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DOCKETS ENTERED on November 8, 2000

TABLE OF CONTENTS

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76N-052N OTC Nasal Decongestants *
90N-0056 Parenteral Drug Prod. Containing Aluminum as an Ingredient *
95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98F-0165 safe use of ionizing radition for reduction of salmonella *
98N-1265 Distribution of Compounded Drug Products *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-0623 Revoke determination that TSRH Pedicle Spinal Screw System *
99P-5215 Provisions of Title 21 of the Code of Federal Regulations *
00D-1274 FDA Modernization Act of 1997: Section 216 *
00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz *
00P-0788 Totally Implanted Spinal Cord Stimulator *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
76N-052N OTC Nasal Decongestants

ANS 1 HF-26 to Stanford U School of Medicine Vol#: 76

C 236 Stanford U School of Medicine Vol#: 76

EMC 4 S Culberson Vol#: 73

EMC 5 M Rousselle Vol#: 73

EMC 6 V Lowry Vol#: 73

EMC 7 K Sheldon Vol#: 73

EMC 8 S Taylor Vol#: 73

EMC 9 R Bennett Vol#: 73

EMC 10 B Stiles Vol#: 73

EMC 11 K Stidham Vol#: 73

EMC 12 K Bradley Vol#: 73

EMC 13 R Messera Vol#: 73

EMC 14 R Unnerstall Vol#: 73

EMC 15 V Joslin Vol#: 73

EMC 16 S Richardson PhD Vol#: 73

81N-0022 OTC Weight Control Drug Products for Human Use

ANS 5 HF-26 to Stanford & School of Medicine Vol#: 95

C 118 Stanford & School of Medicine Vol#: 95

EMC 2 S Culberson Vol#: 95

EMC 3 M Rousselle Vol#: 95

EMC 4 V Lowry Vol#: 95

EMC 5 Rs Bennett Vol#: 95

EMC 6 M Montoya Vol#: 95

EMC 7 B Stiles Vol#: 95

EMC 8 R Unnerstall Vol#: 95

84V-0234 Laser light show

EXP 4 KR Entertainment Vol#: 1

90N-0056 Parenteral Drug Prod. Containing Aluminum as an Ingredient

MT 1 HFD-007 Vol#: 4

MT 2 HFD-007 Vol#: 4

95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

C 319 E Hottenstein Vol#: 5

REF 1 unsigned Vol#: 5

97N-0242 BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACT

BKG 1 BACKGROUND MATERIAL Vol#: 4

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

LET 5922 Rainbow Light Vol#: 47

LET 5923 Rainbow Light Vol#: 47

LET 5924 Rainbow Light Vol#: 47

LET 5925 Rainbow Light Vol#: 47

LET 5926 Rainbow Light Vol#: 47

LET 5927 Rainbow Light Vol#: 47

LET 5928 Rainbow Light Vol#: 47

LET 5929 Rainbow Light Vol#: 47

LET 5930 Rainbow Light Vol#: 47

LET 5931 Jarrow Formulas, Inc. Vol#: 47

LET 5932 Jarrow Formulas, Inc. Vol#: 47

LET 5933 Jarrow Formulas, Inc. Vol#: 47

LET 5934 Jarrow Formulas, Inc. Vol#: 47

LET 5935 Jarrow Formulas, Inc. Vol#: 47

LET 5936 Jarrow Formulas, Inc. Vol#: 47

LET 5937 Nature's Life Vol#: 47

LET 5938 Twin Laboratories, Inc. Vol#: 47

LET 5939 Twin Laboratories, Inc. Vol#: 47

LET 5940 Twin Laboratories, Inc. Vol#: 47

LET 5941 Twin Laboratories, Inc. Vol#: 47

LET 5942 Natural Balance, Inc. Vol#: 47

LET 5943 Jarrow Formulas, Inc. Vol#: 47

LET 5944 Natural Balance Vol#: 47

LET 5945 Twin Laboratories, Inc. Vol#: 47

LET 5946 Twin Laboratories, Inc. Vol#: 47

LET 5947 Twin Laboratories, Inc. Vol#: 47

LET 5948 Twin Laboratories, Inc. Vol#: 47

LET 5949 Twin Laboratories, Inc. Vol#: 47

LET 5950 Twin Laboratories, Inc. Vol#: 47

LET 5951 NBTY, Inc. Vol#: 47

LET 5952 Zhishin, LLC Vol#: 47

LET 5953 Zhishin, LLC Vol#: 47

LET 5954 Zhishin, LLC Vol#: 47

LET 5955 Nature's Herbs Vol#: 47

LET 5956 NBTY Inc. Vol#: 47

LET 5957 NBTY Inc. Vol#: 47

LET 5958 NBTY Inc. Vol#: 47

LET 5959 Immunity Today, LLC Vol#: 47

LET 5960 Country Life Vol#: 47

LET 5961 NBTY, Inc. Vol#: 47

LET 5962 NBTY, Inc. Vol#: 47

LET 5963 NBTY, Inc. Vol#: 47

LET 5964 NBTY, Inc. Vol#: 47

LET 5965 NBTY, Inc. Vol#: 47

LET 5966 NBTY, Inc. Vol#: 47

LET 5967 NBTY, Inc. Vol#: 47

LET 5968 NBTY, Inc. Vol#: 47

LET 5969 NBTY, Inc. Vol#: 47

LET 5970 NBTY, Inc. Vol#: 47

LET 5971 NBTY, Inc. Vol#: 47

LET 5972 NBTY, Inc. Vol#: 47

LET 5973 NBTY, Inc. Vol#: 47

LET 5974 NBTY, Inc. Vol#: 47

LET 5975 NBTY, Inc. Vol#: 47

LET 5976 NBTY, Inc. Vol#: 47

LET 5977 NBTY, Inc. Vol#: 47

LET 5978 NBTY, Inc. Vol#: 47

98F-0165 safe use of ionizing radition for reduction of salmonella

C 4 M Worth Vol#: 2

98N-1265 Distribution of Compounded Drug Products

C 6156 R Rooks Vol#: 174

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

C 2565 L Kunkle Vol#: 79

C 2566 K Ruge Vol#: 79

C 2567 C Rucker Vol#: 79

C 2568 A Rose Vol#: 79

C 2569 P Mallory Vol#: 79

C 2570 V Lynch Vol#: 79

C 2571 H Kren Vol#: 79

C 2572 L Rollins Vol#: 79

C 2573 C Corbett Vol#: 79

C 2574 W Orton Vol#: 79

C 2575 G Schulz Vol#: 79

C 2576 J Staab Vol#: 79

C 2577 L Yessis Vol#: 79

C 2578 S Stolarik Vol#: 79

C 2579 C Doud Vol#: 79

C 2580 D Uhl Vol#: 79

C 2581 Herb Crown Vol#: 79

C 2582 R Morrison Vol#: 79

C 2583 S Kinney Vol#: 79

C 2584 E Humberston Vol#: 79

C 2585 no signature Vol#: 79

C 2586 J Green Vol#: 79

C 2587 E Pust Vol#: 79

C 2588 J. Cascio Vol#: 79

C 2589 D Hutchison, M.D. Vol#: 79

C 2590 M Verlin Vol#: 79

C 2591 M Verlin Vol#: 79

C 2592 R Dell Vol#: 80

C 2593 R Lotz Vol#: 80

C 2594 H Morris Vol#: 80

C 2595 E Figuereo Vol#: 80

C 2596 B Shoss Vol#: 80

C 2597 Liberal Cycle Center Vol#: 80

C 2598 C Morris Vol#: 80

C 2599 J Denton Vol#: 80

C 2600 B. P. Vol#: 80

C 2601 no signature Vol#: 80

EMC 237 P Swain Vol#: 79

EMC 238 R Sanfratello Vol#: 79

EMC 239 M Cochrane Vol#: 79

EMC 240 T Wall Vol#: 79

EMC 241 P Lopez Vol#: 79

EMC 242 The Golf Network Inc. Vol#: 79

EMC 243 J Peterson Vol#: 79

EMC 244 T Day Vol#: 79

EMC 245 L Salerno Vol#: 79

EMC 246 A Jackson Vol#: 79

EMC 247 Ae Brody Vol#: 79

EMC 248 M Henley Vol#: 79

EMC 249 Southern California U for Professional S Vol#: 79

EMC 250 P Hansen Vol#: 79

EMC 251 S. Hapka Vol#: 79

EMC 252 K LaShelle Vol#: 79

EMC 253 B Spagnolo Vol#: 79

EMC 254 C. Felps Vol#: 79

EMC 255 M DeLong Vol#: 79

EMC 256 J D'Angelo Vol#: 79

EMC 257 P Caron Vol#: 79

EMC 258 J Anglada Vol#: 79

EMC 259 R Sande Vol#: 79

EMC 260 D. Beretta Vol#: 79

EMC 261 B. McAfee Vol#: 79

EMC 262 L Rogers Vol#: 79

EMC 263 P Abisognio Vol#: 79

EMC 264 M Lukasiewicz Vol#: 79

EMC 265 E Sohl Vol#: 79

EMC 266 M Prince Vol#: 79

EMC 267 G Nelson Vol#: 79

EMC 268 L Frins Vol#: 79

EMC 269 FARM Vol#: 79

EMC 270 S Lock Vol#: 79

EMC 271 L Bucklin Vol#: 79

EMC 272 B Currie Vol#: 79

EMC 273 D Steele Vol#: 79

EMC 274 J Wood Vol#: 79

EMC 275 M. Shearer Vol#: 79

98P-0623 Revoke determination that TSRH Pedicle Spinal Screw System

PDN 1 HFZ-001 to Arnold Levin Vol#: 1

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

C 16074 S. Wilmot Vol#: 475

C 16075 L Samson Vol#: 475

C 16076 M Miller Vol#: 475

C 16077 H Fogarty Vol#: 475

C 16078 K. Snider Vol#: 475

C 16079 V Long Vol#: 475

C 16080 Hahn-McNutt Vol#: 475

C 16081 A. Claussen Vol#: 475

C 16082 P. Borges Vol#: 475

C 16083 C. Coulter Vol#: 475

C 16084 S. Andersen Vol#: 475

C 16085 L Gallea Vol#: 475

C 16086 J. Sforza Vol#: 475

C 16087 no signature Vol#: 475

C 16088 J. Wenzke Vol#: 475

C 16089 A Cowans Vol#: 475

C 16090 D. Johnson Vol#: 475

C 16091 L Farris Vol#: 475

C 16092 C. Mellenthin Vol#: 475

C 16093 D. Bohman Vol#: 475

C 16094 T Oittmeier Vol#: 475

C 16095 V. Feldt Vol#: 475

C 16096 K Mackey Vol#: 475

C 16097 J. Dybdal Vol#: 475

C 16098 M Peterson Vol#: 475

C 16099 M Morgan Vol#: 475

C 16100 J. Widenhouse Vol#: 475

C 16101 L Gerger Vol#: 475

C 16102 O Clifton Vol#: 475

C 16103 T. Beals Vol#: 475

C 16104 M Harsh Vol#: 475

C 16105 W Houser Vol#: 475

C 16106 N. Carney Vol#: 475

C 16107 R Tinucci Vol#: 475

C 16108 S. Lentz Vol#: 475

C 16109 R Skufca Vol#: 475

C 16110 C Seaman Vol#: 475

C 16111 M Ponce Vol#: 475

C 16112 C. Robertson Vol#: 475

C 16113 W Wright Vol#: 475

C 16114 L Arellanes Vol#: 475

C 16115 M Woznicki Vol#: 475

C 16116 J. Joyce Vol#: 475

C 16117 R. Wells Vol#: 475

C 16118 L. Reed Vol#: 475

C 16119 W. Foxman Vol#: 475

C 16120 L Childs Vol#: 475

C 16121 P Germond Vol#: 475

C 16122 E. Leavy Vol#: 475

C 16123 J Erwin Vol#: 475

C 16124 V Maloney Vol#: 475

C 16125 G Pierre Vol#: 475

C 16126 S Keller Vol#: 475

C 16127 O. Fusino Vol#: 475

C 16128 D Rautin Vol#: 475

C 16129 F Stout Vol#: 475

C 16130 G Petronio Vol#: 475

C 16131 L Kurinzi Vol#: 475

C 16132 K. Langan Vol#: 475

C 16133 W Stanford Vol#: 475

C 16134 B. Paris Vol#: 475

C 16135 L. Giblin Vol#: 475

C 16136 L Bennett Vol#: 475

C 16137 K Hayden Vol#: 475

C 16138 L. Brady Vol#: 475

C 16139 J Jacobs Vol#: 475

C 16140 Z Nierenberg Vol#: 475

C 16141 C McNamara Vol#: 475

C 16142 R Pogacar Vol#: 475

C 16143 A Pizzi Vol#: 475

C 16144 I Szucs Vol#: 475

C 16145 M. Kimball Vol#: 475

C 16146 R Kiesel Vol#: 475

C 16147 R Laughlin Vol#: 475

C 16148 L. Weston Vol#: 475

C 16149 L. Akins Vol#: 475

C 16150 E James Vol#: 476

C 16151 M. Bolanos Vol#: 476

C 16152 N Bunnell Vol#: 476

C 16153 L Jaloway Vol#: 476

C 16154 Leslie Lehner Vol#: 476

C 16155 P. Martin Vol#: 476

C 16156 P Munson Vol#: 476

C 16157 L Loveday Vol#: 476

C 16158 J Moorman Vol#: 476

C 16159 M McElroy Vol#: 476

C 16160 G Kuhn Vol#: 476

C 16161 K. Gillerlain Vol#: 476

C 16162 S Willis Vol#: 476

C 16163 I. Kemmerer Vol#: 476

C 16164 H Annis Vol#: 476

C 16165 M McCarty Vol#: 476

C 16166 Ba Janikowski Vol#: 476

C 16167 B. Henneberg Vol#: 476

C 16168 L Bakker Vol#: 476

C 16169 L Miller Vol#: 476

C 16170 L Miller Vol#: 476

C 16171 F. Bubolz Vol#: 476

C 16172 L Shopher Vol#: 476

C 16173 J Connor Vol#: 476

C 16174 E. Brown Vol#: 476

C 16175 E Fleischmann Vol#: 476

C 16176 Reggie Smith Vol#: 476

C 16177 A Tschampl Vol#: 476

C 16178 H Davis Vol#: 476

C 16179 D Wojcik Vol#: 476

C 16180 E Levey Vol#: 476

C 16181 Aa Hewitt Vol#: 476

C 16182 L Kiron Vol#: 476

C 16183 G. Barnes Vol#: 476

C 16184 J Anneberg Vol#: 476

C 16185 H Daniels Vol#: 476

C 16186 R. Reilly Vol#: 476

C 16187 B. Baum Vol#: 476

C 16188 D Bozick Vol#: 476

C 16189 V Maslin Vol#: 476

C 16190 M. Unruh Vol#: 476

C 16191 K Guinn Vol#: 476

C 16192 K Duckworth Vol#: 476

C 16193 E. Davis Vol#: 476

C 16194 B. Odell Vol#: 476

C 16195 Nn Greist Vol#: 476

C 16196 S. Nolan Vol#: 476

C 16197 S Chase Vol#: 476

C 16198 T Fventes Vol#: 476

C 16199 D Steagall Vol#: 476

C 16200 K Talbot Vol#: 476

C 16201 C Cover Vol#: 476

C 16202 C. Meeker Vol#: 476

C 16203 R. Frank Vol#: 476

C 16204 E Karl Vol#: 476

C 16205 A Jackowski Vol#: 476

C 16206 L Stone Vol#: 476

C 16207 C Garno & D Potter Vol#: 476

C 16208 N Zuzzio Vol#: 476

C 16209 N Ueltschy Vol#: 476

C 16210 B Tnuth Vol#: 476

C 16211 J Dittmer Vol#: 476

C 16212 M. Smith Vol#: 476

C 16213 M. Runck Vol#: 476

C 16214 C. Danner Vol#: 476

C 16215 J. Borth Vol#: 476

C 16216 P Azab Vol#: 476

C 16217 J. Hathaway Vol#: 476

C 16218 J Jacobik Vol#: 476

C 16219 M Clark Vol#: 476

C 16220 George Burnette Vol#: 476

C 16221 T. Tucker Vol#: 476

C 16222 R. Rossi Vol#: 476

C 16223 T Shea Vol#: 476

C 16224 G Bratton Vol#: 476

C 16225 J Donnaud Vol#: 476

C 16226 M. Jewell Vol#: 476

C 16227 H Robertson Vol#: 476

C 16228 D. Clark Vol#: 476

C 16229 P. Stamp Vol#: 476

C 16230 C. Cibrone Vol#: 476

C 16231 F. Martin Vol#: 476

C 16232 J Marchetti Vol#: 476

C 16233 V. Zill Vol#: 476

C 16234 K Ryer Vol#: 476

C 16235 C. Dirik Vol#: 476

C 16236 L Villwock Vol#: 476

C 16237 D Hofemeister Vol#: 476

C 16238 D. Wilson Vol#: 476

C 16239 H. McLoughlin Vol#: 476

C 16240 D Leone Vol#: 476

C 16241 Janice Kennedy Vol#: 476

C 16242 W Lansing Vol#: 476

C 16243 S McHenry Vol#: 476

EMC 3284 B Lerman Vol#: 475

EMC 3285 L Ferran Vol#: 475

EMC 3286 V Saxena Vol#: 475

EMC 3287 D Andrews Vol#: 475

EMC 3288 M. Roth Vol#: 475

EMC 3289 R Woodruff Vol#: 475

EMC 3290 L DeVaney Vol#: 475

99P-5215 Provisions of Title 21 of the Code of Federal Regulations

PDN 1 HF-22 to AAPS et al. Vol#: 1

00D-0790 Use of Published Literature Supporting New Animal Drug Appro

GDL 2 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

00D-1274 FDA Modernization Act of 1997: Section 216

C 1 S Rohr Vol#: 1

00D-1563 Industry on Carcinogenicity Study protocol submissions

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

00M-1536 PMA PSA2 Immunoassay on Chiron Diagnostics ACS:180 & ACS Cen

AAV 1 Chiron Corp Vol#: 1

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

ANS 2 Deputy Assistant Secretary for Health Vol#: 68

C 38 Stanford University School of Medicine Vol#: 68

EMC 19 C Chmielewski Vol#: 68

00N-1545 Applications for FDA approval to market a New Drug Postmarke

NPR 1 Vol#: 1

00N-1561 Federal Preemption of state and local cigarette and smokeles

NFR 1 Vol#: 1

NFR 2 Vol#: 1

00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz

EMC 1 D Poole Vol#: 1

00P-0788 Totally Implanted Spinal Cord Stimulator

MM 3 ANS Meeting held 5/18/2000 Vol#: 4

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

C 7363 M McCarthy Vol#: 322

C 7364 T Aleger Vol#: 322

C 7365 G Townsherd Vol#: 322

C 7366 V Parcilla Vol#: 322

C 7367 D Derby Vol#: 322

C 7368 K Dennison Vol#: 322

C 7369 V Nicola Vol#: 322

C 7370 M Kristin Vol#: 322

C 7371 S Shafer Vol#: 322

C 7372 W Tobiassen Vol#: 322

C 7373 C Smith Vol#: 322

C 7374 K Baack Vol#: 322

C 7375 D Brunctti Vol#: 322

C 7376 K Kennedy Vol#: 322

C 7377 S Broadway Vol#: 322

C 7378 D Gardner Vol#: 322

C 7379 K Bobrow Vol#: 322

C 7380 C Flanigan Vol#: 322

C 7381 B Whelan Vol#: 322

C 7382 B Parks Vol#: 322

C 7383 A Jordan Vol#: 322

C 7384 S Kuhus Vol#: 322

C 7385 D Wilpon Vol#: 322

C 7386 R Whelan Vol#: 322

C 7387 J Marco, LCSW Vol#: 322

C 7388 M Rush Vol#: 322

C 7389 N Finley Vol#: 322

C 7390 N Dillon Vol#: 322

C 7391 L Monroe Vol#: 322

C 7392 N Bunderson Vol#: 322

C 7393 J Poll Vol#: 322

C 7394 P Lauerman Vol#: 322

C 7395 E Shimp Vol#: 322

C 7396 M Herod Vol#: 322

C 7397 C Bleick Vol#: 322

C 7398 A Kukal Vol#: 322

C 7399 B Tripp Vol#: 322

C 7400 J Hahn Vol#: 322

C 7401 M Cook Vol#: 322

C 7402 R Burgos Vol#: 322

C 7403 J Lidsky Vol#: 322

C 7404 J Hempel Vol#: 322

C 7405 S Babbitt Vol#: 322

C 7406 M Pratt Vol#: 322

C 7407 D Smith Vol#: 322

C 7408 G Stover Vol#: 322

C 7409 J Vitovec Vol#: 322

C 7410 P Siddall Vol#: 322

C 7411 W Nakao Vol#: 322

C 7412 K Griest Vol#: 322

C 7413 S Dodge Vol#: 322

C 7414 E Snyder Vol#: 322

C 7415 F Kine Vol#: 322

C 7416 J Beesman Vol#: 322

C 7417 V Kime Vol#: 322

C 7418 K Pell Vol#: 322

C 7419 R Doran Vol#: 322

C 7420 C Roussean Vol#: 322

C 7421 R Bashaws Vol#: 322

C 7422 J Hagaman Vol#: 322

C 7423 S Brownan Vol#: 322

C 7424 J Lee Vol#: 322

C 7425 A Johnson Vol#: 322

C 7426 D Sayre Vol#: 322

C 7427 S Marquez Vol#: 322

C 7428 B Robinson Vol#: 322

C 7429 S Mumau Vol#: 322

C 7430 B Downey Vol#: 322

C 7431 M Williams Vol#: 322

C 7432 J Stroh Vol#: 322

C 7433 S Hockaday Vol#: 322

C 7434 K Dobson Vol#: 322

C 7435 D Wright Vol#: 322

C 7436 C Heng Vol#: 322

C 7437 K Hall Vol#: 322

C 7438 P Viers Vol#: 322

C 7439 J Berglund II Vol#: 322

C 7440 J Hall Vol#: 322

C 7441 R Karl Vol#: 322

C 7442 J Nolan Vol#: 322

C 7443 L LaForge Vol#: 322

C 7444 L Nothstein Vol#: 322

C 7445 M Kohn Vol#: 322

C 7446 D Monteser Vol#: 322

00V-1614 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Midwest Stereo Vol#: 1