National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting, 69090-69091 [2010-28376]
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Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices
under section 513(f)(1) of the FD&C Act,
request FDA to classify the device under
the criteria set forth in section 513(a)(1)
of the FD&C Act. FDA shall, within 60
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 act, FDA has
determined, under § 10.115(g)(2) (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. Therefore, 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.
emcdonald on DSK2BSOYB1PROD with NOTICES
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (§ 10.115). The
guidance represents the agency’s current
thinking on tissue adhesive with
adjunct wound closure device intended
for topical approximation of skin. 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 statute
and regulations.
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: Tissue Adhesive
with Adjunct Wound Closure Device
Intended for the Topical Approximation
of Skin,’’ 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–
796–8149 to receive a hard copy. Please
use the document number 1683 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
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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 parts 50 and 56
have been approved under OMB control
number 0910–0130; 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 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.
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.
Dated: November 4, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2010–28333 Filed 11–9–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; 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.
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Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel Research Centers in Trauma, Burn and
Peri-Operative Injury.
Date: December 3, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn By Marriott-Bethesda,
7335 Wisconsin Avenue, Bethesda, MD
20814.
Contact Person: Brian R. Pike, PhD
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN18, Bethesda, MD
20892. 301–594–3907. pikbr@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: November 3, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–28300 Filed 11–9–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; 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 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 on
Alcohol Abuse and Alcoholism; Initial
Review Group; Biomedical Research Review
Subcommittee.
Date: March 15–16, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
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Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices
Contact Person: Philippe Marmillot, PhD,
Scientific Review Officer, National Institutes
of Health, National Institute on Alcohol
Abuse and Alcoholism, 5635 Fishers Lane,
Room 2019, Bethesda, MD 20892, 301–443–
2861, marmillotp@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards., National
Institutes of Health, HHS)
Dated: November 3, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
emcdonald on DSK2BSOYB1PROD 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 USC,
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 on
Alcohol Abuse and Alcoholism Initial
Review Group; Clinical Treatment and
Health Services Research Review
Subcommittee.
Date: March 15–16, 2011.
Time: 8:30 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, 7400
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Katrina Foster, PhD,
Scientific Review Officer, National Institute
on Alcohol Abuse and Alcoholism, National
Institutes of Health, 5635 Fishers Lane, Room
2019, Rockville, MD 20852, 301–443–4032,
katrinaf@mail.nih.gov.
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[FR Doc. 2010–28374 Filed 11–9–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Director, Office of
Biotechnology Activities; Notice of
Meeting
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Dated: November 3, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
National Institutes of Health
[FR Doc. 2010–28376 Filed 11–9–10; 8:45 am]
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards, National
Institutes of Health, HHS)
There will be a workshop entitled
‘‘Retroviral and Lentiviral Vectors for
Long-Term Gene Correction: Clinical
Challenges in Vector and Trial Design.’’
The meeting will be open to the public;
attendance is limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Recombinant DNA
Advisory Committee.
Date: December 9, 2010.
Time: 8 a.m. to 5:30 p.m.
Date: December 10, 2010.
Time: 8 a.m. to 1 p.m.
Agenda: The Office of Biotechnology
Activities (OBA), NIH Recombinant DNA
Advisory Committee and the European
Network for the Advancement of Clinical
Gene Transfer (CliniGene) will host a
workshop on Retroviral and Lentiviral
Vectors for Long-Term Gene Correction:
Clinical Challenges in Vector and Trial
Design at the Bethesda Marriott on December
9 and 10, 2010. The meeting will cover the
following topics: Developments in retrovirus
and lentivirus integration and insertional
mutagenesis research, including nonenhancer mediated mechanisms of
insertional mutagenesis; modifications to
retroviral and lentiviral vectors to enhance
their safety; research on in vitro and animal
models to evaluate the safety of human gene
transfer; and ethical issues in the design of
new clinical trials. The agenda is posted to
OBA’s Web site: https://oba.od.nih.gov/
rdna_rac/rac_meetings.html. Please check
the meeting agenda for more information.
Place: Bethesda Marriott, 5151 Pooks Hill
Road, Bethesda, Maryland 20814.
Contact Person: Chezelle George, Program
Assistant, Office of Science Policy, Office of
Biotechnology Activities, National Institutes
of Health, 6705 Rockledge Drive, Suite 750,
Bethesda, MD 20892, 301–496–9838, 301–
496–9839, georgec@mail.nih.gov.
Any interested person may file written
comments with the panel by forwarding the
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69091
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.
Background information may be obtained by
contacting NIH OBA by e-mail
oba@od.nih.gov
Dated: November 1, 2010.
Jacqueline Corrigan-Curay,
Acting Director, Office of Biotechnology
Activities, National Institutes of Health.
[FR Doc. 2010–28373 Filed 11–9–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Meeting
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
Interagency Autism Coordinating
Committee (IACC) Subcommittee on
Safety.
The Interagency Autism Coordinating
Committee (IACC) Subcommittee on
Safety will be meeting on Monday,
November 29, 2010. The subcommittee
plans to discuss issues related to autism
and safety. This meeting will be open to
the public and will be accessible
through a conference call.
Name of Committee: Interagency Autism
Coordinating Committee (IACC).
Type of Meeting: Subcommittee on Safety.
Date: November 29, 2010.
Time: 9 a.m. to 12 p.m. Eastern Time.
Agenda: To discuss issues related to
autism and safety.
Place: The Neuroscience Center, 6001
Executive Boulevard, Conference Room B1/
B2, Rockville, MD 20852.
Conference Call Access: Dial: 800–369–
1754. Access code: 5105457.
Cost: The meeting is free and open to the
public.
Registration: https://
www.acclaroresearch.com/oarc/11–29–10/.
Pre-registration is recommended to expedite
check-in. Seating in the meeting room is
limited to room capacity and on a first come,
first served basis.
Access: Metro accessible—White Flint
Metro (Red Line).
Contact Person: Ms. Lina Perez, Office of
Autism Research Coordination, National
Institute of Mental Health, NIH, 6001
Executive Boulevard, NSC, Room 8185a,
Rockville, MD 20852. Phone: 301–443–6040.
E-mail: IACCPublicInquiries@mail.nih.gov.
Please Note:
The meeting will be open to the public and
accessible through a conference call.
Members of the public who participate using
the conference call phone number will be
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]]>Agencies
[Federal Register Volume 75, Number 217 (Wednesday, November 10, 2010)]
[Notices]
[Pages 69090-69091]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28376]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; 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 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 on Alcohol Abuse and
Alcoholism; Initial Review Group; Biomedical Research Review
Subcommittee.
Date: March 15-16, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400
Wisconsin Avenue, Bethesda, MD 20814.
[[Page 69091]]
Contact Person: Philippe Marmillot, PhD, Scientific Review
Officer, National Institutes of Health, National Institute on
Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Room 2019,
Bethesda, MD 20892, 301-443-2861, marmillotp@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.271,
Alcohol Research Career Development Awards for Scientists and
Clinicians; 93.272, Alcohol National Research Service Awards for
Research Training; 93.273, Alcohol Research Programs; 93.891,
Alcohol Research Center Grants; 93.701, ARRA Related Biomedical
Research and Research Support Awards., National Institutes of
Health, HHS)
Dated: November 3, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-28376 Filed 11-9-10; 8:45 am]
BILLING CODE 4140-01-P
