This is a Request for Information (RFI) for planning purposes only, as defined in FAR 15.201e. 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 RFI. The Chemical Biological Medical Systems Joint Project Management Office (CBMS JPMO) is seeking information on the capabilities of various commercial entities in one or more of the areas listed below. The CBMS 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. The current CBMS products include Food and Drug Administration (FDA) licensed/approved/cleared biologics, drugs, and diagnostic devices. The CBMS JPMO is seeking companies with experience and the capability, if necessary to establish a teaming approach concept, to accomplish the development, manufacture and production of CBRN prophylactics, therapeutics, and diagnostics. Specific functional capabilities include, but are not limited to, (1) program management of technically complex efforts, (2) integration of multiple functional disciplines, (3) technical expertise in pharmaceutical product development, (4) regulatory interactions with the Food and Drug Administration leading to product approval/licensure/clearance under the Federal Food, Drug and Cosmetic Act or Section 351 under the Public Health Service Act, and (5) successful partnering or subcontracting with innovative companies. Additionally, experience with product development under 21 CFR 314 Subpart I or 601 Subpart H (i.e. Animal Rule) is desired. Some of the planned requirements for future CBRN prophylactic, therapeutic, or diagnostic systems which could be developed under this future contract may include: (A) Development, through FDA licensure and production, of a pre-exposure indication filovirus vaccine with a balance of onset and duration of protection for administration to healthy individuals, developed under the Animal rule, and which provides broad spectrum protection against aerosol exposure to multiple species of the Ebola and Marburg viruses. If multivalent Ebola / Marburg is not available as single product, a separate Ebola vaccine providing protection against Zaire and Sudan species along with a separate Marburg vaccine is acceptable. (B) Development through FDA-approval and production of a central nervous system therapeutic(s) to treat nerve agent intoxication and minimize injury to the central nervous system; (C) Development through FDA-approval and production of a new MCM to treat sulfur mustard (HD) poisoning. HD is a vesicant chemical agent that affects the eyes, lungs, and skin and causes mild to severe or lethal organ damage that degrades Force capabilities; (D) Development through FDA-clearance and production of a Radiological Biodosimetry Medical Diagnostic Device that will be carried by the individual Warfighter and can be read and interpreted immediately for the efficient and proper triage and subsequent treatment of potential radiation casualties; (E) Development through FDA-licensure or approval and production of a Radiological Prophylaxis MCM that is administered before anticipated radiation exposure to prevent or reduce the damage and complex injuries associated with acute radiation syndrome; (F) Development through FDA-licensure or approval and production of a Cyanide Poisoning Prophylaxis and a Soldier-carried Therapeutic to protect and treat military members from cyanide poisoning resulting from either ingestion or inhalation of a cyanide chemical agent; (G) Development of a man-portable Next Generation Diagnostic System (NGDS) to identify, diagnose, and quantify biological warfare agents in a variety of matrices. The primary acquisition objective of CBMS is to obtain a contract solution that efficiently, effectively, and economically provides and maintains a high standard for CBRN medical countermeasure advanced development, manufacture, and production to support the Government in meeting DoDs objectives. As such, the Government is seeking information on current industry capability and interest to meet the following criteria: (A) Provide a seamless/transparent transition from basic and applied research to advanced development. (B) Perform under a performance-based arrangement, committed to delivering highly reliable and innovative solutions that meet or exceed customer requirements and expectations. (C) Provide innovative alternative solutions of integrating industry partners and best practices as required to develop MCMs and diagnostic platforms. (D) Ensure new capability requirements are quickly incorporated into the development process to minimize adverse impacts to long-term operational plans. (E) Provide continuous, timely, and up-to-date market research and roadmap recommendations based on industry advanced development, manufacturing, and production capability improvements. (F) Demonstrate existing capabilities to manage each effort, including assuming sponsorship for all products requiring FDA approval. (G) Perform under a contract type that would allow for a sustained period of time, over option years, during which additional developmental end items falling within a general SOW may be ordered for development through FDA licensure or approval. (H) Incorporate other enabling technologies critical for the use of pharmaceuticals throughout the contemporary operating environment which include: pharmaceutical stability across a wide range of temperatures, other than syringe and needle administration, individual unique identification (IUID) labeling of individual doses of the pharmaceuticals, and a visual, user-readable temperature to time indicator that confirms the product is usable. The CBMS JPMO anticipates awarding a contract before March 2010. Questions regarding information required to provide a complete response to this RFI should be forwarded to the Contracting Officer listed below. The CBMS JPMO intends conducting a pre-solicitation conference in FY09 which will provide a forum for open discussion and additional information. Respondents are invited to provide materials related to their capabilities to fulfill all or any of the CBRN requirements specified above, including: application of best commercial practices; program management structure; products/services technical descriptions (i.e. product data sheets); length of time similar products/services have been provided; cost drivers of advanced development and manufacture of products; number, size, location of suppliers; production capability to meet requirements; quality management system including, quality controls and statistical process controls; intellectual property availability; stability of current configuration / technology, DoD experience, and customer service capability. 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. The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. All written responses must be received within 45 days of issue. Responses should be addressed to the Government Contract Specialist/Alternate Contracting Officer, Cynthia Gnam:
contact@example.gov. (Primary Contracting Officer, Lynn Selfridge:
contact@example.gov) Respondents shall designate a company point of contact for the Government. 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: Cynthia Gnam, 64 Thomas Johnson Drive, Frederick, Maryland 21702. Material that is advertisement only in nature is not desired. Contracting Office Address: US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801 Point of Contact(s): Cynthia Gnam,
+1 (555) 000-0000
