1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. Solicitation number 2021-SS39 Cattle 17 ea

Minimum Specifications:

Statement of Work (SOW)

For the potency testing of pilot foot and mouth disease (FMD) vaccines for potential stockpiling in the North American FMD Vaccine Bank (NAFMDVB) and/or the National Animal Vaccine and Veterinary Countermeasures Bank (NAVVCB)

1.0       General

Background

The NAFMDVB is the strategic reserve of FMD antigen to be used for vaccine formulation in case of introduction of virus into USA, Canada, or Mexico. The NAVVCB is an additional reserve of FMD antigen for the United States.  These supplies would be critical to provide vaccination in the early weeks of an official eradication or control campaign in the event of a foot-and-mouth disease outbreak in North America.

These high potency vaccines are produced by commercial vaccine manufacturers outside of the United States. The NAFMDVB and NAVVCB requires that antigens should satisfy the requirements for purity, safety, potency and efficacy (PGP and PD50) described in Part 113 of the 9CFR and in the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals before being accepted by the bank(s). The potency test requires the vaccination of seventeen (17) cattle. The results of the potency tests described here directly inform NAFMDVB and NAVVCB decisions on whether an antigen should be accepted (initial potency testing) or replaced (5-year stability testing).

Bovines are one of the natural hosts of FMDV and also the most economically important domestic animal susceptible to FMD. The emergency vaccine is intended to be used in this species and the level of protection afforded by FMD emergency vaccines can only be determined by immunization of the target host. The PD50 in cattle is the required test for FMD vaccines by the Manual of Diagnostics Tests and Vaccines for Terrestrial Animals published by the World Organization for Animal Health. 

1.2 Objective

To determine the efficacy and potency of FMD vaccines before being acquired by the North American Foot-and-Mouth Disease Vaccine Bank (NAFMDVB) and/or the National Animal Vaccine and Veterinary Countermeasures Bank (NAVVCB), and to determine potency and stability of the stored antigens at five-year intervals.

1.3 Scope of Work

Vaccine bank staff (VMOs with the support of Microbiologists/Biologist, BSLTs) will conduct PD50 studies to determine potency of pilot serials produced from antigen of interest to the bank(s) for stockpiling.

1.5 Place of Performance

Potency tests for FMD vaccine produced from antigen concentrate, which will involve the use of live virus, may only be performed at the Plum Island Animal Disease Center (PIADC) located on Plum Island, NY.

1.6 Applicable Documents

Code of Federal Regulations (CFR), Title 9 – Animals and Animal Products. Chapter 1 – APHIS, USDA. Subchapter E – Viruses, Serum, Toxins, and Analogous Products; Organisms and Vectors. Part 113 – Standard Requirements.

Protocol Number: 212.00-20-P. “Potency of Inactivated Foot and Mouth Disease Vaccines in Cattle” as approved by the PIADC Institutional Animal Care and Use Committee (IACUC).

Terrestrial Manual, 8th Edition, 2018, Volumes 1, 2 and 3. World Organization for Animal Health (OIE).

Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Online Edition, 2019; Chapters 1.1.10 Vaccine Banks and 3.1.8 Foot and Mouth Disease (Infection with Foot and Mouth Disease Virus). Accessed 17 June 2021. https://www.oie.int/en/what-we-do/standards/codes-and-manuals/terrestrial-manual-online-access/

Specific Requirements/Tasks

The contractor must be an authorized USDA Class B vendor. The contractor will deliver cattle that meet the following specifications to support the evaluation of VAC via potency testing.

ANIMAL REQUIREMENTS:

• COWS – HOLSTEIN BREED

• Age and weight will be determined according to the needs of each research project. If

   unspecified, cattle should weigh 400 ‐ 500 lbs.

• Cattle must be open heifers or castrated males unless otherwise specified.

• Cattle must be polled or dehorned, tolerate being haltered, be of tractable temperament,  

   and be free of behavioral vices such as charging and kicking.

• Cattle must have un‐pigmented (PINK) tongues.

• Cattle must be free of external parasites and have been treated for internal parasites

   within the last 3 months, e.g. Ivermectin or equivalent.

• Hooves shall be trimmed prior to shipment if necessary.

• Cattle must be tested and shown to be free of BVD by the ear notch test.

Mandatory Vaccinations:

• Cattle must receive vaccinations against the following: IBR, BVD (Types 1 and 2), 

   PI3, BRSV, and Leptospirosis with boosters as necessary, for example Bovi‐Shield

   Gold®

• FP®5 L5 HB by Pfizer or equivalent.

• In addition, calves should receive Mannheimia (Pasteurella) haemolytica (e.g. One  

   Shot® by Pfizer) and seven way Clostridium vaccinations.

• Cattle on day of shipment must be healthy with no overt signs of disease, e.g.

   Respiratory disease, lameness, warts and ringworm.

• Cattle must receive appropriate antibiotics prior to shipping to prevent shipping fever

   unless otherwise specified.

ACCEPTANCE/REJECTION OF ANIMALS:

• Cows will be evaluated after 7 days quarantine. In the event of illness after

               appropriate incubation time the government shall submit an Animal Incident Report by 

               fax within 5 business days. In the event of death, an Animal Incident Report will be

               faxed to the vendor within 48 hours after death of the animal.

• Animals that show clinical signs of illness that are due to the husbandry may be

   treated or humanely destroyed if the illness has progressed to a point when death is

   certain to occur regardless of therapeutic intervention. A credit will be required from

   the contractor within 48 hours after receipt of the Animal Incident Report noting time   

   of death. If it is medically determined that illness or death of an animal is caused by a

   condition present prior to delivery, replacement of the animal(s) including shipment

   shall be required or credit issued at the agency’s choice within 24 hours of generation  

   of Animal Incident Report.

ANIMALS CANNOT BE REMOVED ONCE THEY REACH THE ORIENT POINT FACILITY IN ACCORDANCE WITH DHS AND ARS POLICY.

DELIVERY REQUIREMENTS

The Contractor shall furnish and deliver (F.O.B. Origin) the animals within the negotiated time frame on each request and documentation to the:

                  USDA, ARS, NAA, PIADC, 40550 Rt. 25,

                  Warehouse facility, Orient Point, NY 11957.

Delivery shall be between the hours of 06:00 a.m. to 11:00 a.m., Tuesday thru Thursday, excluding Federal holidays. Orient Point facility access is through the east gate which is guarded by security The Contractor shall unload animals via a supplied wooden animal stockade ramp into the back of a government provided animal transport trailer.

Contractor employee(s) must adhere to facility safety regulations. Transportation of animals should be planned to:

                  • minimize transit time and the risk of zoonoses

                  • protect against environmental extremes

                  •avoid overcrowding

                  • provide food and water when indicated

                  • protect against physical trauma.

The transportation, care, and use of animals should be in accordance with the Animal Welfare Act (7 U.S.C. 2131 et. seq.) and other applicable Federal laws, guidelines, and policies. For guidance refer to The Care and Use of Laboratory Animals prepared by the Institute for Laboratory Animal Research, National Academy of Science

                  • Cows are to be delivered per the “Animal Welfare Act Regulations

                     Pertaining to Transportation, 9 CFR 3.112‐3.118,”

ADDITIONAL REQUIREMENTS

• Section 508 Accessibility Compliance Clause ‐ Does not Apply

• WARRANTY – Not Applicable

DOCUMENTATION – The Contractor shall provide the following:

            • Prior to shipment to PIADC, a veterinary examination and issuance of the

interstate/intrastate health certificate for shipment shall be provided with delivery. The health certificate shall include at a minimum, general information identifying the animal by number/id; the departure date of transport to the Plum Island Orient Point Warehouse Facility; Breed; Gender; Age or Birth Date Range; Dehorned; Weaned; Castrated (if applicable); the dates and dosages of vaccines and anti‐parasitic, anti‐fungal, antibiotic drugs; any other tests and corresponding results; and any other relevant information.

• Veterinarian certification of recent medical history and treatments given to animals with delivery.

• Contact information for attending veterinarian for means of evaluating the vendor’s

animal care history.

• Freight ‐ FOB Destination. (Must be reassessed if multiple agencies combine deliveries.)

• Performance ‐ The Contractor shall furnish and deliver the animals in accordance with

the specifications by the due EVALUATION CRITERIA.

Best Value ‐ A selection process which is used to determine which offer is the best

trade‐off between price/cost and performance capabilities where quality is considered

an integral performance factor. In essence, it is getting the best deal for our money, all

factors considered.

Award will be made to the offeror offering the "best value" to the Government, price

and the identified "technical factors" considered. All of the technical factors combined

are significantly more important than price; however, in the event that offerors are

considered essentially equal in terms of technical competence price may become the

determining factor in contract selection.

The following evaluation criteria shall be used: Technical Capability, Past Performance

and Price.

TECHNICAL CAPABILITY OF THE FIRM ‐ the Contractor’s capability to meet the specifications, including quality, to meet the Agency's need, documentation, delivery time frames and a minimum 3 years animal livestock/laboratory production. The SAMS website will be used to verify the Contractor’s Business Start Date for evaluation of the minimum business requirement. Travel duration shall be a factor in determining a contractor’s availability to provide research animals.

PAST PERFORMANCE. Past performance history may be based on the

Government’s knowledge of any previous purchases of this type of acquisition, customer surveys, and previous purchases with the Contractor, or any other verifiable information available to the Contracting Officer.

PRICE. Price includes all animals; testing; ear tags; inoculations, as required;

transportation; and any discount terms offered

2. This solicitation, is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-05.

3. This is a combined synopsis/solicitation for Cattle. The government intends to award a firm fixed price purchase order as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. This procurement is unrestricted.

The NIACS code is 112111 with a size standard of 1 million

4.  Delivery

FOB destination to to USDA, FADDL, Orient Pt NY 11957

d) Offers due to [email protected] by 22 Jul 2021 at 10:00 AMCST