Opportunity Information: Apply for RFA DE 12 004

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Functional Restoration of Salivary Glands (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 Aug 1, 2011 and posted on Aug 1, 2011.
  • Applicants must submit their applications by Nov 29, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $3,000,000.00 to eligible and selected applicants.
  • Eligible applicants include: City or township governments Public and State controlled institutions of higher education County governments Independent school districts Small businesses Private institutions of higher education State governments For profit organizations other than small businesses Native American tribal governments (Federally recognized) Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education 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) Public housing authorities/Indian housing authorities.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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 Organizations) are eligible to apply. Foreign (non U.S.) components of U.S. Organizations are allowed.
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Opportunity Summary:

The Functional Restoration of Salivary Glands (R01) funding opportunity (RFA-DE-12-004) was a discretionary research grant announcement from the National Institutes of Health focused on developing ways to restore salivary gland function after it has been damaged. The core purpose was to stimulate research that could move beyond symptomatic management of dry mouth and instead support true functional recovery. The announcement emphasized a broad, solution-oriented scope, explicitly encouraging multiple scientific and engineering strategies that could either repair and regenerate a patient s own salivary tissue or replace lost function through creation and implantation of a bioengineered salivary gland.

From a scientific standpoint, the FOA was built around three main intervention themes: repair of injured salivary glands, regeneration of host salivary gland tissue, and replacement approaches using bioengineering. That framing leaves room for a wide range of legitimate R01-level projects, including studies of mechanisms of gland injury and recovery, stem or progenitor cell driven regeneration, tissue scaffolds and biomaterials, developmental and regenerative signaling pathways, vascular and neural integration needed for secretion, and engineered constructs intended to replicate salivary gland architecture and output. The emphasis on "functional restoration" signals that the NIH was looking for work that could plausibly lead to measurable recovery of saliva production and quality, not only histologic repair. While the short description does not list disease causes, salivary gland dysfunction is commonly associated with cancer therapies (especially head and neck radiation), autoimmune conditions such as Sjogren syndrome, medication effects, and other insults, so the FOA was positioned to attract projects relevant to these clinically important settings.

Administratively, this was an NIH R01 grant mechanism under the health research activity area, tied to CFDA 93.121 (Oral Diseases and Disorders Research). It was posted on August 1, 2011, with an original and final application due date of November 29, 2011, and it was later archived on December 30, 2011. The announcement listed an estimated total funding level of $3,000,000, indicating NIH planned to support a limited number of meritorious projects aligned with the FOA goals within that total set aside amount. The opportunity did not require cost sharing or matching, which typically lowers barriers for applicants and allows budgets to be driven by the scientific needs of the project rather than an ability to provide institutional funds.

Eligibility was intentionally expansive. In addition to the usual academic and nonprofit research institutions, eligible applicants included a wide spectrum of domestic governmental entities (state, county, city or township, special districts), public and private institutions of higher education, independent school districts, public housing authorities and Indian housing authorities, small businesses, and for profit organizations other than small businesses. The FOA also highlighted eligibility for a range of mission-driven and capacity-building institutions and organizations, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations. Importantly, the announcement allowed non-U.S. entities (foreign organizations) to apply, and it permitted foreign components of U.S. organizations, opening the door to international expertise in regenerative medicine, biomaterials, and salivary gland biology.

For prospective applicants at the time, the practical takeaway was that NIH was actively seeking R01 proposals that could credibly advance the field toward therapies that restore saliva production through biological repair, regenerative strategies, or engineered replacements. The full text of the announcement was hosted on the NIH grants site at http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-12-004.html, and support for access or linking issues was routed through the NIH Office of Extramural Research webmaster (FBOWebmaster@OD.NIH.GOV).

Frequently Asked Questions (FAQ)

What is the Functional Restoration of Salivary Glands (R01) funding opportunity?

It was an NIH discretionary research grant announcement titled "Functional Restoration of Salivary Glands (R01)" with funding opportunity number RFA-DE-12-004. It focused on developing ways to restore salivary gland function after damage, with an emphasis on moving beyond symptomatic management of dry mouth and toward true functional recovery.

Which NIH grant mechanism was used?

The opportunity used the NIH R01 research project grant mechanism.

What was the main goal of the announcement?

The core purpose was to stimulate research aimed at functional restoration of salivary glands, including approaches that could repair or regenerate a patient's own salivary tissue or replace lost function through a bioengineered salivary gland that could be created and implanted.

What kinds of approaches were encouraged?

The announcement explicitly encouraged multiple scientific and engineering strategies, including (1) repair of injured salivary glands, (2) regeneration of host salivary gland tissue, and (3) replacement approaches using bioengineering.

What were the three main intervention themes described in the FOA?

The FOA was organized around three intervention themes: repair of injured salivary glands, regeneration of host salivary gland tissue, and replacement approaches using bioengineering.

What types of research projects could fit within the scope?

Based on the description, legitimate R01-level projects could include studies on mechanisms of gland injury and recovery; stem or progenitor cell-driven regeneration; tissue scaffolds and biomaterials; developmental and regenerative signaling pathways; vascular and neural integration needed for secretion; and engineered constructs intended to replicate salivary gland architecture and output.

Does the opportunity focus on symptom management of dry mouth?

No. The announcement emphasized moving beyond symptomatic management of dry mouth and instead supporting research aimed at true functional recovery of salivary gland output.

What does "functional restoration" mean in the context of this FOA?

"Functional restoration" indicates interest in work that could plausibly lead to measurable recovery of saliva production and saliva quality, not only histologic or structural repair.

Did the description specify particular diseases or causes of salivary gland dysfunction?

The short description did not list specific disease causes. It noted that salivary gland dysfunction is commonly associated with cancer therapies (especially head and neck radiation), autoimmune conditions such as Sjogren syndrome, medication effects, and other insults, and the FOA was positioned to attract projects relevant to these clinically important settings.

What was the CFDA number and program area?

The opportunity was tied to CFDA 93.121, identified as Oral Diseases and Disorders Research.

When was the opportunity posted?

It was posted on August 1, 2011.

What were the application due dates?

The original and final application due date listed was November 29, 2011.

Is this funding opportunity still open?

No. The announcement was archived on December 30, 2011.

How much funding was expected to be available?

The announcement listed an estimated total funding level of $3,000,000, indicating NIH planned to support a limited number of meritorious projects aligned with the FOA goals within that total set-aside amount.

Did the opportunity require cost sharing or matching?

No. The opportunity did not require cost sharing or matching.

Who was eligible to apply?

Eligibility was described as expansive and included academic and nonprofit research institutions as well as many domestic governmental and organizational types, including state, county, city or township governments, special districts, public and private institutions of higher education, independent school districts, public housing authorities and Indian housing authorities, small businesses, and for-profit organizations other than small businesses.

Were mission-driven or capacity-building institutions specifically mentioned as eligible?

Yes. The FOA highlighted eligibility for Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations.

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

Yes. The announcement allowed non-U.S. entities (foreign organizations) to apply.

Were foreign components of U.S. organizations permitted?

Yes. The opportunity permitted foreign components of U.S. organizations.

Where could applicants find the full text of the announcement?

The full text was hosted on the NIH grants site at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-12-004.html

Who was listed as a contact for access or linking issues?

Support for access or linking issues was routed through the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.

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