This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. Your responses to the information requested will assist the Government in determining the appropriate acquisition method.

PURPOSE AND OBJECTIVES:

In reaction to prompt total-body ionizing radiation with a dose range of 0.5 to 10 Gy (photons), the typical symptoms of radiation exposure in humans include nausea, vomiting, diarrhea, and peripheral blood lymphocyte depletion . The duration of initial or prodromal symptoms and the latent phase of radiation syndrome is anywhere from 1 h to 2 weeks. Without appropriate medical care, the median lethal dose of radiation, the LD50/60 (the dose that kills 50% of the exposed population within 60 days after exposure), is estimated to be 4.5 Gy . However, the likelihood of survival can be significantly increased with appropriate aggressive medical intervention and care .
The Radiation Biodosimetry High Throughput (HT) Test is designed to be run in clinical laboratory produces a quantitative estimate of the actual absorbed dose a person received from 0 to 10 Gy. The result will be used in conjunction with signs, symptoms, and hematology to give the health care provider additional information to allow the correct level of care to be administered to each patient.
The objective of this proposed request for services and subsequent test acquisition is to:
Acquire FDA approved/cleared Radiation Biodosimetry HT Test systems including acquisition of sufficient quantities of the tests, reagents, instruments and associated consumables to ensure a level of national readiness that does not presently exist.
As part of delivering the FDA approved/cleared Radiation Biodosimetry HT Test systems the Offeror may include the following efforts:
1. Performance of the formal Validation of the Radiation Biodosimetry HT Test system in preparation for regulatory filing.
2. Provide services that support filing sufficient data to request Emergency Use Authorization of the Radiation Biodosimetry HT Test system.
3. Provide services that support the FDA filing and subsequent approval of the Radiation Biodosimetry HT Test system.
4. Support manufacturing preparations for the Radiation Biodosimetry HT Test System and manufacturing of an initial supply of HT devices, tests, reagents and associated consumables.
5. Support manufacturing and maintenance of HT devices, tests, reagents and associated consumables to maintain national readiness for a period of up to 15 years.

PROJECT REQUIREMENTS:
The Biomedical Advanced Research and Development Authority (BARDA) (a component of the United States [U.S.] Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response) is seeking capability statements from businesses having the ability to provide verification, validation, regulatory approval, manufacturing and acquisition services for high throughput devices that determine whether an individual has absorbed a dose of 0 - 10 Gray (Gy ) to help accurately medical professionals in treating individuals after a radiological or nuclear incident.
The narrative (including figures, schematics, diagrams, photographs, etc.) should describe the capabilities of the Offeror and demonstrate their ability to meet the below criteria:
1. Document that the High Throughput Radiation Biodosimetry Device and Assay:
a. Is quantitative with an accuracy of approximately ± 1.0 Gy from 24 to 168 hours post-irradiation over a dose range of 0 to 10 Gy.
b. Can be used in conjunction with signs, symptoms, and hematology to guide the medical treatment of affected individuals.
c. Can be used in a clinical laboratory setting by trained individuals and is highly automated.
d. Can be run on a system of no more than 120 pre-placed instruments whose throughput that will allow up to a four hundred thousand test results to be reported within 7 days.
e. With pre-event verification, could immediately be effectively and accurately run in a Clinical Laboratory Improvements Amendment (CLIA) accredited or public health laboratory that have the instrument installed and in use for other clinical assays.
f. Has integrated standards and controls to monitor instrument and assay performance.
g. Has sufficient validated assay (pre-verification) data, including in vivo irradiated human and non-human primate results, to support entering into design validation phases consistent with the United States Food and Drug Administration (FDA) quality systems regulations and pre-market clearance within one year of contract award. Is mature enough to enter into validation activities consistent with the United States Food and Drug Administration (FDA) guidelines within the next year (minimum TRL of 6 at proposal submission; see: https://www.medicalcountermeasures.gov/federal-initiatives/guidance/integrated-trls.aspx).
h. Yields a reportable result 99% of the time.
i. Uses commercially available instruments with sufficient pre-placements in CLIA accredited laboratories to perform the required number of tests in the United States. These instruments may require improvements to the installed instrument base to perform this test.

2. Document the Offeror's capability to develop an HT device and progress on test verification package sufficient for FDA filing.

a. Provide a list of what elements are being pursued in the verification of the biodosimetry device system.
b. Provide a timeline for HT device and test verification activities yet to be completed.

3. Document the Offeror's capability to develop an HT device and test validation package sufficient for FDA filing.

a. Provide a short description of the strategy that will be employed to create the validation data set because the intended use population is not available.
b. Provide list of what elements that will be pursued in the validation plan to show the equivalence of information between species.

4. Document a plan and evidence of a workable strategy for obtaining an FDA investigational device exemption (IDE) submission, including a premarket notification (510(k)) or a premarket approval (PMA).

a. Provide a brief table of contents for the submission package and workable timeline.
b. Provide evidence of a commitment to, experience and expertise in generating the submission package.
c. Provide evidence of a commitment to generating the data to support USG filing of a Pre-Emergency Use Authorization (Pre-EUA) package for use of the product during a declared emergency, declared potential emergency or identification of material threat under an Emergency Use Authorization (EUA).

5. Document the Offeror's quality documentation and capabilities:

a. Provide evidence of an established medical device quality system with sufficient content to support the planned filing, staff to update and maintain the files, and adherence to the FDA Design Control Guidance For Medical Device Manufacturers.
b. Provide a schedule of routine internal reviews of the medical device quality system and a plan for an independent audit of the system prior to the regulatory submission.

6. Document the Offeror's risk management system by briefly describing the activities required to document preliminary hazard analyses, FMEA plans, and risk control plans.

7. Document the Offeror's ability to provide the following assay and reagent kit
capabilities:

a. Document the Offeror's plan for GMP compliant pilot manufacturing of the initial lots of reagents and kits needed for pre-submission activities Provide an outline for how reagents, assay kits and testing devices would be manufactured kits to prepare the nation (i.e. produce enough assay and reagent kits for 400,000 HT tests within 7 days).

8. Provide documentation on specimen collection tubes or consumables capabilities:

a. Provide an outline of a plan for GMP compliant pilot manufacturing of the initial lots of specialized specimen collection tubes (if needed for the test) or additional volume for commercially available tubes for pre-submission activities GMP compliant.
b. Provide an outline of a plan for manufacturing sufficient pilot lots of specimen collection tubes or kits for the stability, verification and validation activities planned prior to the FDA submission.
c. The Offeror shall provide an outline of a plan and proposed timeline for the manufacture of collection tubes or consumables to prepare the nation (i.e. produce enough assay and reagent kits for 400,000 HT tests within 7 days) and their subsequent replenishment for up to 15 years.

9. The Offeror must provide evidence that they have or have plans to achieve the following instrument manufacturing capabilities, if the instrument being used for the assay is not commercially available:

a. The Offeror shall outline a plan of how the instrument manufacturing will move from pilot manufacturing to GMP manufacturing and how they will verify the equivalency of the GMP products.
b. The Offeror shall provide a brief manufacturing plan of a specific quantity of the GMP quality instruments to generate the results required to run (i.e. 400,000 HT tests within 7 days).
c. The Offeror shall provide an outline of likely instrument maintenance requirements and intervals.
10. The Offeror must provide the following instrument manufacturing capabilities, if the instrument being used for the assay is commercially available:

a. The Offeror shall provide an outline of how the already fielded instruments can be upgraded to produce equivalent results to a newly manufactured instrument with the biodosimetry test and software installed (if needed), a timeline and the cost.
b. The Offeror shall provide a brief description of how to leverage a sufficient number of fielded instruments and install upgrades to ensure the USG capability (i.e. 400,000 HT tests within 7 days).
c. The Offeror shall provide an outline of how to recertify the instrument and at what interval.

11. The offeror must provide products for the sustainability of preparedness:

a. The Offeror shall provide a table of contents for a training manual to ensure the ability of the USG to train a core group of individuals on the biodosimetry assay.
b. If the instrument used to run the assay does not have a maintenance manual generated by the manufacturer, the Offeror shall describe a plan to provide such a manual for pre-event, event and post-event activities.
c. The Offeror shall provide an operationalization plan outline describing a feasible scenario for implementation at clinical laboratories with the capacity needed for a nuclear detonation response (400,000 HT tests in 7 days).

12. The Offeror shall provide a list of other instrumentation needed to maximize the throughput and accuracy of the biodosimetry test.

13. The Offeror shall provide information on how the patient data will get to the medical authority for the specific victim.

ANTICIPATED PERIOD OF PERFORMANCE:
The base contract(s) are expected to be awarded in late FY 2016 or early FY 2017. The base contract award(s) are expected to include the manufacturing and an initial resupply of tests, reagents and other items and these activities are expected to be triggered following approval of the Radiation Biodosimetry HT Test by the FDA and at the discretion of the government. Completion of the initial supplies and subsequent resupplying efforts are expected to be initiated by excision of contract options at the discretion of the government.
OTHER IMPORTANT CONSIDERATIONS:
A similar notice is anticipated for Radiation Biodosimetry Point of Care (POC) Tests. Please consider carefully whether the proposed test most closely meets the HT or POC requirements and respond to the appropriate notice.
CAPABILITY STATEMENT/INFORMATION SOUGHT:
Respondents must provide, as part of their responses, a capability statement that fully describes their currently available device and the level of analytical verification and clinical validation that they have attained. The description shall include the Technical Readiness Level of both the device and assay (see: https://www.medicalcountermeasures.gov/federal-initiatives/guidance/integrated-trls.aspx).

Respondents must provide, as part of their responses, a capability statement that specifically addresses the items under PROJECT REQUIREMENTS. Respondents' opinions about the difficulty and/or feasibility of the potential requirements or proposed acquisitions, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts relative to this proposed solicitation will be gratefully received.
Information submitted should be relevant and specific in the technical area under consideration, on each of the following qualifications: 1) Experience: An outline of previous similar projects, specifically the techniques employed in the services described above; 2) Personnel: Name, professional qualifications and specific experience in the work requested; 3) Facilities: Availability and description of the facilities and equipment required to conduct this type of work. Also, we will consider appropriateness of professional and technical personnel classifications; any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but is not limited to, government and commercial contracts the organization performed, references (i.e., names, titles, telephone numbers) and any other information serving to document the organization's capability (e.g., awards, commendations, etc).

All capability statements must provide the following: 1) company name and address; 2) point of contact, 3) phone/fax/email; 4) NAICS Code(s), 5) business size and status; 6) capability information in response to the project requirements and qualifications identified in this notice; and 7) type of business your organization classifies itself as (i.e. HUBZONE). Written capability statements must be RECEIVED NO LATER THAN close of business December 4, 2015 and e-mailed to the Contracting Officers. Only electronic Microsoft Word capability statements will be accepted by the points of contact.
THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. 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. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.
Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

 

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