Dockets:

1976N-0052N
BKG 4
Volume 85

Reference 1 - Comment No. LET86, Docket No. 1981N-0022 (formerly Docket No. 81N-0022).

Reference 2 - Horwitz et al., "Phenylpropanolamine & Risk of Hemorrhagic Stroke: Final Report of The Hemorrhagic Stroke Project," May 10, 2000 in Comment No. C230, Docket No. 1976N-0052N (formerly Docket No. 76N-052N) and Comment No. RPT14, Docket No. 1981N-0022 (formerly Docket No. 81N-0022).

Reference 3 - Phenylpropanolamine case reports from 1991 to 2000 on file in Docket Nos. 1976N-0052N (formerly 76N-052N) and 1981N-0022 (formerly 81N-0022).

Reference 4 - Consumer Healthcare Products Association (CHPA), "Comments on the Hemmorhagic Stroke Project Report," May 24, 2000, in Comment No. C231, Docket No. 1976N-0052N (formerly Docket No. 76N-052N) and Comment No. C113, Docket No. 1981N-0022 (formerly Docket No. 81N-0022).

Reference 5 - Food and Drug Administration, Transcript of Nonprescription Drugs Advisory Committee meeting, October 19, 2000, in Docket Nos. 1976N-0052N, (formerly 76N-052N) and 1981N-0022 (formerly 81N-0022), part 2, part 3.

Reference 6 - Food and Drug Administration, Public Health Advisory, "Safety of Phenylpropanolamine," November 6, 2000, Comment No. M1 in Docket No. 1976N-0052N (formerly 76N-052N) and Comment No. M7 in Docket No. 1981N-0022 (formerly 81N-0022).

Reference 7 - Office of Management and Budget, "Guidelines to Standardized Measures of Costs and Benefits and the Format of Accounting Statements," M0008, March 22, 2000, downloaded from http://www.whitehouse.gov/omb/memoranda/index.html, accessed June 13, 2001.

Reference 8 - Jarvis, Lisa, "PPA Ban Is a Serious Threat to OTC Diet Aids," Chemical Market Reporter, November 20, 2000. Published Material

Reference 9 - U.S. Security and Exchange Commission, Form 10-K, Voluntary Market Withdrawals, fiscal year ended December 31, 2000, American Home Products Corp., in Docket Nos. 1976N-0052N (formerly Docket No. 1976N-052N) and 1981N-0022.

Reference 10 - F-D-C Reports- "The Tan Sheet," "Dexatrim Natural Fattens Chattem's First Quarter; Extensions Planned," vol. 9, no. 14, April 2, 2001. Published Material

Reference 11 - F-D-C Reports- "The Tan Sheet," "AHP Dimetapp, Robitussin PPA Withdrawals Lead To $80 Mil. Charge In 2000," vol. 9, no. 5, January 29, 2001. Published Material

Reference 12 - Taylor, Thomas N., "The Medical Economics of Stroke," Drugs, supp. 3: 51-58, 1997. Published Material

Reference 13 - U.S. Census Bureau, No. 768, Consumer Price Index by Major Group., downloaded from http://www.census.gov/statab/freq/00s0768.txt, accessed June 12, 2001. U.S. Bureau of Labor Statistics, accessed July 23, 2004. Updated 1999 data to 2003 (18.56 percent increase in medical care CPI).

Reference 14 - Kernan, Walter N. et al., "Phenylpropanolamine and the Risk of Hemorrhagic Stroke," The New England Journal of Medicine, 43: 1826-1832, 2000. Published Material

Reference 15 - Fisher, A., L., G. Chestnut, and D. M. Violette, "The Value of Reducing Tisks of Death: a Note on New Evidence," Journal of Policy Analysis and Management, 8: 88-100, 1989. Published Material