Opportunity Information: Apply for RFA CA 13 006
Apply for RFA CA 13 006
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "NCI Experimental Therapeutics Clinical Trials Network with Phase 1 Emphasis (ET CTN) (UM1)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.395 Cancer Treatment Research.
- This funding opportunity was created on Feb 8, 2013 and posted on Feb 8, 2013.
- Applicants must submit their applications by Aug 23, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $8,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $850,000.00 in funding.
- The number of recipients for this funding is limited to 10 candidate(s).
- Eligible applicants include: Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education State governments Others (see text field entitled Additional Information on Eligibility for clarification).
- 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 Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Non domestic (non U.S.) Entities (Foreign Organizations) Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply but only if they are based in Canada. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply except for Canadian components. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NCI Experimental Therapeutics Clinical Trials Network with Phase 1 Emphasis (ET CTN) (UM1) funding opportunity (RFA-CA-13-006) is a National Cancer Institute (NCI) initiative designed to strengthen and streamline the nation-wide system for running early-stage cancer treatment trials. The main goal is to build a single, coordinated experimental therapeutics clinical trials program, called the ET CTN, that brings together multidisciplinary teams to plan and carry out early phase clinical studies, with a clear emphasis on Phase 1 testing. In practical terms, this program is meant to improve how promising investigational cancer agents move from concept to first-in-human evaluation and other early clinical testing, using a shared network structure rather than disconnected efforts across separate groups.
This opportunity uses the UM1 cooperative agreement mechanism, which signals that awardees will not operate completely independently; instead, they will work closely with NCI in a collaborative, networked model. The trials supported through this network are tied directly to Investigational New Drug (IND) applications held by NCI, specifically through the Division of Cancer Treatment and Diagnosis (DCTD) and its Cancer Therapy Evaluation Program (CTEP). A core feature of the ET CTN model is that network members participate in investigational-agent-specific, trans-network project teams. Those teams are expected to shape the drug development plan for specific agents and then execute experimental therapeutics clinical trials aligned with that plan. The emphasis on “experimental therapeutics” highlights that these trials are not only about establishing basic safety, but also about generating informative early clinical data that can guide whether and how an agent should advance, including the kinds of endpoints, patient populations, and translational questions that help a development program move forward efficiently.
From a funding and scale standpoint, the announcement anticipated around 10 awards, with an estimated total funding level of about $8.5 million. The listed award ceiling is $850,000. There is no cost sharing or matching requirement, meaning applicants are not required to contribute non-federal funds as a condition of the award. The activity aligns with CFDA 93.395 (Cancer Treatment Research), reflecting its focus on clinical evaluation of cancer therapies rather than, for example, basic discovery work or purely observational research.
Eligibility is broad and includes many types of organizations that can credibly support early-phase clinical trials infrastructure and operations. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), small businesses, and for-profit organizations other than small businesses, as well as state governments and other entities referenced in the full FOA. The eligibility language also explicitly includes several institution types often highlighted in federal research programs, such as Historically Black Colleges and Universities (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 (AANAPISIs), along with eligible federal agencies. International participation is limited: non-U.S. entities may apply only if they are based in Canada, and non-U.S. components of U.S. organizations are generally not eligible unless they are Canadian components. At the same time, “foreign components” as defined by NIH policy are allowed, which typically means a U.S. applicant could include certain foreign elements within a project when permitted and justified under NIH rules.
Key administrative details place this opportunity in 2013: it was posted and created on February 8, 2013, with an original and current closing date of August 23, 2013, and an archive date of September 23, 2013. The sponsoring agency is the National Institutes of Health (NIH), through NCI, and the primary web source for the full announcement was hosted on the NIH grants site. For access or technical issues, the announcement directs inquiries to the NIH Office of Extramural Research (OER) webmaster contact. Overall, the ET CTN (UM1) announcement reflects NCI’s intent to run a coordinated, NCI-led early clinical therapeutics enterprise where awardee groups help design and execute Phase 1-focused, IND-enabling and IND-supported studies for investigational cancer agents managed through CTEP.
Frequently Asked Questions (FAQs)
What is the ET CTN (UM1) funding opportunity?
The NCI Experimental Therapeutics Clinical Trials Network with Phase 1 Emphasis (ET CTN) (UM1) funding opportunity (RFA-CA-13-006) is a National Cancer Institute (NCI) initiative to strengthen and streamline the nationwide system for conducting early-stage cancer treatment trials. It is designed to build a single, coordinated experimental therapeutics clinical trials program (the ET CTN) that brings multidisciplinary teams together to plan and conduct early phase clinical studies, with a clear emphasis on Phase 1 testing.
What is the main goal of this program?
The main goal is to create a unified, coordinated network for experimental therapeutics clinical trials so that promising investigational cancer agents can move more efficiently from concept to first-in-human evaluation and other early clinical testing, using a shared network structure rather than disconnected efforts across separate groups.
What types of clinical trials does ET CTN focus on?
The program focuses on early phase clinical studies with a strong emphasis on Phase 1 trials. The emphasis on experimental therapeutics indicates the trials are intended not only to assess basic safety, but also to generate informative early clinical data that can guide whether and how an agent should advance in development.
What does "experimental therapeutics" mean in this context?
In this opportunity, "experimental therapeutics" highlights early clinical testing designed to produce data that informs drug development decisions, such as appropriate endpoints, patient populations, and translational questions that help a development program move forward efficiently, beyond establishing initial safety.
What is the funding mechanism used for this opportunity?
This opportunity uses the UM1 cooperative agreement mechanism.
What does a UM1 cooperative agreement imply about NCI involvement?
A UM1 cooperative agreement indicates awardees will not operate completely independently. Instead, awardees are expected to work closely with NCI in a collaborative, networked model.
How are the supported trials connected to IND applications?
Trials supported through this network are tied directly to Investigational New Drug (IND) applications held by NCI, specifically through the Division of Cancer Treatment and Diagnosis (DCTD) and its Cancer Therapy Evaluation Program (CTEP).
What role do trans-network project teams play?
A core feature of the ET CTN model is participation in investigational-agent-specific, trans-network project teams. These teams are expected to shape the drug development plan for specific agents and then execute experimental therapeutics clinical trials aligned with that plan.
How many awards were anticipated under this announcement?
The announcement anticipated approximately 10 awards.
What was the estimated total funding level for the program?
The estimated total funding level was about $8.5 million.
What is the maximum award amount (award ceiling)?
The listed award ceiling is $850,000.
Is cost sharing or matching required?
No. There is no cost sharing or matching requirement, meaning applicants are not required to contribute non-federal funds as a condition of the award.
What CFDA number is associated with this opportunity?
This opportunity aligns with CFDA 93.395 (Cancer Treatment Research).
What kinds of organizations are eligible to apply?
Eligibility includes a broad range of organizations, including public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), small businesses, for-profit organizations other than small businesses, and state governments, as well as other entities referenced in the full FOA.
Are minority-serving institutions included in the eligibility language?
Yes. The eligibility language explicitly includes institution types such as Historically Black Colleges and Universities (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 (AANAPISIs), along with eligible federal agencies.
Are non-U.S. organizations eligible to apply?
International participation is limited. Non-U.S. entities may apply only if they are based in Canada.
Can a U.S. organization include non-U.S. components?
Non-U.S. components of U.S. organizations are generally not eligible unless they are Canadian components. At the same time, "foreign components" as defined by NIH policy are allowed, which typically means a U.S. applicant could include certain foreign elements within a project when permitted and justified under NIH rules.
When was this funding opportunity posted?
It was posted and created on February 8, 2013.
What was the application closing date?
The original and current closing date was August 23, 2013.
When was the opportunity archived?
The archive date was September 23, 2013.
Which agency sponsored this opportunity?
The sponsoring agency is the National Institutes of Health (NIH), through the National Cancer Institute (NCI).
Where was the full announcement hosted?
The primary web source for the full announcement was hosted on the NIH grants site.
Who should be contacted for access or technical issues related to the announcement?
For access or technical issues, the announcement directs inquiries to the NIH Office of Extramural Research (OER) webmaster contact.
What is the overall intent of the ET CTN (UM1) announcement?
Overall, the announcement reflects NCI's intent to run a coordinated, NCI-led early clinical therapeutics enterprise where awardee groups help design and execute Phase 1-focused, IND-enabling and IND-supported studies for investigational cancer agents managed through CTEP.
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