81 FR 12742 - National Institute of Neurological Disorders and Stroke; Notice of Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 47 (March 10, 2016)

Page Range		12742-12743
FR Document		2016-05335

Federal Register, Volume 81 Issue 47 (Thursday, March 10, 2016)

[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Pages 12742-12743]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05335]


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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.

[[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: http://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

12742 Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices

Restoration Act (Pub. L. 100–670) 1. The date an exemption under Dated: March 7, 2016.
generally provide that a patent may be section 505(i) of the Federal Food, Drug, Leslie Kux,
extended for a period of up to 5 years and Cosmetic Act (the FD&C Act) (21 Associate Commissioner for Policy.
so long as the patented item (human U.S.C. 355(i)) became effective: July 3, [FR Doc. 2016–05389 Filed 3–9–16; 8:45 am]
drug product, animal drug product, 2008. The applicant claims July 2, 2008, BILLING CODE 4164–01–P
medical device, food additive, or color as the date the investigational new drug
additive) was subject to regulatory application (IND) became effective.
review by FDA before the item was However, FDA records indicate that the DEPARTMENT OF HEALTH AND
marketed. Under these acts, a product’s IND effective date was July 3, 2008, HUMAN SERVICES
regulatory review period forms the basis
which was 30 days after FDA receipt of
for determining the amount of extension National Institutes of Health
the IND.
an applicant may receive.
A regulatory review period consists of 2. The date the application was National Institute of Neurological
two periods of time: A testing phase and initially submitted with respect to the Disorders and Stroke; Notice of
an approval phase. For human drug human drug product under section Meetings
products, the testing phase begins when 505(b) of the FD&C Act: October 19,
the exemption to permit the clinical Pursuant to section 10(d) of the
2012. FDA has verified the applicant’s
investigations of the drug becomes Federal Advisory Committee Act, as
claim that the new drug application
effective and runs until the approval amended (5 U.S.C. App.), notice is
(NDA) for OPSUMIT (NDA 204410) was hereby given of a meeting of the
phase begins. The approval phase starts initially submitted on October 19, 2012.
with the initial submission of an National Advisory Neurological
application to market the human drug 3. The date the application was Disorders and Stroke Council.
product and continues until FDA grants approved: October 18, 2013. FDA has The meeting will be open to the
permission to market the drug product. verified the applicant’s claim that NDA public as indicated below, with
Although only a portion of a regulatory 204410 was approved on October 18, attendance limited to space available.
review period may count toward the 2013. Individuals who plan to attend and
actual amount of extension that the This determination of the regulatory need special assistance, such as sign
Director of USPTO may award (for review period establishes the maximum language interpretation or other
example, half the testing phase must be potential length of a patent extension. reasonable accommodations, should
subtracted as well as any time that may notify the Contact Person listed below
However, the USPTO applies several
have occurred before the patent was in advance of the meeting.
statutory limitations in its calculations
issued), FDA’s determination of the The meeting will be closed to the
of the actual period for patent extension.
length of a regulatory review period for public in accordance with the
In its application for patent extension,
a human drug product will include all provisions set forth in sections
this applicant seeks 1,151 days of patent 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
of the testing phase and approval phase
term extension. as amended. The grant applications and
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the III. Petitions the discussions could disclose
human drug product OPSUMIT confidential trade secrets or commercial
(macitentan). OPSUMIT is indicated for Anyone with knowledge that any of property such as patentable materials,
the treatment of pulmonary arterial the dates as published are incorrect may and personal information concerning
hypertension to delay disease submit either electronic or written individuals associated with the grant
progression. Subsequent to this comments and ask for a redetermination applications, the disclosure of which
approval, the USPTO received a patent (see DATES). Furthermore, any interested would constitute a clearly unwarranted
term restoration application for person may petition FDA for a invasion of personal privacy.
OPSUMIT (U.S. Patent No. 7,094,781) determination regarding whether the Name of Committee: National Advisory
from Actelion Pharmaceuticals Ltd., and applicant for extension acted with due Neurological Disorders and Stroke Council.
the USPTO requested FDA’s assistance diligence during the regulatory review Date: May 26–27, 2016.
in determining this patent’s eligibility period. To meet its burden, the petition Open: May 26, 2016, 8:00 a.m. to 2:30 p.m.
for patent term restoration. In a letter must be timely (see DATES) and contain Agenda: Report by the Director, NINDS;
dated May 11, 2015, FDA advised the Report by the Associate Director for
sufficient facts to merit an FDA Extramural Research; Administrative and
USPTO that this human drug product
investigation. (See H. Rept. 857, part 1, Program Developments; and an Overview of
had undergone a regulatory review
98th Cong., 2d sess., pp. 41–42, 1984.) the NINDS Intramural Program.
period and that the approval of
Petitions should be in the format Place: National Institutes of Health,
OPSUMIT represented the first Building 31, 31 Center Drive, 6th Floor,
permitted commercial marketing or use specified in 21 CFR 10.30.
Conference Room 10, Bethesda, MD 20892.
of the product. Thereafter, the USPTO Submit petitions electronically to Closed: May 26, 2016, 2:30 p.m. to 4:45
requested that FDA determine the http://www.regulations.gov at Docket p.m.
product’s regulatory review period. No. FDA–2013–S–0610. Submit written Agenda: To review and evaluate grant
petitions (two copies are required) to the applications.
II. Determination of Regulatory Review Place: National Institutes of Health,
Period Division of Dockets Management (HFA–
Building 31, 31 Center Drive, 6th Floor,
305), Food and Drug Administration,
Conference Room 10, Bethesda, MD 20892.
mstockstill on DSK4VPTVN1PROD with NOTICES

FDA has determined that the 5630 Fishers Lane, Rm. 1061, Rockville,
applicable regulatory review period for Closed: May 26, 2016, 4:45 p.m. to 5:15
MD 20852. Petitions that have not been p.m.
OPSUMIT is 1,935 days. Of this time,
made publicly available on http:// Agenda: To review and evaluate the
1,570 days occurred during the testing Division of Intramural Research Board of
www.regulations.gov may be viewed in
phase of the regulatory review period, Scientific Counselors’ Reports.
the Division of Dockets Management
while 365 days occurred during the Place: National Institutes of Health,
approval phase. These periods of time between 9 a.m. and 4 p.m., Monday
Building 31, 31 Center Drive, 6th Floor,
were derived from the following dates: through Friday. Conference Room 10, Bethesda, MD 20892.

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Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices 12743

Closed: May 27, 2016, 8:00 a.m. to 11:00 Date: April 11, 2016. Drive, Room 7W266, Rockville, MD 20850,
a.m. Time: 8:30 a.m. to 4:30 p.m. 240–276–6385, lovingeg@mail.nih.gov.
Agenda: To review and evaluate grant Agenda: Advocacy Community This notice is being published less than 15
applications. Engagement in Future National Cancer days prior to the meeting due to the timing
Place: National Institutes of Health, Research Initiatives. limitations imposed by the review and
Building 31, 31 Center Drive, 6th Floor, Place: National Institutes of Health, 50 funding cycle.
Conference Room 10, Bethesda, MD 20892. South Drive, Building 50, Conference Rooms
Contact Person: Robert Finkelstein, Ph.D., (Catalogue of Federal Domestic Assistance
1328/1334, Bethesda, MD 20892.
Director of Extramural Research, National Program Nos. 93.392, Cancer Construction;
Contact Person: Amy Williams, NCI Office
Institute of Neurological Disorders and 93.393, Cancer Cause and Prevention
of Advocacy Relations, National Cancer
Stroke, NIH, 6001 Executive Blvd., Suite Research; 93.394, Cancer Detection and
Institute, NIH, 31 Center Drive, Building 31,
3309, MSC 9531, Bethesda, MD 20892, (301) Diagnosis Research; 93.395, Cancer
Room 10A28, Bethesda, MD 20892, 301–594–
496–9248. Treatment Research; 93.396, Cancer Biology
3194, williaam@mail.nih.gov.
Research; 93.397, Cancer Centers Support;
Any interested person may file written (Catalogue of Federal Domestic Assistance 93.398, Cancer Research Manpower; 93.399,
comments with the committee by forwarding Program Nos. 93.392, Cancer Construction; Cancer Control, National Institutes of Health,
the statement to the Contact Person listed on 93.393, Cancer Cause and Prevention
this notice. The statement should include the HHS)
Research; 93.394, Cancer Detection and
name, address, telephone number and when Diagnosis Research; 93.395, Cancer Dated: March 4, 2016.
applicable, the business or professional Treatment Research; 93.396, Cancer Biology David Clary,
affiliation of the interested person. Research; 93.397, Cancer Centers Support; Program Analyst, Office of Federal Advisory
In the interest of security, NIH has 93.398, Cancer Research Manpower; 93.399,
instituted stringent procedures for entrance Committee Policy.
Cancer Control, National Institutes of Health, [FR Doc. 2016–05333 Filed 3–9–16; 8:45 am]
onto the NIH campus. All visitor vehicles,
HHS)
including taxicabs, hotel, and airport shuttles BILLING CODE 4140–01–P
will be inspected before being allowed on Dated: March 4, 2016.
campus. Visitors will be asked to show one David Clary,
form of identification (for example, a DEPARTMENT OF HEALTH AND
Program Analyst, Office of Federal Advisory
government-issued photo ID, driver’s license, HUMAN SERVICES
Committee Policy.
or passport) and to state the purpose of their
visit. [FR Doc. 2016–05334 Filed 3–9–16; 8:45 am]
National Institutes of Health
Information is also available on the BILLING CODE 4140–01–P
Institute’s/Center’s home page: http://
Center For Scientific Review; Notice of
www.ninds.nih.gov, where an agenda and
any additional information for the meeting Closed Meetings
DEPARTMENT OF HEALTH AND
will be posted when available. HUMAN SERVICES Pursuant to section 10(d) of the
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Federal Advisory Committee Act, as
National Institutes of Health
Related to Neurological Disorders; 93.854, amended (5 U.S.C. App.), notice is
Biological Basis Research in the National Cancer Institute; Notice of hereby given of the following meetings.
Neurosciences, National Institutes of Health, Closed Meetings The meetings will be closed to the
HHS). public in accordance with the
Dated: March 3, 2016.
Pursuant to section 10(d) of the provisions set forth in sections
Federal Advisory Committee Act, as 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Sylvia L. Neal,
amended (5 U.S.C. App.), notice is as amended. The grant applications and
Program Analyst, Office of Federal Advisory hereby given of the following meeting.
Committee Policy. the discussions could disclose
The meeting will be closed to the confidential trade secrets or commercial
[FR Doc. 2016–05335 Filed 3–9–16; 8:45 am] public in accordance with the property such as patentable material,
BILLING CODE 4140–01–P provisions set forth in sections and personal information concerning
552b(c)(4) and 552b(c)(6), title 5 U.S.C., individuals associated with the grant
as amended. The contract proposals and applications, the disclosure of which
DEPARTMENT OF HEALTH AND the discussions could disclose
HUMAN SERVICES would constitute a clearly unwarranted
confidential trade secrets or commercial invasion of personal privacy.
National Institutes of Health property such as patentable material,
and personal information concerning Name of Committee: Center for Scientific
individuals associated with the contract Review Special Emphasis Panel; PAR–15–
National Cancer Institute; Notice of 356: Major Opportunities for Research in
Meeting proposals, the disclosure of which Epidemiology of Alzheimer’s Disease and
would constitute a clearly unwarranted Cognitive Resilience (R01).
Pursuant to section 10(a) of the invasion of personal privacy. Date: March 23, 2016.
Federal Advisory Committee Act, as Time: 11:00 a.m. to 4:00 p.m.
amended (5 U.S.C. App.), notice is Name of Committee: National Cancer
Institute Special Emphasis Panel; Cognitive Agenda: To review and evaluate grant
hereby given of a meeting of the Assessment of Cancer. applications.
National Cancer Institute Council of Date: March 16–17, 2016. Place: National Institutes of Health, 6701
Research Advocates. Time: 10:00 a.m. to 5:00 p.m. Rockledge Drive, Bethesda, MD 20892,
The meeting will be open to the Agenda: To review and evaluate contract (Virtual Meeting).
public, with attendance limited to space proposals. Contact Person: George Vogler, Ph.D.,
available. Individuals who plan to Place: National Cancer Institute, 9609 Scientific Review Officer, Center for
mstockstill on DSK4VPTVN1PROD with NOTICES

attend and need special assistance, such Medical Center Drive, Room 7W266, Scientific Review, National Institutes of
Rockville, MD 20850 (Telephone Conference Health, 6701 Rockledge Drive, Room 3140,
as sign language interpretation or other
Call). MSC 7770, Bethesda, MD 20892, (301) 237–
reasonable accommodations, should 2693, voglergp@csr.nih.gov.
Contact Person: Gerald G. Lovinger, Ph.D.,
notify the Contact Person listed below
Scientific Review Officer, Research This notice is being published less than 15
in advance of the meeting. Technology and Contract Review Branch, days prior to the meeting due to the timing
Name of Committee: National Cancer Division of Extramural Activities, National limitations imposed by the review and
Institute Council of Research Advocates. Cancer Institute, NIH, 9609 Medical Center funding cycle.

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Document Created: 2018-02-02 15:12:00
Document Modified: 2018-02-02 15:12:00

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
Dates		May 26-27, 2016.
FR Citation		81 FR 12742

81 FR 12742 - National Institute of Neurological Disorders and Stroke; Notice of Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 47 (March 10, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health