SOURCES SOUGHT
A -- Verification, Validation, and Acquisition of Radiation Biodosimetry Point of Care Triage Test-Small
- Notice Date
- 11/18/2015
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Acquisitions Management, Contracts, & Grants (AMCG), Office of the Assistant Secretary for Preparedness & Response (ASPR), Department of Health and Human Services, 330 Independence Ave. SW, G640, Washington, District of Columbia, 20201, United States
- ZIP Code
- 20201
- Solicitation Number
- HHSO-2016-BIOD-POCS-00001
- Archive Date
- 12/19/2015
- Point of Contact
- Carl A. Newman, Phone: 202-205-1156, Amorette McKeithan, Phone: 2026924623
- E-Mail Address
-
carl.newman@hhs.gov, amorette.mckeithan@hhs.gov
(carl.newman@hhs.gov, amorette.mckeithan@hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. 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 Point of Care (POC) Triage Test is designed to be administered by a person with little or no medical training in an assembly center, field hospital, tent, emergency room or triage station and determine whether an individual has absorbed a dose of 2 Gy or greater. The intent of this assay is to separate the individuals with irradiation-related medical needs from the "concerned citizens" who do not need specific treatment. The objective of this proposed request for services and subsequent test acquisition is to: Acquire FDA approved/cleared Radiation Biodosimetry POC 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 POC Test systems the Offeror may include the following efforts: 1. Performance of the formal Validation of the Radiation Biodosimetry POC Test system in preparation for regulatory filing. 2. Provide services that support filing sufficient data to request Emergency Use Authorization of the Radiation Biodosimetry POC Test system. 3. Provide services that support the FDA filing and subsequent approval of the Radiation Biodosimetry POC Test system. 4. Support manufacturing preparations for the Radiation Biodosimetry POC Test System and manufacturing of an initial supply of POC devices, tests, reagents and associated consumables. 5. Support manufacturing and maintenance of POC 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 small businesses having the ability to provide verification, validation, regulatory approval, manufacturing and acquisition services for point of care devices that determine whether an individual has absorbed a dose of 2 Gray (Gy ) or greater to help accurately triage 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 Point of Care Radiation Biodosimetry Device and Assay: a. Is qualitative and accurately reports whether an individual has absorbed less than 2 Gy or greater than/equal to 2 Gy of ionizing radiation from 24 to 168 hours post-irradiation The instrument is portable and robust with a durable case/packaging, water-resistant, and has established performance factors for humidity and temperature beyond "room temperature". b. If the instrument contains rechargeable batteries, those batteries shall be maintainable without removing the instrument from its packaging, excluding maintenance required at periodic manufacturer inspections during long term storage. c. No larger than: Height: 20 inches, Width: 20 inches, Depth: 20 inches, Weight: 40 lbs. d. The assay medium (cartridge, plate, strip, etc.) Is sturdy with resilient protective packaging. e. Can be used as a triage or sorting tool during a radiological emergency. f. Is low complexity and requires minimal training. g. Requires no sample preparation external to the test device/medium. h. Can be run in emergency rooms, temporary triage stations, or field hospitals. i. Has a throughput that will allow up to a million test results to be reported within 7 days (using multiple devices). J. No more than 3000 instruments are required to perform a million test results within 7 days. k. Provides a rapid result (optimally within less than 20 minutes) and time to first result is short (optimally within 30 minutes). l. Requires few consumables. m. Has integrated standards and controls to monitor instrument and assay performance. n. Has sufficient laboratory data, including in vivo irradiated human and non-human primate results, to support beginning, 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. o. Is at a minimum TRL of 6 at proposal submission (see: https://www.medicalcountermeasures.gov/federal-initiatives/guidance/integrated-trls.aspx). p. Yields a reportable result ≥ 99% of the time. q. Demonstrates an overall false negative rate of 5% or lower with an upper limit of the 95% confidence interval (CI) of 10% or lower and an overall false positive rate of 5% or lower with an upper limit of the 95% CI of 10% or lower. 2. Document the offeror's capability to develop a POC device and progress on a test verification package sufficient for FDA filing. a. Provide a list of what elements that are being pursued in the verification of the POC biodosimetry device system. b. Provide a timeline for POC device and test verification activity completion. 3. Document the offeror's capability to develop a POC 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 and expertise in generating the submission package. c. Provide evidence of a commitment to generating the data to support the 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). d. Submit proof of having held a Pre-Submission meeting for the subject device with the FDA. 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 (if applicable): a. Document the offeror's plan GMP compliant pilot manufacturing of the initial lots of reagents and kits needed for pre-submission activities If the pilot lots are manufactured in a non-GMP facility, the offeror shall provide an outline of the plan to transfer assay and reagent kits to a GMP compliant facility and the qualification procedures to ensure the newly manufactured kits perform equivalently or better than the pilot kits. b. 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 1M tests for a point of care tests within 7 days). 8. Provide documentation on specimen collection tubes or consumables capabilities (if applicable): a. Provide an outline of a plan GMP compliant pilot manufacturing of the consumables, initial lots of specialized specimen collection tubes (if needed for the test), or additional volume for commercially available tubes for pre-submission activities. b. Provide an outline of a plan for manufacturing sufficient GMP compliant pilot lots of consumables, 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 1M tests for a point of care 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. 1M tests for a point of care 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. 1M Point of Care 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 RTR 3 sites, assembly centers (AC), or in emergency rooms at medical centers at the volume needed for a nuclear detonation response (1M 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/is expected to be awarded in late FY 2016 or early FY 2017. The base contract award(s) are expected to include the Options for manufacturing and an initial resupply of tests, reagents and other items that outdate and these activities are expected to be excised following approval of the Radiation Biodosimetry POC 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. These awards are dependent of costs and availability of funds. OTHER IMPORTANT CONSIDERATIONS: A similar notice is anticipated for Radiation Biodosimetry High-Throughput (HT) Tests. Please consider carefully whether the proposed test most closely meets the POC or HT 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 small business your organization classifies itself as (i.e.: women-owned, HUBZONE, etc.). Written capability statements must be RECEIVED NO LATER THAN close of business December 4, 2015 and e-mailed to the Contracting Officer. Only electronic capability statements will be accepted by the point 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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