From:	Rados, William M
Sent:	Thursday, August 02, 2001 5:19 PM
To:	Dockets, FDA
Subject:	Comments to Docket No. 01D-0297
I am submitting comments to the Agency on Docket No. 01D-0297, Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff.  This guideline explains how to develop, prepare, and submit panel packages for public release.  Public release would include posting the packages on the FDA public Website.  

New regulations under Section 508 of the Rehabilitation Act went into effect June 21, 2001, that require postings on federal Websites to be fully accessible to persons with disabilities.  (See http://www.section508.gov/ for background information about this regulation.)  The CDRH guideline should include instructions to those preparing panel packages to provide those packages to FDA in a format that meets the provisions of Section 508.  The FDA Internet/Intranet Work Group has developed guidelines on how to comply with Section 508.  Those guidelines (available on the FDA intranet at http://intranet.fda.gov/oirm/manuals/internet/internetguide.htm#Accessibility) should be incorporated into the 
guidance for preparing panel packages and those who prepare the packages should be instructed to follow them whenever possible, as long as doing so does not impose an undue burden.

William M. Rados
Program Manager - FDA Website
301-827-7131