Opportunity Information: Apply for RFA NS 11 009
Apply for RFA NS 11 009
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Coordinating Center for the Network of Excellence in Neuroscience Clinical Trials (NEXT CCC) (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 Dec 7, 2010 and posted on Dec 7, 2010.
- Applicants must submit their applications by Mar 11, 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 $18,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,750,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Small businesses County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Independent school districts For profit organizations other than small businesses Private institutions of higher education Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) City or township governments State governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government 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.
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Opportunity Summary:
The National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), released this funding opportunity to support a single organization to serve as the Clinical Coordinating Center (CCC) for the Network for Excellence in Neuroscience Clinical Trials (NEXT). The central idea behind NEXT is to create a standing, ready-to-activate clinical trial network that can quickly move promising neuroscience therapies into well designed exploratory human studies. Rather than being built around one specific disease, the network is meant to be flexible and scalable, with the ability to bring in the right clinical experts and trial sites depending on the neurological condition and the opportunity at hand. The CCC is one of three major components of the network; separate solicitations cover the Clinical Sites and the Data Coordinating Center, making it clear that this announcement focuses specifically on the operational and clinical trial coordination function.
The research emphasis is on multiple, scientifically sound exploratory clinical trials and related clinical research studies, including work that may be biomarker-informed. The announcement points to examples like Phase 2 clinical trials, as well as studies designed to validate biomarkers and clinical outcome measures that would later support larger, more definitive trials. In practical terms, this means the network is intended to help the field test treatments that have strong rationale and preliminary evidence (from academia, foundations, or industry), while also strengthening the measurement tools and endpoints needed for later-stage testing. The target populations can include adults and/or pediatric participants, and the disorders fall broadly under neurological diseases and conditions rather than a narrow therapeutic area.
A key deliverable of the overall NEXT effort is infrastructure: a robust, standardized, and accessible system that makes it easier to develop protocols and implement studies rapidly. The CCC role is therefore positioned as the operational hub for the clinical side of the network, supporting efficient trial start-up and execution across a collection of clinical sites and specialist investigators. Even though the network is not disease-specific, it is expected to have the ability to coordinate a cadre of specialists so that, when a disease-specific trial opportunity arises, the network can respond quickly with the appropriate expertise and operational readiness.
This is a discretionary grant opportunity using a cooperative agreement mechanism (U01), which signals substantial NIH programmatic involvement during the project rather than a hands-off relationship. NINDS is the sponsoring institute, and the opportunity is categorized under health. The FOA expected to make one award, indicating that a single CCC would be selected to coordinate the network at the national level. The estimated total funding listed for the opportunity is $18,500,000, with an award ceiling of $1,750,000 (as provided in the source data). No cost sharing or matching requirement is indicated, so applicants were not required to contribute non-federal matching funds as a condition of award.
Eligibility is broad and includes many types of domestic organizations and governmental entities. Eligible applicants listed include public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3) entities), for-profit organizations (including small businesses and other for-profits), state and local governments (including county, city/township, special district governments, and independent school districts), public housing authorities/Indian housing authorities, and Native American tribal governments and organizations (both federally recognized and other tribal organizations). The additional eligibility language also includes various institution types and community-focused entities such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. In effect, the announcement is structured to allow many kinds of capable institutions to compete, as long as they can credibly operate as the clinical coordination backbone for a multi-study neuroscience trials network.
Administratively, the opportunity was posted on December 7, 2010, with an original and current closing date of March 11, 2011, and an archive date of April 11, 2011. The funding opportunity number is RFA-NS-11-009, and the CFDA number is 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The full announcement was made available through the NIH Grants Guide at the provided link, and NIH Office of Extramural Research (OER) webmaster contacts were supplied for technical access or linking issues.
Frequently Asked Questions (FAQs)
What is this funding opportunity about?
This opportunity supports a single organization to serve as the Clinical Coordinating Center (CCC) for the Network for Excellence in Neuroscience Clinical Trials (NEXT), a standing clinical trial network designed to rapidly launch well designed exploratory human studies in neuroscience.
Which agency is offering this grant?
The funding opportunity is offered by the National Institute of Neurological Disorders and Stroke (NINDS), which is part of the National Institutes of Health (NIH).
What does NEXT stand for and what is its purpose?
NEXT stands for the Network for Excellence in Neuroscience Clinical Trials. Its purpose is to maintain a ready-to-activate, flexible, and scalable clinical trials network that can quickly move promising neuroscience therapies into exploratory clinical studies.
Is NEXT focused on one specific neurological disease?
No. The network is not built around a single disease. It is intended to be flexible so it can bring in the appropriate clinical experts and trial sites depending on the neurological condition and the trial opportunity.
What is the Clinical Coordinating Center (CCC) expected to do?
The CCC is the operational hub for the clinical side of NEXT. It is expected to support efficient trial start-up and execution across a collection of clinical sites and specialist investigators, and to help the network respond quickly when disease-specific trial opportunities arise.
Are other NEXT components funded under this same announcement?
No. This announcement focuses specifically on the CCC. Separate solicitations cover the Clinical Sites and the Data Coordinating Center (DCC).
What kinds of studies are emphasized under this opportunity?
The emphasis is on multiple, scientifically sound exploratory clinical trials and related clinical research studies. Examples mentioned include Phase 2 clinical trials, as well as studies to validate biomarkers and clinical outcome measures that can support larger, more definitive trials later on.
Can studies be biomarker-informed?
Yes. The announcement explicitly notes that the work may be biomarker-informed and includes studies intended to validate biomarkers and clinical outcome measures.
What stages of clinical research are highlighted?
The opportunity points to exploratory human studies, with examples such as Phase 2 clinical trials, along with measurement and validation studies that strengthen endpoints for subsequent definitive trials.
What neurological populations are included (adult or pediatric)?
Target populations can include adults and/or pediatric participants.
What disease areas are in scope?
The scope broadly covers neurological diseases and conditions rather than a narrow therapeutic area.
How many awards does NIH expect to make?
The opportunity is expected to make one award, meaning a single organization would be selected to serve as the CCC at the national level.
What is the funding mechanism?
The mechanism is a cooperative agreement (U01), which indicates substantial NIH programmatic involvement during the project.
What is the estimated total funding and the award ceiling listed?
The estimated total funding listed is $18,500,000, and the award ceiling provided in the source data is $1,750,000.
Is cost sharing or matching required?
No cost sharing or matching requirement is indicated, so applicants were not required to provide non-federal matching funds as a condition of award.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic organizations and governmental entities, including public and private institutions of higher education; nonprofits (501(c)(3) and non-501(c)(3)); for-profit organizations (including small businesses); and state and local governments (including county, city/township, special district governments, and independent school districts).
Are tribal governments and tribal organizations eligible?
Yes. Eligible applicants include Native American tribal governments and organizations, including federally recognized tribes and other tribal organizations.
Are public housing authorities eligible?
Yes. Public housing authorities/Indian housing authorities are listed as eligible applicants.
Do the eligibility statements include HBCUs, HSIs, and other mission-focused institutions?
Yes. The additional eligibility language includes Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and other community-focused entities such as faith-based or community-based organizations and regional organizations.
Are U.S. territories or possessions included in eligibility?
Yes. The eligibility language includes U.S. territories or possessions.
What is the funding opportunity number (FOA number)?
The FOA number is RFA-NS-11-009.
What is the CFDA number for this opportunity?
The CFDA number is 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
When was this opportunity posted and when did it close?
It was posted on December 7, 2010. The original and current closing date is March 11, 2011.
When was the opportunity archived?
The archive date is April 11, 2011.
Where was the full announcement made available?
The full announcement was made available through the NIH Grants Guide at the link provided in the source information.
Who should be contacted for technical access or linking issues?
NIH Office of Extramural Research (OER) webmaster contacts were supplied for technical access or linking issues.
What is the main deliverable or outcome NEXT is trying to build?
A key deliverable is infrastructure: a robust, standardized, and accessible system that makes it easier to develop protocols and implement studies rapidly across the network.
What is meant by a "standing, ready-to-activate" network?
It means the network is intended to maintain operational readiness so it can quickly mobilize the appropriate experts and sites and start exploratory neuroscience studies without having to build a new network for each disease area.
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