Opportunity Information: Apply for PAR 10 185
Apply for PAR 10 185
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAID Clinical Trial Planning Grant (R34)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy, Immunology and Transplantation Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on May 5, 2010 and posted on May 5, 2010.
- Applicants must submit their applications by Jan 14, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Private institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) State governments Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public housing authorities/Indian housing authorities County governments 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 For profit organizations other than small businesses Public and State controlled institutions of higher education Small businesses.
- 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 NIAID Clinical Trial Planning Grant (R34), Funding Opportunity Number PAR-10-185, is a National Institutes of Health discretionary grant opportunity designed to fund the up-front work needed to get an investigator-initiated clinical trial fully ready to launch. Rather than paying for the conduct of the clinical trial itself, this FOA focuses on the complete planning, design, and assembly of the core materials and documentation that must be in place before a trial can be implemented. The proposed trial must be hypothesis-driven, structured around clearly defined milestones, aligned with the scientific mission of the National Institute of Allergy and Infectious Diseases (NIAID), and judged by NIAID to be a high-priority area for the Institute. Applicants are pointed to NIAID's planning priorities webpage for guidance on topics and research areas considered within scope.
This opportunity uses the NIH R34 clinical trial planning mechanism and is explicitly linked to two companion announcements that support the next step, meaning the actual implementation of investigator-initiated trials. Those parallel FOAs are PAR-10-184 (implementation for non-high-risk trials) and PAR-10-186 (implementation for high-risk trials). A key operational requirement is that NIAID pre-approval is mandatory before an application can be submitted under any of these three FOAs. In practice, that means investigators should expect to engage NIAID program staff early to confirm that the planned clinical trial concept fits NIAID priorities and that the application is appropriate for the R34 planning pathway.
The FOA sits in NIH health-related research funding and is associated with CFDA numbers 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research). There is no cost sharing or matching requirement. The announcement was posted May 5, 2010, with an original and current closing date of January 14, 2013, and an archive date of February 14, 2013, meaning it is a historical opportunity rather than an active open solicitation today.
Eligibility is broad and includes many common applicant types across academia, government, nonprofit, and industry. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with or without 501(c)(3) status (other than institutions of higher education), for-profit organizations other than small businesses, and small businesses. Government entities at multiple levels are eligible, including state governments, county governments, city or township governments, special district governments, and certain housing authorities including public housing authorities and Indian housing authorities. The FOA also lists a range of additional eligible entities such as federally recognized Native American tribal governments, other tribal organizations, tribally controlled colleges and universities, historically black colleges and universities, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, faith-based and community-based organizations, U.S. territories or possessions, and even non-U.S. (foreign) organizations and regional organizations, along with eligible federal agencies.
Funding levels and the anticipated number of awards are not set as fixed targets in the announcement. Instead, NIAID indicates that the total amount awarded and the number of awards will depend on the volume of applications received and, importantly, their quality, proposed duration, and overall costs. For applicants, this signals that budgets and timelines need to be well-justified and right-sized to the planning work being proposed, with clear deliverables and milestone-based progress.
In short, PAR-10-185 supports the practical and regulatory-ready planning package for high-priority, hypothesis-driven NIAID-relevant clinical trials, serving as a bridge between a strong scientific trial concept and a subsequent application to fund trial execution. The full archived announcement is available via NIH at http://grants.nih.gov/grants/guide/pa-files/PAR-10-185.html, and NIH provides standard support contacts for access or linking issues through the NIH Office of Extramural Research webmaster.
FAQs: NIAID Clinical Trial Planning Grant (R34) - PAR-10-185
What is PAR-10-185 (NIAID Clinical Trial Planning Grant R34)?
PAR-10-185 is a National Institutes of Health (NIH) discretionary funding opportunity from the National Institute of Allergy and Infectious Diseases (NIAID) that supports the up-front planning work needed to get an investigator-initiated clinical trial ready to launch. It uses the NIH R34 clinical trial planning grant mechanism.
What does this grant pay for?
This opportunity funds planning, design, and assembly of the core materials and documentation required before a clinical trial can be implemented. The focus is on producing a complete, regulatory-ready planning package rather than paying for the conduct of the clinical trial itself.
Does this grant fund the actual conduct (implementation) of the clinical trial?
No. PAR-10-185 is explicitly for clinical trial planning and preparation. It is not intended to support enrollment, intervention delivery, or other activities associated with running the trial.
What kind of clinical trial concept is expected to be supported?
The proposed trial must be hypothesis-driven, aligned with NIAID's scientific mission, structured around clearly defined milestones, and considered by NIAID to be a high-priority area for the Institute.
How do I know if my trial topic is within NIAID priorities?
The announcement points applicants to NIAID's planning priorities webpage for guidance on the topics and research areas considered within scope. In addition, investigators are expected to consult NIAID program staff early (see the pre-approval requirement) to confirm fit with NIAID priorities.
Is NIAID pre-approval required before submitting an application?
Yes. NIAID pre-approval is mandatory before an application can be submitted under PAR-10-185.
When should investigators contact NIAID program staff?
Investigators should expect to engage NIAID program staff early to confirm that the planned clinical trial concept fits NIAID priorities and that the application is appropriate for the R34 clinical trial planning pathway.
Are there related funding opportunities for actually implementing the trial after planning?
Yes. PAR-10-185 is explicitly linked to two companion announcements that support implementation (the next step after planning): PAR-10-184 (implementation for non-high-risk trials) and PAR-10-186 (implementation for high-risk trials).
Does the FOA distinguish between high-risk and non-high-risk trials for implementation?
Yes. Implementation is supported under different companion FOAs depending on risk level: PAR-10-184 for non-high-risk trials and PAR-10-186 for high-risk trials.
Is pre-approval required for the companion implementation FOAs as well?
Yes. The operational requirement stated is that NIAID pre-approval is mandatory before an application can be submitted under any of the three FOAs (PAR-10-185, PAR-10-184, and PAR-10-186).
What are the CFDA numbers associated with this opportunity?
The FOA is associated with CFDA 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research).
Is there a cost sharing or matching requirement?
No. The announcement states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is broad and includes many applicant types across academia, government, nonprofit, and industry. Eligible applicants include public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and multiple levels of government entities.
Are small businesses eligible to apply?
Yes. Small businesses are listed as eligible applicants.
Are for-profit organizations eligible to apply?
Yes. For-profit organizations other than small businesses are listed as eligible applicants, and small businesses are also eligible.
Are nonprofit organizations eligible to apply?
Yes. Nonprofits with or without 501(c)(3) status (other than institutions of higher education) are listed as eligible applicants.
Are colleges and universities eligible to apply?
Yes. Both public/state-controlled institutions of higher education and private institutions of higher education are listed as eligible applicants.
Are government entities eligible to apply?
Yes. The FOA lists eligible government entities at multiple levels, including state governments, county governments, city or township governments, special district governments, and certain housing authorities (including public housing authorities and Indian housing authorities). Eligible federal agencies are also listed.
Are tribal governments and tribal organizations eligible to apply?
Yes. Federally recognized Native American tribal governments, other tribal organizations, and tribally controlled colleges and universities are included among eligible entities.
Are minority-serving institutions eligible to apply?
Yes. The FOA lists historically black colleges and universities (HBCUs), Hispanic-serving institutions, and Alaska Native and Native Hawaiian-serving institutions among eligible entities.
Are faith-based and community-based organizations eligible to apply?
Yes. Faith-based and community-based organizations are listed as eligible entities.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are listed among eligible entities.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. Non-U.S. (foreign) organizations and regional organizations are listed as eligible entities.
How much funding is available, and how many awards will be made?
The FOA does not set fixed targets for either funding levels or the anticipated number of awards. NIAID indicates that the total amount awarded and the number of awards will depend on the volume of applications received and their quality, proposed duration, and overall costs.
What does the FOA imply about budgeting and timelines?
Because award amounts and counts depend on quality, duration, and costs, applicants should propose well-justified budgets and timelines that are right-sized to the planning work, with clear deliverables and milestone-based progress.
What is the submission window and current status of this opportunity?
The announcement was posted on May 5, 2010. The original and current closing date listed is January 14, 2013, and the archive date is February 14, 2013. This indicates it is a historical opportunity rather than an active open solicitation today.
Where can I find the full archived FOA text?
The full archived announcement is available through NIH at: http://grants.nih.gov/grants/guide/pa-files/PAR-10-185.html
Who do I contact if I have trouble accessing the FOA link or have linking issues?
NIH provides standard support contacts for access or linking issues through the NIH Office of Extramural Research webmaster.
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