[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