exposureschedules-foodanddrugadministration（7页）.docVIP

Summary of Comments from the ANPRM on sunlamps W. Howard Cyr 21 August 1999 C1-Winn = Winnebego County C2-SC = South Carolina C-3-DS = Don Smith, Tucson, consultant to Smart Tan, also individual response C4-Aegis = Aegis, Robert Wagner C-5-Caswell = Mike Caswell C6-Sylv = Sylvania C7 Sperti C8-NW = Northwestern Univ C9 - Wolff = Wolff Systems C10 = Caswell = Mike Caswell C11-AZ = Arizona C12-WA = Washington state C13-Interelectric C14-Sun C15-DS = Don Smith, Tucson, consultant to Smart Tan, also individual response C16-AAD = Acad of Dermatology C17-ST = Smart Tan Network C18 = SAE = Suntanning Assoc for Educ C19-SCF = Skin Cancer Foundation C20- Mayhall = Mayhall of Michigan C21-TX = Texas C22-Ainsleigh = H. Gordon Ansleigh C23NW = Northwestern Univ. C24-Ansleigh C25-Universal = Universal Insurance Co C26-Trop = Tropical Tan Exposure Schedules Problems with current exposures schedules: Need real time measurements of lamp output C19-SCF 95% of salons not following exposure guidelines C23- NW 1/3 of salons starting at maximum exposure setting no insurance problems C25 – Universal definition of UVB (290 –320 CDER)(280-320 IEC)(260-320 CDRH) - C10-Caswell need consistent definitions of UVA1,UVA2, UVB, and UVC – C15-DS need to include exposure schedules in performance standards – C2-SC pay particular attention to new bulbs (more dosage) – C12 WA use of MED is confusing – use the method of NOAA (UV index) C14 – Sun the current FDA exposure schedule tans with no burns – C10-Caswell the current FDA exposure schedule doesn’t tan people until after several sessions – C5-Caswell, C15-DS Much of the current recommended exposure schedules was developed for phototype I Different schedule for different phototypes: Need to consider level of existing tan – C9-Wolff Schedules are needed for different skin types – C1-Winn, C9-Wolff Use Fitzgerald Scale C21-TX Use 9 different phototypes – C15-DS a detailed exposure schedules for 9 different phototypes, included previous