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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
lab scientist

  • 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.  

 

 

In Vitro Diagnostic (IVD) Support Team

Current Federal Regulations require that in vitro diagnostic (IVD) devices distributed outside of a single laboratory must be reviewed by the U.S. Food and Drug Administration (FDA) prior to distribution unless otherwise stated to be exempt. The IVD Device Support Team can provide administrative support in the preparation and submission of PreSubmission (PreSub), 510(k) and other regulatory documents to FDA as well as technical support and guidance regarding development of intended use statements, materials and reagent selection, instrument platform selection, and analytical and clinical study designs for IVDs developed at CDC to be distributed externally.

lab scientists next to computerKey functions and Activities

  • Coordinate centralized communication with leadership from CDC and the Food and Drug Administration’s (FDA)/Office of In Vitro Diagnostics and Radiological Health (OIR) to provide economy of effort and a standard of quality information exchange.
  • Develop procedures and documents to assist CDC laboratory scientists with preparing for IVD regulatory submissions to FDA/OIR.
  • Streamline the FDA review of CDC IVDs by providing technical and administrative support to CDC laboratory scientists. 

 

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 Activitieslab scientists looking at laptop

  • 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.

 

 

 
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