Opportunity Information: Apply for PAR 13 268
Apply for PAR 13 268
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "NIDDK Multi Center Clinical Study Implementation Planning Cooperative Agreements (U34)" 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 Dec 11, 2014 and posted on Jul 9, 2013.
- Applicants must submit their applications by Dec 12, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $225,000.00 in funding.
- Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) County governments Special district governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Independent school districts Private institutions of higher education State governments Native American tribal governments (Federally recognized) Small businesses.
- 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) 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:
The NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreement (U34) (PAR-13-268) is a National Institutes of Health funding opportunity that supports the planning phase for investigator-initiated, multi-center clinical studies in NIDDK mission areas (including diabetes, digestive diseases, and kidney diseases; CFDA 93.847). A key feature of this program is that NIDDK requires a two-step pathway for multi-center clinical studies with three or more sites: first a U34 planning award to build and vet the study, and only then, if planning milestones are successfully completed, a subsequent application for a U01 cooperative agreement to fund the actual conduct of the clinical study. In other words, this U34 is not meant to run the trial; it is meant to do the work that makes a multi-site clinical study ready, credible, and executable.
The purpose of the U34 is to strengthen proposed multi-center clinical studies early, before large-scale resources are committed. It is specifically designed to allow peer reviewers and NIDDK to evaluate the scientific rationale and overall need for the proposed study at an early stage, and to assess whether the study design and protocol are sound, feasible, and appropriately powered and organized for a multi-site environment. The award provides dedicated support to develop the core operational and regulatory documentation that a complex clinical study needs to launch cleanly. This includes creating a detailed manual of operations (often a central reference that standardizes procedures across sites), along with other essential elements required for conduct of the study, such as finalized protocols, plans for recruitment and retention, data collection and management procedures, quality control and assurance processes, safety monitoring approaches, and the organizational structure for coordinating multiple clinical sites.
Because the U34 is a cooperative agreement, it generally implies a more substantial programmatic role for NIH staff than a standard research grant mechanism, with ongoing coordination and input consistent with cooperative agreement norms. The announcement explicitly notes that consultation with NIDDK staff is strongly encouraged prior to submitting a U34 application, signaling that applicants are expected to discuss fit, expectations, and planning deliverables with program staff ahead of time. Completion of the required U34 products is not optional or merely recommended; it is described as a prerequisite for submitting the follow-on U01 application that would support implementation and execution of the study itself.
From an administrative standpoint, this opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument. The listed award ceiling is $225,000, and the opportunity indicates there is no cost-sharing or matching requirement. The opportunity was posted July 9, 2013 (created December 11, 2014) and is now archived, with key dates showing an original closing date of February 14, 2017, a current closing date of December 12, 2014, and an archive date of January 11, 2015. While archived opportunities are no longer open, the structure described (U34 planning followed by U01 implementation for multi-center studies) reflects how NIDDK has historically managed risk and readiness for complex, multi-site clinical research.
Eligibility is broad across many U.S.-based organization types, including public and private institutions of higher education, nonprofit organizations (both 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations other than small businesses, and small businesses, as well as a range of government entities (state, county, city/township, special district), independent school districts, and public housing authorities/Indian housing authorities. The eligibility language also highlights inclusion of various mission-focused and community-anchored institutions and organizations, such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and Asian American Native American Pacific Islander-serving institutions, along with faith-based or community-based organizations and U.S. territories or possessions. Non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations are not eligible to apply; however, foreign components as defined under NIH policy are allowed, which typically means specific elements of the project may be performed outside the U.S. under NIH rules even though the applicant organization must be eligible and primarily U.S.-based.
Overall, the U34 mechanism is best understood as a structured, funded “readiness and launch preparation” phase for multi-center clinical studies in NIDDK’s portfolio. It is intended to force early clarity on whether a proposed study is justified, whether the design will answer the question reliably, and whether the operational plan is mature enough to succeed across three or more clinical sites. Successful completion positions investigators to submit a stronger U01 application for the actual clinical study conduct, with major protocol and operations risks already addressed during the U34 period. For more detail, the archived announcement is linked at http://grants.nih.gov/grants/guide/pa-files/PAR-13-268.html, and the NIH Office of Extramural Research lists contacts for technical difficulties accessing the full announcement.
FAQs: NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreement (U34) (PAR-13-268)
What is PAR-13-268 (NIDDK U34) designed to support?
PAR-13-268 supports the planning phase for investigator-initiated, multi-center clinical studies in NIDDK mission areas. It funds the work needed to make a complex, multi-site clinical study ready to launch, rather than funding the actual conduct of the trial.
Is this U34 meant to fund the actual clinical study (run the trial)?
No. This U34 is described as a planning award. It is intended to produce the operational, regulatory, and protocol deliverables required to responsibly start a multi-center clinical study, not to conduct the study itself.
What is the required two-step pathway NIDDK uses for multi-center studies with three or more sites?
NIDDK requires a two-step pathway for multi-center clinical studies with three or more sites: first, a U34 planning award to build and vet the study; then, only if U34 planning milestones are successfully completed, a subsequent application for a U01 cooperative agreement to fund implementation and conduct of the clinical study.
When would an applicant apply for the U01?
The follow-on U01 application is submitted after completing the U34 planning work and required products. The U34 deliverables are described as a prerequisite for submitting the U01 that would support the study’s execution.
Why does NIDDK use a U34 planning award before a U01 implementation award?
The program is intended to strengthen proposed multi-center clinical studies early, before large-scale resources are committed. It enables peer reviewers and NIDDK to assess scientific rationale, overall need, and whether the study design and protocol are sound, feasible, and appropriately powered and organized for a multi-site environment.
What kinds of planning deliverables does the U34 support?
The U34 provides dedicated support to develop core operational and regulatory documentation needed to launch a complex clinical study. Examples listed include a detailed manual of operations and other essential elements required for conduct of the study.
Does the opportunity specifically mention a Manual of Operations?
Yes. The announcement description highlights creating a detailed manual of operations as a central reference to standardize procedures across participating sites.
What other study elements are expected to be developed during the U34 period?
The description lists multiple elements needed to support study conduct, including finalized protocols, recruitment and retention plans, data collection and management procedures, quality control and quality assurance processes, safety monitoring approaches, and the organizational structure for coordinating multiple clinical sites.
Are the U34 planning products optional?
No. The completion of required U34 products is described as a prerequisite for submitting the follow-on U01 application. In other words, these deliverables are treated as required, not optional.
What does it mean that this award is a cooperative agreement (U34)?
As a cooperative agreement, the mechanism generally implies a more substantial programmatic role for NIH staff than a standard research grant, with ongoing coordination and input consistent with cooperative agreement norms.
Is contacting NIDDK staff before submitting encouraged?
Yes. The description explicitly notes that consultation with NIDDK staff is strongly encouraged prior to submitting a U34 application, indicating that applicants are expected to discuss fit, expectations, and planning deliverables with program staff ahead of time.
What clinical areas does NIDDK consider within its mission for this opportunity?
The opportunity applies to NIDDK mission areas, including diabetes, digestive diseases, and kidney diseases.
What CFDA number is associated with this opportunity?
The information provided lists CFDA 93.847.
What is the maximum award amount (award ceiling) listed?
The listed award ceiling is $225,000.
Is cost sharing or matching required?
No. The opportunity indicates there is no cost-sharing or matching requirement.
What type of funding is this categorized as?
From an administrative standpoint, it is categorized as discretionary funding and uses the cooperative agreement funding instrument.
Is this funding opportunity currently open?
No. The opportunity is described as archived, which means it is no longer open for applications.
What dates are provided for posting and archiving?
The opportunity was posted July 9, 2013, created December 11, 2014, and has an archive date of January 11, 2015. Key dates also show an original closing date of February 14, 2017, and a current closing date of December 12, 2014.
Who is eligible to apply (in general terms)?
Eligibility is broad across many U.S.-based organization types, including public and private institutions of higher education, nonprofit organizations (501(c)(3) and certain non-501(c)(3) entities), for-profit organizations other than small businesses, small businesses, and various government entities (state, county, city/township, special district).
Are K-12 education entities and housing authorities included in eligible organization types?
Yes. The eligibility language includes independent school districts and public housing authorities/Indian housing authorities.
Are community-anchored and mission-focused institutions included (such as HBCUs and tribal colleges)?
Yes. The eligibility highlights inclusion of HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and Asian American Native American Pacific Islander-serving institutions, among others.
Are faith-based or community-based organizations included in eligibility?
Yes. The eligibility language explicitly includes faith-based or community-based organizations.
Are U.S. territories or possessions included?
Yes. The eligibility language includes U.S. territories or possessions.
Can non-U.S. (foreign) institutions apply as the applicant organization?
No. Non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations are described as not eligible to apply.
Are any foreign activities allowed at all under this opportunity?
Yes, as described: foreign components (as defined under NIH policy) are allowed. This typically means specific elements of the project may be performed outside the U.S. under NIH rules, even though the applicant organization must be eligible and primarily U.S.-based.
What is the main practical value of completing a U34 successfully?
Successful completion positions investigators to submit a stronger U01 application for the actual study conduct, with major protocol and operations risks already addressed during the U34 period.
Where is the archived funding announcement link provided?
The archived announcement is linked at http://grants.nih.gov/grants/guide/pa-files/PAR-13-268.html.
What if someone has technical difficulties accessing the full announcement?
The NIH Office of Extramural Research is noted as listing contacts for technical difficulties accessing the full announcement.
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