Opportunity Information: Apply for PAR 12 011

  • The National Institutes of Health in the education environment health sector is offering a public funding opportunity titled "NIH Competitive Revision Applications for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113 Environmental Health 93.233 National Center on Sleep Disorders Research 93.242 Mental Health Research Grants 93.393 Cancer Cause and Prevention Research 93.399 Cancer Control 93.865 Child Health and Human Development Extramural Research.
  • This funding opportunity was created on Jan 20, 2012 and posted on Nov 9, 2011.
  • Applicants must submit their applications by Feb 17, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $10,000,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $500,000.00 in funding.
  • The number of recipients for this funding is limited to 20 candidate(s).
  • Eligible applicants include: Special district governments Public housing authorities/Indian housing authorities Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) County governments City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses State governments Public and State controlled institutions of higher education Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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 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 NIH grant opportunity PAR 12-011, titled "NIH Competitive Revision Applications for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U01)," was a discretionary cooperative agreement program designed to fund competitive revision requests to existing NIH U01 awards. The central purpose was to let investigators who already held an active U01 from one of the participating NIH Institutes and Centers expand the scope of their currently funded project so it could address tobacco regulatory science priorities tied to the U.S. Food and Drug Administration's (FDA) authority over tobacco products. In practical terms, this was not a brand-new standalone grant for an entirely new research project; it was specifically a revision mechanism meant to add new aims, data collection, analyses, or other scope expansions onto an already funded U01, with the added work directly aligned to questions that inform FDA tobacco product regulation under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31.

A key feature of the announcement was its emphasis on FDA-relevant research priorities. Even if an investigator's original U01 did not focus on tobacco use, the FOA explicitly welcomed revisions that pivoted part of the existing project toward tobacco-related topics, as long as the proposed expansion addressed the FOA's regulatory-science priorities connected to FDA's tobacco authorities. The scientific focus had to involve smoking and tobacco-related products and/or their constituents, which typically includes areas like product characteristics, exposure to constituents, patterns of use, health effects, addiction-related outcomes, and other evidence that could support regulatory decision-making. The announcement also made clear that NIH would administer these awards using funds provided by the FDA Center for Tobacco Products (CTP), reflecting the statutory mandate for tobacco regulatory science created by the FSPTCA and the interagency structure often used for this kind of work, where NIH manages the research grant process while FDA-CTP provides targeted funding.

Mechanistically, the awards were cooperative agreements (U01), meaning recipients should expect a more collaborative relationship with the funding agency than with a typical investigator-initiated grant. Cooperative agreements generally involve substantial programmatic involvement by NIH staff during the project, which can include coordinated milestones, shared planning, or other structured interactions intended to keep the work aligned with program goals. The opportunity anticipated around 20 awards, with an estimated total funding level of about $10,000,000 and an award ceiling of $500,000 (generally interpreted as a maximum per award, per year, depending on the FOA's detailed budget guidance). There was no cost sharing or matching requirement.

The eligible applicant landscape was broad and included many types of domestic organizations such as state and local governments, tribal governments and tribal organizations, public housing authorities, independent school districts, nonprofits (with or without 501(c)(3) status), private and public institutions of higher education, small businesses, and other for-profit entities outside of small business as well. The FOA also allowed foreign participation: non-U.S. entities (foreign institutions) could apply, non-U.S. components of U.S. organizations were eligible, and foreign components (as defined by NIH policy) were permitted. It also highlighted eligibility for specific institution types and community-serving organizations, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Despite this broad institutional eligibility, the applicant pool was still practically constrained by the main requirement: the revision had to be tied to an active, eligible U01 award issued by a participating NIH Institute or Center, since it was a competitive revision rather than a new award.

From an administrative standpoint, the FOA was posted November 9, 2011, with a closing date of February 17, 2012, and it was archived March 19, 2012, indicating it was a time-limited opportunity. It was associated with multiple CFDA listings spanning environmental health, mental health research, cancer-related research, child health and human development extramural research, and sleep disorders research, reflecting the cross-cutting nature of tobacco regulatory science across disease areas and populations. For further details and the complete program requirements, NIH provided the full announcement link (grants.nih.gov, PAR 12-011) and directed technical access questions to the NIH Office of Extramural Research webmaster contact.

Frequently Asked Questions (FAQs)

What is PAR 12-011?

PAR 12-011 is an NIH funding opportunity announcement titled "NIH Competitive Revision Applications for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U01)." It supported competitive revision requests (not brand-new standalone projects) to expand the scope of existing, active NIH U01 awards so the added work could address tobacco regulatory science priorities connected to FDA authority under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31.

Is this a new grant for a completely new research project?

No. This opportunity was specifically a competitive revision mechanism for investigators who already had an active, eligible NIH U01 award from a participating NIH Institute or Center. The intent was to add new aims, data collection, analyses, or other scope expansions to the currently funded project.

What type of award mechanism was used?

The awards were cooperative agreements (U01). In cooperative agreements, NIH staff typically have substantial programmatic involvement during the project, which may include coordinated milestones, shared planning, and structured interactions to help keep work aligned with program goals.

Who was this opportunity intended for?

It was intended for investigators who already held an active U01 award from one of the participating NIH Institutes and Centers and who wanted to expand that ongoing project to include research aligned with FDA tobacco regulatory science priorities under the FSPTCA.

Do you need to already have an NIH U01 award to apply?

Yes. Even though institutional eligibility was broad, this was a competitive revision to an existing award, so it had to be tied to an active, eligible U01 issued by a participating NIH Institute or Center.

What was the main purpose of the competitive revision?

The central purpose was to let existing U01 investigators expand their currently funded scope to answer questions that inform FDA tobacco product regulation under the Family Smoking Prevention and Tobacco Control Act.

Does the original U01 project have to already be about tobacco?

No. The announcement explicitly welcomed revisions even if the original U01 did not focus on tobacco use, as long as the proposed expansion added tobacco-related work that addressed the FOA's FDA regulatory-science priorities.

What kinds of research topics were considered relevant?

The scientific focus had to involve smoking and tobacco-related products and/or their constituents, and be aligned with evidence needs for tobacco product regulation. Examples of relevant areas included product characteristics, exposure to constituents, patterns of use, health effects, addiction-related outcomes, and other evidence that could support regulatory decision-making.

How was FDA involved in this NIH funding opportunity?

NIH administered the awards, but the program used funds provided by the FDA Center for Tobacco Products (CTP). This reflects the interagency structure used for tobacco regulatory science where NIH manages the research grant process and FDA-CTP provides targeted funding aligned with the FSPTCA mandate.

How many awards were anticipated?

The opportunity anticipated around 20 awards.

What was the estimated total funding for the program?

The estimated total funding level was about $10,000,000.

Was there an award budget cap?

Yes. The opportunity described an award ceiling of $500,000, generally interpreted as a maximum per award, per year, depending on the FOA's detailed budget guidance.

Is cost sharing or matching required?

No. There was no cost sharing or matching requirement.

What types of organizations were eligible to apply?

Eligible applicants included many types of domestic organizations, such as state and local governments, tribal governments and tribal organizations, public housing authorities, independent school districts, nonprofits (with or without 501(c)(3) status), private and public institutions of higher education, small businesses, and other for-profit entities (including for-profits outside of small business).

Were foreign organizations allowed to apply?

Yes. The FOA allowed foreign participation, including applications from non-U.S. entities (foreign institutions), non-U.S. components of U.S. organizations, and foreign components (as defined by NIH policy).

Did the FOA highlight any specific institution types as eligible?

Yes. It highlighted eligibility for institution types and community-serving organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

What were the key dates for this opportunity?

The FOA was posted on November 9, 2011. The closing date was February 17, 2012. It was archived on March 19, 2012, indicating it was a time-limited opportunity.

What does it mean that the FOA is archived?

Based on the information provided, archived status indicates the opportunity was time-limited and is no longer an active, open solicitation under that announcement.

Which CFDA areas were associated with this FOA?

The FOA was associated with multiple CFDA listings spanning environmental health, mental health research, cancer-related research, child health and human development extramural research, and sleep disorders research, reflecting the cross-cutting nature of tobacco regulatory science.

Where could applicants find the full official announcement and requirements?

NIH directed applicants to the full announcement link on grants.nih.gov (PAR 12-011) for complete program requirements.

Who was listed for technical access questions?

NIH directed technical access questions to the NIH Office of Extramural Research webmaster contact.

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