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Definitive Contract HHSO100201600037C
Award Date
9/30/16
Potential Completion Date
9/29/26
Potential Value
$100M
Overview
🤔 AI Insights
Buyer Personas
Industry Personas
Buyer Personas In this Market
5
Activity
Transactions
1
Subawards
2
Opportunity Stack
2
Federal Agency
Office of the Assistant Secretary for Preparedness and Response
Awardee
Mriglobal
Ultimate Awardee
Not listed
NAICS Category
541711 - Research and Development in Biotechnology
PSC Category
AN13 - Health R&D Services; Health Care Services; Experimental Development
Federal Contract Vehicle
Not listed
Set-Aside Type
No Set-Aside Used
Extent Competed
Full and Open Competition
Major Defense Program
Not listed
Pricing Type
Cost Plus Fixed Fee
Place of Performance
Kansas City, MO 64110, USA
Solicitation Procedures
Negotiated Proposal / Quote
Number Of Offers Received
4
Legislative Mandate
Not listed
National Interest Action
Not listed
Research Type
Not listed
Primary Consortia Member
Not listed
Description
Update #1
Update #2
Update #3
BIODOSIMETRY HIGH-THROUGHPUT DIAGNOSTIC TESTS
Posted 9/30/16, 12:00 AM
Name
Description
Solicitation Number
Federal Agency
Type
Posted Date
(Click to sort descending)
Validation and Acquisition of a Radiation Biodosimetry High Throughput Test
Added: Mar 21, 2016 9:16 am FEDERAL BUSINESS OPPORTUNITIES PRESOLICITATION NOTICETitleValidation and Acquisition of a Radiation Biodosimetry High Throughput TestGeneral InformationDocument Type: Presolicitation NoticeSolicitation Number: RFP-16-100-SOL-00010Posted Date: 3/21/16Classification Code: A-Research and DevelopmentNAICS Code: 541-Professional, Scientific, and Technical Services/541711-Research and Development in BiotechnologyContracting Office AddressOffice of the Assistant Secretary for Preparedness & Response (ASPR)Department of Health and Human Services 330 Independence Ave. SW G640Washington, District of Columbia 20201 United StatesDescription: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 procurementsPre-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 April 4, 2016, with proposals being due on or about May 31, 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 Carl.Newman@hhs.gov orAmorette McKeithan, Contract Specialist, Phone 202- 692-4623, Email Amorette.McKeithan@hhs.gov.
RFP-16-100-SOL-00010
Department of Health and Human Services Immediate Office of the Secretary
Award Notice 1/2
3/21/16, 9:16 AM
Validation and Acquisition of a Radiation Biodosimetry High Throughput Test
Added: Jun 07, 2016 2:30 pm RFP No. RFP-16-100-SOL-00010 for the Validation and Acquisition of a Radiation Biodosimetry High Throughput Test is hereby attached.
RFP-16-100-SOL-00010
Department of Health and Human Services Immediate Office of the Secretary
Award Notice 2/2
6/7/16, 2:30 PM
Contract Number
Description
Subcontractor
Prime Award
Dollars Obligated
(Click to sort descending)
Updated At
(Click to sort ascending)
7701109989S
Contractor shall provide regulatory and clinical research support as a subcontractor to MRIGlobal for the Biodosimetry High Throughput Diagnostic Test Program, for the Biomedical Advanced Research and Development Authority (BARDA).
North American Science Associates, LLC
Definitive Contract HHSO100201600037C
$100.0k
2/7/20
7101109984S
LOVELACE BIOMEDICAL & ENVIRONMENTAL RESEARCH INSTITUTE INC shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to the performance of the work set forth in Attachment A which states that the primary objective is to test the spectrum of intended use day and dose combinations to fill in gaps in test conditions that have not been previously tested and cannot be examined in human clinical studies.
Lovelace Biomedical And Environmental Research Institute, Inc.
Definitive Contract HHSO100201600037C
$2.0m
2/9/18
Mod #
Description
Reason For Modification
Federal Obligation
(Click to sort descending)
Date
(Click to sort ascending)
Not listed
BIODOSIMETRY HIGH-THROUGHPUT DIAGNOSTIC TESTS
Not listed
$21.3m
9/30/16