Opportunity Information: Apply for RFA FD 19 013
This grant opportunity (RFA-FD-19-013) is a cooperative agreement from the U.S. Food and Drug Administration (FDA), specifically the Center for Drug Evaluation and Research (CDER) Office of Medical Policy (OMP). The purpose is to fund a neutral, independent organization that can serve as a convener and organizer for structured engagements such as conferences, roundtables, workshops, and workgroups. These activities are meant to bring together a broad, multi-stakeholder set of participants with relevant expertise to examine and address issues tied to medical products, the processes used to develop and evaluate them, and the surveillance methods and policy approaches that support ongoing public health activities. Clinical trials are not allowed under this funding announcement, so the work is centered on convening, analysis, and information synthesis rather than testing interventions in human participants.
At its core, the FDA is seeking an organization that can do more than simply host meetings. The funded entity is expected to help identify and refine key topics, perform preliminary research or landscape scans to inform discussions, and then design and execute high-quality forums that are credible, balanced, and technically informed. A major emphasis is on ensuring that the meetings include multiple stakeholder perspectives, which can include regulators, clinicians, researchers, industry, patient and consumer representatives, public health experts, payers, and other relevant groups depending on the topic. The intent is to create a structured setting where complex questions about medical product development, evaluation, and post-market oversight can be explored in a way that is transparent and useful to a wide audience.
A central deliverable implied by the announcement is the synthesis and communication of what comes out of these engagements. That includes capturing discussions accurately, summarizing areas of agreement and disagreement, highlighting evidence gaps, and distilling practical insights that can inform future work in medical product policy and surveillance systems. The opportunity explicitly supports not only the planning and execution of meetings, but also the follow-through: compiling findings, producing summaries or proceedings, and communicating results broadly to organizations and individuals who can use them. In other words, the output is expected to extend beyond the room and translate into accessible, well-organized products that help move the field forward.
The funding mechanism is a U01 cooperative agreement, which generally means substantial involvement from the FDA compared with a typical grant. While the applicant organization runs the day-to-day operations, FDA staff typically collaborate on priorities, coordination, and ensuring the work aligns with public health needs and the agency mission. The opportunity sits within the broader public-facing category of consumer protection/food and nutrition (CFDA 93.103), but the described scope is clearly focused on medical products, related regulatory science and policy questions, and surveillance approaches relevant to public health.
Eligibility is broad. Applicants may include state, county, city, township, and special district governments; public and private institutions of higher education; tribal organizations (other than federally recognized tribal governments, as listed); nonprofits with or without 501(c)(3) status; for-profit organizations (including those other than small businesses); and small businesses. The emphasis on neutrality and independence suggests that the strongest applicants would be those able to demonstrate credibility as an honest broker, the operational capacity to convene diverse groups, and strong methods for agenda-setting, facilitation, documentation, and dissemination.
In terms of scale, the opportunity anticipated a single award (ExpectedAwards: 1) with an award ceiling of $3,500,000. The original posting information lists a creation date of April 9, 2019, and an original closing date of June 11, 2019. Overall, the grant is best understood as support for an independent convening hub that can repeatedly bring together the right experts and stakeholders, structure productive discussions around timely medical product and surveillance issues, and produce clear, widely shared outputs that help inform policy, practice, and future public health-related work without conducting clinical trials.Apply for RFA FD 19 013
- 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 "Convener and organizer of activities and engagements focused on the development of medical products and related processes, surveillance, and policies relevant to ongoing public health activities. (U01) Clinical Trial Not Allowed" 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 Apr 09, 2019.
- Applicants must submit their applications by Jun 11, 2019. (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 $3,500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Public and State controlled institutions of higher education, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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FAQs: FDA Cooperative Agreement RFA-FD-19-013 (U01)
What is the grant opportunity number and what type of funding is it?
The opportunity is RFA-FD-19-013 and it is a U01 cooperative agreement.
Which FDA office is sponsoring this opportunity?
It is sponsored by the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP).
What is the main purpose of this cooperative agreement?
The purpose is to fund a neutral, independent organization to serve as a convener and organizer for structured engagements (such as conferences, roundtables, workshops, and workgroups) focused on issues related to medical products, how they are developed and evaluated, and the surveillance and policy approaches that support public health activities.
What kinds of activities does the funded organization run?
The funded organization is expected to plan, design, and execute structured forums such as conferences, roundtables, workshops, and workgroups, and to support those engagements with preparatory work like topic refinement and preliminary research or landscape scans.
Is the funded organization expected to do more than host meetings?
Yes. The announcement emphasizes that the organization should help identify and refine key topics, conduct preliminary research/landscape scans to inform discussion, design credible and technically informed agendas, ensure balanced participation, and produce high-quality outputs that synthesize what was learned.
Are clinical trials allowed under this funding announcement?
No. Clinical trials are not allowed. The work is centered on convening, analysis, and information synthesis rather than testing interventions in human participants.
What subject areas are in scope for the discussions and work products?
Topics are tied to medical products, the processes used to develop and evaluate them, and the surveillance methods and policy approaches that support ongoing public health activities.
Who should participate in the convenings supported by this award?
The convenings are intended to include a broad, multi-stakeholder set of participants with relevant expertise. Examples described include regulators, clinicians, researchers, industry, patient and consumer representatives, public health experts, payers, and other relevant groups depending on the topic.
Why does the opportunity emphasize neutrality and independence?
The purpose is to support a convener that is credible as an honest broker and can bring multiple stakeholder perspectives together in a structured setting that is balanced and trusted across the community.
What kinds of deliverables or outputs are expected from the convenings?
The opportunity implies deliverables focused on synthesis and communication, including accurate capture of discussions, summaries of areas of agreement and disagreement, identification of evidence gaps, and distillation of practical insights. It also supports compiling findings, producing summaries or proceedings, and communicating results broadly beyond the meetings themselves.
Is dissemination beyond the meeting room part of the scope?
Yes. The announcement supports follow-through that translates meeting results into accessible, well-organized products that can be shared broadly with organizations and individuals who can use them.
How is a U01 cooperative agreement different from a typical grant in this context?
A U01 cooperative agreement generally involves substantial FDA involvement compared with a typical grant. While the awardee runs day-to-day operations, FDA staff typically collaborate on priorities, coordination, and alignment with public health needs and the FDA mission.
What is the CFDA listing referenced for this opportunity?
The opportunity is associated with CFDA 93.103 (consumer protection/food and nutrition), while the described scope focuses on medical products, regulatory science and policy questions, and surveillance approaches relevant to public health.
Who is eligible to apply?
Eligibility is broad and includes state, county, city, township, and special district governments; public and private institutions of higher education; tribal organizations (other than federally recognized tribal governments, as listed); nonprofits with or without 501(c)(3) status; for-profit organizations (including those other than small businesses); and small businesses.
How many awards were expected?
The opportunity anticipated a single award (ExpectedAwards: 1).
What is the maximum funding amount mentioned for this opportunity?
The award ceiling is listed as $3,500,000.
What are the key dates provided for this opportunity?
The information provided lists a creation date of April 9, 2019 and an original closing date of June 11, 2019.
What capabilities would a strong applicant likely need to demonstrate based on the description?
Based on the emphasis in the description, strong applicants would likely be able to demonstrate credibility as a neutral convener, operational capacity to bring together diverse stakeholders, and strong methods for agenda-setting, facilitation, documentation, synthesis, and dissemination.
Does the opportunity fund intervention testing or human subject experimentation?
No. The announcement specifies that clinical trials are not allowed, indicating the funded work is not intended to test interventions in human participants.
What is the overall goal of funding this convening and synthesis work?
The overall goal is to create structured, transparent engagements where complex questions about medical product development, evaluation, and post-market oversight can be explored, and to produce clear outputs that inform future work in medical product policy and surveillance systems in support of public health.
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| Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional Apply for RFA FD 19 016 Funding Number: RFA FD 19 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U01) Clinical Trials Not Allowed Apply for RFA FD 19 026 Funding Number: RFA FD 19 026 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Information Sharing System for State-Regulated Drug Compounding Activities (U01) Clinical Trial Not Allowed Apply for RFA FD 19 025 Funding Number: RFA FD 19 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,600,000 |
| Renewal Application: Critical Path Public Private Partnerships (U18) Clinical Trials Optional Apply for RFA FD 19 027 Funding Number: RFA FD 19 027 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $100,000,000 |
| Implementation of U.S. Food Safety Modernization Act - Identifying, Researching, and Implementing Alternative Methods to Expand the Reach across the Global Supply Chain (U01) - Clinical Trials Not Allowed Apply for RFA FD 19 022 Funding Number: RFA FD 19 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,750,000 |
| Cigar Tobacco Reference Products Program (UC2) Clinical Trials Not Allowed Apply for RFA FD 20 002 Funding Number: RFA FD 20 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $7,400,000 |
| Rare Disease Clinical Outcome Assessment Consortium (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 029 Funding Number: RFA FD 19 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Drug Development Tools Research Grants (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 028 Funding Number: RFA FD 19 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Heart Failure Collaboratory (R18) Clinical Trials Optional Apply for RFA FD 20 005 Funding Number: RFA FD 20 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,150,000 |
| Local Food Producer Outreach, Education, and Training to Enhance Food Safety and FDA Food Safety Modernization Act (FSMA) Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 20 006 Funding Number: RFA FD 20 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 20 004 Funding Number: RFA FD 20 004 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Bioequivalence of Topical Products: Elucidating Fundamental Principles of Dermal Pharmacokinetics for Microdialysis or Microperfusion Techniques (U01) Clinical Trials Not Allowed Apply for RFA FD 20 019 Funding Number: RFA FD 20 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Physiologically-based pharmacokinetic/pharmacodynamic model extrapolation to human from rabbit for ophthalmic drug products (U01) Clinical Trials Not Allowed Apply for RFA FD 20 018 Funding Number: RFA FD 20 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
| Transferring Harmonized Laboratory Data from Healthcare Institutions to Registries Using FHIR Protocol (U01) Clinical Trials Not Allowed Apply for RFA FD 20 017 Funding Number: RFA FD 20 017 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $800,000 |
| Center for Collaborative Research on Complex Generics (U18) Clinical Trials Optional Apply for RFA FD 20 007 Funding Number: RFA FD 20 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Enhancing Regulatory Science for Advancing Pharmaceutical Quality and Manufacturing (U01) Clinical Trials Optional Apply for PAR 20 083 Funding Number: PAR 20 083 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Renewal - Investigation of impact of manufacturing difference and formulation variation on drug release for Levonorgestrel Intrauterine System (U01) Clinical Trials Not Allowed Apply for RFA FD 20 020 Funding Number: RFA FD 20 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
| Novel Approaches to Advance Coordinated Registry Networks (CRNs) (U01 Clinical Trial Optional) Apply for RFA FD 20 021 Funding Number: RFA FD 20 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Drug Development Tools Research Grants (U01 Clinical Trial Optional) Apply for RFA FD 20 009 Funding Number: RFA FD 20 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Building an Integrated Laboratory System to Advance the Safety of Human and Animal Food (U18) Clinical Trial Not Allowed Apply for RFA FD 20 013 Funding Number: RFA FD 20 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
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