Opportunity Information: Apply for RFA CK 10 005
Apply for RFA CK 10 005
- The Centers for Disease Control and Prevention in the health sector is offering a public funding opportunity titled "Improved Diagnostics for Lyme Borreliosis (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.942 Research, Prevention, and Education Programs on Lyme Disease in the United States.
- This funding opportunity was created on Mar 3, 2010 and posted on Mar 3, 2010.
- Applicants must submit their applications by Apr 14, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- Eligible Institutions You may submit an application(s) if your organization has any of the following characteristics Public nonprofit organizations Private nonprofit organizations Small, minority, and women owned businesses Universities Colleges Research institutions Hospitals Community based organizations Faith based organizations Federally recognized or state recognized American Indian/Alaska Native tribal governments American Indian/Alaska Native tribally designated organizations Alaska Native health corporations Urban Indian health organizations Tribal epidemiology centers State and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau) Political subdivisions of States (in consultation with States) A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as Other Documents and label as appropriate.
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Opportunity Summary:
The grant opportunity "Improved Diagnostics for Lyme Borreliosis (U01)" (Funding Opportunity Number RFA CK 10 005) is a CDC cooperative agreement designed to push better Lyme disease laboratory tests from the research setting into real clinical use. The focus is on developing and evaluating diagnostic methods that are more sensitive and more specific than the standard two-tier serologic testing approach, with a major emphasis on tests that can tell the difference between an active, current infection and evidence of a past infection. In practical terms, the CDC is looking to support work that meaningfully improves diagnostic accuracy and clinical decision-making for Lyme borreliosis by reducing false negatives and false positives and by addressing one of the biggest limitations of antibody-based testing: antibodies can persist long after infection has resolved, making it hard to interpret results in patients with prior exposure.
This is a discretionary health funding opportunity using the cooperative agreement mechanism (U01), which typically means CDC expects substantial involvement during the project period, such as collaboration on study design considerations, data and performance expectations, and alignment with public health priorities. The announcement was posted March 3, 2010, with an application deadline of April 14, 2010, and an archive date of May 14, 2010. The program anticipated making about two awards, with an estimated total funding amount of $500,000 and an award ceiling of $250,000 per award. There is no cost sharing or matching requirement, and the award floor is listed as $0, which generally signals flexibility in budget size depending on the proposed work and available funds.
Eligibility is broad and spans many types of organizations that could reasonably conduct diagnostics research or clinical evaluation studies. Eligible applicants include public and private nonprofit organizations, universities and colleges, research institutions, hospitals, community-based and faith-based organizations, and small, minority-, and women-owned businesses. Governmental eligibility includes state and local governments (and their bona fide agents), political subdivisions of states (in consultation with states), and a wide range of U.S. territories and freely associated states listed in the announcement. The opportunity also explicitly includes multiple tribal entities, such as federally or state recognized American Indian/Alaska Native tribal governments, tribally designated organizations, Alaska Native health corporations, urban Indian health organizations, and tribal epidemiology centers. If applying as a bona fide agent for a state or local government, the applicant must provide formal documentation (a letter) from the relevant government entity confirming that status, and the announcement specifies where that documentation must be attached in the application package.
The funded activity falls under CFDA 93.942, described as "Research, Prevention, and Education Programs on Lyme Disease in the United States." While the summary does not spell out specific required aims beyond improved diagnostics, the central deliverable is clear: lab tests that outperform current two-tier serology in clinical utility and that can discriminate active infection from prior exposure. That implies the CDC was interested not just in early-stage discovery, but in credible evaluation work that demonstrates performance characteristics (sensitivity, specificity, and real-world interpretability) strong enough to support clinical adoption. The cooperative agreement structure also suggests awardees would likely coordinate closely with CDC on how diagnostic performance is assessed and how the work is positioned to translate into practice.
For administrative or access issues, the notice directs applicants to the CDC Procurement and Grants Office (TIMS) via phone (770-488-2700) or email (PGOTIM@cdc.gov), which serves as the point of contact for help obtaining the full announcement or navigating submission requirements.
FAQs: Improved Diagnostics for Lyme Borreliosis (U01) - RFA CK-10-005
What is the "Improved Diagnostics for Lyme Borreliosis (U01)" funding opportunity?
It is a CDC cooperative agreement (U01) intended to move improved Lyme disease laboratory diagnostics from research settings into real clinical use. The work is expected to develop and evaluate diagnostic methods that are more sensitive and more specific than the standard two-tier serologic testing approach.
What is the Funding Opportunity Number for this announcement?
The Funding Opportunity Number is RFA CK 10 005.
What is the main goal of the program?
The central goal is to meaningfully improve diagnostic accuracy and clinical decision-making for Lyme borreliosis by reducing both false negatives and false positives, and by supporting tests that can distinguish an active, current infection from evidence of a past infection.
Why is distinguishing active infection from past infection a major emphasis?
A key limitation of antibody-based testing is that antibodies can persist long after an infection has resolved. This can make results difficult to interpret in patients with prior exposure. The CDC emphasizes diagnostics that can separate current infection from past infection evidence to improve real-world clinical interpretability.
What types of diagnostic improvements is CDC looking for?
The announcement emphasizes diagnostic methods that outperform the standard two-tier serologic testing approach in sensitivity and specificity, with strong clinical utility. The focus is on credible development and evaluation that supports clinical adoption.
Is this opportunity focused on early-stage discovery research or clinical evaluation?
Based on the description, the opportunity is oriented toward work that goes beyond early-stage discovery and includes credible evaluation demonstrating performance characteristics strong enough to support clinical adoption and improved clinical decision-making.
What does the U01 cooperative agreement mechanism mean for applicants?
As a cooperative agreement (U01), CDC typically expects substantial involvement during the project period. This can include collaboration on study design considerations, data and performance expectations, and alignment with public health priorities.
Which federal program listing (CFDA) is associated with this opportunity?
The funded activity falls under CFDA 93.942, described as "Research, Prevention, and Education Programs on Lyme Disease in the United States."
When was the announcement posted?
The announcement was posted on March 3, 2010.
What was the application deadline?
The application deadline was April 14, 2010.
When was the archive date?
The archive date was May 14, 2010.
How many awards did CDC anticipate making?
The program anticipated making about two awards.
What was the estimated total funding amount?
The estimated total funding amount was $500,000.
What was the maximum funding amount per award (award ceiling)?
The award ceiling was $250,000 per award.
Is there a minimum award amount (award floor)?
The award floor is listed as $0, which generally indicates flexibility in budget size depending on the proposed work and available funds.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is broad and includes public and private nonprofit organizations, universities and colleges, research institutions, hospitals, community-based and faith-based organizations, and small, minority-, and women-owned businesses.
Are state and local governments eligible?
Yes. Eligible governmental applicants include state and local governments (and their bona fide agents) and political subdivisions of states (in consultation with states).
Are U.S. territories and freely associated states included in eligibility?
Yes. The announcement includes a wide range of U.S. territories and freely associated states listed in the opportunity.
Are tribal entities eligible to apply?
Yes. The opportunity explicitly includes multiple tribal entities, including federally or state recognized American Indian/Alaska Native tribal governments, tribally designated organizations, Alaska Native health corporations, urban Indian health organizations, and tribal epidemiology centers.
What documentation is required if applying as a bona fide agent for a state or local government?
If applying as a bona fide agent, the applicant must provide formal documentation (a letter) from the relevant government entity confirming that status. The announcement also specifies where that documentation must be attached in the application package.
What is the CDC point of contact for administrative or access issues?
Applicants with administrative or access issues are directed to the CDC Procurement and Grants Office (TIMS).
How can applicants contact the CDC Procurement and Grants Office (TIMS)?
By phone at 770-488-2700 or by email at PGOTIM@cdc.gov.
Does the summary list specific required aims beyond improved diagnostics?
The summary does not spell out specific required aims beyond improved diagnostics, but it clearly emphasizes improved clinical utility, stronger sensitivity and specificity than two-tier serology, and the ability to discriminate active infection from prior exposure.
Browse more opportunities from the same category: Health
Next opportunity: Assessment of Post treatment Lyme disease Syndrome (PLDS) (R01)
Previous opportunity: Histology for Interface Stability over Time (HIST)
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Applicants also applied for:
Applicants who have applied for this opportunity (RFA CK 10 005) also looked into and applied for these:
| Funding Opportunity |
|---|
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