Food and Drug Administration

DOCKETS ENTERED on May 14, 1999

TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

97S-0162 30-Day Structure Function Claim Notification Letters Dietary
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-0683 Soy Protein Containing Products
99D-0557 Use of Nonhuman Primate Xenografts in Humans
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock
99V-1388 Projector for Laser Light Show
99V-1389 Laser Light Show
99V-1390 Laser Light Show & Projector for Laser Light Show
99V-1391 Laser Light Show

TOP

77N-0085 Saccharin and Its Salts

CA 27719 L H Ward Vol#: 432

CA 27720 H Martin Vol#: 432

CA 27721 H D Helms Vol#: 432

CA 27722 J M Taylor Vol#: 432

CA 27723 B J Clusserath Vol#: 432

CA 27724 J Reed Vol#: 432

CA 27725 K Atchison Vol#: 432

CA 27726 R Aerts Vol#: 432

CA 27727 M Patten Vol#: 432

CA 27728 D Simmons Vol#: 432

CA 27729 J P Koch, M.D. Vol#: 432

CA 27730 J J Pasquinelli Vol#: 432

CA 27731 C E Dickson Vol#: 432

CA 27732 V Mason Vol#: 432

CA 27733 J Baratti Vol#: 432

CA 27734 S M Harris Vol#: 432

CA 27735 R & L Roberts Vol#: 432

CA 27736 R Richards Vol#: 432

CA 27737 Chattanooga Area Diabetes Association Vol#: 432

CA 27738 M Parkinson Vol#: 432

CA 27739 J C Carmichael Vol#: 432

CA 27740 J R Albers Vol#: 432

CA 27741 American Diabetes Associaion, Minnesota Vol#: 432

CA 27742 F F Avery Vol#: 432

CA 27743 J Rovilea Vol#: 432

CA 27744 L M Starr Vol#: 432

CA 27745 J Pozzo Vol#: 432

CA 27746 Elm Park Construction Co. Vol#: 432

CA 27747 H S Clarke Vol#: 432

CA 27748 J Collins Vol#: 432

CA 27750 A M & W J Lemieux Vol#: 432

CA 27751 P M Brown Vol#: 432

CA 27752 D M Hayes Vol#: 432

CA 27753 C B Sauer Vol#: 432

CA 27754 F D Deane Vol#: 432

CA 27755 R Rascovar Vol#: 432

CA 27756 R Hill Jr. Vol#: 432

CA 27757 S Schnee Vol#: 432

CA 27758 M Rust Vol#: 432

CA 27759 G Hurt Vol#: 432

CA 27760 L Conn Vol#: 432

CA 27761 A Silva Vol#: 432

CA 27762 M P Lund Vol#: 432

CA 27763 D L Dodge Vol#: 432

CA 27764 D McKillip Vol#: 432

CA 27765 L L Stoddard-Tuchman Vol#: 432

CA 27766 J Rosser Vol#: 432

CA 27767 M E Walker Vol#: 432

CA 27768 V Whitt Vol#: 432

CA 27769 W D & C J Nelson Vol#: 432

CA 27770 J L Mayer Vol#: 432

CA 27771 W W Buckminster Vol#: 432

CA 27772 V J Wrenn Vol#: 432

CA 27773 R C Seibel Vol#: 432

CA 27774 Unsigned Vol#: 432

CA 27775 W Kitten Vol#: 432

CA 27776 J H Barrier Vol#: 432

CA 27777 M Barrier Vol#: 432

CA 27778 J Sigel Vol#: 432

CA 27779 Central Investment Corp & Pepsi Cola Vol#: 432

CA 27780 R P Atkinson Vol#: 432

CA 27781 D Hayes Vol#: 432

CA 27782 C Glenn Vol#: 432

CA 27783 M Burgett Vol#: 432

CA 27784 C S Finnan Vol#: 432

CA 27785 D King Vol#: 432

CA 27786 D A Brown Vol#: 432

CA 27787 D Prosser Vol#: 432

CA 27788 V Byrd Vol#: 432

CA 27789 J A Schneider Vol#: 432

CA 27790 J Lamm Vol#: 432

CA 27791 O & M Retailliani Vol#: 432

CA 27793 F G Christian Jr. Vol#: 432

CA 27794 E M Rowley Vol#: 432

CA 27795 E M Dunn Vol#: 432

CA 27796 C A Peterson Vol#: 432

CA 27797 C & B Phillips Vol#: 432

CA 27798 J E Vol#: 432

CA 27799 J Collins Vol#: 433

CA 27800 D E & R R Stauffer Vol#: 433

CA 27801 J M Horowitz Vol#: 433

CA 27802 E B Jacobson Vol#: 433

CA 27803 M Turetzky Vol#: 433

CA 27804 J D Dawson Vol#: 433

CA 27805 S M DiJulio Vol#: 433

CA 27806 H DeVorkin Vol#: 433

CA 27807 K Egon Vol#: 433

CA 27808 P C Smith Vol#: 433

CA 27809 S Bryan Vol#: 433

CA 27810 D Levitt Vol#: 433

CA 27811 J Reames Vol#: 433

CA 27812 J Moss Vol#: 433

CA 27813 P L Dudley Vol#: 433

CA 27814 D Ponikvar Vol#: 433

CA 27815 F Forhy Vol#: 433

CA 27816 D Freeman Vol#: 433

CA 27817 L Shafer Vol#: 433

CA 27818 W Newsom Vol#: 433

CA 27820 T A Zimmerman Vol#: 433

CA 27821 F M Sharp Vol#: 433

CA 27822 G F Kelso Vol#: 433

CA 27823 J R Craig, Jr. Vol#: 433

CA 27824 W G Hansen Vol#: 433

CA 27825 D W Fink Vol#: 433

CA 27826 G Edwards Vol#: 433

CA 27827 K McKinder Vol#: 433

CA 27828 J D Carr Vol#: 433

CA 27829 No Signature Vol#: 433

CA 27830 T G Morris Vol#: 433

CA 27831 H S Smithson Vol#: 433

CA 27832 H L Moreland Vol#: 433

CA 27833 B Dickey Vol#: 433

CA 27834 J L Clark Vol#: 433

CA 27835 M E Hinkle Vol#: 433

CA 27836 P Affholter Vol#: 433

CA 27837 B L Archer Vol#: 433

CA 27838 J W Stamps Vol#: 433

CA 27839 M Livingston Vol#: 433

CA 27840 C L Braly Vol#: 433

CA 27841 V Oversby Vol#: 433

CA 27842 J Batz Vol#: 433

CA 27843 L Aufderheide Vol#: 433

CA 27844 D J O'Connell Vol#: 433

CA 27845 R T Zerba Vol#: 433

CA 27846 J C Maurer Vol#: 433

CA 27847 R English Vol#: 433

CA 27848 M Seimeca Vol#: 433

CA 27849 J Hedlund Vol#: 433

CA 27850 S V Scheffel Vol#: 433

CA 27851 C Mason Vol#: 433

CA 27852 D Nelson Vol#: 433

CA 27853 V A Lewis Vol#: 433

CA 27854 M B Cogle Vol#: 433

CA 27855 M H Woodward Vol#: 433

CA 27856 S Porter Vol#: 433

CA 27857 R C Simmons Vol#: 433

CA 27858 L Dimmick Vol#: 433

CA 27859 C E Bochow Vol#: 433

CA 27860 C L Hitt Vol#: 433

CA 27861 J B Voss Vol#: 433

CA 27862 W Dragt Vol#: 433

CA 27863 D O Merry Vol#: 433

CA 27864 B Winn Vol#: 433

CA 27865 E Scarbrough Vol#: 433

CA 27866 J Starr Vol#: 433

CA 27867 W A Norman Vol#: 433

CA 27868 B Graham Vol#: 433

CA 27869 R R Brown Vol#: 433

CA 27870 T Hermais Vol#: 433

CA 27871 R Moffatt Vol#: 433

CA 27872 M Thompson Vol#: 433

CA 27873 W E Boggess Vol#: 433

CA 27874 J D East Vol#: 433

CA 27875 T D Spinks Vol#: 433

CA 27876 M V Strom Vol#: 433

CA 27877 H A Bruhm Vol#: 433

CA 27878 F H Summers Vol#: 433

CA 27879 J Thomas Vol#: 433

CA 27880 J Nodich Vol#: 433

CA 27881 Witt Vol#: 433

CA 27882 D C Dendinger Vol#: 433

CA 27883 R G Ross Vol#: 433

CA 27884 R L Weaver Vol#: 433

CA 27885 D J Metz Vol#: 433

CA 27886 J Heskett Vol#: 433

CA 27887 S Rotellini Vol#: 433

CA 27888 J P Shaffer Vol#: 433

CA 27889 J Leftwich Vol#: 433

CA 27890 B Geckler Vol#: 433

CA 27891 G C Kinnaman, Sr. Vol#: 433

CA 27892 P Joyce Vol#: 433

CA 27893 J N Stewart Vol#: 433

CA 27894 R O Davis Vol#: 433

CA 27895 N B Olmstead Vol#: 433

CA 27896 D Kupczyk Vol#: 433

CA 27897 H G Preston Jr. Vol#: 433

CA 27898 D Brown Vol#: 433

TOP

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

LET 3553 Uniweal Ltd Vol#: 22

LET 3554 B F Ascher & Co Inc Vol#: 22

LET 3555 Mariposa Botanicals Ltd Vol#: 22

LET 3556 Nature's Own Inc Vol#: 22

LET 3557 Herbs Etc Inc Vol#: 22

LET 3558 Herbs Etc Inc Vol#: 22

LET 3559 Herbs Etc Inc Vol#: 22

LET 3560 Herbs Etc Inc Vol#: 22

LET 3561 Herbs Etc Inc Vol#: 22

LET 3562 HK Entertainment Holdings LLC Vol#: 22

LET 3563 The Daily Wellness Company Vol#: 22

LET 3564 NBTY Inc Vol#: 22

LET 3565 NBTY Inc Vol#: 22

LET 3566 NBTY Inc Vol#: 22

LET 3567 NBTY Inc Vol#: 22

LET 3568 NBTY Inc Vol#: 22

LET 3569 The Vitamin Shoppe Inc Vol#: 22

LET 3570 NBTY Inc Vol#: 22

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

C 1375 Public Citizen Health Research Group Vol#: 28

C 1376 Coldwell Bankers Rehoboth Resort Realty Vol#: 28

C 1377 Lisa Arkin Vol#: 28

C 1378 Tom Goselin Vol#: 28

C 1379 Gary L. Nielsen, D.C. Vol#: 28

C 1380 Sylvia Caris Vol#: 28

C 1381 Pamela Prodan Vol#: 28

C 1382 Terran Doehrer & Jutta Distler Vol#: 28

C 1383 Amy Frankel Vol#: 28

C 1384 Jesse Seligson Vol#: 28

C 1385 Sandy Baker Vol#: 28

C 1386 Mary Jo Rasmussen Vol#: 28

C 1387 Roberta A. Belulovich Vol#: 28

C 1388 Andrea Wolper Vol#: 28

C 1389 P. M. Cooke Vol#: 28

C 1390 K. Banta Vol#: 28

C 1391 wagbt Vol#: 28

C 1392 Sandra Meeker Vol#: 28

C 1393 T. Scatterday Vol#: 28

C 1394 Val Dambacher Vol#: 28

C 1395 Lois Barth Vol#: 28

C 1396 Norma Eigles Vol#: 28

C 1397 Kathleen Leuba Vol#: 28

C 1398 Jenna Blaustein Vol#: 28

C 1399 Ann Somers Vol#: 28

C 1400 Lynn W. Kloss Vol#: 28

C 1401 Armando J. Garica Vol#: 28

C 1402 Feits Vol#: 28

C 1403 W. R. Randolph Vol#: 28

C 1404 Linda Garton Vol#: 28

C 1405 Jane S. Gibson Vol#: 28

C 1406 Rosemary Jermann Vol#: 28

C 1407 Robert DePrisco Vol#: 28

C 1408 RNJKASA Vol#: 28

C 1409 Christina Renda Vol#: 28

C 1410 Renee M. Malina Vol#: 28

C 1411 Elizabeth Kinslinger Vol#: 28

C 1412 Louise C. Monaco Vol#: 28

C 1413 Teresa McCormick Vol#: 28

C 1414 E. Roznar Vol#: 28

C 1415 Gerry Schwarzentraub Vol#: 28

C 1416 Andrew J. Belanger Vol#: 28

C 1417 Sally Dunn Vol#: 28

C 1418 Shachar Erez Vol#: 28

C 1419 Joanne Collins Vol#: 28

C 1420 Tucson Cooperative Warehouse Vol#: 28

C 1421 Tammi Joy Parsons Vol#: 28

C 1422 Kimby Vol#: 28

C 1423 The Tates Vol#: 28

C 1424 Michael Herron Vol#: 28

C 1425 Martin H. Meyer Vol#: 28

C 1426 Anju Sidana Vol#: 28

C 1427 April Frerichs Vol#: 28

C 1428 Todd & Kristin Mizenko Vol#: 28

C 1429 David Shelton Vol#: 28

C 1430 James O. Miller Vol#: 28

C 1431 Amy Tyriver Vol#: 28

C 1432 Matt Mizenko Vol#: 28

C 1433 Alison Trotman Vol#: 28

C 1434 Form Letters 29 Vol#: 29

C 1435 K. M. N. Vol#: 30

C 1436 Anne E. Deutsch Vol#: 30

C 1437 Lovely Previn Lynch Vol#: 30

C 1438 Lorie & Kelly Oblad et al Vol#: 30

C 1439 Sara Bhakti, Ph.D. Vol#: 30

C 1440 Marie David, R.N. Vol#: 30

C 1441 no signature Vol#: 30

C 1442 Chris Johnson Vol#: 30

C 1443 Raymond W. Hasse Vol#: 30

C 1444 Robert & Marianne Alt Vol#: 30

C 1445 Michelle Voelker, RD, LD Vol#: 30

C 1446 Gerhard & Barbara Bedding Vol#: 30

C 1447 Michael Martino & Joyce E. Brisson Vol#: 30

C 1448 Joan O. King Vol#: 30

C 1449 Lalita Kuhn Vol#: 30

C 1450 Patrick Tangredi Vol#: 30

C 1451 Bill Kuhn Vol#: 30

C 1452 Susan E. Allen Vol#: 30

C 1453 National Restaurant Assn. Vol#: 30

C 1454 Gary E. Sherman Vol#: 30

C 1455 Neil E. Levin Vol#: 30

C 1456 Terri Drach Vol#: 30

C 1457 Leslie Leonelli Vol#: 30

C 1458 Simone Lipscomb Vol#: 30

C 1459 L. Nemzo Vol#: 30

C 1460 Elaine J. Attwood Vol#: 30

C 1461 Shelley Reavis Vol#: 30

C 1462 Jeffrey L. Kastel et al Vol#: 30

C 1463 Kathleen Mulica Vol#: 30

C 1464 Jayson Bixler Vol#: 30

C 1465 Daniel Swartz Vol#: 30

C 1466 Alison Trotman Vol#: 30

EXT 15 Gary A. Sshwartz Vol#: 28

EXT 16 Richard G. Rettig Vol#: 28

EXT 17 John Pirillo Vol#: 30

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98N-1265 Distribution of Compounded Drug Products

C 2005 Beatrice Bader Vol#: 77

C 2006 Connie Smith Vol#: 77

C 2007 Darlus Bader Vol#: 77

C 2008 Robin Kajihara Vol#: 77

C 2009 Janice R. Drake Vol#: 77

C 2010 Audrey Tomaselli Vol#: 77

C 2011 Carla Fischer Vol#: 77

C 2012 Sally Snipes Vol#: 77

C 2013 Verdelle E. Anderson Vol#: 77

C 2014 Susan S. Cherry Vol#: 77

C 2015 Rosaline M. Constantine Vol#: 77

C 2016 Nick P. Leveque Vol#: 77

C 2017 Lydia Vandenbroeck Vol#: 77

C 2018 Barbara Case Vol#: 77

C 2019 M. J. Bundum Vol#: 77

C 2020 Anita Hermalin Vol#: 77

C 2021 Jerry Olson Vol#: 77

C 2022 Barbara M. Kast Vol#: 77

C 2023 Joseph R. Blum Vol#: 77

C 2024 Nancy Kerfarian Vol#: 77

C 2025 Martin De. Planque Vol#: 77

C 2026 K. Baumhoper Vol#: 77

C 2027 Joan C. Eads Vol#: 77

C 2028 Carole Kushnir Vol#: 77

C 2029 Amanda O. Ehrenford Vol#: 77

C 2030 Carole Giovacchini Vol#: 77

C 2031 Karen T. Cox Vol#: 77

C 2032 Marcia J. Morgan Vol#: 77

C 2033 Amy Russello Vol#: 77

C 2034 Lee Gammon Vol#: 77

C 2035 Deborah Chandler Vol#: 77

C 2036 Cele Bona Vol#: 77

C 2037 Mavis Abernathy Vol#: 77

C 2038 Frances Naylor Vol#: 77

C 2039 Eloise Neier Vol#: 77

C 2040 Carolyn Kay Jones Vol#: 77

C 2041 Cheryl Hallberg Vol#: 77

C 2042 Christine A. Murr Vol#: 77

C 2043 Elaine Masso Vol#: 77

C 2044 Deborah Rise Vol#: 77

C 2045 Stephanie Sundine Vol#: 77

C 2046 Judith A. Werer Vol#: 77

C 2047 Ann S. Johnson Vol#: 77

C 2048 Mary Ann Brussat Vol#: 77

C 2049 Linda R. Starnes Vol#: 77

C 2050 Katie Riddael Vol#: 77

C 2051 Mary R. Wolfe Vol#: 77

C 2052 William Banetse Vol#: 77

C 2053 M. E. Koppin Vol#: 77

C 2054 Anne M. Fitzmaurice Vol#: 77

C 2055 Pat Pierce Vol#: 77

C 2056 Phyllis Linenfelser Vol#: 77

C 2057 Faye A. Stauferbiel Vol#: 77

C 2058 Judy Gunstream Onkon Vol#: 77

C 2059 Martha Keller Vol#: 77

C 2060 Nancy Bacal Vol#: 77

C 2061 Bonnie Brill Vol#: 77

C 2062 C. Judith Seime Vol#: 77

C 2063 Angeline Vilada Vol#: 77

C 2064 Susan Goldsmith Vol#: 77

C 2065 Karen Kengdale Vol#: 77

C 2066 Darlene S. Ray Vol#: 77

C 2067 Danila B. Oder Vol#: 77

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

C 2147 Carola Villageliu Vol#: 52

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98P-0683 Soy Protein Containing Products

C 131 Center for Science in the Public Interse Vol#: 19

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99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 8 Kayla Schramm Vol#: 1

C 9 Saucy Shirley Vol#: 1

99N-0123 Procedures for Statements on Dietary Supplements

N 2 Vol#: 1

99N-0124 Premarket Notification for a New Dietary Ingredient

N 2 Vol#: 1

99N-0235 Premarket Notification for Food Contact Substances

REF 2 HFS-215 Vol#: 1

99N-0386 Talking with Stakeholders About FDA Modernization

C 28 Coalition for Regulatory Reform Vol#: 2

EC 10 Fragranced Product Information Network Vol#: 2

EC 11 Biotechnology Industry Organization Vol#: 2

EC 12 Christa Garrett Vol#: 2

EC 13 Peggy Davis Vol#: 2

EC 14 Hollie Hoffman Vol#: 2

EC 15 Dr. Susan Vaughan Vol#: 2

TS 8 Dr. Sundlof Slides 4/28/99 CVM Meeting Vol#: 2

99N-1075 Vibrio Parahaemolyticus in molluscan shellfish public health

BKG 1 Vol#: 2

NM 1 Vol#: 1

NRD 1 Vol#: 1

99N-1076 Foodborne Listeria Monocytogenes comments/scientific data

BKG 1 Vol#: 2

NRD 1 Vol#: 1

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99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 152 Roald Cann Vol#: 2

C 153 Christine Wilson Vol#: 2

C 154 Lyn Rosen Vol#: 2

C 155 Mr & Mrs James L. Denison Vol#: 2

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99V-1388 Projector for Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Divine Lightwave Technologies, Inc. Vol#: 1

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99V-1389 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Martin J. Minnicino Vol#: 1

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99V-1390 Laser Light Show & Projector for Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Pangolin Laser Systems, Inc. Vol#: 1

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99V-1391 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 New Wave Entertainment Vol#: 1

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