t THE UPJOHN COMPANY KALAMAZOO, MICHIGAN 49001 TELEPHONE (616) 382-4000 March 1-4, I976 Office of HARRY R ALLEN, M D Manager, FDA Liaison Domestic Pharmaceutical Medical Affairs Hearing Clerk Food and Drug Administration Room L-65 5600 Fishers Lane Rockville, Maryland 20852 Dear Sir: In response to Federal Register Notice, Volume kO, Number 51, March lL, 1975, page 11865, titled "Asbestos-form Particles in Drugs for Parenter Injection", we are supplying the attached memo.

1 / * Rtillippe Douillet 0he Holyoke lane Stony Brook, New York 11790 Re : Docket No. 83P-0404 Deer Mr.

C T ' F ' A Method J 4-1 Asbestiform Amphibole Minerals in Cosmetic Talc Part I: X-ray Diffraction Method Part II: Optical Microscopy and Dispersion-Staining Method Introduction The method which has been adopted for the detection of amphibole minerals in cosmetic talc is the generally accepted method of x-ray diffraction.

FINAL REFORM X-IU Y POWDER DIFFRACTION ANALYSES OF COMMERCIAIJ) to.

M O R A N D U M DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION OM BJECT: The Acting Commissioner THROUGH: Associate Commissioner for Compliance ______ Director, Bureau of Foods August 20, 1973 F !

MEMORANDUM OE MEETING Wednesday, March 10, 1976 BETWEEN: SUBJECT: Andrew Maguire, M.C., 7th District, NJ Christopher Burdick, Legislative Aid John Walcott, Staff Steve d'Arazine, Staff Katherine Meyers, Staff Lowell Dodge, Special Counsel and Heinz J.

February 221 1977 John P .

FILE NAME: Talc (TALC) DATE: 1972 Apr 6 DOC#: TALC061 DOCUMENT DESCRIPTION: Letter to Barry Castleman from the FDA *tME n r DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADM INISTRATION W A SH IN G T O N , D .C . 20204 April 6, 1972 Mr.

FILE NAME: Talc (TALC) DATE: 1975 A p ri DOC#: TALC090 DOCUMENT DESCRIPTION: NIOSH Memo RE Analysis of Talcs for Asbestos Fiber Content MEMORANDUM i . / .

an h e s a m p l in g s t r a t e g y d e c is io n s T made at the tim e of the basic epidemiologic ys- study of an industrial dust hazard ultim ately de ore term ine the m ethods th at will be used to evaluate aal exposures in later regulatory or control situations.

$*ptmafe*r S* S7Z (1b) I(5) Serte& F* Saette.

FUNDAMENTAL AND APPLIED TOXICOLOGY 10, 369-384 (1988) ISSUES Possible Mechanisms to Explain Dust Overloading of the Lungs P.

F,I Cosnt*t.

REFERENCES (FDA Docket No. 94P-0420/CP 1) SECTION II.

Semin Oncol. 1998 Jun;25(3):255-64.