FAR 6.302_Justification_Eggs_CA Signed.pdf

United States Department of Agriculture Justification for Other than Full and Open Competition

Federal Acquisition Regulation (FAR) Part 6.3

1. Identification of the agency and the contracting activity.

APHIS, VS, NVSL CVB, Ames, IA

2. The nature and/or description of the action being approved.

NVSL needs to purchase specific pathogen free (SPF) embryonating chicken eggs, of Premium Plus grade quality, for use with the avian influenza and Newcastle disease virus isolation protocol (SOP- AV-2020). This protocol is accredited by ISOl7025. Also used in the production of AI Agar Gel Immunodiffusion reagents antiserum and antigen (SOP-AV-0101 and SOP-0103). These protocols are accredited by ISOl7034.

CVB needs to purchase SPF embryonating chicken eggs, of Premium Plus grade quality, for use in testing of vaccines, master seeds, and production of challenge virus, which include but are not limited to Avian Influenza, H1N1, Newcastle disease virus, infectious bronchitis, Bursal disease virus, Fowl pox, and a variety of recombinants. CVB also needs to purchase SPF embryonating chicken eggs, Research grade quality, for the use in Avian Leukosis virus testing, Cofal testing, and cell culture work in both primaries and secondaries. CVB is accredited by 18090001.

3. A description of the supplies or services required to meet the agency�s needs (including the estimated value).

Fertilized specific pathogen free chicken eggs, 0 days incubation. The chicken eggs must be Premium Plus grade for NVSL/CVB and Research grade for CVB. This will be for a contract with a base period of one year with four option years. The approximate contract value will be $5,500,000.00.

4. The statutory authority permitting other than full and open competition.

41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1, titled "Only one responsible source and no other supplies or services will satisfy agency requirements."

5. A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.

The embryonating chicken eggs provided by Charles River SPAFAS have been validated and shown to isolate and propagate avian viruses. This source of embryos is the only vendor validated at this time for use in NVSL's SOP-AV-2020, SOP-AV-0101 and SOP-AV-0103 and CVB's testing of vaccines, master seeds, production of challenge virus and production of cell culture.

Since these NVSL protocols are ISOl7025 and ISOl7034 accredited and CVB is IS090001 accredited, the use of an alternate source of SPF eggs may be detrimental to the successful isolation, and identification of avian pathogens, and the production of avian influenza diagnostic reagents.

6. A description of efforts made to ensure offers are solicited from as many potential sources as is practicable.

SAM.gov Contracting Opportunities Announcement/Potential Sources. A notice will be posted on SAM.gov for a minimum of 30 days before contract award to ensure that all potential sources are aware of this requirement per FAR 5.201 and FAR 6.305(d)(3).

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

This source chicken embryos are sold at commercial prices to numerous companies, as well as Federal agencies. NVSL /CVB will pay the same commercial price as other consumers. SPF embryos are not available through any existing contracts or mandatory contract vehicles. In addition, this source has been used in the past for the procurement of SPF embryos. Since this source is the only source of SPF embryos that have been validated for the isolation and propagation of avian pathogens, is the Contracting Officer has determined that the proposed pricing is fair and reasonable.

8. A description of the market research conducted and the results or a statement of the reason Market Research was not conducted.

Alternate sources of SPF embryos may be considered with sufficient documentation of incubation and testing processes. A validation study must be performed to ensure successful identification of selected avian pathogens before procurement. This testing process is estimated to take approximately 4 to 6 months and the process for other companies to be validated is detailed in the attachment entitled "Specifications for Animal Products Specific Pathogen Free (SPF) Embryonating Chicken Eggs". After comepling martket research, the Program Office and Contracting Officer determined that are no existing vendors available through existing contracts or the mandatory contracing vehciles that meet these rigorous validation specifications.

9. Any other facts supporting the use of other than full and open competition.

N/A

10. A listing of the sources, if any, that expressed a written interest in the acquisition.

At the current time only Charles River is capable of providing these eggs because no other company has been certified through NVSL procedures to be pathogen-free. If other sources are found to be interested later, they will be given an opportunity to become certified by following the "Specifications for Animal Products Specific Pathogen Free (SPF) Embryonating Chicken Eggs"

11. A statement of actions, if any, the agency may take to remove or overcome any barriers to competition if subsequent acquisitions are anticipated.

Alternate sources of SPF embryos may be considered with sufficient documentation of incubation and testing processes. A validation study must be performed to ensure successful identification of selected avian pathogens before procurement. This testing process is estimated to take approximately 4 to 6months and the process for other companies to be validated is detailed below

To be considered for this contract a producer of specific pathogen free embryoinated chicken eggs must meeting the following requirements (See attachment which specifies the actions other interested parties can take to have their eggs validated for this procurement):

The interested companies are required to prove their laying flock and embryos are free of the following avian diseases. For Premium Plus grade: Avian Adenovirus groups I, II (HEV), and III (EDS), Avian Encephalomyelitis virus, Avian Influenza (Type A), Avian Nephritis virus, Avian Paramyxovirus type 2, Avian Reovirus, Avian Rhinotracheitis virus, Avian Rotavirus, Avian Tuberculosis, Chicken Anemia virus, Fowl Pox virus, Hemophilus paragallinarum, Infectious Bronchitis viruses (Arkansas, Connecticut, JMK and Massachusetts), Infectious Bursal Disease virus Type 1 & 2, Infectious Laryngotracheitis virus, Lymphoid Leukosis viruses, Marek�s Disease (serotypes 1, 2, 3), Mycoplasma galisepticum, Mycoplasma synoviae, Newcastle Disease, Reticuloendotheliosis virus, Salmonella pullorum-gallinarum, and Salmonella species. For Research grade: All diseases listed for Premium plus grade plus Endogenous GS Antigen.

The interested companies would have to provide embryos at no cost to NVSL to conduct testing Newcastle disease, Paramyxoviruses (APMV) Avian influenza (AI), Infectious Laryngotracheitis virus, Reovirus, Infectious Bursal Disease virus, Infectious Bronchitis virus, and Adenoviruses. We would require sufficient number of eggs to conduct titration of these viruses in embryos from both SPAFAS and other interested companies. The testing would determine if the limit of detection of viruses isolated from the eggs is significantly different than the LOD of SPAFAS eggs. The companies would also be required to provide a sufficient number of eggs at no cost for NVSL to run comparison for diagnostic reagents that are currently produced by NVSL. Reagents included but not limited to AI Agar gel Immunodiffusion antigen and antiserum, and AI and APMV hemagglutination inhibition test antigens and antisera.

Certifications & Approvals

Supporting data that form the basis for and included in this justification are certified accurate and complete.

Terra Jenson, Supervisory Microbiologist, NVSL/DBRL/PTR Insert Name of Program or Technical Personnel Insert Title of Program/Technical Personnel

The information contained in this Justification for Other Than Full and Open Competition is certified accurate and complete to the best of my knowledge and belief.

Contracting Officer

Additional Reviews & Approvals

Signatures are required at each threshold up to the total estimated dollar value of the acquisition

Advocate for competition for the procuring activity (if over $750,000, but not exceeding $15 million). I have reviewed this justification and find it to be accurate and complete to the best of my knowledge and belief. Therefore, unless additional approvals are required as prescribed below, as advocate for competition for the procuring activity, I hereby approve this justification.

Larry Nelson Chief, Procurement Operations Division Procuring Activity Advocate for Competition

Head of the procuring activity (if over $15 million, but not exceeding $75 million). I have reviewed this justification and find it to be accurate and complete to the best of my knowledge and belief. Therefore, unless additional approvals are required as prescribed below, as Head of the Procuring Activity, I hereby approve this justification.

Donald W. Baker, Jr.

Head of the Procuring Activity

Senior Procurement Executive of the Agency (if over $75 million). I have reviewed this justification and find it to be accurate and complete to the best of my knowledge and belief. Therefore, as the Senior Procurement Executive, I hereby approve this justification.

Tiffany J. Taylor Senior Procurement Executive

Notes and Guidance. Delete these notes prior to finalizing document for signature

Acquisitions for commercial items/services with a value exceeding $7.5 million, and acquisitions for non-commercial items/services with a value exceeding the Simplified Acquisition Threshold (SAT) are subject to the competition requirements of FAR Part 6.

Program personnel are advised to work with contracting personnel early on in order to promote and provide for full and open competition to the maximum extent practicable. In circumstances permitting other than full and open competition, program personnel shall provide necessary information to contracting personnel to support and document the circumstances limiting competition through the use of this form. Contracting without providing for full and open competition or full and open competition after exclusion of sources is a violation of statute, unless permitted by one of the exceptions permitted in FAR 6.302.

Advance planning. Contracting without providing for full and open competition shall not be justified on the basis of (1) a lack of advance planning by the requiring activity or (2) concerns related to the amount of funds available to the agency or activity for the acquisition of supplies or services.

Brand Name. Items peculiar to one manufacturer can be a particular brand name, product, or feature of a product, peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer. Brand name specifications shall not be used unless the particular brand name, product or feature is essential to the Government�s requirements and market research indicates other companies� similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the Agency�s needs. See below for posting requirements.

Posting. Contracting Officers shall make justifications (excluding brand name) publicly available within 14 days after contract award in accordance with the procedures at FAR 6.305(d),(e), and (f).

In the case of unusual and compelling urgency, justifications shall be made publicly available within 30 days after contract award in accordance with the procedures at FAR 6.305(b), (d), (e), and (f).

Brand name justifications shall be posted with the solicitation in accordance with FAR 6.305(c) and 5.102(a)(6).

Screening. Before posting this Justification, in accordance with FAR 6.305(e) and 24.202, the Contracting Officer is responsible to redact any information that is exempt from disclosure under Freedom of Information Act or information proprietary to the contractor.

Sole Source 8(a) over $25 million. As a minimum, each justification for a sole source 8(a) contract over $22 million shall include the information required by FAR 6.303(d)(1) through (5).

Signatures. After review and completion by the Program Office and Contracting Officer, the Word document shall be converted to an Adobe PDF file and routed for digital electronic. Signature blocks shall include dates.