Thrombocytopenia Pre-Solicitation Notice.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

FEDERAL BUSINESS

OPPORTUNITIES PRESOLICITATION

NOTICE

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

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

ISSUED ON A LATER DATE.

Title: Project BioShield Procurement of Thrombocytopenia Medical Countermeasures:

Therapeutic for treatment of Thrombocytopenia arising from H-ARS

General Information

Document Type: Pre-Solicitation Notice

Solicitation Number: 75A50122R00021

Product Service Code:

AN13 – Health R&D Services; Health care services; Experimental Development

NAICS Code:

541714 – Research and Development in Biotechnology (except Nanobiotechnology)

Synopsis

Thrombocytopenia, a decrease in platelets, is expected to be a significant health issue following a radiologic event. It is anticipated that the medical management of thrombocytopenia following a mass casualty event will best be served by employing medical practices already in use for oncological and other medical treatments. BARDA is seeking a medical countermeasure (MCM) to treat thrombocytopenia arising from the Hematopoietic subsyndrome of Acute Radiation Syndrome (H- ARS) to augment the United States Government (USG) response capabilities in response to a radiological/nuclear incident.

In order to address this unmet need, the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use Project BioShield (PBS) to procure a U.S. Food and Drug Administration (FDA) approved thrombopoietin receptor agonist, for use as a MCM that can treat thrombocytopenia arising as a pathology of acute exposure to ionizing radiation that may be a consequence of a radiological/nuclear mass casualty event . The procured therapeutic will be delivered to the ASPR/Strategic National Stockpile and maintained as vendor managed inventory. The USG seeks therapeutics that meet the following mandatory criteria: 1) The approved label indication shall be to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation H-ARS and 2) The approved label shall state the drug’s mechanism of action is through stimulation of thrombopoiesis and/or treatment of thrombocytopenia resulting in a statistically significant increase in platelet counts and 3) The MCM is effective when administered at 24-hours or more post-radiation exposure.

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.

Updates to the details provided could arise based on information and insight gained in the interim. Furthermore, BARDA 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 Sam.gov website in July 2022.

Once an RFP is posted, we encourage all responsible sources that meet the mandatory criteria detailed above, to submit a proposal which will be considered by BARDA. It is the Offeror's responsibility to monitor this internet site (www.sam.gov) for the release of the 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.

BARDA may elect to make more than one contract award from the RFP solicitation. Any contract(s) awarded from the RFP solicitation will have for any resultant contract(s) will be up to 120-months with an initial base period of 60-months. 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:

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

Points of Contact:

Richard Hall, BARDA Contract Specialist Richard.hall@hhs.gov

Jonathan Gonzalez BARDA Contracting Officer Jonathan.Gonzalez@hhs.gov

Mary Homer BARDA Radiological and Nuclear Countermeasures Branch Chief Mary.Homer@hhs.gov https://sam.gov/content/home https://www.sam.gov/ https://www.sam.gov/ http://www.sam.gov/ mailto:Jill.Johnson@hhs.gov mailto:Richard.hall@hhs.gov mailto:Mark.Albrecht@hhs.gov mailto:Jonathan.Gonzalez@hhs.gov