Opportunity Information: Apply for RFA FD 19 005
This grant opportunity, titled "Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional" (Funding Opportunity Number RFA FD 19 005), is a cooperative agreement offered by the U.S. Department of Health and Human Services, Food and Drug Administration (FDA). The central goal is to fund a single research effort aimed at creating and moving a new Patient-Reported Outcome (PRO) measure all the way through development and formal qualification for use in non-cystic fibrosis bronchiectasis (NCFB) clinical trials. The award is structured to support the full lifecycle of PRO instrument work, from early concept and patient-centered qualitative research through large-scale quantitative testing, and ultimately to submission for qualification through FDA's Drug Development Tools (DDT) Qualification Program.
The problem this funding is trying to solve is straightforward: NCFB clinical trials, particularly anti-infective studies, often struggle with endpoint selection because "optimal endpoints are currently lacking." In practical terms, that can make it harder to design trials that reliably capture meaningful clinical benefit, compare results across studies, and interpret whether a therapy truly improved outcomes that matter to patients. A qualified PRO would give researchers and sponsors a standardized, validated, and regulator-recognized way to measure patient experience (for example, symptom burden and related impacts) as part of evaluating new treatments. By investing in a PRO that can be qualified under the DDT program, the FDA is signaling an interest in endpoints that can be broadly used across drug development programs rather than being limited to one sponsor or one study.
The scope of work described in the announcement covers three major phases. First is the qualitative phase, where the instrument is developed based on direct input from the target patient population. This phase typically involves methods such as patient interviews and focus groups to ensure the questions reflect the lived experience of NCFB, capture the concepts that patients consider most important, and use language that patients interpret consistently. Second is the quantitative phase, where the draft PRO is tested in larger patient samples to evaluate measurement properties such as reliability, validity, sensitivity to change, scoring approach, and performance across relevant subgroups. Third is the qualification phase, which involves assembling the evidence package and working within the FDA's DDT Qualification Program so that, once qualified for a defined context of use, the tool can be used to support regulatory decision-making in future NCFB trials.
The program uses a U01 cooperative agreement mechanism, which generally means substantial federal scientific or programmatic involvement is expected during the project compared with a typical grant. The listing also notes "Clinical Trial Optional," meaning the research may include clinical trial components if they are appropriate to instrument testing and validation, but a clinical trial is not necessarily required. The intent is not simply to create a questionnaire, but to produce a tool with enough evidence behind it to be accepted and useful for improving trial design, conduct, and interpretation in this disease area.
Key administrative details are also clear. The opportunity was created January 31, 2019, with an original closing date of April 4, 2019. The award ceiling is $2,000,000, and the FDA anticipated making one award, indicating a single, relatively large and coordinated effort rather than multiple smaller projects. The funding instrument and activity category are listed as a cooperative agreement under a category that includes agriculture, consumer protection, and food and nutrition (reflecting FDA's broader classification structure), and the associated CFDA number is 93.103.
Eligibility is broad and includes many types of organizations that could credibly lead a PRO development and qualification effort. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other entities as described in the full announcement. This breadth suggests the FDA was open to proposals led by academic centers, nonprofit research organizations, industry groups, or cross-sector collaborations, as long as the team could execute rigorous qualitative and quantitative research and navigate the formal DDT qualification pathway.
Overall, the opportunity is designed to produce a patient-centered measurement tool that can be used consistently across NCFB drug development, with the long-term impact of enabling better endpoints for anti-infective clinical trials. It directly aligns with FDA interests in advancing modern clinical evaluation methods and personalized, patient-relevant evidence, as reflected in the stated alignment with the agency's research focus on stimulating innovation to improve product performance and patient outcomes.Apply for RFA FD 19 005
- 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 "Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional" 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 Jan 31, 2019.
- Applicants must submit their applications by Apr 04, 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 $2,000,000.00 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, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, 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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Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity is titled "Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA FD 19 005.
Which federal agency is offering this funding?
This is a cooperative agreement offered by the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA).
What is the main purpose of this award?
The central purpose is to fund a single research effort to create a new Patient-Reported Outcome (PRO) measure and take it through development and formal qualification for use in non-cystic fibrosis bronchiectasis (NCFB) clinical trials.
What problem is this funding trying to address in NCFB clinical trials?
The opportunity is aimed at addressing difficulties with endpoint selection in NCFB clinical trials, particularly anti-infective studies, because optimal endpoints are currently lacking.
What is a Patient-Reported Outcome (PRO) in the context of this opportunity?
In this context, a PRO is a patient-centered measure intended to capture aspects of the patient experience (such as symptom burden and related impacts) in a standardized way for use in NCFB clinical trials.
Why does FDA want a PRO measure that is formally qualified?
The intent is to produce a tool with enough evidence to be regulator-recognized and broadly usable across drug development programs, rather than being limited to a single sponsor or a single study.
What is meant by "qualification" for this PRO tool?
Qualification refers to submitting an evidence package and working through FDA's Drug Development Tools (DDT) Qualification Program so the PRO tool, once qualified for a defined context of use, can be used to support regulatory decision-making in future NCFB trials.
What FDA program is specifically mentioned for qualification?
The FDA Drug Development Tools (DDT) Qualification Program is specifically identified as the pathway for qualification.
Is the grant intended to support only the creation of a questionnaire?
No. The stated intent is not simply to create a questionnaire, but to develop a tool and generate sufficient supporting evidence for it to be accepted and useful for improving clinical trial design, conduct, and interpretation in NCFB.
How many awards did FDA anticipate making?
FDA anticipated making one award, indicating a single coordinated effort rather than multiple smaller projects.
What is the maximum funding amount (award ceiling)?
The award ceiling is $2,000,000.
What type of funding mechanism is used?
The mechanism is a U01 cooperative agreement.
What does a U01 cooperative agreement imply about FDA involvement?
A U01 cooperative agreement generally means substantial federal scientific or programmatic involvement is expected during the project compared with a typical grant.
What does "Clinical Trial Optional" mean for this opportunity?
"Clinical Trial Optional" means the research may include clinical trial components if appropriate for instrument testing and validation, but a clinical trial is not necessarily required.
What major phases of work are described in the scope?
The scope describes three major phases: (1) a qualitative phase to develop the instrument based on direct patient input, (2) a quantitative phase to test measurement properties in larger samples, and (3) a qualification phase to prepare and submit evidence through the FDA DDT Qualification Program.
What kinds of activities are included in the qualitative phase?
The qualitative phase is described as patient-centered qualitative research based on direct input from the target patient population, typically involving methods such as patient interviews and focus groups to ensure the instrument reflects lived experience and uses language patients interpret consistently.
What is the goal of the quantitative phase?
The quantitative phase is intended to test the draft PRO in larger patient samples and evaluate measurement properties such as reliability, validity, sensitivity to change, scoring approach, and performance across relevant subgroups.
What is included in the qualification phase?
The qualification phase involves assembling the evidence package and engaging with the FDA DDT Qualification Program so the tool can become qualified for a defined context of use in NCFB clinical trials.
What disease area is the PRO tool meant for?
The tool is intended for non-cystic fibrosis bronchiectasis (NCFB).
In what type of clinical trials is the PRO tool expected to be particularly useful?
The opportunity highlights NCFB clinical trials, particularly anti-infective studies, as an area where improved endpoints are needed.
How could a qualified PRO help NCFB drug development?
A qualified PRO could provide a standardized, validated, regulator-recognized way to measure patient experience, which can help trials capture meaningful clinical benefit, compare results across studies, and interpret whether therapies improve outcomes that matter to patients.
When was this opportunity created?
The opportunity was created on January 31, 2019.
What was the original closing date?
The original closing date was April 4, 2019.
What is the CFDA number associated with this opportunity?
The associated CFDA number is 93.103.
What activity category is listed for this cooperative agreement?
The activity category is listed under a category that includes agriculture, consumer protection, and food and nutrition, reflecting FDA's broader classification structure.
Who is eligible to apply for this funding?
Eligibility is broad and includes state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other entities as described in the full announcement.
Does the opportunity indicate whether proposals can be led by academic, nonprofit, or industry groups?
Yes. The breadth of eligibility indicates FDA was open to proposals led by academic centers, nonprofit research organizations, industry groups, or cross-sector collaborations, as long as the team could conduct rigorous qualitative and quantitative research and navigate the DDT qualification pathway.
What long-term impact is this opportunity aiming for?
The opportunity is designed to produce a patient-centered measurement tool that can be used consistently across NCFB drug development, enabling better endpoints for clinical trials and improving how trials are designed, conducted, and interpreted.
How does this align with FDA interests described in the opportunity summary?
It aligns with FDA interests in advancing modern clinical evaluation methods and patient-relevant evidence, including stimulating innovation to improve product performance and patient outcomes.
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| Funding Opportunity |
|---|
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code Apply for RFA FD 19 014 Funding Number: RFA FD 19 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 008 Funding Number: RFA FD 19 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required) Apply for RFA FD 19 009 Funding Number: RFA FD 19 009 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: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 010 Funding Number: RFA FD 19 010 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 the Illinois Institute of Technology's Institute for Food Safety and Health (U19 Clinical Trial Optional) Apply for RFA FD 19 003 Funding Number: RFA FD 19 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional Apply for RFA FD 19 011 Funding Number: RFA FD 19 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Advancing Post-Market Surveillance of High-Risk Facilities and Products through Signal detection, Data analysis, and the Review of the State of Quality (U01) Clinical Trial Optional Apply for PAR 19 190 Funding Number: PAR 19 190 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional Apply for PAR 19 216 Funding Number: PAR 19 216 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
| Implementation of the Animal Feed Regulatory Program Standards (U18 Clinical Trial Not Allowed) Apply for RFA FD 19 021 Funding Number: RFA FD 19 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Novel Approaches to Translational Evidence Generation to Advance Coordinated Registry Networks (CRNs) via Big Data Analytics Using Disparate Data Sources (U01 Clinical Trial Optional) Apply for RFA FD 19 020 Funding Number: RFA FD 19 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 019 Funding Number: RFA FD 19 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trial Required Apply for RFA FD 19 015 Funding Number: RFA FD 19 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $37,500,000 |
| 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 Apply for RFA FD 19 013 Funding Number: RFA FD 19 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,500,000 |
| 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 |
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