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Personal C are Products Counci Committed to Safety, Q u ality & Innovation July 21, 2009 Division of Dockets Management Food and Drug Administration Room 1061 5630 Fishers Lane Rockville, MD 20852 R E : Comments on: Citizens Petition to the Commissioner of the Food and Drug Administration Seeking a Cancer Warning on Talc Products Docket FDA-2008-P-0309 Dear Division of Dockets Management: The Personal Care Products Council1(the Council) appreciates the opportunity to comment on the above referenced Citizens Petition.

# ATTACHMENT A D escription of Modified Method to R ev ise Proposed Section 1 2 1 .2006(c) (2) Determine the Nz of the talc.

Research report Downloaded from jech.bmj.com on 3 0 M ay 2 0 0 8 Perineal use of talc and risk of ovarian cancer H Langseth,1 S E Hankinson,2 J Siemiatycki,3 E W eiderpass145 1The Cancer Registry of Norw ay, Institute of populationbased Cancer Research, Oslo, Norway; 2 Channing Laboratory, Department of Medicine, Brigham and W o m e n 's Hospital and Harvard Medical School, Boston, M A , U S A ; 3 Department of Social and Preventive Medicine, University of Montreal, Montreal, Canada; 4 Department of Medical Epidemiology and Biostatistics, Karolinska Instituted Stockholm, Sweden; 5 Samfundet Folkhalsan, Helsinki, Finland Correspondence to: E Weiderpass, The Cancer Registry of Norway, 0 3 1 0 Oslo, Norway; eliwei@ki.se Accepted 15 October 2007 ABSTRACT Ovarian cancer is one of the most common gynaecological neoplasms, especially in industrialised countries.

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FILE NAME: Talc (TALC) DATE: 2002 DOC#: TALC176 DOCUMENT DESCRIPTION: Journal Article - A Cohort Mortality and Nested Case-Contol Study of French and Austrian Talc Workers Downloaded from oem.bmjjournals com on 12 April 2006 98 ORIGINAL ARTICLE A cohort mortality and nested case-control study of French and Austrian talc workers , P Wild, K Leodolter, M Refregier, H Schmidt,T Zidek, G Haidinger O ccu p Environ M e d 2 0 0 2 ,5 9 9 8 - 105 See end of article for authors' affiliations Correspondence to Dr P W ild , Avenue de Bourgogne, BP n 27, 54501 Vandoeuvre Cedex, France, Accepted 8 August 2 0 0 1 Objectives: To study whether the mortality from non-malignant and malignant respiratory diseases of workers employed in French and Austrian talc mines and mills is related to their long term occupational exposure.

Memorandum to: From: Subject: The Hearing Clerk Food and Drug Administration Room 6 - 8 6 5600 Fishers Lane ROCKVILLE, Md. 20852, U.S.A.

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FILE NAME: Talc (TALC) DATE: 2002 DOC#: TALC176 DOCUMENT DESCRIPTION: Journal Article - A Cohort Mortality and Nested Case-Contol Study of French and Austrian Talc Workers Downloaded from oem.bmjjournals com on 12 April 2006 98 ORIGINAL ARTICLE A cohort mortality and nested case-control study of French and Austrian talc workers , P Wild, K Leodolter, M Refregier, H Schmidt,T Zidek, G Haidinger O ccu p Environ M e d 2 0 0 2 ,5 9 9 8 - 105 See end of article for authors' affiliations Correspondence to Dr P W ild , Avenue de Bourgogne, BP n 27, 54501 Vandoeuvre Cedex, France, Accepted 8 August 2 0 0 1 Objectives: To study whether the mortality from non-malignant and malignant respiratory diseases of workers employed in French and Austrian talc mines and mills is related to their long term occupational exposure.

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Anticancer Res. 2003 Mar-Apr;23(2C):1955-60.

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FILE NAME: Talc (TALC) DATE: 2004 June DOC#: TALC177 DOCUMENT DESCRIPTION: Article from Law Journal Website - Is Toxic Tort Reform Leading to the Same Disability Claims with New Labels 'bi Burnhan, Brown - Attorneys at Law, Oakland, California SlOtJ-f'.

FILE NAME: Talc (TALC) DATE: 2005 DOC#: TALC178 DOCUMENT DESCRIPTION: Letter in Medical Journal - A Case of Fulminant 'Talc Pneumoconiosis' Where is the Smoking Gun?

Cancer Prevention Coalition u U7 8 8 JUN-5 #7 UIC SCHOOL OF PUBLIC HEALTH, MC 922 2121 W.