Opportunity Information: Apply for RFA FD 19 014
The grant opportunity titled "Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01 - Clinical Trial Required)" is a discretionary federal funding program offered by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). It uses a cooperative agreement mechanism (U01), which typically means the FDA expects substantial scientific or programmatic involvement during the project rather than acting only as a passive funder. The overall goal is to create and formally qualify a new Patient Reported Outcome (PRO) instrument specifically for people with Non-Cystic Fibrosis Bronchiectasis (NCFB), with the intention that this tool can be used as a credible endpoint in clinical trials, especially anti-infective drug studies where current endpoints are considered inadequate or inconsistent.
At the center of the project is development and qualification of a PRO under the FDA Drug Development Tool (DDT) Qualification Program. In practical terms, the funded work is meant to take a PRO measure from early concept to a regulatory-grade tool that has clearly defined context of use, strong evidence that it measures what matters to patients, and sufficient reliability and validity to be used in trials. Because bronchiectasis symptoms and impacts can be complex and variable (for example, cough, sputum production, breathlessness, fatigue, and exacerbations), a well-built PRO can help ensure trials capture meaningful change from the patient perspective, not just clinician observations or laboratory measures.
The FOA expects applicants to complete the full development pathway. That includes a qualitative phase, where researchers typically engage patients and other stakeholders to identify the most relevant symptoms and life impacts, refine concepts, and draft items using methods such as literature review, concept elicitation interviews, focus groups, and cognitive interviewing to confirm questions are understood as intended. It also includes a quantitative phase, where the instrument is tested in appropriate patient populations to evaluate key psychometric properties such as reliability (including test-retest where feasible), validity (content validity as well as construct validity), sensitivity to change, scoring structure, and interpretation thresholds (for example, what constitutes a clinically meaningful improvement or worsening). Finally, it includes the work necessary to submit the evidence package for FDA qualification, meaning the deliverable is not only a questionnaire but a tool supported by a dossier suitable for the DDT qualification process.
The opportunity is framed as a way to strengthen the design, conduct, and interpretation of NCFB anti-infective clinical trials. The underlying problem it is addressing is that NCFB trials often struggle with endpoint selection: exacerbation definitions and reporting can vary, clinical measures may not fully reflect lived experience, and there may be gaps in capturing symptom burden and daily functioning in a standardized way. A qualified PRO could reduce ambiguity, improve comparability across studies, and help align trial outcomes with what patients actually feel and experience, which in turn can support clearer benefit-risk assessment for therapies.
Administratively, this FOA is identified as RFA FD 19 014 and falls under Assistance Listing/CFDA 93.103. It was posted in early 2019 (creation date February 6, 2019) with an original application deadline of April 4, 2019. The program anticipated making a single award, with a maximum funding level (award ceiling) of $2,000,000. Eligibility was broad and included many organization types: federal and non-federal governmental entities (state, county, city/township, special districts), public and private institutions of higher education, tribal governments and tribal organizations, public housing authorities, nonprofit organizations with or without 501(c)(3) status, and for-profit entities (including small businesses and other for-profit organizations). That breadth signals the FDA was open to applications from academic groups, clinical research networks, measurement science experts, patient-focused outcomes groups, and industry or contract research organizations, as long as they could credibly execute a rigorous PRO development and validation program and work within the collaborative expectations of a U01 award.
Strategically, the FOA also connects to a broader FDA research priority: stimulating innovation in clinical evaluation and personalized medicine to improve product performance and patient outcomes. In this context, the innovation is not a new drug itself but a qualified measurement tool that can make trials more patient-centered and more scientifically interpretable. If successful, the resulting PRO instrument would be positioned to become a standardized endpoint option for future NCFB clinical trials, improving the ability to detect meaningful treatment benefits and supporting more efficient and patient-relevant therapeutic development.Apply for RFA FD 19 014
- 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 Required) Activity Code" 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 Feb 06, 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 Required)."
Which federal agency is offering this funding?
This is a discretionary federal funding program from the U.S. Department of Health and Human Services (HHS) through the Food and Drug Administration (FDA).
What type of award mechanism is used?
The funding mechanism is a cooperative agreement (U01). A U01 typically indicates that the FDA expects substantial scientific and/or programmatic involvement during the project rather than acting only as a passive funder.
What problem is this funding opportunity trying to address?
The FOA is intended to address challenges in non-cystic fibrosis bronchiectasis (NCFB) clinical trials related to endpoint selection and consistency. It notes that exacerbation definitions and reporting can vary, clinical measures may not fully reflect lived experience, and trials may not capture symptom burden and daily functioning in a standardized way.
What is the overall goal of the project?
The overall goal is to create and formally qualify a new Patient Reported Outcome (PRO) instrument specifically for people with NCFB, with the intention that it can be used as a credible endpoint in clinical trials, particularly anti-infective drug studies where current endpoints are considered inadequate or inconsistent.
What is a Patient Reported Outcome (PRO) instrument in the context of this FOA?
In this FOA, a PRO instrument is a patient-reported measure intended to capture symptoms and impacts that matter to people living with NCFB (for example, cough, sputum production, breathlessness, fatigue, and exacerbations). The goal is to ensure trials can detect meaningful change from the patient perspective, not only from clinician observations or laboratory measures.
What does it mean to "qualify" a PRO tool under the FDA program referenced in the FOA?
The FOA centers on development and qualification of a PRO under the FDA Drug Development Tool (DDT) Qualification Program. The intent is to take a PRO measure from early concept through to a regulatory-grade tool with a clearly defined context of use and evidence supporting that it measures what matters to patients and performs reliably and validly in clinical trials.
What is the FDA Drug Development Tool (DDT) Qualification Program referenced here?
The FOA specifically references the FDA DDT Qualification Program as the pathway for formal qualification of the PRO instrument. The expectation is that the project will produce not only the questionnaire, but also the supporting evidence package (a dossier) suitable for the DDT qualification process.
What kinds of symptoms or impacts is the PRO tool expected to cover?
The FOA highlights that NCFB symptoms and impacts can be complex and variable, giving examples such as cough, sputum production, breathlessness, fatigue, and exacerbations. The PRO instrument is intended to capture meaningful aspects of the patient experience relevant to NCFB clinical trials.
What development phases does the FOA expect applicants to complete?
The FOA expects completion of the full PRO development pathway, including a qualitative phase and a quantitative phase, followed by preparation of the evidence package needed for FDA qualification.
What is included in the qualitative phase described by the FOA?
The qualitative phase typically involves engaging patients and other stakeholders to identify relevant symptoms and life impacts, refine concepts, and draft items. Methods named include literature review, concept elicitation interviews, focus groups, and cognitive interviewing to confirm that questions are understood as intended.
What is included in the quantitative phase described by the FOA?
The quantitative phase involves testing the instrument in appropriate patient populations to evaluate key psychometric properties such as reliability (including test-retest where feasible), validity (including content validity and construct validity), sensitivity to change, scoring structure, and interpretation thresholds (for example, what constitutes a clinically meaningful improvement or worsening).
What psychometric properties does the FOA explicitly mention?
The FOA explicitly mentions evaluating reliability (including test-retest where feasible), validity (content validity and construct validity), sensitivity to change, scoring structure, and interpretation thresholds for clinically meaningful change.
What is meant by "context of use" for the PRO instrument?
The FOA indicates the PRO should have a clearly defined context of use, meaning it should specify the setting and purpose for which the tool is intended (for example, use as an endpoint in NCFB clinical trials, particularly anti-infective studies).
What deliverables are expected at the end of the project?
The FOA indicates the deliverable is not only a questionnaire, but a PRO instrument supported by an evidence package (dossier) suitable for submission to the FDA for qualification through the DDT qualification process.
How is this work expected to help NCFB anti-infective clinical trials?
The FOA frames the project as a way to strengthen the design, conduct, and interpretation of NCFB anti-infective clinical trials by providing a standardized, patient-centered endpoint option. A qualified PRO could reduce ambiguity, improve comparability across studies, and better align trial outcomes with what patients actually experience.
How many awards were anticipated under this FOA?
The program anticipated making a single award.
What is the maximum funding amount mentioned?
The award ceiling described is $2,000,000.
What is the FOA identifier and assistance listing number?
The FOA is identified as RFA FD 19 014 and falls under Assistance Listing/CFDA 93.103.
When was the opportunity posted and what was the application deadline?
The FOA was posted in early 2019, with a creation date of February 6, 2019, and an original application deadline of April 4, 2019.
Who was eligible to apply based on the FOA description?
Eligibility was described as broad and included federal and non-federal governmental entities (state, county, city/township, special districts), public and private institutions of higher education, tribal governments and tribal organizations, public housing authorities, nonprofit organizations with or without 501(c)(3) status, and for-profit entities (including small businesses and other for-profit organizations).
Does the FOA suggest what types of organizations might be well-suited to apply?
Yes. Based on the breadth of eligibility and the technical requirements, the FOA signals openness to applications from academic groups, clinical research networks, measurement science experts, patient-focused outcomes groups, and industry or contract research organizations, as long as they can execute a rigorous PRO development and validation program and operate within the collaborative expectations of a U01 award.
Why does the FOA emphasize patient-centered measurement?
The FOA emphasizes that NCFB clinical measures may not fully reflect lived experience and that symptom burden and daily functioning may be inconsistently captured. A well-built PRO can help ensure trials measure changes that are meaningful to patients.
How does this FOA connect to broader FDA research priorities?
The FOA is positioned within a broader FDA research priority focused on innovation in clinical evaluation and personalized medicine to improve product performance and patient outcomes. In this case, the innovation is a qualified measurement tool rather than a new therapy.
Is the focus of the project a new drug or a measurement tool?
The FOA focuses on developing and qualifying a measurement tool (a PRO instrument), not on developing a new drug.
What is the intended longer-term impact if the project is successful?
If successful, the resulting PRO instrument would be positioned to become a standardized endpoint option for future NCFB clinical trials, improving the ability to detect meaningful treatment benefits and supporting more efficient and patient-relevant therapeutic development.
What does "Clinical Trial Required" imply in the opportunity title?
The opportunity title includes "(U01 - Clinical Trial Required)." Based on the information provided, the FOA is focused on developing and testing a PRO instrument for use in clinical trials, including quantitative testing in appropriate patient populations and establishing properties like sensitivity to change and interpretation thresholds needed for use as a trial endpoint.
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| 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 |
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| 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 |
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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 |
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