DRAFT PWS.docx

US Department of Agriculture (USDA)

Statement of Work

Contents

Project Rabies National Institutes of Health (NIH) Testing in Mice

General Information

1.0 Scope of Work

United States Department of Agriculture (USDA), Animal Plant and Health Inspection Services (APHIS), National Veterinary Services Laboratory (NVSL), Center for Veterinary Biologics (CVB) uses mice for the regulatory testing of veterinary biologics according to the Title 9 Code of Regulations (9 CFR) Section 113.209. Specifically, the mice are used to evaluate the potency of vaccines against rabies.

2.0 Background

This will be a five-year Indefinite Delivery Indefinite Quantity (IDIQ) contract. Funds will be obligated by delivery orders when mice are needed.

Mice are used to evaluate the efficacy of inactivated rabies vaccines according to the SAM 308, Supplemental Assay Method for Potency Testing of Inactivated Rabies Vaccine in Mice Using the NIH Test. The protocol defines the specification of mice for use as female CF-1 mice within a weight range of 13-15 grams. Historically, the CVB rabies program has been developed over the past forty (40) years using Envigo , female CF-1 mice from colony 206. Since the NIH rabies potency test is highly variable, controlling as many influencing factors as possible is necessary for test success. Female CF-1 mice from colony 206 were selected based upon their genetic line and predictable response in the NIH rabies potency assay. Vaccine manufacturers have followed suit and use Colony 206 for rabies potency testing. The use of a constant mouse line with known genetics results in consistency of intra and inter laboratory results

Contractor Requirements

3.0 Technical Requirements / Tasks

1) Live, white female CF-1 mice (strain Hsd:NSA(CF-1)

2) Weight range 11-13 grams at arrival

3) All mice will be healthy, as determined by a government representative, upon arrival and through a three (3) day quarantine period.

4) All mice to be shipped to CVB will be shipped in new, filtered and disposable, nonreturnable containers. Mice must be antibody-free of Ectromelia Virus, Hantaan Virus, K Virus, Lactic Dehydrogenase Elevating Virus, Lymphocytic Choriomeningitis Virus, Minute Virus of Mice, Mouse Adenovirus type 1, Mouse Adenovirus type 2, Mouse Cytomegalovirus, Mouse Hepatitis Virus, Mouse Parvovirus, Mouse Polyoma Virus, Mouse Rotavirus, Mouse Thymic virus, Mouse Chapparvovirus (MuCPV) Mouse Norovirus, Pneumonia Virus of mice, Respiratory Enteric Virus III (REO III), Sendai Virus, Theiler’s Murine Encephalomyelitis vVrus (TMEV, GD7), Bordetella bronchiseptica, CAR bacillus, Citrobacter rodentium, Clostridium piliforme, Corynebacterium kutscheri, Dermatophytes, Helicobacter bilis, Helicobacter hepaticus, Helicobacter spp., Klebsiella oxytoca, Klebsiella pneumoniae, Mycoplasma pulmonis, Pasteurella multocida, Pasteurella pneumotropica, Pneumocystis murina, Pseudomonas aeruginosa, Salmonella spp., Staphylococcus aureus, Streptobacillus moniliformis, Streptococcus pneumonia, Streptococcus spp, Group B beta, Ectoparasites, Endoparasites, Enteric Protozoan and Encephalitozoon cuniculi as determined by sentinel mouse antibody testing.

5) Mice must not be vaccinated with any rabies product and must remain susceptible to rabies viruses shown by testing at CVB and must remain healthy throughout the pre-challenge testing period.

6) The mice will have a placid temperament, and clinically healthy.

7) The use of antibiotics, growth stimulants, or other drugs by the vendor will be cause for default. The rearing facilities must comply with the Animal Welfare Act (Public Law 91-579) and to its amendments. Documents, verifying compliance will be furnished to the Contracting Officers Representative (COR) at the time of submission of the offer.

8) Mice must be free from mites and lice

9) Mice must be free from all aforementioned agents and diseases (Item 4).

4.0 Government Furnished

The contractor must provide access to summary microbiology reports, including a quarterly microbiologic monitoring report, which is updated quarterly and provides cumulative serologic study results for the past 12-18 months. Additionally, current Microbiologic Monitoring must be provided with each animal shipment.

All quality control data that confirms the mice meet the specifications in Section 3. 4 must be available to the CVB for verification of the health status on all colonies used to fill this contract through a website used to assess the health of the contractor’s mice colony through the life of the contract.

Contractor must have an ongoing quality control program which monitors mice for: Mouse Hepatitis Virus (MHV); Mouse Parvovirus (MPV); Mouse Minute Virus (MMV); Sendai virus; Theiler’s Mouse Encephalomyelitis Virus (TMEV/GDVII) Pneumonia Virus of Mice (PVM); Rotavirus (EDIM); Mouse Adenovirus-1 (MAD-1); Mouse Adenovirus-2 (MAD-2); Lymphocytic Choriomeningitis Virus (LCMV); Ectromelia: Polyoma Virus; Mouse Norovirus (MNV); Mouse Cytomegalovirus (MCMV); Reovirus 3 (Reo 3); Mouse Thymic Virus (MTV0; K virus; Hantaan virus; Clostridium piliforme (Tyzzzer’s disease); Encephalitozoon cuniculi; CAR bacillus; Mycoplasma pulmonis and Lactic Dehydrogenase-Elevating Virus (LDHV).

5.0 Deliverables / Schedule

Delivery of mice is based upon a predetermined test schedule submitted by the CVB Virology staff to site procurement personnel in June or July of the preceding fiscal year. Typically, CVB Virology personnel conduct 16-18 rabies potency test series each year. For each scheduled test, the mice must arrive from the contractor by courier service on the Monday preceding the test initiation. These mice must be alive and meet technical specifications outlined in Section 3. If the mice do not meet the specifications, delivery will be rejected, and the mice must be replaced.

Delivery dates will be specified on the delivery order. All mice will be delivered to:

National Centers for Animal Health (NCAH) Center for Veterinary Biologics 1920 Dayton Avenue Ames, IA. 50010

1.0 PRICE SCHEDULE

This is a commercial indefinite‐delivery indefinite‐quantity contract. The line-item quantities listed in the Pricing Schedule below are estimates for evaluation purposes only and are not intended to convey either a minimum or maximum quantity that will be ordered by the USDA. The unit price that will be paid for any line item will not be changed based on the quantity ordered by the USDA. The ultimate contract price for any given ordering period will be the sum of the delivery orders issued during that period.

A batch of mice consists of 360 mice. Batch prices shall include all delivery costs associated with delivery of these mice per Section 1.0 (E) above. Prices shall also include all efforts to ensure the mice are remain healthy and alive while shipped (cooling efforts).

The minimum guarantee on this contract is $5,000.

Item SUPPLIES/SERVICE EST.QTY UNIT PRICE TOTAL

001. Year 1: October 01, 2023 through September 30, 2024 16 Batch $6,248 $99968 Female CF-1 mice from to be delivered in batches of 360 mice per shipment, estimated number of shipments will be 16-18 and spaced 2-4 weeks.

002. Year 2: October 01, 2024 through September 30, 2025 16 Batch $6,248 $99968 Female CF-1 mice from colony 212 to be delivered in batches of 360 mice per shipment, estimated number of shipments will be 16-18 and spaced 2-4 weeks.

003. Year 3: October 01, 2025 through September 30, 2026 16 Batch $6,248 $99968 Female CF-1 mice from colony 212 to be delivered in batches of 360 mice per shipment, estimated number of shipments will be 16-18 and spaced 2-4 weeks.

004. Year 4: October 01, 2026 through September 30, 2027 16 Batch $6,248 $99968 Female CF-1 mice from colony 212 to be delivered in batches of 360 mice per shipment, estimated number of shipments will be 16-18 and spaced 2-4 weeks.

005. Year 5: October 01, 2027 through September 30, 2028 16 Batch $6,248 $99968 Female CF-1 mice from colony 212 to be delivered in batches of 360 mice per shipment, estimated number of shipments will be 16-18 and spaced 2-4 weeks.

6.0 Travel

NA

7.0 Contractor’s Key Personnel

Describe positions which are considered key to successful performance of the contract and the information required to support key personnel qualifications, e.g., experience which correlates to SOW requirements, education, and past performance on similar projects. Specify if resumes are required and provide resume format if appropriate.

Insert Contractor’s Key Personnel Here

8.0 Security Requirements

Specify security requirements that apply to the contract performance. Specify the level of clearances required and identify positions that are applicable.

Insert Security Requirements Here

9.0 Data Rights

If data is to be produced, furnished, acquired, or used in meeting contract requirements, delineate the respective rights and obligations of the government and the contractor regarding the use, production, and disclosure of that data.

Insert Data Rights Here

10.0 Section 508 – Electronic and Information Technology Standards When information technology is to be acquired, include language describing Section 508 requirements.

Insert Section 508 Here

Attachment If applicable, include an Attachment stating Evaluation Factors and significant Subfactors representing the key areas of importance and emphasis to be considered in the source selection decision.

image1.png