Table of Contents

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

C 1058 Form Letter count 6 Vol#: 32

C 1059 Petro Pryshepa Vol#: 31

C 1060 Richard & Diane Kaminski Vol#: 31

C 1061 Nancy A Mack & Melvin C Mack Vol#: 31

C 1062 Theodore Tremulis Vol#: 31

C 1063 Alfred P Wehner DMD SCd Vol#: 31

C 1064 Marilyn F Woodall Vol#: 31

C 1065 Edward G Denten Vol#: 31

C 1066 The Miller's Vol#: 31

C 1067 Ida M Turan Vol#: 31

C 1068 Ellen Rosten Vol#: 31

C 1069 Carol N Pickel Vol#: 31

C 1070 F Vance Tilley Vol#: 31

C 1071 Donald J Robinson Vol#: 31

C 1072 Edith W Lee Vol#: 31

C 1073 Miriam C Murray Vol#: 31

C 1074 Form Letter count 4 Vol#: 33

C 1075 Elliott Frauenglass, PhD Vol#: 31

C 1076 Elaine J Sherman Vol#: 31

C 1077 Charles L Crist MD Vol#: 31

C 1078 Richard L Wilson Vol#: 31

C 1079 Marlea Rice Warren Vol#: 31

C 1080 Geraldine Lasniewski Vol#: 31

C 1081 Ruby Stanley, Laurence Stanley Vol#: 31

C 1082 Joan Ruane Vol#: 31

C 1083 Marie T Gould Vol#: 31

C 1084 Mary A Bartel Vol#: 31

C 1085 Joan M Coyle Vol#: 31

C 1086 K F Emerick Vol#: 31

C 1087 unsigned Vol#: 31

C 1088 Joseph R Heffron Vol#: 31

C 1089 Kenneth Ledford & Associates Inc Vol#: 31

C 1090 F David Mconald DDS Vol#: 31

C 1091 Bryan Leyton MD Vol#: 31

C 1092 James A McMahon Vol#: 31

C 1093 William L Freeman Vol#: 31

C 1094 Bob & Joan Heian Vol#: 31

EMC 7 Form Letter count 3 Vol#: 34

EMC 8 Harvard School of Public Health Vol#: 31

EMC 9 Harvard School of Public Health Vol#: 31

EXT 5 Snack Food Association Vol#: 31

94S-0120 510K Substantially Equivalent List

LST 90 December 1999 510k Monthly Vol#: 20

LST 91 Cumulative 510K, January - December 1999 Vol#: 21

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

C 9618 3M Minnesota Mining & Manufacturing Co Vol#: 197

C 9619 Congress of the United States Vol#: 197

C 9620 Congress of the United States Vol#: 197

97N-0074 President's National Food Safety Initiative

C 203 Joyce Janicki Vol#: 12

C 204 Marliese Bonk Vol#: 12

C 205 Lyn Rosen Vol#: 12

C 206 D McCormick Vol#: 12

C 207 Form Letter count 2 Vol#: 19

EMC 1 Crystal S Marshall Vol#: 12

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

C 283 Chris Ellison Vol#: 18

C 284 Ray L Walter Vol#: 18

C 285 Rose Falcetta Vol#: 18

C 286 Peg Zilch, Sam Barner Vol#: 18

C 287 Karen G Lyke Vol#: 18

C 288 George Oliner Vol#: 18

C 289 Alice Christiana Vol#: 18

C 290 Mary Kilgallen Vol#: 18

C 291 Ruth Homalion Vol#: 18

C 292 Alice Mercer Vol#: 18

C 293 Colette Bertarn Vol#: 18

C 294 Elynore Tedeschi Vol#: 18

C 295 Jeannette P Matysuk Vol#: 18

C 296 Doris Lowell Vol#: 18

C 297 Douglas Rumpa Vol#: 18

C 298 Anthony Lewan Vol#: 18

C 299 Genevieve Dudash Vol#: 18

C 300 Blanche Roberts Vol#: 18

C 301 Beverly Roberts Vol#: 18

C 302 Bridget Smith Vol#: 18

C 303 C Holloway Vol#: 18

C 304 Pat Walker Vol#: 18

C 305 Leila Nance Vol#: 18

C 306 Martha Velardo Vol#: 18

C 307 Ethel Willis Vol#: 18

C 308 Mary C Aurigemma, Louis J Aurigemma Vol#: 18

C 309 Donald R Lorentz, Helen L Lorentz Vol#: 18

C 310 Doris C Scherer Vol#: 18

C 311 Betty Ladd Vol#: 18

C 312 Eunice Neilsen Vol#: 18

C 313 David G Willbur Jr Vol#: 18

C 314 Guadalupe Garcia Vol#: 18

C 315 Mary A Altharis Vol#: 18

C 316 Sultan A Ali Vol#: 18

C 317 Dr Douglas E Wingeier Vol#: 18

C 318 William R Steinberg Vol#: 18

C 319 Joseph Loisel Vol#: 18

C 320 National Food Processors Association Vol#: 18

C 321 Everett W Henson Vol#: 18

EMC 27 Lianne Epstein Vol#: 18

EMC 28 Kathy Cromartie Vol#: 18

EMC 29 Dawn Robinson Vol#: 18

TR 6 Transcript 7/15/99 Workshop Vol#: 19

TR 7 Transcript 7/16/99 Workshop Vol#: 20

TS 1 Testimony 7/15-16/99 Workshop Vol#: 21

98D-0969 Effects of antimicrobial new animal drugs/use in food-produc

NCR 1 Vol#: 3

NCR 2 Vol#: 3

98H-1202 Civil Money Penalties; Lake Sammamish Mini Mart Inc & Bruce

R 1 GCF-1 Vol#: 1

98N-0044 Effect of dietary supplement on structure/function of body

BKG 2 Background Vol#: 879

C 22402 Hon David E Bonior (CI) Vol#: 876

NFR 1 Vol#: 878

REF 5 References Vol#: 880

98P-0145 Requirements for demonstrating In Vivo Bioequivalence

C 18 Biovail Corporation International Vol#: 6

99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA

N 1 Vol#: 3

99D-5347 Transmission of Zoonoses By Blood and Blood Products

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

99F-5523 Safe Use of Acidified Sodium Chlorite Solutions

EA 1 Environmental Assessment Vol#: 1

NFL 1 Vol#: 1

99H-1330 Civil Money Penalties;Caldwell's Inc,d/b/a Caldwell's Coasta

EXB 2 Caldwell's Inc,dba Caldwell's Coastal Vol#: 1

99H-1491 Civil Money Penalties;Central Village Grocers Inc,d/b/a Jack

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1619 Civil Money Penalty; Del Goebel dba G & S Gas

M 1 HF-3 Vol#: 1

SUP 1 Del Goebel, dba G-S Gas Vol#: 1

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

EXB 1 GCF-1 Vol#: 1

99H-4216 Civil Money Penalty;Jamie W Howell Sr,dba Huckster's Mart

LET 2 Office of Tobacco Programs Vol#: 1

99H-4266 Civil Money Penalty;Pramod Handa,dba Acton Sunoco

SET 1 GCF-1 Vol#: 1

99H-4504 Civil Money Penalty;Paul A. lellamo Sr and Paul A lellamo

LET 2 Office of Tobacco Programs Vol#: 1

99H-4514 Civil Money Penalty;Donald J. Parker,dba Sports Corral

LET 2 Office of Tobacco Programs Vol#: 1

99H-4706 Civil Money Penalty;Helen's Party Store Inc,dba Helen's Part

LET 2 Office of Tobacco Programs Vol#: 1

99H-4729 Civil Money Penalty;Aurora Petroleum Co,dba Fastgas II

LET 2 Office of Tobacco Programs Vol#: 1

LET 3 Office of Tobacco Programs Vol#: 1

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

LET 2 Office of Tobacco Programs Vol#: 1

99H-4889 Civil Money Penalty;High's of Baltimore Incorporated,dba Hig

LET 2 Office of Tobacco Programs Vol#: 1

99H-5376 Civil Money Penalty;Charles Phillips;dba The Boy's Food Stor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5390 Civil Money Penalty;The Pumper,Inc;dba Blimpie Subs and Sala

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5464 Civil Money Penalty;Community Oil Co.,Inc;dba Community Food

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5465 Civil Money Penalty;Cooperative Supply Inc;dba Cenex Coopera

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5466 Civil Money Penalty;Cumberland Farms,Inc;dba Cumberland Farm

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5467 Civil Money Penalty;Debban, Inc;dba Terry's Chevron

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5470 Civil Money Penalty;John Franklin and Anthony Fanelli;dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5477 Civil Money Penalty;L & L Foods,Inc;dba L & L Food Stores #6

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5478 Civil Money Penalty;McCabe Enterprises, Inc and Larry McCabe

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5479 Civil Money Penalty;Mike's Auto Clinic,Inc;dba Mike's Auto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5480 Civil Money Penalty;Donnie Pack;dba Pack's Grocery & Bakery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5481 Civil Money Penalty;Jeff Palmer,Betty Palmer,and Gail Davis

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5482 Civil Money Penalty;Puget Sound Stations,Inc;dba Delridge AM

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5483 Civil Money Penalty;Rocket Oil Company;dba Ideal Station #10

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5484 Civil Money Penalty;Rocky Top Markets,LLC;dba Rocky Top #28

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5485 Civil Money Penalty;Asad Siddiqui;dba Mobil Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5486 Civil Money Penalty;Ahmed Tariq;dba C J Getty Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5487 Civil Money Penalty;Tobacco Outlet, Inc;dba Tobacco Outlet

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5488 Civil Money Penalty;Town & Country No.1,Inc;dba Town & Count

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5489 Civil Money Penalty;Dharmesh Vakil;dba Brookline Sunoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5490 Civil Money Penalty;Wal-Mart Stores,Inc;dba Wal-Mart Super

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5491 Civil Money Penalty;Jeffrey Wilson and Izetta Wilson;dba Wil

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5527 Civil Money Penalty;Butler Drugs,Inc;dba Butler Drugs

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5528 Civil Money Penalty;Atlantic Highland Shell,Inc;dba David

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5529 Civil Money Penalty;Dipak Kumar Patel;dba Harry's Package St

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5530 Civil Money Penalty;Don W. Haney Enterprises,Inc;dba Don's I

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5531 Civil Money Penalty;Holtkamp Automotive Repair,Inc;dba Holt

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5532 Civil Money Penalty;Inara, Inc;dba Mobil Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5533 Civil Money Penalty;Jim & Dorothy,Inc;dba Bay Shore Food Mar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5534 Civil Money Penalty;John Savarino;dba Dixwell Mini Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5535 Civil Money Penalty;Kwik Trip, Inc;dba Kwik Star #714

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5536 Civil Money Penalty;Mahendra U. Patel;dba New Haven Wine &

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5557 Civil Money Penalty;A & A Food Basket,Inc;dba A & A Foods

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5558 Civil Money Penalty;Allsup's Convenience Stores,Inc;dba All

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5559 Civil Money Penalty;Barry Debower;dba Townhouse Lounge

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5560 Civil Money Penalty;Bradford Corporation;dba Bradford House

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5561 Civil Money Penalty;Brian Napoli;dba Mattatuck News & Variet

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5562 Civil Money Penalty;Daniel De La Cruz;dba D & T Mini Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5563 Civil Money Penalty;Debra M.Snyder;dba M & M Convenience Sto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5564 Civil Money Penalty;Edward Jacobs;dba Jake's Express

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5565 Civil Money Penalty;Henicle's Market, Inc;dba Henicle's Mark

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5566 Civil Money Penalty;Jim Obenshain & Betty Obenshain;dba Ham

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5567 Civil Money Penalty;Larry Skidmore;dba Stop & Go

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5568 Civil Money Penalty;Mobil Mart,Inc;dba Mobil Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5569 Civil Money Penalty;Robert Jillson, Juliane Jillson,& David

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5570 Civil Money Penalty;Santiago Rodriguez;dba Ismairy Liquors

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5571 Civil Money Penalty;Walgreen Co;dba Walgreens #3192

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5581 Civil Money Penalty;Evergreen Oil Company;dba Stop 'N Save

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5582 Civil Money Penalty;Deli-Mart, Inc;dba Fourth Street Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5583 Civil Money Penalty;JT. Cap, Inc;dba Easton Crown

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5584 Civil Money Penalty;Kyu Sok Chong;dba Michael's Grocery Stor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5585 Civil Money Penalty;Ok Cha Kim;dba Pearl Kai Mini Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5586 Civil Money Penalty;Phillip's Sub Shop,Inc;dba Corner Carry

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99N-1415 Supplements and other changes to aproved NADA

REF 2 OMB Review for 10/1/99 FR Vol#: 2

99N-4490 Withdrawn or removed from the market for reasons of Safety

BKG 1 BACKGROUND Vol#: 1

NPR 1 Vol#: 1

99N-5002 Acupuncture Devices and Accessories

N 1 Vol#: 1

99P-1658 Codify Existing Practice to determine Active Ingredients

LET 1 HFD-1 Vol#: 1

99P-2554 Administrative Action Against E. Excel International

PDN 1 HFC-1 Vol#: 10

99P-2733 ANADA for Ketanil 200 (Ketamine Hydrochloride Inj.

ACK 2 HFA-305 Vol#: 1

PRC 1 Wildlife Labs, Inc. Vol#: 1

00H-0093 Civil Money Penalty;B-H-T Investment Company,Inc;dba Conoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0094 Civil Money Penalty;Kayla Brumfield;dba A & J General Mercha

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0095 Civil Money Penalty;Merit Oil of Massachusetts,Inc;dba Merit

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0096 Civil Money Penalty;Paul Lautigar;dba ICO Convenience Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0097 Civil Money Penalty;Pride Convenience,Inc;dba Pride

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0098 Civil Money Penalty;W.H. Smith,Inc;dba W.H. Smith News and

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0099 Civil Money Penalty;Bailey Oil Co.,Inc;dba Hub Plaza

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0100 Civil Money Penalty;Country Fair,Inc;dba Country Fair Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0101 Civil Money Penalty;C S I Mart,Inc;dba Kwik Stop Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0102 Civil Money Penalty;Farman Elahi;dba Chestnut Park Dairy Sto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0104 Civil Money Penalty;Harold B. Chrisley;dba Shop-EEZ

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0107 Civil Money Penalty;Steve & Paul's Getty,Inc;dba Getty

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00P-0117 ANADA Suitability for Lincomycin-Spectinomycin Water Soluble

ACK 1 HFA-305 Vol#: 1

CP 1 Phoenix Scientific Inc Vol#: 1

00V-0135 Variance Laserium CSLP Projector

ACK 1 HFA-305 Vol#: 1

VAR 1 Peppermill Casino Vol#: 1