Sole Source Notice _Wildlife Rehab Surveillence SARS-CoV-2

The Government hereby submits a notice of intent to award a sole source one firm fixed price contract to TRANSLATIONAL GENOMICS RESEARCH INSTITUTE (TGen) for Wildlife Rehab SARS-CoV-2 Surveillence at various wildlife rehab facilities all over the U.S.Sole Source (Including Brand Name) Justification under Simplified Procedures for Certain Commercial Items (FAR 13.5)1. Identification of the agency and the contracting activity. Agency Name:USDA APHIS Animal Care4700 River RdRiverdale, MD 20737 Contracting Activity:USDA APHIS AAMD Contracting250 Marquette Ave Suite 410Minneapolis, MN 554012. The nature and/or description of the action being approved.The USDA APHIS Animal Care proposes to enter into a sole source, firm fixed-price contract with Translational Genomics Research Institute (TGen).3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).USDA APHIS Animal Care is partnering with Wildlife Services and Veterinary Services to

conduct an ARP-funded project investigating SARS-CoV-2 in terrestrial and aquatic mammalian wildlife species admitted to wildlife rehabilitation centers nationwide. USDA APHIS is looking for up to 50 participating wildlife rehab centers around the U.S. to participate in this project. To complete this project, we require external collaboration with a laboratory that can provide the following services (estimated value in parentheses):Receive and test samples on a monthly basis as noted below.Test nasal/oral/fecal swabs for SARS-CoV-2 via PCR and provide results within 2wk of sample receipt.Send positive swabs to NVSL for confirmatory testing and sequencing as appropriate. NVSL will determine if all positives to be submitted, or only those with a certain Ct value.Perform sequencing analysis on any positive swabs that are not sequenced by NVSL. Test blood samples for antibodies to SARS-CoV-2 via sVNT and provide results within 2wk of sample receipt.Provide sample collection kits and shipping containers.Develop a Biosecurity Assessment Tool, with collaboration and input from USDA APHIS AC and VS; use tool to survey facilities re: biosecurity practices used during pandemic.Data analysis for both laboratory results and biosecurity surveys, and generation of both individual facility and summary reports for USDA APHIS. Estimated Total Dollar Value: $5.5 million (depends on number of samples that are being obtained and submitted by participating wildlife rehab facilities).4. The statutory authority permitting other than full and open competition. 41 U.S.C § 1901 - Simplified Acquisition Procedures up to $7.5 million, as authorized by FAR 13.500(a) and implemented by FAR 13.501(a).5. A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority. TGen is currently conducting similar work (https://www.tgen.org/news/2022/may/16/tgen-works-with-arizona-zoos-and-state-and-federal-wildlife-agencies-to-test-wild-animals-for-sars-cov2-the-caustive-agent-of-covid-19-in-humans/), but of smaller scope, limited to rehabilitation facilities within the state of Arizona. As such, TGen already has a biosecurity assessment tool in use that could quickly be modified to meet our study needs. TGen has the laboratory and staff capacity to provide sample collection kits, ship supplies, conduct PCR and serology testing, sequence positive samples, and ship positive samples to NVSL for confirmatory testing. Likewise, they have the tools, resources, and staff to further develop a biosecurity assessment tool to meet the needs of our study and, based on their current work, TGen staff are available and capable of analyzing laboratory results and biosecurity assessments and developing summary reports.TGen has established relationships with wildlife and state officials in AZ, and they have the ability to develop collaborations with national and international wildlife agencies (e.g., National Wildlife Rehabilitation Association; International Wildlife Rehabilitation Council), as well as other state wildlife agencies. USDA APHIS WS has pre-existing relationships with state agencies in many states, and can further facilitate communications, collaborations, permitting needs, etc., to meet project goals.Working with TGen will support the ARP missions regarding external collaborations to build laboratory capacity to strengthen our ability for early detection of emerging and zoonotic diseases in animals, as well as improved ability to prevent, detect, report, and respond to SARS-CoV-2. It will also allow for development of data and information sharing systems with other One Health partners.While other laboratories exist that provide PCR and serum sample testing, TGen is uniquely positioned to develop and complete biosecurity assessments, data analysis and reporting (TGen Takes on COVID-19; TGen News & Press Releases: TGen case study documents first reported U.S. transmission of COVID from a pet owner to pets; TGen News & Press Releases : TGen, ASU, NAU, UArizona and ADHS compile 100,000 sequenced genomes of COVID). TGen is uniquely positioned to begin this work quickly and meet proposed project timelines, whereas other laboratories or universities would require additional time for development of biosecurity assessments, dedicated staff, and resources, potentially impacting project budget, timelines, and ability to collect meaningful samples as shifts occur in the SARS-CoV-2 pandemic.6. A description of efforts made to ensure offers are solicited from as many potential sources as is practicable. Efforts were made to solicit interest from national (National Wildlife Rehabilitators Association) and international (International Wildlife Rehabilitation Council) wildlife organizations, as well as other 8(a) and small businesses; unfortunately none of these entities were able to meet project goals and/or timelines necessary to complete this work.7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable. Based on the current market prices and similar testing contracts, the estimated government price is deemed fair and reasonable for testing of this kind.8. A description of the market research conducted and the results or a statement of the reason Market Research was not conducted. Many laboratories in VS’ National Animal Health Laboratory Network (NAHLN) have been conducting PCR or serologic testing of animals for SARS-CoV-2. According to a recent survey of NAHLN laboratories, 4 laboratories are conducting both tests and 25 more are conducting PCR only. In addition to NAHLN laboratories, there are at least two commercial laboratories offering PCR testing. That said, these laboratories focus on diagnostic testing and do not collect epidemiologic information about the animals being testing nor do they collect biosecurity information about the facilities in which the animals live. While some universities have engaged in SARS-CoV-2 projects involved with laboratory testing and epidemiologic factors (COVID-19 & Pets Project - Sarah A. Hamer Laboratory (tamu.edu);), we are unaware of any current projects, especially one focused on wildlife in rehabilitation settings. Further market research into small business laboratories confirmed they did not have the capacity to meet project demands to store and process up to 1,000 samples per month for up to 2.5 years from at least 50 different rehab facilities around the U.S.9. Any other facts supporting the use of other than full and open competition. Creation of technical data packages, statement of work and descriptions of requirements for project completion would add additional burden and expense to the Goverment, as similar work is already being conducted by TGen. TGen is uniquely positioned to rapidly develop a biosecurity assessment tool that meets our project goals and timeline based on their existing biosecurity tool and experience gained in using it in AZ facilities; this is in addition to their ability to provide sample testing, analysis, and reporting.10. A listing of the sources, if any, that expressed a written interest in the acquisition. TGen has expressed interest in the acquisition.11. A statement of actions, if any, the agency may take to remove or overcome any barriers to competition if subsequent acquisitions are anticipated.No subsequent acquisitions are anticipated for this requirement.-----Questions and comments can be sent via EMAIL ONLY to Contracting Officer Kim Yen Tu at Kimyen.n.tu@usda.gov.