Opportunity To Collaborate in the Evaluation of Rapid Diagnostic Tests for HIV and HCV, 8260-8261 [E9-3865]
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Federal Register / Vol. 74, No. 35 / Tuesday, February 24, 2009 / Notices
Newborn Screening: An Ethical Analysis
by The President’s Council on Bioethics
(December 2008); and Controversies in
the Determination of Death: A White
Paper by The President’s Council on
Bioethics (December 2008). Reports are
forthcoming on organ transplantation
and health care reform.
DATES: The meeting will take place
Thursday, March 12, 2009, from 9 a.m.
to 5 p.m., ET; and Friday, March 13,
2009, from 9 a.m. to 10:45 a.m., ET.
ADDRESSES: Renaissance Washington,
DC Hotel, 999 9th Street, NW.,
Washington, DC 20001. Phone 202–898–
9000.
FOR FURTHER INFORMATION CONTACT: Ms.
Diane M. Gianelli, Director of
Communications, The President’s
Council on Bioethics, 1425 New York
Avenue, NW., Suite C100, Washington,
DC 20005. Telephone: 202/296–4669. Email: info@bioethics.gov. Web site:
https://www.bioethics.gov.
SUPPLEMENTARY INFORMATION: The
meeting agenda will be posted at https://
www.bioethics.gov. The Council
encourages public input, either in
person or in writing. At this meeting,
interested members of the public may
address the Council, beginning at 10:30
a.m., on Friday, March 13. Comments
are limited to no more than five minutes
per speaker or organization. As a
courtesy, please inform Ms. Diane M.
Gianelli, Director of Communications,
in advance of your intention to make a
public statement, and give your name
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statement, mail or e-mail it to Ms.
Gianelli at one of her contact addresses
given above.
Dated: February 5, 2009.
F. Daniel Davis,
Executive Director, The President’s Council
on Bioethics.
[FR Doc. E9–3843 Filed 2–23–09; 8:45 am]
BILLING CODE 4154–06–P
Agency Information Collection
Activities: Proposed Collection;
Comment Request
mstockstill on PROD1PC66 with NOTICES
BILLING CODE 1505–01–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration on Aging
Delegation of Authority
Notice is hereby given that I have
delegated to the Assistant Secretary for
Aging the authority vested in the
Secretary of Health and Human Services
under section 119(c) of the Medicare
Improvements for Patients and
Providers Act of 2008, Public Law 110–
275 pertaining to making grants to
Aging and Disability Resource Centers
under the Aging and Disability Resource
Center grant program.
These delegations shall be exercised
under the Department’s policy on
regulations and the existing delegation
of authority to approve and issue
regulations. This delegation excludes
the authority to issue reports to
Congress.
I hereby affirmed and ratified any
actions taken by the Assistant Secretary
for Aging or other Administration on
Aging officials, which involved the
exercise of these authorities prior to the
effective date of this delegation.
This delegation was effective upon
date of signature.
Dated: February 9, 2009.
Charles E. Johnson,
Acting Secretary.
[FR Doc. E9–3839 Filed 2–23–09; 8:45 am]
BILLING CODE 4154–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Opportunity To Collaborate in the
Evaluation of Rapid Diagnostic Tests
for HIV and HCV
Agency for Healthcare Research and
Quality
Correction
In notice document E9–1009
beginning on page 4748 in the issue of
Tuesday, January 27, 2009 make the
following correction:
On page 4749, in the first column,
under the ADDRESSES section, in the
sixth line,
17:23 Feb 23, 2009
[FR Doc. Z9–1009 Filed 2–23–09; 8:45 am]
Centers for Disease Control and
Prevention
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Nov<24>2008
‘‘doris.lefkowitz@.ahrq.hhs.gov’’ should
read ‘‘doris.lefkowitz@ahrq.hhs.gov’’.
Jkt 217001
AGENCY: Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (DHHS).
ACTION: Opportunities for collaboration
for evaluation of rapid diagnostic tests
for HIV and hepatitis C virus (HCV). The
Centers for Disease Control and
Prevention (CDC), National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), has an
opportunity for collaboration to evaluate
diagnostic tests for HIV and HCV. These
evaluations will include evaluation of
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
the sensitivity and specificity of the
tests, and the predictive value of
algorithms using two or more different
rapid tests in combination.
Specific tests are sought to meet one
or more of the following purposes: (1)
Laboratory-based or rapid point-of-care
tests designed to detect both HIV
antigen and antibody; (2) laboratorybased or rapid point-of-care tests that
can distinguish persons with acute HIV
infection from persons who have longerstanding HIV infection; (3) laboratorybased or rapid point-of-care tests that
can be used as supplemental
confirmatory tests to help diagnose
HIV–1 or HIV–2 infection, (4) rapid
laboratory-based or rapid point-of-care
tests designed to detect HCV antibody,
antigen or both. Tests of interest include
those that can detect HIV–1⁄2 and/or
HCV antibody, antigen, RNA, or DNA
when used on whole blood, serum,
plasma, oral fluid or dried blood spots.
Evaluations will include the sensitivity
and specificity of the test when used in
the intended application (e.g., for
screening or confirmation).
SUMMARY: The National Center for HIV/
AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP) at the Centers
for Disease Control and Prevention
(CDC) of the Department of Health and
Human Services (DHHS) seeks one or
more companies that have developed or
are distributing rapid diagnostic tests for
HIV or HCV and are interested in
marketing the tests for use in the United
States. The Division of HIV/AIDS
Prevention and the Division of Viral
Hepatitis are interested in evaluating
such tests. The evaluation will include
determination of sensitivity and
specificity of the test, and may also
evaluate the predictive value of two or
more different tests used in combination
in populations of low prevalence. This
collaboration will have an expected
duration of two (2) to three (3) years.
The goals of the collaboration include
the timely development of data to be
used to determine whether the test
could be used in screening and/or
diagnosis for HIV or HCV in the United
States, and to examine laboratory-based
or rapid point-of-care tests. These tests
require high sensitivity to detect
persons with acute and longer-standing
HIV infection; or high specificity to
distinguish persons with acute infection
from those with longer-standing
infection; or high specificity for tests
that can be used as to confirm HIV–1 or
HIV–2 infection. Acute HIV infection is
defined as the early infection period
associated with a transient symptomatic
illness, high viral load, and expansive
immunologic response. For HCV testing,
E:\FR\FM\24FEN1.SGM
24FEN1
Federal Register / Vol. 74, No. 35 / Tuesday, February 24, 2009 / Notices
with acute or recent HIV infection from
persons with longer standing infections.
NCHHSTP also seeks new methods that
could serve to expedite confirmatory
testing for HIV–1, HIV–2, and HCV
either at the point-of-care or in the
laboratory.
Technology Sought
Selection Criteria
One goal of the National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP) is to develop
new approaches to increase the number
of persons infected with HIV and/or
HCV who know their status and have
access to effective treatment. These
approaches might include increasing the
use of more sensitive screening assays
(such as antigen or nucleic acid
amplification tests) that can identify
persons with acute HIV infection; rapid
tests that can identify resolved or
ongoing HCV infection; and more
sensitive and specific confirmatory
assays that can be used at point-of-care
to obviate the need for clients to return
for confirmed test results. NCHHSTP is
seeking rapid diagnostic tests that are
suitable for commercial distribution and
that are simple: preferably, tests that use
direct, unprocessed specimens (e.g.,
whole blood); can be performed in 30
minutes or less by persons with
minimal training; include all necessary
reagents in the test kit; can be stored at
temperatures between 25 and 39°C; and
have a minimum 1-year shelf life. Of
particular interest are tests with high
sensitivity for early stage HIV infection
and tests that can distinguish persons
mstockstill on PROD1PC66 with NOTICES
rapid tests to be used in the screening
setting require high sensitivity and
confirmatory tests with high specificity.
Confidential proposals, preferably six
pages or less (excluding appendices),
are solicited from companies who have
a product that is suitable for commercial
distribution.
DATES: Formal proposals must be
submitted no later than 30 calendar
days after date of publication in the
Federal Register.
ADDRESSES: Formal proposals should be
submitted to Sal Butera, Associate
Director for Laboratory Science,
NCHHSTP, CDC, 1600 Clifton Road,
NE., Mailstop E–07, Atlanta, GA 30333;
Phone 404–639–6379; Fax 404–639–
3125; e-mail; SButera@cdc.gov.
Scientific questions should be
addressed to Bernard M. Branson, M.D.,
Division of HIV/AIDS Prevention,
NCHSTP, CDC 1600 Clifton Road, NE.,
Mailstop D–21, Atlanta, GA 30333;
Phone 404–639–6166, Fax 404–639–
0897; e-mail BBranson@cdc.gov.
SUPPLEMENTARY INFORMATION:
Proposals submitted for consideration
will be evaluated according to selection
criteria, and should address, as best as
possible and to the extent relevant to the
proposal, each of the following:
(1) Information on the technology
used for the test, including basic
operating principals such as antigen or
antibody components used for
detection;
(2) Data available on the performance
characteristics of the tests in different
populations;
(3) Information on the time required
to perform the test, whether the test is
performed on oral fluid, whole blood,
serum, plasma, or dried blood spots,
and the steps involved in performing
the test;
(4) Information on the storage
requirements and stability of the test;
(5) Interest by the company to seek
FDA approval and market the test in the
United States;
(6) Ability to provide to CDC
approximately 8,000 tests and all related
equipment to enable laboratory
validation at CDC;
(7) Documentation of production
capacity to provide at least 500,000 tests
annually.
VerDate Nov<24>2008
17:23 Feb 23, 2009
Jkt 217001
NCHHSTP and Collaborator
Responsibilities
Frm 00033
Fmt 4703
Sfmt 4703
Dated: February 13, 2009.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
[FR Doc. E9–3865 Filed 2–23–09; 8:45 am]
BILLING CODE 4163–18–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The NCHHSTP role may include, but
will not be limited to, the following:
(1) Providing scientific and technical
expertise needed for the evaluation
project;
(2) Planning and conducting
evaluation studies of the diagnostic tests
and interpreting results; and
(3) Publishing evaluation results.
The NCHHSTP anticipates that the
role of the successful collaborator(s) will
include the following:
(1) Providing NCHHSTP access to
data necessary to identify candidate
tests for further evaluation; and
(2) Providing tests that can be used in
the evaluation.
PO 00000
8261
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Low Income Home Energy
Assistance Program LIHEAP Leveraging
Report.
OMB No.: 0970–0121.
Description: The LIHEAP leveraging
incentive program rewards LIHEAP
grantees that have leveraged non-federal
home energy resources for low-income
households. The LIHEAP leveraging
report is the application for leveraging
incentive funds that these LIHEAP
grantees submit to the Department of
Health and Human Services for each
fiscal year in which they leverage
countable resources. Participation in the
leveraging incentive program is
voluntary and is described at 45 CFR
96.87. The LIHEAP leveraging report
obtains information on the resources
leveraged by LIHEAP grantees each
fiscal year (as cash, discounts, waivers,
and in-kind); the benefits provided to
low-income households by these
resources (for example, as fuel and
payments for fuel, as home heating and
cooling equipment, and as
weatherization materials and
installation); and the fair market value
of these resources/benefits.
HHS needs this information in order
to carry out statutory requirements for
administering the LIHEAP leveraging
incentive program, to determine
accountability and valuation of grantees
leveraged non-federal home energy
resources, and to determine grantees
shares of leveraging incentive funds.
HHS proposes to request a three-year
extension of OMB approval for the
currently approved LIHEAP leveraging
report information collection.
Respondents: State, Local or Tribal
Governments.
E:\FR\FM\24FEN1.SGM
24FEN1
]]>Agencies
[Federal Register Volume 74, Number 35 (Tuesday, February 24, 2009)]
[Notices]
[Pages 8260-8261]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3865]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Opportunity To Collaborate in the Evaluation of Rapid Diagnostic
Tests for HIV and HCV
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (DHHS).
ACTION: Opportunities for collaboration for evaluation of rapid
diagnostic tests for HIV and hepatitis C virus (HCV). The Centers for
Disease Control and Prevention (CDC), National Center for HIV/AIDS,
Viral Hepatitis, STD, and TB Prevention (NCHHSTP), has an opportunity
for collaboration to evaluate diagnostic tests for HIV and HCV. These
evaluations will include evaluation of the sensitivity and specificity
of the tests, and the predictive value of algorithms using two or more
different rapid tests in combination.
-----------------------------------------------------------------------
Specific tests are sought to meet one or more of the following
purposes: (1) Laboratory-based or rapid point-of-care tests designed to
detect both HIV antigen and antibody; (2) laboratory-based or rapid
point-of-care tests that can distinguish persons with acute HIV
infection from persons who have longer-standing HIV infection; (3)
laboratory-based or rapid point-of-care tests that can be used as
supplemental confirmatory tests to help diagnose HIV-1 or HIV-2
infection, (4) rapid laboratory-based or rapid point-of-care tests
designed to detect HCV antibody, antigen or both. Tests of interest
include those that can detect HIV-\1/2\ and/or HCV antibody, antigen,
RNA, or DNA when used on whole blood, serum, plasma, oral fluid or
dried blood spots. Evaluations will include the sensitivity and
specificity of the test when used in the intended application (e.g.,
for screening or confirmation).
SUMMARY: The National Center for HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP) at the Centers for Disease Control and Prevention
(CDC) of the Department of Health and Human Services (DHHS) seeks one
or more companies that have developed or are distributing rapid
diagnostic tests for HIV or HCV and are interested in marketing the
tests for use in the United States. The Division of HIV/AIDS Prevention
and the Division of Viral Hepatitis are interested in evaluating such
tests. The evaluation will include determination of sensitivity and
specificity of the test, and may also evaluate the predictive value of
two or more different tests used in combination in populations of low
prevalence. This collaboration will have an expected duration of two
(2) to three (3) years. The goals of the collaboration include the
timely development of data to be used to determine whether the test
could be used in screening and/or diagnosis for HIV or HCV in the
United States, and to examine laboratory-based or rapid point-of-care
tests. These tests require high sensitivity to detect persons with
acute and longer-standing HIV infection; or high specificity to
distinguish persons with acute infection from those with longer-
standing infection; or high specificity for tests that can be used as
to confirm HIV-1 or HIV-2 infection. Acute HIV infection is defined as
the early infection period associated with a transient symptomatic
illness, high viral load, and expansive immunologic response. For HCV
testing,
[[Page 8261]]
rapid tests to be used in the screening setting require high
sensitivity and confirmatory tests with high specificity.
Confidential proposals, preferably six pages or less (excluding
appendices), are solicited from companies who have a product that is
suitable for commercial distribution.
DATES: Formal proposals must be submitted no later than 30 calendar
days after date of publication in the Federal Register.
ADDRESSES: Formal proposals should be submitted to Sal Butera,
Associate Director for Laboratory Science, NCHHSTP, CDC, 1600 Clifton
Road, NE., Mailstop E-07, Atlanta, GA 30333; Phone 404-639-6379; Fax
404-639-3125; e-mail; SButera@cdc.gov.
Scientific questions should be addressed to Bernard M. Branson,
M.D., Division of HIV/AIDS Prevention, NCHSTP, CDC 1600 Clifton Road,
NE., Mailstop D-21, Atlanta, GA 30333; Phone 404-639-6166, Fax 404-639-
0897; e-mail BBranson@cdc.gov.
SUPPLEMENTARY INFORMATION:
Technology Sought
One goal of the National Center for HIV/AIDS, Viral Hepatitis, STD,
and TB Prevention (NCHHSTP) is to develop new approaches to increase
the number of persons infected with HIV and/or HCV who know their
status and have access to effective treatment. These approaches might
include increasing the use of more sensitive screening assays (such as
antigen or nucleic acid amplification tests) that can identify persons
with acute HIV infection; rapid tests that can identify resolved or
ongoing HCV infection; and more sensitive and specific confirmatory
assays that can be used at point-of-care to obviate the need for
clients to return for confirmed test results. NCHHSTP is seeking rapid
diagnostic tests that are suitable for commercial distribution and that
are simple: preferably, tests that use direct, unprocessed specimens
(e.g., whole blood); can be performed in 30 minutes or less by persons
with minimal training; include all necessary reagents in the test kit;
can be stored at temperatures between 25 and 39[deg]C; and have a
minimum 1-year shelf life. Of particular interest are tests with high
sensitivity for early stage HIV infection and tests that can
distinguish persons with acute or recent HIV infection from persons
with longer standing infections. NCHHSTP also seeks new methods that
could serve to expedite confirmatory testing for HIV-1, HIV-2, and HCV
either at the point-of-care or in the laboratory.
NCHHSTP and Collaborator Responsibilities
The NCHHSTP role may include, but will not be limited to, the
following:
(1) Providing scientific and technical expertise needed for the
evaluation project;
(2) Planning and conducting evaluation studies of the diagnostic
tests and interpreting results; and
(3) Publishing evaluation results.
The NCHHSTP anticipates that the role of the successful
collaborator(s) will include the following:
(1) Providing NCHHSTP access to data necessary to identify
candidate tests for further evaluation; and
(2) Providing tests that can be used in the evaluation.
Selection Criteria
Proposals submitted for consideration will be evaluated according
to selection criteria, and should address, as best as possible and to
the extent relevant to the proposal, each of the following:
(1) Information on the technology used for the test, including
basic operating principals such as antigen or antibody components used
for detection;
(2) Data available on the performance characteristics of the tests
in different populations;
(3) Information on the time required to perform the test, whether
the test is performed on oral fluid, whole blood, serum, plasma, or
dried blood spots, and the steps involved in performing the test;
(4) Information on the storage requirements and stability of the
test;
(5) Interest by the company to seek FDA approval and market the
test in the United States;
(6) Ability to provide to CDC approximately 8,000 tests and all
related equipment to enable laboratory validation at CDC;
(7) Documentation of production capacity to provide at least
500,000 tests annually.
Dated: February 13, 2009.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention.
[FR Doc. E9-3865 Filed 2-23-09; 8:45 am]
BILLING CODE 4163-18-M
