Opportunity Information: Apply for PAR 13 383
Apply for PAR 13 383
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Replication of Key Clinical Trials Initiative (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273 Alcohol Research Programs.
- This funding opportunity was created on Jul 25, 2014 and posted on Nov 4, 2013.
- Applicants must submit their applications by Jul 25, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Independent school districts County governments Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Native American tribal governments (Federally recognized) Special district governments Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments For profit organizations other than small businesses Public housing authorities/Indian housing authorities.
- 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) 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 Replication of Key Clinical Trials Initiative (U01) (Funding Opportunity Number PAR 13 383) is a National Institutes of Health (NIH) discretionary grant opportunity designed to address a clear gap in the evidence base for treating Alcohol Use Disorders (AUD) and alcoholic liver disease: the need to independently replicate influential early stage clinical trial findings. The focus is on replication studies of key, single-site, proof-of-concept clinical trials that previously suggested meaningful benefit from either behavioral interventions or pharmacologic therapies. In practical terms, NIH is signaling that certain widely cited or potentially practice-changing results in this area need stronger confirmation before the field relies on them for broad clinical decision-making, guideline development, or large-scale implementation.
The funding mechanism is a Cooperative Agreement (U01), which generally indicates a more collaborative relationship between the award recipients and NIH compared to a standard research grant. Under a U01, NIH typically expects substantial programmatic involvement, such as coordination on study design elements, milestones, data and safety oversight expectations, and other aspects that help ensure the replication is rigorous, well-governed, and comparable to the original trial being replicated. The overarching purpose is not to explore entirely new hypotheses, but to reproduce and test the reliability of previously reported outcomes using careful methodology, with enough similarity to the original work to make the replication meaningful while still meeting modern standards for trial conduct.
This opportunity sits under the Health funding activity category and is associated with CFDA number 93.273 (Alcohol Research Programs). It explicitly states there is no cost-sharing or matching requirement, meaning applicants are not required to contribute non-federal funds as a condition of the award. The announcement was posted on November 4, 2013, with key administrative dates including an original closing date of January 14, 2016; the record also lists a current closing date of July 25, 2014, and an archive date of August 25, 2014, reflecting the lifecycle of the announcement in federal listings.
Eligibility is broad across many U.S.-based organizational types, reflecting an intent to attract capable clinical research teams from academic, nonprofit, governmental, and private-sector environments. Eligible applicants include public and private institutions of higher education; nonprofits with and without 501(c)(3) status (excluding institutions of higher education where specified); small businesses; for-profit organizations other than small businesses; and a range of governmental entities including state governments, county governments, city or township governments, special district governments, and public housing authorities/Indian housing authorities. The FOA also allows applications from a variety of mission-focused and underserved-serving institutions and organizations, 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 (AANAPISIs). Faith-based and community-based organizations are included as eligible, as are regional organizations and eligible federal agencies. Multiple categories of tribal organizations are eligible, including federally recognized tribal governments and other Indian/Native American tribal governments. U.S. territories or possessions are also listed as eligible.
At the same time, NIH draws a firm boundary around foreign participation for this initiative. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. In addition, foreign components, as defined in the NIH Grants Policy Statement, are not allowed. This restriction indicates NIH wanted these replication efforts carried out fully within U.S.-based institutional and regulatory structures, likely to simplify oversight, ensure consistency in compliance requirements, and focus resources on domestic research infrastructure.
The practical takeaway is that PAR 13 383 was meant to fund a limited number of carefully designed replication clinical trials in AUD and alcoholic liver disease that directly test whether notable single-site behavioral or drug treatment findings hold up when repeated. The intent is to strengthen confidence in therapies that appear promising, identify results that may not generalize, and improve the overall reliability of the treatment evidence base in alcohol-related disorders. For full details, NIH directed applicants to the official FOA page at http://grants.nih.gov/grants/guide/pa-files/PAR-13-383.html, and provided NIH Office of Extramural Research (OER) webmaster contacts for technical access issues.
Frequently Asked Questions (FAQs): Replication of Key Clinical Trials Initiative (U01) - PAR-13-383
What is the Replication of Key Clinical Trials Initiative (U01) (PAR-13-383)?
It is a National Institutes of Health (NIH) discretionary grant opportunity designed to support independent replication of influential early-stage clinical trial findings related to Alcohol Use Disorders (AUD) and alcoholic liver disease.
What problem or gap is this funding opportunity trying to address?
The initiative targets a specific gap in the evidence base: key, widely cited single-site proof-of-concept trials may show meaningful benefits, but the field needs independent replication to confirm whether those findings are reliable enough to inform broad clinical decision-making, guidelines, or large-scale implementation.
What types of studies does this initiative fund?
The focus is on replication studies of key, single-site, proof-of-concept clinical trials that previously suggested meaningful benefit from behavioral interventions or pharmacologic therapies for AUD and/or alcoholic liver disease.
Is this opportunity intended to support entirely new hypotheses?
No. The overarching purpose is not to explore entirely new hypotheses, but to reproduce and test the reliability of previously reported outcomes using careful methodology.
How closely must a replication study match the original trial?
The replication should be similar enough to the original work to make the comparison meaningful, while still meeting modern standards for clinical trial conduct.
What is the funding mechanism for PAR-13-383?
The mechanism is a Cooperative Agreement (U01).
What does a Cooperative Agreement (U01) imply about NIH involvement?
A U01 generally indicates a more collaborative relationship with NIH than a standard research grant. NIH typically expects substantial programmatic involvement, such as coordination on study design elements, milestones, and data and safety oversight expectations, to ensure the replication is rigorous, well-governed, and comparable to the original trial.
What topic areas does this opportunity fall under?
It sits under the Health funding activity category and is aimed at clinical trial replication in the areas of Alcohol Use Disorders (AUD) and alcoholic liver disease.
What CFDA number is associated with this opportunity?
The CFDA number listed is 93.273 (Alcohol Research Programs).
Is cost-sharing or matching required?
No. The announcement explicitly states there is no cost-sharing or matching requirement, meaning applicants are not required to contribute non-federal funds as a condition of the award.
Who is eligible to apply (in general terms)?
Eligibility is broad across many U.S.-based organization types, including academic, nonprofit, governmental, and private-sector organizations.
Are public and private colleges and universities eligible?
Yes. Public and private institutions of higher education are listed as eligible applicants.
Are nonprofit organizations eligible?
Yes. Nonprofits with and without 501(c)(3) status are listed as eligible (with exclusions noted in the source listing where specified).
Are businesses eligible to apply?
Yes. Small businesses and for-profit organizations other than small businesses are listed as eligible.
Which U.S. government entities are eligible?
Eligible government applicants include state governments, county governments, city or township governments, special district governments, and public housing authorities/Indian housing authorities.
Are tribal organizations eligible?
Yes. Multiple categories of tribal organizations are eligible, including federally recognized tribal governments and other Indian/Native American tribal governments.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are listed among eligible applicants.
Are HBCUs and other minority-serving institutions eligible?
Yes. The eligibility list includes 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 (AANAPISIs).
Are faith-based or community-based organizations eligible?
Yes. Faith-based organizations and community-based organizations are listed as eligible applicants.
Are regional organizations eligible?
Yes. Regional organizations are listed as eligible applicants.
Are eligible federal agencies allowed to apply?
Yes. Eligible federal agencies are included among the eligible applicant categories.
Are foreign (non-U.S.) institutions eligible to apply?
No. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply.
Can a U.S. organization apply if the work will be done in a non-U.S. component?
No. Non-domestic components of U.S. organizations are not eligible to apply.
Are foreign components allowed under this opportunity?
No. Foreign components (as defined in the NIH Grants Policy Statement) are not allowed.
Why does the FOA restrict foreign participation?
The listing indicates NIH wanted replication efforts carried out fully within U.S.-based institutional and regulatory structures, likely to simplify oversight, ensure consistency in compliance requirements, and focus resources on domestic research infrastructure.
What is the practical goal of funding these replication trials?
The practical intent is to confirm whether notable single-site behavioral or drug treatment findings hold up when repeated, strengthen confidence in therapies that appear promising, identify results that may not generalize, and improve the overall reliability of the treatment evidence base in alcohol-related disorders.
When was this funding opportunity posted?
The announcement was posted on November 4, 2013.
What dates are listed for closing and archiving?
The record lists an original closing date of January 14, 2016; it also lists a current closing date of July 25, 2014, and an archive date of August 25, 2014, reflecting the lifecycle of the announcement in federal listings.
Where can applicants find the official FOA details?
NIH directed applicants to the official FOA page at http://grants.nih.gov/grants/guide/pa-files/PAR-13-383.html.
Who should be contacted for technical access issues related to the FOA page?
The listing references NIH Office of Extramural Research (OER) webmaster contacts for technical access issues.
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