Food and Drug Administration

DOCKETS ENTERED on May 12, 1999

TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

92N-0139 Statement Policy: Foods Derived from New Plant Varieties
95F-0129 Safe use of Poly(oxy-1,2-ethanediyloxyearcarbonyl-2,6-naphth
95F-0130 Safe Use of Polyethylene Terephthalate Polymers
98N-1038 Irradiation in the production, processing, &handling of food
98N-1265 Distribution of Compounded Drug Products
98P-0151 Introduction Of Downed Cattle Into The Food Supply
98P-0203 Eliminate Forced Molting of Laying Birds
98P-0504 Raw Molluscan Shellfish of Undetectable Levels
99B-1364 Control of Foodbourne Human Salmonella
99D-0296 Fortmal Meetings with Sponsors/Applicant for PDUFA Products
99E-1070 Reboxetine Mesylate, Patent No. 4,229,449
99E-1071 Provigil, Patent No. 4,177,290
99E-1085 Pletal, Patent No. 4,277,479
99E-1114 Ziagen, Patent No. 5,034,394
99E-1115 Lumbar I/F Cage, Patent No. 4,834,757
99N-0554 Public meeting/health & nutrient content claims in food lab
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

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77N-0085 Saccharin and Its Salts

CA 27500 G O Hassell Vol#: 430

CA 27501 L Featherston Vol#: 430

CA 27502 J A Renko Vol#: 430

CA 27503 K Royse Vol#: 430

CA 27504 L L Woody Vol#: 430

CA 27505 J M Moyer Vol#: 430

CA 27506 Randolph Area Chamber of Commerce Vol#: 430

CA 27507 D Schickedanz Vol#: 430

CA 27508 V Allee Vol#: 430

CA 27509 L Van De Warker Vol#: 430

CA 27510 T J Sullivan Vol#: 430

CA 27511 J J Exum Vol#: 430

CA 27512 M J Brisch Vol#: 430

CA 27513 M Byrne Vol#: 430

CA 27514 T L Mueller Vol#: 430

CA 27515 N B Sargent Vol#: 430

CA 27516 M R Hardy Vol#: 430

CA 27518 J E Eisinger Vol#: 430

CA 27519 P Eash Vol#: 430

CA 27520 D A Campbell Vol#: 430

CA 27521 A R Ovard Vol#: 430

CA 27522 P Jenkins Vol#: 430

CA 27523 E Franklin Vol#: 430

CA 27524 F Prokup Vol#: 430

CA 27525 E Botkin Vol#: 430

CA 27526 M R Brochinsky Vol#: 430

CA 27527 F Hegg Vol#: 430

CA 27528 D D Lowe Vol#: 430

CA 27529 F V Sessa Vol#: 430

CA 27530 T Smith Vol#: 430

CA 27532 T C Hunter Vol#: 430

CA 27533 P Richards Vol#: 430

CA 27534 B M Beatty Vol#: 430

CA 27535 J R Muller Vol#: 430

CA 27536 V McGrew Vol#: 430

CA 27537 B Bethea Vol#: 430

CA 27538 V A Hansen Vol#: 430

CA 27539 J S Leamons Vol#: 430

CA 27540 D Glass Vol#: 430

CA 27541 F Lamberton Vol#: 430

CA 27542 M M Moore Vol#: 430

CA 27543 P Mallinger Vol#: 430

CA 27544 C C Clark Vol#: 430

CA 27545 A E Pastorini Vol#: 430

CA 27546 J R Stapleton Vol#: 430

CA 27547 A Edwards Vol#: 430

CA 27548 M P Collins Vol#: 430

CA 27549 E Lipstein Vol#: 430

CA 27550 C D Southard Vol#: 430

CA 27551 R Muhick Vol#: 430

CA 27552 H F Slaughter Vol#: 430

CA 27553 A Dalrymple Vol#: 430

CA 27554 A G Manly Vol#: 430

CA 27555 C A Parrish Vol#: 430

CA 27556 E L Price Vol#: 430

CA 27557 J A Hallan Vol#: 430

CA 27558 J F Sifferle Vol#: 430

CA 27559 A D Tener Vol#: 430

CA 27560 L Kingsley Vol#: 430

CA 27561 C Gomez Vol#: 430

CA 27562 H Rumberger Vol#: 430

CA 27563 L Stirnweis Vol#: 430

CA 27564 S Klayman Vol#: 430

CA 27565 D L Price Vol#: 430

CA 27566 A E Spivey Vol#: 430

CA 27568 T J Lafeber Vol#: 430

CA 27569 T Thompson Vol#: 430

CA 27570 B J Parrish Vol#: 430

CA 27571 B G McDuff Vol#: 430

CA 27572 A Kobline Vol#: 430

CA 27573 S Etra Vol#: 430

CA 27574 D Ellington Vol#: 430

CA 27575 J Ponkivar Vol#: 430

CA 27576 M Bayley Vol#: 430

CA 27577 M R Stables Vol#: 430

CA 27578 J Shaw Vol#: 430

CA 27579 S R Welter Vol#: 430

CA 27580 R Cook Vol#: 430

CA 27581 T B Worden Vol#: 430

CA 27582 C E Thompson, Jr. Vol#: 430

CA 27583 C Allen Vol#: 430

CA 27584 C B Scoble Vol#: 430

CA 27585 F B Thompson Vol#: 430

CA 27586 L Martinez Vol#: 430

CA 27587 S Zdrojowky Vol#: 430

CA 27588 F Berger Vol#: 430

CA 27589 M Morrow Vol#: 430

CA 27590 H Rogers Vol#: 430

CA 27591 L Hershman Vol#: 430

CA 27592 F H Beck Vol#: 430

CA 27593 D DeMarea Vol#: 430

CA 27594 L Sweeney Vol#: 430

CA 27595 J Polivka Vol#: 430

CA 27596 E W Ammons Vol#: 430

CA 27597 N Finley Vol#: 430

CA 27598 E Stendahl Vol#: 430

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92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 5311 Nancy Sutherland Vol#: 90

C 5312 Anita Merecki Vol#: 90

C 5313 Mr Eugene M Roak Vol#: 90

C 5314 Mr & Mrs William Demarco Vol#: 90

C 5315 Kim & Victor Flake Vol#: 90

C 5316 Mark Schonbeck Vol#: 90

C 5317 Neva Anderson Vol#: 90

C 5318 Celia Fink Vol#: 90

C 5319 Constance C Duppenthaler Vol#: 90

C 5320 Jane Brook Vol#: 90

C 5321 Pelar Washington Vol#: 90

C 5322 Alice Bell Vol#: 90

C 5323 Mae Sonefeld Vol#: 90

C 5324 Linda J Reinke Vol#: 90

C 5325 Anne O'Leary Vol#: 90

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95F-0129 Safe use of Poly(oxy-1,2-ethanediyloxyearcarbonyl-2,6-naphth

C 7 DeLyle W. Bloomquist et al Vol#: 1

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95F-0130 Safe Use of Polyethylene Terephthalate Polymers

C 7 DeLyle W. Bloomquist et al Vol#: 1

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98H-1261 Civil Money Penalties;Timothy Terrell,d/b/a Twin Roads Foodm

SUP 1 Twin Roads Foodmart Vol#: 1

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98N-1038 Irradiation in the production, processing, &handling of food

C 1218 Benson R. Cohen Vol#: 26

C 1219 Ruth K. Vol#: 26

C 1220 Melanie Linton Vol#: 26

C 1221 Blueberry Software Vol#: 26

C 1222 Patricia Linton Vol#: 26

C 1223 Patricia Linton Vol#: 26

C 1224 Patricia Murphy Vol#: 26

C 1225 Billy Ray Boyd Vol#: 26

C 1226 Environmental Health Center Vol#: 26

C 1227 David Shelton Vol#: 26

C 1228 Carol Stroebel Vol#: 26

C 1229 Jayme Peck Vol#: 26

C 1230 Nicole Leseigneur Vol#: 27

C 1231 illegible Vol#: 27

C 1232 Scott Taylor Vol#: 27

C 1233 Charles B. Dorsey Vol#: 27

C 1234 Mayo S. Schultz Vol#: 27

C 1235 Fred Baken Vol#: 27

C 1236 Robert Schlifer Vol#: 27

C 1237 Nanette Fyna Vol#: 27

C 1238 Stephanie Danaher Vol#: 27

C 1239 L. A. G. Vol#: 27

C 1240 Andrea Pellicani Vol#: 27

C 1241 Kalia Mussetter Vol#: 27

C 1242 Pamela Vol#: 27

C 1243 Linda J. Edwards Vol#: 27

C 1244 Julie Kreis Vol#: 27

C 1245 Carrie Y. Campion Vol#: 27

C 1246 Judith S. Vol#: 27

C 1247 Pamela Sathly Vol#: 27

C 1248 R. H. D. Vol#: 27

C 1249 Glenn M. Vol#: 27

C 1250 Yael H. Beriner Vol#: 27

C 1251 Elisa V. Vol#: 27

C 1252 Jon Holdway Vol#: 27

C 1253 Betty L. Revard Vol#: 27

C 1254 Rhea P. Fritz Vol#: 27

C 1255 Robert Bell Vol#: 27

C 1256 Terry A. Mills Vol#: 27

C 1257 Carol Mielerick Vol#: 27

C 1258 Tim E. Millerick Vol#: 27

C 1259 Mayot Vol#: 27

C 1260 Stephanie L. Cook Vol#: 27

C 1261 A. O. Ott Vol#: 27

C 1262 illegible Vol#: 27

C 1263 E. F. Vol#: 27

C 1264 E. Griffin Vol#: 27

C 1265 Cindy Samuels Vol#: 27

C 1266 D. E. Vol#: 27

C 1267 O. Schmider Vol#: 27

C 1268 Sylvia Brecker Vol#: 27

C 1269 Isaac G. Vol#: 27

C 1270 Corilee E. Hess Vol#: 27

C 1271 Lynn Weiner Vol#: 27

C 1272 Barbara Duchon Vol#: 27

C 1273 Donna Chinlind Vol#: 27

C 1274 June Norman Vol#: 27

C 1275 D. Vol#: 27

C 1276 M. R. S. Vol#: 27

C 1277 K. S. Vol#: 27

C 1278 Marie Barrantes Vol#: 27

C 1279 K. Vol#: 27

C 1280 S. Greene Vol#: 27

C 1281 Julie Rausen Vol#: 27

C 1282 J. Shikara Kolours Vol#: 27

C 1283 Tiffany Kampmann Vol#: 27

C 1284 Allen Vol#: 27

C 1285 Michael Stoddard Vol#: 27

C 1286 Katherine Chellisly Vol#: 27

C 1287 Ryan Vol#: 27

C 1288 Jed Gladstes Vol#: 27

C 1289 Andrew Vol#: 27

C 1290 illegible Vol#: 27

C 1291 Greg M. Kerrigo Vol#: 27

C 1292 Rebecca Ann Haddock Vol#: 27

C 1293 Chamundi Libanathan Vol#: 27

C 1294 Barry Barnett Vol#: 27

C 1295 Amanda Miller Vol#: 27

C 1296 Rich Harris Vol#: 27

C 1297 Hope D. Gamble Vol#: 27

C 1298 Mary J. Martin Vol#: 27

C 1299 Sandra Grant Vol#: 27

C 1300 Fran Crawford Vol#: 27

C 1301 Joseph M. Smith Vol#: 27

C 1302 Susan Michele Meyer Vol#: 27

C 1303 David Levner Vol#: 27

C 1304 Christopher Dirkers Vol#: 27

C 1305 Briana Elfstrom Vol#: 27

C 1306 Teri Olsen Vol#: 27

C 1307 Mary Cooper Vol#: 27

C 1308 Jean Marie DeSpain Vol#: 27

C 1309 Heather T. Williams Vol#: 27

C 1310 Greg Willson Vol#: 27

C 1311 Arjon Nance Vol#: 27

C 1312 a-janeth Vol#: 27

C 1313 Suzanne Charles Vol#: 27

C 1314 Jon McConnel Vol#: 27

C 1315 Howard Richards Vol#: 27

C 1316 Rachel Mok Vol#: 27

C 1317 Jim Overton Vol#: 27

C 1318 Emily Deans Vol#: 27

C 1319 J. Lynn Addison Vol#: 27

C 1320 Janise Baldo-Pulaski Vol#: 27

C 1321 Bill Kosareff Vol#: 27

C 1322 Jesse Herbert Vol#: 27

C 1323 Tamara Egans Vol#: 27

C 1324 Stacy Underhill Vol#: 27

C 1325 Adobe Rose Vol#: 27

C 1326 Gustavo Gonzalez Vol#: 27

C 1327 Elinor Reed Vol#: 27

C 1328 Betty J. Addison Vol#: 27

C 1329 Kimball S. Egge Vol#: 27

EXT 6 Leigh Reynolds Vol#: 27

EXT 7 Bob Wieselman Vol#: 27

EXT 8 Dirk Dunning Vol#: 27

EXT 9 Enid Arvidson Vol#: 27

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98N-1265 Distribution of Compounded Drug Products

C 1939 Todd Kretchman Vol#: 76

C 1940 Anne Cardosa Vol#: 76

C 1941 Louise D. Minnick Vol#: 76

C 1942 Verna McKinney Vol#: 76

C 1943 Michelle R. Vincill Vol#: 76

C 1944 Angie Bess Vol#: 76

C 1945 Malcolm Lubliner Vol#: 76

C 1946 Angela Martignetti Vol#: 76

C 1947 Earleen Hayes Vol#: 76

C 1948 Marianna Walton Vol#: 76

C 1949 Sara T. Curran Vol#: 76

C 1950 Julie Ann Wright Vol#: 76

C 1951 Sandra L. Thomas Vol#: 76

C 1952 Marcia Robertson's Vol#: 76

C 1953 Patricia Van Buskirk Vol#: 76

C 1954 Elise E. Koleny Vol#: 76

C 1955 Glen & Sharla Quick Vol#: 76

C 1956 Ruth E. Smith Vol#: 76

C 1957 Piedad Manulla Vol#: 76

C 1958 Brenda Dudek Vol#: 76

C 1959 Karen Hadley Vol#: 76

C 1960 Jodi Testa Vol#: 76

C 1961 Martha Gorman Vol#: 76

C 1962 Beth Bass Vol#: 76

C 1963 Helene L. Glass Vol#: 76

C 1964 Christine Monson Vol#: 76

C 1965 Judy Knutson Vol#: 76

C 1966 Mary Miller Vol#: 76

C 1967 Illegible Vol#: 76

C 1968 Susan T. Hollis Vol#: 76

C 1969 Lucille Therien Vol#: 76

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

C 2145 Arthur Siebenfelder Vol#: 52

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98P-0203 Eliminate Forced Molting of Laying Birds

C 1369 Sherry Ochoa Vol#: 31

C 1370 Sarah Conroy Vol#: 31

C 1371 Mr & Mrs Jeffrey Sleete Vol#: 31

C 1372 Darren Vol#: 31

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98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 247 David J. Scarratt Vol#: 18

C 248 Kevin Davis Vol#: 18

C 249 Paul M. Feran Vol#: 18

C 250 United States Senate Vol#: 18

C 251 St Bernard Parish Government Vol#: 18

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99B-1364 Control of Foodbourne Human Salmonella

REC 1 FDA/Bureau of Foods Vol#: 1

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99D-0296 Fortmal Meetings with Sponsors/Applicant for PDUFA Products

C 2 Zeneca Pharmaceuicals Vol#: 1

TOP

99E-1070 Reboxetine Mesylate, Patent No. 4,229,449

LET 2 HFY-20 Vol#: 1

TOP

99E-1071 Provigil, Patent No. 4,177,290

LET 2 HFY-20 Vol#: 1

TOP

99E-1085 Pletal, Patent No. 4,277,479

LET 2 HFY-20 Vol#: 1

TOP

99E-1114 Ziagen, Patent No. 5,034,394

LET 2 HFY-20 Vol#: 1

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99E-1115 Lumbar I/F Cage, Patent No. 4,834,757

LET 2 HFY-20 Vol#: 1

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99H-0230 Civil Money Penalties;Ray Draughon,d/b/a Draughon's Super M

LET 2 Office of Tobacco Programs Vol#: 1

99H-0617 Civil Money Penalty; Saver Systems Inc d/b/a Save-a-Lot

ANS 1 Saver Systems of Kentycky Inc Vol#: 1

99H-1034 Civil Money Penalties;Michael Rupe,d/b/a Mike's Liquors

ANS 1 Mike's Liquors Vol#: 1

99H-1252 Civil Money Penalties;Kams Food Corp,d/b/a Kamas Food Town

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1253 Civil Money Penalties;Rookies Inc, & John Brennan & Serge Ri

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1254 Civil Money Penalties;Muoi Vong,d/b/a Lee's Food Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1255 Civil Money Penalties;Double Quick Inc,d/b/a Double Quick 81

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1256 Civil Money Penalties;Mohan Chhina,d/b/a 7-Eleven #26797

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1257 Civil Money Penalties;Osco Drug Inc,d/b/a Osco Drug

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1258 Civil Money Penalties;Vista Food Market Inc,d/b/a Vista Food

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1262 Civil Money Penalties;C-Shell Ent Ltd,d/b/a Lynnfield Street

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1263 Civil Money Penalties;Stuart's Inc,d/b/a Stuart's Foodtown

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1264 Civil Money Penalties;Richard Wood,d/b/a Wood Amoco Food Sho

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1265 Civil Money Penalties;Read's Golden Rule Store,d/b/a Read's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99N-0386 Talking with Stakeholders About FDA Modernization

C 27 Ameircan Society of Health-System Pharma Vol#: 2

EC 9 ACIL Vol#: 2

TR 8 Transcript 4/28/99 La Jolla, CA Vol#: 10

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99N-0554 Public meeting/health & nutrient content claims in food lab

C 4 Grocery Manufacturers of America Vol#: 1

C 5 General Mills Inc Vol#: 1

C 6 Citizens For Health Vol#: 1

C 7 Consumer Healthcare Products Assoc Vol#: 1

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99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 144 Mrs. Gordon Vol#: 2

C 145 Virginia Osborne Vol#: 2

C 146 Robin J. Herbison Vol#: 2

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