National Institute on Drug Abuse; Notice of Closed Meetings, 57166-57167 [2013-22502]
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Federal Register / Vol. 78, No. 180 / Tuesday, September 17, 2013 / Notices
and 2012, respectively, and 100, 91, and
112 NDA supplements in 2010, 2011,
and 2012, respectively, for which
submission of a patent declaration
would be required. We estimate there
will be 201 instances (based on an
average of 100 NDAs filed and 101 NDA
supplements filed per year) where an
NDA holder would be affected by the
patent declaration requirements. We
estimate, based on a proportional
increase from the number of
declarations for approved NDAs, that
there will be an annual total of 563
declarations (201 instances × 2.8
declarations per instance = 563
declarations) on Form FDA 3542a
submitted with these applications.
Based upon information provided by
regulated entities and other information,
we previously estimated that the
information collection burden
associated with § 314.50(h) (citing
§ 314.53) and FDA Forms 3542 and
3542a will be approximately 5 hours
and 20 hours per response, respectively.
Dated: September 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–22540 Filed 9–16–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Antiviral Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Antiviral Drugs
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
DATES: Date and Time: The meeting will
be held on October 24, 2013, from 8 a.m.
to 5 p.m.
Location: Sheraton Silver Spring
Hotel, Cypress Ballroom, 8777 Georgia
Ave., Silver Spring, MD. The hotel
phone number is 301–589–0800.
Contact Person: Karen AbrahamBurrell, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
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Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, email: AVAC@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
new drug application (NDA) 205123,
simeprevir (a hepatitis C virus protease
inhibitor), manufactured by Janssen
Pharmaceutical Co., with a proposed
indication for the treatment of chronic
hepatitis C genotype 1 infection, in
combination with peginterferon alfa and
ribavirin (two medicines approved to
treat chronic hepatitis C) in adult
patients with compensated liver disease
(including cirrhosis) who are treatment¨
naıve or who have failed previous
interferon therapy (pegylated or nonpegylated) with or without ribavirin.
Compensated liver disease is a stage in
which the liver is damaged but
maintains ability to function.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 9, 2013.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
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names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before October
1, 2013. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by October 2, 2013.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Karen
Abraham-Burrell at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 11, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–22546 Filed 9–16–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
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 materials,
and personal information concerning
E:\FR\FM\17SEN1.SGM
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Federal Register / Vol. 78, No. 180 / Tuesday, September 17, 2013 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; Ruth L.
Kirschstein National Research Service Award
(NRSA) Institutional Research Training
Grants (T32).
Date: October 16, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Contact Person: Eliane Lazar-Wesley,
Ph.D., Scientific Review Officer, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 4245, MSC
9550, 6001 Executive Blvd., Bethesda, MD
20892–9550, 301–451–4530, el6r@nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
SEDAPA R25: PAR 13–084 R25 and PAR 10–
227.
Date: October 17, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Contact Person: Eliane Lazar-Wesley,
Ph.D., Scientific Review Officer, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 4245, MSC
9550, 6001 Executive Blvd., Bethesda, MD
20892–9550, 301–451–4530, el6r@nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; HIV/
AIDS and Substance Abuse.
Date: October 17, 2013.
Time: 1:15 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Nadine Rogers, Ph.D.,
Scientific Review Officer, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
Blvd., Room 4229, MSC 9550, Bethesda, MD
20892–9550, 301–402–2105, rogersn2@
nida.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
DIDARP: Diversity-promoting Institutions
Drug Abuse Research Program (R24).
Date: October 24, 2013.
Time: 1:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Nadine Rogers, Ph.D.,
Scientific Review Officer, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
Blvd., Room 4229, MSC 9550, Bethesda, MD
VerDate Mar<15>2010
17:05 Sep 16, 2013
Jkt 229001
20892–9550, 301–402–2105, rogersn2@
nida.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: September 11, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–22502 Filed 9–16–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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: National Institute on
Aging Special Emphasis Panel; Disability and
Employment.
Date: October 17, 2013.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20892.
Contact Person: Jeannette L. Johnson,
Ph.D., Scientific Review Officer, National
Institute on Aging, National Institutes of
Health, 7201 Wisconsin Avenue, Suite
2C212, Bethesda, MD 20892, 301–402–7705,
JOHNSONJ9@NIA.NIH.GOV.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Genetic
Regulators.
Date: October 17, 2013.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Alicja L. Markowska,
Ph.D., DSC, Scientific Review Branch,
National Institute on Aging, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20892,
301–496–9666, markowsa@nia.nih.gov.
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57167
Name of Committee: National Institute on
Aging Special Emphasis Panel; Alzheimer
Network.
Date: October 24, 2013.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Alexander Parsadanian,
Ph.D., Scientific Review Officer, National
Institute on Aging, Gateway Building 2C/212,
7201 Wisconsin Avenue, Bethesda, MD
20892, 301–496–9666, PARSADANIANA@
NIA.NIH.GOV.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Aging Bone.
Date: October 25, 2013.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Alicja L. Markowska,
Ph.D., DSC, Scientific Review Branch,
National Institute on Aging, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20892,
301–496–9666, markowsa@nia.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: September 11, 2013.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–22491 Filed 9–16–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and
Other Communication Disorders;
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: National Institute on
Deafness and Other Communication
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]]>Agencies
[Federal Register Volume 78, Number 180 (Tuesday, September 17, 2013)]
[Notices]
[Pages 57166-57167]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22502]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse; 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 materials, and personal information concerning
[[Page 57167]]
individuals associated with the grant applications, the disclosure of
which would constitute a clearly unwarranted invasion of personal
privacy.
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel; Ruth L. Kirschstein National Research Service Award
(NRSA) Institutional Research Training Grants (T32).
Date: October 16, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852.
Contact Person: Eliane Lazar-Wesley, Ph.D., Scientific Review
Officer, Office of Extramural Affairs, National Institute on Drug
Abuse, NIH, DHHS, Room 4245, MSC 9550, 6001 Executive Blvd.,
Bethesda, MD 20892-9550, 301-451-4530, el6r@nih.gov.
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel; SEDAPA R25: PAR 13-084 R25 and PAR 10-227.
Date: October 17, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852.
Contact Person: Eliane Lazar-Wesley, Ph.D., Scientific Review
Officer, Office of Extramural Affairs, National Institute on Drug
Abuse, NIH, DHHS, Room 4245, MSC 9550, 6001 Executive Blvd.,
Bethesda, MD 20892-9550, 301-451-4530, el6r@nih.gov.
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel; HIV/AIDS and Substance Abuse.
Date: October 17, 2013.
Time: 1:15 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852, (Telephone Conference
Call).
Contact Person: Nadine Rogers, Ph.D., Scientific Review Officer,
Office of Extramural Affairs, National Institute on Drug Abuse, NIH,
DHHS, 6001 Executive Blvd., Room 4229, MSC 9550, Bethesda, MD 20892-
9550, 301-402-2105, rogersn2@nida.nih.gov.
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel; DIDARP: Diversity-promoting Institutions Drug Abuse
Research Program (R24).
Date: October 24, 2013.
Time: 1:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852, (Telephone Conference
Call).
Contact Person: Nadine Rogers, Ph.D., Scientific Review Officer,
Office of Extramural Affairs, National Institute on Drug Abuse, NIH,
DHHS, 6001 Executive Blvd., Room 4229, MSC 9550, Bethesda, MD 20892-
9550, 301-402-2105, rogersn2@nida.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos.: 93.279,
Drug Abuse and Addiction Research Programs, National Institutes of
Health, HHS)
Dated: September 11, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2013-22502 Filed 9-16-13; 8:45 am]
BILLING CODE 4140-01-P
