MODIFICATION
66 -- JPM MCS REQUEST FOR INFORMATION - Identification of Diagnostic Devices for Biological Threats
- Notice Date
- 3/10/2014
- Notice Type
- Modification/Amendment
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- ACC-APG - 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-13-RFI-NGDSI2
- Response Due
- 4/30/2014
- Archive Date
- 5/30/2014
- Point of Contact
- John Conlin, 508-233-6164
- E-Mail Address
-
ACC-APG - Natick (SPS)
(john.conlin3.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION: 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 Joint Project Management Office Medical Countermeasure Systems (JPM-MCS), 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 sustainment 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 Joint Product Director for Diagnostics (JPdM Dx) in strategic planning for development of the Next Generation Diagnostics System Increment 2 (NGDS Inc 2) acquisition strategy. Specifically, information gathered will be reviewed as part of a market survey in support of the NGDS Inc 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: JPM-MCS is interested in collecting information from companies who are currently in the U.S. domestic healthcare market or are considering a future entry into the market for FDA-cleared diagnostics for human diseases caused by exposure to biological threat agents. JPM-MCS is interested in collecting information about systems that are complementary to, and used in conjunction with, the NGDS increment 1 sample-to-answer molecular (PCR) diagnostic platform used in forward deployed clinical laboratories (i.e. combat support hospitals and ships) Patients may be tested pre-symptomatically or within 12 to 120 hours of exhibiting symptoms, depending on the location of the clinc/laboratory. Biological threats include: -Pathogenic bacteria, DNA and RNA Viruses -Parasites -Fungus -Prions -Biological Toxins (e.g. bacterial, plant and animal derived toxins) 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 -HIPAA-Compliant communications and data processing tools supporting remote data analysis/interpretation of point of care sample analyses (if applicable) -Non-invasive or 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], 15 lbs [T]) -Safe for use with BSL 4 agents (low risk of aerosolizing sample materials) [T] -Open Architecture (supporting 3rd party assay design and development, non-proprietary file formats) [O] -Single Sample Time to Result (5 minutes [O], 30 minutes [T]). If greater than 30 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) -Detection of agent specific proteins and biomolecules -Detection of disease specific host biomarkers (describe the technical maturity and regulatory framework for associated biomarkers) -Sensitivity relevant to the disease state/application -Highly specific -Supportive of syndrome based diagnostics with endemic diseases with the same patient inclusion criteria, if applicable [O] -Aligned with vaccines and therapeutics in production or development. -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 U.S. FDA Clinical Trials no later than January 2016 [T] -Single use consumable or reusable, adaptable instrument/assay based system INFORMATION SOUGHT: 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 qulify 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. SUBMISSION INSTRUCTIONS: 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, john.conlin3.civ@mail.mil; (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. Contracting Office Address: US Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division ATTN: John Conlin, 100 Medway Road, Suite 305, Milford, MA 01757. Point of Contact: Questions and submissions regarding this RFI should be forwarded to John Conlin (john.conlin3.civ@mail.mil or 508-233-6164)
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/cd0bc05914cf53d1595aea90e56f06aa)
- Place of Performance
- Address: ACC-APG - Natick Contracting Division 100 Medway Rd, Ste 305 Milford MA
- Zip Code: 01757
- Zip Code: 01757
- Record
- SN03306406-W 20140312/140310234724-cd0bc05914cf53d1595aea90e56f06aa (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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