POC_Presolicitation_6.1.2017.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

Assistant Secretary for Preparedness & Response Washington, D.C. 20201

FEDERAL BUSINESS OPPORTUNITIES

PRESOLICITATION NOTICE

Title Validation and Acquisition of a Radiation Biodosimetry Point of Care Test

General Information

Document Type: Presolicitation Notice Solicitation Number: RFP-17-100-SOL-00019

Posted Date: 1 June 2017

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, Room G640 Washington, District of Columbia 20201

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 point of care 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 the possibility that several potential 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 as a separate volume in the proposal to demonstrate eligibility validity for a Point of Care Biodosimetry award:

• 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 at least 168 hours post-irradiation;

• Provides a rapid result (within approximately 30 minutes);

• Assay has analytical performance data for the following potentially special populations: pregnancy, immuno-compromised, pediatric, geriatric, burn, and trauma patients;

• 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.

The POC biodosimetry test will produce a qualitative estimate of the ionizing radiation dose a person absorbed from 0 to 10 Gy. It will report whether an individual absorbed < 2 Gy or ≥ 2 Gy and be used as a triage tool. The result will be used in conjunction with clinical signs and symptoms to give the health care staff information to release the individual to evacuate or send them for initial medical care. This will greatly enhance the present health care capabilities for nuclear incident victims.

If a Request for Proposal were to be potentially published, it might include some of the following programmatic objectives:

• Advanced development and clinical validation of a point of care radiation biodosimetry test candidate

• Development of comprehensive milestone-driven test and reagent manufacturing and procurement plans and their execution.

• 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 point of care biodosimetry tests, devices, and 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 additional inventory procurements

• Compliance with Privacy Act and Electronic Information and Technology Accessibility

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 16 June 2017, with proposals being due on or about 31 July 2017. 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.

Funding may limit the USG to a single potential award, though multiple awards may potentially result from this solicitation with an estimated award date in September 2017.

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

Point(s) of Contact Ethan Mueller, Contracting Officer, Phone 301-696-7289, Email ethan.mueller@hhs.gov (preferred) or Troy Francis, Contracting Officer, Phone 202-969-3849, Email troy.francis@hhs.gov (preferred) mailto:ethan.mueller@hhs.gov mailto:troy.francis@hhs.gov