Award of an Urgent Single-Source Grant to Heartland Alliance, Chicago, IL, 35000 [2011-14841]
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Federal Register / Vol. 76, No. 115 / Wednesday, June 15, 2011 / Notices
characteristics of in vitro diagnostic
devices for the detection of MRSA,
including those for the detection or
detection and differentiation of MRSA
versus SA in either human specimens or
bacterial growth detected by continuous
monitoring blood culture systems.
These devices are used to aid in the
prevention and control of MRSA/SA
infections in health care settings. This
document is limited to studies intended
to establish the performance
characteristics of devices that detect
MRSA by growth in culture media or
those devices that test for the protein,
penicillin-binding protein 2a (PBP2a or
PBP2′), expressed by the mecA gene.
This includes culture-based devices that
use selective or chromogenic media. It
does not address the detection of
serological response from the host to the
MRSA antigens or establish the
performance of non-MRSA components
of multianalyte or multiplex nucleic
acid based devices.
jlentini on DSK4TPTVN1PROD with NOTICES
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This draft guidance is being issued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The draft guidance, when finalized, will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 MRSA for
culture-based devices. 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of the draft guidance may do so by using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 ‘‘Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for the Detection of MethicillinResistant Staphylococcus Aureus
(MRSA) for Culture-Based Devices,’’ 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 1729 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
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information found in FDA regulations
and guidance documents. 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 part 801 and 21
CFR 809.10 have been approved under
OMB control number 0910–0485; and
the collections of information in 42 CFR
493.15 have been approved under OMB
control number 0910–0598.
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: June 9, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–14789 Filed 6–14–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Refugee Resettlement
Award of an Urgent Single-Source
Grant to Heartland Alliance, Chicago,
IL
Office of Refugee Resettlement,
ACF, HHS.
ACTION: Notice.
AGENCY:
CFDA Number: 93.676.
Statutory Authority: Awards announced
in this notice are authorized by Section 412
(c)(1)(A) of the Immigration and Nationality
Act (INA) (8 U.S.C. 1522(c)(1)(A), as
amended, and the Refugee Assistance
Extension Act of 1986, Public Law 99–605,
Nov 6, 1986, 100 Stat. 3449.
Project Period: June 1, 2011–May 31,
2012.
SUMMARY: The Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR) announces
the award of a single-source grant for
PO 00000
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training and technical assistance on
incoming Lesbian, Gay, Bi-Sexual and
Transgender (LGBT) refugee cases to
Heartland Alliance, Chicago, IL, for a
total of $250,000. The additional
funding provided by the award will
support services to refugees through
May 31, 2012.
The current resettlement network has
limited understanding of the issues and
subgroups. Heartland Alliance will
develop training and technical
assistance resources, including capacity
building and service delivery,
specifically targeted at assisting newly
arriving LGBT refugees.
Heartland Alliance will have the
opportunity to receive a continuation
award at the same amount in FY 2012,
which will provide the grantee with a
two-year project period.
FOR FURTHER INFORMATION CONTACT:
Kenneth Tota, Deputy Director, Office of
Refugee Resettlement, Administration
for Children and Families, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Telephone (202) 401–4858.
Dated: June 10, 2011.
Eskinder Negash,
Director, Office of Refugee Resettlement.
[FR Doc. 2011–14841 Filed 6–14–11; 8:45 am]
BILLING CODE 4120–27–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
E:\FR\FM\15JNN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 115 (Wednesday, June 15, 2011)]
[Notices]
[Page 35000]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14841]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of Refugee Resettlement
Award of an Urgent Single-Source Grant to Heartland Alliance,
Chicago, IL
AGENCY: Office of Refugee Resettlement, ACF, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
CFDA Number: 93.676.
Statutory Authority: Awards announced in this notice are
authorized by Section 412 (c)(1)(A) of the Immigration and
Nationality Act (INA) (8 U.S.C. 1522(c)(1)(A), as amended, and the
Refugee Assistance Extension Act of 1986, Public Law 99-605, Nov 6,
1986, 100 Stat. 3449.
Project Period: June 1, 2011-May 31, 2012.
SUMMARY: The Administration for Children and Families (ACF), Office of
Refugee Resettlement (ORR) announces the award of a single-source grant
for training and technical assistance on incoming Lesbian, Gay, Bi-
Sexual and Transgender (LGBT) refugee cases to Heartland Alliance,
Chicago, IL, for a total of $250,000. The additional funding provided
by the award will support services to refugees through May 31, 2012.
The current resettlement network has limited understanding of the
issues and subgroups. Heartland Alliance will develop training and
technical assistance resources, including capacity building and service
delivery, specifically targeted at assisting newly arriving LGBT
refugees.
Heartland Alliance will have the opportunity to receive a
continuation award at the same amount in FY 2012, which will provide
the grantee with a two-year project period.
FOR FURTHER INFORMATION CONTACT: Kenneth Tota, Deputy Director, Office
of Refugee Resettlement, Administration for Children and Families, 370
L'Enfant Promenade, SW., Washington, DC 20447, Telephone (202) 401-
4858.
Dated: June 10, 2011.
Eskinder Negash,
Director, Office of Refugee Resettlement.
[FR Doc. 2011-14841 Filed 6-14-11; 8:45 am]
BILLING CODE 4120-27-P
