Center for Scientific Review; Notice of Closed Meetings, 33427 [2013-13124]
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Federal Register / Vol. 78, No. 107 / Tuesday, June 4, 2013 / Notices
anti-inflammatory drug indicated for the
treatment of arthritis. On August 4,
1982, Lilly voluntarily withdrew
ORAFLEX (benoxaprofen) Tablets from
the market because of postmarketing
reports of severe liver toxicity in
patients who took ORAFLEX. In a letter
dated February 6, 2013, Lilly requested
that FDA withdraw approval of NDA
18–250 for ORAFLEX (benoxaprofen)
Tablets under § 314.150(d) (21 CFR
314.150(d)). In that letter, Lilly waived
any opportunity for a hearing otherwise
provided under § 314.150(a). In FDA’s
letter of February 15, 2013, the Agency
acknowledged Lilly’s agreement to
permit FDA to withdraw approval of
ORAFLEX (benoxaprofen) Tablets under
§ 314.150(d) and waive its opportunity
for a hearing.
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(e)) and
§ 314.150(d), and under authority
delegated by the Commissioner of Food
and Drugs to the Director, Center for
Drug Evaluation and Research, approval
of NDA 18–250, and all amendments
and supplements thereto, is withdrawn
(see DATES). Distribution of this
product in interstate commerce without
an approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the FD&C Act (21
U.S.C. 355(a) and 331(d)).
Dated: May 28, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2013–13053 Filed 6–3–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
tkelley on DSK3SPTVN1PROD with NOTICES
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Meeting
[FR Doc. 2013–13123 Filed 6–3–13; 8:45 am]
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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 Children’s Study Advisory
Committee.
The meeting will be open to the
public, with attendance limited to space
available. Registration is required since
space is limited and will begin at 8:00
a.m. Please visit the conference Web site
for information on meeting logistics and
to register for the meeting at meeting
https://www.cvent.com/d/3cq6zz.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
18:33 Jun 03, 2013
Jkt 229001
Name of Committee: National Children’s
Study Advisory Committee.
Date: July 23, 2013.
Time: 9:00 a.m. to 4:30 p.m.
Agenda: The Committee will receive an
update on the current status of Vanguard
Study and will discuss general data
collection methods and retention strategy
and methods.
Place: National Institutes of Health,
Natcher Conference Center, Room E1/E2, 45
Center Drive, Bethesda, MD 20892.
Contact Person: Kate Winseck, MSW,
Executive Secretary, National Children’s
Study, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, NIH, 6100 Executive Blvd.,
Room 5C01, Bethesda, MD 20892, (703) 902–
1339, ncs@circlesolutions.com.
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. For
additional information about the Federal
Advisory Committee meeting, please contact
Circle Solutions at ncs@circlesolutions.com.
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.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: May 29, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institutes of Health
VerDate Mar<15>2010
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
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.,
PO 00000
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33427
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; Systemic
Injury by Environmental Exposure.
Date: June 11, 2013.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Bonnie L Burgess-Beusse,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2182,
MSC 7818, Bethesda, MD 20892, 301–435–
1783, beusseb@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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Stroke, Spinal Cord Injury, and
Neuroimmunology.
Date: June 14, 2013.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Samuel C Edwards, Ph.D.,
IRG CHIEF, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5210, MSC 7846, Bethesda, MD
20892, (301) 435–1246,
edwardss@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.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: May 29, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–13124 Filed 6–3–13; 8:45 am]
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Agencies
[Federal Register Volume 78, Number 107 (Tuesday, June 4, 2013)]
[Notices]
[Page 33427]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13124]
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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; Systemic Injury by Environmental Exposure.
Date: June 11, 2013.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Bonnie L Burgess-Beusse, Ph.D., Scientific
Review Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2182, MSC 7818, Bethesda, MD
20892, 301-435-1783, beusseb@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.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Stroke, Spinal Cord Injury, and
Neuroimmunology.
Date: June 14, 2013.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Samuel C Edwards, Ph.D., IRG CHIEF, Center for
Scientific Review, National Institutes of Health, 6701 Rockledge
Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435-1246,
edwardss@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.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: May 29, 2013.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2013-13124 Filed 6-3-13; 8:45 am]
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