DOCKETS ENTERED on 04/30/99

FDA - Food and Drug Administration

DOCKETS ENTERED on APRIL 30, 1999

Updated as of 4:00 pm, May 11, 1999. The following documents were entered at the Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860 and are hyperlinked to the actual comments/letters/reports as indicated below.

9 TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

80N-0228 OTC PROD FOR THE RELIEF OF ORAL DISCOMFORT
80N-0295 OTC drug review policy statement
81N-0033 Oral Health Care Drug Products for OTC Human Use
92N-0139 Statement Policy: Foods Derived from New Plant Varieties
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability
98D-0994 Draft Guidance for Industry on BACPAC I
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa
98N-0970 Labeling for Menstrual Tampons
98N-1265 Distribution of Compounded Drug Products
98P-0151 Introduction Of Downed Cattle Into The Food Supply
98P-0504 Raw Molluscan Shellfish of Undetectable Levels
98P-1194 Withdrawal NADA Approval for Posilac - rBGH
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock
99P-1172 Add alatrofloxacin to ped. priority list of approved drugs
99P-1173 Add celebrex to pediatric priority list of approved drugs

77N-0085 Saccharin and Its Salts

CA 27236 J K Smith Vol#: 427

CA 27237 R Cates Vol#: 427

CA 27238 J Wesley Vol#: 427

CA 27239 E I Berta Vol#: 427

CA 27240 L Guerrieri Vol#: 427

CA 27241 S A Kunz Vol#: 427

CA 27242 S M Smalley Vol#: 427

CA 27243 S J Guess Vol#: 427

80N-0228 OTC PROD FOR THE RELIEF OF ORAL DISCOMFORT

PR 2 Consumer Healthcare Products Assn Vol#: 10

80N-0295 OTC drug review policy statement

MM 114 HFD-560 & Playtex Products, Inc. Vol#: 3

81N-0033 Oral Health Care Drug Products for OTC Human Use

PR 5 Consumer Healthcare Products Assn Vol#: 58

84G-0257 Affirmation of GRAS Status of Certain Enzymes

BKG 1 Vol#: 27

NFR 2 Vol#: 24

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

C 5020 Wanda & Bob Rankin Vol#: 78

C 5021 Animal Care & Welfare, SPCA Vol#: 78

C 5022 Pat Sells Vol#: 78

C 5023 Ms Eleanor Tamino Vol#: 78

C 5024 Irene Mills Vol#: 78

C 5025 Katherine Capcara Vol#: 78

C 5026 Judson M Horning Vol#: 78

C 5027 Neva Anderson Vol#: 78

C 5028 Elizabeth Bryer Vol#: 78

C 5029 Kelly Devaney Vol#: 78

C 5030 Douglas Walters Vol#: 78

C 5031 Elinor O Lerner Vol#: 78

C 5032 Ann Grobe Vol#: 78

C 5033 Ms Grace Donaldson Vol#: 78

C 5034 Star Olderman Vol#: 78

C 5035 Yvonne Bouchard Vol#: 78

C 5036 Nancy B & Kenneth L Macy Vol#: 78

C 5037 Kate Potter Vol#: 78

C 5038 David Lopez Vol#: 78

C 5039 Bernadette Jones Vol#: 78

C 5040 Ms Laura Buss Vol#: 78

C 5041 Martha Greene Vol#: 78

C 5042 Carol F Peters Vol#: 78

C 5043 Z Andrew Gerry Vol#: 78

C 5044 Douglas E Morris Vol#: 78

C 5045 Susan McMillan Vol#: 78

C 5046 Paul M Lappen Vol#: 78

C 5047 Lynn W Tidman Vol#: 78

C 5048 Catherine Ralston Vol#: 78

C 5049 Barbara M Jenkinson Vol#: 78

C 5050 Virginia Kerns PhD Vol#: 78

C 5051 Linda Forsberg Vol#: 78

C 5052 Judy Rachel Vol#: 78

C 5053 Rebecca Adams Vol#: 78

C 5054 Thomas B Buford Vol#: 78

C 5055 Christine M Phillips Vol#: 78

C 5056 Sharon Cody Vol#: 78

C 5057 Catherine Jelenek Vol#: 78

C 5058 Barbara Goldthwait & John Goldthwait Vol#: 78

C 5059 Ann B Schiff Vol#: 78

C 5060 C Frank Marmero Vol#: 78

C 5061 The Rosenstein Family Vol#: 78

C 5062 Cynthia Weeks Vol#: 78

C 5063 Mrs C Osman Vol#: 78

C 5064 Peter Dvorak Vol#: 78

C 5065 Peggy Tyson-Cobb Vol#: 78

C 5066 A Gordon Reynolds MD Vol#: 78

C 5067 Kara Naber & Mark Andrews Vol#: 78

C 5068 Karen Roseberry Vol#: 78

C 5069 Dorothy A Spencer Vol#: 78

C 5070 Rodd Stodiwell Vol#: 78

C 5071 F C English Vol#: 78

C 5072 Cynthia Arnott-White Vol#: 78

C 5073 Mark Schonbeck Vol#: 78

C 5074 Christine G Johnson Vol#: 78

C 5075 Noel Fine Vol#: 78

C 5076 Laurence Heit Vol#: 78

C 5077 Cathy Haft Vol#: 78

C 5078 Elizabeth A White Vol#: 78

C 5079 Patricia Cox Vol#: 78

C 5080 Erica Morris Vol#: 78

C 5081 John Mayes Vol#: 78

C 5082 Elizabeth A White Vol#: 78

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

C 3693 Honorable Rick Santorum (CI) Vol#: 291

98D-0994 Draft Guidance for Industry on BACPAC I

C 36 Schering Vol#: 2

98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

C 50 Robin Semeria Vol#: 2

98E-0614 AMERGE (naratriptan hydrochloride) Patent No. 4,997,841

N 1 Vol#: 1

98N-0970 Labeling for Menstrual Tampons

C 6 Kimberly-Clark Corporation Vol#: 1

98N-1109 Mercury Compounds in Drugs and Food

NRD 2 Vol#: 2

98N-1265 Distribution of Compounded Drug Products

C 1523 Kathleen Hirsch Vol#: 73

C 1524 Pat Lehman Vol#: 73

C 1525 Ruth Ann Schmitt Vol#: 73

C 1526 Rachel C. Reilly Vol#: 73

C 1527 Marilyn Aineth Vol#: 73

C 1528 Sheila C. DeJohn Vol#: 73

C 1529 Deb Congton Vol#: 73

C 1530 Romena Gardner Vol#: 73

C 1531 Melissa Thieme Vol#: 73

C 1532 Ingrid Sprogve Vol#: 73

C 1533 Deborah A. Massey Vol#: 73

C 1534 P. S. Jaros Vol#: 73

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

C 2129 Maurna Winterer Vol#: 52

C 2130 Franeine Robinson Vol#: 52

C 2131 Terry Goodwin Vol#: 52

C 2132 L. Christian Vol#: 52

C 2133 Chris Seeholz Vol#: 52

C 2134 Phyllis A. Hyde Vol#: 52

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 211 R. Fournier & Sons, Inc. Vol#: 17

C 212 Wes Whitney Vol#: 17

C 213 New York St Dept. of Environmental Conse Vol#: 17

C 214 New Point Oyster Co. Vol#: 17

C 215 Frank M. Flower & Sons, Inc. Vol#: 17

C 216 Skansi Oyster Corp. Vol#: 17

C 217 State of Louisiana House of Representati Vol#: 17

C 218 American Mussel Harvesters, Inc. Vol#: 17

C 219 Faulkner State Vol#: 17

C 220 J. Robert Murdoch Vol#: 17

C 221 Frederick W. Alexander Vol#: 17

C 222 House of Representatives Vol#: 17

C 223 CSPI Vol#: 17

C 224 Coalition for Consumer Choice Vol#: 17

C 225 St. Bernard Parish Government Vol#: 17

C 226 Kamilche Sea Farms, Inc. Vol#: 17

C 227 Tampa Maid Foods, Inc. Vol#: 17

C 228 Long Island Oyster Co. Vol#: 17

C 229 Florida Dept. of Health Vol#: 17

C 230 Florida House of Representatives Vol#: 17

C 231 Northern Oyster Co. Vol#: 17

C 232 Roussos Seafood Restaurant & Catering Vol#: 17

C 233 Lummi Indian Business Council Vol#: 17

C 234 House of Representatives Alabama State H Vol#: 17

C 235 Drago's Seafood Restaurant % Oyster Bar Vol#: 17

LET 3 Mississippi Dept. of Marine Resources Vol#: 17

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 87 Wanda & Bob Rankin Vol#: 3

C 88 Mark Schonbeck Vol#: 3

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 102 Lillian Periman Vol#: 1

C 103 Phil Engel Vol#: 1

C 104 Lee I. Morino Vol#: 1

C 105 Traude Buckland Vol#: 1

C 106 Adele Caramanian Vol#: 1

C 107 Nancy Pindiak Vol#: 1

C 108 Marilyn Evenson Vol#: 1

C 109 Gail Kaplan Vol#: 1

C 110 Ms. Jane C. Powers Vol#: 1

99P-1172 Add alatrofloxacin to ped. priority list of approved drugs

ACK 1 HFA-305 Vol#: 1

CP 1 Pfizer, Inc. Vol#: 1

99P-1173 Add celebrex to pediatric priority list of approved drugs

ACK 1 HFA-305 Vol#: 1

CP 1 G.D. Searle & Co. Vol#: 1