COMMERCIAL OFF THE SHELF FETAL BOVINE SERUM
THIS IS A SOURCES SOUGHT NOTICE ONLY, 22019-SS21, 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
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
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 300-675 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 300-675 liters of US origin FBS that meets our testing requirements from pre-existing lots of FBS. Purchase of multiple lots may be required in order to meet total volume sought.
SOW Format: Objectives
The FBS must to 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
1. 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.
2. The NCAH will select lots of FBS that are free of the antibodies, viruses, and RNA listed. Sufficient lots of FBS will be selected to reach a total combined volume of 300-675 liters. 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.
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 ship the 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 and the Foreign Animal Disease Diagnostic Laboratory (FADDL) on Plum Island, NY. 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 may 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 05 March 2019 0700 CST. All responses under this Sources Sought Notice must be emailed to sarah.c.schauf@usda.gov.
If you have any questions concerning this opportunity, please contact: Sarah.C.Schauf@usda.gov.
Sarah C Schauf, Contracting Officer, Phone 5153377572, Email sarah.c.schauf@aphis.usda.gov
