Document g2zYRo2kJJ51Z8xGVOdK4w9y3

U n iv e r s it y of I l l in o is at C h ic a g o School of Public H ealth (MC 922) 2121 West Taylor Street Chicago, Illinois 60612-7260 0 0 6 5 8 JUN*"5 A11147 May 30, 2008 Carolyn Kachovec, Director Division o f Dockets Management Office of Management Programs Office o f Management Food and Drug Administration Department o f Health & Human Services Rockville, MD 20857 Dear Ms. Kachovec, Further to your attached May 21,2008, letter, I am resubmitting the petition together with copies o f the articles or source cited. Sincerely, Enclosures: May 13, 2008 Petition Seeking a Cancer Warning on Cosmetic Talc Products; Copies o f articles or source cited UIC Phone (312) 996-2296/2297 Fax (312) 906 1371- E-mail epstein@uic.edu http://preventcancer.com DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 May 21, 2008 Samuel S. Epstein, M.D. Chairman, Cancer Prevention Coalition c/o University of Illinois at Chicago School of Public Health, MC 922 2121 West Taylor Street, Rm. 322 Chicago, IL 60612 Dear Dr. Epstein: This letter responds to your petition requesting the Food and Drug Administration to seek a cancer warning on cosmetic talc products. Your petition was received by this office on May 15, 2008. FDA has established procedural regulations that describe the appropriate format for petitions like yours, as well as certain matters on which information must be submitted. The regulations provide that if a petitioner fails to follow the appropriate format, or fails to submit information on a required subject, we cannot accept the petition for filing. Your petition fails to include the relevant information referenced in your petition, therefore, fails to meet the requirements of 21 CFR 10.20(c). For this reason, your petition is not acceptable for filing I am enclosing a copy of the appropriate regulations pertaining to your submission. Please contact Ms. Bigesby at 301/827-6857 if you have questions regarding this regulation. Should you amend your petition to comply with this regulation, we will accept it for filing. Please note, however, that acceptance of the petition for filing is a procedural matter in that it in no way reflects an agency decision on the substantive merits of the petition. Sincerely yours, Carolyn Kafiovec, Director Division of Dockets Management Office of Management Programs Office of Management Ends.