SOURCES SOUGHT
A -- Chemical, Radiological and Nuclear (CRN) Therapeutics
- Notice Date
- 5/5/2009
- Notice Type
- Sources Sought
- Contracting Office
- Department of the Army, U.S. Army Space and Missile Defense Command, U.S. Army Space and Missile Defense Command, Deputy Commander, 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-09-S-0002
- Response Due
- 5/19/2009 11:59:00 PM
- Archive Date
- 7/18/2009
- Point of Contact
- Sandra OConnell, 301-619-2895<br />
- Small Business Set-Aside
- N/A
- Description
- Description The purpose of this announcement is to identify interested companies that have the capability to develop and manufacture specifically identified Chemical, Radiological and Nuclear (CRN) therapeutics for the Department of Defense (DoD). The Chemical Biological Medical Systems Medical Identification and Treatment Systems Joint Product Management Office (CBMS-MITS JPMO) mission is to rapidly provide the Warfighter with safe, robust, affordable medical countermeasures (MCMs) against a broad spectrum of Chemical Biological Radiological and Nuclear (CBRN) threats. Current CBMS-MITS JPMO products include Food and Drug Administration (FDA) approved drugs and diagnostic devices. The CBMS-MITS JPMO is seeking interest by commercial entities with the capability to develop ANY OR ALL of the CRN therapeutics listed below. The Contractor shall be responsible for conducting advanced development activities as well as, if necessary, selecting and managing Subcontractors, with the necessary capability of conducting various activities associated with pharmaceutical development consistent with eventual approval by the U.S. Food and Drug Administration (FDA). Identification of sources having the capability to develop, through FDA approval and production, the following CRN therapeutics is being sought: a)An aerosolized atropine drug delivery system to treat lingering effects of nerve agent intoxication related to muscarinic stimulation; b)A radiological/nuclear therapeutic MCM to be administered following exposure to ionizing radiation that will decrease incapacity and prolong survival by treating the gastrointestinal subsyndrome of Acute Radiation Syndrome. c)Amyl nitrite as an adjunct to current military cyanide treatment regimen. The intent is to obtain FDA-approval of amyl nitrite as part of a three component military treatment regimen (i.e., intravenous sodium nitrite and sodium thiosulfate, and inhaled amyl nitrite) for cyanide intoxication. Therefore, Respondents are requested to describe capability for obtaining FDA approval of amyl nitrite as part of the current cyanide treatment regimen within the next four years. Respondents with interest, experience and capability in providing or establishing a teaming approach in order to develop and manufacture the above mentioned CRN therapeutics are encouraged. However, Respondents with interest in one or more capabilities are also encouraged. Specific functional capabilities include, but are not limited to the following: a)Program management of technically complex efforts. b)Integration of multiple functional disciplines. c)Technical expertise in pharmaceutical product and device development. d)Successful partnering or subcontracting with innovative companies. e)Regulatory interactions with the Food and Drug Administration leading to product approval under the Federal Food, Drug and Cosmetic Act or Section 351 under the Public Health Service Act. f)Experience with product development under the Animal Rule as necessary (Federal Register 67: 37988-37998, May 31, 2002; 21 CFR 314 Subpart I or 21 CFR 601 Subpart H). Questions regarding information required to provide a complete response to this notice should be forwarded electronically to the Contract Specialist listed below. No telephone inquiries will be accepted. This is not a request for competitive proposals, but parties interested in responding must furnish in writing, a 4-5 page (not including cover page, index or list of references) synopsis of their capability to accomplish the described work effort. Companies responding to this notice must provide complete contact information (telephone, address, email address). The North American Industry Classification Systems (NAICS) for this notice are 541711 Research and Development in Biotechnology (with a size standard of 500 employees), and 541712, Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) (with a size standard of 500 employees). Responders must identify their companys business size (based on the NAICS size standard), business status (i.e. small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned. Please also include information regarding any prior experience with U.S. Government contracts and favorable experience working with the FDA. Respondents are encouraged to provide alternative contracting solutions and to describe the benefits and limitations of various contracting and teaming strategies. Respondents should provide whether their level of interest and current capability is to fulfill the entire scope of the effort, or a limited aspect of the effort. For any anticipated teaming arrangements and or anticipated subcontractors, provide documentation regarding their capabilities and the respondents demonstrated ability to carry out identification, awarding and management of subcontractor efforts. The Government will retain comments and information received in response to this notice. Proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. Any information provided to the U.S. Government in response to this sources sought notice is for planning purposes only and will not be used as a selection consideration factor in any U.S. Government contract competition. Should the U.S. Government elect to pursue the subject requirement, an official Request for Proposal will be released at a later date. This Sources Sought Notice allows qualified sources for this requirement to self identify. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this notice. Should the U.S. Government elect to pursue the subject requirement, an official Request for Proposal will be released at a letter date and will be synopsized in accordance with FAR Part 5. All written responses must be received by May 19, 2009. The Government Contracting Officer for this notice is Lynn M. Selfridge. Responses should be addressed to the Government Contract Specialist, Sandra OConnell: Sandra.oconnell@us.army.mil. Respondents shall designate a company point of contact for the Government (telephone, address and Email). Preferred media is electronic (i.e. Microsoft Word, Portable Document Format, or MS Power Point) via e-mail submission. However, other media types (i.e. CD, printed technical information) will be accepted and should be sent to US Army Space & Missile Defense Command, ATTN: Sandra OConnell, 64 Thomas Johnson Drive, Frederick, Maryland 21702. Material that is advertisement only in nature is not desired.
- Web Link
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FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=9fb264d7f7d647ae55194dbfab62c5ec&tab=core&_cview=1)
- Place of Performance
- Address: US Army Space and Missile Defense Command, Deputy Commander ATTN SMDC-CM-AP, P.O. Box 1500 Huntsville AL<br />
- Zip Code: 35807-3801<br />
- Zip Code: 35807-3801<br />
- Record
- SN01809674-W 20090507/090505221954-9fb264d7f7d647ae55194dbfab62c5ec (fbodaily.com)
- Source
-
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