Table of Contents

75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

C 53 SDA/CTFA Vol#: 60

90P-0201 Optimum size & Style of print to be used to label OTC Drugs

NFR 2 Vol#: 7

92S-0181 Substances Exempt from Threshold of Regulation, Food Additiv

LST 11 List of exemptions Vol#: 1

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 1016 A Kostal Vol#: 25

C 1017 H Blackledge Vol#: 25

C 1018 J Seror Vol#: 25

C 1019 K Carver Vol#: 25

C 1020 M Porter Vol#: 25

C 1021 Technical Foods Consultants Vol#: 25

C 1022 M Gayle Vol#: 25

C 1023 K Mason Vol#: 25

C 1024 J Mendelsohn Vol#: 25

C 1025 R Rand Vol#: 25

C 1026 J Trovato Vol#: 25

C 1027 C Schmitz Vol#: 25

C 1028 Nutrition and Fatty Acid Research Vol#: 25

C 1029 L McClean Vol#: 25

C 1030 J Bergen Vol#: 25

C 1031 E Powell Vol#: 25

C 1032 L Wolford Vol#: 25

C 1033 Community Health Centers of King County Vol#: 25

C 1034 L O'Drudy Jr Vol#: 25

C 1035 C Pickel Vol#: 25

C 1036 A Limboch Vol#: 25

C 1037 G Vokoun Vol#: 25

EMC 2 ajzpaz Vol#: 25

EXT 1 American Frozen Food Institute Vol#: 25

EXT 2 Frozen Potato Products Institute Vol#: 25

EXT 3 Chocolate Mfg Assn/National Confectioner Vol#: 25

EXT 4 Institute of Shortening & Edible Oils In Vol#: 25

REF 2 Coronary Heart Disease & Angina Pectoris Vol#: 25

95N-0259 Over the Counter Drug Labeling; Public Hearing

NFR 2 Vol#: 12

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients

RPT 55 Solgar Vitamin and Herb Vol#: 37

RPT 56 Biocare Medical Technology for N/A/T/O Vol#: 37

96N-0420 OTC Human Drugs; Proposed Labeling Requirements

NFR 2 Vol#: 24

97N-0511 Procedures the safe and sanitary processing/importing juice

C 275 B Collige Vol#: 14

C 276 N Tortorich Vol#: 14

C 277 S Grainger Vol#: 14

C 278 J Lemmer Vol#: 14

C 279 K Groves Vol#: 14

C 280 Citrus Grower Associates Inc Vol#: 14

C 281 A Concerned Citizen Vol#: 14

C 282 K Singh Vol#: 14

EMC 17 J Muller Vol#: 14

EMC 18 D Carter Vol#: 14

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

C 188 Form letters count 6 Vol#: 10

C 189 Baylor Sports Medicine Institute Vol#: 9

C 190 R Kelley Vol#: 9

C 191 New Jersey Medical School Vol#: 9

C 192 West Alabama Neurosurgical Spine Consult Vol#: 9

C 193 Fertility & Surgical Associates of Calif Vol#: 9

C 194 TSBC, Reporductive Technologies, Inc Vol#: 9

C 195 The Hinsdale Center For Reproduction Vol#: 9

C 196 MCP Hahnemann University Vol#: 9

C 197 Orthopaedic Institute of Dayton, Inc. Vol#: 9

C 198 Orthopaedic Associates of Bethlehem, Inc Vol#: 9

C 200 Infertility & Gynecology Institute Vol#: 9

C 201 Verkauf, Bernhisel & Tarantino, M.D.'s Vol#: 9

C 202 Central FL. Lions Eye & Tissue Bank, Inc Vol#: 9

C 203 Musculoskeletal Tumor Society Vol#: 9

C 204 Carolinas Medical Center Vol#: 9

C 205 Tulsa Ctr For Fertility & Women's Health Vol#: 9

C 206 AAOS Vol#: 9

C 207 Reproductive Medicine Center Vol#: 9

C 208 Central Ohio Neurological Surgeons Vol#: 9

C 209 UMDNJ, New Jersey's University of the Hl Vol#: 9

C 210 Fertility Center of Northwest Ohio Vol#: 9

C 211 The Center for Reproductive Medicine Vol#: 9

C 212 S Silber Vol#: 9

C 213 Eye Bank Assn. of America Vol#: 9

C 214 A Neuman Vol#: 9

C 215 national Marrow Donor Program Vol#: 9

C 216 Nashville Fertility Center Vol#: 9

C 217 Ke-Hui Cui Vol#: 9

C 218 Rocky Mountain Ctr. For Reproductive Med Vol#: 11

C 219 Mayo Clinic Vol#: 11

C 220 Rocky Mountain Lions Eye Bank Vol#: 11

C 221 MTF, Musculsskeletal Transplant Foundati Vol#: 11

C 222 American Assn. of Tissue Banks Vol#: 11

C 223 Lions Eye Bank of West Central Ohio Vol#: 11

C 224 Indiana Lions Eye Bank Vol#: 11

C 225 Bascom Palmer Eye Institute Vol#: 11

C 226 American Red Cross Vol#: 11

C 227 King & Spalding Vol#: 11

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

LET 4251 Maharishi Ayur-ved Products Int., Inc. Vol#: 30

LET 4252 Maharishi Ayur-ved Products Int., Inc. Vol#: 30

LET 4253 Maharishi Ayur-ved Products Int., Inc. Vol#: 30

LET 4254 Maharishi Ayur-ved Products Int., Inc. Vol#: 30

LET 4255 Rexall Showcase International Vol#: 30

LET 4256 Rexall Showcase International Vol#: 30

LET 4257 Rexall Showcase International Vol#: 30

LET 4258 Rexall Showcase International Vol#: 30

LET 4259 Rexall Showcase International Vol#: 30

LET 4260 Rexall Showcase International Vol#: 30

LET 4261 Whitehall-Robins Healthcare Vol#: 30

LET 4262 Whitehall-Robins Healthcare Vol#: 30

LET 4263 E'OLA International Inc Vol#: 30

LET 4264 E'OLA International Inc Vol#: 30

LET 4265 E'OLA International Inc Vol#: 30

LET 4266 E'OLA International Inc Vol#: 30

LET 4267 E'OLA International Inc Vol#: 30

LET 4268 E'OLA International Inc Vol#: 30

LET 4269 E'OLA International Inc Vol#: 30

LET 4270 E'OLA International Inc Vol#: 30

LET 4271 E'OLA International Inc Vol#: 30

LET 4272 E'OLA International Inc Vol#: 30

LET 4273 E'OLA International Inc Vol#: 30

LET 4274 DRJ Group Inc Vol#: 30

LET 4275 China Shanxi 030012 Vol#: 30

LET 4276 Ocean Essentials Vol#: 30

LET 4277 Herbs Etc Inc Vol#: 30

LET 4278 Herbs Etc Inc Vol#: 30

LET 4279 Herbs Etc Inc Vol#: 30

LET 4280 Herbs Etc Inc Vol#: 30

LET 4281 Herbs Etc Inc Vol#: 30

LET 4282 Herbs Etc Inc Vol#: 30

LET 4283 Herbs Etc Inc Vol#: 30

LET 4284 Health From The Sun Vol#: 30

LET 4285 Health From The Sun Vol#: 30

LET 4286 Health From The Sun Vol#: 30

LET 4287 Health From The Sun Vol#: 30

LET 4288 Health From The Sun Vol#: 30

LET 4289 Health From The Sun Vol#: 30

LET 4290 Health From The Sun Vol#: 30

LET 4291 Health From The Sun Vol#: 30

LET 4292 Health From The Sun Vol#: 30

LET 4293 Health From The Sun Vol#: 30

LET 4294 Health From The Sun Vol#: 30

LET 4295 Health From The Sun Vol#: 30

LET 4296 Health From The Sun Vol#: 30

LET 4297 Health From The Sun Vol#: 30

LET 4298 Health From The Sun Vol#: 30

LET 4299 Health From The Sun Vol#: 30

LET 4300 Health From The Sun Vol#: 30

LET 4301 Health From The Sun Vol#: 30

LET 4302 Natures Answer Inc Vol#: 30

LET 4303 Standard Process Inc Vol#: 30

LET 4304 Standard Process Inc Vol#: 30

LET 4305 Standard Process Inc Vol#: 30

LET 4306 General Nutrition Corporation Vol#: 30

LET 4307 Melaleuca Inc Vol#: 30

LET 4308 Melaleuca Inc Vol#: 30

LET 4309 Melaleuca Inc Vol#: 30

LET 4310 Melaleuca Inc Vol#: 30

LET 4311 Melaleuca Inc Vol#: 30

LET 4312 Melaleuca Inc Vol#: 30

LET 4313 Melaleuca Inc Vol#: 30

LET 4314 Food Science Corporation Vol#: 30

LET 4315 Food Science Corporation Vol#: 30

LET 4316 Food Science Corporation Vol#: 30

LET 4317 Food Science Corporation Vol#: 30

LET 4318 Food Science Corporation Vol#: 30

LET 4319 Food Science Corporation Vol#: 30

LET 4320 Food Science Corporation Vol#: 30

LET 4321 Food Science Corporation Vol#: 30

LET 4322 Food Science Corporation Vol#: 30

LET 4323 Food Science Corporation Vol#: 30

LET 4324 Food Science Corporation Vol#: 30

LET 4325 Food Science Corporation Vol#: 30

98N-0337 Over the counter human drugs labeling requirements

C 3 CTFA Vol#: 4

NFR 2 Vol#: 4

99D-4396 Financial Disclosure By Clinical Investigators

C 1 MedImmune Inc Vol#: 1

C 2 Covance Clinical Development Services In Vol#: 1

C 3 GlaxoWellcome Inc Vol#: 1

C 4 Merck & Co Inc Vol#: 1

C 5 Alcon Research Ltd Vol#: 1

C 6 Abbott Laboratories Vol#: 1

C 7 PhRMA Vol#: 1

C 8 HIMA Vol#: 1

C 9 Bristol-Myers Squibb Pharmaceutical Rese Vol#: 1

C 10 Medtronic Inc Vol#: 1

C 11 AstraZeneca Vol#: 1

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

GDL 1 Guidance Vol#: 1

NAD 1 Vol#:

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

MO 4 GCF-1 Vol#: 1

99H-1450 Civil Money Penalties;Sheree Montgomery,d/b/a Montgomery

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-1922 Civil Money Penalty;Lippe's Package Store Inc,& Robert Hayne

ANS 1 Lippe's Package Store Vol#: 1

99H-1955 Civil Money Penalty;Camellia Food Stores Inc,dba Be-Lo #121

ANS 1 Camellia Food Stores Inc Vol#: 1

99H-1963 Civil Money Penalty;Naegler Brothers Inc,dba Fast-N-Friendly

LET 2 Office of Tobacco Programs Vol#: 1

99H-2457 Civil Money Penalty;Zamiri's Arco,dba Arco AM/PM

MO 1 GCF-1 Vol#: 1

99H-4012 Civil Money Penalty;Ingrams Market,dba Ingrams Market

EXB 1 GCF-1 Vol#: 1

99H-4031 Civil Money Penalty;Fareway Stores Inc,dba Fareway Store #55

LET 2 Office of Tobacco Programs Vol#: 1

99H-4310 Civil Money Penalty;Mala Patel,dba A to Z Convenience Store

LET 2 Office of Tobacco Programs Vol#: 1

99H-4671 Civil Money Penalty;Lester Olson & Mary Ann Olson,dba mary

ANS 1 Mary Ann's Bar Vol#: 1

99H-4696 Civil Money Penalty;Costco Management Services Inc,dba All

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4730 Civil Money Penalty;Aurora Petroleum Co,dba Fatgas III

LET 2 Office of Tobacco Programs Vol#: 1

99H-4748 Civil Money Penalty;Linson 2 Inc,dba 7-Eleven Store #26753

BRF 1 GCF-1 Vol#: 1

99H-4756 Civil Money Penalty;Riley Ent Inc,dba Riley's Crown

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4778 Civil Money Penalty;May's Drug Stores, Inc;The Drug Warehous

LET 2 Office of Tobacco Programs Vol#: 1

99H-4822 Civil Money Penalty;The Three E Corp,dba Family Pride IGA

LET 2 Office of Tobacco Programs Vol#: 1

99H-4882 Civil Money Penalty;Bayview Pharmacy Inc,dba Bayview Pharmac

ANS 1 Bayview Pharmacy Inc Vol#: 1

99H-4911 Civil Money Penalty;A S K Inc,dba B & V Market

LET 2 Office of Tobacco Programs Vol#: 1

99H-4923 Civil Money Penalty;High's of Baltimore Incorporated,dba Hig

LET 2 Office of Tobacco Programs Vol#: 1

99H-4924 Civil Money Penalty;J & J Park Inc,dba J & J Discount Liquor

LET 2 Office of Tobacco Programs Vol#: 1

99H-4939 Civil Money Penalty;Westover Food Mart Inc,dba Westover Food

LET 2 Office of Tobacco Programs Vol#: 1

99H-4996 Civil Money Penalty;So-Lo Foods, Inc;dba Valu Foods Supermar

ANS 1 So-Lo foods Inc,dba Valu Foods Supermark Vol#: 1

99H-5003 Civil Money Penalty;Suk In Chung & Haeng Ja Chung,dba Vermon

EXT 1 Vermont News & Variety Vol#: 1

99H-5036 Civil Money Penalty;Robert Cox;dba Victorian Spirits II

LET 2 Office of Tobacco Programs Vol#: 1

99H-5131 Civil Money Penalty;J & J Greer, Inc;dba Oasis Liquors

LET 2 Office of Tobacco Programs Vol#: 1

99H-5506 Civil Money Penalty;Go-Mart, Inc;dba Go-Mart #22

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5507 Civil Money Penalty;Brad Harrison;dba Lakeview Shell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5508 Civil Money Penalty;Hole In The Wall,Inc;dba Hole In The Wal

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5509 Civil Money Penalty;Houchens Industries,Inc;dba W.R.Houchens

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5510 Civil Money Penalty;Houchens Industries,Inc;dba W.R. Houchen

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5511 Civil Money Penalty;Ronald Un Bae Kim;dba D.R. Mini Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5512 Civil Money Penalty;Loring Enterprises, L.L.C.;dba Glenmont

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5513 Civil Money Penalty;Meteor Stores,Inc;dba Meteor Stores Inc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5514 Civil Money Penalty;Steve B. Miller;dba S.B. Miller's A Plus

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5515 Civil Money Penalty;Pic Quik Stores, Inc;dba Pic Quik Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5516 Civil Money Penalty;Margarita Richardson;dba Evergreen Stati

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5517 Civil Money Penalty;Superlube, Incorporated;dba Leitchfield

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5518 Civil Money Penalty;Whiskey Barrell, Inc;dba Whiskey Barrell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5540 Civil Money Penalty;Albertson's, Inc;dba Albertson's #815

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5541 Civil Money Penalty;B & D Shell, Inc;dba B & D Shell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5542 Civil Money Penalty;Sam Duncan; Hilltop Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5543 Civil Money Penalty;Erie Petroleum, Inc;dba Holiday Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5544 Civil Money Penalty;Handy Stop Corporation;dba Handy Stop #1

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5545 Civil Money Penalty;Kagg, Inc;dba Hurricane Mini Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5546 Civil Money Penalty;Jose Loaiza;dba New Corner Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5547 Civil Money Penalty;Safeway Stores, Incorporated;dba Safeway

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5548 Civil Money Penalty;Scott Road Exxon,LLC;dba Scott Road Exxo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5549 Civil Money Penalty;Shaver's, Inc.;dba Shaver's-McCall #2

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5550 Civil Money Penalty;Larry Walters & Janet Walters;dba Valley

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5551 Civil Money Penalty;Wal-Mart Stores,Inc;dba Wal-Mart #2293

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5552 Civil Money Penalty;Wesson, Inc;dba MOBIL 12

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1