BARDA Nonclinical Development Biological Network   9

Background
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in HHS, provides an integrated approach to develop vaccines, drugs, therapies, and diagnostics for public health medical emergencies (chemical, biological, radiological, nuclear threats and emerging infectious diseases).
Building on PHEMCE recommendations and BARDA’s Strategic Plan, this solicitation establishes a Nonclinical Services Network to provide technical and regulatory assistance and nonclinical services to generate safety and efficacy data supporting medical countermeasure development.

Work Details
Maintain a Multiple Award IDIQ contract network of laboratories providing expertise, capacity, and program management across three capability areas:
1) Animal Model Development and MCM Testing (Biological Agents): develop and characterize small and large animal models under FDA Animal Rule; produce and qualify challenge materials; design and conduct efficacy studies; perform supportive assays and statistical analyses; and deliver data and reports compliant with eCTD and SEND specifications.
2) Analytical Method Development, Qualification, Validation, and Testing: develop, qualify, validate, and transfer high-throughput analytical and bioanalytical methods for small molecules, proteins, biomarkers, and immunological signals under GLP; manage sample lifecycle; and support regulatory submissions.
3) Safety and Toxicity Testing: conduct IND-enabling GLP safety pharmacology, general toxicology, reproductive and developmental toxicology, and special population studies per FDA and ICH guidance; perform PK modeling; and prepare regulatory documentation.
Provide kick-off and annual meetings, site visits, audits, quality assurance, program management, reporting, and deliverables as defined in task orders.

Period of Performance
Five-year IDIQ ordering period with a 60-month base and task order periods as specified in individual RTORs.

Place of Performance
Contractor and approved subcontractor laboratory facilities in the United States, with meetings and site visits at government-designated locations.

Bidder Requirements
Offerors must submit a Small Business Subcontracting Plan.
Offerors must meet the following mandatory qualifications per capability area:
Animal Model Development – AAALAC accreditation or equivalent, USDA research facility license, OLAW Assurance or plan to obtain within 30 days of award, CDC/USDA Select Agent registration including ABSL-3.
Analytical Methods – documentation of at least three analytical/bioanalytical method validations in the past three years and execution of at least three GLP sample analyses.
Safety and Toxicity – AAALAC accreditation, USDA license, OLAW Assurance, and completion of at least five GLP safety/toxicity studies in the past three years.
Offerors must provide a Security Plan, approved Animal Welfare Plan, Data Sharing Plan, key personnel qualifications and CVs, and Letters of Commitment for subcontractors.