Opportunity Information: Apply for RFA FD 10 016
Apply for RFA FD 10 016
- The Food Drug Administration in the agriculture consumer protection environment food and nutrition health information and statistics natural resources science and technology and other research and development sector is offering a public funding opportunity titled "Scientific Priorities to Improve the Diagnosis, Treatment and Prevention of Tuberculosis and other Tropical Diseases." and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on Jul 12, 2010 and posted on Jul 12, 2010.
- Applicants must submit their applications by Aug 11, 2010 NOTE On time submission requires that applications be successfully submitted to Grants.gov no later than 500 p.m. local time (of the applicant institution/organization). Application Due Date(s) August 11, 2010 Peer Review Date(s) August 2010 Council Review Date(s) September 7 9, 2010 Earliest Anticipated Start Date(s) September, 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 $3,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $2,000,000.00 in funding.
- The number of recipients for this funding is limited to 3 candidate(s).
- Eligible applicants include: Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Independent school districts State governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Public and State controlled institutions of higher education County governments Native American tribal governments (Federally recognized).
- Eligible Agencies of the Federal Government Faith based or Community based Organizations
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Opportunity Summary:
The FDA Office of Critical Path Programs offered this funding opportunity (RFA-FD-10-016) as a cooperative agreement aimed at speeding up the development of products that can improve the diagnosis, treatment, and prevention of tuberculosis (TB) and other tropical diseases as defined under section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(3)). The core idea is not just to fund a single research project, but to support the creation and operation of structured, multi-stakeholder collaborative partnerships that can identify the most important scientific and infrastructure bottlenecks holding back progress, set priorities, and then coordinate work to address those gaps. A second major emphasis is sustainability: applicants are expected to propose a workable model for continued collaboration and continued funding beyond the FDA award, including mechanisms such as consortia and other arrangements that bring in financial or in-kind support from partners.
Eligibility is tied to the Critical Path public-private partnership framework described in section 566 of the FDC Act. In practice, this includes institutions of higher education (as defined by the Higher Education Act) and qualifying nonprofit organizations (notably 501(c)(3) entities exempt under 501(a)), including consortia of such organizations. The broader eligibility list in the announcement also indicates that a wide range of entity types could apply (including certain government entities and for-profit organizations), but the narrative stresses that proposals should align with the public-private partnership intent. Applications were expected to be partnership-driven and operationally detailed: they needed to name collaborators, define roles and responsibilities, and include letters from collaborators confirming their participation. Proposals also needed to explain how additional funding and support would be mobilized to keep the work moving after initial FDA support, and projects could involve development of a single product or products intended for use in combination regimens.
The scope of work was organized around several priority areas where FDA saw persistent barriers to progress. One priority is bridging the gap between early discovery and first-in-human testing. The problem being targeted is that many promising anti-TB or tropical disease compounds are not commercially attractive, so they stall before entering clinical development. The grant therefore invited proposals that would organize and facilitate nonclinical evaluation programs to generate the kinds of evidence needed to move candidates forward, including in vitro studies, animal studies, and other assessments of toxicology, pharmacology, microbiology, and vaccine immunology when relevant. Competitive proposals in this area would be expected to show practical strategies for coordinating stakeholders across discovery and development, and for financing and executing the early testing packages that can support entry into human trials.
A second priority area focuses on alternative uses of existing products, essentially repurposing. FDA highlighted that some already-approved products (originally developed for other diseases) may have potential against TB or tropical diseases and may even be used off-label, yet sponsors often have little financial incentive to pursue formal FDA approval for these new indications. Applications were encouraged to propose end-to-end strategies to identify candidate products, review the existing evidence, conduct a gap analysis to determine what is missing for regulatory support, organize collaborations to fund needed clinical studies, and ultimately support the preparation and submission of a marketing application for the new indication.
A third priority addresses biomarkers for global vaccine programs. Vaccine development for TB and many tropical diseases is slowed by the lack of reliable immunologic biomarkers that predict protective efficacy. The opportunity therefore sought programs that could (1) review and evaluate candidate biomarkers already proposed or under development, (2) assess what is still needed, and (3) build collaborations capable of funding and managing discovery, standardization, and validation. Importantly, FDA signaled interest in programs that can connect biomarker work to real clinical trials and clinical specimen resources, since validation typically requires well-characterized samples and outcomes.
A fourth area is capacity building for clinical studies in settings where TB and tropical diseases are most prevalent, often in resource-limited regions with weaker clinical research infrastructure. Two example capacity-building tracks were emphasized. One is development of an open-source electronic case report form (eCRF) suitable for studies in resource-poor settings, aligned with CDISC/HL7 TB domain data standards and terminology, and designed for interoperability with other open-source clinical trial systems used in similar environments. Applicants were also encouraged to consider practical data-transfer technologies such as satellite communications or mobile phones. The second track is laboratory training to enable high-quality trials that meet standards acceptable to FDA, with flexibility in training delivery models (centralized training, web-based options, and on-site approaches) and explicit attention to implementation, funding, and long-term sustainability through stakeholder collaboration.
A fifth priority area is diagnostics development, tied to a then-recent public workshop on TB diagnostics hosted by FDA, CDC, and NIH (June 2010). The grant invited proposals to build on those workshop outcomes, particularly to develop and evaluate diagnostic biomarkers that could serve as reliable surrogates for relapse-free cure and predictors of relapse in TB clinical trials. It also emphasized the need for new rapid, reliable TB diagnostics and drug-resistance tests that are realistic for use in resource-poor settings, reflecting the real-world constraints where disease burden is highest.
A sixth area targets combination therapy for tuberculosis. Because TB treatment depends on multi-drug regimens and because drug resistance complicates regimen design, FDA sought programs using in vitro and in vivo approaches to identify the most effective combinations and determine appropriate treatment durations for both drug-susceptible and drug-resistant TB. Applicants were expected to present clear timelines with milestones, define intermediate and final goals, and specify measurable short-, medium-, and long-term outcomes with public health relevance, reporting progress over time rather than only at the end.
Administratively, this was a discretionary funding opportunity using the cooperative agreement mechanism, which typically means substantial involvement from the funding agency compared with a standard grant. The announcement explicitly stated that FDA was expected to participate in designing the collaborative partnership programs formed under these awards and would provide oversight of funded activities. The opportunity anticipated around three awards, with an estimated total funding level of $3,000,000, an award ceiling of $2,000,000, and an award floor of $100,000, with no cost-sharing or matching requirement listed. Key dates included a posted date of July 12, 2010, an application due date of August 11, 2010 (with submission required via Grants.gov by 5:00 p.m. local time), peer review in August 2010, council review in early September 2010, and an earliest anticipated start date in September 2010. The CFDA listing referenced was 93.103 (Food and Drug Administration Research), and the point of contact provided was Martin Bernard (Martin.Bernard@fda.hhs.gov, 301-443-5869).
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This is FDA funding opportunity RFA-FD-10-016 from the FDA Office of Critical Path Programs. It was offered as a cooperative agreement to accelerate development of products that can improve the diagnosis, treatment, and prevention of tuberculosis (TB) and other tropical diseases (as defined under section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360n(a)(3)).
What is the main purpose of the award?
The main purpose is to support the creation and operation of structured, multi-stakeholder collaborative partnerships (not just a single research project). These partnerships are expected to identify key scientific and infrastructure bottlenecks, set priorities, and coordinate work to address major gaps slowing progress in TB and tropical disease product development.
What makes this opportunity different from a typical research grant?
The opportunity emphasizes building and running partnership programs that coordinate multiple stakeholders, rather than funding a single investigator-driven project. It also stresses sustainability: applicants were expected to propose a workable plan to keep the collaboration and funding going beyond the FDA award.
What award mechanism is used?
The mechanism is a cooperative agreement. The announcement stated that FDA was expected to participate in designing the collaborative partnership programs formed under these awards and would provide oversight of funded activities, reflecting substantial agency involvement compared with a standard grant.
Who was eligible to apply?
Eligibility was tied to the Critical Path public-private partnership framework described in section 566 of the Federal Food, Drug, and Cosmetic Act. In practice, the narrative highlights institutions of higher education (as defined by the Higher Education Act) and qualifying nonprofit organizations (notably 501(c)(3) entities exempt under 501(a)), including consortia of such organizations.
Could other types of organizations apply besides universities and 501(c)(3) nonprofits?
The broader eligibility list in the announcement indicated that a wide range of entity types could apply (including certain government entities and for-profit organizations). However, the narrative stressed that proposals should align with the public-private partnership intent and be partnership-driven.
Were partnerships required?
Yes, proposals were expected to be partnership-driven and operationally detailed. Applications needed to name collaborators, define roles and responsibilities, and include letters from collaborators confirming their participation.
What did applicants need to include about collaborators?
Applications were expected to identify collaborators, specify their roles and responsibilities, and provide letters from those collaborators confirming participation.
What did the opportunity require regarding sustainability after FDA funding ends?
Applicants were expected to propose a workable model for continued collaboration and continued funding beyond the FDA award. The announcement mentioned mechanisms such as consortia and other arrangements that bring in financial or in-kind support from partners.
Was cost-sharing or matching required?
No cost-sharing or matching requirement was listed in the announcement.
How many awards were expected and what was the total funding level?
The opportunity anticipated around three awards with an estimated total funding level of $3,000,000.
What were the award ceiling and floor?
The award ceiling was $2,000,000 and the award floor was $100,000.
What diseases and product areas were the focus?
The focus included tuberculosis (TB) and other tropical diseases defined under section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act. The opportunity covered products and approaches aimed at improving diagnosis, treatment, and prevention, including drugs, vaccines, biomarkers, diagnostics, and combination therapy strategies.
Could a project focus on a single product, or did it need to cover multiple products?
Projects could involve development of a single product or products intended for use in combination regimens.
What were the main priority areas (scope of work) highlighted by FDA?
FDA organized the scope around several priority areas: (1) bridging early discovery to first-in-human testing, (2) repurposing/alternative uses of existing products, (3) biomarkers for global vaccine programs, (4) capacity building for clinical studies in high-burden and resource-limited settings (including eCRFs and lab training), (5) diagnostics development (including biomarkers for relapse-free cure and rapid drug-resistance tests), and (6) combination therapy development for TB.
What does "bridging early discovery to first-in-human testing" mean in this announcement?
This priority targets the gap where promising anti-TB or tropical disease compounds stall before clinical development due to limited commercial attractiveness. The opportunity invited proposals to organize and facilitate nonclinical evaluation programs to generate evidence needed to advance candidates, including in vitro studies, animal studies, and assessments of toxicology, pharmacology, microbiology, and vaccine immunology when relevant.
What kinds of activities were encouraged for nonclinical evaluation programs?
Activities mentioned included in vitro studies, animal studies, and other assessments supporting candidate advancement, such as toxicology, pharmacology, microbiology, and (when relevant) vaccine immunology, along with practical strategies to coordinate stakeholders and finance and execute early testing packages.
What does the repurposing (alternative uses of existing products) priority involve?
This area focuses on already-approved products that may have potential against TB or tropical diseases, including situations where products may be used off-label but lack financial incentives for sponsors to seek formal FDA approval for new indications. Applications were encouraged to propose end-to-end strategies: identify candidate products, review existing evidence, perform a gap analysis, organize collaborations to fund needed clinical studies, and support preparation and submission of a marketing application for the new indication.
What is meant by "biomarkers for global vaccine programs" in this opportunity?
Vaccine development for TB and many tropical diseases is slowed by the lack of reliable immunologic biomarkers that predict protective efficacy. The opportunity sought programs to review and evaluate candidate biomarkers, assess what is still needed, and build collaborations that can fund and manage discovery, standardization, and validation, ideally connected to real clinical trials and clinical specimen resources.
Why did FDA emphasize linking biomarker work to clinical trials and specimens?
The announcement signaled interest in connecting biomarker work to clinical trials and clinical specimen resources because validation typically requires well-characterized samples and outcome data.
What types of capacity-building activities were highlighted for resource-limited settings?
Two example tracks were emphasized: (1) development of an open-source electronic case report form (eCRF) suitable for studies in resource-poor settings, aligned with CDISC/HL7 TB domain data standards and terminology, and interoperable with other open-source trial systems; and (2) laboratory training to enable high-quality trials meeting standards acceptable to FDA, with attention to implementation, funding, and sustainability through stakeholder collaboration.
What standards and interoperability expectations were mentioned for the eCRF?
The eCRF was expected to be aligned with CDISC/HL7 TB domain data standards and terminology and designed for interoperability with other open-source clinical trial systems used in similar environments.
What data-transfer technologies were suggested for studies in resource-poor settings?
Applicants were encouraged to consider practical data-transfer technologies such as satellite communications or mobile phones.
What training delivery models were acceptable for the laboratory training track?
The announcement described flexibility in training delivery models, including centralized training, web-based options, and on-site approaches.
What was the diagnostics development priority focused on?
The diagnostics priority was tied to a public workshop on TB diagnostics hosted by FDA, CDC, and NIH (June 2010). Proposals were invited to build on those workshop outcomes, including developing and evaluating diagnostic biomarkers that could serve as reliable surrogates for relapse-free cure and predictors of relapse in TB clinical trials. The opportunity also emphasized the need for new rapid, reliable TB diagnostics and drug-resistance tests that are realistic for use in resource-poor settings.
What is the combination therapy priority for TB?
This area targets identifying effective multi-drug regimens and determining appropriate treatment durations for both drug-susceptible and drug-resistant TB. FDA sought programs using in vitro and in vivo approaches to evaluate combinations, with clear timelines, milestones, intermediate and final goals, and measurable short-, medium-, and long-term outcomes with public health relevance, including progress reporting over time.
Did the announcement specify expectations for timelines and milestones?
Yes. For combination therapy work in particular, applicants were expected to present clear timelines with milestones, define intermediate and final goals, and specify measurable short-, medium-, and long-term outcomes, reporting progress over time rather than only at the end.
What was the CFDA number for this opportunity?
The CFDA listing referenced was 93.103 (Food and Drug Administration Research).
When was the opportunity posted and when were applications due?
The posted date was July 12, 2010. The application due date was August 11, 2010, with submission required via Grants.gov by 5:00 p.m. local time.
What were the review and start-date timelines mentioned?
The announcement listed peer review in August 2010, council review in early September 2010, and an earliest anticipated start date in September 2010.
How were applications required to be submitted?
Applications were required to be submitted via Grants.gov by 5:00 p.m. local time on the due date.
Who was the point of contact for the opportunity?
The point of contact provided was Martin Bernard (Martin.Bernard@fda.hhs.gov, 301-443-5869).
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