Opportunity Information: Apply for PAR 11 082

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pathophysiology and Clinical Studies of Osteonecrosis of the Jaw (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 Dec 22, 2010 and posted on Dec 22, 2010.
  • Applicants must submit their applications by Jan 7, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Native American tribal governments (Federally recognized) For profit organizations other than small businesses Independent school districts 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 County governments Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public and State controlled institutions of higher education City or township governments Private institutions of higher education Small businesses.
  • 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:

The Pathophysiology and Clinical Studies of Osteonecrosis of the Jaw (R01) funding opportunity (PAR-11-082) was a discretionary National Institutes of Health grant announcement administered by the National Institute of Dental and Craniofacial Research (NIDCR). It invited institutions and organizations to submit Research Project Grant (R01) applications focused on osteonecrosis of the jaw (ONJ), with an emphasis on building a stronger scientific and clinical evidence base around why ONJ occurs, who is most at risk, how the condition progresses over time, and what approaches may prevent or treat it more effectively. The overall intent was to move the field beyond scattered case reports and inconsistent definitions by supporting well-designed research that clarifies disease mechanisms and generates actionable clinical evidence.

From a scientific standpoint, the FOA centered on four connected goals. First, it encouraged studies of ONJ pathophysiology, meaning research that digs into the biological and physiological processes that lead to jawbone necrosis. This could include investigations into bone remodeling, vascular supply, inflammation, immune responses, oral microbiology, wound healing after dental procedures, and how medications or systemic diseases might disrupt these processes specifically in jaw tissues. Second, it prioritized identification of risk factors, supporting work aimed at determining which patient characteristics, exposures, comorbidities, dental triggers, or treatment histories increase the likelihood of developing ONJ. Third, it sought projects that establish the natural history of ONJ, meaning careful longitudinal observation of how ONJ begins, how it advances, what stages or clinical patterns are typical, which factors predict improvement versus deterioration, and what outcomes matter most to patients and clinicians. Fourth, it called for evidence generation for treatment, supporting research that strengthens the basis for clinical decision-making, including evaluation of interventions, management strategies, or treatment pathways in ways that are methodologically sound and clinically relevant.

The award mechanism was the NIH Research Project Grant (R01), which is the standard NIH mechanism for investigator-driven research projects. The funding activity category was Health, and the CFDA program listing associated with the opportunity was 93.121 (Oral Diseases and Disorders Research). The announcement stated that cost sharing or matching was not required, which generally reduces barriers to applying because applicants do not need to commit non-federal funds as a condition of the award.

Eligibility under this FOA was broad and included many types of domestic and non-domestic organizations. Eligible applicants included public and state-controlled institutions of higher education and private institutions of higher education, nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education), for-profit organizations other than small businesses, and small businesses. Government entities were also eligible, including state governments, county governments, city or township governments, special district governments, and public housing authorities/Indian housing authorities. The announcement also included Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments), as well as tribally controlled colleges and universities (TCCUs). Additional eligible applicant types specifically noted included Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving institutions, historically black colleges and universities (HBCUs), faith-based or community-based organizations, regional organizations, eligible federal government agencies, and U.S. territories or possessions. Importantly, it also allowed non-U.S. entities (foreign organizations) to apply, which can be relevant for multinational cohorts, international clinical datasets, or collaborations in settings where ONJ risk factors or treatment patterns differ.

In terms of timing and status, the FOA was posted and created on December 22, 2010. The original closing date and the listed current closing date were both January 7, 2014, and the archive date was February 7, 2014, meaning the opportunity is no longer active and is maintained for historical reference. Applicants at the time would have been expected to consult the full announcement for submission deadlines, application requirements, review criteria, and any special instructions typical of NIH FOAs.

For reference and full details, the opportunity’s additional information link pointed to the NIH grants guide page for PAR-11-082 at http://grants.nih.gov/grants/guide/pa-files/PAR-11-082.html. The contact information provided for access or linking problems directed users to the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.

Frequently Asked Questions (FAQs)

1. What is the title and identifier of this funding opportunity?

The funding opportunity was titled "The Pathophysiology and Clinical Studies of Osteonecrosis of the Jaw (R01)" and carried the identifier PAR-11-082.

2. Which agency and NIH institute administered this opportunity?

This was a discretionary National Institutes of Health (NIH) grant announcement administered by the National Institute of Dental and Craniofacial Research (NIDCR).

3. What grant mechanism did this announcement use?

The award mechanism was the NIH Research Project Grant (R01), the standard NIH mechanism for investigator-driven research projects.

4. What was the overall purpose of PAR-11-082?

The intent was to strengthen the scientific and clinical evidence base for osteonecrosis of the jaw (ONJ) by supporting well-designed research that clarifies why ONJ occurs, who is at highest risk, how it progresses over time, and what approaches may prevent or treat it more effectively. A key aim was moving the field beyond scattered case reports and inconsistent definitions.

5. What specific scientific areas did the FOA emphasize?

The FOA centered on four connected goals:

  • Pathophysiology: biological and physiological processes leading to jawbone necrosis
  • Risk factors: patient characteristics, exposures, comorbidities, triggers, and treatment histories associated with ONJ
  • Natural history: longitudinal understanding of onset, progression, staging/patterns, predictors of improvement vs. deterioration, and meaningful outcomes
  • Treatment evidence generation: methodologically sound evaluation of interventions, management strategies, or treatment pathways to support clinical decision-making

6. What kinds of pathophysiology topics were considered relevant?

Examples noted in the announcement included investigations into bone remodeling, vascular supply, inflammation, immune responses, oral microbiology, wound healing after dental procedures, and the ways medications or systemic diseases might disrupt these processes specifically in jaw tissues.

7. What types of risk factors was the FOA interested in identifying?

The announcement highlighted work aimed at determining which patient characteristics, exposures, comorbidities, dental triggers, or treatment histories increase the likelihood of developing ONJ.

8. What does "natural history of ONJ" mean in the context of this FOA?

It referred to careful longitudinal observation of how ONJ begins, how it advances over time, what stages or clinical patterns are typical, which factors predict improvement versus deterioration, and which outcomes matter most to patients and clinicians.

9. What did the FOA mean by "evidence generation for treatment"?

It meant supporting research that strengthens the basis for clinical decision-making by evaluating interventions, management strategies, or treatment pathways in a way that is clinically relevant and methodologically sound.

10. What was the funding activity category?

The funding activity category was Health.

11. What CFDA program listing was associated with this opportunity?

The CFDA program listing was 93.121, titled Oral Diseases and Disorders Research.

12. Was cost sharing or matching required?

No. The announcement stated that cost sharing or matching was not required.

13. Who was eligible to apply?

Eligibility was broad and included many types of domestic and non-domestic organizations, including higher education institutions, nonprofit organizations (with or without 501(c)(3) status, other than institutions of higher education), for-profit organizations (other than small businesses), small businesses, and multiple levels and types of government entities.

14. Were U.S. colleges and universities eligible?

Yes. Eligible applicants included public and state-controlled institutions of higher education and private institutions of higher education.

15. Were nonprofits eligible, including those without 501(c)(3) status?

Yes. Eligible applicants included nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education).

16. Were for-profit organizations and small businesses eligible?

Yes. Eligible applicants included for-profit organizations other than small businesses, and small businesses.

17. What types of government entities were eligible?

Eligible government applicants included state governments, county governments, city or township governments, special district governments, and public housing authorities/Indian housing authorities. The FOA also listed eligible federal government agencies, and U.S. territories or possessions.

18. Were tribal governments and tribal organizations eligible?

Yes. The announcement included Native American tribal governments (federally recognized), tribal organizations (other than federally recognized tribal governments), and tribally controlled colleges and universities (TCCUs).

19. Did the FOA encourage or allow applications from minority-serving and community-based organizations?

It listed several specific eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving institutions, historically black colleges and universities (HBCUs), as well as faith-based or community-based organizations and regional organizations.

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

Yes. The FOA explicitly allowed non-U.S. entities (foreign organizations) to apply, which could support multinational cohorts, international clinical datasets, or collaborations where ONJ risk factors or treatment patterns differ.

21. When was this FOA posted and created?

The FOA was posted and created on December 22, 2010.

22. What were the closing and archive dates?

The original closing date and the listed current closing date were both January 7, 2014. The archive date was February 7, 2014.

23. Is this opportunity currently active?

No. Because it has an archive date (February 7, 2014) and the closing date has passed, it is no longer active and is maintained for historical reference.

24. Where can someone find the full announcement details?

The additional information link pointed to the NIH Grants Guide page for PAR-11-082 at:

http://grants.nih.gov/grants/guide/pa-files/PAR-11-082.html

25. Who should be contacted for access or linking problems related to the FOA page?

The contact for access or linking problems was the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.

26. What would applicants have been expected to review in the full announcement?

Applicants would have been expected to consult the full announcement for submission deadlines, application requirements, review criteria, and any special instructions typical of NIH FOAs.

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