Opportunity Information: Apply for PAR 15 302
Apply for PAR 15 302
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Establishing Outcome Measures for Clinical Studies of Oral and Craniofacial Diseases and Conditions (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121 Oral Diseases and Disorders Research.
- This funding opportunity was created on Jul 17, 2015 and posted on Jul 17, 2015.
- Applicants must submit their applications by Sep 7, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments Special district governments Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education Independent school districts For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) County governments Public housing authorities/Indian housing authorities City or township governments.
- 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 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 allowed.
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Opportunity Summary:
PAR-15-302 is an NIH discretionary grant opportunity using the R01 research project grant mechanism titled "Establishing Outcome Measures for Clinical Studies of Oral and Craniofacial Diseases and Conditions." The central purpose of the announcement is to strengthen the scientific foundation of how clinical research in oral and craniofacial health measures whether an intervention, exposure, or clinical course meaningfully changes patient status. In practical terms, the opportunity supports projects that develop, refine, and rigorously test outcome measures for use in clinical studies involving oral and craniofacial diseases and conditions, with particular emphasis on demonstrating that these measures are reliable (they produce consistent results under consistent conditions) and valid (they truly measure what they are intended to measure).
The work supported under this announcement is focused on outcome measures that can stand up to the demands of clinical research, where measurement quality directly affects whether findings are interpretable, reproducible, and clinically useful. Applications are expected to address the methodological steps needed to build "well-founded" outcomes, which commonly includes defining the construct being measured, standardizing protocols, assessing measurement error, and establishing multiple forms of validity and reliability. Depending on the specific outcome, this can include evaluating inter-rater and intra-rater reliability, test-retest reliability, internal consistency for multi-item instruments, and responsiveness or sensitivity to change over time. Validity work may include content validity (expert and stakeholder alignment), criterion validity (comparison to an accepted reference where available), construct validity (expected relationships with other measures), and clinical meaningfulness (linking measured changes to outcomes that matter in real care, such as function, symptoms, or quality of life). The overarching idea is that oral and craniofacial clinical studies need robust endpoints, and this program is designed to fund the foundational measurement science that makes those endpoints credible.
The opportunity falls under the Health funding activity category and is associated with CFDA 93.121, Oral Diseases and Disorders Research. It does not require cost sharing or matching, which means applicants are not expected to provide a formal financial match as part of the award. The announcement was posted and created on July 17, 2015, with an original and current closing date of September 7, 2018, and an archive date of October 8, 2018. While those dates indicate the specific version provided is archived, the summary of scope remains useful for understanding what NIH was seeking to fund under this FOA and for identifying similar current NIH opportunities focused on clinical outcome measurement and validation in dental, oral, and craniofacial research.
Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state governments, county governments, city or township governments, special district governments, and independent school districts, as well as public housing authorities and Indian housing authorities. Academic eligibility includes public and state-controlled institutions of higher education and private institutions of higher education. The FOA also allows nonprofit organizations both with and without 501(c)(3) status (other than institutions of higher education), for-profit organizations other than small businesses, and small businesses. It explicitly includes Native American tribal governments (federally recognized) and Native American tribal organizations other than federally recognized tribal governments, along with tribally controlled colleges and universities. The eligibility language also highlights institutions and organizations that NIH often encourages to participate, such as historically black colleges and universities, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, and Asian American, Native American, and Pacific Islander-serving institutions, as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
Restrictions on foreign participation are spelled out in a way typical for NIH announcements. Non-U.S. entities (foreign organizations) and non-U.S. institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined by the NIH Grants Policy Statement, meaning a U.S. applicant may include certain well-justified foreign elements (for example, collaboration, data sources, or specialized expertise abroad) if they are scientifically necessary and compliant with NIH policy.
The sponsoring agency is the National Institutes of Health, and the full announcement is linked through the NIH grants guide at http://grants.nih.gov/grants/guide/pa-files/PAR-15-302.html. For technical issues accessing or linking to the announcement, the listed point of contact is the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.
FAQs: NIH PAR-15-302 (R01) - Establishing Outcome Measures for Clinical Studies of Oral and Craniofacial Diseases and Conditions
What is PAR-15-302?
PAR-15-302 is an NIH discretionary funding opportunity announcement (FOA) that uses the R01 Research Project Grant mechanism. Its title is "Establishing Outcome Measures for Clinical Studies of Oral and Craniofacial Diseases and Conditions."
What is the main goal of this grant opportunity?
The central goal is to strengthen the scientific basis for how oral and craniofacial clinical research measures whether an intervention, exposure, or clinical course meaningfully changes a patient's status. In practice, it supports foundational work to develop, refine, and rigorously test outcome measures so clinical study results are interpretable, reproducible, and clinically useful.
What types of projects are supported under this FOA?
The FOA supports projects that develop, refine, and rigorously test outcome measures for clinical studies involving oral and craniofacial diseases and conditions. A key emphasis is demonstrating that proposed outcome measures are reliable (consistent under consistent conditions) and valid (they measure what they intend to measure).
What does NIH mean by "outcome measures" in this context?
Within the scope provided, outcome measures are endpoints or assessment tools used in clinical studies to capture meaningful change in patient status related to oral and craniofacial diseases and conditions. These measures need to meet the demands of clinical research, where measurement quality affects whether study findings can be trusted and replicated.
What is meant by an outcome measure being "reliable"?
Reliability is described as the ability of a measure to produce consistent results under consistent conditions. The FOA highlights that applications may evaluate several forms of reliability depending on the measure being developed or tested.
What types of reliability testing are mentioned in the opportunity description?
The description notes several reliability-related evaluations that may be relevant, including inter-rater reliability, intra-rater reliability, test-retest reliability, and internal consistency for multi-item instruments. It also mentions responsiveness or sensitivity to change over time as part of rigorous evaluation, depending on the outcome measure.
What is meant by an outcome measure being "valid"?
Validity is described as whether a measure truly measures what it is intended to measure. The FOA frames validity as a critical feature needed for outcome measures to be credible in clinical research.
What types of validity are mentioned in the opportunity description?
The opportunity description references content validity (alignment with experts and stakeholders), criterion validity (comparison to an accepted reference when available), construct validity (relationships with other measures that behave as expected), and clinical meaningfulness (connecting measured change to outcomes that matter in real care, such as function, symptoms, or quality of life).
What kinds of methodological steps are applicants expected to address?
Applications are expected to address methodological steps needed to build well-founded outcomes. Examples listed include defining the construct being measured, standardizing protocols, assessing measurement error, and establishing multiple forms of validity and reliability.
Why is NIH emphasizing measurement quality for oral and craniofacial clinical studies?
The FOA rationale is that measurement quality directly affects whether clinical research findings are interpretable, reproducible, and clinically useful. The program is intended to fund the measurement science needed to make clinical endpoints credible for oral and craniofacial studies.
What is the funding mechanism for PAR-15-302?
This FOA uses the R01 Research Project Grant mechanism.
What is the funding activity/category associated with this opportunity?
The opportunity falls under the Health funding activity category.
What CFDA program is associated with this funding opportunity?
The FOA is associated with CFDA 93.121, Oral Diseases and Disorders Research.
Does this grant require cost sharing or matching funds?
No. The information provided states that cost sharing or matching is not required, meaning applicants are not expected to provide a formal financial match as part of the award.
When was this FOA posted, and what are the key dates listed?
The announcement was posted and created on July 17, 2015. The original and current closing date listed is September 7, 2018, and the archive date is October 8, 2018.
Is PAR-15-302 still open for applications?
Based on the dates provided, this specific version is archived (archive date: October 8, 2018) and lists a closing date of September 7, 2018. That indicates it is not an active, open application opportunity in the provided form.
If the FOA is archived, is the content still useful?
Yes. The provided summary notes that while the specific FOA version is archived, the scope remains useful for understanding what NIH was seeking to fund and for identifying similar current NIH opportunities focused on clinical outcome measurement and validation in dental, oral, and craniofacial research.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organizations and governmental entities. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public housing authorities; Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses.
Are tribal governments and tribal organizations eligible?
Yes. The FOA explicitly includes Native American tribal governments (federally recognized) and Native American tribal organizations other than federally recognized tribal governments. It also includes tribally controlled colleges and universities.
Are U.S. territories or possessions eligible to apply?
Yes. The eligibility language highlights regional organizations and U.S. territories or possessions as eligible.
Are certain types of institutions specifically highlighted as encouraged or included?
Yes. The eligibility language highlights historically black colleges and universities, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, and Asian American, Native American, and Pacific Islander-serving institutions. It also includes faith-based or community-based organizations, eligible federal agencies, and regional organizations.
Can a foreign organization apply as the main applicant?
No. The provided restrictions state that non-U.S. entities (foreign organizations) and non-U.S. institutions are not eligible to apply as the applicant organization.
Can a non-domestic component of a U.S. organization apply?
No. The information provided states that non-domestic components of U.S. organizations are not eligible to apply.
Are foreign components allowed in a project led by a U.S. applicant?
Yes. Foreign components are allowed as defined by the NIH Grants Policy Statement. The description indicates that a U.S. applicant may include well-justified foreign elements (such as collaboration, data sources, or specialized expertise abroad) if they are scientifically necessary and compliant with NIH policy.
Which agency sponsors this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
Where can the full FOA be found?
The full announcement is available through the NIH Grants Guide at: http://grants.nih.gov/grants/guide/pa-files/PAR-15-302.html.
Who should be contacted for technical issues accessing or linking to the announcement?
For technical issues accessing or linking to the announcement, the listed point of contact is the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.
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