DoD Neurofibromatosis, Clinical Trial Consortium Award

Notice ID:

W81XWH-21-NFRP-CTCA

Department/Ind. Agency:

DEPT OF DEFENSE

Sub-tier:

DEPT OF DEFENSE

Sub Command:

W4PZ USA MED RSCH ACQUIS ACT

Office:

W4PZ USA MED RSCH ACQUIS ACT

All Dates/Times are:

(UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA

Updated Published Date:

(UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA

Original Published Date:

2021-08-20 14:21:00

Original Response Date:

Oct 29, 2021 11:59 pm EDT

Inactive Policy:

15 days after response date

Original Inactive Date:

Nov 13, 2021

Initiative:

• None***--***

Product Service Code:

AN13 - Health R&D Services; Health care services; Experimental Development

NAICS Code:

54171 - Research and Development in the Physical, Engineering, and Life Sciences

Original Set Aside:

Applications to the Fiscal Year 2021 (FY21) Neurofibromatosis Research Program (NFRP) are being solicited by the U.S. Army Medical Research Acquisition Activity (USAMRAA) using delegated authority provided by United States Code, Title 10, Section 2371 (10 USC 2371). The execution managing agent for this research announcement is the Congressionally Directed Medical Research Programs (CDMRP). The NFRP was initiated in 1996 to provide support for research of exceptional scientific merit that promotes the understanding, diagnosis, and treatment of neurofibromatosis (NF) including NF type 1 (NF1) and type 2 (NF2) and schwannomatosis. This FY21 Research Announcement is being offered as a Research Other Transaction Agreement (rOTA) under the authority of 10 USC 2371. The FY21 NFRP Clinical Trial Consortium Award is intended to support a major goal/product-driven 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. Studies supported by this award will include: · Phase 1 and Phase 2 trials which are the primary focus of this award. · Certain observational trials with appropriate justification and at the discretion of the USAMRAA Agreements Officer. To be included, observational studies will require review by the NFRP Advisory Board and Program Office. · Correlative studies as a part of a trial funded by this award may be considered. · Support for repositories/tissue collection from NFRP Clinical Trial Consortium clinical trials supported may be considered based on the availability of long-term funding, priorities, and resources. The participants will be jointly responsible for prioritizing, proposing, conducting, and analyzing Phase I and Phase II clinical trials focused on therapeutic interventions for NF1, NF2, and schwannomatosis. The NFRP CTCA is open from 20 August 2021 11:59pm ET, 29 October 2021. Submission of a pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) (https://eBRAP.org/). Pre-applications must be submitted by 5:00pm ET 17 September 2021. The NFRP CTCA is available for download on Grants.gov beginning on 20 August 2021. Search opportunity number W81XWH121NFRPCTCA. Questions may be directed to Jason Kuhns, Agreements Officer, at jason.d.kuhns.civ@mail.mil

BLDG 820 PBO 820 CHANDLER STREET

FORT DETRICK , MD 21702-5014

USA