Food and Drug Administration

DOCKETS ENTERED on June 2, 1999

TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

97S-0162 30-Day Structure Function Claim Notification Letters Dietary
98N-0583 Exports: Notification and Recordkeeping requirements
98N-1038 Irradiation in the production, processing, &handling of food
98N-1265 Distribution of Compounded Drug Products
98P-1075 Ticlopidine Hydrochloride Tablets (250 mg)
98P-1191 ANDA referencing Naprelan
98P-1194 Withdrawal NADA Approval for Posilac - rBGH
99D-0484 Accelerated approval products/submission promotional materia
99D-0557 Use of Nonhuman Primate Xenografts in Humans
99N-0438 Contamination ready-to-eat foods associated food prepartion
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock
99P-1266 Regulation minimum potency limit 90% dietary supplements
99P-1654 Stay Effect Date for Approval of ANDA for generic DIPRIVAN

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

LET 3571 Metagenics Inc Vol#: 23

LET 3572 Feeling Find Company LLC Vol#: 23

LET 3573 Feeling Find Company LLC Vol#: 23

LET 3574 Feeling Find Company LLC Vol#: 23

LET 3575 Feeling Find Company LLC Vol#: 23

LET 3576 Owner Herbs Etc Inc Vol#: 23

LET 3577 Owner Herbs Etc Inc Vol#: 23

LET 3578 Owner Herbs Etc Inc Vol#: 23

LET 3579 Owner Herbs Etc Inc Vol#: 23

LET 3580 Prevail Corporation Vol#: 23

LET 3581 Prevail Corporation Vol#: 23

LET 3582 Prevail Corporation Vol#: 23

LET 3583 Prevail Corporation Vol#: 23

LET 3584 Prevail Corporation Vol#: 23

LET 3585 Prevail Corporation Vol#: 23

LET 3586 Prevail Corporation Vol#: 23

LET 3587 Prevail Corporation Vol#: 23

LET 3588 Prevail Corporation Vol#: 23

LET 3589 Prevail Corporation Vol#: 23

LET 3590 Prevail Corporation Vol#: 23

LET 3591 Prevail Corporation Vol#: 23

LET 3592 Nature's Herbs Vol#: 23

LET 3593 General Vitamin Corp Vol#: 23

LET 3594 New Chapter Inc Vol#: 23

LET 3595 Horizon Nutraceuticals Vol#: 23

LET 3596 Chattem Inc Vol#: 23

LET 3597 Basic Research dba Silver Sage Vol#: 23

LET 3598 Basic Research dba Evanstown Research La Vol#: 23

LET 3599 Basic Research dba Wellness Dynamics Vol#: 23

LET 3600 Basic Research dba Silver Sage Vol#: 23

LET 3601 Basic Research dba Silver Sage Vol#: 23

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98F-0823 1-Octene as an optional monomer in preparation of polyers

NFR 1 HFS-215 Vol#: 1

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98N-0583 Exports: Notification and Recordkeeping requirements

C 3 Custom Services International Vol#: 1

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

C 2340 Cheryl L. Glicker Vol#: 54

C 2341 American Society for Microbiology Vol#: 54

C 2342 Lucy M. Vol#: 54

C 2343 ConAgra Refrigerated Prepared Foods Vol#: 54

C 2344 AMI, American Meat Institute Vol#: 54

C 2345 FARM, Farm Animal Reform Movement Vol#: 54

C 2346 Roy Wagner Vol#: 54

C 2347 Arizona Cactus Ranch Vol#: 54

C 2348 Bryna B. Banks Vol#: 54

C 2349 Annat O. Provo Vol#: 54

C 2350 R. Kozaryn Vol#: 54

C 2351 Susan E. Marshall Vol#: 54

C 2352 Ross Pollard Vol#: 54

C 2353 Jude Hobbs Vol#: 54

C 2354 Rose Kuras Vol#: 54

C 2355 Solar Law Vol#: 54

C 2356 Dawn Brozovsky Vol#: 54

C 2357 Joy Wells Vol#: 54

C 2358 Mike Feeney Vol#: 54

C 2359 15 Signatures Vol#: 54

C 2360 Jovial King et al Vol#: 54

C 2361 The Renaissance Consulting Group Vol#: 54

C 2362 Mark J. Smitek Vol#: 54

C 2363 Lisa Jean Silva Vol#: 54

C 2364 Todd Olk Vol#: 54

C 2365 Emily G. Rieman Vol#: 54

C 2366 Jane Vite, R.N., M.Ed. Vol#: 54

C 2367 Heather Noloriga Vol#: 54

C 2368 A. McCann Vol#: 54

C 2369 Fern Snyder Vol#: 54

C 2370 Arienne Ellis Vol#: 54

C 2371 Kerri Mackenzie Vol#: 54

C 2372 Sharilyn Schauer Vol#: 54

C 2373 Demeter Assn., Inc. Vol#: 54

C 2374 Suzanne Gluck-Sosis Vol#: 54

C 2375 Jayus Fox-Sky Vol#: 54

C 2376 Jocelyn B. Eikenburg Vol#: 54

C 2377 Natalie Daugherity Vol#: 57

C 2378 Mary C. Sclinibben Vol#: 57

C 2379 Janis Forde Vol#: 57

C 2380 Margo Ross Vol#: 57

C 2381 Cindy Larson Vol#: 57

C 2382 Marjorie Fitzgerald Vol#: 57

C 2383 Sharon Walker Vol#: 57

C 2384 McCandless Res. & Development Foundation Vol#: 57

C 2385 McCandless Res. & Development Foundation Vol#: 57

C 2386 McCandless Res. & Development Foundation Vol#: 57

C 2387 Barbara Starre, RN, MSN, MT Vol#: 57

C 2388 Suzanne Wuerthele, Ph.D. Vol#: 57

C 2389 Joan M. Gossett Vol#: 57

C 2390 Todd Trogar Vol#: 57

C 2391 The Campaign Vol#: 57

C 2392 Lorinda Norton Vol#: 57

C 2393 Susan Banks Vol#: 57

C 2394 Patti Waters Vol#: 57

C 2395 Suzanne R. Carlson Vol#: 57

C 2396 Dorothea Sotiros Vol#: 57

C 2397 Karocka Rottenberg Vol#: 57

C 2398 Janet Deery Vol#: 57

C 2399 Congress of the United States Vol#: 57

C 2400 Anna Borzha Vol#: 57

C 2401 CSPI Vol#: 57

C 2402 Louis Mincer Vol#: 57

C 2403 Meg Whittle Vol#: 57

C 2404 Sandy Bonk Vol#: 57

C 2405 Dolores M. Walther Vol#: 57

C 2406 Gertrude A. Hoffmann Vol#: 57

C 2407 Tabetha A. Block Vol#: 57

C 2408 American Dietetic Assn. Vol#: 57

C 2409 HSUS, Humane Society of the United State Vol#: 57

C 2410 Glen & Kathleen Stofer Vol#: 57

EXT 35 Dr. Alison Bailey Vol#: 54

EXT 36 Conrad O. Krahling Vol#: 57

LET 1 Food Irradiation Alert Vol#: 54

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98N-1265 Distribution of Compounded Drug Products

C 2938 Dionne R. Schneider Vol#: 110

C 2939 ATN Publications Vol#: 110

C 2940 Linda Baum Vol#: 110

C 2941 Howard L. Levine Vol#: 110

C 2942 Nancy P. Shulman Vol#: 110

C 2943 Therese Smith Vol#: 110

C 2944 Karen Schnick Vol#: 110

C 2945 National Community Pharmacists Assn Vol#: 110

C 2946 Alabama Pharmacy Association Vol#: 110

C 2947 College Pharmacy Vol#: 110

C 2948 West Virginia Pharmacists Assn Vol#: 110

C 2949 American Pharmaceutical Assn Vol#: 110

C 2950 Brown & Fortunato, P.C. Vol#: 110

C 2951 Michelle Schott Vol#: 110

C 2952 Celia Shaw Vol#: 110

C 2953 Anne Marsey Vol#: 110

C 2954 Marly Yourish C.N.M. Vol#: 110

C 2955 American Preventive Medical Assn Vol#: 110

C 2956 Victoria Falk Vol#: 110

C 2957 Mechelle Buhan Vol#: 110

C 2958 William A. (Bill) Stalknecht Vol#: 110

C 2959 Susanne B. Lansing Vol#: 110

C 2960 Nancy K. Geiser Vol#: 110

C 2961 Joanne Meystedt Vol#: 110

C 2962 Werner Lindemaier Vol#: 110

C 2963 Rebecca McGuire Vol#: 110

C 2964 Triple D. Corporation Vol#: 110

C 2965 Debbie King Vol#: 110

C 2966 Katherine V. Mayes Vol#: 110

C 2967 Rosemary Coffey Vol#: 110

C 2968 Nancy Writers Vol#: 110

C 2969 Lisa StanRus Vol#: 110

C 2970 K. Gordon Vol#: 110

C 2971 Texas Pharmacy Association Vol#: 110

C 2972 Betty B. Tuhs Vol#: 110

C 2973 Madeline Dowdell Vol#: 110

C 2974 Pamela Escobar Vol#: 110

C 2975 Geri Galfano Vol#: 110

C 2976 Shirley Zachariasen Vol#: 110

C 2977 Janis D. Eley Vol#: 110

C 2978 Brenda J. Hill Vol#: 110

C 2979 Lorraine Connors Vol#: 110

C 2980 Paula Williams Vol#: 110

C 2981 Elaine Gast Vol#: 110

C 2982 Rhonda D. Mann Vol#: 110

C 2983 Beverly Bailey Vol#: 110

C 2984 Lou Lee Thomas Vol#: 110

C 2985 Nikki L Blaha Vol#: 110

C 2986 Janet L. Larson Vol#: 110

C 2987 Beatrice Prentice Vol#: 110

C 2988 Kathy F. Pielsticker Vol#: 110

C 2989 Pearl VanVaketis Vol#: 110

C 2990 Janice Rudy Vol#: 110

C 2991 Constano M Callahan Vol#: 110

C 2992 Diana L. Winiecke Vol#: 110

C 2993 Alice E. Kloss Vol#: 110

C 2994 Busy E. Stout Vol#: 110

C 2995 Nancy C. Metz Vol#: 110

C 2996 Danella Johnson Vol#: 110

C 2997 Mary Abbott Vol#: 110

C 2998 Melisa A. Thayson Vol#: 110

C 2999 Rose Polrier Vol#: 110

C 3000 Marilyn J. Hamilton Vol#: 110

C 3001 Marlyn Graves Vol#: 110

C 3002 Heather Logan-Kelly Vol#: 110

C 3003 Brock M. Stone Vol#: 110

C 3004 Charlotte Ward Vol#: 110

C 3005 A. W. Kamstra Vol#: 110

C 3006 Rebecca G. Wood Vol#: 110

C 3007 Carolyn Anderson Vol#: 110

C 3008 Jermaine A. Breslow Vol#: 110

C 3009 James Fadiman Vol#: 110

C 3010 Martha Steinbrugge Vol#: 110

C 3011 Beth Dick Vol#: 110

C 3012 Lirly Smith Vol#: 110

EXT 8 Holleb & Coff Vol#: 110

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98P-1075 Ticlopidine Hydrochloride Tablets (250 mg)

LET 1 HFD-001 to Hoffman-LaRoche Inc Vol#:

LET 2 Hoffmann-LaRoche Inc. Vol#: 1

LET 3 HFD-001 to Hoffman-Laroche Vol#: 1

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98P-1191 ANDA referencing Naprelan

LET 1 HFD-001 to Elan Pharmaceuticals Vol#: 2

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98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 133 The Campaign Vol#: 3

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99D-0484 Accelerated approval products/submission promotional materia

C 6 Abbott Laboratories Vol#: 1

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99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 12 Form letter count 81 Vol#: 2

C 13 Bernadette M Sonefeld Vol#: 1

C 14 Adela Pisrevsky Vol#: 1

C 15 Sonia Kopp Vol#: 1

C 16 Rosanne J DiMilia Vol#: 1

C 17 Kelly Beard-Tittone Vol#: 1

C 18 International Center For Technology Asse Vol#: 1

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99D-1454 Nasal spray, inhalation solution, suspension&spray drug prod

GDL 1 HFD-570 Vol#: 1

NAD 1 Vol#: 1

99H-0442 Civil Money Penalties;Fred D Duell,d/b/a One Stop

LET 2 Office of Tobacco Programs Vol#: 1

99H-1018 Civil Money Penalties;P M Place Stores Co,d/b/a Place's Disc

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-1185 Civil Money Penalties;Krakow Store Inc,d/b/a Krakow Store

ANS 1 Krakow Store Inc Vol#: 1

99H-1546 Civil Money Penalties;Kmart Corp,d/b/a Kmart Store #9689

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1547 Civil Money Penalties;Pac"N"Save Inc,d/b/a Pac"N"Save

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1548 Civil Money Penalties;Denny's Ent Inc,d/b/a Denny's Conoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1549 Civil Money Penalties;Risco Inc,d/b/a Casey's General Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1550 Civil Money Penalties;Rix Corp,d/b/a Rix Amoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1551 Civil Money Penalties;Avanti Petroleum Inc,d/b/a Budget Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1552 Civil Money Penalties;Wareco Inc,d/b/a Wareco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1553 Civil Money Penalties;Winn-Dixie Stores Inc,d/b/a Winn-Dixie

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1554 Civil Mone Penalties;Manning Foods Inc,d/b/a Manning Foods

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1555 Civil Money Penalties;Leeds Foods Inc,d/b/a Stratford Ford

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1556 Civil Money Penalties;Old's Auto Supply Service Inc,d/b/a

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1557 Civil Money Penalties; J B Quick Stop Inc,d/b/a E Z Stop #3

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1558 Civil Money Penalties;FBR Group Inc,d/b/a 76 Express

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1559 Civil Money Penalties;Tom Thumb Food Market's Inc,d/b/a Tom

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1561 Civil Money Penalties;Jesse Thomas Shelton,d/b/a 52 & 8 Shel

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1562 Civil Money Penalties; Robert M Work,d/b/a Smoking Pleasure

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1565 Civil Money Penalties;Larry Keep,d/b/a Forestland Sales & Se

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1566 Civil Money Penalties;Richard Bush,d/b/a Bananas

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1567 Civil Money Penalties;John Bowan,d/b/a John's Speedy Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1568 Civil Money Penalties;Jimmy Wade,d/b/a Jimmy's Variety Pic

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1569 Civil Money Penalties;Bob Stoddard,d/b/a Bob's Easy Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1570 Civil Money Penalties;Robert Richter,d/b/a Country Station

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1571 Civil Money Penalties;Lori Richling,d/b/a Greenway Co-op #8

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1572 Civil Money Penalties;Kathy Phillips,d/b/a Haden's Time Save

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1573 Civil Money Penalties;Don Stratmann & James Franks,d/b/a FS

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1574 Civil Money Penalties;Gary Pasquale & Gloria Pasquale,d/b/a

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1575 Civil Money Penalties;Bruce Matthees & Roxanne Matthees,d/b/

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

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99N-0438 Contamination ready-to-eat foods associated food prepartion

C 4 CONTEC Contamination Control Technology Vol#: 1

C 5 Hospitality Institute Of Tech Management Vol#: 1

C 6 National Restaurant Association Vol#: 1

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99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 653 Linda Grassie Vol#: 7

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99P-1266 Regulation minimum potency limit 90% dietary supplements

C 1 Powers & Associates, Inc Vol#: 1

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99P-1654 Stay Effect Date for Approval of ANDA for generic DIPRIVAN

CR 1 HFA-305 Vol#: 1

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