Opportunity Information: Apply for RFA NS 12 004
Apply for RFA NS 12 004
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Spinal Muscular Atrophy (SMA) Biomarker Study (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Jun 9, 2011 and posted on Jun 9, 2011.
- Applicants must submit their applications by Sep 1, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,750,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Private institutions of higher education City or township governments County governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Small businesses For profit organizations other than small businesses.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Organizations) are eligible to apply, but will have to work with the U.S. based NeuroNEXT infrastructure.
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Opportunity Summary:
The Spinal Muscular Atrophy (SMA) Biomarker Study (U01) funding opportunity (RFA-NS-12-004) was a National Institute of Neurological Disorders and Stroke (NINDS) initiative under the National Institutes of Health designed to support a focused clinical research study aimed at evaluating candidate biomarkers in SMA. In practical terms, the goal was to move beyond purely clinical observations and test measurable biological indicators that could help track disease status, progression, or treatment response in people with SMA. Because biomarkers can make clinical trials faster and more informative, this FOA was framed around producing data that could be useful for future SMA therapeutic development and trial readiness.
A central feature of the opportunity was its reliance on the NeuroNEXT infrastructure, a clinical trials network created to streamline and standardize neurological research across multiple sites. Applicants were expected to conduct the biomarker study through NeuroNEXT (as established under earlier RFAs RFA-NS-11-009, RFA-NS-11-010, and RFA-NS-11-008), while also having the flexibility to bring in additional “ad hoc” clinical sites if that would improve recruitment, access to SMA populations, or specialized capabilities. This setup signaled that NINDS wanted the study to benefit from NeuroNEXT’s established operational capacity (for example, coordinated site management, harmonized procedures, and network-based study execution) while still allowing the project to scale to the needs of SMA research.
The award mechanism was a U01 cooperative agreement, which is distinct from a standard research grant because it involves substantial scientific and programmatic involvement from NIH staff. This FOA explicitly described the project as milestone-driven, meaning awardees would be expected to propose clear, measurable milestones and timelines, and NIH program staff would actively participate in shaping the project plan and monitoring progress. Cooperative agreements are often used when the agency wants close coordination to ensure that a complex, multi-site project stays aligned with broader program goals, meets operational standards, and delivers agreed-upon outputs on schedule.
In terms of funding and scale, the FOA anticipated making a single award, with an estimated total funding level of about $1,750,000. Cost sharing or matching was not required, which lowers barriers for academic and nonprofit applicants and makes budgeting more straightforward. The funding activity category was health, and the listing was tied to CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), reflecting its placement within NIH’s neuroscience and neurological disorders research portfolio.
Eligibility was intentionally broad and inclusive. A wide range of U.S.-based entities could apply, including public and private institutions of higher education, nonprofits (including both 501(c)(3) organizations and certain non-501(c)(3) nonprofits), state and local governments, tribal governments and tribal organizations, public housing authorities, independent school districts, special district governments, and for-profit organizations (including small businesses). The FOA also highlighted additional eligible applicants such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Foreign organizations were allowed to apply as well, but with an important condition: they would need to work with the U.S.-based NeuroNEXT infrastructure, reinforcing that the operational backbone of the study was expected to remain anchored within that network.
From an administrative timeline perspective, the announcement was posted on June 9, 2011, with an original and current closing date of September 1, 2011. The opportunity was later archived on October 2, 2011, which simply reflects that it was a time-limited solicitation rather than an open-ended program announcement. The official FOA was available through the NIH Grants Guide link provided in the listing.
Finally, the contact details included were primarily for technical assistance related to accessing the announcement online or resolving linking issues, directing applicants to the NIH Office of Extramural Research (OER) Webmaster. For applicants at the time, the key takeaway was that this was a single-project, network-enabled, NIH-involved cooperative agreement aimed at producing rigorously collected, clinically relevant biomarker evidence in SMA, using standardized infrastructure and milestone-based management to maximize the likelihood of actionable results.
Frequently Asked Questions (FAQs): Spinal Muscular Atrophy (SMA) Biomarker Study (U01) - RFA-NS-12-004
What is this funding opportunity?
This opportunity is the Spinal Muscular Atrophy (SMA) Biomarker Study (U01) funding opportunity announcement (FOA) RFA-NS-12-004, a National Institute of Neurological Disorders and Stroke (NINDS) initiative under the National Institutes of Health (NIH). It was designed to support a focused clinical research study evaluating candidate biomarkers in people with SMA.
What is the main purpose of the study being funded?
The purpose is to move beyond purely clinical observations by testing measurable biological indicators (biomarkers) that could help track SMA disease status, progression, or treatment response. The FOA emphasizes producing data that could support future SMA therapeutic development and improve clinical trial readiness.
Why are biomarkers important in the context of SMA research?
According to the FOA description, biomarkers can make clinical trials faster and more informative by providing measurable biological signals that may track disease status or treatment response. The study is intended to generate clinically relevant biomarker evidence that can be useful for future therapeutic development.
What NIH institute is sponsoring this opportunity?
The sponsoring institute is the National Institute of Neurological Disorders and Stroke (NINDS), within the National Institutes of Health (NIH).
What is the award mechanism for this FOA?
The award mechanism is a U01 cooperative agreement. This is different from a standard research grant because it includes substantial scientific and programmatic involvement from NIH staff.
What does it mean that this is a "cooperative agreement" (U01)?
In this FOA, a cooperative agreement indicates that NIH program staff are expected to have substantial involvement in the project. The NIH role includes active participation in shaping the project plan and monitoring progress, particularly because the project is described as complex and multi-site.
What does "milestone-driven" mean for this opportunity?
Milestone-driven means applicants were expected to propose clear, measurable milestones and timelines. Awardees would be monitored against those milestones, with NIH staff actively involved in project planning and progress oversight.
How many awards were expected to be made?
The FOA anticipated making a single award.
What is the estimated total funding level for this opportunity?
The FOA described an estimated total funding level of about $1,750,000.
Is cost sharing or matching required?
No. The FOA states that cost sharing or matching was not required.
What is the activity category for this funding?
The funding activity category is health.
What CFDA number is associated with this opportunity?
This listing is tied to CFDA 93.853, which corresponds to Extramural Research Programs in the Neurosciences and Neurological Disorders.
What research infrastructure was this study expected to use?
A central feature of the FOA is reliance on the NeuroNEXT infrastructure, a clinical trials network created to streamline and standardize neurological research across multiple sites. Applicants were expected to conduct the biomarker study through NeuroNEXT.
What is NeuroNEXT in the context of this FOA?
NeuroNEXT is described as a clinical trials network intended to streamline and standardize multi-site neurological research. In this FOA, NeuroNEXT served as the operational backbone for executing the SMA biomarker study.
Were applicants allowed to use clinical sites outside NeuroNEXT?
Yes. While the study was expected to be conducted through NeuroNEXT, the FOA also allowed inclusion of additional "ad hoc" clinical sites if that would improve recruitment, access to SMA populations, or provide specialized capabilities.
Why did the FOA emphasize using NeuroNEXT?
The FOA signals that NINDS wanted the project to benefit from NeuroNEXT's established operational capacity, including coordinated site management, harmonized procedures, and network-based study execution, while still allowing the study to scale as needed for SMA research.
Which earlier RFAs are referenced in relation to NeuroNEXT?
The FOA references earlier RFAs associated with establishing NeuroNEXT: RFA-NS-11-009, RFA-NS-11-010, and RFA-NS-11-008.
Who was eligible to apply?
Eligibility was broad. U.S.-based eligible applicants included public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) organizations); state and local governments; tribal governments and tribal organizations; public housing authorities; independent school districts; special district governments; and for-profit organizations (including small businesses).
Were minority-serving institutions and community-based organizations included in eligibility?
Yes. The FOA specifically highlighted additional eligible applicants such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.
Could for-profit entities apply?
Yes. For-profit organizations, including small businesses, were listed among eligible applicant types.
Could foreign organizations apply?
Yes, foreign organizations were allowed to apply, but with an important condition: they would need to work with the U.S.-based NeuroNEXT infrastructure. The FOA reinforces that the operational backbone of the study was expected to remain anchored within NeuroNEXT.
When was the FOA posted and when did it close?
The announcement was posted on June 9, 2011. The original and current closing date was September 1, 2011.
What does it mean that the opportunity was archived?
The listing states the opportunity was archived on October 2, 2011. In the FOA context provided, archiving indicates it was a time-limited solicitation rather than an open-ended program announcement.
Where could applicants access the official FOA?
The official FOA was available via the NIH Grants Guide link referenced in the listing.
What kind of support contact was provided in the listing?
The contact details provided were primarily for technical assistance related to accessing the announcement online or resolving linking issues, directing applicants to the NIH Office of Extramural Research (OER) Webmaster.
What is the high-level takeaway about what NINDS wanted to fund?
This was a single-project, network-enabled cooperative agreement with active NIH involvement, aimed at generating rigorously collected and clinically relevant SMA biomarker data, using standardized infrastructure and milestone-based management to support actionable results for future therapeutic development and trial readiness.
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