FDAMA Home Page, Food and Drug Administration Modernization Act of 1997
 

FDAMA Home Page

 

FDAMA Information from FDA's Centers:

Center for Biologics Evaluation and Research

Center for Devices and Radiological Health

Center for Drug Evaluation and Research

Center for Food Safety and Applied Nutrition

Center for Veterinary Medicine

Office of Regulatory Affairs

FDA Dockets

  

Implementation Charts

Implementation Chart of Remaining Items

Implementation Chart of Completed Items

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

 

link to  Adobe Acrobat site Some of the documents listed in the Implementation Charts are in Portable Document Format (PDF) to retain the original format. To view or print these documents, you must use the Adobe Acrobat viewer. Acrobat is free and available directly from Adobe's website.

If your browser does not support tables, you may obtain a printed copy of the FDAMA Implementation Chart by writing FDA at the following address:

FDA Office of Executive Secretariat, HF-40
5600 Fishers Lane
Rockville, MD 2085

 



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Web page updated by clb 2001-DEC-05.