Center for Scientific Review; Notice of Closed Meetings, 67988 [2010-27915]
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Federal Register / Vol. 75, No. 213 / Thursday, November 4, 2010 / Notices
Biologics Evaluation and Research
(HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6210; or Sabina Reilly, Center
for Devices and Radiological Health
(HFZ–450), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 240–276–4095.
SUPPLEMENTARY INFORMATION:
jlentini on DSKJ8SOYB1PROD with NOTICES
I. Background
FDA is announcing the availability of
a document entitled ‘‘Guidance for
Industry: Cellular Therapy for Cardiac
Disease,’’ dated October 2010. This
guidance document provides sponsors
who are developing cellular therapies
for the treatment of cardiac disease with
recommendations regarding the: (1)
Design of preclinical and clinical
studies, (2) CMC information that
should be included in an IND for
cardiac cellular therapy, and (3)
information about the product’s delivery
system that should be submitted. This
guidance also includes a discussion of
regulatory considerations regarding
cellular delivery systems.
In the Federal Register of April 2,
2009 (74 FR 14992), FDA announced the
availability of the draft guidance
entitled ‘‘Guidance for Industry: Somatic
Cell Therapy for Cardiac Disease’’ dated
March 2009. FDA received several
comments on the draft guidance and
those comments were considered as the
guidance was finalized. In addition,
additional changes were made to
improve the document. The guidance
announced in this notice finalizes the
draft guidance dated March 2009.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on this topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
the IND regulations (21 CFR part 312)
have been approved under OMB control
number 0910–0014, the good laboratory
practice regulations (21 CFR part 58)
have been approved under OMB control
number 0910–0119, the investigational
VerDate Mar<15>2010
16:47 Nov 03, 2010
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device exemption (IDE) regulations (21
CFR part 812) have been approved
under OMB control number 0910–0078,
and the informed consent regulations
(21 CFR part 50) have been approved
under OMB control number 0910–0130.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm,
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm, or
https://www.regulations.gov.
Dated: October 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–27881 Filed 11–3–10; 8:45 am]
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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; Member
Conflict: Biological Chemistry and
Macromolecular Biophysics.
Date: December 2–3, 2010.
PO 00000
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Time: 11 a.m. to 10 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact: Donald L. Schneider, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5160,
MSC 7842, Bethesda, MD 20892, (301) 435–
1727, schneidd@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: BST Member Conflict Review Panel.
Date: December 2, 2010.
Time: 1:15 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National of Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call.)
Contact Person: Ping Fan, MD, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5154,
MSC 7840, Bethesda, MD 20892, 301–408–
9971, fanp@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Behavioral and Social
Consequences of HIV/AIDS.
Date: December 3, 2010.
Time: 11 a.m. to 3 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: Jose H. Guerrier, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
1137, guerriej@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Chromatin
Insulators.
Date: December 7–8, 2010.
Time: 8 a.m. to 9 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting.)
Contact Person: Michael H. Chaitin, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5202,
MSC 7850, Bethesda, MD 20892, (301) 435–
0910, chaitinm@csr.nih.gov.
(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: October 29, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–27915 Filed 11–3–10; 8:45 am]
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[Federal Register Volume 75, Number 213 (Thursday, November 4, 2010)]
[Notices]
[Page 67988]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-27915]
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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; Member Conflict: Biological Chemistry and Macromolecular
Biophysics.
Date: December 2-3, 2010.
Time: 11 a.m. to 10 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact: Donald L. Schneider, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5160, MSC 7842, Bethesda, MD 20892, (301) 435-
1727, schneidd@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: BST Member Conflict Review Panel.
Date: December 2, 2010.
Time: 1:15 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National of Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call.)
Contact Person: Ping Fan, MD, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5154, MSC 7840, Bethesda, MD 20892, 301-408-
9971, fanp@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Behavioral and Social Consequences of HIV/
AIDS.
Date: December 3, 2010.
Time: 11 a.m. to 3 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: Jose H. Guerrier, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD
20892, 301-435-1137, guerriej@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Chromatin Insulators.
Date: December 7-8, 2010.
Time: 8 a.m. to 9 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting.)
Contact Person: Michael H. Chaitin, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5202, MSC 7850, Bethesda, MD
20892, (301) 435-0910, chaitinm@csr.nih.gov.
(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: October 29, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-27915 Filed 11-3-10; 8:45 am]
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