Final JA W81K0425DA010 Redacted.pdf

This is a Justification Review Document for a sole source contract for Allergen Extract Biological Products & Diluents in support of the United States Army Centralized Allergen Extract Laboratory (USACAEL). The contract will be a Single Indefinite Delivery Indefinite Quantity (IDIQ) type, with five one-year ordering periods. USACAEL processes and formulates allergen extract patient treatment prescriptions and diagnostic testing antigens for over 30,000 military personnel annually across Army, Navy, Air Force, Space Command, Coast Guard, Veterans Affairs, Public Health, and Marine Corps facilities, shipping approximately 100,000 vials globally each year.

The procurement is being conducted on a non-competitive basis due to unique regulatory requirements. The sole source supplier is the only FDA-approved manufacturer of these allergen extract supplies, with biological product licenses permitting sale and marketing of extracts for insects, pollens, molds, foods, and other antigens. Market research conducted in March 2025 confirmed no other vendors can fully support the specific regulatory and formulation needs. The contract aims to ensure continuous supply of critically important allergen extract stock solutions, vials, syringes, and related ancillary supplies, with potential pricing adjustments to accommodate market fluctuations and provide procurement flexibility.