DOCKETS ENTERED on June 7, 2001

TABLE OF CONTENTS

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90S-0308 Generic Drug Speeches & Policy and Procedure Guides

M 712 HFD-600 Vol#: 51

M 713 HFD-600 Vol#: 51

M 714 HFD-600 Vol#: 51

97P-0441 Regulatory Status of Cholestin red yeast rice

EMC 2 Jessie A. Graham Vol#: 15

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 7391 Horizon Nutraceuticals Vol#: 56

LET 7392 Source Naturals Inc Vol#: 56

LET 7393 Source Naturals Inc Vol#: 56

LET 7394 Source Naturals Inc Vol#: 56

LET 7395 Source Naturals Inc Vol#: 56

LET 7396 Source Naturals Inc Vol#: 56

LET 7397 Source Naturals Inc Vol#: 56

LET 7398 Source Naturals Inc Vol#: 56

LET 7399 Twin Laboratories Inc Vol#: 56

LET 7400 Omega NutriPharm Inc Vol#: 56

LET 7401 Young Life Research Clinic Vol#: 56

LET 7402 Young Life Research Clinic Vol#: 57

LET 7403 Country LIfe Vol#: 56

LET 7404 NBTY Inc Vol#: 56

LET 7405 NBTY Inc Vol#: 56

LET 7406 NBTY Inc Vol#: 56

LET 7407 NBTY Inc Vol#: 56

LET 7408 NBTY Inc Vol#: 56

LET 7409 NBTY Inc Vol#: 56

LET 7410 NBTY Inc Vol#: 56

LET 7411 NBTY Inc Vol#: 56

LET 7412 NBTY Inc Vol#: 56

LET 7413 NBTY Inc Vol#: 56

LET 7414 Rand Marketing Vol#: 56

LET 7415 NOW Foods Vol#: 56

LET 7416 NOW Foods Vol#: 56

LET 7417 Natural Organics Inc Vol#: 56

LET 7418 Natural Organics Inc Vol#: 56

LET 7419 Natural Organics Inc Vol#: 56

LET 7420 Melaleuca Inc Vol#: 56

LET 7421 Melaleuca Inc Vol#: 56

LET 7422 Melaleuca Inc Vol#: 56

LET 7423 Melaleuca Inc Vol#: 56

LET 7424 Melaleuca Inc Vol#: 56

LET 7425 Melaleuca Inc Vol#: 56

LET 7426 Melaleuca Inc Vol#: 56

LET 7427 Melaleuca Inc Vol#: 56

LET 7428 Nutramax Laboratories Inc Vol#: 56

LET 7429 Arbonne International Vol#: 56

LET 7430 Solgar Vitamin and Herb Vol#: 56

LET 7431 Solgar Vitamin and Herb Vol#: 56

LET 7432 Solgar Vitamin and Herb Vol#: 56

LET 7433 Solgar Vitamin and Herb Vol#: 56

LET 7434 Solgar Vitamin and Herb Vol#: 56

LET 7435 Solgar Vitamin and Herb Vol#: 56

LET 7436 Solgar Vitamin and Herb Vol#: 56

LET 7437 Country Life Vol#: 56

LET 7438 NBTY Inc Vol#: 56

LET 7439 NBTY Inc Vol#: 56

LET 7440 NBTY Inc Vol#: 56

LET 7441 NBTY Inc Vol#: 56

LET 7442 NBTY Inc Vol#: 56

LET 7443 NBTY Inc Vol#: 56

LET 7444 NBTY Inc Vol#: 56

LET 7445 NBTY Inc Vol#: 56

LET 7446 NBTY Inc Vol#: 56

LET 7447 NBTY Inc Vol#: 56

LET 7448 Sato Pharmaceutical Co Ltd Vol#: 56

LET 7449 Country Life Vol#: 56

LET 7450 Country Life Vol#: 56

LET 7451 AIM International Inc Vol#: 56

LET 7452 AIM International Inc Vol#: 56

LET 7453 AIM International Inc Vol#: 56

LET 7454 Jarrow Formulas Inc Vol#: 56

LET 7455 Alva-Amco Pharmacal Companies Inc Vol#: 56

LET 7456 Alva-Amco Pharmacal Companies Inc Vol#: 56

LET 7457 Alva-Amco Pharmacal Companies Inc Vol#: 56

LET 7458 Alva-Amco Pharmacal Companies Inc Vol#: 56

LET 7459 Sato Pharmaceutical Co LTD Vol#: 56

LET 7460 Basic Research LLC dba Silver Sage Vol#: 56

LET 7461 Basic Research LLC dba Silver Sage Vol#: 56

LET 7462 Basic Research LLC dba Silver Sage Vol#: 56

LET 7463 Basic Research LLC dba Silver Sage Vol#: 56

LET 7464 Basic Research LLC dba Silver Sage Vol#: 56

LET 7465 Basic Research LLC dba Silver Sage Vol#: 56

LET 7466 Feida Union Pharmaceutical Manufactory Vol#: 56

LET 7467 Feida Union Pharmaceutical Manufactory Vol#: 56

LET 7468 Traditional Medicinals Inc Vol#: 56

LET 7469 Nutritional Specialties Inc Vol#: 56

LET 7470 Nutritional Specialties Inc Vol#: 56

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 4858 S.T.O.P., Safe Tables Our Priority Vol#: 154

C 4859 Teresa A. Doyle Vol#: 154

C 4860 Ms. Jami Tolpin Vol#: 154

C 4861 Dawn Anderson Vol#: 154

C 4862 Karen Kindel Vol#: 154

C 4863 John & Nancy Arnold Vol#: 154

C 4864 Ron & Shirley Usher Vol#: 154

C 4865 Leah Levine Vol#: 154

C 4866 Jody B. Caldwell Vol#: 154

C 4867 Victoria Principal Productions Vol#: 154

C 4868 Kathy Badenhop Vol#: 154

C 4869 Gina Petruziello Vol#: 154

C 4870 Amy L. Klingemann Vol#: 154

C 4871 Sue R. Watson Vol#: 154

C 4872 Patti Breitman Vol#: 154

C 4873 Englewood Animal Rescue Sanctuary Vol#: 154

C 4874 Mrs. Gordon A. Scott Vol#: 154

C 4875 J. Richman Vol#: 154

C 4876 Nicole Montalbano Vol#: 154

C 4877 Mrs. Lisa Koester Vol#: 154

C 4878 Donna Piercy Vol#: 154

C 4879 Ms. Janet L. Morris Vol#: 154

C 4880 April Townsend Vol#: 154

C 4881 Maura McCormick Vol#: 154

C 4882 Karen Ball Vol#: 154

EMC 2034 Candice Zawoiski Vol#: 154

EMC 2035 Victoria Michalski Vol#: 154

EMC 2036 Dr. Lori Ugolik Vol#: 154

EMC 2037 Caroline Harzewski Vol#: 154

EMC 2038 Cheri Vallone Vol#: 154

EMC 2039 Roberta S. Wright Vol#: 154

EMC 2040 Kristy Arganbright Vol#: 154

EMC 2041 Susan Rhodes Vol#: 154

EMC 2042 Glenn Cronick Vol#: 154

EMC 2043 Laura Winkle Vol#: 154

EMC 2044 Marlo Mytty Vol#: 154

EMC 2045 Marcia Kay Foster Vol#: 154

EMC 2046 Pamela Gillett Vol#: 154

EMC 2047 Nelda Laws Vol#: 154

EMC 2048 Lisa Gallyer Vol#: 154

EMC 2049 Crown Hill Technologies Vol#: 154

EMC 2050 Marilyn Jasper Vol#: 154

EMC 2051 Aimes K. Leonard Vol#: 154

EMC 2052 Robin Fahey Cameron Vol#: 154

EMC 2053 Bernadette McCrea Vol#: 154

EMC 2054 Ward Vol#: 154

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

EMC 3 Public Citizen Vol#: 1

99N-1075 Vibrio Parahaemolyticus in molluscan shellfish public health

C 9 MAF, Ministry of Arg & Forestry to Manat Vol#: 1

99P-5106 Identify Sources of Natural Flavorings

EMC 77 Linda Kasunick Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 3601 Jennifer J. Walker Vol#: 295

C 3602 Deb Hanson Vol#: 295

C 3603 Elizabeth Rosenberg Vol#: 295

C 3604 Rebecca Henderson Vol#: 295

C 3605 Colette Corwin Vol#: 295

C 3606 Bastrop County Citizens Vol#: 295

C 3607 Grace McMenamy Vol#: 295

C 3608 Joe & Barbara Graham Vol#: 295

C 3609 Sandra Lance Vol#: 295

C 3610 Connie Urciuoli Vol#: 295

C 3611 Elizabeth Essley Vol#: 295

C 3612 Sister Mary Martha Pitschmann Vol#: 295

C 3613 Mr & Mrs Bernard V Gottlieb Vol#: 295

C 3614 illegible Vol#: 295

C 3615 Susan Jane Hall Vol#: 295

C 3616 Leah R. Amrit Vol#: 295

C 3617 Linda McLain Vol#: 295

C 3618 Armen Donelian Vol#: 295

C 3619 Mr. & Mrs. R. Van Dell Vol#: 295

C 3620 Joshua Forman Vol#: 295

C 3621 Laura Hostetler Vol#: 295

C 3622 Leona Bergman Vol#: 295

C 3623 Karl J Novak Vol#: 295

C 3624 Beth Magura Vol#: 295

C 3625 M. F. Sokolowski Vol#: 295

C 3626 Nancy McGuire Vol#: 295

C 3627 illegible Vol#: 295

C 3628 Jillene Moore Vol#: 295

C 3629 Caroline Collier Vol#: 295

C 3630 Kate Dunsmore Vol#: 295

C 3631 Barbara Graham Vol#: 295

C 3632 Ron Flax Vol#: 295

C 3633 Shawn Ellison Vol#: 295

C 3634 Beat Schillinger Vol#: 295

C 3635 Diane Burns Vol#: 295

C 3636 John A Stevenson Vol#: 295

C 3637 S & D Iglehart Vol#: 295

C 3638 illegible Vol#: 295

C 3639 J. Wimberly Vol#: 295

C 3640 illegible Vol#: 295

C 3641 Elizabeth A Hober Vol#: 295

C 3642 Sandy Anderson Vol#: 295

C 3643 Betsy Kohnstamm Vol#: 295

C 3644 illegible Vol#: 295

C 3645 Jon de Neeve Vol#: 295

C 3646 Ross Anderson Vol#: 295

C 3647 Jessica L Markowitz-Freyer Vol#: 295

C 3648 Paul Falcon Vol#: 295

C 3649 Barbara Swain Vol#: 295

C 3650 John P. Wright Vol#: 295

00D-1681 Potassium Iodide as a Thyroid Blocking Agent

EMC 7 Angie Klein Vol#: 1

00N-1269 Labeling for human prescription drug/Biologic Products

C 38 American Society for Clinical Pharmacolo Vol#: 4

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 2152 S. Petrina Vol#: 204

C 2153 R. Johnson Vol#: 204

C 2154 Brian Adams Vol#: 204

C 2155 Diane Dowling Vol#: 204

C 2156 Herschel Elliott Vol#: 204

C 2157 Paul Rochford Vol#: 204

C 2158 William F. Johnson Vol#: 204

C 2159 Mary Cahill, RN Vol#: 204

C 2160 Linda Shapiro Vol#: 204

C 2161 Dorothy M. Bauer Vol#: 204

C 2162 Ric Alexander Vol#: 204

C 2163 Dan Monasevitch Vol#: 204

C 2164 Nina Morris Vol#: 204

C 2165 Gail C. Criminger Vol#: 204

C 2166 Joyce & Don Paulson Vol#: 204

C 2167 Mildred Illmensee Vol#: 204

C 2168 Andrea B. Guenstin Vol#: 204

C 2169 Kim Morris Vol#: 204

C 2170 James B. Tomkinson Vol#: 204

C 2171 Adreana E. Ioteur Vol#: 204

C 2172 Jody Sloan Vol#: 204

C 2173 Sonia Mumay Vol#: 204

C 2174 Brent Labenberg Vol#: 204

C 2175 Rabbi Norman Hirsh Vol#: 204

C 2176 Ursula Bamberger Vol#: 204

C 2177 Richard Tregidgo Vol#: 204

C 2178 Jim Nedtwig & Beth Henning Vol#: 204

C 2179 Mary Schmitt-Hemesath Vol#: 204

C 2180 Andrew Lopez Vol#: 204

C 2181 Dana Rudikoff Vol#: 204

C 2182 Marc Tyler Vol#: 204

C 2183 Jane & Paula Rendelson Vol#: 204

C 2184 Debra Holzman Vol#: 204

C 2185 Glen Creel Vol#: 204

C 2186 Pamela Cubbage Vol#: 204

C 2187 Claire Fiorentino Vol#: 204

C 2188 Roger & Chaisia Hawkins Vol#: 204

C 2189 Julia Rush Vol#: 204

C 2190 David C. Ganchmo Vol#: 204

C 2191 Suzanne Clark Vol#: 204

C 2192 Phyllis Adams Vol#: 204

C 2193 Steve Holtzman Vol#: 204

C 2194 E. LeFort Vol#: 204

C 2195 James Spivak Vol#: 204

C 2196 Marian Terwilliger Vol#: 204

C 2197 Dale J. Galloway Vol#: 204

C 2198 C Benke Vol#: 204

C 2199 Alvis & Lynda Skerbergs Vol#: 204

C 2200 Dee Alsberg Vol#: 204

C 2201 Carol L. Douglas Vol#: 204

C 2202 Theresa Connolly Vol#: 204

C 2203 Gerri Glass Vol#: 204

C 2204 Jana Glass Vol#: 204

C 2205 Lauretta Parrish Vol#: 204

C 2206 Joan Spoerl Vol#: 204

C 2207 Tony Moore, D.D.S. Vol#: 204

C 2208 Catherine Stock Vol#: 204

C 2209 Dr. Subina Krumpe Vol#: 204

C 2210 S. Longe Vol#: 204

C 2211 Ruth McIntosh Vol#: 204

C 2212 Kristine Gilbert Vol#: 204

C 2213 Ms. Grace Fowler Vol#: 204

C 2214 Unreadable Vol#: 204

C 2215 L M Pina Vol#: 204

C 2216 Craig Klungness Vol#: 204

C 2217 Illegible Vol#: 204

C 2218 Dan Lambert Vol#: 204

C 2219 S. Hubbard Vol#: 204

C 2220 Keren Duran Vol#: 204

C 2221 unreadable Vol#: 204

C 2222 Wendy R. Parks Vol#: 204

C 2223 Bryan Vol#: 204

C 2224 Helena Jennings Olson Vol#: 204

C 2225 Dorothea Jump Vol#: 204

C 2226 Roberta C.R. Greenblatt Vol#: 204

C 2227 Anne Sheble Vol#: 204

C 2228 David J. Shufelt Vol#: 204

C 2229 Margaret & Anthony Orefice Vol#: 204

C 2230 Nancy Young Vol#: 204

C 2231 Brennan Michaels Vol#: 204

C 2232 Aleta Weaver Vol#: 204

C 2233 James Eustace Vol#: 204

C 2234 Miriam Shakow Vol#: 204

C 2235 Ms. Amy Kemp Vol#: 204

C 2236 Virginia Ware Vol#: 204

C 2237 Sandy Couto Vol#: 204

C 2238 Madeliene J. Walt Vol#: 204

C 2239 unreadable Vol#: 204

C 2240 Yayoi K. Stanford Vol#: 204

C 2241 E. C. English Vol#: 204

C 2242 Christine Krippene Vol#: 204

C 2243 Steven Leiben Vol#: 204

C 2244 Jennifer Lesko & Shinsan Griswold Vol#: 204

C 2245 Akire Bubar Vol#: 204

C 2246 Douglas S. Baier Vol#: 204

C 2247 Len E. Campbell Vol#: 204

C 2248 Marcia Bailey Vol#: 204

C 2249 Maine Organic Farmers & Gardeners Assn. Vol#: 204

C 2250 unreadable Vol#: 204

C 2251 unreadable Vol#: 204

C 2252 George Martin Vol#: 204

C 2253 Nancy Starr Vol#: 204

C 2254 Jo Clawson Vol#: 204

C 2255 Fran Barnett Vol#: 204

C 2256 Cynthia Anderson Vol#: 204

C 2257 Mark Allen Jr. Vol#: 204

C 2258 Michelle Goodwin Vol#: 204

C 2259 Lucy Hartlove Vol#: 204

C 2260 George Kallman Vol#: 204

C 2261 Kelly L. Mitchell Vol#: 204

C 2262 Ira Hankin Vol#: 204

C 2263 Aubrey K. Nicoll Vol#: 204

C 2264 Robert S. Nocoll Vol#: 204

C 2265 Kimberly Odell Vol#: 204

C 2266 Anthony R. Bandy-Zalatoris Vol#: 204

C 2267 William H. Friedland Vol#: 204

C 2268 Ursula Zepralka Vol#: 204

C 2269 Jennifer L. Morrow, Ph.D. Vol#: 204

C 2270 Jean Bernard Vol#: 204

C 2271 George Black Vol#: 204

C 2272 James A. van Zee, Ph.D. Vol#: 204

C 2273 Charles Vance Vol#: 204

C 2274 Leah Loveday Vol#: 204

C 2275 Rosemary Schmitz Vol#: 204

C 2276 Joan Kulash Vol#: 204

C 2277 J. Mason Vol#: 204

C 2278 Donna Myhre Vol#: 204

C 2279 Cheryl Sturgis Vol#: 204

C 2280 Meghan Darakjy Vol#: 204

C 2281 Tamra Stallings Vol#: 204

C 2282 Donna Hetrick & Family Vol#: 204

C 2283 Pam Davis Vol#: 204

C 2284 Ellen Spring Vol#: 204

C 2285 Charlotte Cimino Vol#: 204

C 2286 Carol King Vol#: 204

C 2287 Dr. D. Cassat Vol#: 104

C 2288 Elizabeth Hargrave Vol#: 204

C 2289 Annamarie Smith Vol#: 204

C 2290 L. Patton Vol#: 204

C 2291 Maddi Alana Vol#: 204

C 2292 Sheila Maybanks Vol#: 204

C 2293 unreadable Vol#: 204

C 2294 Tracey Hamilton Vol#: 204

C 2295 Mike May Vol#: 204

C 2296 Renee Weller Vol#: 204

C 2297 B. Tokas Vol#: 204

C 2298 unreadable Vol#: 204

C 2299 Patrick Chee Vol#: 204

C 2300 G. Harbin Vol#: 204

C 2301 Brett Daran Vol#: 204

C 2302 Mike Cohen Vol#: 204

C 2303 C. Gagleaidorri Vol#: 204

C 2304 Karen Hudson Vol#: 204

C 2305 Ms. Elaine Sperbeck Vol#: 204

C 2306 Ursula Light Vol#: 204

C 2307 Sonya Stanchfield Vol#: 204

C 2308 D. Dobos Vol#: 204

C 2309 Greta Perry Vol#: 204

C 2310 J. Newman Vol#: 204

C 2311 Jacque Blix Vol#: 204

C 2312 C. Henley Vol#: 204

C 2313 Tom Gilbert Vol#: 204

C 2314 Callie Smerk Vol#: 204

C 2315 Rene Rinewalt Vol#: 204

C 2316 David Perle Vol#: 204

C 2317 Dan Edwards Vol#: 204

C 2318 Maveret M. McClellan Vol#: 204

C 2319 A. Blicharski Vol#: 204

C 2320 Regina Helen Bily Vol#: 204

C 2321 Nancy Gillis Vol#: 204

C 2322 Suzanne Pope Vol#: 204

C 2323 Marisa Gonzillez Vol#: 204

C 2324 Denise Raven Vol#: 204

C 2325 G. Rhodes Vol#: 204

C 2326 Tamara Righettini Vol#: 204

C 2327 Patricia Pyeatt Vol#: 204

C 2328 K. L. Reese Vol#: 204

C 2329 Kurt Selch Vol#: 204

C 2330 Peter Cobbs Vol#: 204

C 2331 Christopher Albright Vol#: 204

C 2332 Dana Colestock Vol#: 204

C 2333 Louis Streek Vol#: 204

C 2334 Lauren D. Palcho Vol#: 204

C 2335 Michael Holland Vol#: 204

C 2336 Alan Granley Vol#: 204

C 2337 Ashley Schwartzman Vol#: 204

C 2338 Adam Acerra Vol#: 204

C 2339 Guy Fletcher Vol#: 204

C 2340 Darrell Towers Vol#: 204

EXT 1 American Crop Protection Assn et al Vol#: 204

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 110601 Mary A Sewell Vol#: 760

C 110602 Rosemary C Harrison Vol#: 760

C 110603 M Hughes Vol#: 760

C 110604 Deb Houser Vol#: 760

C 110605 L Martin Vol#:

C 110606 Jay & Dena Nigh Vol#: 760

C 110607 Miriam Rainville Vol#: 760

C 110608 Elloyac Jatho Vol#: 760

C 110609 S Laskowski Vol#: 760

C 110610 B Fischoff Vol#: 760

C 110611 T Bennington-Ryan Vol#: 760

C 110612 Rosemary Copp Vol#: 760

C 110613 Number not in use Vol#: 760

C 110614 Number not Used Vol#: 760

EMC 5011 Jeff Triplett Vol#: 760

EMC 5012 Gretchen Soltani Vol#: 760

EMC 5013 Kerstyn Stahre Vol#: 760

EMC 5014 Kyle Wiswall Vol#: 760

EMC 5015 Betsy Woods Vol#: 760

EMC 5016 Patricia Vinet Vol#: 760

00P-1340 Withdrawn of ROWASA Suppositories

LET 2 HFD-7 to Able Laboratories, Inc. Vol#: 1

00P-1603 Rescind Any Contraindications For Use of Misoprostol In Preg

C 5 Joanne McNally Vol#: 1

01D-0044 Clinical Laboratory Improvement Amendments of 1988

C 23 American Association of Bioanalysts Vol#: 2

C 24 Polymer Technology Systems Inc Vol#: 2

C 25 Qualigen Inc Vol#: 2

C 26 State of New York Dept of Health Vol#: 2

C 27 Medtox Laboratories Inc Vol#: 2

C 28 Quidel Corporation Vol#: 2

C 29 Diagnology Ltd Vol#: 2

C 30 Yale University Vol#: 2

01D-0086 Disclosing information; Open CBER Mtgs/Testing or Approvals

C 4 PhRMA Vol#: 1

01D-0146 Deficient Submissions filed/Investigation of New Animal Drug

C 1 Novartis Animal Health US, Inc. Vol#: 1

01M-0254 P980050/S001; Cardioverter Defibrillator System

AAV 1 Medtronic, Inc. Vol#: 1

01N-0069 Information From U.S. Processors That Export to European Cmt

N 2 Vol#: 1

01P-0034 Restaurant Foods Containing Methylcellulose or Carrageenin

EMC 1 Chanh Cong Huynh Vol#: 1

01V-0260 Laser Light Show LM 8XL Beam Projection System (150 nw Diooe

ACK 1 HFA-305 Vol#: 1

VAR 1 Fantasy Sounds Vol#: 1