Opportunity Information: Apply for RFA FD 17 002
This funding opportunity from the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), focuses on improving Zika virus diagnostics by identifying short, highly specific Zika peptide sequences that can be used to build a more accurate IgM-based serology test. The work is framed by the public health urgency that emerged during the 2015-2016 Zika outbreak in the Americas, which led the World Health Organization (WHO) to declare a Public Health Emergency of International Concern in early 2016. Although WHO later ended that emergency designation, the announcement stressed that Zika and its consequences remain a long-term public health problem. In the United States, the HHS emergency declaration related to Zika was still in effect at the time of this announcement, underscoring the need for sustained diagnostic readiness.
The core problem the FDA is trying to solve is that existing diagnostic options have major limitations depending on when a patient is tested. Molecular tests such as RT-PCR are most useful during the brief period of viremia, since Zika virus typically circulates in blood for only about a week. After that window closes, viral RNA may no longer be detectable, including in cases where a newborn was infected in utero. That makes nucleic acid testing unreliable for many real-world diagnostic situations. Serology can fill that gap because IgM antibodies persist longer and can indicate recent infection, but current Zika IgM tests often produce false positives due to antibody cross-reactivity with other closely related flaviviruses such as dengue, West Nile, and yellow fever. Because of this, a positive Zika IgM result frequently requires confirmatory testing, adding time, complexity, and burden to public health and clinical decision-making.
To address this, the opportunity calls for a research plan that uses well-established methods with a high likelihood of success, supported by a team with demonstrated experience in the proposed technology. The recommended approach is peptide microarray (peptide chip) technology, where large sets of peptides are displayed on a solid surface (often glass or plastic) and probed with patient or reference sera to determine which peptides are bound by antibodies. This method is widely used to map antibody epitopes, profile immune responses over time, discover serologic biomarkers, and support diagnostic and vaccine development. In the Zika context, the aim is to create an epitope map across the Zika proteome to identify the most immunogenic and, most importantly, Zika-specific peptides. The announcement notes prior work in dengue showing that some conserved dengue peptides overlap with other viruses, while others do not, suggesting that uniquely Zika-specific targets should be discoverable with systematic screening.
A key deliverable is a set of differential peptide targets that can discriminate Zika IgM responses from responses generated by other common, cross-reactive arboviruses. The intended outcome is that these peptide targets could be incorporated into serological diagnostic assays that reduce or eliminate the need for burdensome confirmatory testing after an initial positive IgM result. From a regulatory and public health standpoint, the FDA highlights that the peptide information generated would be broadly shared, either via an FDA website posting or publication in peer-reviewed literature, so that companies, test developers, and public health institutions can use the findings to design, refine, or evaluate targeted diagnostic products. The broader value is improved medical countermeasure preparedness: being able to rapidly distinguish an emerging pathogen from a group of similar viruses that commonly confuse serologic testing.
The opportunity also emphasizes why better Zika diagnosis matters clinically, especially for pregnant women. Early and accurate identification of infection is tied to assessing risk for congenital outcomes such as microcephaly, a condition where an infant’s head is smaller than expected for age and sex and which can lead to lifelong disabilities and, in severe cases, life-threatening complications. The FDA positions the lack of highly specific Zika diagnostic tools as a critical readiness gap that hampers outbreak response and ongoing surveillance, particularly in areas where multiple arboviruses co-circulate.
In practical terms, the solicitation specifies sample expectations to ensure the peptide screening effort tests specificity against relevant confounders. It calls for approximately 10 Zika viral samples and recommends inclusion of potential co-infection or cross-reactivity comparators: 10 samples each for dengue virus types 1 through 4, yellow fever virus, West Nile virus, and chikungunya virus, plus two uninfected samples from collaborators. This panel is meant to help identify peptide targets that remain reliable even in the realistic clinical setting where patients may have prior exposure to related viruses or where multiple viruses circulate in the same region.
Administratively, the program is offered as a discretionary cooperative agreement under Funding Opportunity Number RFA-FD-17-002 (CFDA 93.103). The agency anticipated a single award, with an award ceiling of $299,150. The posting lists a creation date of March 31, 2017, and an original closing date of June 1, 2017, indicating it was a targeted, time-bound effort to quickly generate actionable peptide data for the diagnostic community.Apply for RFA FD 17 002
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Identification of Target Peptide Sequences for Zika IgM Diagnostic Device" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Mar 31, 2017.
- Applicants must submit their applications by Jun 01, 2017. (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 $299,150.00 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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| Funding Opportunity |
|---|
| Food Safety Preventive Controls and Produce Safety Standards: Building Competency in Latin America in Support of the U.S. Food Safety Modernization Act Apply for RFA FD 17 011 Funding Number: RFA FD 17 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,100,000 |
| Creation and Implementation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC) Apply for RFA FD 18 002 Funding Number: RFA FD 18 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $30,000 |
| Global Pediatric Clinical Trials Network Apply for RFA FD 17 014 Funding Number: RFA FD 17 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24) Apply for RFA FD 17 013 Funding Number: RFA FD 17 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Building Research Capacity in Global Tobacco Product Regulation Program (U18) Apply for RFA FD 18 003 Funding Number: RFA FD 18 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $450,000 |
| Vet-LIRN Network Capacity-Building Projects Apply for PAR 18 604 Funding Number: PAR 18 604 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $225,000 |
| National Laboratory Curriculum Framework Development Apply for RFA FD 18 005 Funding Number: RFA FD 18 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Cooperative Agreement to Support the Western Center for Food Safety (U19) Apply for RFA FD 18 008 Funding Number: RFA FD 18 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| Data Standards for Clinical Research and Drug Development (U24) Apply for RFA FD 18 015 Funding Number: RFA FD 18 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Bioequivalence of Topical Products: Elucidating the Thermodynamic and Functional Characteristics of Compositionally Different Topical Formulations (U01) Apply for RFA FD 18 010 Funding Number: RFA FD 18 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Formulation drug product quality attributes in dermal physiologically-based pharmacokinetic models for topical dermatological drug products and transdermal delivery systems (U01) Apply for RFA FD 18 019 Funding Number: RFA FD 18 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Three-Dimensional Approach for Modeling Nasal Mucociliary Clearance via Computational Fluid Dynamics (CFD) (U01) Apply for RFA FD 18 020 Funding Number: RFA FD 18 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $280,000 |
| Computational fluid dynamics (CFD) and discrete element modeling (DEM) approach for predictions of dry powder inhaler (DPI) drug delivery (U01) Apply for RFA FD 18 014 Funding Number: RFA FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $380,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Non-Invasive Techniques (U01) Apply for RFA FD 18 012 Funding Number: RFA FD 18 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Renewal Applications: Centers of Excellence in Regulatory Science and Innovation (U01) Apply for RFA FD 18 011 Funding Number: RFA FD 18 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Assuring Radiation Protection (U18) Apply for RFA FD 18 021 Funding Number: RFA FD 18 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
| Exploration of HL7 FHIR Standards for Clinical Research and Post-market Surveillance (U24) Apply for RFA FD 18 016 Funding Number: RFA FD 18 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFD FD 18 018 Funding Number: RFD FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) Apply for RFA FD 18 009 Funding Number: RFA FD 18 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act Apply for RFA FD 18 013 Funding Number: RFA FD 18 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,200,000 |
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