2020 Midazolam Autoinjectors PBS - Pre-solicitation Notice_10222020.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

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

PRESOLICITATION NOTICE

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

ON A LATER DATE.

Title: Project Bioshield:

Midazolam Autoinjectors

General Information

Document Type: Pre-Solicitation Notice

Posted Date: October 22, 2020 Solicitation Number: 75A50121R00003

Classification Code: A – Research & Development

NAICS Code:

541 -- Professional, Scientific, and Technical Services/541714 -- Research and Development in Biotechnology

Synopsis

The 2007 PHEMCE Implementation Plan for Chemical, Biological, Radiological, and Nuclear (CBRN) Threats called for updating the CHEMPACK formulary with improved medical countermeasures, such as anticonvulsants, as they became available. In 2011, the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) recommended that an improved anticonvulsant be developed and procured to address this need. Attributes of this product would include a non-IV route of administration (e.g. IM) that is fast acting, has greater efficacy than existing products, and is approved by the Food and Drug Administration (FDA) for adult and pediatric indications. More specifically, the PHEMCE recommended that all diazepam autoinjectors (Convulsant Antidote Nerve Agent, CANA) in the Strategic National Stockpile’s (SNS) CHEMPACK Program be replaced with the improved anticonvulsant midazolam in an autoinjector for rapid intramuscular administration.

The CHEMPACK Program addresses some significant challenges to preparedness for a nerve agent attack.

Prepositioning antidotes throughout the country addresses the time constraint on effective medical treatment and thus reduces the time for delivery relative to the time to provide a 12-hour Push Package released from a strategically placed SNS site. SNS/CHEMPACKs account for all of the CANA acquired and maintained by the SNS specifically for the treatment of nerve agent-induced seizures. Development and acquisition of pediatric and adult midazolam autoinjectors, and their approval as a drug/device combination product for the treatment of status epilepticus in both populations, would fulfill the requirement to replace all existing diazepam autoinjectors in the SNS/CHEMPACKs with midazolam autoinjectors.

This acquisition will allow BARDA to procure, stockpile, and invest in the completion of post-marketing requirements that will ensure the continued availability of Midazolam autoinjectors for use in the treatment of nerve agent seizures, if needed.

The Government seeks to support Advanced Research and Development (ARD) activities necessary for the completion of remaining regulatory activities to obtain FDA approval for midazolam autoinjectors for the treatment of status epilepticus in adult and pediatric (>2 years) populations. In addition, procure midazolam autoinjectors for delivery to the SNS, and to support completion of Post-marketing Requirements – to be defined by FDA upon approval – in order to ensure continued utility of the stockpile. In order to meet these objectives, Offerors would need to demonstrate fulfillment of the following Mandatory Criteria in order for their proposals to be evaluated and considered for an award under a potential solicitation:

1) The Offeror must have the capability to manufacture midazolam autoinjectors that are FDA approved or at the Phase 3 clinical level of development;

2) The Offeror must have demonstrated that their proposed autoinjectors are able to meet the FDA reliability standard for medical devices (99.999% reliability). The Offeror must have obtained FDA feedback regarding their regulatory approach;

3) The Offeror must have demonstrated their autoinjectors can be used in emergency situations by first responders and untrained personnel (Human Factors Studies are acceptable).

Proposed capability should include the ability to deliver midazolam autoinjectors, as a drug/device combination product, to SNS/CHEMPACKs.

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, the Biomedical Advanced Research and Development (BARDA) Division of Contracts Management and Acquisition (CMA) 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 beta.SAM.gov website under Contract Opportunities in November 2020 for 30 days with proposals being due in December 2020. 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 (https://beta.sam.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 a contract with both cost reimbursement and firm-fixed aspects will be awarded in or around March - May 2021. The anticipated period of performance for any resultant contract(s) will be for a total of 60 months and up to 120 months, if all Option periods are 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:

Jill Johnson BARDA Contracting Officer Jill.Johnson@hhs.gov Phone: 202-690-7137 https://www.sam.gov/ mailto:christopher.scott@hhs.gov

Jessica Coleman BARDA Contract Specialist Jessica.Coleman@hhs.gov Phone: 202-730-8664

Efrain Garcia, PhD BARDA/CBRN Countermeasures Efrain.Garcia@hhs.gov Phone: 202-205-3817 mailto:sabrina.mcintyre@hhs.gov mailto:david.boucher@hhs.gov