The sole purpose of this modification to the Notice is to extend the date for receipt of responses to September 27, 2011. No other changes are made. CBMS-MITS REQUEST FOR INFORMATION - Identification of a Prophylactic Medical Radiation Countermeasure (MRADC) Number W911QY-11-S-0001 This is a Request for Information (RFI) for planning purposes only, as defined in FAR 15.201e. This is not a solicitation or request for competitive proposals. 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. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. BACKGROUND: Chemical Biological Medical Systems - Medical Identification and Treatment Systems (CBMS-MITS) Joint Project Management Office (JPMO) is the Department of Defense (DoD) organization responsible for the development, procurement, fielding, and sustaining of medical treatment and prophylactic capabilities against chemical, biological, radiological and nuclear agents. Fielded medical countermeasures (MCM) in the CBMS-MITS portfolio include U.S. Food and Drug Administration (FDA)-approved therapeutics and pretreatments for nerve agent threats. Ongoing MCM development programs include prophylactics, improved therapeutics, and pretreatments for nerve agent threats, as well as therapeutics for Acute Radiation Syndrome resulting from radiation exposure. Future development efforts to address the radiation/nuclear threat include prophylactic MCM. Fulfilling a MRADC prophylaxis capability is anticipated to be conducted under the "Animal Rule" (21 Code of Federal Regulations [CFR] 314 Subpart I or 21 CFR 601 Subpart H). REQUIREMENT: The DoD has a requirement for a prophylactic countermeasure that protects against or reduces the extent of the debilitating effects of radiological/nuclear threats. The preferred prophylaxis will provide broad-spectrum protection against multiple isotopes and levels of challenge, from partial shielding to total body irradiation events. The prophylactic MRADC must be safe, efficacious, have a rapid onset, be easily administered, induce minimal to no performance-decrementing side effects, be approved by the FDA, be compatible with current military Chemical, Biological, Radiological, and Nuclear (CBRN) countermeasures, and require minimal logistical burdens. PURPOSE AND OBJECTIVES: The primary purpose for this RFI is to obtain information regarding interest and capability of various entities (e.g., industry, academia, small businesses) to develop a broad-spectrum prophylactic Medical Radiation Countermeasures (MRADC). The objective is to collect information as follows: A. Describe the potential candidate, to include general background information, proposed indication, human dose, and route of administration. B. Describe animal model development efforts that support a prophylactic indication. Include any proprietary information and limitations, if any, on sharing of animal models or testing paradigms with the government and its contractors. C. Summarize supporting efficacy studies for a prophylactic indication (e.g., dose modification factor; time to protection; duration of protection; challenge level of radiation; and quantity/number of administrations required to achieve full protection, etc.). Indicate if supportive care considerations are addressed and type of exposure (e.g., partial shielding, total body irradiation). D. Summarize pre-clinical and clinical safety studies, where available, to support a prophylactic indication (e.g., genetic and reproduction toxicology studies; short-term and long-term toxicology studies; range-finding toxicology, toxicokinetic/pharmacokinetic studies; absorption, distribution, metabolism and excretion (ADME) studies; safety pharmacology analysis; and mechanism of action studies). E. Describe formulation development efforts, proposed formulation and any relevant chemical, physical, and immunological characteristics. Summarize manufacturing process development, to include assay qualification and validation, production qualification and validation, process scale-up. Provide any available information on candidate stability, shelf life and storage conditions. F. Provide an assessment of candidate maturity, stage of development using the Technology Readiness Level (TRL) for Medical Product Development in Appendix A. Note: Candidate maturity is assessed at a given TRL when ALL of the activities listed for a given TRL are completed. If efforts are ongoing to address a higher TRL activity, the candidate is assessed at the next lowest TRL where all activities are complete. G. Indicate company business size (based on the NAICS size standard), business status (i.e., large business, small business, disadvantaged, service-disabled veteran-owned small business), and date of incorporation. Responders are invited to provide materials related to their capabilities to fulfill ANY OR ALL of the requirements specified above. Respondents should provide responses whether their level of interest and current capability is to fulfill the entire scope of the effort, or a limited aspect of the effort, such as teaming as a subcontractor with another firm. The Government will retain comments and information received in response to this RFI. Propriety information should be identified as Company Proprietary. Do not use Government Security classification markings. Excluded from the request for information are drugs or biologics intended solely for use in post exposure settings (i.e., therapeutic). Also excluded are next generation antibiotics and probiotics, blocking, decorporation, and purgative agents, blood (or blood component) replacements or substitutes, antiemetics and other comfort or supportive measures. Questions regarding this RFI should be forwarded to the CBMS e-mail address listed below within five (5) days after RFI release. SUBMISSION INSTRUCTIONS: All written responses must be received within fifteen (15) days of issuance of this RFI. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to Mr. Larry Mize; (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 Contracting Office Address and Point of Contact identified below. Material that is advertisement only in nature is not desired. Contracting Office Address: US Army Contracting Command, Aberdeen Proving Grounds Natick Division ATTN: Larry Mize, 64 Thomas Johnson Drive, Frederick, Maryland 21702 Point of Contact(s):
contact@example.gov
