Opportunity Information: Apply for CDC RFA GH15 15510201SUPP16
Apply for CDC RFA GH15 15510201SUPP16
- The Department of Health and Human Services, Centers for Disease Control - CGH in the health sector is offering a public funding opportunity titled "Program Expansion Supplement: Strengthening High Quality Laboratory Services Scale-up 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 Aug 02, 2016.
- Applicants must submit their applications by Oct 01, 2016 Electronically submitted applications must be submitted no later than 1159 p.m., ET, on the listed application due date.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,345,600.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The Program Expansion Supplement: Strengthening High Quality Laboratory Services Scale-up for HIV Diagnosis, Care, Treatment and Monitoring in Malawi is a PEPFAR-supported cooperative agreement led by the U.S. Centers for Disease Control and Prevention (CDC) to help Malawi’s Ministry of Health (MOH) strengthen and sustain high-quality laboratory systems that underpin HIV prevention, diagnosis, treatment initiation, and long-term monitoring. The opportunity is framed around Malawi’s significant HIV burden and its progress toward epidemic control: in 2012, adult HIV prevalence (ages 15+) was reported at 10.8%, with incidence at 0.76 among ages 15 to 49. That same year, more than 1.7 million people received HIV counseling and testing, and importantly, Malawi started more people on antiretroviral therapy (ART) than the estimated number of new infections (114,120 started ART versus 66,000 newly infected). This “tipping point” is presented as a major achievement, but one that increases the need for reliable lab services because a growing treatment cohort requires ongoing eligibility assessment, routine monitoring, and rapid detection of treatment failure and drug-related adverse events.
A central theme of the grant is that Malawi’s national HIV response is expanding quickly through prevention and treatment policies, including Voluntary Medical Male Circumcision (VMMC) and Option B for prevention of mother-to-child transmission (PMTCT). By the end of the third quarter of 2013, the country reported 459,261 people alive on ART, with coverage estimated at 47% for children under 15 and 81% for adults. Alongside treatment scale-up, the MOH and partners have been expanding diagnostic capacity through additional point-of-care sites for HIV diagnosis and CD4 testing, strengthening malaria and tuberculosis microscopy networks, improving district-level hematology and chemistry testing, and supporting molecular testing capacity at referral hospitals for HIV diagnosis and monitoring. The supplement emphasizes, however, that expansion alone is not enough; these services must be consistently accurate, quality assured, and dependable across the system to support clinical decision-making and public health goals.
The opportunity specifically aligns with Malawi’s national strategic priorities for health and diagnostics and reflects evolving clinical guidelines. Malawi’s newer National HIV Treatment Guidelines raised the CD4 eligibility threshold to 500 cells/mm3 and recommend the use of viral load testing for treatment monitoring, both of which increase demand for laboratory throughput, quality systems, specimen transport logistics, competent staff, and external quality assurance. In practical terms, this means that the lab network needs to handle higher testing volumes and more sophisticated monitoring while maintaining quality standards that prevent misdiagnosis, inappropriate treatment decisions, and delayed identification of treatment failure.
This supplement builds on a long history of PEPFAR and CDC-Malawi investments dating back to 2002, focusing on workforce development and laboratory quality management. Prior work referenced in the notice includes support for pre-service curriculum development and in-service training in HIV testing, CD4, viral load, early infant diagnosis (EID), biosafety, and quality management systems. The program also points to improvements in testing quality through the rollout of Strengthening Laboratory Management Toward Accreditation (SLMTA) in at least 42 central, referral, and district laboratories, indicating that accreditation-oriented quality improvement is a core strategy. In addition, PEPFAR support helped the national reference laboratory develop quarterly dry tube specimen proficiency testing and quality control materials, and some laboratories were enrolled in external quality assurance (EQA) programs for HIV PCR, clinical chemistry, hematology, and GeneXpert testing. Taken together, these elements show the supplement is meant to consolidate and extend an existing platform rather than start from scratch, with an emphasis on institutionalizing quality and expanding access to reliable diagnostics.
From an administrative standpoint, this is a discretionary funding opportunity offered by the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), under CFDA 93.067, using a cooperative agreement mechanism (meaning CDC anticipates substantial involvement in program implementation and technical direction). The funding opportunity number is CDC RFA GH15 15510201SUPP16. The opportunity anticipated a single award, with an award ceiling of $1,345,600, and the application deadline was October 1, 2016 (with electronic submissions due by 11:59 p.m. Eastern Time). Eligibility is listed broadly as “Others,” with clarification expected in the full announcement’s eligibility section, suggesting that the applicant pool may include certain organizations beyond standard categories, depending on CDC’s additional guidance.
Overall, the grant can be summarized as a targeted investment to help Malawi translate major HIV program gains into durable outcomes by strengthening the laboratory backbone of the national response. It prioritizes quality-assured HIV diagnostics and monitoring (including viral load and EID), continued implementation of laboratory quality management and accreditation pathways (such as SLMTA), stronger proficiency testing and EQA participation, and sustained capacity building so that as Malawi expands ART coverage and prevention interventions, the laboratory system can keep pace with the clinical and public health demands that come with reaching and maintaining the “tipping point.”
Frequently Asked Questions (FAQs)
What is the Program Expansion Supplement focused on?
The Program Expansion Supplement: Strengthening High Quality Laboratory Services Scale-up for HIV Diagnosis, Care, Treatment and Monitoring in Malawi is a PEPFAR-supported cooperative agreement led by the U.S. Centers for Disease Control and Prevention (CDC). Its core focus is strengthening and sustaining high-quality laboratory systems that support HIV prevention, diagnosis, treatment initiation, and long-term monitoring in Malawi.
Who is leading and supporting this opportunity?
The cooperative agreement is led by CDC and supported through PEPFAR. It is designed to help Malawi's Ministry of Health (MOH) strengthen national laboratory services that underpin the HIV response.
Why does this supplement emphasize laboratory quality, not just expansion?
The opportunity highlights that simply adding more testing sites and instruments is not enough. Results need to be consistently accurate, quality assured, and dependable across the laboratory network so clinicians and programs can make correct decisions, avoid misdiagnosis, and identify treatment failure and adverse events quickly.
How does Malawi's HIV situation relate to the purpose of this grant?
The notice frames the work around Malawi's significant HIV burden and progress toward epidemic control. It references 2012 indicators including adult HIV prevalence (10.8% among ages 15+), incidence (0.76 among ages 15 to 49), and major HIV testing volumes (more than 1.7 million people receiving HIV counseling and testing). It also notes a "tipping point" achievement in 2012: more people started on ART than the estimated number of new infections (114,120 started ART versus 66,000 newly infected). As the treatment cohort grows, laboratory services become even more critical for eligibility assessment, routine monitoring, and early detection of treatment failure and drug-related adverse events.
What major HIV program expansions in Malawi are mentioned in the opportunity?
The opportunity describes a rapidly expanding national HIV response through prevention and treatment policies, including Voluntary Medical Male Circumcision (VMMC) and Option B for prevention of mother-to-child transmission (PMTCT). It also reports that by the end of the third quarter of 2013, Malawi had 459,261 people alive on ART, with estimated coverage of 47% for children under 15 and 81% for adults.
What types of laboratory and diagnostic capacity expansions are referenced?
The notice mentions multiple areas of diagnostic scale-up, including additional point-of-care sites for HIV diagnosis and CD4 testing, strengthening malaria and tuberculosis microscopy networks, improving district-level hematology and chemistry testing, and supporting molecular testing capacity at referral hospitals for HIV diagnosis and monitoring.
How do Malawi's newer HIV treatment guidelines increase demand for lab services?
The opportunity notes that Malawi's newer National HIV Treatment Guidelines raised the CD4 eligibility threshold to 500 cells/mm3 and recommend viral load testing for treatment monitoring. These changes increase demand for laboratory throughput, quality systems, specimen transport logistics, competent staff, and external quality assurance.
Which HIV-related tests and services are specifically emphasized?
The supplement prioritizes quality-assured HIV diagnostics and monitoring, including viral load testing and early infant diagnosis (EID). It also references CD4 testing and broader clinical monitoring support through hematology and chemistry testing as part of the laboratory backbone needed for HIV care and treatment.
What is meant by a "cooperative agreement" in this opportunity?
This opportunity uses a cooperative agreement mechanism, which the notice explains means CDC anticipates substantial involvement in program implementation and technical direction (as opposed to a grant where the funder is typically less directly involved in day-to-day program direction).
What is the funding opportunity number for this supplement?
The funding opportunity number is CDC RFA GH15 15510201SUPP16.
What is the CFDA number listed for this opportunity?
The notice lists CFDA 93.067.
What is the award structure and size described in the notice?
The opportunity anticipated a single award. The award ceiling is listed as $1,345,600.
What was the application deadline?
The application deadline was October 1, 2016, with electronic submissions due by 11:59 p.m. Eastern Time.
Who is eligible to apply, based on the information provided?
Eligibility is listed broadly as "Others," with the notice indicating that clarification is expected in the full announcement's eligibility section. This suggests the applicant pool may include certain organizations beyond standard categories, depending on CDC's additional guidance in the complete eligibility language.
How does this supplement relate to prior CDC and PEPFAR investments in Malawi?
The notice describes this supplement as building on CDC-Malawi and PEPFAR investments dating back to 2002. It references prior work in workforce development and laboratory quality management, including pre-service curriculum development and in-service training in HIV testing, CD4, viral load, EID, biosafety, and quality management systems.
What quality improvement and accreditation approach is highlighted?
The opportunity highlights Strengthening Laboratory Management Toward Accreditation (SLMTA) as a core strategy and notes rollout in at least 42 central, referral, and district laboratories. This signals an emphasis on accreditation-oriented quality improvement and institutionalizing quality systems rather than short-term fixes.
What kinds of external quality assurance (EQA) and proficiency testing are mentioned?
The notice states that PEPFAR support helped the national reference laboratory develop quarterly dry tube specimen proficiency testing and quality control materials. It also notes that some laboratories were enrolled in EQA programs for HIV PCR, clinical chemistry, hematology, and GeneXpert testing.
Why are specimen transport and logistics specifically mentioned?
The opportunity links increased testing demand (including viral load monitoring and expanded eligibility assessment) with the need for specimen transport logistics. This reflects the practical requirement to move samples reliably across the network so results are timely and usable for clinical decision-making and public health monitoring.
What is the main outcome this supplement is trying to achieve?
As described in the notice, the main goal is to help Malawi translate major HIV program gains into durable outcomes by strengthening the laboratory backbone of the national response. The emphasis is on sustaining accurate, quality-assured diagnostics and monitoring so the laboratory system can keep pace with expanding ART coverage and prevention interventions, and support continued progress toward and maintenance of the "tipping point."
What risks or consequences does the notice associate with weak laboratory quality?
The opportunity indicates that inadequate quality can lead to misdiagnosis, inappropriate treatment decisions, and delayed identification of treatment failure. These issues can undermine both individual patient outcomes and broader public health goals.
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