Loren Data's SAM Daily™

fbodaily.com
Home Today's SAM Search Archives Numbered Notes CBD Archives Subscribe
SAMDAILY.US - ISSUE OF MARCH 16, 2024 SAM #8145
SPECIAL NOTICE

65 -- 65--INTENT TO SOLE SOURCE - PZP ZONASTAT-H VACCINE

Notice Date
3/14/2024 12:41:55 PM
 
Notice Type
Special Notice
 
NAICS
325412 — Pharmaceutical Preparation Manufacturing
 
Contracting Office
NATIONAL OPERATIONS CENTER DENVER CO 80225 USA
 
ZIP Code
80225
 
Solicitation Number
140L0124Q0009
 
Response Due
3/29/2024 9:00:00 AM
 
Archive Date
07/01/2024
 
Point of Contact
Slade, David, Phone: 3032366702, Fax: (303) 236-9421
 
E-Mail Address
dslade@blm.gov
(dslade@blm.gov)
 
Description
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.
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/2a3cdc00afa94dfca582d4629158e050/view)
 
Record
SN06996643-F 20240316/240314230048 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

FSG Index  |  This Issue's Index  |  Today's SAM Daily Index Page |
ECGrid: EDI VAN Interconnect ECGridOS: EDI Web Services Interconnect API Government Data Publications CBDDisk Subscribers
 Privacy Policy  Jenny in Wanderland!  © 1994-2024, Loren Data Corp.