Intent to sole source - PZP zonastat-H vaccine

SPECIAL NOTICE OF INTENT TO SOLE SOURCE PORCINE ZONA PELLUCIDA (PZP) ZONASTAT-H IMMUNOCONTRACEPTIVE VACCINE

The Bureau of Land Management (BLM) protects and manages wild horses and burros (WHB) under the authority of the Wild Free-Roaming Horses and Burros Act of 1971 to ensure that healthy herds thrive on healthy rangelands. In some herds, the BLM administers fertility control to free-roaming WHB that live on public lands. One of the fertility control methods used is the administration of the porcine zona pellucida (PZP) immunocontraceptive vaccine known as ZonaStat-H, by hand-injection or by dart-based delivery. PZP ZonaStat-H is a proprietary formulation of anti-PZP vaccine, described in published scientific reports and in the produce registration with the US Environmental Protection Agency (EPA), where it is regulated according to EPA Registration Number: 86833-1 and associated production, formulation, labeling, and use requirements. The BLM¿s specific requirements for PZP ZonaStat-H production and delivery are detailed in the synopsis specifications, below.

The BLM Wild Horse and Burro Program seeks to procure quantities of between 1,000 and 8,000 0.5 mL doses of PZP ZonaStat-H over a 2-year period that would begin at contract award date. The contractor supplying PZP ZonaStat-H would also provide the necessary quantity of vaccine adjuvants (Freund's modified complete adjuvant for primer doses, and Freund's incomplete adjuvant for booster doses). Because the vaccine must remain frozen until within ~ 1 day of use, it must be delivered by overnight shipping method that ensures the vaccine stays frozen. Adjuvant delivery may be at ambient temperatures, but it is preferable if it stays at about 4 degrees C (adjuvant must not be frozen).

Qualifications:
The vaccine production facility must have the proven capabilities, any necessary licensure, and regulatory approvals necessary to produce and distribute PZP ZonaStat-H for use in federally protected wild horses and burros.

Requirements:
Vaccine production must meet standards identified in the EPA product registration for PZP ZonaStat-H (registration number 86833-1), and consistent with production descriptions in peer-reviewed literature about ZonaStat-H vaccine (i.e., Kane, A.J. 2018. A review of contemporary contraceptives and sterilization techniques for feral horses. Human¿Wildlife Interactions 12:111-116.). The contractor must identify and justify any deviations from EPA-approved vaccine formulation, or formulation identified in peer-reviewed scientific literature that describes ZonaStat-H production.

THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTES. However, all responsible sources may submit a capability statement to the Contracting Officer via email to dslade@blm.gov to express their ability to provide these products for future needs.