Notice2022-14211
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
Primary source
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Published
July 5, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 127 (Tuesday, July 5, 2022)</title>
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[Federal Register Volume 87, Number 127 (Tuesday, July 5, 2022)]
[Notices]
[Pages 39836-39837]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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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