Opportunity Information: Apply for CDC RFA GH 24 0097
This funding opportunity, titled "Strengthening Laboratory Capacity and Quality for HIV Diagnosis, Care, Treatment, and Monitoring in Malawi under PEPFAR" (Funding Opportunity Number CDC RFA GH 24 0097), is a CDC-led cooperative agreement focused on improving and sustaining Malawi's national laboratory system as the country works toward HIV epidemic control. The award is structured as technical and programmatic support delivered in close collaboration with the Malawi Ministry of Health, with an emphasis on building long-term national ownership rather than short-term service delivery. While the listed award ceiling for Year 1 is shown as 0 (meaning no fixed per-award cap is provided in the notice), CDC anticipates approximately $8,375,000 in total funding for the first fiscal year, contingent on available funds, and expects to make two awards.
The core purpose is to strengthen laboratory systems so that HIV diagnostics and monitoring are consistently available, accessible, and high quality across the country, while also addressing broader public health system gaps that affect testing performance. A central theme is sustainability: supporting the Ministry of Health to improve governance and stewardship of public health laboratory functions, reinforcing national structures so improvements continue after external support decreases. A related priority is strengthening National Reference Laboratories so they can better support surveillance and respond to outbreaks, recognizing that strong reference laboratory capacity benefits HIV programs and wider disease detection and response efforts.
On the service quality and patient outcomes side, the opportunity prioritizes improving viral load testing performance, particularly where viral load coverage and viral suppression are lagging among specific age groups and populations. The focus is not only on increasing the number of tests, but on using patient-centered approaches to understand why gaps occur (for example, access barriers, specimen referral issues, result return delays, or challenges with follow-up) and then implementing practical fixes across the diagnostic network. The opportunity also supports expanding and strengthening point-of-care testing platforms, with an explicit push toward integrated, multi-disease testing models rather than HIV-only approaches, which can improve efficiency and make testing more responsive to what patients and facilities actually need.
Another major component is quality management, especially for rapid testing. The grant highlights rapid testing continuous quality improvement (RTCQI) as a pathway to achieving national certification, signaling an intent to standardize and improve the reliability of rapid HIV testing across sites. Beyond rapid testing, the opportunity includes expanding external quality assessment (EQA) coverage so that multiple test parameters are routinely evaluated, helping detect performance problems early and ensuring labs maintain consistent accuracy over time. This quality focus also extends to preparing additional laboratories for ISO accreditation, which generally requires stronger quality systems, documentation, staff competency processes, equipment maintenance practices, and corrective and preventive action systems.
The notice also calls out several targeted diagnostic access gaps that affect clinical care and prevention. These include improving access to testing for advanced HIV disease (AHD), which is important for identifying and managing patients at higher risk of severe illness, and improving access to tests that support pre-exposure prophylaxis (PrEP) services, which are central to HIV prevention efforts. In parallel, the opportunity emphasizes regular diagnostic network optimization, meaning periodic, data-driven reviews of where instruments and testing sites are placed, how specimens move through referral routes, whether turnaround times are acceptable, and whether the network is operating efficiently and equitably. Related to this, it prioritizes increasing utilization of high-throughput instruments in conventional molecular laboratories to improve viral load coverage, which suggests a focus on making better use of existing capacity, reducing bottlenecks, and improving throughput where demand is high.
Finally, the opportunity explicitly includes strengthening biosafety and waste management, reflecting the operational realities of laboratory scale-up and the need to protect staff, patients, and communities. Better biosafety practices and proper waste handling are treated as essential system components, not optional add-ons, especially as testing expands and integrates across multiple disease areas. Overall, the grant is positioned as a comprehensive laboratory systems strengthening effort under PEPFAR, combining governance and sustainability goals with practical improvements in access, efficiency, quality assurance, and readiness for both routine HIV services and broader public health needs.
Key administrative details include: the opportunity is discretionary funding using a cooperative agreement mechanism (indicating substantial CDC involvement), falls under the health activity category, is associated with CFDA 93.067, lists eligible applicants as unrestricted, and had an original closing date of 2024-02-22, with the opportunity posted on 2023-11-21.Apply for CDC RFA GH 24 0097
- The Centers for Disease Control - CGH in the health sector is offering a public funding opportunity titled "Strengthening Laboratory Capacity and Quality for HIV Diagnosis, Care, Treatment, and Monitoring in Malawi under the President's Emergency Plan for AIDS Relief (PEPFAR)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.067.
- This funding opportunity was created on 2023-11-21.
- Applicants must submit their applications by 2024-02-22. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Unrestricted.
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Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Strengthening Laboratory Capacity and Quality for HIV Diagnosis, Care, Treatment, and Monitoring in Malawi under PEPFAR" and the Funding Opportunity Number is CDC RFA GH 24 0097.
Who is leading this funding opportunity?
The opportunity is CDC-led and is structured as a cooperative agreement, which indicates substantial CDC involvement in the program.
What type of funding mechanism is being used?
This is a cooperative agreement under discretionary funding. The cooperative agreement mechanism typically means the funder (CDC) will have an active role in supporting and collaborating on implementation.
What is the overall purpose of the award?
The purpose is to improve and sustain Malawi's national laboratory system as the country works toward HIV epidemic control, with a focus on strengthening laboratory systems so HIV diagnostics and monitoring are consistently available, accessible, and high quality across the country.
How does the opportunity approach sustainability and long-term impact?
A central theme is sustainability through building long-term national ownership rather than short-term service delivery. The award emphasizes supporting the Malawi Ministry of Health to improve governance and stewardship of public health laboratory functions so gains can continue as external support decreases.
Who is the primary in-country partner for implementation?
Implementation is described as being delivered in close collaboration with the Malawi Ministry of Health.
Is this opportunity focused only on HIV, or does it support broader public health goals?
While HIV diagnosis, care, treatment, and monitoring are central, the opportunity also addresses broader public health system gaps that affect testing performance. It includes strengthening National Reference Laboratories for surveillance and outbreak response, and it promotes integrated, multi-disease testing models.
What is the anticipated funding amount for the first fiscal year?
CDC anticipates approximately $8,375,000 in total funding for the first fiscal year, contingent on the availability of funds.
How many awards does CDC expect to make?
CDC expects to make two awards.
What does it mean that the Year 1 award ceiling is listed as 0?
The notice shows a Year 1 award ceiling of 0, which is described as meaning no fixed per-award cap is provided in the notice. At the same time, CDC provides an anticipated total funding amount for the first year.
What laboratory system areas are prioritized for improvement?
The opportunity prioritizes strengthening laboratory systems to improve access, quality, and reliability of testing, along with governance and stewardship. It also emphasizes network optimization, better utilization of existing capacity, quality management systems, and biosafety and waste management.
What does the opportunity say about National Reference Laboratories?
It prioritizes strengthening National Reference Laboratories so they can better support surveillance and respond to outbreaks, recognizing that strong reference laboratory capacity supports HIV programs and broader disease detection and response.
What is the focus related to viral load testing?
The opportunity prioritizes improving viral load testing performance, especially where viral load coverage and viral suppression are lagging among specific age groups and populations. The emphasis is on improving performance and patient outcomes, not just increasing the number of tests.
Does the opportunity address reasons why patients may not receive viral load testing or results on time?
Yes. It calls for patient-centered approaches to understand why gaps occur, such as access barriers, specimen referral issues, delays in returning results, or challenges with follow-up, and then implementing practical fixes across the diagnostic network.
What role do point-of-care (POC) testing platforms play in this opportunity?
The opportunity supports expanding and strengthening point-of-care testing platforms, with an explicit push toward integrated, multi-disease testing models rather than HIV-only approaches.
What is meant by integrated, multi-disease testing models?
The notice describes a shift toward using point-of-care and testing platforms in ways that support multiple diseases, which can improve efficiency and make testing more responsive to patient and facility needs (rather than being limited to HIV-only testing).
What quality management approaches are highlighted?
Quality management is a major component, especially for rapid testing. The opportunity highlights rapid testing continuous quality improvement (RTCQI) and expanding external quality assessment (EQA) coverage to evaluate multiple test parameters routinely.
What is RTCQI and why is it important in this opportunity?
RTCQI stands for rapid testing continuous quality improvement. It is highlighted as a pathway to achieving national certification and as a method to standardize and improve the reliability of rapid HIV testing across sites.
How does the opportunity address external quality assessment (EQA)?
It includes expanding EQA coverage so that multiple test parameters are routinely evaluated, which helps detect performance problems early and supports consistent testing accuracy over time.
Does this opportunity support laboratory accreditation efforts?
Yes. The opportunity includes preparing additional laboratories for ISO accreditation, which typically involves strengthening quality systems, documentation, staff competency processes, equipment maintenance practices, and corrective and preventive action systems.
What specific diagnostic access gaps are called out?
The notice calls out improving access to testing for advanced HIV disease (AHD) and improving access to tests that support pre-exposure prophylaxis (PrEP) services.
Why is advanced HIV disease (AHD) testing emphasized?
AHD testing is described as important for identifying and managing patients at higher risk of severe illness, which makes it a critical gap to address for clinical care outcomes.
How does the opportunity support PrEP services?
It emphasizes improving access to tests that support PrEP services, recognizing PrEP as a central element of HIV prevention efforts.
What is diagnostic network optimization in the context of this grant?
Diagnostic network optimization is described as regular, periodic, data-driven reviews of the diagnostic network, including where instruments and testing sites are placed, how specimens move through referral routes, whether turnaround times are acceptable, and whether the network is operating efficiently and equitably.
Does the opportunity address instrument utilization in molecular laboratories?
Yes. It prioritizes increasing utilization of high-throughput instruments in conventional molecular laboratories to improve viral load coverage, indicating a focus on reducing bottlenecks and making better use of existing capacity where demand is high.
What does the opportunity say about biosafety and waste management?
It explicitly includes strengthening biosafety and waste management as essential components of laboratory scale-up, emphasizing protecting staff, patients, and communities as testing expands and integrates across multiple disease areas.
What activity category is associated with this opportunity?
The notice lists the activity category as health.
What CFDA number is associated with this opportunity?
The opportunity is associated with CFDA 93.067.
Who is eligible to apply?
The notice lists eligible applicants as unrestricted.
When was the opportunity posted and when did it close?
The opportunity was posted on 2023-11-21 and had an original closing date of 2024-02-22.
Is the program framed as short-term service delivery?
No. It is framed as technical and programmatic support aimed at building long-term national ownership and strengthening national structures so improvements persist over time.
What outcomes is the grant ultimately trying to improve?
Based on the notice, the grant aims to improve availability, accessibility, and quality of HIV diagnostics and monitoring nationwide, strengthen system governance and sustainability, improve viral load testing performance and follow-up, expand quality assurance and accreditation readiness, close key diagnostic access gaps (including AHD and PrEP-related testing), improve network efficiency and equity, and strengthen outbreak/surveillance readiness through stronger reference laboratories.
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