Title
Validation and Acquisition of a Radiation Biodosimetry High Throughput Test

General Information
Document Type: Presolicitation Notice
Solicitation Number: RFP-16-100-SOL-00010
Posted Date: 3/21/16 (Amendment 0002 dated 5/20/16)
Classification Code: A-Research and Development
NAICS Code: 541-Professional, Scientific, and Technical Services/541711-Research and Development in Biotechnology

Contracting Office Address
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

Description:

Within the Federal government, the Department of Health and Human Services (HHS) is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective medical countermeasures for the adverse health effects resulting from intentional exposure to CBRN threat agents, pandemics and emerging infectious disease threats.

HHS, through the interagency Public Health Emergency and Medical Countermeasure Enterprise (PHEMCE) is responsible for the integration of requirements for the advanced development and procurement of medical countermeasures for CBRN, pandemic influenza and emerging infectious disease threats. The 2014 HHS PHEMCE Strategy and Implementation Plan describes the strategic policy goals and objectives for identifying requirements and establishes the priorities for the development of the medical countermeasures against chemical, biological, radiological, and nuclear threats, pandemic influenza and emerging infectious diseases.

Under the Project BioShield (PBS) Act (2004) and the Pandemic and All-Hazards Preparedness Act (2006), BARDA was charged with developing medical countermeasures (MCMs) to address radiological and nuclear threats to the United States as determined by the Department of Homeland Security as Material Threats. In the aftermath of an improvised nuclear device (IND) detonation or a nuclear accident, having rapid and accurate measurements of internal radiation absorption in exposed persons can inform life-saving medical decisions. The high-throughput biodosimetry test is a dose-dependent measurement of the biological changes caused by ionizing radiation that result in internal body damage. The test results will determine the level, duration, and combination of medical care administered to an individual. BARDA anticipates that contracts awarded from this RFP will serve to facilitate the test validation, EUA and FDA diagnostic filings, and the initial stockpiling of biodosimetry tests for use in a nuclear incident.

HHS, through ASPR and BARDA, anticipates 1-2 contract award(s) will be made to radiation biodosimetry test developers. The anticipated period of performance for any resultant contracts may be for a total of up to 120 months which includes the base plus option periods. Additional details and requirements will be described in the solicitation.

Mandatory Criteria for Eligibility
Offerors must meet the following mandatory criterion and data must be provided in the proposal to demonstrate eligibility validity for a High-throughput Biodosimetry award:

• Semi-quantitative or quantitative test with an accuracy of ± 1 Gy (± 0.5 Gy preferred) across an absorbed-dose range of 2-6 Gy, measured from 24 hours to at least 7 days post-irradiation
• Using an arrangement of no more than 150 instruments, commercially placed in clinical reference, hospital, or public healthcare laboratories, can potentially generate a daily result output capability of more than 60,000 test results over at least 7 days post-incident.
• Assay has analytical performance demonstrating the comparability of results between in vivo irradiated human and non-human primate samples, to support entering into design validation per requirements in the U.S. FDA Quality Systems Regulations.

If a Request for Proposal were published, it might include some of the following programmatic objectives:
• Advanced development and clinical validation of a high-throughput radiation biodosimetry test candidate
• Development of comprehensive milestone-driven test and reagent manufacturing and procurement plans and their execution.
• Provision of specialized specimen collection tube capabilities (if required for the test),
• Establishment and maintenance of Quality, Risk, Security, and Earned Value Management Systems.
• Development of a comprehensive milestone-driven instrument manufacturing or upgrade plan and activities to execute the plan after regulatory action has occurred.
• Development of items for Sustainability of Preparedness
• Provision of Project Management, Reporting, Meetings/Site Visit Capabilities
• Establishment and maintenance of a national stockpile of high-throughput biodosimetry testing reagents
• Activities to potentially upgrade the test for greater throughput, higher efficiency, or lower cost without posing new device or assay safety or effectiveness questions
• Provision to execute Post-Marketing Commitments and/or Requirements
• Establish and maintain inventory procurements

Pre-solicitation Notice Objective:

This Pre-solicitation Notice is issued pursuant to FAR Subpart 5.2. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This Pre-solicitation Notice does not commit the Government to contract for any supply or service whatsoever. Further, AMCG is not at this time seeking proposals, and will not accept unsolicited proposals.

It is anticipated that an RFP may be available electronically through the FedBizOpps website on or about June 6, 2016, with proposals being due on or about July 21, 2016. Any responsible offeror may submit a proposal that will be considered by the Government. It is the offeror's responsibility to monitor this internet site (www.fbo.gov) for the release of this solicitation as well as any amendments. Potential offerors will be responsible for downloading their own copy of the solicitation and any amendments via this website. No collect calls will be accepted. No facsimile transmissions will be accepted. All responses should be identified with the RFP number, name of firm, size standard of the firm, name of requestor, mailing address, telephone number, fax number, and email address, and should be submitted to the Point of Contact(s) identified in this notice.

Multiple awards may result from this solicitation with an estimated award date in September 2016.

Furthermore, all respondents must be registered in the System for Award Management (SAM) https://www.sam.gov.

Point of Contact:

Carl Newman, Contracting Officer, Phone 202-205-1156, Email [email protected] or
Amorette McKeithan, Contract Specialist, Phone 202- 692-4623, Email [email protected].