Opportunity Information: Apply for RFA DK 14 016

  • The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Type 1 Diabetes TrialNet Clinical Centers (U01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
  • This funding opportunity was created on Aug 15, 2014 and posted on Aug 15, 2014.
  • Applicants must submit their applications by Dec 3, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $2,000,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $450,000.00 in funding.
  • Eligible applicants include: Public and State controlled institutions of higher education State governments Public housing authorities/Indian housing authorities Independent school districts Native American tribal governments (Federally recognized) Small businesses County governments Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal 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 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. The only non domestic (non U.S.) Entities that are eligible to apply are those located in North America.
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Opportunity Summary:

The Type 1 Diabetes TrialNet Clinical Centers (U01) opportunity (Funding Opportunity Number RFA-DK-14-016) is a National Institutes of Health (NIH) cooperative agreement designed to strengthen and sustain the clinical infrastructure behind Type 1 Diabetes TrialNet. TrialNet is an international network of clinical research centers focused on delaying or preventing type 1 diabetes (T1D). This FOA is not primarily about funding a single new scientific hypothesis; instead, it supports the people, systems, and operational capacity that allow TrialNet Clinical Centers to consistently carry out TrialNet studies and clinical trials, including the practical work of identifying eligible participants, enrolling them, administering interventions when applicable, and conducting required follow-up over time.

The award mechanism is a U01 cooperative agreement, which generally indicates a more hands-on partnership between NIH and the awardee than a standard grant. In practical terms, the expectation is that funded Clinical Centers will operate as part of a coordinated consortium, following TrialNet protocols, meeting common performance and reporting expectations, and collaborating closely with the broader TrialNet structure. The supported activities center on recruiting, treating, and following research participants in TrialNet trials and studies, which may include screening and monitoring individuals at elevated risk for T1D as well as participating in intervention or prevention-oriented clinical research efforts.

A specific feature of this announcement is that it provides funds not only for the main Clinical Centers, but also for Clinical Centers to support Affiliate Sites. Affiliate Sites typically expand geographic reach and access to participants by enabling additional locations to conduct screening, enrollment, and certain study procedures under the oversight and systems of the parent Clinical Center. This structure is intended to help TrialNet reach more families and at-risk individuals, reduce barriers to participation, and increase the pace and quality of enrollment into prevention and delay trials.

The opportunity was posted on August 15, 2014, with an original and current closing date of December 3, 2014, and an archive date of January 3, 2015. The FOA listed an estimated total funding amount of $2,000,000, with an award ceiling of $450,000. There is no cost-sharing or matching requirement, meaning applicants were not required to contribute non-federal matching funds as a condition of the award.

Eligibility is broad and includes many types of domestic organizations and governments, such as public and private institutions of higher education, nonprofits (including both 501(c)(3) and non-501(c)(3) organizations), small businesses, for-profit organizations (other than small businesses), and various levels of government (state, county, city/township, special district), as well as independent school districts and public or Indian housing authorities. The eligibility language also explicitly includes a wide range of mission-serving and community-based institutions and organizations, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISI institutions, along with faith-based and community-based organizations and eligible federal agencies.

The FOA also allows non-U.S. participation with defined limits. Non-domestic entities (foreign organizations and foreign institutions) are eligible, and foreign components of U.S. organizations are allowed as described in NIH policy, but the only non-U.S. entities eligible to apply directly are those located in North America. In addition, non-domestic components of U.S. organizations are eligible, and foreign components are permitted under NIH definitions and rules, which supports TrialNet’s international, networked model while still constraining eligibility to meet the program’s geographic and administrative requirements.

Administrative details provided in the source indicate the program is cataloged under CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research) and is categorized under the broader funding activity area of Food and Nutrition/Health. For further official details, NIH provided the full announcement link through the NIH grants guide (http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-14-016.html). For access issues or linking problems, the contact point listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.

FAQs: Type 1 Diabetes TrialNet Clinical Centers (U01) - RFA-DK-14-016

What is the Type 1 Diabetes TrialNet Clinical Centers (U01) funding opportunity?

It is an NIH cooperative agreement (U01) funding opportunity (Funding Opportunity Number RFA-DK-14-016) intended to strengthen and sustain the clinical infrastructure that supports Type 1 Diabetes TrialNet, an international network of clinical research centers focused on delaying or preventing type 1 diabetes (T1D).

What is the main purpose of this FOA?

The FOA is designed to support the people, systems, and operational capacity needed for TrialNet Clinical Centers to consistently carry out TrialNet studies and clinical trials. It is not primarily focused on funding a single new scientific hypothesis, but on enabling reliable TrialNet operations across participating sites.

What does "TrialNet" refer to in this announcement?

TrialNet is an international network of clinical research centers that conducts clinical research aimed at delaying or preventing type 1 diabetes. This FOA supports the clinical center infrastructure that makes TrialNet studies and trials possible in practice.

What does it mean that this is a U01 cooperative agreement?

A U01 cooperative agreement generally indicates a more hands-on partnership between NIH and the awardee than a standard grant. Under this FOA, funded Clinical Centers are expected to operate as part of a coordinated consortium, follow TrialNet protocols, meet common performance and reporting expectations, and collaborate closely within the broader TrialNet structure.

What activities are Clinical Centers expected to support?

Supported activities focus on recruiting, treating (when applicable), and following research participants in TrialNet trials and studies. This includes practical work such as identifying eligible participants, enrolling them, administering interventions when applicable, and conducting required follow-up over time.

Does this funding support screening and monitoring people at risk for type 1 diabetes?

Yes. The FOA describes activities that may include screening and monitoring individuals at elevated risk for T1D, as well as participating in intervention or prevention-oriented clinical research efforts conducted through TrialNet.

How does the FOA address geographic reach and access for participants?

A specific feature of the announcement is that it provides funds not only for main Clinical Centers, but also for Clinical Centers to support Affiliate Sites. Affiliate Sites help expand geographic reach and access by enabling additional locations to conduct screening, enrollment, and certain study procedures under the oversight and systems of the parent Clinical Center.

What are Affiliate Sites in this program?

Affiliate Sites are additional locations associated with a parent Clinical Center. They typically help extend TrialNet's reach by supporting screening, enrollment, and certain procedures, while operating under the oversight and systems of the main Clinical Center.

Why does the FOA include support for Affiliate Sites?

The Affiliate Site structure is intended to help TrialNet reach more families and at-risk individuals, reduce barriers to participation, and increase the pace and quality of enrollment into prevention and delay trials.

When was this funding opportunity posted, and what were the key dates?

The opportunity was posted on August 15, 2014. The original and current closing date listed was December 3, 2014. The archive date was January 3, 2015.

How much total funding was estimated under this FOA?

The FOA listed an estimated total funding amount of $2,000,000.

What was the award ceiling for an individual award?

The award ceiling listed in the FOA was $450,000.

Is cost-sharing or matching required?

No. The FOA states there is no cost-sharing or matching requirement, meaning applicants were not required to contribute non-federal matching funds as a condition of the award.

Who is eligible to apply?

Eligibility is broad and includes many types of domestic organizations and governments, such as public and private institutions of higher education; nonprofit organizations (including 501(c)(3) and non-501(c)(3)); small businesses; for-profit organizations (other than small businesses); and various levels of government (state, county, city/township, special district), as well as independent school districts and public or Indian housing authorities. The FOA also explicitly includes a wide range of mission-serving and community-based institutions, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISI institutions, along with faith-based and community-based organizations and eligible federal agencies.

Are for-profit organizations eligible?

Yes. The eligibility list includes small businesses and for-profit organizations (other than small businesses), among other eligible applicant types.

Are government entities eligible to apply?

Yes. The FOA includes eligibility for various levels of government, including state, county, city/township, and special district governments, as well as independent school districts and public or Indian housing authorities.

Does the FOA specifically include minority-serving and community-based institutions?

Yes. The eligibility language explicitly includes institutions such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISI institutions. It also includes faith-based and community-based organizations.

Can non-U.S. organizations apply?

Yes, with limits. Non-domestic entities (foreign organizations and foreign institutions) are eligible, but the only non-U.S. entities eligible to apply directly are those located in North America.

Are foreign components of U.S. organizations allowed?

Yes. The FOA allows foreign components of U.S. organizations as described in NIH policy, and it also notes that non-domestic components of U.S. organizations are eligible under NIH definitions and rules.

What is the CFDA number associated with this program?

The program is cataloged under CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).

What is the broader funding activity area listed for this FOA?

The FOA is categorized under the broader funding activity area of Food and Nutrition/Health.

Where can applicants find the full official announcement?

NIH provided the full announcement link through the NIH grants guide at http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-14-016.html.

Who should be contacted for access issues or problems with the official link?

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

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