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]

DOCKETS ENTERED on July 29, 1999

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]

 
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
97P-0197 Require that warning labels about risks of salmonella enteri *
98N-0617 Treatment of Narcotic Dependence*
98N-1038 Irradiation in the production, processing, &handling of food *
98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell *
98N-1265 Distribution of Compounded Drug Products *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-2547 Alendronate Sodium Tablets *
99P-2548 Performance Standard for Electrode Lead Wires *
99V-2536 Laser Light Show *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

C 1 B Sachao Vol#: 2

C 2 Emily A Fano MA Vol#: 2

C 3 Mary Lou Randour, PhD Vol#: 2

C 4 Andrea Heaton Vol#: 2

C 5 Diana Moreton Vol#: 2

C 6 Rose Reina-Rosenbaum Vol#: 2

C 7 Jane Hoffman Vol#: 2

C 8 Anne Johnson Vol#: 2

C 9 Constance M Faust Vol#: 2

EC 1 William McMullin Vol#: 2

97P-0197 Require that warning labels about risks of salmonella enteri

C 2 B Sachao Vol#: 1

C 3 Emily A Fano MA Vol#: 1

C 4 Mary Lou Randour, PhD Vol#: 1

C 5 Andrea Heaton Vol#: 1

C 6 Diana Moreton Vol#: 1

C 7 Rose Reina-Rosenbaum Vol#: 1

C 8 Jane Hoffman Vol#: 1

C 9 Anne Johnson Vol#: 1

C 10 Constance M Faust Vol#: 1

EC 1 William McMullin Vol#: 1

98N-0320 Health Claim or Nutrient Content Claim;Information Collectio

N 3 Vol#: 1

S 1 Vol#: 1

98N-0617 Treatment of Narcotic Dependence

EC 1 Paul (privacy request) Vol#: 1

98N-1038 Irradiation in the production, processing, &handling of food

C 4258 Christina Ittermann Vol#: 105

C 4259 Christina Ittermann Vol#: 105

C 4260 Marilyn Atteberry Vol#: 105

C 4261 Donna Stellhorn Vol#: 105

C 4262 John G. Hibbs, N.D. Vol#: 105

C 4263 Ruth A. Pryor, M.D. Vol#: 105

C 4264 Brett R. Skelton Vol#: 105

C 4265 Carolyn Vol#: 105

C 4266 Wendy Anderson Vol#: 105

C 4267 Robert Wolf Vol#: 105

C 4268 American Assn of Nutritional Consultants Vol#: 105

C 4269 Joyce Jenkins Vol#: 105

C 4270 Joe King Vol#: 105

C 4271 Laura Hagen Vol#: 105

C 4272 Andrew R. Hutchison Vol#: 105

C 4273 Bonnie Wodin Vol#: 105

C 4274 Jessica Kespohl Vol#: 105

C 4275 Jahcob Harp Vol#: 105

C 4276 Jane Kochersperger Vol#: 105

C 4277 Christina Burkhouse Vol#: 105

C 4278 Heidi Hanson Vol#: 105

C 4279 Len Maceachron Vol#: 105

C 4280 Michael Mazzetti Vol#: 105

C 4281 David Fonye Vol#: 105

C 4282 Trish Gorman Vol#: 105

C 4283 Daniel Greycloud Jacob Vol#: 105

C 4284 M. Miyzaan-Kendrick Vol#: 105

C 4285 Daniel Cantor Vol#: 105

C 4286 Mark Knapp Vol#: 105

C 4287 Russell M. Pirkot Vol#: 105

C 4288 Wayne & Tina Moody Vol#: 105

C 4289 Will & Ellie Siegel Vol#: 105

C 4290 Annamaria Laverty & Robert Wisniewski Vol#: 105

C 4291 Dorothy A. Hickman Vol#: 105

C 4292 Juliana Barnet Vol#: 105

C 4293 Betty Long Vol#: 105

C 4294 Yoshika Ikuta Vol#: 105

C 4295 Jessica Chandler Vol#: 105

C 4296 Chris Olds Vol#: 105

C 4297 Amy A. Hansen Vol#: 106

C 4298 Thomas J. Kjolsing Vol#: 106

C 4299 Alice Slater Vol#: 106

C 4300 Leslie Emmons Vol#: 106

C 4301 Ann Tubbs Vol#: 106

C 4302 Claire B. Feder Vol#: 106

C 4303 Donald J. Hepner Vol#: 106

C 4304 Corinne Carey et al Vol#: 106

C 4305 Elsa Beystrum Vol#: 106

C 4306 Janet Allen Vol#: 106

C 4307 Ernest Goitein Vol#: 106

C 4308 Brenda Hendricks Vol#: 106

C 4309 Kevin Mayer Vol#: 106

C 4310 Nancy Long Vol#: 106

C 4311 Mae T. Hendricks Vol#: 106

C 4312 Stephen P. Roseman Vol#: 106

C 4313 James C. Frinier Vol#: 106

C 4314 Marianne Kink Vol#: 106

C 4315 Diane L. Dover Vol#: 106

C 4316 Barbara W. Hart Vol#: 106

C 4317 Rose Hirschfeld Vol#: 106

C 4318 Mady H. Schichor Vol#: 106

C 4319 Aric Schichor Vol#: 106

C 4320 Neda H. Vol#: 106

C 4321 AEI-Brookings Joint Ctr for Regulatory S Vol#: 106

C 4322 Ileana Grams Vol#: 106

C 4323 Laura R. Waldman Vol#: 106

C 4324 S. N. Vol#: 106

C 4325 Susan DuBois Vol#: 106

C 4326 Sandra Thomas Vol#: 106

C 4327 Summer Stahl Vol#: 106

C 4328 Sanjeev Balajee Vol#: 106

C 4329 Eleanor Uhlop Vol#: 106

C 4330 Jim Vol#: 106

C 4331 Russel & Math Beth Kujan Vol#: 106

C 4332 David Lapoint Vol#: 106

C 4333 Roy K. Smith Vol#: 106

C 4334 Megan Bates Gardner Vol#: 106

C 4335 L. I. Alliance Vol#: 106

C 4336 Susan M. Gruca Vol#: 106

C 4337 Mrs. Paul T. Burch Vol#: 106

C 4338 Donna Brogan Vol#: 106

C 4339 Michael Harvey Vol#: 106

C 4340 Jennifer Reimenschneider Vol#: 106

C 4341 Kim Fiola Vol#: 106

C 4342 Marilyn Pelrine & family Vol#: 106

LET 3 HFW-14 to John Breaux (CI) Vol#: 106

LET 4 HFW-14 to Charles E. Grassley (CI) Vol#: 106

LET 5 HFW-14 to Mr. Stephen P. Kunz Vol#: 106

LET 6 HFW-14 to Wally Herger (CI) Vol#: 106

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

C 1 B Sachao Vol#: 1

C 2 Emily A Fano MA Vol#: 1

C 3 Mary Lou Randour, PhD Vol#: 1

C 4 Andrea Heaton Vol#: 1

C 5 Diana Moreton Vol#: 1

C 6 Rose Reina-Rosenbaum Vol#: 1

C 7 Jane Hoffman Vol#: 1

C 8 Anne Johnson Vol#: 1

C 9 Constance M Faust Vol#: 1

EC 1 William McMullin Vol#: 1

98N-1265 Distribution of Compounded Drug Products

C 4487 Michelle D Warner Vol#: 148

C 4488 Margaret Theis Vol#: 148

C 4489 Marilyn J Stevenson Vol#: 148

C 4490 Holly A Ruff PhD Vol#: 148

C 4491 Dianne P Burnett Vol#: 148

C 4492 Coreen O Murray Vol#: 148

C 4493 David Brasington Vol#:

C 4494 J C English Vol#: 148

C 4495 Barbara E Clauss Vol#: 148

C 4496 Verna Ikehara Vol#: 148

C 4497 Claire Halbardier Vol#: 148

C 4498 Mary Williams Vol#: 148

C 4499 S Kaye Nolen Vol#: 148

C 4500 Raymond Nolen Vol#: 148

C 4501 Judith A Kayser Vol#: 148

C 4502 Doris Waggoner Vol#: 148

C 4503 Lillian Frederiksen Vol#: 148

C 4504 Wendy Huggins Vol#: 148

C 4505 Bernadette Jasinski Vol#: 148

C 4506 Meyer Scharlack Vol#: 148

C 4507 Melvin Baldwin Vol#: 148

C 4508 Judy Conklin Vol#: 148

C 4509 Patricia Rackowski Vol#: 148

C 4510 Julie Hayward Vol#: 148

C 4511 Carol M Sullivan Vol#: 148

C 4512 Laura Maggi Vol#: 148

C 4513 Debbie Athanasiou Vol#: 148

C 4514 Sophia Haritos Vol#: 148

C 4515 Judith McNea Vol#: 148

C 4516 Diane C Nixon Vol#: 148

C 4517 Gloria Bruns Vol#: 148

C 4518 Janet Liberati Vol#: 148

C 4519 Mrs Nancy Stevens Vol#: 148

C 4520 Michaeline Brucken Vol#: 148

C 4521 Susan Goldsmith Vol#: 148

C 4522 M A Muharemovic MD Vol#: 148

C 4523 Lew Anneder MD Vol#: 148

C 4524 Lois Farakee Vol#: 148

C 4525 Carole Krones Vol#: 148

C 4526 Alison L Denning Vol#: 148

C 4527 Louise Arganbright Vol#: 148

C 4528 Iola Hedinger Vol#: 148

C 4529 Helen Silberlight Vol#: 148

C 4530 Audrey M Jennings-Fetzer Vol#: 148

C 4531 Josephine G Merrell Vol#: 148

C 4532 Judith Konopnicki Vol#: 148

C 4533 Carol Reo Vol#: 148

C 4534 Mary Clare Donnelly Vol#: 148

C 4535 May Phillips Vol#: 148

C 4536 Maureen A O'Hara Vol#: 148

C 4537 Terry Armour Vol#: 148

C 4538 Diane S Kravarik Vol#: 148

C 4539 Marilyn Levine Vol#: 148

C 4540 Marie Spodek Vol#: 148

C 4541 Lea Carlson Vol#: 148

C 4542 Roslyn Hyman Vol#: 148

C 4543 Denise M Zehr Vol#: 148

C 4544 Christine Kozyra Vol#: 148

C 4545 J S Page Vol#: 148

C 4546 Diane B Robinette Vol#: 148

C 4547 Ernest C Taylor Vol#: 148

C 4548 M Bedrick Vol#: 148

C 4549 Dr Marilyn Jean Hauser Vol#: 148

C 4550 Heidi Cornehls Vol#: 148

C 4551 Louise Arganbright Vol#: 148

C 4552 Laurie W Stoelting Vol#: 148

C 4553 Lydia Shoup Vol#: 148

C 4554 Rita Scharfer Vol#: 148

C 4555 Roberta Piell Vol#: 148

C 4556 Lois E Forabee Vol#: 148

C 4557 D R Scott Vol#: 148

C 4558 Gloria L Patrick Vol#: 148

C 4559 Frida Kehrer Vol#: 148

C 4560 Julie Writer Vol#: 148

C 4561 Nathalie Mruk Vol#: 148

C 4562 Louise Mingis Vol#: 148

C 4563 Pierina Valenti Vol#: 148

C 4564 Nancy Friedwald Vol#: 148

C 4565 Barbara Burke Vol#: 148

C 4566 Patricia Davis Vol#: 148

C 4567 Patrick & Mary Busha Vol#: 148

C 4568 Diane R Gradus Vol#: 148

C 4569 Marylynee Eiseman Vol#: 148

C 4570 Carole McCarthy Vol#: 148

C 4571 Erntrude H Heaver Vol#: 148

C 4572 Edward T Adams Vol#: 148

C 4573 Sally Reiher Vol#: 148

C 4574 Elizabeth Doucette Vol#: 148

C 4575 Tom & Linda Huckstorf Vol#: 148

C 4576 Lee Adkins Vol#: 148

C 4577 Eleanse Shaffer Vol#: 148

C 4578 Joan Cassella Vol#: 148

C 4579 Betty Jo Ham Vol#: 148

C 4580 Evelyn Swanson Vol#: 148

C 4581 T Raczkowski Vol#: 148

C 4582 F M Lavaglio Vol#: 148

C 4583 Michael Johnson Vol#: 148

C 4584 Frieda King Vol#: 148

C 4585 Diane Mignano Vol#: 148

C 4586 Jacquelyn B Holz Vol#: 148

C 4587 Martha Keller & Bradford Ensminger Vol#: 148

C 4588 Evelyn B Harrold Vol#: 148

99H-1961 Civil Money Penalty;Kenneth Estes,dba Estes General Store

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-1974 Civil Money Penalty;Rocky Mountain Pharmacy of Estes Park

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-2313 Civil Money Penalty;Alves Service Ctr Inc,dba Alves Cunoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2314 Civil Money Penalty; C J C Sales Inc,dba J D's Quick Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2315 Civil Money Penalty;Mi Suk Chance,dba Ann's Place

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2316 Civil Money Penalty;DB Companies Inc,dba Dairy Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2317 Civil Money Penalty;Ghasan Eid,dba Town Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2318 Civil Money Penalty;E-Z Serve Convenience Stores Inc,dba E-Z

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2319 Civil Money Penalty;Friendly Express Inc,dba Friendly Expres

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2320 Civil Money Penalty;Jimmy D Griffin,dba Tobacco Shoppe

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2321 Civil Money Penalty;Hartz Foods Inc,dba Hartz Foods #12

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2322 Civil Money Penalty;Steven Hipes,dba 7-Eleven Food Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2323 Civil Money Penalty;Harold Hurlbut,dba Dorsett-Mckelvey Mobi

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2324 Civil Money Penalty;Nick Hussain & Rubina Hussain,dba Open

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2325 Civil Money Penalty;Kobal Inc,dba Fall River Texaco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2326 Civil Money Penalty;Paul W Kuesel,dba D & P's Lounge

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2327 Civil Money Penalty;Lepiers' Inc,dba :Lepiers

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2328 Civil Money Penalty;Balti Manibog,dba Kukui Grove Self-Serve

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2329 Civil Money Penalty;Steve Marrow,dba Home Town Cafe

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2330 Civil Money Penalty;Olimpio Massa,dba Family Meat Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2331 Civil Money Penalty;Emma Matthews,dba Highpoint Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2332 Civil Money Penalty;Edna E Moss,dba Moss

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2333 Civil Money Penalty;James M Nail,dba Nail's One Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2334 Civil Money Penalty;The Stop & Shop Co Inc,dba Stop & Shop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2340 Civil Money Penalty;B L Super Market Inc,dba B & L Supermark

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2341 Civil Money Penalty;Camden Oil Co LLC,dba Conoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2342 Civil Money Penalty;Harr of Maryland Inc,dba Jim's IGA

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2343 Civil Money Penalty;Robin Heck,dba B&C Liquor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2344 Civil Money Penalty;Kenny's Market Inc,dba Kenny's Markets

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2345 Civil Money Penalty;Chong Yul Kim,dba Union Mills Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2346 Civil Money Penalty;William Love,dba Love Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2347 Civil Money Penalty;PBS Inc and Para H Smith,dba J & B Packa

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2348 Civil Money Penalty;Sheetz Inc,dba Sheetz #46

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-2349 Civil Money Penalty;Bill Young,dba Young's Fine Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1337 Clara Garber Vol#: 21

C 1338 Ellen McConnell Vol#: 21

C 1339 Lesley Williams Vol#: 21

C 1340 Norma Sporn Vol#: 21

C 1341 Leta Willhouse Vol#: 21

C 1342 Charles L. Tezzly Vol#: 21

C 1343 Dr. Vivienne Perkins Vol#: 21

C 1344 Harriet Pace Vol#: 21

C 1345 Connie & Michael Schmotzer Vol#: 21

C 1346 Susan Berndt Vol#: 21

C 1347 Irene L. Lasko Vol#: 21

C 1348 Joyce Kusheba Vol#: 21

C 1349 Jean Mitchell Vol#: 21

C 1350 K. Anderson Vol#: 21

C 1351 Joyce Stoffers Vol#: 21

C 1352 Jayni & Chevy Chase Vol#: 21

C 1353 Jackie Johnson Vol#: 21

C 1354 Doug La Follette Secretary of State Vol#: 21

C 1355 Portia Vol#: 21

C 1356 Evelyn Anderman Vol#: 21

C 1357 Margaret Gregg Vol#: 21

C 1358 Carolyn D. Moore Vol#: 21

C 1359 Eleanor DiFranco Vol#: 21

C 1360 Evelyn Durkee Vol#: 21

C 1361 Margaret H. Knutson Vol#: 21

C 1362 James M. Garden Vol#: 21

C 1363 Thelma M. Segal Vol#: 21

C 1364 John Walter, M.D. Vol#: 21

C 1365 Marsha A. McDaniel Vol#: 21

C 1366 Jennifer Oppenheim Vol#: 21

C 1367 Lois Montalbano Vol#: 21

C 1368 Debbie Floyd Vol#: 21

C 1369 Susan A. Austin Vol#: 21

99P-2547 Alendronate Sodium Tablets

ACK 1 HFA-305 Vol#: 1

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

99P-2548 Performance Standard for Electrode Lead Wires

ACK 1 HFA-305 Vol#: 1

CP 1 PACEART Associates, L.P. Vol#: 1

99V-2536 Laser Light Show

ACK 1 HFA-305 Vol#: 1