Opportunity Information: Apply for PAR 13 040
Apply for PAR 13 040
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIA Clinical Trial Planning Grant Program (R34)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866 Aging Research.
- This funding opportunity was created on Dec 12, 2012 and posted on Dec 12, 2012.
- Applicants must submit their applications by Jan 7, 2016. (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 $225,000.00 in funding.
- Eligible applicants include: Special district governments Public housing authorities/Indian housing authorities County governments Native American tribal governments (Federally recognized) State governments Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have 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 Private institutions of higher education Small businesses.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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 Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:
The NIA Clinical Trial Planning Grant Program (R34), Funding Opportunity Number PAR-13-040, is a National Institutes of Health discretionary grant designed to fund the up-front planning work that needs to happen before launching a large, complex, or multi-site clinical trial focused on aging. The core idea behind this opportunity is that well-run clinical trials do not begin with recruitment; they begin with rigorous preparation. NIA is using this mechanism to strengthen the quality and feasibility of future trials aimed at finding effective treatments and improving health outcomes for diseases and conditions associated with aging, including disorders affecting neural systems. Rather than paying for the full execution of a clinical trial, this program supports the detailed groundwork required to make the eventual trial scientifically sound, operationally realistic, and ready to implement.
This R34 FOA specifically emphasizes planning activities that reduce the risk of delays, protocol changes, and inconsistent trial conduct once a study goes live. A central expected product is a complete, trial-ready Protocol and a Manual of Procedures (MOP), aligned with recommendations from the NIA Clinical Research Study Investigators Toolbox. In practical terms, applicants are expected to use the planning period to lock down the clinical and statistical design, specify outcomes and measurement approaches, detail operational workflows across sites, and standardize procedures so that each participating location conducts the study the same way. For multi-site trials, this typically includes planning for recruitment and retention strategies, data management and quality assurance plans, safety monitoring approaches, training and certification of study staff, and clear definitions of roles and responsibilities across coordinating centers and clinical sites. The overarching purpose is to ensure the eventual trial is robust, well planned and designed, and well executed, which is especially important in aging research where comorbidities, functional outcomes, and long follow-up periods can complicate trial operations.
From an administrative standpoint, this is a grant (Funding Instrument Type: Grant) in the health activity area, associated with CFDA number 93.866 (Aging Research). The program does not require cost sharing or matching. The listed award ceiling is $225,000, signaling that the budget is intended for planning and development activities rather than the full costs of running the trial itself. The opportunity was posted on December 12, 2012, with an original and final closing date of January 7, 2016, and it was archived on February 7, 2016, meaning it is no longer open for new submissions under that specific announcement, though similar mechanisms may exist under newer FOAs.
Eligibility is broad and includes many U.S.-based organizational types that commonly participate in clinical research. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education, nonprofit organizations (both 501(c)(3) and certain non-501(c)(3) nonprofits), for-profit organizations other than small businesses, and small businesses. It also includes various units of government such as state governments, county governments, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities. Tribal entities are eligible, including federally recognized Native American tribal governments and certain tribal organizations that are not federally recognized, as well as tribally controlled colleges and universities. The FOA also identifies a range of institution types and community-based entities as eligible, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, Asian American Native American Pacific Islander-serving institutions (AANAPISIs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. Foreign institutions are not eligible to apply, and foreign components of U.S. organizations are not allowed, consistent with NIH policy restrictions stated in the announcement.
The sponsoring agency is the National Institutes of Health, with the National Institute on Aging as the institute driving the scientific purpose of the program. The full announcement was hosted through the NIH Grants Guide (linked in the opportunity), and the contact listed for access or technical issues is the NIH Office of Extramural Research (OER) Webmaster. Overall, PAR-13-040 represents a targeted planning mechanism meant to raise the success rate and execution quality of later-stage NIA-funded clinical trials by ensuring that the critical design, protocol finalization, and multi-site operational planning are completed before a trial begins.
FAQs: NIA Clinical Trial Planning Grant Program (R34) - PAR-13-040
What is the NIA Clinical Trial Planning Grant Program (R34) under PAR-13-040?
PAR-13-040 is a National Institutes of Health (NIH) discretionary grant opportunity led by the National Institute on Aging (NIA). It uses the R34 mechanism to fund the up-front planning work needed before launching a large, complex, or multi-site clinical trial focused on aging.
What is the main purpose of this R34 program?
The purpose is to support rigorous trial preparation so that a future clinical trial is scientifically sound, operationally realistic, and ready to implement. The program is designed to reduce the risk of delays, protocol changes, and inconsistent trial conduct after a study goes live.
Does this funding pay for running the clinical trial itself?
No. This program is specifically intended to fund planning and development activities rather than the full execution of a clinical trial.
What kinds of clinical trials is this planning grant intended to support?
It is intended for planning large, complex, or multi-site clinical trials focused on aging, including diseases and conditions associated with aging and disorders affecting neural systems.
What are the expected deliverables from the planning period?
A central expected product is a complete, trial-ready Protocol and a Manual of Procedures (MOP), aligned with recommendations from the NIA Clinical Research Study Investigators Toolbox.
What is a Manual of Procedures (MOP) in this context?
Based on the opportunity description, the MOP is part of the expected trial-ready package and is used to standardize procedures so that each participating location conducts the study the same way, particularly important for multi-site trials.
What planning activities does PAR-13-040 emphasize?
The FOA emphasizes planning activities that help prevent later problems, including finalizing the clinical and statistical design, specifying outcomes and measurement approaches, detailing operational workflows across sites, and standardizing trial conduct.
What additional planning areas are typically included for multi-site trials?
For multi-site trials, the planning period typically includes recruitment and retention strategies, data management and quality assurance plans, safety monitoring approaches, training and certification of study staff, and clear definitions of roles and responsibilities across coordinating centers and clinical sites.
Why does NIA emphasize planning so heavily for aging-related trials?
The opportunity notes that aging research can involve comorbidities, functional outcomes, and long follow-up periods, all of which can complicate trial operations. Rigorous planning is positioned as a way to improve feasibility and execution quality.
What is the funding instrument type for this opportunity?
The funding instrument type is a Grant.
What is the activity area and CFDA number associated with this program?
The activity area is health, and it is associated with CFDA number 93.866 (Aging Research).
Is cost sharing or matching required?
No. The opportunity states that cost sharing or matching is not required.
What is the award ceiling listed for PAR-13-040?
The listed award ceiling is $225,000, reflecting that the budget is meant for planning and development activities rather than running the full trial.
When was this funding opportunity posted, and what were the closing dates?
It was posted on December 12, 2012. The original and final closing date listed is January 7, 2016.
Is PAR-13-040 still open for new submissions?
No. The opportunity was archived on February 7, 2016, which means it is no longer open for new submissions under that specific announcement.
Could similar planning grant opportunities exist even though this one is archived?
Yes. The description notes that while PAR-13-040 is no longer open, similar mechanisms may exist under newer funding opportunity announcements (FOAs).
Who is the sponsoring agency and institute for this opportunity?
The sponsoring agency is the National Institutes of Health (NIH), and the National Institute on Aging (NIA) drives the scientific purpose of the program.
Where was the full announcement hosted?
The full announcement was hosted through the NIH Grants Guide, as referenced in the opportunity description.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organizational types commonly involved in clinical research, including higher education institutions (public/state-controlled and private), nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits), for-profit organizations other than small businesses, and small businesses.
Are government entities eligible to apply?
Yes. Eligible government applicants include state governments, county governments, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities.
Are Tribal entities eligible to apply?
Yes. Eligible applicants include federally recognized Native American tribal governments, certain tribal organizations that are not federally recognized, and tribally controlled colleges and universities.
Are minority-serving institutions and community-based organizations included in eligible applicant types?
Yes. The FOA identifies eligible institution types and community-based entities including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, Asian American Native American Pacific Islander-serving institutions (AANAPISIs), and faith-based or community-based organizations, among others.
Are U.S. territories or possessions eligible?
Yes. The FOA includes U.S. territories or possessions among eligible applicants.
Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply.
Are foreign components of U.S. organizations allowed?
No. The opportunity states that foreign components of U.S. organizations are not allowed, consistent with NIH policy restrictions described in the announcement.
What is the overarching goal of PAR-13-040 according to the description?
The overarching goal is to raise the success rate and execution quality of later-stage NIA-funded clinical trials by ensuring critical design, protocol finalization, and multi-site operational planning are completed before a trial begins.
Who is listed as the contact for access or technical issues related to the announcement?
The contact listed for access or technical issues is the NIH Office of Extramural Research (OER) Webmaster.
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