[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7606-7607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02793]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Opportunity To Collaborate in the Evaluation of Simplified 
Nucleic Acid Tests for Detecting and Quantifying HIV

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (DHHS).

ACTION: General notice.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), 
Department of Health and Human Services (HHS) announces an opportunity 
for industry and the public to collaborate on a project to evaluate 
simplified nucleic acid tests. HHS/CDC is interested in evaluating 
simplified nucleic acid tests that (1) can be used near a patient with 
rapid turn-around of results (2) can be used to aid in the diagnosis of 
HIV-1 infection, and (3) have the potential to be used in moderately 
complex and/or waived laboratories as defined under the Clinical 
Laboratory Improvement Amendment (CLIA) regulations. Tests of interest 
include those that use whole blood, serum, plasma, or dried blood 
spots. Performance will be evaluated relative to HHS/Food and Drug 
Administration (FDA)-approved qualitative and quantitative nucleic acid 
tests as well as antibody immunoassays. More than one collaborator may 
be selected.

DATES: Formal proposals must be received on or before April 13, 2015.

ADDRESSES: Formal proposals should be submitted to Division of HIV/AIDS 
Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB 
Prevention, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE., Mailstop E-46, Atlanta, Georgia 30329, Attn: Simplified 
Nucleic Acid Tests Evaluation Project. If you are interested in 
submitting a proposal, please send a letter of interest to Dr. Michele 
Owen at <a href="/cdn-cgi/l/email-protection#ea998785d8aa898e89c48d859c"><span class="__cf_email__" data-cfemail="cdbea0a2ff8daea9aee3aaa2bb">[email protected]</span></a> by March 13, 2015. The letter of interest is not 
considered a formal proposal and is not required; however, it is highly 
recommended, as it will assist CDC in planning for the review process. 
The formal proposal will still need to be submitted according to the 
instructions in this notice.

FOR FURTHER INFORMATION CONTACT: Questions on the project should be 
addressed to: Laura Wesolowski, National Center for HIV/AIDS, Viral 
Hepatitis, STD, and TB Prevention, Centers for Disease Control and

[[Page 7607]]

Prevention, 1600 Clifton Road NE., Mailstop E-46, Atlanta, GA 30329, 
telephone: (404) 639-6007, email: <a href="/cdn-cgi/l/email-protection#c2aeaba5f582a1a6a1eca5adb4"><span class="__cf_email__" data-cfemail="8ce0e5ebbbccefe8efa2ebe3fa">[email protected]</span></a>.
    Scientific questions should be addressed to Michele Owen, National 
Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers 
for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop A-
25, Atlanta, GA 30329; Phone 404-639-1046, email <a href="/cdn-cgi/l/email-protection#5b283634691b383f38753c342d"><span class="__cf_email__" data-cfemail="5d2e30326f1d3e393e733a322b">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: HHS/CDC seeks to collaborate with one or 
more companies that have developed a simplified nucleic acid test that 
can detect acute or established HIV-1 infection. Acute HIV infection is 
the early infection period associated with high viral load that occurs 
before the development of HIV antibodies, and established infection is 
that which occurs once antibodies are detectable.
    The objective of the collaboration is timely collection of data to 
evaluate the performance characteristics of simplified nucleic acid 
tests when used in their intended applications. The evaluation will be 
conducted in phases. The first round of evaluation will be done on well 
characterized stored or mock laboratory specimens. Following the 
initial round of evaluation, a subset of tests with high performance 
will be evaluated with prospectively collected specimens. Only tests 
that are near production (i.e., not first generation prototypes) will 
be eligible for the collaboration. Companies that are interested in 
collaborating must be planning to produce a simplified nucleic acid 
test for distribution in the United States and to seek FDA approval for 
diagnostic or prognostic use (priority given to tests with both 
applications). Confidential proposals, preferably six pages or less 
(excluding appendices), are solicited from companies which have a 
product that is suitable for commercial distribution. This 
collaboration will have an expected duration of 1 to 6 years.
    Currently, nucleic acid testing conducted as part of HHS/CDC's 
laboratory algorithm is associated with a delay in returning results 
because testing is often conducted in referral laboratories. Likewise, 
pooled nucleic acid testing causes delays due to the time required to 
create and break down pools in the event of a positive pool. Rapid 
identification of acute and established HIV-1 infection using a 
simplified nucleic acid test may have a significant impact on patients 
with positive test results obtaining care and services more quickly. 
Therapeutic monitoring could also be conducted more efficiently using a 
simplified nucleic acid test.
    For this project, preference may be given to manufacturers that 
have produced rapid nucleic acid tests that can aid in HIV-1 diagnosis, 
and be used for monitoring responses to therapy. Tests should be simple 
to use on unprocessed specimens (e.g., whole blood) or include specimen 
processing in the design of the test. Preference will also be given for 
tests that can be performed in 60 minutes or less, that have the 
potential to be designated moderately complex or waived under the 
Clinical Laboratory Improvement Amendments (CLIA), and that are capable 
of both qualitative and quantitative applications.

HHS/CDC and Collaborator Responsibilities

    HHS/CDC's role may include, but will not be limited to, the 
following:
    (1) Providing scientific and technical expertise needed for the 
research project;
    (2) Providing appropriate panels of specimens, and conducting the 
tests;
    (3) Planning and conducting research studies of the diagnostic 
tests and interpreting results; and
    (4) Publishing research results.
    HHS/CDC anticipates that the role of the successful collaborator(s) 
will include the following:
    (1) Providing tests and finalized protocols that can be used in the 
evaluation; and
    (2) Providing the CDC Division of HIV/AIDS Prevention access to 
necessary data about the diagnostic tests in support of the research 
activities.

Selection Criteria

    Proposals submitted for consideration should address, as fully as 
possible and to the extent relevant to the proposal, each of the 
following:
    (1) Data available on the performance of the test in persons with 
acute and established HIV-1 infection.
    (2) Information on the technology used for the test and its basic 
operating principals for detecting HIV RNA and/or DNA.
    (3) Information on:
    a. the time required to perform the test;
    b. whether the test is performed on whole blood, serum, plasma, or 
dried blood spots; and
    c. the steps involved in performing the test on each specimen type;
    (4) Information on the storage requirements and stability of the 
test.
    (5) Plans and capability of the company to seek HHS/FDA approval 
and whether the company intends to seek a diagnostic claim, a 
prognostic claim (for patient monitoring) or both.
    (6) Plans the company has for seeking CLIA waiver status, if FDA 
approved.

    Dated: February 6, 2015.
Ron A. Otten,
Acting Deputy Associate Director for Science, Centers for Disease 
Control and Prevention.
[FR Doc. 2015-02793 Filed 2-10-15; 8:45 am]
BILLING CODE 4163-18-P


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