Added: May 15, 2013 3:15 pm
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 and the Government will not reimburse respondents for preparation of the response.
The Chemical Biological Medical Systems (CBMS) Joint Project Management Office (JPMO), under the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), 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 (CBRN) warfare agents.
Information gathered in response to this RFI will be used to support the CBMS-Biosurveillance Joint Product Director (CBMS-BSV JPMO) in strategic planning for development of the Next Generation Diagnostics System (NGDS) acquisition strategy. Specifically, information gathered will be reviewed as part of a market survey in support of the NGDS Increment 2 acquisition program planned to begin August 2014.
The North American Industry Classification System (NAICS) code for the NGDS Increment 2 program is 334516 quote mark Analytical Laboratory Instrument Manufacturing, quote mark which has a small business size standard of 500 employees. Under this NAICS code, the Government will consider a concern with 500 or fewer employees to be a small business.
BACKGROUND and REQUIREMENTS:
CBMS is interested in collecting information from companies who are currently in the U.S. domestic healthcare market or are considering a future entry into that market who may have technologies or systems adaptable to Department of Defense requirements for FDA-cleared diagnostics for human diseases caused by exposure to CBRN warfare threat agents and in support stakeholder agencies, potentially, endemic agents.
CBRN threats include:
-Biological Pathogens (e.g. bacteria, DNA and RNA Viruses, parasites, fungus, prions, etc.)
-Toxins (e.g. bacterial, plant and animal derived toxins)
-Chemical Warfare Agents
-Toxic Industrial Compounds potentially used as improvised weapons
-External radiation exposures
-Ingestion of radiological materials
Applications for these technologies and systems include:
-Use at small clinical laboratories providing centralized support to fixed site and mobile hospitals less than 200 beds
-Point of Care diagnostics in a CLIA-waived setting
-Individual self testing
-Advanced sample preservation approaches for sample transport under austere conditions and remote analysis up to 7 days after sample collection
-Reliable self sampling techniques for a broad range of clinical sampling types to support remote analysis
-HIPAA-Compliant communications and data processing tools supporting remote data analysis/interpretation of point of care sample analyses
-Non-invasive, very low invasive population screening tools to identify people who may benefit from follow-on diagnostic testing
Desired characteristics, as applicable to threat agent and/or application
[T] Threshold, [O] Objective
-Portable, total system weight (0.5 lbs [O], 148 lbs [T])
-Requires no more than one 2' Biological Safety Cabinet to operate
-Safe for use with BSL 4 agents
-Single Sample Time to Result (20 minutes [O], 90 minutes [T]). If greater than 90 minutes, please explain why this is the state of the art for the threat/application
-Complexity (CLIA-waived [O], Moderate [T]), if highly complex please explain why this is the state of the art for the threat/application
-Electronically enabled for data archiving and communications (or explain how the data may be captured permanently)
-Sensitivity relevant to the disease state/application
-Supportive of syndrome based diagnostics with endemic diseases with the same patient inclusion criteria, if applicable
-Aligned with vaccines and therapeutics in production or development.
-Catalog of existing compatible infectious disease assays
-Exiting or emerging FDA regulatory framework to support development and 510k clearance/ PMA approval
-FDA cleared for in-vitro diagnostics [O] or sufficiently mature to begin of U.S. FDA Clinical Trials by January 2016 [T]
Respondents are invited to provide materials related to their capabilities to fulfill ANY OR ALL of the requirements specified in this RFI. Respondents are requested to indicate their level of interest and whether they possess the capability to fulfill the entire scope of the effort, or to fulfill a limited aspect of the effort as part of a team or as a subcontractor with another firm.
Respondents should indicate whether they qualify as a small business under the NAICS code listed above, and, if so, they should specify whether they qualify under additional small business classifications, such as, Small Disadvantaged Business, Historically Black Collleges and Univeristies/Minority Institutions, Women Owned Business, or Service-Disabled Veteran Owend Small Business.
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.
All written responses must be received within fifteen (15) calendar days of issuance of this RFI. Submissions should:
(1) use Microsoft Word or Adobe Portable Document Format (PDF);
(2) be sent by email to John Conlin, email@example.com;
(3) be minimum 11 point font on 8.5 quote mark X 11 quote mark 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 15 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.
Point of Contact(s):
Questions and submissions regarding this RFI should be forwarded to John Conlin (firstname.lastname@example.org or 508-233-6164)