Attachment 1: Statement of Work

US Department of Agriculture (USDA)

Statement of Work

SECTION A – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

A.1 Definitions/Acronyms
Vendor, Contractor, or Manufacturer – These terms are used interchangeably throughout the document...
VAC – Vaccine Antigen Concentrate sometimes referred to by industry as “For Further Manufacture.”
FFM – “For Further Manufacture” used interchangeably with VAC F.O.B. destination – See clause 52.247-34
FUP – Final Use Product. VAC quantity is defined in terms of the minimum number of doses of finished vaccine it can yield. The finished vaccine is also referred to as FUP. Guaranteed Shelf Life – The period of time during which the contractor guarantees their VAC will pass potency, purity and efficacy tests. During this period, any VAC that fails testing is required to be replaced at no cost to the Government. When a failure is identified, the guaranteed shelf life period immediately pauses. It is resumed upon the new VAC replacement entering storage. Due to this, contract duration may be extended as needed to ensure full coverage of guaranteed shelf life.
A.2 Embedded Hyperlinks
APHIS Forms 2007
https://www.aphis.usda.gov/sites/default/files/aphis2007.pdf APHIS Form 2008
https://www.aphis.usda.gov/sites/default/files/APHIS_2008.pdf

21 U.S.C.151-159

https://uscode.house.gov/view.xhtml?path=/prelim@title21/chapter5&edition=prelim

9 CFR § 94.18

https://www.ecfr.gov/current/title-9/section-94.18

9 CFR Parts 101-123

https://www.ecfr.gov/current/title-9/chapter-I/subchapter-E

9 CRF § 113.3

https://www.ecfr.gov/current/title-9/section-113.47

9 CFR § 113.46

https://www.ecfr.gov/current/title-9/section-113.46

9 CFR § 113.47

https://www.ecfr.gov/current/title-9/section-113.47

9 CFR § 113.55

https://www.ecfr.gov/current/title-9/section-113.55
Title 9, Code of Federal Regulations (9 CFR), Part 114.9 (d) https://www.ecfr.gov/current/title-9/part-114/section-114.9#p-114.9(d) A.3 Specifications
The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) requires the production of a foot and mouth disease (FMD) vaccine antigen concentrates (VAC), and as required, the opportunity to finish VAC into final vaccine. The USDA also requires the ability to directly purchase vaccine from the manufacturer in case of immediate need. The effective period of the contract will be equivalent to a five-year VAC and Direct purchase vaccine ordering period plus the manufacturer’s guaranteed shelf-life from date of release