Opportunity Information: Apply for RFI NOT FD 18 014
The Food and Drug Administration (FDA), within the Department of Health and Human Services, issued this Request for Information (RFI) to gather input from the public on how to build a coordinated effort to create publicly available, standardized "core sets" of Clinical Outcome Assessments (COAs) and related endpoints for specific disease areas. The central idea is to identify, for a given condition, a minimum set of outcomes that should be measured consistently because they capture what matters most to patients and are sensitive enough to show meaningful change over time. These core sets are meant to cover key aspects of the patient experience, such as disease burden (how the condition affects daily life), treatment burden (the practical and physical costs of managing care), and, when relevant, physical functioning.
The FDA is not simply looking for new instruments; it is seeking information that can shape a program designed to develop these core sets in a disciplined, transparent way. The envisioned approach relies on qualified third parties running a clearly managed and methodologically sound process under a development protocol. That protocol would emphasize four main features: first, consistent use of appropriate methods for COA development, including alignment with FDA patient-focused drug development methodological guidance; second, prioritizing already-public measures that have been extensively vetted, to avoid reinventing the wheel and to reduce unnecessary proprietary fragmentation; third, publishing interim outputs at each milestone so that concepts, draft recommendations, and candidate measures are visible and usable by the broader community as they evolve; and fourth, structured engagement of major stakeholder groups at key points through public meetings and workshops. Those stakeholders include patient advocacy organizations, FDA medical product reviewers, industry sponsors, government and academic researchers, clinicians, health technology assessment groups, payers, and others involved in healthcare decision-making.
The rationale comes from the FDA's patient-focused work since 2012, when it began holding disease-specific meetings to hear directly from patients about how diseases affect their lives and what tradeoffs they face with existing treatments. The FDA frames this as more than contextual background; patient input can and should translate into stronger evidence of benefits and risks in clinical development, especially when trials use COA tools and endpoints that are scientifically sound. When COAs are well-developed and properly used in trials, their results can support regulatory decision-making and can sometimes be reflected in product labeling, which then helps clinicians and patients make better informed treatment choices at the point of care.
A major problem the RFI highlights is that COA development has been happening in a fragmented and uncoordinated way across many diseases. Patient groups, sponsors, and consultants often work independently, leading to a patchwork of different measures and, frequently, proprietary tools. That creates repeated "learning curves" for new programs, drives up costs, and reduces efficiency and sustainability over time. It can also produce uneven quality, because not every group has the same technical expertise, resources, or experience in COA development. The FDA notes that inconsistent COA quality reduces the usefulness of data for decision-makers and can undermine confidence in outcomes evidence, which in turn can discourage companies from investing in capturing the patient perspective, even though doing so could improve how therapies are developed and evaluated.
In practical grant and administrative terms, the opportunity is listed as discretionary and uses a cooperative agreement funding instrument, with an award ceiling of $1,000,000 and an expectation of one award. It is cataloged under CFDA 93.103 and categorized under Agriculture, Consumer Protection, Food and Nutrition (reflecting FDA's broader mission categories rather than the disease-focused nature of the work). The funding opportunity number is RFI NOT FD 18 014, it was created July 31, 2018, and the original closing date was October 15, 2018. Eligibility is broadly described as "Others," with additional eligibility specifics referenced in the full announcement materials.
Overall, this RFI is best understood as the FDA laying groundwork for a structured, multi-stakeholder program to standardize patient-centered outcome measurement in clinical trials. Instead of many disconnected efforts producing different endpoints and tools, the FDA is signaling interest in a common infrastructure: shared, public, high-quality COA core sets that can be used across studies in a disease area, lowering startup burden, improving consistency, and strengthening the credibility and decision value of patient-focused evidence.Apply for RFI NOT FD 18 014
- 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 "Request for Information (RFI): FDA Standard Core Clinical Outcome Assessments and Endpoints" 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 Jul 31, 2018.
- Applicants must submit their applications by Oct 15, 2018. (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 $1,000,000.00 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).
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Browse more opportunities from the same category: Agriculture, Consumer Protection, Food and Nutrition
Next opportunity: Visitor Contact, Educational and Public Programs
Previous opportunity: Exploring and Restoring the Anacostia River
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFI NOT FD 18 014
Applicants also applied for:
Applicants who have applied for this opportunity (RFI NOT FD 18 014) also looked into and applied for these:
| Funding Opportunity |
|---|
| Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 002 Funding Number: RFA FD 19 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional Apply for RFA FD 19 005 Funding Number: RFA FD 19 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| 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 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFI NOT FD 18 014", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.