Opportunity Information: Apply for PAR 13 149

  • The National Institutes of Health 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 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.)
  • Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Native American tribal governments (Federally recognized) County governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Special district governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education 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) 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.
Apply for PAR 13 149

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Opportunity Summary:

The NIAID Clinical Trial Implementation Grant (R01) is a discretionary NIH funding opportunity (FOA number PAR-13-149) from the National Institute of Allergy and Infectious Diseases that supports the implementation of investigator-initiated clinical trials that are not considered high risk. The central aim is to fund hypothesis-driven trials that fit squarely within NIAID's scientific mission in allergy, immunology, and infectious diseases, and that NIAID views as high priority. Applicants are specifically encouraged to align proposed work with NIAID's stated planning priorities and research areas, referenced on the institute's website, because the trial topic must not only be mission-relevant but also positioned as important to the institute's current programmatic needs.

This opportunity uses the NIH R01 research project grant mechanism, but it is explicitly tailored to clinical trial implementation rather than early exploratory work. In practical terms, it is meant for carrying out a defined clinical trial protocol rather than proposing multiple trials or a broad clinical research program. A key structural restriction is that only one clinical trial may be included per application, which signals that the application is expected to be focused and fully developed around a single, clearly justified study with an implementable design.

The funding instrument type is a grant, and the activity category is health. The opportunity is associated with CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research. There is no cost-sharing or matching requirement, meaning applicants are not required to provide non-federal matching funds as a condition of award.

Eligibility is broad and includes many types of domestic applicants such as public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status, with the usual NIH distinctions), for-profit organizations (other than small businesses and also including small businesses), and a wide range of government entities (state, county, city or township, special district governments, independent school districts, and public housing authorities/Indian housing authorities). The FOA also recognizes a variety of mission-relevant institutions and community-based entities as eligible, including faith-based or community-based organizations and several categories of minority-serving institutions such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs. In addition, the announcement allows non-U.S. participation: non-domestic (non-U.S.) entities and foreign institutions are eligible to apply, non-domestic components of U.S. organizations are eligible, and foreign components (as defined under NIH policy) are allowed, which can be important for infectious disease trials that may require international sites or populations.

The announcement was posted and created on March 22, 2013. The original and current closing date listed is January 13, 2016, and the archive date is February 13, 2016, indicating that this particular FOA is no longer active for new submissions under those dates and has been moved to the NIH archived listings. Applicants looking for a current equivalent would typically need to search NIH's active FOAs for the most recent NIAID clinical trial implementation R01 announcement and confirm current requirements, clinical trial definitions, and submission policies.

For reference and full details, the FOA points to the NIH Grants Guide page (the Additional Information link) and provides contacts for technical access issues through the NIH Office of Extramural Research webmaster email addresses.

Frequently Asked Questions (FAQs)

What is the NIAID Clinical Trial Implementation Grant (R01)?

The NIAID Clinical Trial Implementation Grant (R01) is an NIH discretionary funding opportunity from the National Institute of Allergy and Infectious Diseases (NIAID) that supports the implementation of investigator-initiated clinical trials that are not considered high risk. The funding opportunity announcement (FOA) number provided is PAR-13-149, and it uses the NIH R01 research project grant mechanism, tailored specifically for clinical trial implementation.

What kind of clinical trials does this FOA support?

This FOA supports hypothesis-driven clinical trials that fit within NIAID's scientific mission in allergy, immunology, and infectious diseases. It is intended for implementing a defined clinical trial protocol rather than proposing multiple trials or a broad clinical research program, and it focuses on trials that NIAID views as high priority and not high risk.

What is the main purpose or central aim of this opportunity?

The central aim is to fund hypothesis-driven clinical trials that are mission-relevant to NIAID and aligned with NIAID's priorities. The FOA emphasizes that the trial topic must both fit NIAID's mission areas (allergy, immunology, and infectious diseases) and be positioned as important to NIAID's current programmatic needs.

How important is alignment with NIAID planning priorities and research areas?

Alignment is specifically encouraged. Applicants are encouraged to align proposed work with NIAID's stated planning priorities and research areas referenced on the institute's website, because the trial topic must be mission-relevant and also reflect what NIAID considers high priority at the time.

Is this FOA meant for early exploratory studies or for implementing a finished trial protocol?

It is explicitly tailored to clinical trial implementation rather than early exploratory work. In practical terms, it is meant for carrying out a defined clinical trial protocol.

Can an application propose more than one clinical trial?

No. A key restriction is that only one clinical trial may be included per application, indicating that the application is expected to be focused on a single, clearly justified study with an implementable design.

What is the funding mechanism and type?

The opportunity uses the NIH R01 research project grant mechanism. The funding instrument type is a grant, and the activity category is health.

What CFDA numbers are associated with this opportunity?

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

Is cost-sharing or matching required?

No. There is no cost-sharing or matching requirement, meaning applicants are not required to provide non-federal matching funds as a condition of award.

Who is eligible to apply?

Eligibility is broad and includes many types of applicants such as public and private institutions of higher education; nonprofit organizations (including those with and without 501(c)(3) status, consistent with NIH distinctions); for-profit organizations (including small businesses and other than small businesses); and a wide range of government entities (state, county, city or township, special district governments, independent school districts, and public housing authorities/Indian housing authorities).

Are community-based and faith-based organizations eligible?

Yes. The FOA recognizes faith-based or community-based organizations as eligible applicants.

Are minority-serving institutions eligible to apply?

Yes. Several categories of minority-serving institutions are identified as eligible, including HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs.

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

Yes. The announcement allows non-U.S. participation, including eligibility for non-domestic (non-U.S.) entities and foreign institutions to apply.

Can U.S. organizations include non-U.S. components?

Yes. Non-domestic components of U.S. organizations are eligible, and foreign components (as defined under NIH policy) are allowed. This can be relevant for infectious disease trials that may require international sites or populations.

When was this FOA posted?

The announcement was posted and created on March 22, 2013.

What were the closing date and archive date for this FOA?

The original and current closing date listed is January 13, 2016, and the archive date is February 13, 2016.

Is this FOA currently active for new submissions?

Based on the listed closing and archive dates, this particular FOA is no longer active for new submissions under those dates and has been moved to the NIH archived listings.

If this FOA is archived, what should applicants do to find a current equivalent?

Applicants would typically need to search NIH's active FOAs for the most recent NIAID clinical trial implementation R01 announcement and confirm current requirements, clinical trial definitions, and submission policies.

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

The FOA points to the NIH Grants Guide page via the Additional Information link for reference and full details.

Who should be contacted for technical access issues related to the FOA information?

The FOA provides contacts for technical access issues through NIH Office of Extramural Research webmaster email addresses.

Browse more opportunities from the same agency: National Institutes of Health

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