A18_-_JOFOC_-_GonaCon_Equine_REDACTED_1.pdf

SOLE SOURCE JUSTIFICATION

FOR OTHER THAN FULL AND OPEN COMPETITION

DEPARTMENT OF INTERIOR

BUREAU OF LAND MANAGEMENT

WILD HORSE AND BURRO PROGRAM HQ-260

GONACON-EQUINE VACCINE ACQUISITION

This document sets forth the justification and approval as required by FAR 6.303-1(a)(1).

1. Program Agency and Contracting Activity.

The Department of the Interior, Bureau of Land Management (BLM), Wild Horse and Burro Program (WH&BP) Headquarters Office (HQ-260) is requesting the BLM National Operations Center (NOC) Acquisitions office to contract on a sole source basis.

2. Nature and/or Description of Action Being Approved.

This requirement is a new contract and would be awarded to a 501(c)(3) non-profit organization known as SpayFirst! Inc. (Norman, Oklahoma).

Over the next 5 years, BLM’s Wild Horse and Burro (WHB) program needs to acquire at least 1,000 doses, and perhaps as many as 8,000 doses, of a proprietary immunocontraceptive (fertility control) vaccine known as GonaCon-Equine. GonaCon-Equine can have the effect of reducing fertility rates in treated wild horse mares. This vaccine was especially noted in a 2020 BLM report to Congress about WHB management. This vaccine saves the government money, in terms of wild horse foals that do not get born, because the mother horse is temporarily infertile.

3. Description of Supplies or Services.

The vaccine is registered with the US Environmental Protection Agency (EPA), which regulates it as a ‘pesticide’ because it has the effect of reducing the growth rates of a feral animal in settings where population control is a management goal. No substitute EPA-registered GnRH fertility control vaccines are available for use in wild horses in the USA. GonaCon-Equine is the specifically designated fertility control vaccine to use in certain wild horse herds. There is another kind of EPA-approved fertility control vaccine for wild horses (the PZP vaccine known as “ZonaStat-H”), but repeatedly using the same type of fertility control vaccine in an area leads to the most effective fertility control results. Therefore, in areas where GonaCon-Equine has been used in the past, it must be used in the future.

Making the GonaCon-Equine vaccine is a highly technical process. It must be prepared in aseptic conditions in a biochemical laboratory production facility type of setting. This vaccine is a preparation of gonadotropin releasing hormone (GnRH) molecules as the antigen (the molecule against which the immune response is being caused). In GonaCon-Equine vaccine, GnRH proteins are chemically attached to a much larger carrier protein (purified hemocyanin).

burros. Private owners of domestic horses cannot purchase or use it, but non-governmental entities that manage feral horse or burro sanctuaries for non-governmental purposes have purchased and may continue to purchase it. GonaCon-Equine is available for purchase in 2021 at the catalog price of $50 per horse dose (in a 2 mL vial) via the SpayFirst Inc. web site, www.gonacon.com.

The contract would be issued with a 3-year period of performance. This provides the US government with flexibility for future management options. After the 3-year time period, BLM may or may not transition to a greater use of other fertility control methods for wild horses and burros, depending on the results of research and management applications, and budgets.

There should be some flexibility in the exact number of doses needed in the next 5 years; the number of vaccine doses the government ultimately needs in this time period will depend on BLM WHB operational constraints, which cannot now be predicted accurately. At least 1,000 doses will be needed, and perhaps as many as 8,000. Structuring the contract with a 1,000-dose base quantity and seven 1,000-dose option quantities will allow for that needed flexibility.

8. Efforts to Identify Additional Sources Including the Market Research Conducted.

The following market research was done to support GonaCon-Equine vaccine acquisition:

a. The Contracting Officer queried the Small Business Dynamic Search under NAICS code 325412, Pharmaceutical Preparation Manufacturing with additional text of “equine vaccines”. The query resulted in no matches; therefore, no additional small business subcategory searches were performed in the Small Business Dynamic Search.

b. Additionally the Contracting Officer queried “equine vaccines” on AbilityOne, GSA Advantage, and FPDS-NG where no results were found.

c. The BLM WHB program research coordinator corresponded regularly with the government agency that invented, developed, and tested GonaCon-Equine vaccine, the USDA APHIS WS NWRC. The assistant director of the NWRC confirmed to BLM that the USDA agreed to give the sole rights to produce and distribute GonaCon-Equine to the non-profit organization known as SpayFirst! Inc. This is also substantiated by written records about that agreement (evidenced filed under A14).

d. A query on the internet for purchasing GonaCon-Equine vaccine only brought up the

SpayFirst! Website.

e. This research supports that SpayFirst! Inc. is currently the only available source to provide the GonaCon-Equine vaccine to the BLM.

9. Future Plans to Permit Competition.

Continual Market Research will be conducted to address potential competition to produce GonaCon-Equine for future acquisitions. The BLM WHB program is also engaged in supporting fertility control research, which may lead to alternate methods for wild horse and burro fertility control.

10. Recommendation and Certification from Program Office.

Based on the above, I recommend this acquisition be conducted on a sole source basis to SpayFirst! Inc.

_________________ ___10/7/2021___ Date

Research Coordinator BLM Wild Horse and Burro Program

11. Certifications from the Contracting Officer.

Only one (1) manufacturer/vendor is capable of providing the required GonaCon-Equine fertility control vaccine for wild horses and burros.

The anticipated price to the Government will be fair and reasonable. The potential contractor does have a catalog list price for this commercially available product; it is expected that the price per dose in the contract would be comparable to the catalog list price. Before award, a price analysis will be conducted to further determine prices fair and reasonable.

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Date

Contracting Officer BLM NOC Acquisitions