National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings, 43333-43334 [2011-18286]
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Federal Register / Vol. 76, No. 139 / Wednesday, July 20, 2011 / Notices
IV. 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
21 CFR Part 807, subpart E, have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR Part 812 have
been approved under OMB control
number 0910–0078; the collections of
information in 21 CFR 56.115 have been
approved under OMB control number
0910–0130; the collections of
information in 21 CFR 50.23 have been
approved under OMB control number
0910–0586; the collections of
information in 21 CFR Part 58 have been
approved under OMB control number
0910–0119; and the collections of
information in 21 CFR Part 801 have
been approved under OMB control
number 0910–0485.
II. Significance of Guidance
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 focused ultrasound
stimulator system for aesthetic use
classified under 878.4590 (21 CFR Part
878). In order to be classified as a class
II device under 878.4590, an ultrasound
stimulator for aesthetic use must
comply with the requirements of special
controls; a manufacturer must address
the issues requiring special controls as
identified in the guidance, either by
following the recommendations in the
guidance document or by some other
means that provides equivalent
assurances of safety and effectiveness.
sroberts on DSK5SPTVN1PROD with NOTICES
days of receiving such a request, classify
the device by written order. This
classification shall be the initial
classification of the device. Within 30
days after the issuance of an order
classifying the device, FDA must
publish a notice in the Federal Register
announcing such classification. Because
of the timeframes established by section
513(f)(2) of the FD&C Act, FDA has
determined, under 21 CFR 10.115(g)(2),
that it is not feasible to allow for public
participation before issuing this
guidance as a final guidance document.
Thus, FDA is issuing this guidance
document as a level 1 guidance
document that is immediately in effect.
FDA will consider any comments that
are received in response to this notice
to determine whether to amend the
guidance document.
Elsewhere in this issue of the Federal
Register, FDA is publishing a final rule
classifying focused ultrasound
stimulator systems for aesthetic use into
class II (special controls) under section
513(f)(2) of the FD&C Act.
V. 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.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘Class II Special Controls
Guidance Document: Focused
Ultrasound Stimulator System for
Aesthetic Use,’’ you may either send an
e-mail 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 1701 to
identify the guidance you are requesting
BILLING CODE 4160–01–P
VerDate Mar<15>2010
18:29 Jul 19, 2011
Jkt 223001
Dated: July 15, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–18280 Filed 7–19–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; 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
PO 00000
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43333
confidential trade secrets or commercial
property such as patentable materials,
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 of
Neurological Disorders and Stroke Special
Emphasis Panel, Stem Cells.
Date: July 27, 2011.
Time: 9 a.m. to 3 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: Raul A. Saavedra, PhD,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research,
NINDS/NIH/DHHS/Neuroscience Center,
6001 Executive Blvd., Suite 3208, MSC 9529,
Bethesda, MD 20892–9529, 301–496–9223,
saavedrr@ninds.nih.gov.
This notice is being published less than 15
days prior to the meeting due to timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel, Rare Diseases.
Date: August 2, 2011.
Time: 9 a.m. to 3 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: Raul A. Saavedra, PhD,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research,
NINDS/NIH/DHHS/Neuroscience Center,
6001 Executive Blvd., Suite 3208, MSC 9529,
Bethesda, MD 20892–9529, 301–496–9223,
saavedrr@ninds.nih.gov.
This notice is being published less than 15
days prior to the meeting due to timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel, Epilepsy Genetic Centers
Without Walls.
Date: August 5, 2011.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Amalfi Hotel, 20 West Kinzie Street,
Chicago, IL 60654.
Contact Person: William C. Benzing, PhD,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research,
NINDS/NIH/DHHS/Neuroscience Center,
6001 Executive Blvd., Suite 3208, MSC 9529,
Bethesda, MD 20892–9529, 301–496–0660,
Benzingw@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
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43334
Federal Register / Vol. 76, No. 139 / Wednesday, July 20, 2011 / Notices
Dated: July 13, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
[FR Doc. 2011–18286 Filed 7–19–11; 8:45 am]
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
sroberts on DSK5SPTVN1PROD with NOTICES
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 of
Child Health and Human Development
Special Emphasis Panel, The Development of
Infant Behavioral Affect Specificity to
Discrete Emotions.
Date: July 25, 2011.
Time: 11:30 a.m. to 12:20 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Rockville, MD 20852,
(Telephone Conference Call).
Contact Person: Carla T. Walls, PhD,
Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6100 Executive
Blvd., Room 5B01, Bethesda, MD 20892,
(301) 435–6898, wallsc@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.
(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)
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 of
Child Health and Human Development
Special Emphasis Panel, Children in Rural
Poverty.
Date: August 9, 2011.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Mayflower Hotel, 1127
Connecticut Avenue, NW., Washington, DC
20036.
Contact Person: Marita R. Hopmann, PhD,
Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6100 Executive
Blvd., Room 5B01, Bethesda, MD 20892,
301–435–6911, hopmannm@mail.nih.gov.
(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)
[FR Doc. 2011–18288 Filed 7–19–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
Jkt 223001
Dated: July 14, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–18297 Filed 7–19–11; 8:45 am]
[FR Doc. 2011–18299 Filed 7–19–11; 8:45 am]
18:29 Jul 19, 2011
(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)
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
VerDate Mar<15>2010
Name of Committee: National Institute of
Child Health and Human Development,
Special Emphasis Panel, FES Controller for
Upper Limb Movement.
Date: August 9, 2011.
Time: 1 to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Rockville, MD 20852,
(Telephone Conference Call).
Contact Person: Sathasiva B. Kandasamy,
PhD, Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6100 Executive
Blvd., Room 5B01, Bethesda, MD 20892,
301–435–6680, skandasa@mail.nih.gov.
Dated: July 14, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
Dated: July 14, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
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National Institute of General Medical
Sciences Notice of Closed Meeting
E:\FR\FM\20JYN1.SGM
20JYN1
]]>Agencies
[Federal Register Volume 76, Number 139 (Wednesday, July 20, 2011)]
[Notices]
[Pages 43333-43334]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18286]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Neurological Disorders and Stroke; 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 individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Neurological Disorders
and Stroke Special Emphasis Panel, Stem Cells.
Date: July 27, 2011.
Time: 9 a.m. to 3 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: Raul A. Saavedra, PhD, Scientific Review
Officer, Scientific Review Branch, Division of Extramural Research,
NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Blvd., Suite
3208, MSC 9529, Bethesda, MD 20892-9529, 301-496-9223,
saavedrr@ninds.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to timing limitations imposed by the review and funding
cycle.
Name of Committee: National Institute of Neurological Disorders
and Stroke Special Emphasis Panel, Rare Diseases.
Date: August 2, 2011.
Time: 9 a.m. to 3 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: Raul A. Saavedra, PhD, Scientific Review
Officer, Scientific Review Branch, Division of Extramural Research,
NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Blvd., Suite
3208, MSC 9529, Bethesda, MD 20892-9529, 301-496-9223,
saavedrr@ninds.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to timing limitations imposed by the review and funding
cycle.
Name of Committee: National Institute of Neurological Disorders
and Stroke Special Emphasis Panel, Epilepsy Genetic Centers Without
Walls.
Date: August 5, 2011.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Amalfi Hotel, 20 West Kinzie Street, Chicago, IL 60654.
Contact Person: William C. Benzing, PhD, Scientific Review
Officer, Scientific Review Branch, Division of Extramural Research,
NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Blvd., Suite
3208, MSC 9529, Bethesda, MD 20892-9529, 301-496-0660,
Benzingw@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.853,
Clinical Research Related to Neurological Disorders; 93.854,
Biological Basis Research in the Neurosciences, National Institutes
of Health, HHS)
[[Page 43334]]
Dated: July 13, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-18286 Filed 7-19-11; 8:45 am]
BILLING CODE 4140-01-P
