contact Person: Gerald G. Lovinger, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
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12743
Drive, Room 7W266, Rockville, MD 20850,
240–276–6385, lovingeg@mail.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 Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: March 4, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–05333 Filed 3–9–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings 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
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–15–
356: Major Opportunities for Research in
Epidemiology of Alzheimer’s Disease and
Cognitive Resilience (R01).
Date: March 23, 2016.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: George Vogler, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3140,
MSC 7770, Bethesda, MD 20892, (301) 237–
2693, voglergp@csr.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.
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[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Pages 12742-12743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05335]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice
of Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of a meeting of the
National Advisory Neurological Disorders and Stroke Council.
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 the discussions could
disclose confidential trade secrets or commercial property such as
patentable materials, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Advisory Neurological Disorders and
Stroke Council.
Date: May 26-27, 2016.
Open: May 26, 2016, 8:00 a.m. to 2:30 p.m.
Agenda: Report by the Director, NINDS; Report by the Associate
Director for Extramural Research; Administrative and Program
Developments; and an Overview of the NINDS Intramural Program.
Place: National Institutes of Health, Building 31, 31 Center
Drive, 6th Floor, Conference Room 10, Bethesda, MD 20892.
Closed: May 26, 2016, 2:30 p.m. to 4:45 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Building 31, 31 Center
Drive, 6th Floor, Conference Room 10, Bethesda, MD 20892.
Closed: May 26, 2016, 4:45 p.m. to 5:15 p.m.
Agenda: To review and evaluate the Division of Intramural
Research Board of Scientific Counselors' Reports.
Place: National Institutes of Health, Building 31, 31 Center
Drive, 6th Floor, Conference Room 10, Bethesda, MD 20892.
[[Page 12743]]
Closed: May 27, 2016, 8:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Building 31, 31 Center
Drive, 6th Floor, Conference Room 10, Bethesda, MD 20892.
Contact Person: Robert Finkelstein, Ph.D., Director of
Extramural Research, National Institute of Neurological Disorders
and Stroke, NIH, 6001 Executive Blvd., Suite 3309, MSC 9531,
Bethesda, MD 20892, (301) 496-9248.
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.ninds.nih.gov, where an agenda and any additional
information for the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.853,
Clinical Research Related to Neurological Disorders; 93.854,
Biological Basis Research in the Neurosciences, National Institutes
of Health, HHS).
Dated: March 3, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-05335 Filed 3-9-16; 8:45 am]
BILLING CODE 4140-01-P
