Public Comment Procedure

• 90-day comment period after date of publication in Federal Register

• comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, Docket Number 96N-0417 or

• submit electronic comments to http://www.fda.gov/dockets/ecomments, Docket Number 96N-0417