Attachment A - Draft Statement of Work

U.S. FOOD AND DRUG ADMINISTRATION

STATEMENT OF WORK

Scientific and Regulatory Support Services (SRS) Indefinite Delivery/Indefinite Quantity (IDIQ) Contract

Contract Vehicle
TBD
Document Status

DRAFT

RFQ Issue Date
TBD
NAICS Code
NAICS 541690: Other Scientific and Technical Consulting Services NAICS 541990: All Other Professional, Scientific, and Technical Services

1.0
Background
2.0
Objectives
3.0
Scope of Work
4.0
Task Areas
Task Area 1
Program and Project Management
Task Area 2
IT Architecture and Integration Services
Task Area 3
Statistical Computing Support
Task Area 4
Data Standards
Task Area 5
Knowledge and Records Management
Task Area 6
Data Management and Data Quality
Task Area 7
Business Analysis Support
Task Area 8
Training
Task Area 9
Reviewer Customer Service Support
Task Area 10
Outreach and Communication Support
Task Area 11
AI-Augmented Scientific and Regulatory Analysis
Task Area 12
Research, Technical Guidance, Scientific Investigations, and Publishing Task Area 13
Laboratory Technical and Administrative Support
Task Area 14
Transition Services
5.0
Deliverables
6.0
Personnel
7.0
Period of Performance
8.0
Place of Performance
9.0
Travel
10.0
Other Direct Costs
11.0
Government Furnished Equipment / Information
12.0
Technical Standards and Guidelines
13.0
Security and Privacy Requirements
14.0
Section 508 Compliance
15.0
Contract Types
16.0
Government Points of Contact
17.0
Contractor Performance Evaluations
18.0
Payment and Invoicing

1.0 BACKGROUND

The Food and Drug Administration (FDA) is a science-based regulatory agency critically important to the stability of the nation's public health and health care systems. FDA protects and promotes the health and safety of all Americans by enhancing the availability of safe medical products, foods, and animal products, and by promoting innovation that addresses unmet medical and public health needs. FDA decisions must be based on the best available scientific data and employ the best tools and methods available to ensure products meet the highest quality standards, while fostering innovation in the products it regulates. In support of its regulatory mission, FDA conducts scientific research across a broad range of disciplines including vaccines, drug safety, food safety, medical devices, biologics, toxicology, radiological products, and more. FDA's science is increasingly data-centric, complex, and collaborative, involving multidisciplinary groups across its Centers and Offices.