SOLICITATION NOTICE
A -- Ex-RAD™ (ON 01210.Na) RADIOPROTECTION PROGRAM
- Notice Date
- 5/1/2009
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Other Defense Agencies, Uniformed Services University of the Health Sciences, Directorate of Contracting, 4301 Jones Bridge Road, Bethesda, Maryland, 20814-4799
- ZIP Code
- 20814-4799
- Solicitation Number
- HU0001-09-R-0007
- Point of Contact
- Christina Johnson,, Phone: (301) 295-3069, Jeff Floyd,, Phone: 301-295-3923
- E-Mail Address
-
cjohnson@usuhs.mil, jfloyd@usuhs.mil
- Small Business Set-Aside
- Total Small Business
- Description
- It is the intent of the Uniformed Services University of the Health Sciences (USUHS), Bethesda, MD to award on a sole source basis, a research and development (R&D) contract with Onconova Therapeutics, Inc. of Lawrenceville, NJ to identify and investigate if their patented compound, ON 01210.Na (Ex-RAD TM ), can be used as a countermeasure for exposure to ionizing radiation in humans. Onconova Therapeutics, Inc. will conduct studies to develop ON 01210.Na as a radioprotectant and compile the dossier for registration of ON 01210.Na with the US FDA as a radioprotectant. The studies to be commissioned under this new contract will further allow development of the drug per the FDA's Animal Efficacy Rule (21 CFR Parts 314 and 601) and the agency's requirements for filing a new drug application (NDA) under Onconova Therapeutics, Inc. sponsorship. These studies would include but not limited to preclinical toxicology, mechanistic, efficacy via multiple routes of administration in small and large animal species and human clinical trials. The Government anticipates the performance period will be five (5) years. The statutory authority permitting this award under other than full and open competition is 10 U.S.C. 2304(c)(1), as cited in FAR 6.302-1(a) which authorizes USUHS to award contracts when there is only one responsible source and no other supplies or services will satisfy agency requirements. The ON 01210.Na (Ex-RAD TM ) compound is owned and patented by Onconova Therapeutics, Inc., and no other compound is available or suitable for this series of studies. The Ex-RAD TM radiation protection program is being funded as a Congressional special interest item and is based on the demonstrated ability that the compound has been among the most promising compounds for eventual use as a radioprotectant. This notice is not a Request for Proposal. All inquiries must be in writing and may be emailed to Christina Johnson at cjohnson@usuhs.mil and Jeff Floyd at hfloyd@usuhs.mil (in subject line, reference: ON 01210.Na) or faxed to 301-295-1716. No phone inquiries will be accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=57bfe43aa8d8e816cdccc9fc9d2f8303&tab=core&_cview=1)
- Record
- SN01807581-W 20090503/090501222755-57bfe43aa8d8e816cdccc9fc9d2f8303 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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