MODIFICATION
A -- CBMS-MITS REQUEST FOR INFORMATION - Identification of a Therapeutic Medical Radiation Countermeasure
- Notice Date
- 9/20/2011
- Notice Type
- Modification/Amendment
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- ACC-APG SCRT - Natick (SPS), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY11S0006
- Response Due
- 9/27/2011
- Archive Date
- 11/26/2011
- Point of Contact
- Lawrence Mize, 301-619-9813
- E-Mail Address
-
ACC-APG SCRT - Natick (SPS)
(lawrence.mize@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- The purpose of this modification to the original Notice is solely to extend the time for receipt of responses until September 27, 2011. No other changes have been made. CBMS-MITS REQUEST FOR INFORMATION - Identification of a Therapeutic Medical Radiation Countermeasure (MRADC) Number W911QY-11-S-0006 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 DoD organization responsible for the development, procurement, fielding, and sustaining of medical treatment and prophylactic capabilities against chemical, biological, radiological and nuclear agents. The current CBMS-MITS portfolio includes therapeutics, pretreatments and prophylactics at varying stages of clinical development, including FDA-approved drugs. REQUIREMENT: CBMS-MITS has a requirement for a therapeutic countermeasure that treats the debilitating effects of radiological/nuclear threats. This therapeutic is expected to be developed under the "Animal Rule" (21 Code of Federal Regulations [CFR] 314 Subpart I or 21 CFR 601 Subpart H). The therapeutic will provide broad-spectrum treatment of acute radiation syndrome (ARS). PURPOSE AND OBJECTIVES: The primary objective of issuing this RFI is to seek information and comments from companies that are developing therapeutic Medical Radiation Countermeasures (MRADC) to treat ARS. The MRADC must be safe, efficacious for at least 4 hours, quick acting, free from performance-decrementing side effects, relatively non-invasive, possess the ability to be approved by the U.S. Food and Drug Administration (FDA), compatible with current military Chemical, Biological, Radiological, and Nuclear (CBRN) countermeasures, and usable in a contemporary operational environment. Excluded from the request for information are drugs or biologics intended solely for use prior to exposure (i.e., prophylaxis). 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. As such, the Government is researching information and interest about current industry capabilities via responses to the areas listed below: A.Describe your company's candidate that is currently under development, to include general background information, pertinent research efforts, proposed indication(s) and proposed human dose and route of administration. Specifically, identify the candidate's capabilities to treat ARS. B.Provide a status of in vitro and/or animal model development (i.e., small animal species, large animal species, route of exposure). Include any proprietary information and limitations, if any, on sharing of animal models or testing paradigms with the government and its contractors. C.Provide a summary of any pertinent data resulting from efficacy studies; 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; mechanism of action studies. D.Describe formulation development efforts, the candidate's proposed formulation and any relevant chemical, physical, and immunological characteristics. Summarize any efforts related to 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. E.Provide an assessment of candidate maturity, stage of development using the Technology Readiness Level (TRL) for Medical Product Development in Appendix A. When using these criteria, a medical countermeasure product should be rated at a particular level only after the sponsor has completed all activities listed in that level (e.g., a products is rated at TRL 4 once it completes all of the activities listed in TRL 4). F.Express level of interest in ongoing participation as a consultant for development of the candidate. 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, etc.), 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. Questions regarding this RFI should be forwarded to the CBMS e-mail address listed below within six (6) 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): Lawrence.Mize@us.army.mil
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/16ef39fc3f7125cab65ec1afcf0c09a4)
- Place of Performance
- Address: ACC-APG SCRT - Natick (SPS) ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street Natick MA
- Zip Code: 01760-5011
- Zip Code: 01760-5011
- Record
- SN02584601-W 20110922/110920235916-16ef39fc3f7125cab65ec1afcf0c09a4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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