[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38055-38056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12435]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


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

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

ACTION: General notice.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), within 
the Department of Health and Human Services (HHS), announces an 
opportunity for industry and the public to collaborate on a project to 
evaluate nucleic acid and serologic tests. CDC is interested in 
evaluating serologic and nucleic acid tests that can be used to aid in 
the diagnosis of HIV-1 infection, including serologic tests that can 
secondarily differentiate recent infection, and nucleic acid tests for 
the quantitation or semi-quantitation of HIV RNA. Tests of interest 
include those that use whole blood, serum, plasma, or dried blood 
spots. Performance will be evaluated relative to Food and Drug 
Administration (FDA)-approved qualitative and quantitative nucleic acid 
tests as well as serologic immunoassays. More than one collaborator may 
be selected.

DATES: Letters of interest must be received on or before Friday, 
September 15, 2023. Formal proposals must be received on or before 
Friday, November 10, 2023.

ADDRESSES: Send Letters of Interest and Formal Proposals to Division of 
HIV Prevention, National Center for HIV, Viral Hepatitis, STD, and TB 
Prevention, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, Mailstop H18-2, Atlanta, Georgia 30329. Attn: HIV Serologic 
and Nucleic Acid Tests Evaluation Project.

FOR FURTHER INFORMATION CONTACT: Jeffrey Johnson, National Center for 
HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease 
Control and Prevention, 1600 Clifton Road NE, Mailstop 18-2, Atlanta, 
GA 30329; Telephone 404-639-4976; Email: [email protected].

SUPPLEMENTARY INFORMATION: 

Background

    Priority for technical evaluations are rapid tests or mail-in 
sample collection methods that can be self-administered outside of 
clinic settings. Secondarily, tests or collection methods that have the 
potential for both HIV-1 diagnostic and prognostic use for monitoring 
responses to therapy are preferred.
    The objective of the collaboration is timely collection of data to 
evaluate the performance characteristics of simplified nucleic acid and 
serologic tests or protocols when used in their intended applications. 
Only tests that are under or near production (i.e., not first-
generation prototypes) will be eligible for the collaboration. 
Companies that are interested in collaborating must be planning to 
market a test protocol for distribution in the United States and to 
seek FDA approval for diagnostic or prognostic use.
    Currently, nucleic acid testing conducted as part of CDC's 
laboratory algorithm has 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. Moreover, there are 
significant financial stability, geographic isolation, and stigma 
barriers to accessing testing in clinical settings that prevent 
sustained continuum of care for many populations, including the most 
vulnerable. Methods to support rapid identification of HIV-1 infection 
or viral suppression using a simplified nucleic acid or serologic test, 
or use of self-collection methods, may have a significant impact on 
individuals by allowing them to obtain care and services more quickly.
    Tests should be simple to use on unprocessed specimens (e.g., whole 
blood) or include specimen processing in the design of the test. For 
nucleic acid tests, preference may also be given to tests that are 
capable of both qualitative and quantitative applications. Key 
benchmarks are the ability to demonstrate improved sensitivity of 
diagnostic tests over current FDA-approved laboratory-based tests and 
nucleic acid monitoring test protocols that are suitable for lower 
complexity settings.

CDC and Collaborator Roles and Responsibilities

    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 assistance with project management and data analysis;
    (3) Providing testing support as determined by CDC as needed; and
    (4) Publishing research results.
    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 Prevention access to 
necessary data about the diagnostic tests in support of the evaluation 
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, DNA, antibody, or antigen.
    (3) Information on:
    a. the time required to perform the test or sample collection 
method;
    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 
or sample collection method;
    (4) Information on the storage requirements and stability of the 
test.
    (5) Plans, capability, and clinical trial designs 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, for 
appropriate tests, if FDA approved.

[[Page 38056]]

Letters of Interest

    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.

Formal Proposals

    Confidential proposals, preferably six pages or less (excluding 
appendices), are solicited from companies which have a product that is 
suitable for regulatory approval and commercialization. This 
collaboration will have an expected duration of 1 to 4 years.

    Dated: June 7, 2023.
Tiffany Brown,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2023-12435 Filed 6-9-23; 8:45 am]
BILLING CODE 4163-18-P