Ebola_Vaccine_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 Vaccine

General Information

Document Type: Pre-Solicitation Notice

Posted Date: April 18, 2017

Solicitation Number: RFP#17-100-SOL-00013

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 vaccine suitable for protection against Ebola virus.

There are currently no vaccines that are licensed for use against Ebola virus. BARDA is seeking a vaccine that can be safely and effectively used for the U.S. civilian population in individuals with an elevated risk of exposure to Ebola, specifically Zaire Ebolavirus.

All proposals submitted to any future solicitations shall have evidence of an active IND (with the Food and Drug Administration) with ongoing or completed Phase 2 or 3 clinical studies and shall provide evidence of 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 contract award(s) with both cost reimbursement and firm-fixed CLINs will be awarded on or around August-September 2017. The anticipated base period of performance for any resultant contract(s) 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

Point of Contact:

Christopher Scott Contracting Officer Christopher.Scott@hhs.gov Phone: 202-205-8580 https://www.sam.gov/ mailto:Christopher.Scott@hhs.gov