Opportunity Information: Apply for RFA DK 09 503
Apply for RFA DK 09 503
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Limited Competition Clinical Centers and Data Coordinating Center for the Complementary and Alternative Medicine for Urological Symptoms (CAMUS) Trial (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213 Research and Training in Complementary and Integrative Health 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
- This funding opportunity was created on Sep 17, 2009 and posted on Sep 17, 2009.
- Applicants must submit their applications by Nov 17, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $600,000.00 to eligible and selected applicants.
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments City or township governments Private institutions of higher education Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses Independent school districts Nonprofits that do not have 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) County governments Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Special district governments 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:
This funding opportunity (RFA DK 09 503) is a limited competition cooperative agreement (U01) issued by the National Institutes of Health, through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Its main goal is not to start a new study, but to keep an existing, ongoing clinical trial on track through completion. Specifically, it supports continued treatment and participant follow-up at the established recruiting sites, along with ongoing data coordination, final study closeout, and the final statistical analysis needed to produce the trial results.
The underlying project is the Complementary and Alternative Medicine for Urological Symptoms (CAMUS) Study, a randomized, placebo-controlled clinical trial evaluating phytotherapy with saw palmetto in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). At the time of the announcement, 370 men had already been randomized and were actively receiving study treatment and follow-up across 11 Clinical Centers. Because participants were already enrolled and the trial infrastructure was already in place, the limited competition format reflects the intent to fund the existing CAMUS network to finish what it started rather than expand to new sites or launch new recruitment.
The FOA funds two core functions. First, it supports the 11 Clinical Centers so they can continue delivering the study intervention, monitoring participant safety and adherence, collecting protocol-specified outcomes, and completing follow-up visits through the end of the trial. Second, it supports the Data Coordinating Center (DCC), which is responsible for continued trial-wide data collection and management, coordinating data flow and quality control across all sites, maintaining the central database, supporting required reporting, and leading the orderly closeout of the study. The DCC is also expected to conduct the final analyses once follow-up is complete, which is essential for determining whether saw palmetto demonstrates benefit compared with placebo for the targeted urinary symptom outcomes.
In terms of funding and expected awards, NIDDK planned to commit about $600,000 total in FY 2010 to make 12 awards in all: 11 awards for the Clinical Centers and 1 award for the Data Coordinating Center. The announcement also notes an intention to provide a single additional award of up to $200,000 to the Data Coordinating Center in FY 2011, reflecting the reality that centralized coordination and analysis work often continues after the last participant visit as databases are locked, queries are resolved, and final analyses and reports are completed.
Administratively, the opportunity was posted on September 17, 2009, with an original and current closing date of November 17, 2009, and it was archived on December 18, 2009. The funding instrument is a cooperative agreement (U01), which typically means NIH staff anticipate having substantial programmatic involvement in the conduct of the project compared with a standard research project grant. There is no cost sharing or matching requirement stated. The activity categories and CFDA listings tied to the announcement include 93.213 (Research and Training in Complementary and Integrative Health) and 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), reflecting both the complementary/integrative therapy being tested and the NIDDK mission area that includes kidney and urologic conditions.
Eligibility is broad on paper and includes many organization types, such as nonprofit and for-profit entities, public and private institutions of higher education, state and local governments, tribal governments and organizations, and certain designated institution types (for example, HBCUs, Hispanic-serving institutions, tribally controlled colleges, and Alaska Native/Native Hawaiian-serving institutions), as well as non-U.S. entities and regional organizations. However, because this is explicitly a limited competition tied to continuing an existing multi-site trial with 11 active clinical centers and a designated coordinating structure, the practical applicant pool is effectively constrained to the established CAMUS participating institutions and coordinating center capable of immediately continuing the protocol-specified responsibilities without interruption.
Overall, this FOA is best understood as a continuation and completion mechanism for a late-stage, ongoing randomized clinical trial in men with LUTS/BPH, ensuring that participant care and follow-up are finished properly at the clinical sites, and that the coordinating center has resources to manage the data, close out operations cleanly, and deliver the final analyses needed to report definitive findings on saw palmetto versus placebo.
Frequently Asked Questions (FAQs)
What is the name and identifier of this funding opportunity?
This opportunity is identified as RFA DK 09 503. It is issued by the National Institutes of Health (NIH) through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
What type of award is being offered?
The funding instrument is a cooperative agreement (U01). A U01 mechanism typically involves substantial programmatic involvement by NIH staff compared with a standard research project grant.
What is the main purpose of this FOA?
The primary purpose is to keep an existing, ongoing clinical trial on track through completion. It is designed to support continued treatment and participant follow-up at established recruiting sites, along with ongoing data coordination, final study closeout, and the final statistical analysis needed to produce trial results.
Is this FOA intended to start a new clinical trial?
No. The FOA is specifically described as a continuation and completion mechanism for an ongoing trial, rather than a mechanism to initiate a new study.
Which clinical trial does this FOA support?
This FOA supports the Complementary and Alternative Medicine for Urological Symptoms (CAMUS) Study.
What is the CAMUS Study evaluating?
CAMUS is a randomized, placebo-controlled clinical trial evaluating phytotherapy with saw palmetto in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
How many participants were already enrolled at the time of the announcement?
At the time of the announcement, 370 men had already been randomized and were actively receiving study treatment and follow-up.
How many sites are involved in the CAMUS Study?
The trial includes 11 Clinical Centers conducting participant treatment and follow-up.
Why is this a limited competition?
The FOA is a limited competition because participants were already enrolled and the trial infrastructure was already in place. The intent is to fund the existing CAMUS network to finish the trial rather than expand to new sites or launch new recruitment.
What core functions does the FOA fund?
The FOA funds two core functions: (1) continued operations at the 11 Clinical Centers, and (2) continued operations at the Data Coordinating Center (DCC), including final analysis and closeout activities.
What activities are supported at the Clinical Centers?
Clinical Centers are supported to continue delivering the study intervention, monitoring participant safety and adherence, collecting protocol-specified outcomes, and completing follow-up visits through the end of the trial.
What activities are supported at the Data Coordinating Center (DCC)?
The DCC is supported to continue trial-wide data collection and management, coordinate data flow and quality control across all sites, maintain the central database, support required reporting, lead the orderly study closeout, and conduct the final statistical analyses once follow-up is complete.
What is meant by "final study closeout" in this FOA?
Based on the description provided, closeout includes completing follow-up, managing end-of-study data activities, coordinating query resolution, locking the database, and completing final analyses and reporting needed to deliver definitive trial results.
How many awards were expected, and what were they for?
NIDDK planned to make 12 awards total in FY 2010: 11 awards for the Clinical Centers and 1 award for the Data Coordinating Center.
How much funding did NIDDK plan to commit in FY 2010?
NIDDK planned to commit approximately $600,000 total in FY 2010 to support the 12 awards.
Was any additional funding described beyond FY 2010?
Yes. The FOA notes an intention to provide a single additional award of up to $200,000 to the Data Coordinating Center in FY 2011 to support continued centralized coordination and analysis work after the last participant visit.
Why would the DCC need support after participant follow-up ends?
The FOA indicates that centralized coordination and analysis often continue after the last participant visit, including resolving data queries, locking the database, and completing final analyses and reports.
Does this opportunity require cost sharing or matching funds?
No cost sharing or matching requirement is stated for this opportunity.
Who is the sponsoring NIH Institute for this FOA?
The FOA is issued through NIDDK, part of the National Institutes of Health.
What are the relevant CFDA listings mentioned for this opportunity?
The CFDA listings tied to the announcement include 93.213 (Research and Training in Complementary and Integrative Health) and 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
Why are there two CFDA listings associated with this FOA?
The CFDA listings reflect both the complementary/integrative therapy being tested (saw palmetto phytotherapy) and the NIDDK mission area that includes kidney and urologic conditions.
What is the posting date for this FOA?
The opportunity was posted on September 17, 2009.
What was the application closing date?
The original and current closing date listed is November 17, 2009.
Is this FOA still open?
No. The opportunity was archived on December 18, 2009.
What types of organizations are listed as eligible?
Eligibility is described broadly and includes nonprofit and for-profit entities, public and private institutions of higher education, state and local governments, tribal governments and organizations, certain designated institution types (such as HBCUs, Hispanic-serving institutions, tribally controlled colleges, and Alaska Native/Native Hawaiian-serving institutions), and non-U.S. entities and regional organizations.
If eligibility is broad, who can realistically apply?
Despite broad eligibility language, this is explicitly a limited competition tied to continuing an existing multi-site trial with 11 active Clinical Centers and a designated coordinating structure. Practically, the applicant pool is constrained to established CAMUS participating institutions and the coordinating center that can immediately continue protocol-specified responsibilities without interruption.
Does this FOA support expanding the CAMUS Study to new clinical sites?
The description emphasizes continuing the existing CAMUS network to finish the trial, and it does not describe expansion to new sites.
Does this FOA support recruiting new participants?
The FOA is framed around continued treatment and follow-up for already-enrolled participants and does not indicate new recruitment as a goal.
What is the end product expected from this funding?
The funding is intended to ensure the trial completes participant follow-up, closes out properly, and produces final statistical analyses to determine whether saw palmetto demonstrates benefit compared with placebo for the targeted urinary symptom outcomes.
What patient population is the CAMUS Study focused on?
The study population is men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
What treatment is being studied in CAMUS?
The intervention being evaluated is phytotherapy with saw palmetto, compared against placebo.
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