A--INTEREST IN ABILITY TO DELIVER HUMAN PLASMA FRACTION IV-4 PASTE

REQUEST FOR INFORMATION RFI Number: W911QY-10-S-0001 INTEREST IN ABILITY TO DELIVER HUMAN PLASMA FRACTION IV-4 PASTE This is a Request for Information (RFI) for planning purposes only. This is NOT a solicitation for proposals, proposal abstracts, or quotations. This notice is for market research purposes only to obtain information regarding (1) the availability and capability of all qualified business sources, (2) including small businesses; HUB Zone small businesses; service-disabled small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. The North American Industry Classification System (NAICS) Code(s) is/are 541711. Your responses to the information requested will assist the Government in determining the appropriate acquisition method for purchasing human plasma fraction IV 4 paste. BACKGROUND: The mission of the Chemical Biological Medical Systems - Medical ldentification and Treatment Systems Joint Product Management Office (CBMS-MITS JPMO) 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. REQUIREMENT: The Department of Defense (DoD) through the CBMS-MITS JPMO is seeking information from commercial entities with the capability to produce human plasma fraction IV-4 paste (FrIV4) fractionated either by the Cohn process or by the Kistler/Nitschmann method. The FrIV4 paste must be processed from pooled human plasma collected in the U.S., that complies with the requirements codified in 21 CFR 600-640, 21 CFR 210-211 and Recommendations and Guidelines published by the FDA and the Department of Health and Human Services (DHHS). PURPOSE AND OBJECTIVES: CBMS-MITS is seeking information from plasma protein manufacturers to develop knowledge to characterize the availability of FrIV4 paste. The following information is requested: " Indicate the method that will be utilized to produce the FrIV4 paste " If available, a description of analytical assays utilized to characterize the product and support lot release (e.g., data that would be included in a Certificate of Analysis or list of product specifications). " Describe Good Manufacturing Practices (GMP) o Statement indicating conformance to appropriate GMP processes o Viral removal/inactivation steps prior to generation of final FrIV4 paste product " Indicate the potential overall yield of FrIV4 paste, for example, in kg/month or kg/year " The estimated cost per kilogram to include the possibility of any volume discounts " The frequency with which lots of FrIV4 can be purchased " Describe any anticipated risks associated with delivering material on a regular interval " Describe any partnering anticipated to produce/deliver the material SUBMISSION INSTRUCTIONS: 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. Questions regarding this RFI should be forwarded to the CBMS e-mail address listed below within ten (10) days after RFI release. All written responses must be received by Friday, November 5, 2010. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to EMAIL ADDRESS: contact@example.gov ; (3) be minimum 11 font on 8.5 X 11 paper; (4) be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (5) include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address(es); and (6) not exceed 10 single sided pages in total (not including cover page and cover letter). Other media types (i.e. CD, printed technical information) that meet the submission criteria above will be accepted and should be sent to the address below. Material that is advertisement only in nature is not desired. DISCLAIMER AND IMPORTANT NOTES: The Government will not pay for any information submitted in response hereto. This notice does not obligate the Government to issue a solicitation or to award a contract. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organizations qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to the respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation which may be published in the future. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. Contacting Office Address: JPEO CBMS Natick, RDE COM Contracting Office 64 Thomas Johnson Drive Frederick, MD 21702 Point of Contact: Mr. Drake Russell, Contract Specialists, JPEO CBD, email address: contact@example.gov