12-1-21 SOW CSF DIVA vaccine DRAFT bc changes (002)--12-2-21.pdf

Statement of Work 2021

U.S. Department of Agriculture (USDA) Animal & Plant Health Inspection Services (APHIS)

Veterinary Services (VS)

Classical Swine Fever Virus Vaccine, DIVA, For the National Veterinary Stockpile

TITLE OF CONTRACT

Classical Swine Fever Virus Vaccine, DIVA, for the National Veterinary Stockpile

SERVICE

Provide Classical Swine Fever Virus (CSFV) Vaccine, Modified Live Virus, suitable for use in vaccination programs that employ “differentiating infected from vaccinated animals” (DIVA) techniques, prior to and during outbreaks of Classical Swine Fever (CSF).

1. BACKGROUND

The National Veterinary Stockpile (NVS) is the nation's repository of vaccines and other critical veterinary supplies and equipment. It exists to augment state and local resources in the fight against dangerous animal diseases that could potentially devastate American agriculture, seriously affect the economy, and threaten the public’s health.

Homeland Security Presidential Directive 9 established the NVS in 2004. It established a goal for the NVS to deploy within 24 hours “sufficient amounts of animal vaccine, antiviral, or therapeutic products to appropriately respond to the most damaging animal diseases affecting human health and the economy…” The directive reflects the nation’s concern that terrorists could simultaneously, in multiple locations, release disease threats of an unprecedented magnitude; thus, the need for an NVS that could deliver at the least cost, large quantities of critical veterinary supplies and equipment to the right place at the right time for as long as is necessary.

The NVS stores its inventory in multiple locations and in sufficient volume to ensure its ability to respond to multiple, large-scale, simultaneous animal disease outbreaks.

The NVS obtains guidance and direction in defining “dangerous animal diseases” from the NVS’ Steering Committee. The Steering Committee recommended the near-term acquisition of CSFV Vaccine, suitable for use in vaccination programs that employ “differentiating infected from vaccinated animals” (DIVA).

2. OBJECTIVES

Purchase and store finished ready-to-use (RTU) Classical Swine Fever Virus Vaccine, DIVA that should be available to use within 24 hours

3. SCOPE

The NVS seeks a contract to obtain and store finished, RTU CSFV Vaccine, DIVA, in storage sites inside or outside the United States (U.S.).

CONCEPT OF OPERATIONS

The government wishes to acquire limited supplies of vaccine that the manufacturer will quarantine and store on licensed premises prior to disease outbreaks and to establish a reliable source of additional vaccine that it can purchase during outbreaks if government inventories are insufficient. The contractor will ship the vaccine to locations specified by the government.

SCOPE OF WORK

The NVS seeks a contract for1 million doses of finished CSFV Vaccine, suitable for use in CSF control or eradication programs. Vaccine must be suitable for distribution and sale in the United States, as regulated by the USDA CVB.

TYPE OF CONTRACT

This contract will be for:

1. The production, storage, and delivery within 7 days of release, of CSFV Vaccine, DIVA. This vaccine must be suitable and eligible for distribution in the United States, as demonstrated by a United States Veterinary Biologics Product License or Permit for Distribution and Sale, as issued by the United States Department of Agriculture, CVB, or as demonstrated by an application and commitment (Licensing Plan) to obtain a License or Permit.

REQUIREMENTS

Contractor holding a current USDA Product License or Permit for Distribution and Sale will be given favorable consideration. Regardless, all Contractors, with current or prospective product licenses or permits must provide, conduct, report, submit, describe, determine, demonstrate, or acknowledge:

1. Acknowledge Contractors are responsible for all steps in the production, finishing, bottling, labelling, testing, shipping, storage and disposal of finished vaccine or vaccine antigen concentrate

2. Provide evidence demonstrating DIVA capability of the vaccine. Evidence includes a description of diagnostic tests that allow vaccinates to be differentiated from field infected animals; describe sources and availability of differentiating diagnostic tests; provide reference materials that describe performance (e.g., sensitivity, specificity, accuracy) of the differentiating diagnostic tests

3. Acknowledge all work will be conducted according to an OP on file at the CVB, in facilities accepted as suitable by the CVB

4. Submit to the CVB, immediately after product is manufactured and tested:

a. APHIS Form 2008 for each finished Serial

b. All OP test results reported on APHIS Form 2008 are satisfactory

c. Serials that fail any OP test are replaced at the Contractor’s expense

5. Provide a Safety Data Sheet (SDS) for CSFV Vaccine to the NVS; acknowledge SDS disseminated at NVS’ discretion

6. Determine stability of finished vaccine. If requested by the Contracting Officer (CO) or Contracting Officer’s Representative (COR), conduct near end-of-dating potency tests on

Serials owned by the NVS. Report test results to the COR. If requested by the CO or COR, submit a request for an extension-of-dating to the CVB. The cost of conducting end-of-dating potency tests, submitting extension-of-dating requests to CVB, and conducting (frequency determined by USDA) and reporting stability monitoring of Serials for which CVB has approved an extension of dating, will be priced separately per contractor proposal and Government acceptance.

7. Describe the ability and agree to re-label vaccine in the event an extension-of-dating is authorized. Re-labelling costs will be priced separately per contractor proposal and Government acceptance.

8. Acknowledge that samples to be tested for purpose of extending dating will be drawn from stored NVS stockpiles. The cost of collecting, preparing, and shipping samples of finished vaccine to be tested at a foreign manufacturing facility, and the price for conducting potency tests at the testing site, for extending dating, will be priced separately per contractor proposal and Government acceptance

9. Acknowledge storage costs for any vaccine held at the contractor facility during the base period of the contract will be included in the price of the vaccine. Acknowledge there may be a need for the contractor to store vaccine beyond base contract period. Demonstrate storage capability and capacity for extended storage in circumstances such as when an extension-of-dating has been granted. The government reserves the right to request additional storage time as needed. The additional storage time should not exceed 3 years for finished vaccine. Storage for vaccine beyond the base contract period will be priced separately per contractor proposal and Government acceptance, with one exception: non-expired vaccine stored after the period-of-performance (POP) end date (see item 10).

10. The Contractor must provide storage until vaccine expiry, at no additional charge, for NVS-owned vaccine that is within dating but beyond the Contract’s POP end date. After expiry vaccines will be disposed. The Contractor must offer disposal services. Disposal costs during and after (e.g., sufficient period to cover disposal of any NVS-owned vaccine) the base contract period will be priced separately per contractor proposal and Government acceptance.

11. Indicate if shipping costs to a storage location within the United States are included in the cost per dose. If shipping costs are not included in the price per dose then price shipping costs separately per contractor proposal and Government acceptance; provide separate quotes for shipping finished vaccine within the base contract period, and 3 years beyond the base contract period.

12. An IDIQ component for the delivery of CSFV Vaccine, DIVA, from existing inventories, suitable and eligible for distribution in the United States within 28 days. The cost of delivery of vaccine from existing inventories will be priced separately per contractor proposal and Government acceptance.

The Contractor will deliver one million doses of ready-to-use CSFV Vaccine suitable for use in vaccination programs that employ DIVA techniques. The vaccine should be licensed or permitted for distribution and sale in the United States by the USDA CVB.

PERIOD OF PERFORMANCE

Period of performance, at a minimum will last for two years past initial acceptance of one million doses.

This may be extended if product testing allows for longer shelf-life of product.

SUBMITTING INVOICES FOR PAYMENT

USDA uses the Invoice Processing Platform (IPP) for electronic submission and tracking of purchase orders, invoices, and payment information to its suppliers of goods and services: Enroll at https://ipp.gov. The IPP is a government-wide secure web-based invoice processing service offered free of charge to government agencies and their suppliers by the U.S. Department of Treasury’s Financial Management Service (FMS).

Upon contract award, you will receive a notification of your one-time enrollment requirement in an automatic invoice payment notification system available through IPP. This one-time enrollment in IPP means that you will receive a series of e-mails from Treasury services.

Contractors must submit invoices and attach all supporting documentation as required within 5 business days of completion of services provided. Supporting documentation includes, maintenance inspection checklist, timecard for labor, travel receipts etc. The IPP Approver will review the supporting documents before approving invoices in IPP, if supporting documentation is not provided the invoice will be rejected. IPP will issue a notification to contractor that they must submit supporting documentation and resubmit the invoice.

Government Contacts: (please do not contact the Government contacts for questions) please direct them to the Contracting Officer)

GOVERNMENT CONTACTS

Contracting Officer’s Representative Bruce Carter, D.V.M.

Global Vaccine Manager Center for Veterinary Biologics

USDA-APHIS-VS-STAS

1920 Dayton Road Ames, IA 50010

(515) 337-6100 Email: Bruce.a.carter@aphis.usda.gov

Point of Contact for Invoicing/IPP Approver:

Lisa Brown USDA APHIS VS SPRS Logistics Center, National Veterinary Stockpile Phone: 301-851-3553 Email: Lisa.a.Brown@aphis.usda.gov https://ipp.gov/ mailto:Bruce.a.carter@aphis.usda.gov mailto:Lisa.a.Brown@aphis.usda.gov