[Federal Register Volume 87, Number 127 (Tuesday, July 5, 2022)]
[Notices]
[Pages 39836-39837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14211]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Invitation to Manufacturers of Platforms for Nucleic Acid 
Amplification or Detection Suitable for Assay Development and Molecular 
Diagnostics for Detection of Agents That Cause Infectious Diseases

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

ACTION: Notice.

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[[Page 39837]]

SUMMARY: The Centers for Disease Control and Prevention (CDC), located 
within the Department of Health and Human Services (HHS), is interested 
in obtaining information on available platforms for nucleic acid 
amplification or detection that meet criteria outlined below in the 
SUPPLEMENTARY INFORMATION section below.

DATES: Manufacturers are asked to contact CDC at the address below by 
August 19, 2022.

FOR FURTHER INFORMATION CONTACT: Laura Hughes-Baker, Centers for 
Disease Control and Prevention, 1600 Clifton Road NE, MS H24-12, 
Atlanta, GA 30329-4027. Telephone: (404) 639-1402; Email: 
<a href="/cdn-cgi/l/email-protection#10757f737566757e64252221507374733e777f66"><span class="__cf_email__" data-cfemail="41242e222437242f35747370012225226f262e37">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 
    Background: Nucleic acid amplification or detection is used in many 
diagnostic tests. Rapid and accurate results that can specifically 
detect small amounts of pathogen material are essential to identifying 
and tracking diseases. The recent pandemic has demonstrated the need 
for tests that can be used in public health laboratories across the 
United States and internationally.
    Many CDC laboratories across the agency use a particular diagnostic 
platform for nucleic acid detection. Because this current platform will 
be retired in the future, CDC is interested in hearing from 
manufacturers regarding the availability of current and potential 
platforms that could support CDC's overall diagnostics and 
surveillance.
    Criteria: Ideally, the replacement platform should:
    <bullet> Be suitable for research, surveillance, or assay 
development, and in vitro diagnostic purposes;
    <bullet> Have Food and Drug Administration (FDA) clearance for 
diagnostic use or a research platform capable of obtaining FDA 
clearance;
    <bullet> Be compatible with a 96 well format;
    <bullet> Be compatible with diagnostic, surveillance, or 
characterization tests targeting a variety of pathogens; and
    <bullet> Have software that allows for flexibility in analysis.
    Manufactures who may have a platform that meets these criteria 
should submit information to CDC at <a href="/cdn-cgi/l/email-protection#680d070b0d1e0d061c5d5a59280b0c0b460f071e"><span class="__cf_email__" data-cfemail="482d272b2d3e2d263c7d7a79082b2c2b662f273e">[email protected]</span></a> or the address 
provided in the FOR FURTHER INFORMATION section above.
    All information submitted to CDC will be kept confidential as 
allowed by relevant federal law, including the Freedom of Information 
Act (5 U.S.C. 552) and the Trade Secrets Act (18 U.S.C. 1905).

Disclaimer and Important Notes

    This notice is for planning purposes; it does not constitute a 
formal announcement for comprehensive applications. In accordance with 
Federal Acquisition Regulation 48 CFR 15.201(e), responses to this 
notice are not offers and cannot be accepted by the Government to form 
a binding award. CDC will not provide reimbursement for costs incurred 
in responding to this notice.

    Dated: June 29, 2022.
Angela K. Oliver,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2022-14211 Filed 7-1-22; 8:45 am]
BILLING CODE 4163-18-P


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