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 July 30, 2002

TABLE OF CONTENTS

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98N-0046 Comprehensive List of Current Guidance Documents at FDA *
98N-0359 Program priorities/Center for Food Safety & Applied Nutritin *
98N-1215 Foreign Establishment Registration and Listing *
99D-5046 Human Blood & Blood Components Intended for Transfusion *
00D-1562 Clinical Data In Marketing Applications *
01D-0064 Encapsulated Amalgam,Amalgam Alloy & Dental Mercury Labeling *
01N-0234 Food Contact Substance Notification System *
01P-0120 Ban Unsafe IV Catheters and other Devices *
01P-0533 Determine whether Rubrmin PC 1mg/mL & 10-ml has been volunta *
01P-0572 Petition for Regulation of Ariva Tobacco Lozenges *
02D-0232 S7B Pharmacology Studies re:Potential Delayed Ventricular Re *
02D-0237 QIE Evaluation of Stability Data *
02D-0242 Pharmacy Compounding Compliance Policy Guide *
02N-0101 Amfepramone(diethylpropion) Amineptine; Burprenorphine *
02N-0209 Governing First Amendment Case Law *
02N-0253 Withdrawal of 53 Guidances on Individual Product Labeling *
02P-0075 Flavored Candy-like Products Containing Tobacco *
02P-0120 Request the immediate ban of Meridia (sibutramine) *
02P-0207 SRNT petition to regulate SF Garrett's Nicotine Water *

77N-0318 Penicillin & Tetracycline and all Combinations

C 203 Number Not Used Vol#: 4

78N-0038 Sunscreen Drug Products

EC 2 Mrs. BJ Baydowicz Vol#: 146

85V-0324 VARIANCE RE PROJECTOR FOR LASER LIGHT SHOW/LUXME MOD 1001

VRA 8 HFZ-1 to Laser Spectacles, Inc. Vol#: 1

91V-0204 Laser Light Show

VRA 6 HFZ-1 to Mare-Bare, Inc./dba Stardust H Vol#: 1

95N-253J Jurisdiction nicotine cigarette/smokeless tobacco products

C 1624 Diane Wilson Vol#: 752

C 1625 Dawn Gross Vol#: 752

C 1626 Walter Ramsey Vol#: 752

C 1627 L. L. Hurst Vol#: 752

98N-0046 Comprehensive List of Current Guidance Documents at FDA

EC 3 Medicsight Vol#: 1

98N-0359 Program priorities/Center for Food Safety & Applied Nutritin

EC 8 National Latex Allergy Network Vol#: 7

98N-1215 Foreign Establishment Registration and Listing

EC 13 Streamlining, Incorporated Vol#: 2

99D-5046 Human Blood & Blood Components Intended for Transfusion

EC 6 S & D Merchandise Vol#: 1

99V-2974 Projector for Laser Light Show

VRA 3 HFZ-1 to L and L Productions Vol#: 1

00D-1562 Clinical Data In Marketing Applications

EC 6 Fred Hutchinson Cancer Research Center Vol#: 1

01D-0064 Encapsulated Amalgam,Amalgam Alloy & Dental Mercury Labeling

C 1 American Dental Education Assn (ADEA) Vol#: 1

01N-0234 Food Contact Substance Notification System

EC 2 LUBRICANTES RALOY Vol#: 1

01N-0548 Guidelines for Voluntary Nutrition Labeling of Raw Fruits

EC 1 Ms. Nani Sexton Vol#: 1

01P-0120 Ban Unsafe IV Catheters and other Devices

EC 9 Terumo Medical Corp Vol#: 1

EC 10 Medamicus Inc. Vol#: 1

01P-0533 Determine whether Rubrmin PC 1mg/mL & 10-ml has been volunta

LET 2 HFD-7 to PharmaForce, Inc. Vol#: 1

01P-0572 Petition for Regulation of Ariva Tobacco Lozenges

C 9 Attorneys General of California et al. Vol#: 1

RC 1 Star Scientific, Inc. Vol#: 1

01V-0497 Laser Light Show

VRA 1 HFZ-1 to Abracadabra Superstore Vol#: 1

02D-0232 S7B Pharmacology Studies re:Potential Delayed Ventricular Re

C 2 Merck & Co., Inc. Vol#: 1

02D-0237 QIE Evaluation of Stability Data

C 1 Merck & Co., Inc. Vol#: 1

02D-0242 Pharmacy Compounding Compliance Policy Guide

C 1 McGuff Compounding Pharmacy Services, In Vol#: 1

02N-0101 Amfepramone(diethylpropion) Amineptine; Burprenorphine

M 1 HFD-430 to Office of Drug Safety-Postmak Vol#: 1

M 2 HFD-430 to OPDRA Vol#: 1

02N-0152 Obtain Timely Pediatric Studies & Adequate Pediatric Labelin

C 148 D. de la Cruz, MD Vol#: 4

02N-0209 Governing First Amendment Case Law

C 13 American Medical Assn Vol#: 5

EC 152 Mr. Jerry Lopeman Vol#: 4

EC 153 Mrs. Christie D. Michas Vol#: 4

EC 154 Mr. Peter Michas Vol#: 4

EC 155 Ms. Gabriella Roleff Vol#: 4

EC 156 Mr. Ray Gebauer Vol#: 4

EC 157 Mr. RON STEPHENS Vol#: 4

EC 158 Ms. Leigh Mouring Vol#: 4

EC 159 Dr. Robert Lookabaugh Vol#: 4

EC 160 Mannatech Vol#: 4

EC 161 Mrs. Carol Rempel Vol#: 4

EC 162 Miss Nichole Rice Vol#: 4

EC 163 Mrs. Linda Clark Vol#: 4

EC 164 YMCA Vol#: 4

EC 165 Mr. Steven Keller Vol#: 4

EC 166 Mrs. Diane Mueller, RN Vol#: 4

EC 167 Mrs. Ruth Oystol Vol#: 4

EC 168 Products of Distinction Vol#: 4

EC 169 Mrs. Allison Gilbert Vol#: 4

EC 170 MANNATECH INDEPENDANT DISTRIBUTOR Vol#: 4

EC 171 Mr. Wynn Fernandes Vol#: 4

EC 172 Ms. Mariko Hayashi-Hall Vol#: 4

EC 173 Mr. Franklin Johnson Vol#: 4

EC 174 Mrs. Charla Cupit Vol#: 4

EC 175 Mrs. Ida Flowers Vol#: 4

EC 176 Mr. Eric Donahue Vol#: 4

EC 177 Mr. Charles Hicks Vol#: 4

EC 178 Mannatech Vol#: 4

EC 179 Mr. Tom Clark Vol#: 4

EC 180 Dr. Jan Morse Vol#: 4

EC 181 Ms. Alexandra Burchette Vol#: 4

EC 182 Mrs. Janet Swift Vol#: 4

EC 183 Mrs. Barbara Neller Vol#: 4

EC 184 Mr. Glen TeVault Vol#: 4

EC 185 Mr. David Wallin Vol#: 4

EC 186 mannatech Vol#: 4

EC 187 Number Not Used Vol#: 4

EC 188 Mrs. Barbara Cochern Vol#: 4

EC 189 Ms. Dusty Hughes Vol#: 4

EC 190 Mrs. Stephanie Reed Vol#: 4

EC 191 Mr. John Schmitt Vol#: 4

EC 192 Ms. Christine bell Vol#: 4

EC 193 MannaHealth Consultants International Vol#: 4

EC 194 Ms. Martha Goodwin Vol#: 4

EC 195 Blessed Health Vol#: 4

EC 196 Family Health Manna Vol#: 4

EC 197 Ms. Margaret Little Vol#: 4

EC 198 Mirrorr Records Vol#: 4

EC 199 NIKKEN INC. Vol#: 4

EC 200 Dr. Budweiser Hawkins Vol#: 4

EC 201 Klees Remodeling and Restoration Vol#: 4

EC 202 Advanced Wellness Technology Vol#: 4

EC 203 Mr. Wesley Flanary Vol#: 4

EC 204 Mr. Robert Anderson Vol#: 4

EC 205 Dr. Pete Diffenderfer Vol#: 4

EC 206 Mr. Raymond Ahner Vol#: 4

EC 207 World health & Wellness Network Vol#: 4

EC 208 Ms. Jo Cooper Vol#: 4

EC 209 Texas Realty Vol#: 4

EC 210 Ms. Denise McDermott Vol#: 4

EC 211 Mannatech Inc. Vol#: 4

EC 212 Mr. Christopher Torres Vol#: 4

EC 213 none Vol#: 4

EC 214 Dr. Ron Violet Vol#: 4

EC 215 Mr. Carl Kellogg Vol#: 4

EC 216 California State Univ. Vol#: 4

EC 217 Mr. DINO KARAMITSOS Vol#: 4

EC 218 Ms. Patricia Nellans Vol#: 4

EC 219 Dr. David Wilkins Vol#: 4

EC 220 none Vol#: 4

EC 221 Mrs. Carol Thiessen Vol#: 4

EC 222 Mrs. Sharon Thomas Vol#: 4

EC 223 Mrs. Mavis Douglass Vol#: 4

EC 224 Mrs. Beth M. Davis Vol#: 4

EC 225 Mrs. Cynthia Ayers Vol#: 4

EC 226 Mrs. Carol Troyer Vol#: 4

EC 227 Ms. Rita Kampf Vol#: 4

EC 228 Mrs. Rebecca Arrington Vol#: 4

EC 229 Independent Mannatech Associate Vol#: 4

EC 230 RLW Enterprises Vol#: 4

EC 231 Mr. George DeCarlo Vol#: 4

EC 232 Mrs. Carol Enderson Vol#: 4

EC 233 Ms. Jan Barosh Vol#: 4

EC 234 Number Not Used Vol#: 4

EC 235 Mr. Brian Clark Vol#: 4

EC 236 Mannatech distributor Vol#: 4

EC 237 Mr. Gary Webb Vol#: 4

EC 238 Mannatech Vol#: 4

EC 239 Mannatech Vol#: 4

EC 240 Mannatech Vol#: 4

EC 241 Mannatech Vol#: 4

EC 242 Mannatech Vol#: 4

EC 243 Internation Home Business Online Vol#: 4

EC 244 Mrs. June Steen Vol#: 4

EC 245 Ms. S. Stone Vol#: 4

EC 246 Mannataeh Inc. Vol#: 4

EC 247 None Vol#: 4

EC 248 N/A Vol#: 4

EC 249 Mrs. Jill Welker Vol#: 4

02N-0215 Export Certificates

EC 5 Number Not Used Vol#: 1

02N-0253 Withdrawal of 53 Guidances on Individual Product Labeling

EC 3 Number Not Used Vol#: 1

EC 4 Number Not Used Vol#: 1

EC 5 Global Wellness & Wealth 101 Vol#: 1

EC 6 Mrs. Carol Rempel Vol#: 1

EC 7 Mrs. Tanya Mullakady Vol#: 1

EC 8 Number Not Used Vol#: 1

EC 9 Phytolink Vol#: 1

EC 10 G & J Enterprise Vol#: 1

EC 11 Mrs. Dicksey higgins Vol#: 1

EC 12 Ms. Sarah Walz Vol#: 1

EC 13 Mr. Marvin Larrew Vol#: 1

02P-0075 Flavored Candy-like Products Containing Tobacco

C 9 Attorneys General of California et al. Vol#: 1

RC 1 Star Scientific, Inc. Vol#: 1

02P-0120 Request the immediate ban of Meridia (sibutramine)

C 3 American Assn for Clinical Chemistry (AA Vol#: 1

02P-0207 SRNT petition to regulate SF Garrett's Nicotine Water

C 1 Star Scientific, Inc. Vol#: 1

02V-0201 Laser Light Show

VRA 1 HFZ-1 to AV-Pro Inc. Vol#: 1

02V-0240

VRA 1 HFZ-1 to Lazerus Laser Systems Vol#: 1

02V-0301

VRA 1 HFZ-1 to Counter Clockwise Productions Vol#: 1

02V-0323

VRA 1 HFZ-1 to The Hamlet on Olde Oyster Bay Vol#: 1