Opportunity Information: Apply for PAR 13 036

  • The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Utilizing the PLCO Biospecimens Resource to Bridge Gaps in Cancer Etiology and Early Detection Research (U01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393 Cancer Cause and Prevention Research.
  • This funding opportunity was created on Dec 6, 2012 and posted on Dec 6, 2012.
  • Applicants must submit their applications by Jun 19, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities For profit organizations other than small businesses State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) Private institutions of higher education County governments Public and State controlled institutions of higher education Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments 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:

This NIH funding opportunity (PAR-13-036) invited research teams to use the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial biospecimen resource to answer important unanswered questions in cancer causes (etiology) and to advance early detection research. The central idea was to capitalize on PLCO's uniquely valuable bank of pre-diagnostic specimens and rich participant data to bridge gaps that are difficult to address with newly collected samples, particularly for studying biological changes that occur before a cancer is clinically detected. The award mechanism was a U01 cooperative agreement, meaning projects were expected to involve substantial scientific and programmatic involvement from NIH staff compared with a standard research grant, and to operate in a more collaborative, milestone-driven way.

The opportunity fell under the NIH/NCI cancer cause and prevention research area (CFDA 93.393) and supported discretionary, peer-reviewed projects focused on leveraging PLCO biospecimens for studies such as biomarker discovery and validation for early detection, investigations of risk factors and mechanisms underlying cancer development, and analyses aimed at improving understanding of cancer etiology across PLCO-relevant cancer types and potentially beyond. In practical terms, applicants were expected to propose well-justified, high-impact studies that rely on PLCO's stored blood and other specimens, along with the trial's screening, clinical, and epidemiologic data, to generate evidence that could move the field forward in a way that would be hard to replicate in smaller or less deeply characterized cohorts. Because PLCO includes long follow-up and samples collected before diagnosis for many participants, it is particularly suited to questions about early biological signals, timing of biomarker emergence, and relationships between exposures, screening, and subsequent cancer outcomes.

Administratively, the program was posted on December 6, 2012, and remained open until June 19, 2015, with an archive date of July 20, 2015. There was no cost sharing or matching requirement. The funding instrument type was a cooperative agreement (U01), which generally implies that investigators would work closely with NIH program staff on issues such as access to and use of PLCO specimens, coordination with resource managers, adherence to resource use policies, and potentially harmonization of methods or data sharing expectations so that resulting datasets and findings could have broader utility.

Eligibility was broad and included many U.S.-based organizational types such as state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The announcement also explicitly allowed a wide range of additional eligible applicants and components, including faith-based or community-based organizations, 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). Importantly, non-U.S. entities (foreign organizations and foreign institutions) were eligible to apply, and non-U.S. components of U.S. organizations were eligible, with foreign components allowed consistent with NIH policy.

Overall, the grant opportunity was designed to stimulate rigorous, well-powered studies that make strategic use of an existing national biospecimen and data resource to accelerate progress in understanding why cancers develop and how they might be detected earlier. By focusing on PLCO, NIH aimed to maximize scientific return on a major public investment, encourage carefully designed studies with strong epidemiologic and laboratory methods, and promote findings that could translate into improved risk stratification, earlier diagnosis, and ultimately better cancer prevention and outcomes. For full details, NIH referenced the official announcement page at http://grants.nih.gov/grants/guide/pa-files/PAR-13-036.html, with support available through the NIH Office of Extramural Research webmaster contact listed in the notice.

Frequently Asked Questions (FAQs) - NIH PAR-13-036 (PLCO Biospecimen Resource)

What is PAR-13-036?

PAR-13-036 was an NIH funding opportunity that invited research teams to use the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial biospecimen resource to answer important unanswered questions about cancer causes (etiology) and to advance early detection research.

What was the main goal of this funding opportunity?

The main goal was to capitalize on PLCO's uniquely valuable bank of pre-diagnostic specimens and rich participant data to study biological changes that happen before cancer is clinically detected. The program aimed to bridge research gaps that are difficult to address using newly collected samples or smaller, less deeply characterized cohorts.

What types of studies was this opportunity meant to support?

It supported discretionary, peer-reviewed projects that leverage PLCO biospecimens and associated data for work such as biomarker discovery and validation for early detection, investigations of risk factors and mechanisms underlying cancer development, and analyses that improve understanding of cancer etiology across PLCO-relevant cancer types and potentially beyond.

Why was the PLCO resource considered especially valuable for this research?

PLCO includes long follow-up and specimens collected before diagnosis for many participants, making it well suited for research on early biological signals, the timing of biomarker emergence, and relationships between exposures, screening, and later cancer outcomes.

What kinds of specimens and data were expected to be used?

Applicants were expected to propose studies that rely on PLCO's stored blood and other specimens, together with the trial's screening, clinical, and epidemiologic data.

What is meant by "pre-diagnostic" specimens?

In this context, "pre-diagnostic" refers to specimens collected from participants before a cancer was clinically detected, allowing researchers to investigate biological changes that occur prior to diagnosis.

What award mechanism was used for PAR-13-036?

The award mechanism was a U01 cooperative agreement.

What does a U01 cooperative agreement imply for how projects operate?

A U01 cooperative agreement generally means projects were expected to involve substantial scientific and programmatic involvement from NIH staff compared with a standard research grant, and to operate in a more collaborative, milestone-driven way.

How might NIH staff be involved under a U01 for this opportunity?

NIH staff involvement could include working with investigators on access to and use of PLCO specimens, coordination with resource managers, adherence to resource use policies, and potentially harmonization of methods or data sharing expectations so resulting datasets and findings could have broader utility.

What NIH/NCI research area did this opportunity fall under?

It fell under NIH/NCI cancer cause and prevention research and was associated with CFDA 93.393.

Was cost sharing or matching required?

No. The opportunity explicitly stated there was no cost sharing or matching requirement.

When was the opportunity posted and how long was it open?

The program was posted on December 6, 2012, and remained open until June 19, 2015.

When was the opportunity archived?

The archive date was July 20, 2015.

Who was eligible to apply?

Eligibility was broad and included many U.S.-based organizational types such as state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses.

Were community-based or faith-based organizations eligible?

Yes. The announcement explicitly allowed faith-based or community-based organizations among eligible applicants.

Were minority-serving institutions included in the eligible applicant list?

Yes. The eligible entities listed included 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).

Could foreign (non-U.S.) organizations apply?

Yes. Non-U.S. entities (foreign organizations and foreign institutions) were eligible to apply under this opportunity, consistent with NIH policy.

Could a U.S. organization include a foreign component?

Yes. Non-U.S. components of U.S. organizations were eligible, and foreign components were allowed consistent with NIH policy.

What was NIH trying to accomplish by focusing on an existing national resource like PLCO?

NIH designed the opportunity to stimulate rigorous, well-powered studies that make strategic use of an existing national biospecimen and data resource, maximize scientific return on a major public investment, and encourage carefully designed studies with strong epidemiologic and laboratory methods.

What kinds of impacts were intended from the supported research?

The program aimed to promote findings that could translate into improved risk stratification, earlier diagnosis, and ultimately better cancer prevention and outcomes.

Where could applicants find the official announcement information?

NIH referenced the official announcement page at http://grants.nih.gov/grants/guide/pa-files/PAR-13-036.html.

Who was listed as a support contact in the notice?

Support was available through the NIH Office of Extramural Research webmaster contact listed in the notice.

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