From: Henryruhe@aol.com Sent: Monday, November 29, 2004 3:43 PM To: fdadockets@oc.fda.gov Cc: Henryruhe@aol.com Subject: Re: FDA Docket #2004P-0411/CP 1 Please file these supporting references and arguments as an addition to my earlier October 14, 2004 response to FDA Docket #2004P-0411/CP 1.Thankyou, Committee to Monitor Poppers 1651 Market Street #303 S.F. Ca. 94103 415-864-0738 henryruhe@aol.com November 16, 2004 Division of Dockets Management FDA 5630 Fishers Lane, Room 1061(HFA-305) Rockville, MD 20852-0003 Re: Citizens Petition to Compel Enforcement of Amyl Nitrite in re 21 CFR 250.100 FDA Docket #2004P-0411/CP 1 filed September 9 2004 Dr. Lester Crawford, FDA Commissioner: Enclosed are supporting research articles listed as references in my supporting declaration dated October 14, 2004. These articles are numbered to correspond with the reference listings. In addition, additional supporting research information is enclosed. Additional references: 98. Dax, Elizabeth et al., 1991. Amyl nitrite alters human in vitro immune function. Immunopharmacology and Immunology 13(4): 577-587. 99.Dax, Elizabeth et al., 1988. Effects of Nitrites on the Immune System of Humans. Health Hazards of Nitrite Inhalants,NIDA Research MONOGRAPH 83: 75-79. 100.Dax, Elizabeth et al., 1987. Amyl-nitrite inhalation althers immune function in normal volunteers. Abstract WP.119 at International AIDS Conference. 101.Colfax, Grant et al., 2004. Substance use during sex is associated with high-risk behavior: an episode-specific analysis, controlling for participant and sex partner characteristics. Abstract at the XV International AIDS Conference, Bangkok. 102. Soderberg, Lee et al., 1997. Acute blood toxicity of the inhaled inhalant, cyclohexyl nitrite. International Journal of Immunopharmacology 19(5): 305-310. 103. Moss, Andrew et al., 1987. Risk factors for AIDS and HIV seropositivity in homosexual men. American Journal of Epidemiology 125(6): 1035-1046. 104.Ostrow, David. 1996. Substance use, HIV, and gay men. FOCUS,Aguide to AIDS Research and Counseling. 11(7):1-3. 105. Soderberg Lee. NIDA research description 106. Soderberg,Lee. NIDA research funding abstract 107.Fung, Ho-Leung. NIDA research funding abstract Sincerely, Hank Wilson Committee to Monitor Poppers/SURVIVE AIDS fd