Opportunity Information: Apply for PAR 13 150

  • 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 and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
  • This funding opportunity was created on Mar 22, 2013 and posted on Mar 22, 2013.
  • Applicants must submit their applications by Jan 13, 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 $150,000.00 in funding.
  • Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) State governments Native American tribal governments (Federally recognized) City or township governments Independent school districts Public housing authorities/Indian housing authorities Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education For profit organizations other than 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:

The NIAID Clinical Trial Planning Grant (R34) (Funding Opportunity Number PAR-13-150) is a National Institutes of Health funding opportunity from the National Institute of Allergy and Infectious Diseases designed specifically to support the up-front work required to launch an investigator-initiated clinical trial. Rather than paying for the clinical trial itself, this mechanism focuses on the complete planning, design, and preparation activities needed so a trial can be implemented efficiently and responsibly. The FOA emphasizes that proposed trials must be hypothesis-driven, built around clear, milestone-defined development steps, and aligned with NIAID's research mission in allergy, immunology, and infectious diseases. NIAID also signals that projects should fall within areas the Institute considers high priority, and it directs applicants to review NIAID planning priorities and mission materials on the Institute's website to ensure a strong programmatic fit.

The grant sits in the NIH "Health" activity category and is associated with CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). It is a discretionary grant program with no cost-sharing or matching requirement, meaning applicants are not required to contribute non-federal funds as a condition of the award. The award ceiling listed for this opportunity is $150,000, indicating the maximum amount that can be requested under the announcement as posted. In practical terms, applicants would use these funds to develop the essential building blocks of a compliant and fundable clinical trial package, such as finalizing the protocol and statistical analysis plan, establishing recruitment and retention approaches, preparing case report forms and data management plans, clarifying operational logistics across sites (if multi-site), planning safety monitoring and oversight, addressing regulatory and ethical requirements, and producing other documentation that would be needed before enrolling participants.

Eligibility is broad and intentionally inclusive across many organization types. Eligible applicants include federal, state, county, and local government entities; Native American tribal governments and tribal organizations (both federally recognized and other than federally recognized, as specified); public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; small businesses; and for-profit organizations (other than small businesses). The eligibility section further highlights a wide range of mission-driven and underserved-serving institutions and organizations that may apply, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), as well as faith-based and community-based organizations. Importantly, non-U.S. entities are also eligible: foreign organizations and foreign institutions may apply, non-U.S. components of U.S. organizations are eligible, and foreign components as defined by the NIH Grants Policy Statement are allowed. This structure makes the announcement relevant to both domestic and global health research teams, provided the proposed clinical trial planning effort fits NIAID priorities.

Key dates show the opportunity was posted and created on March 22, 2013, with an original and final closing date of January 13, 2016, and an archive date of February 13, 2016. That means the specific announcement is no longer accepting applications, but it remains a useful reference for understanding how NIAID frames and supports clinical trial planning through the R34 mechanism. For applicants looking for the full details, NIH provided an official Additional Information link to the archived FOA on the NIH Grants Guide, which would include the complete requirements, review criteria, and any special instructions that were in effect during the active period. Contact details in the listing point to the NIH Office of Extramural Research (OER) webmaster emails for technical issues accessing or linking to the announcement.

FAQs: NIAID Clinical Trial Planning Grant (R34) - PAR-13-150

What is the NIAID Clinical Trial Planning Grant (R34) under PAR-13-150?

It is a National Institutes of Health (NIH) funding opportunity from the National Institute of Allergy and Infectious Diseases (NIAID) intended to support the up-front work needed to plan an investigator-initiated clinical trial. The focus is on planning, design, and preparation activities rather than paying for the clinical trial itself.

What is the Funding Opportunity Number (FOA) for this grant?

The Funding Opportunity Number is PAR-13-150.

What is the main purpose of this R34 opportunity?

The purpose is to fund the complete planning and preparation work required so a clinical trial can be implemented efficiently and responsibly. This includes developing the essential documentation and operational plans needed before participant enrollment.

Does this grant pay for conducting the clinical trial?

No. The opportunity is designed to support clinical trial planning and preparation, not the clinical trial itself.

What kinds of activities are typically supported with these planning funds?

Examples of supported planning activities include finalizing the clinical trial protocol and statistical analysis plan, developing recruitment and retention approaches, preparing case report forms, building data management plans, clarifying operational logistics (including multi-site logistics if applicable), planning safety monitoring and oversight, addressing regulatory and ethical requirements, and producing other documentation needed before enrolling participants.

What does NIAID emphasize about the type of trials proposed?

NIAID emphasizes that proposed trials must be hypothesis-driven, built around clear development steps defined by milestones, and aligned with NIAID's research mission in allergy, immunology, and infectious diseases.

How important is alignment with NIAID priorities?

Programmatic fit is highlighted as important. NIAID signals that projects should fall within areas the Institute considers high priority and directs applicants to review NIAID planning priorities and mission materials on the Institute's website to ensure strong alignment.

What NIH activity category is associated with this opportunity?

The activity category listed is "Health."

Which CFDA numbers are associated with this grant?

This opportunity is associated with CFDA 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).

Is cost-sharing or matching required?

No. It is listed as a discretionary grant program with no cost-sharing or matching requirement, meaning applicants are not required to contribute non-federal funds as a condition of the award.

What is the maximum award amount listed for this opportunity?

The award ceiling listed is $150,000, which indicates the maximum amount that could be requested under the announcement as posted.

Who is eligible to apply?

Eligibility is broad and includes federal, state, county, and local government entities; Native American tribal governments and tribal organizations (including federally recognized and other than federally recognized, as specified); public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; small businesses; and for-profit organizations (other than small businesses).

Are specific institution types (like HBCUs or Hispanic-serving institutions) mentioned as eligible?

Yes. The listing highlights that a wide range of mission-driven and underserved-serving institutions and organizations may apply, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), as well as faith-based and community-based organizations.

Are foreign (non-U.S.) organizations eligible to apply?

Yes. Foreign organizations and foreign institutions may apply. The listing also states that non-U.S. components of U.S. organizations are eligible and that foreign components (as defined by the NIH Grants Policy Statement) are allowed.

Does this opportunity support global health research teams?

It can be relevant to both domestic and global health research teams because non-U.S. entities and foreign components are allowed, provided the clinical trial planning effort fits NIAID priorities in allergy, immunology, and infectious diseases.

When was this funding opportunity posted and when did it close?

The opportunity was posted and created on March 22, 2013. The original and final closing date listed was January 13, 2016.

Is this FOA currently accepting applications?

No. The listing indicates an archive date of February 13, 2016, which means the specific announcement is no longer accepting applications.

Why might this archived announcement still be useful?

Even though it is archived, it can be a useful reference for understanding how NIAID frames and supports clinical trial planning through the R34 mechanism, including the types of planning activities and expectations emphasized in the announcement.

Where can someone find the full official details for this opportunity?

NIH provided an official Additional Information link to the archived FOA on the NIH Grants Guide. That source would include complete requirements, review criteria, and any special instructions that were in effect during the active period.

Who is listed as a contact for technical issues related to accessing or linking to the announcement?

Contact details in the listing point to the NIH Office of Extramural Research (OER) webmaster emails for technical issues accessing or linking to the announcement.

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Previous opportunity: NIAID Clinical Trial Implementation Grant (R01)

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