Opportunity Information: Apply for PA 16 295

  • The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Factors Underlying Differences in Female and Male Presentation for Dental, 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, 93.313, 93.866,.
  • This funding opportunity was created on May 27, 2016 and posted on May 27, 2016.
  • Applicants must submit their applications by Sep 07, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:

Factors Underlying Differences in Female and Male Presentation for Dental, Oral, and Craniofacial Diseases and Conditions (R01) is a National Institutes of Health (NIH) research grant opportunity from HHS (agency listing HHS-NIH11) that was released as Funding Opportunity Announcement PA-16-295. Its central goal is to fund hypothesis-driven research that explains why many dental, oral, and craniofacial (DOC) diseases and conditions look different in females versus males. Rather than simply documenting that a difference exists, the FOA is focused on uncovering the biological and related mechanisms that produce sex-based differences in how DOC conditions develop, present clinically, and progress over time.

The scientific scope centers on sex-based differences in DOC disease manifestations and encourages studies that dig into several major contributing domains. These domains include immune reactivity (for example, whether innate or adaptive immune responses differ by sex in ways that change disease onset or severity), genetic variation (including sex-linked genetic effects or differential gene regulation), environmental triggers (such as exposures, behaviors, infections, or other external factors that may interact with sex to alter risk), aging (including how age-related immune or tissue changes diverge in females and males), and hormonal changes (such as puberty, menstrual cycling, pregnancy, menopause, and androgen-related influences) that could shape disease susceptibility, symptom patterns, tissue responses, and recovery. The FOA highlights the importance of studying how these factors may interact, since sex differences often reflect combined effects rather than a single isolated cause.

The announcement points to several example conditions to illustrate the kinds of DOC-related topics that fit the program, while also making clear that the list is not exhaustive. Examples include Sjogrens Syndrome (SS), which has well-known sex differences in prevalence and autoimmune features; orofacial pain conditions, where symptom burden and pain processing may differ by sex; temporomandibular joint disorder (TMD), often discussed in the context of sex-linked differences in pain sensitivity, joint biology, and hormonal modulation; salivary gland tumors, where sex differences may relate to tumor biology, immune surveillance, or exposure patterns; and human papillomavirus (HPV)-associated oropharyngeal cancers, where sex differences could involve infection dynamics, immune response to HPV, behavioral exposures, or tumor microenvironment differences. Across these examples, the common thread is interest in mechanisms that explain female and male differences in presentation, not only descriptive epidemiology.

This opportunity uses the NIH R01 mechanism, meaning it is intended for substantial, multi-year research projects with a clear conceptual framework, strong preliminary rationale, and a rigorous plan for experimentation and analysis. The FOA falls under the broad activity category of Health and lists CFDA numbers 93.121, 93.313, and 93.866, reflecting alignment with NIH program areas that support oral health and related biomedical research. The posting date and creation date are May 27, 2016, and the listed closing date for the referenced cycle is September 7, 2019, indicating it was an active opportunity during that window.

Eligibility is broad and includes many organizational types that commonly apply for NIH grants. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities and Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status (excluding institutions of higher education in those categories as specified); for-profit organizations (other than small businesses); small businesses; and additional eligible entities as described in the full FOA. In practice, this breadth is meant to encourage participation from universities, medical and dental schools, research institutes, nonprofits, and qualified companies capable of carrying out rigorous biomedical research.

Overall, PA-16-295 is aimed at strengthening the evidence base for why sex matters in dental, oral, and craniofacial health and disease. By prioritizing mechanistic work on immunity, genetics, environment, aging, and hormones, the FOA is designed to move the field toward clearer biological explanations that can ultimately inform better diagnostics, prevention strategies, and more tailored interventions for females and males experiencing DOC-related diseases and conditions.

Frequently Asked Questions (FAQs)

What is the title of this NIH funding opportunity?

The opportunity is titled Factors Underlying Differences in Female and Male Presentation for Dental, Oral, and Craniofacial Diseases and Conditions (R01).

Which agency is offering this grant?

This is a National Institutes of Health (NIH) research grant opportunity under the U.S. Department of Health and Human Services (HHS), with the agency listing noted as HHS-NIH11.

What is the Funding Opportunity Announcement (FOA) number?

The FOA number is PA-16-295.

What is the main purpose of this FOA?

The central purpose is to fund hypothesis-driven research that explains why dental, oral, and craniofacial (DOC) diseases and conditions differ in how they develop, present clinically, and progress over time in females versus males.

Is this FOA looking for studies that only document sex differences?

No. The FOA emphasizes that it is not focused on simply documenting that differences exist. It prioritizes research that uncovers biological and related mechanisms that produce sex-based differences in DOC conditions.

What does "DOC" stand for in this announcement?

DOC refers to dental, oral, and craniofacial diseases and conditions.

What research mechanism is used for this opportunity?

This opportunity uses the NIH R01 mechanism, which is intended for substantial, multi-year research projects with a clear conceptual framework, strong rationale, and a rigorous experimental and analytical plan.

What general scientific areas does the FOA encourage applicants to study?

The FOA encourages mechanistic studies across several major domains that may contribute to sex-based differences in DOC disease manifestations, including:

  • Immune reactivity (including innate and adaptive immune response differences by sex)
  • Genetic variation (including sex-linked genetic effects and differential gene regulation)
  • Environmental triggers (exposures, behaviors, infections, and other external factors that may interact with sex)
  • Aging (sex differences in age-related immune or tissue changes)
  • Hormonal changes (puberty, menstrual cycling, pregnancy, menopause, and androgen-related influences)

Does the FOA support studying interactions among factors like hormones, immunity, and environment?

Yes. The FOA highlights the importance of studying how these factors may interact, since sex differences in DOC conditions often reflect combined effects rather than a single isolated cause.

What types of diseases or conditions are mentioned as examples?

The FOA provides examples of DOC-related topics that fit the program, including:

  • Sjogrens Syndrome (SS)
  • Orofacial pain conditions
  • Temporomandibular joint disorder (TMD)
  • Salivary gland tumors
  • HPV-associated oropharyngeal cancers

Is the list of example conditions exhaustive?

No. The announcement states that the listed examples are illustrative and not exhaustive.

What is the common thread across the example conditions?

Across the examples, the common focus is on understanding the mechanisms that explain female and male differences in presentation, rather than focusing on descriptive epidemiology alone.

What kinds of sex-related influences does the FOA specifically call out under "hormonal changes"?

The FOA specifically points to hormonal influences such as puberty, menstrual cycling, pregnancy, menopause, and androgen-related influences as possible contributors to differences in susceptibility, symptoms, tissue responses, and recovery.

What activity category is associated with this FOA?

The FOA lists the activity category as Health.

Which CFDA numbers are associated with this opportunity?

The FOA lists the following CFDA numbers: 93.121, 93.313, and 93.866.

When was this opportunity posted and created?

The posting date and creation date listed are both May 27, 2016.

What is the closing date mentioned for the referenced cycle?

The listed closing date for the referenced cycle is September 7, 2019.

Who is eligible to apply for this NIH R01 opportunity?

Eligibility is broad and includes many organizational types commonly eligible for NIH grants, including:

  • State, county, city, township, and special district governments
  • Independent school districts
  • Public and state-controlled institutions of higher education
  • Private institutions of higher education
  • Federally recognized Native American tribal governments and other tribal organizations
  • Public housing authorities and Indian housing authorities
  • Nonprofit organizations with and without 501(c)(3) status (as specified in the FOA, excluding institutions of higher education in those categories)
  • For-profit organizations (other than small businesses)
  • Small businesses
  • Additional eligible entities as described in the full FOA

What kinds of organizations does the FOA appear intended to attract in practice?

Based on the breadth of eligible entity types described, the FOA is meant to encourage participation from organizations such as universities, medical and dental schools, research institutes, nonprofits, and qualified companies capable of conducting rigorous biomedical research.

What is the overall expected impact of research funded through PA-16-295?

The FOA is aimed at strengthening the evidence base for why sex matters in dental, oral, and craniofacial health and disease. By prioritizing mechanistic work in immunity, genetics, environment, aging, and hormones, it is designed to move the field toward clearer biological explanations that can ultimately inform better diagnostics, prevention strategies, and more tailored interventions for females and males with DOC-related diseases and conditions.

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