SOURCES SOUGHT
A -- CBMS-MITS REQUEST FOR INFORMATION (RFI) - Identification of a Physical Dosimetry or Biodosimeter as a Medical Radiation Countermeasure (MRADC)
- Notice Date
- 1/4/2012
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except 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
- W911QY-12-S-0003
- Response Due
- 2/15/2012
- Archive Date
- 4/15/2012
- Point of Contact
- Richard Totten, 301-619-2446
- E-Mail Address
-
ACC-APG SCRT - Natick (SPS)
(richard.totten1@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- CBMS-MITS REQUEST FOR INFORMATION (RFI) - Identification of a Physical Dosimetry or Biodosimeter as a Medical Radiation Countermeasure (MRADC) Number W911QY-12-S-0003 This is a 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 (CBMS) Joint Project Management Office (JPMO) is the DoD organization responsible for the advanced development, procurement, fielding, and sustaining of medical treatment, prophylactic, and diagnostic capabilities against chemical, biological, radiological and nuclear agents. The current CBMS portfolio includes therapeutics, pretreatments, prophylactics, and diagnostics at varying stages of clinical development, including FDA-approved drugs. REQUIREMENT: CBMS has a requirement to confirm, quantify, and diagnose the effects of radiation post-exposure (i.e. physical dosimetry and biodosimetry) in a rapid, sensitive, high-throughput, portable and low cost manner. This technology would provide rapid identification of individuals who have been exposed from low to high-dose radiation in order to accurately assess radiation exposure levels. With the purpose of triage and treatment for individuals or populations, biodosimetry is the use of physiological, chemical or biological markers to reveal the exposure level of ionizing radiation to human tissues. It is anticipated that biodosimeter development will involve animal studies under the "Animal Rule" (21 Code of Federal Regulations [CFR] 314 Subpart I or 21 CFR 601 Subpart H) and should be considered in any development plans. PURPOSE AND OBJECTIVES: The primary objective of issuing this RFI is to seek information and comments from companies who are developing an applicable physical dosimeter or biodosimeter in order to identify the level of radiation and/or to inform a medical treatment intervention, based on the radiation exposure. The biodosimeter must be accurate, sensitive to multiple levels of radiation, relatively non-invasive, scalable for high throughput, diagnose radiation effects in sufficient time frame to reduce or prevent morbidity and mortality, possess the ability to be cleared by the U.S. Food and Drug Administration (FDA), and usable in a contemporary operational environment. 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 physical-dosimetry or biodosimetry capability that is currently under development, to include general background information (biomarkers, targets, assay format etc.), pertinent scientific research efforts including proof of concept results, and method of diagnosis or application. Explain the scientific grounding for diagnosis and any challenges to be addressed. B.Provide a status of in vitro and/or animal model development (i.e., small animal species, large animal species, route of exposure in relation to diagnosis). 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 description of time to diagnose, specificity and sensitivity of assays, throughput, manufacturing capabilities, and special requirements of use. D.Summarize any efforts related to manufacturing process development, to include assay qualification and validation, production qualification and validation, and process scale-up. E.Provide an overview of accomplishments relevant to Pre-Market Approval (PMA) or 510 (k) clearance. F.Express level of interest in ongoing participation as a consultant for development of a physical- or biodosimetry capability. 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. H.Describe any intellectual property concerns to include your company's rights and ability to sell or license any intellectual property as well as your company's interest in selling or licensing the intellectual property. Proprietary information should be marked as described in the paragraph below. 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 fifteen (15) days after RFI release. SUBMISSION INSTRUCTIONS: All written responses must be received within thirty (30) 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 US 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, 1564 Freedman Dr., Ft Detrick, Maryland 21702 Point of Contact(s): Lawrence.Mize@us.ARMY.MIL
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/76a2078d70c0d54f5cbfacaaa332dade)
- 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
- SN02648526-W 20120106/120104234255-76a2078d70c0d54f5cbfacaaa332dade (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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