SOLICITATION NOTICE
A -- To obtain a FDA licensed countermeasure for radiation injury to increase the survival rate following radiation exposure in minimal time and minimal cost.
- Notice Date
- 2/27/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
- ZIP Code
- 35807-3801
- Solicitation Number
- W9113M-06-R-0013
- Response Due
- 3/15/2006
- Archive Date
- 5/14/2006
- Small Business Set-Aside
- Total Small Business
- Description
- The U.S. Army Space and Missile Defense Command (USASMDC) is providing notice that a Request for Proposal (RFP), W9113M-06-R-0013 will be issued on or about 17 March 2006. This requirement is being set aside 100% for small businesses. In accordance with DFARS 252.204-7004, all interested contractors shall be registered in the Central Contractor Registration (CCR) database. CCR registration can be accomplished at the following website: www.ccr.gov. The North American Industry Classification System (NAICS) code for this procurement is 541710 with a size standard of 500 employees. The Government does not intend to use FAR Part 12 for this acquisition. Development of the medical radiation countermeasure product(s) shall require a contractor to coordin ate and manage the activities associated with advanced development of the product. The contractor(s) will be responsible for conducting the various activities associated with drug/biologic development in manners that are consistent with eventual approval or licensure with the FDA. Associated activities will include, but are not limited to; manufacturing process development and related tasks, current Good Manufacturing Practices (cGMP)-compliant small-scale manufacturing and testing of the radiation counter measure product, Good Laboratory Practices (GLP)-compliant acute toxicology testing in animals, filing of an Investigational New Drug (IND) application, and conducting a Phase I clinical trial in accordance with FDA regulations and guidelines. After succes sful completion of the Phase I clinical study and Government review, the contractor shall conduct necessary follow-on advanced developed activities leading to FDA approval of the developmental end item. Production quantities will also be required. Proposa ls will be evaluated on a Best Value basis. Delivery schedules will be proposed by the offerors and will be used as one of the evaluation criteria associated with a Best Value evaluation. Proposed delivery schedule calling for delivery of the approved FD A product within 5 to 8 years after contract award is anticipated, but all proposed delivery schedules will be evaluated. All interested parties can view, download, and print a copy of the solicitation and any resulting amendments when released at the SMDC website hyperlink: http:www.smdc.army.mil/contracts/contracts.html. No paper copies of the RFP will be provided and no mailing list will be maintained because the acquisition will be posted on the above website. Questions or correspondence should be dire cted by e-mail to shelley.marken@det.amedd.army.mil and please reference the RFP number W9113M-06-R-0013.
- Place of Performance
- Address: US Army Space and Missile Defense Command, Deputy Commander ATTN SMDC-CM-AP, P.O. Box 1500 Huntsville AL
- Zip Code: 35807-3801
- Country: US
- Zip Code: 35807-3801
- Record
- SN00995605-W 20060301/060227212556 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |