Opportunity Information: Apply for PAR 16 020
Apply for PAR 16 020
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853,.
- This funding opportunity was created on Oct 29, 2015 and posted on Oct 29, 2015.
- Applicants must submit their applications by Aug 17, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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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Opportunity Summary:
The Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases (U01) opportunity (Funding Opportunity Number PAR 16-020) is a National Institutes of Health program run through the Department of Health and Human Services, specifically the National Institute of Neurological Disorders and Stroke (NINDS). It is designed to fund practical, clinic-focused studies that make upcoming interventional trials in rare neurological and neuromuscular diseases more feasible, faster to launch, and more likely to succeed. Rather than paying for a full-scale efficacy trial, this program targets the kinds of pre-trial work that often slows rare disease development down: proving that outcome measures are trustworthy, confirming that biomarkers behave the way investigators think they do, and defining the patient populations well enough that future trials can be designed with confidence.
A central theme of the FOA is "trial readiness." In the rare disease setting, many promising therapies stall because the field lacks validated endpoints, the natural history is not well characterized, or the patient population is too heterogeneous to power a trial efficiently. This funding supports clinical studies that close those gaps. Examples of the intended work include validating clinical outcome assessments (for instance, functional scales, performance tests, or patient-reported outcomes) so that they are sensitive to change and meaningful in the target disease, and validating or qualifying biomarkers that can help measure disease activity, progression, or treatment response. The FOA also supports cohort characterization work, such as defining disease subtypes, mapping progression rates, or identifying the right inclusion and exclusion criteria for subsequent trials. The underlying goal is to generate the evidence and infrastructure that lets a later therapeutic trial be designed with clearer endpoints, better stratification, and more reliable assumptions about variability and progression.
The funding mechanism is a U01 cooperative agreement, which signals that NIH expects substantial scientific involvement during the project compared with a standard research grant. In practical terms, applicants should anticipate coordination with NINDS program staff and adherence to NIH expectations about milestone-driven progress, data quality, and study conduct, consistent with the collaborative nature of cooperative agreements. The activity category is Health, and the CFDA numbers associated with the announcement are 93.853 (and listed additionally as 93.853 in the source data).
Eligibility is broad and includes many types of U.S. organizations that commonly conduct clinical research. Eligible applicants listed in the notice include state, county, city/township, and 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/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding higher education where specified); for-profit organizations other than small businesses; and small businesses. The listing also includes an "Others" category with reference to additional eligibility clarification in the full FOA text, which is typical for NIH announcements where specific conditions can apply depending on the proposed work and applicant type.
In terms of timing and administrative details, the announcement was posted and created on October 29, 2015, and the listed closing date in the provided record is August 17, 2018 (both as the original and current closing date). The record does not specify an award ceiling or the expected number of awards in the fields provided, which usually means those details are either not set as a fixed amount in the summary record or are described in the full NIH announcement and dependent on available funds and meritorious applications.
Overall, this FOA is aimed at investigators who are close to being ready for a rare disease clinical trial but still have key design uncertainties that could jeopardize success. By funding rigorous clinical studies focused on endpoint validation, biomarker work, and cohort definition, NINDS intends to shorten the timeline to trial initiation and increase the chances that future trials in rare neurological and neuromuscular diseases will produce clear, interpretable, and clinically meaningful results.
Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases (U01).
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PAR 16-020.
Which agency is offering this funding?
This is a National Institutes of Health (NIH) program under the U.S. Department of Health and Human Services (HHS), run specifically through the National Institute of Neurological Disorders and Stroke (NINDS).
What is the main purpose of this funding opportunity?
The program is designed to fund practical, clinic-focused studies that make upcoming interventional trials in rare neurological and neuromuscular diseases more feasible, faster to launch, and more likely to succeed.
Is this funding intended to pay for a full-scale efficacy clinical trial?
No. The program is focused on pre-trial, trial-readiness work rather than a full-scale efficacy trial.
What does "clinical trial readiness" mean in this FOA?
In this FOA, "trial readiness" refers to generating the evidence and study groundwork needed so that a later therapeutic trial can be designed with more confidence. That includes strengthening endpoints, improving understanding of the disease course and variability, and defining patient populations well enough to support clear and efficient trial design.
What kinds of problems in rare disease research is this FOA trying to address?
The FOA targets common reasons rare disease trials stall, such as:
- Lack of validated or trustworthy endpoints
- Natural history not being well characterized
- Patient populations being too heterogeneous to design and power trials efficiently
What types of studies are considered responsive to this FOA?
The FOA supports clinical studies that close trial-design gaps, including work like validating outcome measures, validating or qualifying biomarkers, and characterizing patient cohorts to support better future trial design.
Does the FOA support validation of clinical outcome assessments?
Yes. Examples described include validating clinical outcome assessments such as functional scales, performance tests, and patient-reported outcomes, with an emphasis on ensuring they are sensitive to change and meaningful in the target disease.
Does the FOA support biomarker validation or qualification?
Yes. The FOA supports validating or qualifying biomarkers that can help measure disease activity, progression, or treatment response, so that future interventional trials can rely on them more confidently.
Does the FOA support work to define or characterize patient cohorts?
Yes. The FOA supports cohort characterization work, including defining disease subtypes, mapping progression rates, and identifying inclusion and exclusion criteria that can be used to design subsequent interventional trials.
What is the overall outcome NINDS is trying to achieve with this program?
The overall goal is to produce the evidence and infrastructure that helps later therapeutic trials use clearer endpoints, better stratification, and more reliable assumptions about variability and progression, ultimately improving the chances that future trials produce interpretable and clinically meaningful results.
What funding mechanism is used?
The mechanism is a U01 cooperative agreement.
What does a U01 cooperative agreement imply about NIH involvement?
A U01 indicates NIH expects substantial scientific involvement during the project compared with a standard research grant. Applicants should anticipate coordination with NINDS program staff and NIH expectations related to milestone-driven progress, data quality, and study conduct, consistent with the collaborative nature of a cooperative agreement.
What is the activity/category listed for this opportunity?
The activity category is listed as Health.
What CFDA number is associated with this announcement?
The CFDA number associated with the announcement is 93.853 (also listed additionally as 93.853 in the source information provided).
Who is eligible to apply?
Eligibility is broad and includes many U.S. organization types commonly involved in clinical research, including:
- State governments
- County governments
- 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
- Other Native American tribal organizations
- Public housing authorities / Indian housing authorities
- Nonprofit organizations with 501(c)(3) IRS status (excluding higher education where specified)
- Nonprofit organizations without 501(c)(3) IRS status (excluding higher education where specified)
- For-profit organizations other than small businesses
- Small businesses
What does the "Others" eligibility category mean?
The listing includes an "Others" category that points to additional eligibility clarification in the full FOA text. This is typical for NIH announcements where specific eligibility conditions can depend on the proposed work and the applicant type.
When was this opportunity posted?
The announcement was posted/created on October 29, 2015.
What is the closing date for the opportunity in the record provided?
The listed closing date in the provided record is August 17, 2018 (shown as both the original and current closing date).
Does the provided record include an award ceiling?
No. The fields provided do not specify an award ceiling.
Does the provided record state the expected number of awards?
No. The fields provided do not list the expected number of awards.
What does it mean that the award ceiling and number of awards are not specified in the record?
Based on the information provided, it suggests those details are either not set as fixed amounts in the summary record or are described elsewhere in the full NIH announcement and may depend on available funds and meritorious applications.
Who is this FOA best suited for?
This FOA is aimed at investigators who are close to being ready for a rare disease interventional clinical trial but still face key uncertainties that could jeopardize trial success, such as uncertain endpoints, unproven biomarkers, or insufficient cohort definition.
What kinds of deliverables is this FOA trying to produce for future trials?
Based on the description provided, the FOA is trying to produce trial-enabling outputs like stronger endpoint evidence (validated outcome measures), more reliable biomarker performance data, and clearer definitions of patient subtypes and progression rates to support better-designed interventional trials.
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