Legislation and Regulation
There are a number of federally mandated regulations and clearance functions that affect the research and practice of CDC which apply to all CDC employees, contractors, and awardees conducting data collection activities, whether the activities are for research or public health practice or occur in domestic or global settings.
CDC sponsored data collection activities are required to comply with the U.S. Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA) regulations for the protection of human research participants and comply with the federal Animal Welfare Act (AWA) as well as the Public Health Service Policy on Humane Care and Use of Laboratory Animals. In addition, the Paperwork Reduction Act (PRA), the Privacy Act, the Public Health Service Act (PHSA), the E-Government Act of 2002, the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, and the Family Educational Rights and Privacy Act (FERPA) all include legislation or regulations that affect the research and public health practice of CDC.
The CDC Office of Scientific Regulatory Services (OSRS) is responsible for providing oversight and ensuring adherence to these regulations and clearance requirements.
Legislation and Regulation at CDC
- Animal care and use in CDC laboratory
research
Work to ensure compliance with federal laws and principles in the care and use of laboratory animals at CDC. - Privacy and confidentiality protection in CDC public
health activities
Guidance on HIPAA Privacy Rule, FERPA, and Certificates and Assurances of Confidentiality.
- Human participant protection in CDC research
Protecting the rights and welfare of those who participate in CDC-sponsored public health research. - Minimize paperwork burden and protect privacy
Minimize paperwork burden, maximize utility of information, and improve quality and use of federal information.
Additional Information
- About the CDC Office of Scientific
Regulatory Services (OSRS)
Information on our Offices and
Programs... - Contact Us
Page last modified: July 14, 2008
Content source: Office of the Chief Science Officer (OCSO)