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).
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Frequently Asked Questions (FAQs)
What is this FDA opportunity about?
This is a Request for Information (RFI) from the Food and Drug Administration (FDA), within the U.S. Department of Health and Human Services. The FDA is asking the public for input 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.
Is this a grant solicitation or an information-gathering request?
Based on the description provided, it is an RFI intended to gather public input and help the FDA shape a future program approach. The text also includes administrative and funding listing details (including a cooperative agreement instrument and an award ceiling), but the core action described is the FDA collecting information to design a coordinated development program.
What does FDA mean by "core sets" of COAs and endpoints?
A "core set" refers to a minimum set of outcomes and endpoints that should be measured consistently in a given disease area because they reflect what matters most to patients and are sensitive enough to detect meaningful change over time.
Why does the FDA want standardized core sets for specific disease areas?
The FDA is trying to reduce fragmentation in COA development. The RFI explains that many groups (patient organizations, sponsors, consultants) often develop measures independently, resulting in a patchwork of different and often proprietary tools. Standardized, public core sets are intended to improve consistency, efficiency, sustainability, and confidence in outcomes evidence.
What kinds of patient experiences are these core outcome sets intended to capture?
The RFI emphasizes measuring key aspects of the patient experience, including:
- Disease burden (how the condition affects daily life)
- Treatment burden (the practical and physical costs of managing care)
- Physical functioning (when relevant)
Is the FDA asking for brand-new COA instruments to be developed?
Not primarily. The description states the FDA is not simply looking for new instruments. Instead, it is seeking information that can shape a disciplined and transparent program to develop core sets, with a preference for prioritizing already-public measures that have been extensively vetted.
How does the FDA envision the core sets being developed?
The FDA envisions a process run by qualified third parties using a clearly managed, methodologically sound development protocol. The protocol is described as emphasizing consistent methods aligned with FDA patient-focused drug development methodological guidance, use of vetted public measures, publication of interim outputs at milestones, and structured multi-stakeholder engagement through public meetings and workshops.
What are the key features the FDA wants in the development protocol?
The RFI describes four main features for the protocol:
- Consistent use of appropriate COA development methods, aligned with FDA patient-focused drug development methodological guidance.
- Prioritizing already-public, extensively vetted measures to avoid duplicative work and reduce proprietary fragmentation.
- Publishing interim outputs at each milestone so evolving concepts and draft recommendations are visible and usable.
- Structured engagement of major stakeholder groups at key points through public meetings and workshops.
Who does the FDA expect to be involved as stakeholders?
The stakeholder groups named in the description 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.
What problem is the FDA trying to solve with this RFI?
The RFI highlights that COA development has been fragmented and uncoordinated, with many separate efforts producing different measures and often proprietary tools. This can increase costs, create repeated learning curves, reduce efficiency, and lead to uneven quality depending on the resources and expertise of the group developing the tool.
How does inconsistent COA quality affect clinical development and decision-making?
The description states that inconsistent COA quality reduces the usefulness of data for decision-makers and can undermine confidence in outcomes evidence. That loss of confidence can discourage companies from investing in capturing patient perspectives, even though patient-focused measurement could improve how therapies are developed and evaluated.
How does this connect to the FDA's patient-focused work?
The RFI is positioned as building on the FDA's patient-focused work since 2012, when the agency 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 emphasizes that patient input should translate into stronger evidence of benefits and risks in clinical development when scientifically sound COAs and endpoints are used.
How can COA results be used in FDA decision-making and communications?
The description notes that 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. That labeling can help clinicians and patients make better informed treatment choices at the point of care.
What does it mean that the approach relies on "qualified third parties"?
It means the FDA anticipates external organizations (not the FDA itself) would run the core set development process, using a defined protocol and a transparent, methodologically rigorous approach, while engaging stakeholders and publishing interim outputs as the work progresses.
What does "publicly available" mean in the context of these core sets?
In this RFI, "publicly available" is tied to the goal of reducing proprietary fragmentation and making measures and interim outputs visible and usable by the broader community as they evolve, rather than being locked behind proprietary restrictions.
What is the funding instrument mentioned for this opportunity?
The listing information describes the opportunity as using a cooperative agreement funding instrument.
What is the award ceiling and expected number of awards?
The award ceiling is listed as $1,000,000, and there is an expectation of one award.
What is the CFDA number associated with this opportunity?
The opportunity is cataloged under CFDA 93.103.
How is this opportunity categorized?
It is categorized under Agriculture, Consumer Protection, Food and Nutrition. The description notes this reflects FDA's broader mission categories rather than the disease-focused nature of the work.
What is the funding opportunity number?
The funding opportunity number is RFI NOT FD 18 014.
When was this opportunity created and when did it close?
It was created on July 31, 2018, and the original closing date was October 15, 2018.
Who is eligible to apply, based on the information provided?
Eligibility is broadly described as "Others," with additional eligibility specifics referenced as being available in the full announcement materials.
What is the overall goal of the FDA's effort described in this RFI?
The goal is to lay the groundwork for a structured, multi-stakeholder program that standardizes patient-centered outcome measurement in clinical trials within disease areas. The intended result is shared, public, high-quality COA core sets that can be used across studies, lowering startup burden, improving consistency, and strengthening the credibility and decision value of patient-focused evidence.
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