Next Generation Diagnostics System (NGDS) Increment 1

Added: Jan 04, 2012 8:52 am Modified: Mar 01, 2013 1:43 pmTrack Changes This contract action was not awarded as a fixed price type because uncertainties involved in contract performance did not permit costs to be estimated with sufficient accuracy to use any type of fixed price contract. As such, a cost-reimbursement type action was awarded (FAR 16.301-2).

Next Generation Diagnostics System (NGDS) Increment 1 Deployable Component system, system consumables, U.S. Food and Drug Administration (FDA) cleared biological warfare agent (BWA), other infectious disease and Chemical Biological Radiological and Nuclear (CBRN) threat in vitro diagnostic (IVD) assays, BWA and non-BWA environmental assays and contractor logistics support.

Added: Jan 04, 2012 8:52 am Modified: Aug 06, 2012 4:12 pmTrack Changes _________________________________________________
***UPDATE 6 August 2012***
The Government would like learn whether interested vendors have reached a decision to propose or not to propose against solicitation W911QY-12-R-0021. Any vendor may contact the Government via email to the contract specialist, John Conlin at john.conlin3.civ@mail.mil. The response need only indicate one of the following statuses: Yes, plan to propose at this time; No, do not plan to propose at this time; or Undecided at this time.

Responses will be used by the Government strictly for planning purposes and will be considered informational only. Responses to this notice will not be construed by the Government to be part of any proposal subsequently submitted by a vendor. The final decision to submit a proposal against solicitation W911QY-12-R-0021 is exclusively the vendor's, and the vendor shall not be bound by its response to this notice.

The Government requests that responses be received no later than Thursday, August 9, 2012 at 12:00pm. Questions may be directed to John Conlin at john.conlin3.civ@mail.mil.


_________________________________________________
***UPDATE 20 July 2012***
The NGDS Increment 1 Solicitation has been released and can be accessed under the FBO announcement located at this page:
https://www.fbo.gov/notices/17aa07c70d3f269b865969d86bd095a8

Additional information, including Industry Day materials and Q&A is available at: http://www3.natick.army.mil/ngds.html

_________________________________________________


The Contracting Specialists responsible for this action are Mr. John Conlin and Ms. Yvette M. Daltorio. Please direct any questions regarding this announcement to Mr. John Conlin, by email at John.Conlin3.civ@mail.mil or Ms. Yvette M. Daltorio, by email at yvette.m.daltorio.ctr@mail.mil.

Added: Jan 04, 2012 8:52 am Modified: Jul 20, 2012 3:58 pmTrack Changes _________________________________________________
***UPDATE 20 July 2012***
The NGDS Increment 1 Solicitation has been released and can be accessed under the FBO announcement located at this page:
https://www.fbo.gov/notices/17aa07c70d3f269b865969d86bd095a8

Additional information, including Industry Day materials and Q&A is available at: http://www3.natick.army.mil/ngds.html

_________________________________________________


The Contracting Specialists responsible for this action are Mr. John Conlin and Ms. Yvette M. Daltorio. Please direct any questions regarding this announcement to Mr. John Conlin, by email at John.Conlin3.civ@mail.mil or Ms. Yvette M. Daltorio, by email at yvette.m.daltorio.ctr@mail.mil.

Added: Jan 04, 2012 8:52 am Modified: May 10, 2012 4:15 pmTrack Changes This synopsis is being posted to both the Federal Business Opportunities (FBO) page located at http://www.fbo.gov and the Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division (ACC-APG NCD) site located at http://www3.natick.army.mil/NGDS.html. While it is understood that FBO is a single point of entry for posting of synopsis and solicitations to the internet, NCD is the alternative in case FBO is unavailable. Please feel free to use either site to access the information posted by the ACC-APG NCD.

The ACC-APG NCD on behalf of the Joint Project Manager for Chemical Biological Medical Systems (JPM CBMS) under the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) intends to release a solicitation to procure, on a full and open competitive basis, the Next Generation Diagnostics System (NGDS) Increment 1 Deployable Component system, system consumables, U.S. Food and Drug Administration (FDA) cleared biological warfare agent (BWA), other infectious disease and Chemical Biological Radiological and Nuclear (CBRN) threat in vitro diagnostic (IVD) assays, BWA and non-BWA environmental assays, and contractor logistics support. The NGDS Increment 1 Deployable Component candidates selected for initial award must either be currently under clinical evaluation as an IVD for the U.S. market (clinical trial); be cleared via a 510(k) or Premarket Approval (PMA) by the FDA as an IVD or submitted for clearance or approval; or have received approval by the European Medicines Agency (EMA) as an IVD. The contractual intent is to for the system to be FDA cleared for CBRN warfare threat diagnostics at the time of fielding. Required CBRN threat assays not available at the time of selection will be developed under this contract. NGDS Increment 1 is anticipated to be, a portable, reusable, adaptable analytical system for preparing and processing human clinical samples (e.g., blood, sputum, stool, urine, etc.). At a minimum, the fielded system will be suitable for use at field microbiology laboratories (land-based Army, Air Force and Navy Role deployable medical treatment facilities, including shipboard environments).

The Government anticipates that three contracts, incorporating a combination of firm fixed price and cost type Indefinite Delivery/Indefinite Quantity (IDIQ) CLINs, will be awarded for the procurement for the competitive prototyping stage requirements. Upon completion of the competitive prototyping stage, the Government anticipates conducting a down select which will result in one contract taking the contractor through the remainder of the TD Phase to FDA clearance. The contract is anticipated to be a 10-year effort with a base period of approximately nine months and nine one year option periods. The guaranteed minimum order will be the negotiated value of the first delivery order, and the cumulative total of all delivery orders awarded to all awardees will not exceed $250,000,000.00 over the life of the contract.
Proposals shall include a small business participation plan. NAICS Code 334516 - Analytical Laboratory Instrument Manufacturing with a small business size standard of 500 Employees will apply.

The Government currently estimates that the Request for Proposals (RFP) will be released within the next 20 days, and proposals will be due 45 days after the RFP is released. The proposed solicitation number is W911QY-12-R-0021.

In order to be eligible for award, firms must be registered in the Central Contractor Registry (CCR). Offeror may obtain information on registration in the CCR by calling 1-888-227-2423, or via the Internet at https://www.ccr.gov.

The Contracting Specialists responsible for this action are Mr. John Conlin and Ms. Yvette M. Daltorio. Please direct any questions regarding this announcement to Mr. John Conlin, by email at John.Conlin3.civ@mail.mil or Ms. Yvette M. Daltorio, by email at yvette.m.daltorio.ctr@mail.mil within 15 days of this notice.

Added: Jan 04, 2012 8:52 am Modified: Apr 27, 2012 1:29 pmTrack Changes Updated DRAFT Solicitation Documents, please go to website http://www3.natick.army.mil/NGDS.html "Solicitation Documents" folder to view documents.

Added: Jan 04, 2012 8:52 am Modified: Mar 22, 2012 2:33 pmTrack Changes -----

22 March 2012: Registration for the NGDS Industry Day is now available at http://www3.natick.army.mil/NGDS.html

-----

Purpose
The purpose of the Next Generation Diagnostics System (NGDS) solicitation is to:
* Award multiple contracts to vendors of commercially available FDA-cleared diagnostic platforms for initial competitive prototyping;
* Develop and manufacture FDA-cleared in-vitro diagnostic and environmental surveillance assays for biological warfare agents (BWA), infectious diseases, and other pathogens of operational concern;
* Integrate the platform to be interoperable with DoD CBRN and medical information systems.

Background

The NGDS Increment 1 system proposed is an FDA-cleared, reusable, adaptable diagnostic device for the analysis of biological (clinical) liquid samples. Increment 1 medical diagnostic capabilities will provide health care providers with timely and accurate information to guide individual patient treatment. Additionally, the BW threat identification information obtained during diagnostic testing will provide battle field commanders with biological hazard situational awareness to support Force Protection and Force Health Protection decision making. The NGDS Increment 1 is intended to eventually replace the current Joint Biological Agent Identification and Diagnostic System (JBAIDS).

The proponent for this effort is the Chemical Biological Medical Systems - Biosurveillance (CBMS-BSV) Joint Product Management Office of the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD).

Industry Day Information

CBMS-BSV will conduct an NGDS Industry Day at 12:30 p.m. on 3 April 2012 and from 8:00 a.m. - 12:00 p.m. of 4 April 2012 in Room L-6 at the Cook Convention Center in Memphis, TN to discuss the NGDS draft RFP. Please read the draft Request for Proposal (RFP) for detailed information on the NGDS contract requirements. The documents will be available at the following link: http://www3.natick.army.mil/NGDS.html.

Contractors are encouraged to submit comments/questions regarding the draft RFP documents via email to john.conlin3@us.army.mil. Contractors should provide specific questions/comments in writing to the Contract Specialist, Mr. John Conlin at John.Conlin3@us.army.mil, no later than 12:00 pm EST on 2 April 2012. Every effort will be made to answer/discuss each comment/question received by 12:00 pm EST 2 April 2012 during the NGDS Industry Day using non-attribution procedures. Additionally, questions/comments presented and submitted in writing at the NGDS Industry Day will be addressed during Industry Day within the available time available. All questions/comments will be posted to the website following the Industry Day. The objective of the draft RFP and Industry Day is to enhance the Government solicitation documents and Contractor proposal preparations/submittals.

The 3 April 2012 session is an open forum and will begin at 12:30 p.m. on 3 April 2012 in Room L-6 at the Cook Convention Center in Memphis, TN. Contractors will be offered the opportunity to schedule a one-on-one meeting with the Government on 4 April 2012 between the hours of 8:00 a.m. - 12:00 p.m., but must request a meeting in advance as part of the registration process.

Contractors wishing to attend Industry Day must register no later than 3:00 p.m. on 30 March 2012 at http://www3.natick.army.mil/NGDS.html.

Release of the draft RFP is anticipated on 27 March 2012. Release of the draft RFP is NOT a commitment by the Government to award a contract and the Government will NOT pay any costs incurred as a result of this release. Questions and comments should be emailed to John.Conlin3@us.army.mil and entitled "NGDS Comments/Questions".

Please be advised that all communications concerning this acquisition (including, but not limited to, management/technical issues, pricing issues, administration issues, and proposal issues) must be coordinated through the Contract Specialist, Mr. John Conlin, John.Conlin3@us.army.mil.

Added: Jan 04, 2012 8:52 am Modified: Mar 15, 2012 2:54 pmTrack Changes Purpose
The purpose of the Next Generation Diagnostics System (NGDS) solicitation is to:
* Award multiple contracts to vendors of commercially available FDA-cleared diagnostic platforms for initial competitive prototyping;
* Develop and manufacture FDA-cleared in-vitro diagnostic and environmental surveillance assays for biological warfare agents (BWA), infectious diseases, and other pathogens of operational concern;
* Integrate the platform to be interoperable with DoD CBRN and medical information systems.

Background

The NGDS Increment 1 system proposed is an FDA-cleared, reusable, adaptable diagnostic device for the analysis of biological (clinical) liquid samples. Increment 1 medical diagnostic capabilities will provide health care providers with timely and accurate information to guide individual patient treatment. Additionally, the BW threat identification information obtained during diagnostic testing will provide battle field commanders with biological hazard situational awareness to support Force Protection and Force Health Protection decision making. The NGDS Increment 1 is intended to eventually replace the current Joint Biological Agent Identification and Diagnostic System (JBAIDS).

The proponent for this effort is the Chemical Biological Medical Systems - Biosurveillance (CBMS-BSV) Joint Product Management Office of the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD).

Industry Day Information

CBMS-BSV will conduct an NGDS Industry Day at 12:30 p.m. on 3 April 2012 and from 8:00 a.m. - 12:00 p.m. of 4 April 2012 in Room L-6 at the Cook Convention Center in Memphis, TN to discuss the NGDS draft RFP. Please read the draft Request for Proposal (RFP) for detailed information on the NGDS contract requirements The documents will be available on 20 March 2012 at the following link: http://www3.natick.army.mil/NGDS.html.

Contractors are encouraged to submit comments/questions regarding the draft RFP documents via email to john.conlin3@us.army.mil. Contractors should provide specific questions/comments in writing to the Contract Specialist, Mr. John Conlin at John.Conlin3@us.army.mil, no later than 12:00 pm EST on 2 April 2012. Every effort will be made to answer/discuss each comment/question received by 12:00 pm EST 2 April 2012 during the NGDS Industry Day using non-attribution procedures. Additionally, questions/comments presented and submitted in writing at the NGDS Industry Day will be addressed during Industry Day within the available time available. All questions/comments will be posted to the website following the Industry Day. The objective of the draft RFP and Industry Day is to enhance the Government solicitation documents and Contractor proposal preparations/submittals.

The 3 April 2012 session is an open forum and will begin at 12:30 p.m. on 3 April 2012 in Room L-6 at the Cook Convention Center in Memphis, TN. Contractors will be offered the opportunity to schedule a one-on-one meeting with the Government on 4 April 2012 between the hours of 8:00 a.m. - 12:00 p.m., but must request a meeting in advance as part of the registration process.

Contractors wishing to attend Industry Day must register no later than 3:00 p.m. on 30 March 2012 at http://www3.natick.army.mil/NGDS.html.

Release of the draft RFP is anticipated on 27 March 2012. Release of the draft RFP is NOT a commitment by the Government to award a contract and the Government will NOT pay any costs incurred as a result of this release. Questions and comments should be emailed to John.Conlin3@us.army.mil and entitled "NGDS Comments/Questions".

Please be advised that all communications concerning this acquisition (including, but not limited to, management/technical issues, pricing issues, administration issues, and proposal issues) must be coordinated through the Contract Specialist, Mr. John Conlin, John.Conlin3@us.army.mil.

An NGDS Bidder's Library will be established and the link will be provided for all RFP documents. To obtain access to the Bidder's Library, please complete the request form at http://www3.natick.army.mil/NGDS.html. (Note: the website will be available on 20 March 2012)

Added: Jan 04, 2012 8:52 am Draft solicitation documents for the Next Generation Diagnostic System Increment 1 are available for industry review and comment from January 4, 2012 through January 20, 2012. The documents can be accessed through the following website:

http://www3.natick.army.mil/mastsoldet.cfm?recordID=W911QY12R0021


Program Description: The Chemical Biological Medical Systems Joint Project Management Office (CBMS JPMO), under the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), is preparing to issue a Request for Proposals for Commercial Off-The-Shelf (COTS) systems for the Next Generation Diagnostic System (NGDS) Increment 1 program. The NGDS Increment 1 acquisition program is intended to provide FDA-cleared diagnostic capabilities for Chemical, Biological, Radiological, and Nuclear (CBRN) threats and emerging threats of operational concern. The anticipated acquisition strategy for NGDS is to develop, test and field an initial U.S. Food and Drug Administration (FDA)-cleared CBRN diagnostic capability and add additional FDA-cleared assays over a 4-year period. The NGDS program is also interested in enabling technologies to enhance the patient screening and collection and transport of clinical samples for diagnostic analysis.