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2004Q-0083
PDN 1
Volume 9

Petition Denial

Table of Contents

Tab 1 - Agency for Healthcare Research and Quality, Systems to Rate the Scientific Evidence. http://www.ahrq.gov/clinic/epcsums/strengthsum.htm#Contents

Tab 2 - American Cancer Society, Cancer Facts and Figures, 2004. Published Material

Tab 3 - Cade, J., Thompson, R., Burley, V., and Warm D. Development, Validation and Utilization of Food-Frequency Questionnaires-A Review, Public Health Nutrition, 5: page 573, 2002. See, also, Subar, A., et al., Comparative validation of the Block, Willett, and National Cancer Institute Food Frequency Questionnaires, American Journal of Epidemiology, 154: 1089-1099, 2001. Published Material

Tab 4 - Chengyu H., Xiuquan Z., Zhongkai Q., Li G., Shusheng P., Jiangrong L., Ruming X., Li Z. “A case-control study of dietary factors in patients with lung cancer.” Biomedical and Environmental Sciences, 5: 257-265, 1992. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 5 - Federal Judicial Center. Reference Manual on Scientific Evidence, Second Edition, p. 93, 2000. Published Material

Tab 6 - Federal Register, volume 65, no. 175, "Food Labeling: Health Claims; Plant Sterol/Stanol Esters and Coronary Heart Disease," page 54711, 2000.

Tab 7 - Galanis DJ., Kolonel LN., Lee J., Nomura A. "Intakes of selected foods and beverages and the incidence of gastric cancer among the Japanese residents of Hawaii: a prospective study." International Journal of Epidemiology, 27: 173-180, 1998. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 8 - Gao YT., McLaughlin JK., Blot WJ., Ji BU., Dai Q., Fraumeni JF. "Reduced risk of esophageal cancer associated with green tea consumption." Journal af the National Cancer Institute, 86: 855-858,1994. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 9 - Goto R., Masuoka H., Yoshida K., Mori M,, Miyake H. "A case control study of the pancreas.” Gan No Rinsho, 344-350, 1990. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 10 - Graham HN. "Green tea composition, consumption, and polyphenol chemistry." Preventive Medicine; 21: 334-350, 1992. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 11 - Greenwald P., Kramer B., Weed D. Cancer Prevention and Control, Chapter 6, page 83. Marcel Dekker Publishing, 1995. Published Material

Tab 12 - Hakim, LA., Harris,: R.B., Weisgerher, U.M. "Tea intake and squamous cell carcinoma of the skin: influence of type of tea beverages." Cancer Epidemiology, Biomarkers, and Prevention, 9: 727-731, 2000. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 13 - Hill A.B. "The environment and disease: association or causation?" Proc R Soc Med, 58: 295-300, 1965. Published Material

Tab 14 - Hill MJ, Morson BC, Bussey HJ. "Aetiology of adenoma-caminoma sequence in large bowel." Lancet, 1: 245-247, 1978. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 15 - Hohenberger P., Gretschel S, "Gastric Cancer." The Lancet, 362: 305-315, 2003. Published Material

Tab 16 - Hoshiyama Y., Sasaba T. "A case-control study of stomach cancer and its relation to diet, cigarettes, and alcohol consumption in Saitama Prefecture, Japan." Cancer Causes and Control, 3: 441-448, 1992. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 17 - Hoshiyama Y., Kawaguchi T:, Miura Y,, Mizoue T., Tokui N., Yatsuya H., Sakata K., Kondo T., Kikuchi S., Toyoshima H., Hayakawa N., Tamakoshi A., Ohno Y., Yoshimura T. "A prospective study of stomach cancer death in relation to green tea consumption in Japan." British Journal of Cancer, 87: 309-312, 2002. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 18 - Hoshiyama Y., Kawaguchi T., Miura Y., Mizoue T., Tokui N., Yatsuya H., Sakata K., Kondo T., Kikuchi S., Toyoshima H., Hayakawa N., Tamakoshi A, Ohno Y., Yoshimura T. Japan Collaborative Cohort Study Group. "A nested case-control study of stomach cancer in relation to green tea consumption in Japan." British Journal of Cancer, 90: 135-138, 2004. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 19 - Imai K., Litt D., Suga K., Nakachi K. "Cancer preventive effect of drinking green tea among a Japanese population." Preventive Medicine, 26: 769-775, 1997. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 20 - Inoue M., Tajima K,, Hirose K., Kuroishi T., Gao C., Kitoh T. "Life-style and subsite of gastric cancer -joint effect of smoking and drinking habits." International Journal of Cancer, 56: 494-499, 1994, (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 21 - Inoue M., Tajima K,, Mizutani M,, Iwata H., Iwase T., Miura S., Hirose K., Hamajima N., Tominaga S. "Regular consumption of green tea and the risk of breast cancer recurrence: follow-up study from the hospital based epidemiologic research program at Aichi Cancer Center, Japan." Cancer Letters, 167: 175-182, 2001. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 22 - Inoue M., Tajima K., Hirose N., Hamajima N., Takezaki T., Kuroishi T., Tominaga S, "Tea and coffee consumption and the risk of digestive tract cancers: data from a comparative case-referent study in Japan." Cancer Causes and Control, 9: 209-216, 1998. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 23 - Institute of Medicine, National Academy of Sciences. Dietary Reference Intakes for Vitamin A, Vitamin: K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Chapter 5, page 313, Vitamin K and Chapter 9, pages 174-175, Iron, National Academy Press, Washington, D.C. 2001. Published Material

Tab 24 - Institute of Medicine, National Academy of Sciences, Dietary Supplements: A Framework for Evaluating Safety, Chapter 7, Categories of Scientific Evidence - In Vitro Data. National Academy Press. Washington, D.C. 2005. Published Material

Tab 25 - Jian L., Xie LP., Lee AH., Binns CW. "Protective effect of green tea against prostate cancer: a case-control study in southeast China." International Journal of Cancer, 108: 130-135, 2004. Published Material

Tab 26 - Ji, B., Chow, W., Yang, G., McLaughlin, J.K., Gao, R,, Zheng, W., Shu, X., Jin, F., Fraumeni, J.F., Gao, Y. “The influence of cigarette smoking, alto 1, and green tea consumption on the ;risk of carcinoma of the cardia and distal stomach in Shanghai, China.” Cancer, 77: 2449-2457, 1996. (See Dodket Number 2004Q-0083; SUP 1) - Not included with volume

Tab 27 - Ji B., Chow W., Hsing AW., McLaughlin JK., Dai Q., Gao Y., Blot WJ., Fraumeni JF. “Green tea consumption and the risk of pancreatic and colorectal cancers.” International Journal of Cancer, 70: 255-258, 1997. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 28 - Kato I., Tominaga S., Matsuura A., Yoshii Y., Shirai M., Kobayashi S, "A comparative case control study of colorectal cancer and adenoma." Japanese~Journal of Cancer Research, 81: 1101-1108, 1990. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 29 - Key TJ., Schatzkin A., Willet WC., Allen NE., Spencer EA., Travis KC. "Diet, nutrition and the prevention of cancer.” Public Health Nutrition, 7: 187-200, 2004. Published Material

Tab 30 - Koizumi Y., Tsubono Y., Nakaya N., Nishino Y., Shibuya D., Matsuoka H., Tsuji I. "No association between green tea and the risk of gastric cancer: pooled analysis of two prospective studies in Japan." Cancer, Epidemiology, Biomarkers, and Prevention, 12: 472-473, 2003. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 31 - Kono S., lkeda M., Tokudome S., Kuratsune M. "A case-control study of gastric cancer and diet in northern Kyushu, Japan." Japanese Journal of Cancer Research, 79: 1067-1074, 1988. (See Docket Number 20044-0083; QHC 1) - Not included with volume

Tab 32 - Kono S., Shininchi K,, lkeda N., Yanai F,, Imanishi K. "Physical activity, dietary habits and adenomatous polyps of the sigmoid colon: a study of self-defense officials in Japan." Journal of Clinical Epidemiology, 44: 1255-1261, 1991. (SeeDocket-Number 2004Q-0083; QHC 1) - Not included with volume

Tab 33 - Kumra V., Markoff BA. "Who’s smoking now? The epidemiology of tobacco use in the United States and abroad." Clinical Chest Medicine, 21: 1-9, 2000. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 34 - Lee H., Wu H., Chuang, Y., Chang A., Chao H., Chen K., Chen H,, Lai G., Huang H., Chen C. "Epidemiologic characteristics and multiple risk factors of stomach cancer in Taiwan." Anticancer Research, 10: 875-882, 1990. (See Docket Number 2004P-0083; QHC 1) - Not included with volume

Tab 35 - Le Marchand L., Murphy SP., Hankin JH., Wilkens LR., Kolonel LN. "Intake of flavonoids and lung/cancer.” Journal of the National Cancer Institute, 92: 154-160, 2000. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 36 - Miller AB., Howe GR., Jain M., Craib KJP, Harrison L. "Food items and good groups as risk factors in a case control study of diet and cola-rectal cancer." International Journal of Cancer, 32: 155-161, 1983. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 37 - Mizuno S., Watanabe S., Nakamura K., Gmata M., Oguchi H., Obashi K., Ohyanagi H., Fujiki T., Motojimi K. "A multi-institute case control study on the risk factors of developing pancreatic cancer." Japanese Journal of Clinical Oncology, 22: 286-291, 1992. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 38 - Montesano R., Hall J. "Environmental causes of human cancers." European Journal of Cancer, 37: S67-S87, 2001. (See Docket Number 2004Q-0083.; QHC 1) - Not included with volume

Tab 39 - Mu LN., Zhou XF., Ding BG., Wang RH., Zhang ZF,, Chen CW., Wei GR., Zhou XM., Jian QW., Yu SZ. "A case-control: study on drinking green tea and decreasing risk of cancers in the alimentary canal among cigarette smokers and alcohol drinkers."” Chinese Journal of Epidemiology, 24: 192-195, 2003. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 40 - Nakachi K,, Suemasu K., Suga K., Takeo T., Imai K., Higashi Y. "Influence of drinking green tea on breast cancer malignancy among Japanese patients." Japanese Journal of Cancer Research, 89: 254-261, 1998. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 41 - Nagano J., Kono S., Preston DL., Mabuchi K. "A prospective study .of green tea consumption and cancer incidence, Hiroshima and Nagsaki Japan." Cancer Causes and Control, 12: 501-508, 2001, (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 42 - NCI, DCPC Chemoprevention Branch and Agent Development Committee. "Clinical development plan: tea extracts, green tea polyphenols, epigallocatechin gallate." Journal of Cellular Biochemistry; 265: 236-257, 1996. (See Docket Number.2004Q-0083; QHC 1) - Not included with volume

Tab 43 - National Cancer Institute, Gastric Cancer (PDQB): Prevention; Health Professional Version.
http://www.nci.nih.gov/cancertopics/pdq/prevention/gastric/HealthProfessional/page1

Tab 44 - Schatzkin A., Freedman LS., Dawsey SM., Lanza E. "Interpreting precursor studies: what polyp tials tell us about large bowl cancer.” Journal of the National Cancer Institute, 86: 1053-1057, 1994. Published Material

Tab 45 - Setiawan VW., Zhang ZF., Yu GP,, Lu QY., Li YL., Lu ML., Wang MR., Guo CH., Yu SZ., Kurtz RC., Hsieh CC. "Protective effect of green tea on the risks of chronic gastritis and stomach cancer." International Journal of Cancer, 92: 600-604, 2001. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 46 - Sonada T., Nagata Y., Mori M., Miyanaga N., Takashima N., Okumura K., Goto K., Naito S., Fujimoto K., Hirao Y., Takahashi A., Tsukamoto T., Fujioka T., and Akaza H. "A case control study of diet and prostate cancer in Japan: possible protective effect of traditional Japanese diet." Cancer Science, 95: 238-242, 2004. Published Material

Tab 47 - Spilker, B. Guide to Clinical Studies. Raven Press, New York, New York, 1991. Published Material

Tab 48 - Subar, AF., Thompson, FE., Kipnis, V., Midthune D., Hurwitz, P., McNutt, S., McIntosh, A., and Rosenfeld, S. "Comparative validation of the block, Willett, and National Cancer Institute food frequency questionnaires." American Journal of Epidemiology, 154: 1089-1099, 2001. Published Material

Tab 49 - Suzuki Y., Tsubono Y., Nakaya N., Koizumi Y., and Tsuji I. "Green tea and the risk of breast cancer: pooled analysis of two prospective studies in Japan." British Journal of Cancer, 90: 1361-1363, 2004. Published Material

Tab 50 - Szklo M. and Nieto F.J., Epidemiology Beyond the Basics, Aspen Publishing, 2000. Published Material

Tab 51 - Tajima K., Tominaga S. "Dietary habits and gastro-intestinal cancers: a comparative case-control study of stomach and large intestinal cancers in Nagoya, Japan." Japanese Journal of Cancer Research, 76: 705-716, 1985. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 52 - Tewes FJ., Koo LC., Meisgen TJ., Rylander R. "Lung cancer riskand mutagenicity of tea." Environmental Research, 52: 23-33, 1990. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 53 - Tsubono Y., Nishino Y., Komatsu S., Hsieh C., Kanemura S., Tsuji I., Nakatsuka H., Fukao A., Satoh H., Hisamichi S. 1’Green tea and the risk of gastric cancer.” New England Journal of Medicine, 344: 632-636, 2001. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 54 - U.S. Department of Agriculture, Agricultural Research Service. 2004. USDA Nutrient Database for Standard Reference, Release 17. Nutrient Data Laboratory Home Page. http://www.nal.usda.gov/fnic/foodcomp

Tab 55 - Wakai K., Ohno Y., Obata K., Aoki K. "Prognostic significant of Selected lifestyle factors in urinary bladder cancer." Japanese Journal of Cancer Research, 84: 1223-1229, 1993. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 56 - Wang M., Guo C., Li M. "A case control study an the dietary risk factors of upper digestive tract cancer." Chinese Journal of Epidemiology, 20: 95-97, 1999. (See Docket Number 2004Q-0089; QHC 1) - Not included with volume

Tab 57 - Watanabe Y., Tada M., Kawamoto K., Uozumi G., Kajiware Y., Hayashi K., Yamaguchi K., Murakami K., Misaki F., Akasaka Y. "A case control study of cancer of the rectum and colon." Nippon Shokakibyo Gakkai Zasshi, 81: 185-193, 1984. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 58 - Wilson, E.B., An Introduction to Scientific Research, pages 46-48, Dover Publishing, 1990. Published Material

Tab 59 - Wu AH., Yu MC., Tseng C., Hankin J., Pike M. "Green tea and risk of breast cancer in Asian Americans." International Journal of Cancer, 106: 574-579, 2003. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 60 - Ye WM., Yi YN., Luo RX., Zhou TS., Lin RT., Chen GD. "Diet and gastric cancer: a case control study in Fujian Province, China." World Journal of Gastroenterology, 4: 516-518, 1998. (See Docket Number 2004Q-0083; QMC 1) - Not included with volume

Tab 61 - Yu G., Hsieh C., Wang L,, Yu S., Li X., Jin T. “Green-tea.eonsumption and risk of stomach cancer: a population based case control study in Shanghai, China.” Cancer Causes and Control, 6: 5632-538; 1995. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 62 - Zhang H., Cai B. "The impact of tobacco on lung health in China." Respirology, 8: 17-21, 2003. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 63 - Zhang M., Binns CW., Lee AH. "Tea consumption and ovarian cancer risk: a case-control study in China." Cancer, Epidemiology, Biomarkers, and Prevention, 11: 713-718, 2002. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 64 - Zhong L., Goldberg MS., Gao Y., Hanley JA., Perent M., Jin F. "A population-based case control study of lung cancer and green tea consumption among women living in Shanghai, China." Epidemiology, 12: 695-700, 2001. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume

Tab 65 - Zhou BF., Stamler J., Dennis B., Moag-Stahlberg.A., Ukuda N., Robertson C., Zhao L., Chan Q., Elliot P. "Nutrient intakes of middle-aged men and women in China, Japan, United Kingdom, and United States in the late 1990s: The INTERMAP study." Journal of Human Hypertension, 17: 623-630, 2003. (See Docket Number 2004Q-0083; QHC 1) - Not included with volume


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