Sponsor Deadline
Posted: 4/18/2022

Congressionally Directed Medical Research Programs (CDMRP) -- Neurofibromatosis Research Program -- Clinical Trial Consortium Award

The NFRP Clinical Trial Consortium Award mechanism was first offered in FY06, and subsequently in FY11 and FY16, with awards being made as grants or cooperative agreements. This FY21 research announcement is being offered through a different type of award mechanism, a Research Other Transaction Award (rOTA) under the authority of 10 USC 2371.

The FY21 NFRP Clinical Trial Consortium Award is intended to support a major goal/productdriven consortium of exceptional institutions and investigators that will accelerate the clinical translation of basic NF research and ultimately decrease the impact of the disease. The objectives of the rOTA are the conception, design, development, and conduct of collaborative Phase I and II clinical evaluations of promising therapeutic agents for the management or treatment of NF1, NF2, and schwannomatosis.

The NFRP Clinical Trial Consortium requires collaboration of multiple organizations and individuals for the purpose of rapidly executing clinical trials. Therefore, the offeror must have a demonstrated history of collaborative research in such a structure.

 

Deadlines:
• Required Pre-Application Submission Deadline:  Sep. 17, 2021
• Application Submission Deadline: Oct. 29, 2021

Eligibility Requirements
  • The Consortium Director at the Operations Center must be an independent investigator at or above the level of Associate Professor (or equivalent) with experience in developing and running large-scale initiatives such as clinical trials or consortia.
  • Resource sharing/matching is a requirement, with government resources not to exceed the total amount provided by other parties to the maximum extent practicable.
  • Resource sharing in a transaction occurs when a portion of the total cost of the project is to be paid out of funds provided by sources other than the federal government. Contributions can be in cash or non-cash (i.e., in-kind) form, and costs can be either direct or indirect, so long as the contributions are allowable, allocable, reasonable, and consistently accounted for by the awardee. Generally, cash contributions are preferred over in-kind contributions as they are easier to value and often represent a higher level of commitment to the success of the program.
  • Eligible investigators must apply through an organization. Organizations eligible to apply include federal agencies, national, international, for-profit, nonprofit, public, and private organization
Amount Description

The maximum period of performance for this initial award is 10 years. The USAMRDC may consider extending this period of performance to include noncompetitive follow-on work contingent upon receipt of future congressional appropriations.

Upon award, funding from the government of proposals received in response to this research announcement is expected to be limited to approximately $25M, of which $5M is currently available, contingent upon the availability of federal funds for this program. Funding for any trials proposed after the FY21 funding cycle is contingent upon receipt of future congressional appropriations.

Funding Type
Eligibility
Posted
4/18/2022
Deadline
Sponsor: