Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail] 

DOCKETS ENTERED on June 2, 2000

Table of Contents

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75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
76N-052N OTC Nasal Decongestants*
78N-0038 Sunscreen Drug Products*
81N-0022 OTC Weight Control Drug Products for Human Use *
88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE *
96P-0215 Withdrawal Norplant's approval for sale in the United States *
97N-0436 Methods informing consumers of contents of bottle water *
97N-484S Human Cellular and Tissue-Based Products *
97P-0078 Recognized the Term "Soymilk" as the Established Common of U *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
99P-0033 Combat the spread of transmissible spongiform encephalopathy *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-3030 Health Claim: Saw Palmetto & Benign Prostatic Hyperplasia *
00D-0805 Requirements for Emergency Research *
00D-1033 Clinical Trials for Serious/Life-Threatening Diseases *
00D-1197 180-Day Exclusivity Under the Hatch-Waxman Amendments *
00N-0504 Egg Safety Action Plan *
00N-1256 Over-the-Counter Drug Products;Public Hearing *
00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1276 Health Claim: Plant stanol esters and heart disease *
00P-1326 Crabmeat; Amendment of Common or Usual Name Regulation *
75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

C 54 CTFA Vol#: 60

76N-052N OTC Nasal Decongestants

C 231 Consumer Healthcare Products Assn Vol#: 73

78N-0038 Sunscreen Drug Products

C 560 CTFA Vol#: 133

C 561 Regional Medical Physics Dept Vol#: 133

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

C 113 Consumer Healthcare Products Assn Vol#: 93

88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

THE LINKED COMMENTS BELOW DUPLICE THOSE FOR 92N-0297, ALSO BELOW

C 84 Lee Medical International, Inc Vol#: 2

C 85 Rebel Distributors Corp Vol#: 2

C 86 Citrus Regional Blood Center Vol#: 2

C 87 R. Weinstein of Texas Vol#: 2

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

C 71 Lee Medical International, Inc Vol#: 3

C 72 Rebel Distributors Corp Vol#: 3

C 73 Citrus Regional Blood Center Vol#: 3

C 74 R. Weinstein of Texas Vol#: 3

96M-0311 Guideline on Infectious Disease Issues in Xenotransplantatio

N 1 Vol#: 50

96N-0048 Sterility Requirements for Inhalation Solution Products

NFR 1 Vol#: 1

96P-0215 Withdrawal Norplant's approval for sale in the United States

C 227 Luana L. Wilson Vol#: 6

97N-0436 Methods informing consumers of contents of bottle water

C 84 U. S. Environmental Protection Agency Vol#: 2

97N-484S Human Cellular and Tissue-Based Products

C 477 LifeSource Fertility Center Vol#: 25

97P-0078 Recognized the Term "Soymilk" as the Established Common of U

C 104 White Wave, Inc Vol#: 1

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

LET 4855 Morgan, Lewis, & Bockius Vol#: 37

LET 4856 Morgan, Lewis, & Bockius Vol#: 37

LET 4857 Herbal Science Inc. Vol#: 37

LET 4858 Herbal Science Inc. Vol#: 37

LET 4859 Herbal Science Inc. Vol#: 37

LET 4860 Nature's way Vol#: 37

LET 4861 DMD Pharmaceuticals Vol#: 37

LET 4862 NBTY Vol#: 37

LET 4863 NBTY Vol#: 37

LET 4864 NBTY Vol#: 37

LET 4865 NBTY Vol#: 37

LET 4866 NBTY Vol#: 37

LET 4867 NBTY Vol#: 37

LET 4868 NBTY Vol#: 37

LET 4869 NBTY Vol#: 37

LET 4870 NBTY Vol#: 37

LET 4871 NBTY Vol#: 37

LET 4872 NBTY Vol#: 37

LET 4873 NBTY Vol#: 37

LET 4874 NBTY Vol#: 37

LET 4875 NBTY Vol#: 37

LET 4876 NBTY Vol#: 37

LET 4877 NBTY Vol#: 37

LET 4878 DMD Pharmaceuticals Vol#: 37

LET 4879 Pharmative Corporation Vol#: 37

LET 4880 Pharmative Corporation Vol#: 37

LET 4881 Pharmative Corporation Vol#: 37

LET 4882 Matrix Health Products Inc. Vol#: 37

LET 4883 Matrix Health Products Inc. Vol#: 37

LET 4884 Matrix Health Products Inc. Vol#: 37

LET 4885 Matrix Health Products Inc. Vol#: 37

LET 4886 Matrix Health Products Inc. Vol#: 37

LET 4887 Matrix Health Products Inc. Vol#: 37

LET 4888 Matrix Health Products Inc. Vol#: 37

LET 4889 Pharmative Corporation Vol#: 37

99H-0258 Civil Money Penalties;Khamis Sirhan,d/b/a Sirhan's Grocery

LET 2 Office of Policy Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-1032 Civil Money Penalties;Bert Malone,d/b/a Lazy Lee's One Stop

SF 1 GCF-1 Vol#:

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

C 12925 Ingeborg Roberts Vol#: 400

C 12926 Loti Hines Vol#: 400

C 12927 Elizabeth Ann Shanger Vol#: 400

C 12928 Catherine L. Coryell Vol#: 400

C 12929 Meredith P. Fort Vol#: 400

C 12930 Barbara Stephens Vol#: 400

C 12931 Mark Payne Vol#: 400

C 12932 Hollis MacArthur Vol#: 400

C 12933 Kay Licina Vol#: 400

C 12934 Debra C. Winsberg Vol#: 400

C 12935 Keith & Barbara Evans Vol#: 400

C 12936 Lea Wood Vol#: 400

C 12937 Sara Freed Vol#: 400

C 12938 Edward Busby Vol#: 400

C 12939 Rhonda Hess Vol#: 400

C 12940 Rhoda Brown Vol#: 400

C 12941 Josh Brown Vol#: 400

C 12942 Thomas P. Aeillo Vol#: 400

C 12943 Debi Turek Vol#: 400

C 12944 Beth Lutz Vol#: 400

C 12945 Cherie Pickett Vol#: 400

C 12946 Connie Henry Vol#: 400

C 12947 Lorraine Visalli Vol#: 400

C 12948 Deisha Myles Vol#: 400

C 12949 Irene Hicks Vol#: 400

C 12950 Julia Cato Vol#: 400

C 12951 Catherine R. Caine Vol#: 400

C 12952 Susan E. Gribbin Vol#: 400

C 12953 Betty Butterworth Vol#: 400

C 12954 Katherine Laewell Vol#: 400

C 12955 Marcy Greenhut Vol#: 400

C 12956 Sharon Schmiedel Vol#: 400

C 12957 Faith Thiel Vol#: 400

C 12958 Victoria Sims Lieberman Vol#: 400

C 12959 Darlene Levinson Vol#: 400

C 12960 Irene A. Wrenner Vol#: 400

C 12961 Charity A. Malice Vol#: 400

C 12962 Rhonda McHaley Vol#: 400

C 12963 Joan Helmenstine Vol#: 400

C 12964 Bailey Y. Young Vol#: 400

C 12965 Thomas & Susan Brinkman Vol#: 400

C 12966 Lorri Corrigan Vol#:

C 12967 Kristen M. Walker Vol#: 400

C 12968 Kerry Koskinen Vol#: 400

C 12969 Dean Wiegert Vol#: 400

C 12970 Linda M. Pimentel Vol#: 400

C 12971 Monica Clark Vol#: 400

C 12972 Robert Young Vol#: 400

C 12973 Tracy L. Gillette Vol#: 400

C 12974 Marilyn A. Skebey Vol#: 400

C 12975 Mary C. Abeyta Vol#: 400

C 12976 Norbert & Jacquelin McCaffrey Vol#: 400

C 12977 Nita Grover Vol#: 400

C 12978 Jennifer Tran Vol#: 400

C 12979 Lillian Holf Vol#: 400

C 12980 Caren J. Howes Vol#: 400

C 12981 Derek Weatherill Vol#: 400

C 12982 Ray N. Franklin Vol#: 400

C 12983 Kim Alegant Vol#: 400

C 12984 Donald M. Maze Vol#: 400

C 12985 N. L. Nicalo Vol#: 400

C 12986 Lisa A. Rings Vol#: 400

C 12987 B. J. Ames Vol#: 400

C 12988 Barbara L. Oswalt Vol#: 400

C 12989 L. Larkin Vol#: 400

C 12990 Trudy Bialic Vol#: 400

C 12991 Jeannette R. Fones Vol#: 400

C 12992 Roxana Kornhauser Vol#: 400

C 12993 Barbara White Vol#: 400

C 12994 Sue Glass Vol#: 400

C 12995 Walter Sniadajewski Vol#: 400

C 12996 Marilyn Montae Vol#: 400

C 12997 Suzye Poley Vol#: 400

C 12998 Kimberly DiPerta Vol#: 400

C 12999 Claudia Susan Barrett Vol#: 400

C 13000 Susan Dailey Vol#: 400

C 13001 Jason A. Lambert Vol#: 400

C 13002 Madaline Sparks Vol#: 400

C 13003 Susan Lynn Blue Vol#: 400

C 13004 Cheryl A. Rosselle Vol#: 400

EMC 2718 Maryella Johnson Vol#: 400

EMC 2719 Andrea E. Still Vol#: 400

EMC 2720 Rominesjl Vol#: 400

EMC 2721 D. Newman Vol#: 400

EMC 2722 Walter Grant Vol#: 400

EMC 2723 Linn Sperry Steward Vol#: 400

EMC 2724 adfga Vol#: 400

EMC 2725 Jenny Michalak Vol#: 400

EMC 2726 tmqu Vol#: 400

EMC 2727 eena Vol#: 400

EMC 2728 Thomas E. Noerper Vol#: 400

EMC 2729 J. Purdy Vol#: 400

EMC 2730 Greg & Jan Chomycia Vol#: 400

EMC 2731 June Tejeda Vol#: 400

EMC 2732 Jeremy Wood Vol#: 400

EMC 2733 Julian Powers Vol#: 400

EMC 2734 Pam Leland-Nelson Vol#: 400

EMC 2735 deg 33 Vol#: 400

EMC 2736 Andrew Rock Vol#: 400

EMC 2737 Sooner 98 Vol#: 400

EMC 2738 Gina Martinez Vol#: 400

EMC 2739 Lori Langley Vol#: 400

EMC 2740 Fiddlewitch Vol#: 400

EMC 2741 abraxis Vol#: 400

99P-0033 Combat the spread of transmissible spongiform encephalopathy

C 362 Jami Tolpin Vol#: 9

C 363 J. Scott Douglas Vol#: 9

C 364 Rob Allen Vol#: 9

C 365 Kenneth Henry Heger Vol#: 9

LET 3 HFV-1 to Joseph Mendelson, III Vol#: 9

99P-1340 Declared Eternity eau de Parfum Misbranded

C 628 Dianne M. Varallo Vol#: 14

C 629 Lynnette Ikuta Vol#: 14

EMC 118 Linda Kane Vol#: 14

99P-3030 Health Claim: Saw Palmetto & Benign Prostatic Hyperplasia

C 197 Mr. Mrs. Gil Havinga Vol#: 8

C 198 Helen T. Mocedon Vol#: 8

SUP 2 Emord & Associates, P. C. Vol#: 8

00D-0805 Requirements for Emergency Research

C 2 Memorial Health Vol#: 1

00D-1033 Clinical Trials for Serious/Life-Threatening Diseases

C 1 Mayo Foundation Vol#: 1

C 2 Pharmaceutical Res & Mgf of America Vol#: 1

00D-1197 180-Day Exclusivity Under the Hatch-Waxman Amendments

C 1 Teva Pharmaceuticals USA Vol#: 1

00F-0813 Components of paper and paperboard incontact with aqueous an

NFR 1 Vol#: 1

00N-0504 Egg Safety Action Plan

C 23 M. G. Waldbaum Company Vol#: 2

00N-1256 Over-the-Counter Drug Products;Public Hearing

APE 40 Gynetics Inc. Vol#: 2

APE 41 ASEC Vol#: 2

APE 42 Heeger & Barnett, LLP Vol#: 2

APE 43 Population Council Vol#: 2

APE 44 MedImpact Healthcare Systems Inc. Vol#: 2

APE 45 National Assoc of Health Underwriters Vol#: 2

APE 46 National Women's Health Network (NWHN) Vol#: 2

APE 47 Merck & Co. Vol#: 2

CH 38 ReProtect Vol#: 1

CH 39 Rita & Bill Clark Vol#: 1

CH 40 Marilyn & William Kerner Vol#: 1

CH 41 James J. Weiner Vol#: 1

CH 42 Lawrence M. Du Buske, MD Vol#: 1

CH 43 STOPP Int'l Vol#: 1

CH 44 Ann Keilly Vol#: 1

CH 45 William Alexander Vol#: 1

CH 46 Veronica Aheehan Vol#: 1

CH 47 APUA Vol#: 1

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

C 4 Mary Kate Creutz Vol#: 1

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

C 669 Maria Smith Vol#: 20

C 670 Erika Kane Vol#: 20

C 671 John Flower Vol#: 20

C 672 C. Jean McLain Vol#: 20

C 673 Chaitanya Nitai Vol#: 20

C 674 Chris Knutron Vol#: 20

C 675 Corrine Gaitz Vol#: 20

C 676 Nate Corrly Vol#: 20

C 677 M. Neidhardt Vol#: 20

C 678 Regina M. Bennetts Vol#: 20

C 679 Mr. & Mrs. Samon Carter Vol#: 20

C 680 Jacqueline Tan Sandt Vol#: 20

C 681 Angela Sonzogni Vol#: 20

C 682 Robert Lugg Vol#: 20

C 683 Christina Jaqua Vol#: 20

C 684 Gene Salecker Vol#: 20

C 685 Geraldine Schwartz Vol#: 20

00P-1276 Health Claim: Plant stanol esters and heart disease

LET 1 McNeil Consumer Healthcare Vol#: 4

LET 2 McNeil Consumer Healthcare Vol#: 4

MM 1 HFS-830 & McNeil Consumer Healthcare Vol#: 4

MM 2 HFS-830 & McNeil Consumer Healthcare Vol#: 4

00P-1326 Crabmeat; Amendment of Common or Usual Name Regulation

ACK 1 HFA-305 Vol#: 1