The USDA, Animal and Plant Health Inspections Service (APHIS), Veterinary Services (VS), Center for Veterinary Biologics (CVB) Lab in Ames, IA, intends to procure the services of a contractor to work with CVB personnel to design a project that will scientifically validate the pathogenicity of the Infectious Bovine Rhinotracheitis Challenge Virus per the attached statement of work. Proposals should demonstrate proven expertise in this area of research. The Principal Investigator should have a Doctor of Veterinary Medicine, and the work needs to be done in a facility that has adequate infrastructure to ensure that Good Laboratory Practices (or equivalent) will be followed. The facility must be able to provide biocontainment and isolation. The facility must have livestock-handling capability and expertise enough to manage up to 30 cattle at a time. The Government reserves the right to only award selected portions of the contract. The contract will be administered on a modular (in task) basis; whereby, the subsequent tasks are contingent on the successful completion of the preceding task. NAICS Code: 541710. Simplified procurement procedures will be used per FAR 12. THIS IS A COMBINED SYNOPSIS/SOLICITATION for prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a WRITTEN SOLICITATION WILL NOT BE ISSUED. This solicitation document incorporates provisions and clauses which are in effect through Federal Acquisition Circular 01-09. Applicable FAR clauses are incorporated by reference: Prompt Payment 52.249-1 (4/84); Changes--Fixed price 52.243-1 (8/87); Offerer Representations and Certifications 52.212-3 (10/98); Contract Terms and Conditions-Commercial Items 52.212-4 (4/98); Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items 52.212-5(10/98); and First Article Approval-Government Testing (Sept 1989) Alt (Sept 1989) 52.209-4. Award will be made based on the trade-off process. Non-price factors which will be considered include: past performance and proven expertise in this area of research. Quotations are due by Friday September 26, 2003 10:00 AM CST. Submit faxed quotations to 612-370-2136, Attn: Larry Nelson. Contact Larry Nelson at 612-336-3225 or e-mail at
[email protected] with any questions Referenced FAR clauses can be accessed for review on the Internet at the following web site: http://www.arnet.gov/far. All offers must be signed. Offers should include tax payer identification number, DUNS number and business size. Statement of Work: 1.0 Background The Center for Veterinary Biologics (CVB) is a part of the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS). The CVB is responsible for implementing the provisions of the Virus-Serum-Toxin Act to ensure that veterinary biologics available for the diagnosis, prevention, and treatment of animal diseases are pure, safe, potent and effective. The CVB is comprised of two sections: 1. CVB Policy, Evaluation and Licensing (CVB-PEL) 2. CVB Inspection and Compliance (CVB-IC) Both sections are primarily located in Ames, Iowa with a small CVB-PEL office in Riverdale, Maryland. The Directorate for CVB consists of two section Directors responsible for the direction of all CVB program activities. CVB primary activities include: " Biologics licensing, permitting, and policy development. " Biologics inspection and compliance of licensed products. " Confirmatory assays on new biologics products prior to licensure. " Reference and reagent production, evaluation, and distribution. " Developmental activity & training. In keeping with the "furnished or approved by APHIS" language of the 9 CFR, CVB prepares and provides for shipment to biologics manufacturers virus intended for vaccination-challenge studies. The host animal test described in 9 CFR 113.310 is used to assay the protective effect of modified live infectious bovine rhinotracheitis (IBR) virus vaccine serials, and it could be used to assay the protection provided by killed IBR virus vaccines. Additional testing may be requested by CVB-IC personnel for a field problem, or may be needed for correlation of in vitro assays to a current 9 CFR assay. All of these vaccination-challenge studies require a validated challenge strain suitable for demonstrating protection. 2.0 Objectives The objective of this study is to validate the effectiveness of CVB supplied IBR challenge viruses to produce clinically relevant disease in susceptible calves, and thus ensure that measured parameters of disease will meet criteria set forth in 9 CFR 113.310. Additionally, information obtained will be used to guide policy making decisions, update laboratory testing at CVB, and advise biologics manufacturers on vaccination-challenge protocols. 3.0 Scope of work Contractor(s) will work with CVB personnel to design a project that will scientifically validate the pathogenicity of the IBR challenge virus. Measured parameters related to the validation of the challenge virus will be acceptable to APHIS. We anticipate that a minimum of 30 calves housed for up to 60 days will be required to complete this work. Contractor will conduct the animal work related to the challenge studies. It will be required that the contractor(s) have very specific expertise and knowledge necessary to perform the work to be conducted. The Government reserves the right to only award selected portions of the contract. The contract will be administered on a modular (in Tasks) basis; whereby, the subsequent tasks are contingent on the successful completion of the preceding task. 4.0 Definitions CVB-USDA-Center for Veterinary Biologics. CVB-PEL Policy, Evaluation, and Licensing unit of the Center for Veterinary Biologics. COTR-Contraction Officers Technical Representative. 5.0 Contractor Task Management- The contractor(s) shall provide management of all the tasks assigned to them. 5.1a. Deliverable: Biweekly Status Reports - Contractor(s) shall submit biweekly status reports for the duration of this contract. Task status will consist of identifying work completed, work projected (including expected timetables), problems encountered and recommended solutions. 5.1b. Deliverable Due Date: The contractor(s) shall submit status reports on a biweekly basis on the Friday of the working week, for the duration of the task via electronic mail to the COTR. 5.1c. Performance Measures: The COTR shall validate that biweekly status reports are timely as indicated in the due date and the inclusion of data required is accurate and complete. Inaccurate or incomplete status reports shall be corrected and resubmitted at no cost to the government. 6.0 Tasks To Be Performed It is expected that actual delivery deadlines and general project timetables will be proposed by the contractor(s), and agreed to by the COTR at the start of the project. 6.1 Performance of the test The IBR challenge virus will be validated in susceptible calves in two phases. The goal of phase I is to assist the investigators in defining the challenge virus dilution (viral dose) inducing infection and clinical disease in calves. Data from this preliminary assay will serve as basis for determining the range of test virus dilutions to be assayed in the phase II or large challenge-inoculation study. By using a sufficient number of animals in phase II, we will be able to fully characterize the effectiveness of the challenge material to cause clinical disease. Briefly, IBR challenge-inoculation will usually result in generalized clinical host response and/or respiratory disease. Parameters to be evaluated by the contractor shall include, but not limited to: recording of clinical signs such as fever, anorexia, depression, nasal and lacrimal discharge. Contractor will also collect blood samples and nasal swabs as agreed for testing at CVB laboratory or elsewhere. Statistical analysis of results will be performed in collaboration with CVB statisticians. 6.1a Deliverables: " An experimental protocol, timelines, and bid for the project. " Tasks identified under Task Management above. 6.1b Deliverable Due Date: " Experimental protocol and timelines for the project shall be submitted at beginning of contract + 10 business days. " Completion of experimentation: beginning of contract + 1 year. " Tasks identified under Task Management above. 7.0 Quality Assurance The contractor(s) shall deliver a biweekly status report as described in section 5.1 of this document. The biweekly status reports will be read by the COTR who will work with the contractor to resolve any issues. 8.0 Performance 8.0.1 Period of Performance The period of performance is expected to be award date plus 12 months for the validation of challenge virus studies. 8.0.2 Performance Standards Contractor performance will be measured by the ability to adhere to deliverable deadlines as agreed between the COTR and the contractor at the start of the project. 8.0.3 Nonperformance In the event that the tasks outlined in section 6.0 (Tasks to be Performed) are not performed according to performance measures also identified in section 6.0: " The Government will notify the contractor of failure to perform according to performance measures, and the contractor will revise task deliverable at no cost to the Government within the time scales required by the project as outlined in section 6.0. " The Government will notify the contractor of failure to complete tasks according to deadlines outlined in section 6.0. Sustained failure to complete tasks on time will result in cancellation of the contract. It will also be required that the contractor reimburse the Government for any costs related to tasks not done to appropriate performance measures. The Government also reserves the right to only award selected portions of the contract. The contract will be administered on a modular (in Tasks) bases; whereby, the subsequent tasks are contingent on the successful completion of the preceding task. 9.0 Government Roles and Responsibilities The CVB shall designate a representative(s) to coordinate all aspects of this project. All work performed at the CVB laboratory will be coordinated with the contractor(s) by the COTR. 10.0 Ownership of Intellectual Material and Code. The government will own and have intellectual rights to all deliverables described in section 6.0 Tasks to be Performed. The contractor shall not copy or use any of these deliverables for personal or financial gain. Any publications resulting from this project will require prior authorization by the COTR.