National Center for Complementary & Alternative Medicine; Notice of Closed Meeting, 12744 [2011-5226]
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12744
Federal Register / Vol. 76, No. 45 / Tuesday, March 8, 2011 / Notices
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supporting, or life sustaining, if FDA
finds that such a device should be
subject to part 803 in order to protect
the public health (section
519(a)(1)(B)(i)(III) of the FD&C Act). If
such class I or class II devices are not
the subject of an FDA notice or letter,
the malfunction reports for these
devices are to be submitted in
accordance with the criteria established
by the Secretary (and, by delegation,
FDA), which criteria shall require the
reports to be in summary form and
made on a quarterly basis (section
519(a)(1)(B)(ii) of the FD&C Act).
Under section 519(a) of the FD&C Act,
as amended by FDAAA, there is no
change to the obligation for an importer
to submit malfunction reports to the
manufacturer in accordance with part
803 for devices that it imports into the
United States (section 519(a)(1)(B)(iii) of
the FD&C Act).
FDA intends to provide notice in the
Federal Register that lists the types of
devices that should be subject to part
803 in order to protect the public health,
as required by section 519(a)(1)(B)(i)(III)
of the FD&C Act). In addition, FDA
intends to, by rulemaking, establish
malfunction reporting criteria for
devices subject to section 519(a)(1)(B)(ii)
of the FD&C Act. In the interim, in the
interest of public health, FDA is
publishing this notice under section
519(a)(1)(B)(i)(III), to clarify that, to the
extent there is any confusion as to
current malfunction reporting
requirements, all device manufacturers
and importers of class I and those class
II devices that are not permanently
implantable, life supporting, or life
sustaining, must continue to report in
full compliance with part 803, pending
further FDA notice under section
519(a)(1)(B)(i)(III), as to specific devices
or device types subject to part 803, and
the establishment of criteria in
accordance with section 519(a)(1)(B)(ii).
FDA considers it necessary to subject all
such devices to part 803 in the interim,
in order to protect the public health by
ensuring that there is no gap in
malfunction reporting for any device.
II. 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.
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[FR Doc. 2011–5146 Filed 3–7–11; 8:45 am]
Dated: March 2, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
BILLING CODE 4160–01–P
[FR Doc. 2011–5228 Filed 3–7–11; 8:45 am]
Dated: March 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute On Deafness and
Other Communication Disorders;
Notice of Closed Meetings
National Center for Complementary &
Alternative Medicine; 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 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.
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 Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel; Clinical
Trials—Communications.
Date: March 31, 2011.
Time: 12 p.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6120
Executive Blvd., Rockville, MD 20852.
(Telephone Conference Call.)
Contact Person: Christine A. Livingston,
PhD, Scientific Review Officer, Division of
Extramural Activities, National Institutes of
Health/NIDCD, 6120 Executive Blvd.—MSC
7180, Bethesda, MD 20892, (301) 496–8683,
livingsc@mail.nih.gov.
Name of Committee: National Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel; P50 Grant
Review.
Date: April 8, 2011.
Time: 11 a.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6120
Executive Blvd., Rockville, MD 20852.
(Telephone Conference Call.)
Contact Person: Christine A. Livingston,
PhD, Scientific Review Officer, Division of
Extramural Activities, National Institutes of
Health/NIDCD, 6120 Executive Blvd.—MSC
7180, Bethesda, MD 20892, (301) 496–8683,
livingsc@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.173, Biological Research
Related to Deafness and Communicative
Disorders, National Institutes of Health, HHS)
Name of Committee: National Center for
Complementary and Alternative Medicine
Special Emphasis Panel, NCCAM Education
Panel.
Date: March 24–25, 2011.
Time: 12 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott, 5520
Wisconsin Avenue, Chevy Chase, MD 20815.
Contact Person: Peter Kozel, PhD.,
Scientific Review Officer, NCCAM, 6707
Democracy Boulevard, Suite 401, Bethesda,
MD 20892–5475, 301–496–8004,
kozelp@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.213, Research and Training
in Complementary and Alternative Medicine,
National Institutes of Health, HHS)
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Dated: March 2, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–5226 Filed 3–7–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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Agencies
[Federal Register Volume 76, Number 45 (Tuesday, March 8, 2011)]
[Notices]
[Page 12744]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5226]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Complementary & Alternative Medicine; 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 for Complementary and
Alternative Medicine Special Emphasis Panel, NCCAM Education Panel.
Date: March 24-25, 2011.
Time: 12 p.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Courtyard by Marriott, 5520 Wisconsin Avenue, Chevy
Chase, MD 20815.
Contact Person: Peter Kozel, PhD., Scientific Review Officer,
NCCAM, 6707 Democracy Boulevard, Suite 401, Bethesda, MD 20892-5475,
301-496-8004, kozelp@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.213,
Research and Training in Complementary and Alternative Medicine,
National Institutes of Health, HHS)
Dated: March 2, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-5226 Filed 3-7-11; 8:45 am]
BILLING CODE 4140-01-P