THIS IS A SOURCES SOUGHT NOTICE ONLY, 2020-SS45, and a SOLICITATION IS NOT CURRENTLY AVAILABLE The United States Department of Agriculture, APHIS is issuing this sources sought synopsis as a means of conducting market research to identify parties having an interest in and the resources to support this requirement for:

Fetal Bovine Serum

Commercial off the shelf: BVD nucleic acid and antibody negative

The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 325413. With a size standard of 1250 emp  The Government contemplates a single award for this requirement.

Background

The National Centers for Animal Health (NCAH) is seeking pre-existing, off-the-shelf lots of Fetal Bovine Serum (FBS). NCAH wants to purchase up to 200 liters of US origin, 100% FBS that meets specified testing requirements. This must be unadulterated, 100% fetal bovine serum that has not been gamma irradiated.

Fetal bovine serum (FBS) is used as a media additive in cell culture for growth promotion. Cell cultures are used for testing associated with infectious viral agents as well as reagent production. These activities are conducted as part of diagnosing animal diseases, performing agricultural research, and regulation of veterinary biologics.

FBS from fetal calves is often contaminated with viral material or antibodies that interfere with testing for certain viruses. Specifically, FBS contaminated with Bovine Viral Diarrhea virus (BVDV) or BVDV antibody will interfere with testing for bovine diseases. Infectious virus, non-infectious viral particles, and antibody can all negatively affect testing. Infectious BVDV in FBS can infect cell cultures leading to false positive results in virus isolation testing as well as contaminate reagents which could be sent to external consumers. Non-infectious BVDV RNA will lead to false positives on PCR testing. Extraneous antibodies in the serum will interfere with virus neutralization tests, virus isolation tests, and reagent production (stock virus, antiserum, conjugate, and antigen). These antibodies may neutralize potentially infectious viruses, resulting in false negative results.

SOW Format: Scope

The NCAH expects to purchase up to 200 liters of US origin FBS that meets our testing requirements from pre-existing lots of FBS. In particular, this FBS needs to be BVDV nucleic acid and antibody negative.

SOW Format: Objectives

The FBS must be free of extraneous infectious viruses, antibodies against certain microorganisms, and the presence of particular non-infectious RNA. See provided list. The FBS must be unadulterated, 100% fetal bovine serum that has not been gamma irradiated. This FBS will be used in testing required for diagnosing animal diseases, agricultural research, and regulation of veterinary biologics.

SOW Format: Tasks

         The contractor shall provide NCAH with samples from pre-existing, off-the-shelf lots of FBS they expect are likely to meet the listed testing specifications. The volume of each sample must be at least 250 ml. The NCAH will test these samples for extraneous infectious viruses, antibodies against certain microorganisms, and the presence of particular non-infectious RNA. See provided list. In addition to the extraneous viruses and antibodies, the lots must also be free of bacteria, fungi, and mycoplasma. The hemoglobin level must be lower than 20 mg/dL and the endotoxin level must be lower than 2.5 EU/ml.

         The NCAH will select lots of FBS that are free of the antibodies, viruses, and RNA listed. Following acquisition of the FBS, additional testing may be conducted on the delivered product to verify the absence of infectious virus, viral RNA, and antibodies from the list. Any confirmed positive results for the following can cause rejection of the FBS. If rejected, shipment will be returned and re-performance will be necessary at no cost to the government.

         The contractor shall work with NCAH to arrange gamma irradiation of accepted lots of FBS before those lots are delivered to NCAH. The material would need to be irradiated while frozen with a minimum dose of 25 kGy and a maximum dose of 40 kGy.

SOW Format: Delivery

The contractor shall provide the NCAH with samples of FBS for testing from pre-existing, off-the-shelf lots. The sample from each lot of FBS to be tested must be at least 250 ml in volume.

Once testing requirements have been met and a lot has been accepted, the contractor shall arrange for gamma irradiation of that lot and then ship the irradiated FBS from the selected lot(s) to the NCAH where a final round of testing may occur.

SOW Format: Place of Performance

Testing of the serum for specified antigen, antibody, and RNA listed will occur at NCAH in Ames, IA. Testing for hemoglobin and endotoxin levels shall be completed by the contractor.

SOW Format: Period of Performance

Each round of testing by NCAH and FADDL will take approximately 4-6 weeks to complete. Full contract to be completed within 6 months.

Testing to be performed by USDA labs

FBS can be rejected for the presence of any of the following:

Extraneous infectious virus:

Bovine viral diarrhea and Hobi-like viruses

Border disease virus

Bluetongue virus

Bovine adenovirus

Infectious bovine rhinotracheitis virus (bovine herpesvirus 1)

Parainfluenza-3 virus

Bovine respiratory syncytial virus

Reovirus

Rabies virus

Senecavirus A

Non-infectious RNA

Bovine viral diarrhea and Hobi-like viruses

Border disease virus

Senecavirus A

Extraneous antibody:

Reovirus

Rabies virus

Bovine viral diarrhea and Hobi-like viruses

Border disease virus

Bluetongue virus

Bovine adenovirus

Infectious bovine rhinotracheitis virus (bovine herpesvirus 1)

Bovine herpes mammilitis virus (bovine herpesvirus 2)

Bovine herpesvirus 4

Parainfluenza-3 virus

Bovine respiratory syncytial virus

Bovine rotavirus

Malignant catarrhal fever viruses

Vesicular stomatitis virus

Bovine papular stomatitis virus

Pseudocowpox virus

Bovine parvovirus

Bovine coronavirus

Bovine enteroviruses (types 1-7)

Epizootic hemorrhagic disease virus

Orf virus

Coxiella burnetii

Hemagglutinating encephalomyelitis virus

Porcine parvovirus

Pseudorabies virus (suid herpesvirus 1)

Swine adenovirus

Transmissible gastroenteritis virus

Canine adenovirus 1 and 2

Canine coronavirus

Canine distemper virus

Canine herpesvirus

Canine parainfluenza virus

Canine parvovirus

Feline calicivirus

Feline infectious peritonitis virus

Feline panleukopenia virus

Feline viral rhinotracheitis

There is no solicitation at this time. This request for capability information does not constitute a request for proposals; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred. 

If your organization has the potential capacity to perform these contract services, please provide the following information: 1) organization name, address, email address, website address, telephone number, and size and type of ownership for the organization; and 2) tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements.

The government will evaluate market information to ascertain potential market capacity to 1) provide services/supplies consistent in scope and scale with those described in this notice and otherwise anticipated; Based on the responses to this sources sought notice/market research, this requirement may be set-aside for small businesses or procured through full and open competition, and multiple awards may be made. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.

Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed services are invited to submit a response to this Sources Sought Notice by 23 March 2020 1600CST. All responses under this Sources Sought Notice must be emailed to [email protected].

If you have any questions concerning this opportunity, please contact: Sarah.C.Schau