National Center on Minority Health and Health Disparities; Notice of Closed Meeting, 54056 [E9-25287]
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54056
Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices
II. Significance of Special Controls
Guidance Documents
FDA believes that adherence to the
recommendations described in this
guidance document, in addition to the
general controls, will provide
reasonable assurance of the safety and
effectiveness of cardiac allograft gene
expression profiling test systems
classified under § 862.1163 (21 CFR
862.1163). In order to be classified as a
class II device under § 862.1163, a
cardiac allograft gene expression
profiling test system must comply with
the requirement of special controls;
manufacturers must address the issues
requiring special controls as identified
in the guidance documents, either by
following the recommendations in the
guidance documents or by some other
means that provides equivalent
assurances of safety and effectiveness.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. To receive ‘‘Class II Special
Controls Guidance Document: Cardiac
Allograft Gene Expression Profiling Test
Systems,’’ you may either send an email request to dsmica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to 301–
847–8149 to receive a hard copy. Please
use the document number 1686 to
identify the guidance you are
requesting.
CDRH maintains an entry on the
Internet for easy access to information
including text, graphics, and files that
may be downloaded to a personal
computer with Internet access. Updated
on a regular basis, the CDRH home page
includes device safety alerts, Federal
Register reprints, information on
premarket submissions (including lists
of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
at https://www.regulations.gov.
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IV. Paperwork Reduction Act of 1995
Elsewhere in this issue of the Federal
Register, FDA is publishing a final rule
establishing as special controls for the
cardiac allograft gene expression
profiling test systems the guidance
document that is the subject of this
notice. The preamble to that rule
VerDate Nov<24>2008
17:33 Oct 20, 2009
Jkt 220001
addresses the application of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520) to the information
collection provisions referenced in this
guidance document.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified 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.
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: October 13, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–25269 Filed 10–20–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 9, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and
Radiological Health.
[FR Doc. E9–25313 Filed 10–20–09; 8:45 am]
National Institutes of Health
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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 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
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 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; BSPH
Member Conflict Applications.
Date: October 23, 2009.
Time: 3:30 p.m. to 5 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: Mark P. Rubert, Ph.D,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
1775, rubertm@csr.nih.gov.
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National Center on Minority Health and
Health Disparities; Notice of Closed
Meeting
Name of Committee: National Center on
Minority Health and Health Disparities
Special Emphasis Panel; Conference Grant
Review.
Date: November 10, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Prabha L. Atreya, Ph.D,
Chief, Office of Scientific Review, National
Center on Minority Health and Health
Disparities, 6707 Democracy Boulevard,
Suite 800, Bethesda, MD 20892, (301) 594–
8696, atreyapr@mail.nih.gov.
Dated: October 14, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–25287 Filed 10–20–09; 8:45 am]
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Agencies
[Federal Register Volume 74, Number 202 (Wednesday, October 21, 2009)]
[Notices]
[Page 54056]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25287]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center on Minority Health and Health Disparities; Notice
of Closed Meeting
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 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 Center on Minority Health and Health
Disparities Special Emphasis Panel; Conference Grant Review.
Date: November 10, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Two Democracy Plaza, 6707
Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Prabha L. Atreya, Ph.D, Chief, Office of
Scientific Review, National Center on Minority Health and Health
Disparities, 6707 Democracy Boulevard, Suite 800, Bethesda, MD
20892, (301) 594-8696, atreyapr@mail.nih.gov.
Dated: October 14, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-25287 Filed 10-20-09; 8:45 am]
BILLING CODE 4140-01-P