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 Us]

DOCKETS ENTERED on September 12, 2000

TABLE OF CONTENTS

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78N-0038 Sunscreen Drug Products*
95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *
98N-0331 Medical Devices;Implementation third party review under FDA *
99D-4910 Mammography Quality Standards Act Final Regulations #3 *
00D-1407 Safety Pharmacology Studies for Human Pharmaceuticals *
00N-0930 Nominations for Working Groups: Pharmaceutical Science AC *
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal *
00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1297 Permit an OTC drug mfg to include "may contain" in label *
00P-1329 Permit dietary supplement manufacturer to include the phrase *
00V-1512 Laser light show*

78N-0038 Sunscreen Drug Products

C 582 Playtex Products, Inc Vol#: 145

C 583 The Estee Lauder Companies Inc. Vol#: 145

C 584 Hawaiian Tropic Tanning Research Lab,Inc Vol#: 145

C 585 Japan Cosmetic Industry Assn Vol#: 145

EMC 4 Fusaro RM, et al Vol#: 145

95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

EMC 25 Lisa Levine, M.D. Vol#: 4

EMC 26 Cybrgrace Vol#: 4

EMC 27 Emily Harting Vol#: 4

EMC 28 Health Care For All Vol#: 4

EMC 29 Amy Strenke Vol#: 4

EMC 30 St. Edward's University Vol#: 4

EMC 31 Jonathan Perloe Vol#: 4

EMC 32 Paul Wilkins Vol#: 4

EMC 33 Goodman Research Group, Inc. Vol#: 4

EMC 34 Central Mnnesota Sexual Assault Ctr. Vol#: 4

EMC 35 Emily Cronbach Vol#: 4

EMC 36 Georgians for Choice Vol#: 4

EMC 37 J. Ford Vol#: 4

EMC 38 Michaela Poepping Vol#: 4

EMC 39 Sarah Lawrence College Vol#: 4

EMC 40 Theresa S. Wiggins Vol#: 4

EMC 41 Christy Sherman, Ph.D. Vol#: 4

EMC 42 Cara Roper Vol#: 4

EMC 43 Susan Edwards Vol#: 4

EMC 44 Tara Reddy Vol#: 4

EMC 45 Joanna B. Vol#: 4

EMC 46 Peter H. Jones, Ph.D. Vol#: 4

98F-0484 Closure-Sealing Gaskets for Food Containers

NFR 1 Vol#: 1

98N-0331 Medical Devices;Implementation third party review under FDA

C 8 Entela, Inc. Vol#: 1

C 9 UL Vol#: 1

99D-4910 Mammography Quality Standards Act Final Regulations #3

C 40 Institute for Mammography Research, Inc. Vol#: 1
 
 

99F-0127 Safe use of trimethylolethane as a dispersant for pigment

NFR 1 Vol#: 1
 
 

99P-2630 Establish a Daily Value for "added sugars"

EC 25 Ms. Goodwin Elizabeth Vol#: 11

EC 26 PE Retired Vol#: 11

00D-1407 Safety Pharmacology Studies for Human Pharmaceuticals

C 4 Schering Corp. Vol#: 1
 
 

00D-1434 Waiver for Immediate Release Solid Oral Dosage Forms Based

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1
 
 

00N-0836 Environmental Impact Considerations

N 3 Vol#: 1

SS 1 Supporting Statement Vol#: 1
 
 

00N-0928 Request for Samples & Protocols; Agency Information Collecti

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1

00N-0930 Nominations for Working Groups: Pharmaceutical Science AC

C 1 VCU, Virginia Commonwealth University Vol#: 1
 
 

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

CH 640 Phyllis Toyra Vol#: 24

CH 641 John J. Fisher Vol#: 24

CH 642 Kathryn Seitz Vol#: 24

CH 643 Helene & John Vachet Vol#: 24

CH 644 Susan Yokota Vol#: 24

CH 645 Pippa Newell Vol#: 24

CH 646 Emily Cronbach Vol#: 24

CH 647 Angela Herring, MD Vol#: 24

00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal

C 32 Nukewatch Vol#: 6

C 33 Sun Orchard Inc Vol#: 6

C 34 EM Maleson,D Porcello,L Papandrea,A Rupp Vol#: 6

EC 49 Mr. Conor Petren Vol#: 6

EC 50 Ms. Nicole Consumer Vol#: 6

EC 51 US Citizen Vol#: 6

EMC 69 Alexis Danzig Vol#: 6

EMC 70 Erik Wiatr Vol#: 6

EMC 71 Henry Reed Vol#: 6

EMC 72 sric2 Vol#: 6

EMC 73 Susan Westmoreland Vol#: 6

EMC 74 Frank Mix Vol#: 6

EMC 75 Robert M Behr Vol#: 6

EMC 76 Dave Wittmer Vol#: 6

EMC 77 Miriam Reed Vol#: 6

EMC 78 J Rehrich Vol#: 6

EMC 79 James Hopson Vol#: 6

EMC 80 Tim Deller Vol#: 6

EMC 81 William I Peltz Vol#: 6

EMC 82 James Kovacs Vol#: 6

EMC 83 Cheryl A Becker Vol#: 6

EMC 84 Bonnie Nethercutt Vol#: 6

EMC 85 Deborah Sweet Vol#: 6

EMC 86 Thomas J Montagno PhD Vol#: 6

EMC 87 Wm McCall Vol#: 6

EMC 88 Laura J Haas Vol#: 6

EMC 89 Kathleen Fegan Vol#: 6

EMC 90 Janie Kazas Vol#: 6

EMC 91 Kenneth Scott Vol#: 6

EMC 92 Robert A Kluson PhD Vol#: 6

EMC 93 Greg Wingard Vol#: 6

EMC 94 Marcia Hoodwin Vol#: 6

EMC 95 Joe Myers Vol#: 6

EMC 96 Fred Jakobcic Vol#: 6

EMC 97 deedub Vol#: 6

EMC 98 Clem Wilkes Vol#: 6

EMC 99 S Locke Bogart Vol#: 6

EMC 100 Carol Dombrovski Vol#: 6

EMC 101 Mitch Lau Vol#: 6

00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop

C 16 Wampole Labs., Inc. Vol#: 1
 
 

00N-1449 Changes to an Approved NDA or ANDA;Agency Information Collec

N 1 Vol#: 1
 
 

00N-1467 Hepatitis B Surface Antigen;Agency Information Collection

N 1 Vol#: 1

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

EMC 2116 Janet Bobertz Vol#: 243

EMC 2117 Erin Eberle Vol#: 243

EMC 2118 Catherine Yu Vol#: 243

EMC 2119 Mary Gibson Vol#: 243

EMC 2120 Robert Fuller Vol#: 243

EMC 2121 Suzanne Cooper Vol#: 243

EMC 2122 Jeanne Hegeman Vol#: 243

EMC 2123 A. Helen Steely Vol#: 243

EMC 2124 Mollie Peters Vol#: 243

EMC 2125 Shane Powell Vol#: 243

EMC 2126 Madelyn Gratop Vol#: 243

EMC 2127 Julie Weldon Vol#: 243

EMC 2128 Kristina Gravette Vol#: 243

EMC 2129 Selene Hall Vol#: 243

EMC 2130 Mark Dolce Vol#: 243

EMC 2131 Jeff Sharp Vol#: 243

EMC 2132 Llse-D Bear Vol#: 243

EMC 2133 Linda Mauser Vol#: 243

EMC 2134 Ellen Finkelstein Vol#: 243

EMC 2135 Anne-Marie Mitchell Vol#: 243

EMC 2136 Richard Kemp Vol#: 243

EMC 2137 Kathy Stranc Vol#: 243

EMC 2138 Anne Finan Vol#: 243

EMC 2139 Jodi Alberts Vol#: 243

EMC 2140 Donna Hoaglin Vol#: 243

EMC 2141 Mitch Romanowski Vol#: 243

EMC 2142 Jennifer Dirking Vol#: 243

EMC 2143 Nels Olson Vol#: 243

EMC 2144 Robert Bliss Vol#: 243

EMC 2145 Alice Michelbach Ph.D Vol#: 243

EMC 2146 David Wolfe Vol#: 243

EMC 2147 Lisa DeLange Vol#: 243

EMC 2148 Arlene Manns Vol#: 243

EMC 2149 Sharlene Carney Vol#: 243

EMC 2150 D. Soman Vol#: 243

EMC 2151 Jean Flynn Vol#: 243

EMC 2152 Tony Novelli Vol#: 243

EMC 2153 Nathan Donnelly Vol#: 243

EMC 2154 Gary Small Vol#: 243

EMC 2155 Virginia Heick Vol#: 243

EMC 2156 Walter Barnes Vol#: 243

EMC 2157 Gary Webb Vol#: 243

EMC 2158 Ray Wenger Vol#: 243

EMC 2159 Nick Hoffman Vol#: 243

EMC 2160 Susan Prager Vol#: 243

EMC 2161 Jessica Cersosimo Vol#: 243

EMC 2162 Ignacio Moreno Semhan Vol#: 243

EMC 2163 Mary LaFrance Vol#: 243

EMC 2164 Chris Kozura Vol#: 243

EMC 2165 Deborah Johnson Vol#: 243

EMC 2166 Marilyn Kendall Vol#: 243

EMC 2167 Emily Willoughby Vol#: 243

EMC 2168 Martin Hughes Vol#: 243

EMC 2169 Carlena Schroeder Vol#: 243

EMC 2170 Deborah Walston Vol#: 243

EMC 2171 Lynne Moore Vol#: 243

EMC 2172 Willduisa Doanes Vol#: 243

EMC 2173 Penelope Curtis Vol#: 243

EMC 2174 Barbara Bogner Vol#: 243

EMC 2175 Tim King Vol#: 243

EMC 2176 Frankie Summers Vol#: 243

EMC 2177 Lisa Bearsley Vol#: 243

EMC 2178 Lauri Wild Vol#: 243

EMC 2179 Solomon Goldstein Vol#: 243

EMC 2180 Susan McClellan Vol#: 243

EMC 2181 Deborah Carney Vol#: 243

EMC 2182 Holley White Vol#: 243

EMC 2183 Tim Wright Vol#: 243

EMC 2184 Sue Voelkel Vol#: 243

EMC 2185 John R. Anderson Vol#: 243

EMC 2186 Josh Miller Vol#: 243

EMC 2187 Susie Silva Vol#: 243

EMC 2188 Valerie Hendrix Vol#: 243

EMC 2189 Christopher Swier Vol#: 243

EMC 2190 Diane Ford Vol#: 243

EMC 2191 Cynthia Lewis Vol#: 243

EMC 2192 Kay Kole Leary Vol#: 243

EMC 2193 Mary Ennis Vol#: 243

EMC 2194 Jan Nelson Vol#: 243

EMC 2195 Paul de Spa Vol#: 243

EMC 2196 Don Fox Vol#: 243

EMC 2197 Allison Memmo Vol#: 243

EMC 2198 H. J. Richardson Vol#: 243

EMC 2199 Greg Bowman Vol#: 243

EMC 2200 Margaret Lancaster Vol#: 243

EMC 2201 Carol Brown Vol#: 243

EMC 2202 Jesse Amesimeku Vol#: 243

EMC 2203 Miriam Jones Vol#: 243

EMC 2204 Lyle Krych Vol#: 243

EMC 2205 Bridget Baird Vol#: 243

EMC 2206 Beth Hewitt Vol#: 243

EMC 2207 Frank James Vol#: 243

EMC 2208 Mark Swindells Vol#: 243

EMC 2209 Keith Leaning Vol#: 243

EMC 2210 Jim & Phyllis Pierce Vol#: 243

EMC 2211 Mark Himeda Vol#: 243

EMC 2212 Janine Y. Carroll Vol#: 243

EMC 2213 Amy Flanary Vol#: 243

EMC 2214 Birchill Swanson Vol#: 243

EMC 2215 Lea Cullen Vol#: 243

EMC 2216 Gene J. Koprowski Vol#: 243

EMC 2217 A. Jean Anderson Vol#: 243

EMC 2218 Jill Rubin Vol#: 243

EMC 2219 Joshua Barclay Vol#: 243

EMC 2220 David Latham Vol#: 243

EMC 2221 Anne Gray Vol#: 243

EMC 2222 Kristin Hood Vol#: 243

EMC 2223 Ameet Ravital Vol#: 243

EMC 2224 Max Feirstein Vol#: 243

EMC 2225 Kathleen Norbut Vol#: 243

EMC 2226 Joan Gibson Vol#: 243

EMC 2227 Matt Adams Vol#: 243

EMC 2228 Nue Ah-nee Vol#: 243

EMC 2229 Amber L. Kershman Vol#: 243

EMC 2230 Sharon Spriggs Vol#: 243

EMC 2231 Zahed Ali Vol#: 243

EMC 2232 Donna Cowman Vol#: 243

EMC 2233 Joshua Farley Vol#: 243

EMC 2234 Jeff Payson Vol#: 243

EMC 2235 Steve Weigner Vol#: 243

EMC 2236 Sarah Mann Vol#: 243

EMC 2237 Terrilyn Bayne Vol#: 243

EMC 2238 Hilary Flowers Vol#: 243

EMC 2239 Amber Kershman Vol#: 243

EMC 2240 Marguerite Czajka Vol#: 243

EMC 2241 Vb4mny Vol#: 243

EMC 2242 Julie Knowles Vol#: 243

EMC 2243 Cha Smith Vol#: 243

EMC 2244 Terry Reed Vol#: 243

EMC 2245 Deb Asch Vol#: 243

EMC 2246 Doris Reller Vol#: 243

EMC 2247 Johnny Vance Vol#: 243

EMC 2248 Lisa Ledwidge Vol#: 243

EMC 2249 Buntoon Srethasirote Vol#: 243

EMC 2250 Richard Cichon Vol#: 243

EMC 2251 Pedma-Dorje Wright Vol#: 243

EMC 2252 Bryan Winget Vol#: 243

EMC 2253 Samuel DeFazio Vol#: 243

EMC 2254 Dutch Van Spell Vol#: 243

EMC 2255 J. M. Faltas Vol#: 243

EMC 2256 Matthew DeCoster Vol#: 243

EMC 2257 Robin Blier Vol#: 243

EMC 2258 Niki Nash Vol#: 243

00P-1297 Permit an OTC drug mfg to include "may contain" in label

ACK 3 HFA-305 Vol#: 1

CP 3 Consumer Healthcare Products Assoc (CHPA Vol#: 1

00P-1329 Permit dietary supplement manufacturer to include the phrase

ACK 2 HFA-305 Vol#: 1

CP 2 Consumer Healthcare Products Assoc (CHPA Vol#: 1
 
 

00P-1439 Iceberg Water Deviating From Identity Standard

N 1 Vol#: 1

00V-1512 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 Steve White Vol#: 1