Ebola_Therapeutics_Pre-Sol_Notice.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

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

FEDERAL BUSINESS OPPORTUNITIES

PRESOLICITATION NOICE

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION MAY BE

ISSUED ON A LATER DATE.

Title: Ebola Therapeutics

General Information

Document Type: Pre-Solicitation Notice

Posted Date: April 18, 2017 Solicitation Number: RFP#17-100-SOL-00014 Classification Code: A – Research & Development

NAICS Code:

541 -- Professional, Scientific, and Technical Services/541711 -- Research and Development in Biotechnology

Synopsis

Ebola virus is a single-stranded, negative sense RNA virus of the Filoviridae family. Infections by Ebola virus result in a highly lethal VHF; mortality has ranged from 25-90 percent depending on the outbreak and the virus species by which it was caused. Medical countermeasures (MCM) against Ebola virus are urgently needed should future outbreaks of this virus occur, similar to the 2014-2015 epidemic in West Africa. The 2014 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan identifies Ebola virus as a high-priority threat as determined by the Secretary of Homeland Security. Strategies to mitigate the threat of Ebola virus include the development of a therapeutic suitable for treatment of Ebola Virus Disease.

There are currently no therapeutics that are licensed for use against Ebola virus. BARDA is seeking therapeutic(s) that can be safely and effectively used to treat Ebola infection for U.S. civilian population.

The therapeutic(s) at a minimum shall have an active IND with safety data from a Phase 1 clinical trial, and non-clinical efficacy in a nonhuman primate model of Ebola infection.

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. Furthermore, 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 in May 2017 for 45 days with proposals being due in June 2017. Once any RFP is posted we encourage all responsible sources, particularly small businesses, to submit a proposal which will be considered by the agency. 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.

It is anticipated that one or more contracts with both cost reimbursement and firm-fixed aspects will be awarded in or around August-September 2017. The anticipated base period of performance for any resultant contracts will be for a total of 60 months and up to 10 years with options if exercised.

Additional details and requirements will be described in the solicitation.

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

Contracting Office Address:

Office of the Assistant Secretary for Preparedness & Response (ASPR) Department of Health and Human Services 200 C St. SW Washington, District of Columbia 20024 United States

Points of Contact:

Jason Bell Contracting Officer Jason.Bell@hhs.gov Phone: 202-260-1457 https://www.sam.gov/ mailto:Jason.Bell@hhs.gov