Opportunity Information: Apply for PAR 13 002
Apply for PAR 13 002
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NHLBI Clinical Trial Pilot Studies (R34)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233 National Center on Sleep Disorders Research 93.837 Cardiovascular Diseases Research 93.838 Lung Diseases Research 93.839 Blood Diseases and Resources Research.
- This funding opportunity was created on Oct 2, 2012 and posted on Oct 2, 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: Public and State controlled institutions of higher education For profit organizations other than small businesses County governments Public housing authorities/Indian housing authorities Special district governments Small businesses City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education 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 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 NHLBI Clinical Trial Pilot Studies (R34) opportunity (Funding Opportunity Number PAR-13-002) was a National Institutes of Health discretionary grant program designed to support short, targeted pilot studies that generate the specific evidence investigators need to plan a strong, full-scale clinical trial. The core purpose of this FOA was to help applicants close critical knowledge gaps that would otherwise make a definitive trial proposal premature or uncompetitive. Rather than funding an entire clinical trial, the R34 mechanism was positioned as a stepping-stone: it supported focused preparatory work that directly strengthens the rationale, methods, and operational plan for a later, larger investigator-initiated clinical trial application aimed at preventing or treating heart, lung, blood, or sleep disorders.
The FOA emphasized that proposed pilot work had to produce practical, decision-making data for trial design. Examples of appropriate pilot objectives included demonstrating feasibility of recruitment, retention, adherence, or intervention delivery; testing aspects of the experimental design; estimating intervention parameters (such as dose, intensity, frequency, or implementation steps); refining outcome measures or timing; evaluating variability to inform power and sample size assumptions; and collecting other information that materially improves the rigor and credibility of a future full-scale trial. In other words, the pilot study needed to answer real uncertainties that could derail or weaken a later trial if left unresolved. A key expectation was that the pilot would be both necessary and sufficient to enable the next step: a well-justified, well-designed clinical trial application.
At the same time, the announcement drew a clear line around what it would not support. Applications that only proposed writing a protocol, producing a manual of operations, or building general trial infrastructure without generating the pilot data needed for trial design were explicitly considered inappropriate for this FOA. The intent was to fund empirical work, not purely administrative preparation. Reviewers were instructed to assess whether the proposed pilot activities truly filled essential gaps and whether the resulting data would realistically position the investigators to propose a robust, full-scale clinical trial immediately after the R34 period.
An additional feature of the review approach was that, beyond judging the pilot study itself, the review group would also consider the importance and potential public health impact of the larger clinical trial the pilot was meant to enable. This meant applicants needed to articulate not only a compelling pilot plan, but also a credible vision for the eventual definitive trial, including why that future trial would matter for clinical practice and population health in the NHLBI mission areas.
From an administrative standpoint, the program was offered as a grant funding instrument in the health research activity category and aligned with multiple CFDA listings relevant to NHLBI priorities, including sleep disorders research (93.233) and research on cardiovascular diseases (93.837), lung diseases (93.838), and blood diseases and resources (93.839). The listed award ceiling was $225,000, and there was no cost-sharing or matching requirement.
Eligibility was broad across U.S.-based organizations and governments, spanning public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits), for-profit organizations (including small businesses and other for-profits), and various governmental entities (state, county, city/township, special district). The FOA also explicitly included a range of mission-relevant and capacity-building institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, and U.S. territories or possessions. Foreign institutions were not eligible to apply, non-U.S. components of U.S. organizations were not eligible, and foreign components (as defined by NIH policy) were not allowed, keeping the work fully domestic in scope.
In terms of timing and status, the opportunity was posted on October 2, 2012, with an original and current closing date of January 7, 2016, and an archive date of February 7, 2016, indicating it is no longer an active solicitation. The full announcement was historically available through the NIH grants guide at the link provided in the source, and NIH’s Office of Extramural Research webmaster contacts were listed for technical access issues.
FAQs: NHLBI Clinical Trial Pilot Studies (R34) - PAR-13-002
What is the NHLBI Clinical Trial Pilot Studies (R34) opportunity (PAR-13-002)?
PAR-13-002 was a National Institutes of Health (NIH) discretionary grant funding opportunity from the National Heart, Lung, and Blood Institute (NHLBI) that supported short, targeted pilot studies. The goal was to generate specific evidence investigators need in order to plan a strong, full-scale, investigator-initiated clinical trial focused on preventing or treating heart, lung, blood, or sleep disorders.
What was the main purpose of this R34 funding opportunity?
The core purpose was to help applicants close critical knowledge gaps that would make a definitive clinical trial application premature or uncompetitive. The R34 was designed as a stepping-stone that funded focused preparatory empirical work to strengthen the rationale, methods, and operational plan for a later, larger clinical trial application.
Did this FOA fund full-scale clinical trials?
No. The R34 mechanism under this FOA was not intended to fund an entire clinical trial. It supported pilot work that directly informed and improved the design and feasibility of a future full-scale clinical trial.
What kinds of pilot objectives were considered appropriate?
Appropriate pilot objectives were those that produced practical, decision-making data for trial design, such as:
- Demonstrating feasibility of recruitment
- Demonstrating feasibility of retention
- Assessing participant adherence
- Testing intervention delivery procedures
- Testing aspects of the experimental design
- Estimating intervention parameters (dose, intensity, frequency, or implementation steps)
- Refining outcome measures or the timing of assessments
- Evaluating variability to inform power and sample size assumptions
- Collecting other information that materially improves the rigor and credibility of a future full-scale trial
What was the FOA expecting the pilot study to accomplish by the end of the project?
A key expectation was that the pilot would be both necessary and sufficient to enable the next step: submitting a well-justified, well-designed clinical trial application immediately after the R34 period. In practice, that meant the pilot needed to resolve real uncertainties that could otherwise derail or weaken the later definitive trial.
What types of activities were explicitly not supported under this FOA?
The FOA drew a clear boundary around ineligible approaches. Applications were considered inappropriate if they only proposed administrative or preparatory tasks without generating pilot data needed for trial design. Examples explicitly described as inappropriate included:
- Only writing a protocol
- Only producing a manual of operations
- Only building general trial infrastructure without collecting pilot data that informs trial design
How were applications reviewed beyond the pilot study itself?
Reviewers were instructed to evaluate not only whether the pilot study filled essential gaps, but also whether the resulting data would realistically position investigators to propose a robust, full-scale clinical trial after the R34 period. In addition, the review group would consider the importance and potential public health impact of the larger clinical trial that the pilot was intended to enable.
Why did applicants need to describe the future full-scale trial?
Because the review approach considered the importance and potential public health impact of the eventual definitive trial, applicants needed to present a credible vision for that later trial and explain why it would matter for clinical practice and population health within NHLBI mission areas.
What research areas were within scope for this program?
The program was aimed at supporting pilot work that would enable future clinical trials to prevent or treat disorders within NHLBI mission areas: heart, lung, blood, and sleep disorders.
What was the maximum award amount listed for this opportunity?
The listed award ceiling for this FOA was $225,000.
Was cost-sharing or matching required?
No. The FOA indicated there was no cost-sharing or matching requirement.
What type of funding instrument and activity category did this program use?
It was offered as a grant funding instrument in the health research activity category.
Which CFDA program areas were referenced as relevant to this opportunity?
The FOA aligned with multiple CFDA listings tied to NHLBI priorities, including:
- 93.233 (sleep disorders research)
- 93.837 (research on cardiovascular diseases)
- 93.838 (lung diseases research)
- 93.839 (blood diseases and resources)
Who was eligible to apply?
Eligibility was broad across U.S.-based organizations and governments, including:
- Public and private institutions of higher education
- Nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits)
- For-profit organizations (including small businesses and other for-profits)
- Governmental entities (state, county, city/township, special district)
- U.S. territories or possessions
Did the FOA specifically name any institution types as included?
Yes. The FOA explicitly included a range of mission-relevant and capacity-building institution types, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations.
Were foreign institutions eligible to apply?
No. Foreign institutions were not eligible to apply.
Could a U.S. organization include a non-U.S. component or foreign component?
No. Non-U.S. components of U.S. organizations were not eligible, and foreign components (as defined by NIH policy) were not allowed. The FOA kept the work fully domestic in scope.
When was this funding opportunity posted, and is it still active?
The opportunity was posted on October 2, 2012. Its original and current closing date was January 7, 2016, and its archive date was February 7, 2016. Based on these dates, it is no longer an active solicitation.
Where was the full announcement historically available?
The full announcement was historically available through the NIH grants guide at the link provided in the source information for the opportunity.
Who was listed for technical access issues related to the announcement?
NIH Office of Extramural Research webmaster contacts were listed for technical access issues.
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