Opportunity Information: Apply for PAR 16 269
Apply for PAR 16 269
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "NIAID Clinical Trial Implementation Grant (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855, 93.856,.
- This funding opportunity was created on May 18, 2016 and posted on May 18, 2016.
- Applicants must submit their applications by May 13, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The NIAID Clinical Trial Implementation Grant (R01), funding opportunity number PAR 16 269, is a discretionary federal grant program administered by the National Institutes of Health (NIH) under the U.S. Department of Health and Human Services (HHS), specifically associated with the National Institute of Allergy and Infectious Diseases (NIAID). The purpose of this Funding Opportunity Announcement (FOA) is to support the implementation of investigator-initiated clinical trials that are not considered high risk. In practical terms, it is designed for researchers who already have a well-developed, hypothesis-driven clinical trial concept and are ready to carry it out, rather than for exploratory or preliminary planning work. The trial must align with NIAID's research mission and must be viewed as a high priority area for the Institute, and applicants are directed to NIAID's planning priorities webpage to confirm that alignment.
A central feature of the announcement is that it targets hypothesis-driven clinical trials, meaning the proposed study should be structured around clearly defined scientific questions and testable hypotheses, with rigorous methods and endpoints that can answer those questions. The FOA emphasizes that supported trials should be "investigator-initiated," indicating they are conceived and led by the applicant rather than being a predesigned government-run protocol. At the same time, the trials must be "non-high-risk," which generally signals that the Institute is looking for studies where the overall risk profile is manageable and appropriate for this mechanism, as opposed to trials involving especially novel, uncertain, or potentially hazardous interventions that may require different oversight or specialized funding approaches.
The FOA places an important constraint on application structure: only one clinical trial may be proposed per R01 application under this announcement. That means applicants cannot bundle multiple distinct clinical trials into a single submission; they must select one trial and present a complete implementation plan for that single study. This requirement helps keep the scope focused and makes it easier for reviewers and the Institute to evaluate feasibility, scientific impact, and alignment with NIAID priorities.
Eligibility is broad and includes many types of organizations that can sponsor or conduct clinical research. Eligible applicants listed include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized as governments; public housing authorities and Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status (excluding those that are institutions of higher education in the specified categories); for-profit organizations other than small businesses; and small businesses. The announcement also includes an "Others" category with additional eligibility clarification referenced in the full text of the FOA, signaling that some additional applicant types may be permitted depending on NIH policy and the specific language in the complete solicitation.
From an administrative standpoint, the opportunity is categorized under the Health funding activity category and references CFDA (now commonly referred to through assistance listing) numbers 93.855 and 93.856, which correspond to NIH/NIAID program areas. The FOA was posted and created on May 18, 2016, and lists a closing date of May 13, 2019 (with the original and current closing date shown as the same). The summary information provided does not specify an award ceiling or the expected number of awards, which typically means applicants would need to consult the full FOA and NIH budget guidance to understand typical budget ranges, limits, and competitive award volumes for this mechanism.
Overall, this grant opportunity is best read as an NIH R01 pathway specifically intended to fund the execution phase of a single, well-justified, NIAID-mission-relevant clinical trial that is scientifically rigorous, hypothesis-driven, and appropriate for a non-high-risk implementation framework. Applicants are expected to demonstrate both scientific merit and strong alignment with NIAID high-priority research areas, using the Institute's published priorities as a guide when shaping and positioning the proposed trial.
FAQs: NIAID Clinical Trial Implementation Grant (R01) - PAR 16-269
What is the NIAID Clinical Trial Implementation Grant (R01) opportunity?
It is a discretionary federal grant program administered by the National Institutes of Health (NIH) under the U.S. Department of Health and Human Services (HHS), and it is specifically associated with the National Institute of Allergy and Infectious Diseases (NIAID). The funding opportunity number is PAR 16-269.
What is the main purpose of this Funding Opportunity Announcement (FOA)?
The FOA is intended to support the implementation of investigator-initiated clinical trials that are not considered high risk. It is designed for applicants who already have a well-developed, hypothesis-driven clinical trial concept and are ready to carry out the trial.
Is this FOA intended for early-stage planning or exploratory work?
No. The description emphasizes that the opportunity is for researchers who are ready to implement a clinical trial, rather than for exploratory studies or preliminary planning work.
What does "investigator-initiated" mean in this FOA?
"Investigator-initiated" indicates the clinical trial is conceived and led by the applicant, rather than being a predesigned, government-run protocol.
What kind of clinical trials does this FOA prioritize?
The FOA targets hypothesis-driven clinical trials. The proposed study should be structured around clearly defined scientific questions and testable hypotheses, with rigorous methods and endpoints capable of answering those questions.
What does "non-high-risk" mean in the context of this grant?
The summary indicates NIAID is looking for trials where the overall risk profile is manageable and appropriate for this R01 mechanism, as opposed to trials involving especially novel, uncertain, or potentially hazardous interventions that may require different oversight or specialized funding approaches.
Do proposed trials need to align with NIAID priorities?
Yes. The clinical trial must align with NIAID's research mission and must be viewed as a high priority area for the Institute. Applicants are directed to consult NIAID's planning priorities webpage to confirm alignment.
How many clinical trials can be included in a single R01 application under PAR 16-269?
Only one clinical trial may be proposed per R01 application under this announcement. Applicants cannot bundle multiple distinct clinical trials into a single submission.
Why does the FOA limit applications to one clinical trial per submission?
The provided summary explains that this requirement helps keep the scope focused and makes it easier for reviewers and the Institute to evaluate feasibility, scientific impact, and alignment with NIAID priorities.
Who is eligible to apply?
Eligibility is broad and includes many organization types that can sponsor or conduct clinical research. The listed eligible applicants include:
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Native American tribal organizations (other than federally recognized tribal governments)
- Public housing authorities and Indian housing authorities
- Nonprofits with 501(c)(3) status (excluding institutions of higher education in the specified categories)
- Nonprofits without 501(c)(3) status (excluding institutions of higher education in the specified categories)
- For-profit organizations (other than small businesses)
- Small businesses
The eligibility section mentions an "Others" category. What does that mean?
The summary notes an "Others" category with additional eligibility clarification referenced in the full text of the FOA. This suggests additional applicant types may be permitted depending on NIH policy and the specific language in the complete solicitation.
What is the funding activity category for this opportunity?
The opportunity is categorized under the Health funding activity category.
Are there CFDA or Assistance Listing numbers associated with this FOA?
Yes. The summary references CFDA numbers 93.855 and 93.856 (commonly referred to now as Assistance Listing numbers), which correspond to NIH/NIAID program areas.
When was PAR 16-269 posted?
The FOA was posted (and created) on May 18, 2016.
What is the closing date for this FOA?
The summary lists a closing date of May 13, 2019, and indicates the original and current closing date are the same.
Does the summary provide an award ceiling or expected number of awards?
No. The summary information provided does not specify an award ceiling or the expected number of awards. It indicates applicants would typically need to consult the full FOA and NIH budget guidance for details such as typical budget ranges, limits, and competitive award volumes for this mechanism.
What stage of work should an applicant be prepared to describe in the application?
The summary frames this as an execution/implementation-phase opportunity. Applicants should be prepared to present a complete implementation plan for a single clinical trial, demonstrating scientific rigor, feasibility, and alignment with NIAID mission priorities.
In one sentence, what is this grant best suited for?
This R01 opportunity is best suited for funding the execution phase of a single, well-justified, NIAID-mission-relevant clinical trial that is hypothesis-driven, scientifically rigorous, and appropriate for a non-high-risk implementation framework.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 16 269) also looked into and applied for these:
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| Partnerships for Structure-Based Design of Novel Immunogens for Vaccine Development (R01) Apply for RFA AI 16 047 Funding Number: RFA AI 16 047 Agency: HHS-NIH11 Category: Health Funding Amount: Case Dependent |
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| Systems Approach to Immunity and Inflammation (U19) Apply for RFA AI 16 050 Funding Number: RFA AI 16 050 Agency: HHS-NIH11 Category: Health Funding Amount: $1,500,000 |
| Limited Interaction Targeted Epidemiology (LITE) to Advance HIV Prevention (UG3/UH3) Apply for RFA AI 16 031 Funding Number: RFA AI 16 031 Agency: HHS-NIH11 Category: Health Funding Amount: Case Dependent |
| HIV/AIDS Vaccine Facility (C06) Apply for PAR 16 290 Funding Number: PAR 16 290 Agency: HHS-NIH11 Category: Health Funding Amount: Case Dependent |
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