National Institute of Nursing Research; Notice of Meeting, 571-572 [2010-33331]
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Federal Register / Vol. 76, No. 3 / Wednesday, January 5, 2011 / Notices
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diagnostic devices (IVDs) intended for
the detection of antibodies to Borrelia
burgdorferi. These devices are used to
aid in the diagnosis of Lyme disease.
This draft guidance is not final nor is it
in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by April 5, 2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Draft Guidance for
Industry and Food and Drug
Administration Staff; Establishing the
Performance Characteristics of In Vitro
Diagnostic Devices for the Detection of
Antibodies to Borrelia burgdorferi’’ to
the Division of Small Manufacturers,
International, and Consumer Assistance,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
rm. 4613, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request, or fax your request to 301–
847–8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Prasad Rao, Center for Devices and
Radiological Health Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5508, Silver Spring,
MD 20993–0002, 301–796–6203.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance recommends
studies for establishing the performance
characteristics of in vitro diagnostic
devices for the detection of antibodies to
B. burgdorferi in human serum, plasma,
and blood. These devices are used to aid
in the diagnosis of Lyme disease. This
document does not apply to B.
burgdorferi nucleic acid amplification
assays. A manufacturer who intends to
market an in vitro device for the
detection of antibodies to B. burgdorferi
must conform to the general controls of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) and, unless exempt,
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obtain premarket clearance or approval
prior to marketing the device.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized will
represent the Agency’s current thinking
on establishing the performance
characteristics of in vitro diagnostic
devices for the detection of antibodies to
B. burgdorferi. 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.
information in 21 CFR 56.115 have been
approved under OMB control number
0910–0130.
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 draft 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 ‘‘Draft Guidance for Industry and
Food and Drug Administration Staff;
Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for the Detection of Antibodies
to Borrelia burgdorferi,’’ 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 1721 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This draft 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
(the PRA) (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 801 and 21 CFR 809.10 have been
approved under OMB control number
0910–0485; the collections of
information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078; the collections of
information in 42 CFR 493.15 have been
approved under OMB control number
0910–0598; the collections of
information 21 CFR 50.23 have been
approved under OMB control number
0910–0586 and the collections of
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Dated: December 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–33293 Filed 1–4–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Nursing Research;
Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Council for Nursing
Research.
The meeting will be open to the
public as indicated below, with
attendance 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.
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 Advisory
Council for Nursing Research.
Date: January 18–19, 2011.
Open: January 18, 2011, 1 p.m. to 4:45 p.m.
Agenda: Discussion of Program Policies
and Issues.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 6C, Room 6, Bethesda, MD 20892.
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Federal Register / Vol. 76, No. 3 / Wednesday, January 5, 2011 / Notices
Closed: January 19, 2011, 9 a.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 6C, Room 6, Bethesda, MD 20892.
Contact Person: Mary E. Kerr, FAAN, RN,
PhD, Deputy Director, National Institute of
Nursing, National Institutes of Health, 31
Center Drive, Room 5B–05, Bethesda, MD
20892–2178, 301/496–8230,
kerrme@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.
Any interested person may file written
comments with the committee by forwarding
the 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.
Information is also available on the
Institute’s/Center’s home page: https://
www.nih.gov/ninr/a_advisory.html, where an
agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.361, Nursing Research,
National Institutes of Health, HHS)
Dated: December 29, 2010.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–33331 Filed 1–4–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
jlentini on DSKJ8SOYB1PROD 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 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: National Institute of
Mental Health Special Emphasis Panel K99.
Date: February 3, 2011.
Time: 1:30 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
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Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Megan Libbey, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6148, MSC 9609,
Rockville, MD 20852–9609, 301–402–6807,
libbeym@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel ITVC
Conflicts.
Date: February 9, 2011.
Time: 10:30 a.m. to 2 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: Enid Light, PhD, Scientific
Review Officer, Division of Extramural
Activities, National Institute of Mental
Health, NIH, Neuroscience Center, 6001
Executive Boulevard, Room 6132, MSC 9608,
Bethesda, MD 20852–9608, 301–443–3599,
elight@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel, Conte
Centers for Basic and Translational Mental
Health Research.
Date: February 25, 2011.
Time: 8 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz Carlton Hotel, 1150 22nd Street,
NW., Washington, DC 20037.
Contact Person: Rebecca C Steiner, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd, Room 6149, MSC 9608,
Bethesda, MD 20892–9608, 301–443–4525,
steinerr@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS)
Dated: December 29, 2010.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–33330 Filed 1–4–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; 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.
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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
Biomedical Imaging and Bioengineering
Special Emphasis Panel.
Date: March 14–16, 2011.
Time: 6 p.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: JW Marriott, 900 W. Olympic Blvd.,
Los Angeles, CA 90015.
Contact Person: Manana Sukhareva, PhD,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707
Democracy Boulevard, Suite 959, Bethesda,
MD 20892, 301–451–3397,
sukharem@mail.nih.gov.
Dated: December 29, 2010.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–33325 Filed 1–4–11; 8:45 am]
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 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 open to the
public, with attendance 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: National Institute of
Child Health and Human Development
Special Emphasis Panel.
Date: January 19, 2011.
Time: 2 p.m. to 4 p.m.
Agenda: To provide concept review of
proposed concept review.
Place: National Institutes of Health, 6100
Executive Boulevard, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Sathasiva B. Kandasamy,
PhD, Scientific Review Administrator,
Division of Scientific Review, National
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]]>Agencies
[Federal Register Volume 76, Number 3 (Wednesday, January 5, 2011)]
[Notices]
[Pages 571-572]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-33331]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Nursing Research; Notice of Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of a meeting of the
National Advisory Council for Nursing Research.
The meeting will be open to the public as indicated below, with
attendance 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.
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 Advisory Council for Nursing
Research.
Date: January 18-19, 2011.
Open: January 18, 2011, 1 p.m. to 4:45 p.m.
Agenda: Discussion of Program Policies and Issues.
Place: National Institutes of Health, Building 31, 31 Center
Drive, Conference Room 6C, Room 6, Bethesda, MD 20892.
[[Page 572]]
Closed: January 19, 2011, 9 a.m. to 1 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Building 31, 31 Center
Drive, Conference Room 6C, Room 6, Bethesda, MD 20892.
Contact Person: Mary E. Kerr, FAAN, RN, PhD, Deputy Director,
National Institute of Nursing, National Institutes of Health, 31
Center Drive, Room 5B-05, Bethesda, MD 20892-2178, 301/496-8230,
kerrme@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.
Any interested person may file written comments with the
committee by forwarding the 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.
Information is also available on the Institute's/Center's home
page: https://www.nih.gov/ninr/a_advisory.html, where an agenda and
any additional information for the meeting will be posted when
available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.361,
Nursing Research, National Institutes of Health, HHS)
Dated: December 29, 2010.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-33331 Filed 1-4-11; 8:45 am]
BILLING CODE 4140-01-P
