FDA Modernization Act

Implementation Charts

Implementation Chart of Remaining Items (last updated 4-28-2005)

Implementation Chart of Completed Items (last updated 4-28-2005)

These charts represent the status of the agency's implementation of the Food and Drug Administration Modernization Act of 1997 (Public Law No. 105-115). The first chart shows those items yet to be completed, and the second shows those items already completed. The tasks outlined are those that were specifically required by the statute (which are marked with **), or those that the agency has deemed necessary either because they are needed to conform FDA's regulations or guidance to the statute or because regulations or guidance are needed to ensure appropriate implementation of the statute.

Terms Used in the Charts:

• The first column, "Section," refers to the section of the statute that the initiative is implementing.
• The second column, "Description," provides a brief description of what the initiative will do.
• The third column, "Statutory Deadline," provides the deadline listed in the statute for that initiative, where applicable.
• The fourth column, "Agency Contact," provides the name of the person at FDA who can be contacted regarding this initiative.

Acronyms Used in the Charts:

• CDER = Center for Drug Evaluation and Research
• CBER = Center for Biologics Evaluation and Research
• CDRH = Center for Devices and Radiological Health
• CVM = Center for Veterinary Medicine
• CFSAN = Center for Food Safety and Applied Nutrition
• ORA = Office of Regulatory Affairs
• OP = Office of Policy
• OMB = Office of the Ombudsman
• OMS = Office of Management and Systems
• OSHI = Office of Special Health Issues

** --indicates a task that is required by the new statute