Opportunity Information: Apply for PAR 09 263
Apply for PAR 09 263
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Ancillary Studies in Clinical Trials of CNS/PNS Disorders NINDS Accelerated Awards Program (R01)" 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 Sep 17, 2009 and posted on Sep 17, 2009.
- Applicants must submit their applications by Aug 16, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Private institutions of higher education Small businesses City or township governments Public and State controlled institutions of higher education For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts State governments Special district governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The funding opportunity titled "Ancillary Studies in Clinical Trials of CNS/PNS Disorders NINDS Accelerated Awards Program (R01)" (Funding Opportunity Number PAR 09-263) is a discretionary grant program issued by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH). Its central goal is to promote and support ancillary studies that are conducted alongside ongoing NINDS-funded clinical trials focused on neurological disorders affecting the central nervous system (CNS) and peripheral nervous system (PNS). In practice, this means the program is meant for research projects that add value to an existing NINDS clinical trial by asking additional, well-justified scientific questions that can be addressed using the trial setting, infrastructure, participants, samples, data streams, or follow-up procedures. The FOA points applicants to NINDS policy language defining "ancillary studies," emphasizing that proposals should clearly fit within that definition and genuinely leverage the parent trial rather than duplicating its primary aims.
This opportunity uses the NIH Research Project Grant (R01) mechanism, which is the standard NIH award structure for investigator-initiated research projects and typically supports a defined set of research aims, a multi-year plan, and a budget appropriate to the work proposed. The "accelerated awards" framing signals an intention to facilitate timely add-on studies that align with active clinical trials, where timing can be critical because enrollment, specimen collection, imaging timepoints, and outcome assessments may already be underway. Because ancillary studies must be coordinated with the parent trial, applicants generally need to show strong integration with the clinical trial leadership and operations, and they should demonstrate that the ancillary work can be executed without compromising the conduct, integrity, or participant safety of the ongoing trial.
Funding levels and the number of awards were not fixed in advance. Instead, awards under this FOA were explicitly dependent on the availability of appropriated funds, and the total number and size of awards would vary based on the scientific merit of applications, the duration of the proposed work, and the reasonableness of requested costs. This structure is typical for NIH FOAs where NINDS wants to maintain flexibility to fund the most compelling proposals rather than committing to a specific set-aside amount.
Eligibility for applicants was broad and included many categories of domestic and non-domestic organizations. Eligible applicants listed in the source information included public and private institutions of higher education, nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities), for-profit organizations (including small businesses and other for-profits), and a wide range of governmental entities (state governments, county governments, city or township governments, special district governments, and independent school districts). The FOA also explicitly included organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, tribal governments (both federally recognized and other than federally recognized, as specified), U.S. territories or possessions, public housing authorities/Indian housing authorities, regional organizations, and faith-based or community-based organizations. Foreign (non-U.S.) entities were also listed as eligible, indicating NINDS was open to supporting ancillary work from international organizations when it is scientifically appropriate and feasible within the structure of an NINDS-funded trial.
Administratively, the opportunity was posted on September 17, 2009, with an original and final closing date of August 16, 2012, and an archive date of September 16, 2012. It falls under the NIH funding activity category of Health and is associated with CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). There was no cost sharing or matching requirement, which aligns with standard NIH research grant practice. For applicants seeking the complete announcement details, NIH provided an official link to the FOA on the NIH Grants Guide, and offered contact points through the NIH Office of Extramural Research (OER) webmaster for access or technical linking issues.
FAQs: Ancillary Studies in Clinical Trials of CNS/PNS Disorders (NINDS Accelerated Awards Program, R01) - PAR 09-263
What is the purpose of this funding opportunity?
This NINDS funding opportunity supports ancillary studies that run alongside ongoing NINDS-funded clinical trials in neurological disorders affecting the central nervous system (CNS) and peripheral nervous system (PNS). The intent is to fund add-on research questions that can be answered by leveraging the parent trial's participants, infrastructure, specimens, data collection, assessments, or follow-up schedule.
What is meant by an "ancillary study" in this FOA?
An ancillary study is a scientifically justified project that is distinct from, but integrated with, an existing NINDS-funded clinical trial. The proposed work should clearly fit NINDS policy language on ancillary studies, and it should genuinely leverage the parent trial rather than duplicate or restate the parent trial's primary aims.
What type of award mechanism does this program use?
This opportunity uses the NIH Research Project Grant (R01) mechanism. The R01 is the standard NIH award structure for investigator-initiated research projects, typically supporting a defined set of research aims, a multi-year research plan, and a budget appropriate for the proposed work.
What does "Accelerated Awards Program" mean in this context?
The accelerated framing reflects the need for timely add-on studies that align with active clinical trials. Timing can be critical because enrollment, specimen collection, imaging timepoints, outcome assessments, and follow-up activities may already be underway in the parent trial.
What kinds of clinical trials are eligible as the parent trial?
The ancillary study must be conducted alongside an ongoing clinical trial that is funded by NINDS and focused on disorders of the CNS and/or PNS. The ancillary project is expected to use the parent trial setting or resources in a way that adds value beyond the parent trial's primary objectives.
How should an applicant show that the ancillary study is integrated with the parent trial?
Because ancillary studies must be coordinated with the parent trial, applications are expected to demonstrate strong integration with the clinical trial leadership and operations. The proposal should also show that the ancillary activities can be carried out without compromising the conduct, integrity, or participant safety of the ongoing trial.
Can the ancillary study use the parent trial's participants, samples, or data?
Yes. The FOA specifically contemplates ancillary studies that use the parent trial's participants, samples/specimens, data streams, trial infrastructure, timepoints, and/or follow-up procedures, as long as the ancillary study is well-justified and fits the definition of an ancillary study.
Does this FOA allow studies that duplicate the parent trial's aims?
No. The FOA emphasizes that the ancillary proposal should leverage the parent trial and should not duplicate the parent trial's primary aims. Applicants are expected to clarify how the ancillary study is distinct while still being meaningfully connected to the parent clinical trial.
Is there a fixed amount of funding available or a guaranteed number of awards?
No. The FOA did not set a fixed number of awards or a fixed total funding level. Awards were dependent on the availability of appropriated funds, and the number and size of awards could vary.
What factors influence award size and the number of awards made?
The FOA indicates that awards would vary based on the availability of funds, the scientific merit of applications, the duration of the proposed work, and the reasonableness of the requested costs.
Is cost sharing or matching required?
No. The FOA states that there is no cost sharing or matching requirement, consistent with standard NIH research grant practice for this type of opportunity.
Who is the issuing agency and what NIH institute runs this program?
The program is a discretionary grant opportunity issued by the National Institute of Neurological Disorders and Stroke (NINDS), which is part of the National Institutes of Health (NIH).
What is the Funding Opportunity Number?
The Funding Opportunity Number is PAR 09-263.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
What is the NIH funding activity category for this FOA?
The NIH funding activity category listed for this opportunity is Health.
When was this opportunity posted, and what were the closing dates?
The opportunity was posted on September 17, 2009. The original closing date and the final closing date were both August 16, 2012. The archive date was September 16, 2012.
What organizations are eligible to apply?
Eligibility is broad and includes public and private institutions of higher education; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (including small businesses and other for-profits); and governmental entities such as state, county, city or township governments, special district governments, and independent school districts.
Are minority-serving institutions and tribal organizations included in eligibility?
Yes. The FOA explicitly includes organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, tribal governments (federally recognized and other than federally recognized, as specified), and other listed community-based or regional entities.
Are U.S. territories and certain housing authorities eligible applicants?
Yes. The FOA lists U.S. territories or possessions as eligible, and it also includes public housing authorities/Indian housing authorities among eligible applicant types.
Are faith-based and community-based organizations eligible?
Yes. The FOA explicitly includes faith-based and community-based organizations among the eligible applicant categories.
Can non-U.S. (foreign) organizations apply?
Yes. Foreign (non-U.S.) entities were listed as eligible applicants, indicating NINDS was open to supporting ancillary work from international organizations when scientifically appropriate and feasible within the structure of an NINDS-funded trial.
Where can applicants find the official full announcement?
NIH provided an official link to the FOA on the NIH Grants Guide for complete announcement details.
Who should be contacted for access or technical issues related to the FOA link?
The FOA indicates that contact points were available through the NIH Office of Extramural Research (OER) webmaster for access or technical linking issues.
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