RFP - Intranasal Nalmefene Drug-Device Combination   4

Background
The Office of the Biomedical Advanced Research and Development Authority within the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use Project BioShield (PBS) to support the procurement of an intranasal nalmefene drug-device combination product for use by adult and pediatric populations for the treatment of opioid, including fentanyl overdose.

Work Details
The solicitation includes responses to vendor questions related to technical manufacturing capabilities, budget spreadsheet, CO guidance information, maximum annual salary cap, key personnel, residency requirements, geographic location requirements, BARDA security requirements, quality agreement template, quality management system plan, supply chain security requirements, stockpiling of materials, HHS SECTION 508 PRODUCT ASSESSMENT TEMPLATE, subcontractor resources and experiences, BCP location for BARDA in the Distributor’s network, account set up team requirements, Person in Plant requirement clarification, physical inventory count requirement clarification,
transportation plan for logistics service provider,
air freight rates requirement confirmation,
plastic components shipping without temperature controls confirmation,
ISO seals acceptance confirmation,
live GPS monitoring suggestion confirmation,
shipping costs responsibility clarification,
firm fixed price applicability confirmation for option years,
distribution model creation clarification for local EMS/hospital entities and replenishment of stock in VMI clarification.