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U.S. Department of Health and Human Services

Medical Devices

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ODE Executive Secretary Guidance Manual G87-3

This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s.


General Program Memorandum G87-3

August 7, 1987



ODE Executive Secretary Guidance Manual

The ODE Executive Secretary Guidance Manual has been developed by this 
office to provide Executive Secretaries of ODE advisory panels with a 
convenient reference source of information concerning the rules and 
procedures governing advisory panels and the responsibilities of 
Executive Secretaries of these panels.  The Manual includes a copy of 
the "FDA PUBLIC ADVISORY COMMITTEES," A Handbook for Committee Members 
and Executive Secretaries (OCtober, 1984), and selected Center 
supplements to the Handbook.

The individual Executive Secretary Advisories (ESAs) are intended to 
augment the information in the Handbook as well as the regulations 
governing advisory committees (21 CFR Part 14).  In addition, the ESAs 
convey guidance, suggestions, or information which will be useful to 
Executive Secretaries in ensuring that regulatory and procedural 
requirements are met in an efficient and consistent manner.

The ESAs describe policies and procedures that have been developed 
over many years of panel administration; thus, they are effective 
immediately.  I recognize, however, that panel administration is very 
complex and that present ESAs may need refinement or additional ESAs 
may be required.  Executive Secretaries have been encouraged to share 
their experiences with their colleagues and with me, and I have 
solicited their suggestions for additional ESAs.  Center staff are 
encouraged to discuss matters pertaining to a particular panel with 
the Executive Secretary of that panel or with Roger W. Barnes, the ODE 
focus point for matters involving panel policies, procedures or 
administration.