Compliance

Select Agents and Toxins (SAT)

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the United States Department of Health and Human Services (HHS) and the United States Department of Agriculture (USDA) established requirements regarding possession, use, and transfer of select agents and toxins.  CDC’s Internal Select Agents and Toxins Compliance Program provides policy guidance and technical assistance to assist CDC laboratories that work with select agents and toxins in complying with federal regulations. This program ensures accountability for the 700+ CDC scientists who work with select agents and toxins (SAT) in complying with regulatory requirements.

Key functions and Activities

• Develop and implement site-specific Security, Safety, and Incident Response Plans.
• Implement SAT compliance training.
• Ensure the accuracy and completeness of SAT inventory and records.
• Prepare laboratories for (re)certification inspections that allow them to possess, use and transfer SAT material.
• Provide strategies for mitigating risks of potential violations during inspections.  

 

 

Laboratory Developed Tests (LDT)

Risk for safety of the patient or the public due to unsubstantiated claims of clinical utility has recently moved FDA to begin to exercise regulatory authority over Laboratory Developed Tests (LDTs).  CDC’s LDTs play a critical role in our ability to respond quickly to emerging infections and biochemical and biological terrorism when no commercial alternative or none of comparable quality is available. 

Key functions and Activities

• Coordinate centralized communication with leadership from CDC and the Office of in Vitro Diagnostics (OIVD), FDA to provide economy of effort and a standard of quality information exchange.
• Develop procedures and documents to assist CDC scientists with preparing for FDA regulatory clearance submissions.
• Streamline the FDA review of CDC assays, optimize limited staffing resources, and facilitate CDC compliance with FDA requirements. 

 

Dual Use Research of Concern

Great achievements in the life sciences over the last 50 years have produced advances that have revolutionized the practice of medicine and public health. The very technologies that have fueled these benefits to society, however, pose a potential risk as well—the possibility that these technologies could also be used to create the next generation of chemical, biological or other weapons of mass destruction. A portion of the research leading to these advances has been termed "dual-use research of concern" (DUR) to convey the idea that some technologies and discoveries intended to improve health and well-being can also be intentionally misused to pose a biological, chemical or other threat to public health or national security.

Key functions and Activities

• Coordinate and manage the Institutional Biosecurity Board (IBB) that considers the possibility for deliberate misuse of CDC's research findings and technologies and how such information with dual-use potential can be responsibly communicated.
• Interface with the National Science Advisory Board for Biosecurity (NSABB)
• Provide guidance and consultation to CDC scientists and CDC leadership regarding DUR issues.