SOLICITATION NOTICE
65 -- Advanced Anticonvulsant System (AAS)
- Notice Date
- 10/16/2006
- Notice Type
- Solicitation Notice
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- 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-0022
- Response Due
- 11/8/2006
- Archive Date
- 1/7/2007
- Small Business Set-Aside
- N/A
- Description
- The Medical Identification and Treatment Systems (MITS) Joint Product Management Office located in Frederick, MD has a requirement for the further development of midazolam in the Advanced Anticonvulsant System (AAS), for use as an adjunctive treatmen t for seizures associated with nerve agent intoxication. The Request for Proposal (RFP) is expected to be issued on or about November 8, 2006. The North American Industry Classification System (NAICS) code for this procurement is 325412 with a size stand ard of 750 employees. The Government does not intend to use FAR Part 12 for this acquisition, because it has been determined that AAS is not a commercial item. The Government has already filed an Investigational New Drug (IND) application for a new indic ation for midazolam in an autoinjector and is currently conducting a Phase 1 clinical study and definitive animal efficacy studies. The requested effort shall require a Contractor to coordinate and manage all activities associated with drug development co nsistent with eventual approval by the Food and Drug Administration under the Animal Rule (Federal Register 67: 37988-37998, May 31, 2002; 21 CFR 314 Subpart I). Associated activities will include: obtaining current Good Manufacturing Practices (cGMP) c ompliant active pharmaceutical ingredient (API); compounding an acceptable formulation that is compatible with and stable in an autoinjector; cGMP compliant manufacturing and testing of the midazolam-filled autoinjector product; International Conference on Harmonisation compliant stability testing; conducting Good Laboratory Practices compliant non-clinical studies and Good Clinical Practices compliant Phase 2 clinical studies; preparation and submission of a New Drug Application (NDA). The RFP will also i nclude an option for initial production of 150,000 doses loaded into autoinjectors. An important aspect of this requirement is that the drug and autoinjector are approved by the FDA as a system. The offeror must have the capacity to manufacture both the drug and the autoinjector, either in its own facility, or with subcontracted effort, but the outcome of this requirement is for a total FDA approved product. Specifications for the autoinjector may be obtained by contacting Sandra OConnell, email address as shown below. Proposals will be evaluated on a Best Value basis. The NDA will be submitted by the successful offeror. The expected delivery of this product is First Quarter of the Government Fiscal Year 12 (1QFY12). Alternate delivery schedules may be proposed by the offerors but the Governments preference is for not later than FY12. All interested parties will be able to view, download, and print a copy of the solicitation and any resulting amendments when released at the USASMDC 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. Questions or correspondence should be directed only by e-mail to Sandra.oconnell@det.amedd.army.mil and should refere nce RFP number W9113M-06-R-0022.
- 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
- SN01166054-W 20061018/061016220622 (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 |