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 30, 1999

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]

92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
96N-0417 CGMP in Packing or Holding Dietary Supplements *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
97N-0074 President's National Food Safety Initiative *
97P-0197 Require that warning labels about risks of salmonella enteri *
98N-0044 Effect of dietary supplement on structure/function of body *
98N-0056 Sec 111(b)Pediatric Studies of list of Approved Drugs FDAMA
98N-1038 Irradiation in the production, processing, &handling of food *
98N-1215 Foreign Establishment Registration and Listing *
98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell *
98N-1265 Distribution of Compounded Drug Products *
98P-0752 Add Cerezyme (imiglucerase for inj) to pediatric priority li *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
98P-1219 Drug products containing oxycodone hydrocloride tablet 
99D-0239 Resolving scientific disputes concerning regulation Medical *
99D-0674 Investigational new drug applications - phase 2&3 of drugs *
99N-1591 Animal Drug Availabililty Act; Veterinary Feed Directive *
99P-0189 Levlite Tablets *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-1589 Stay effective date of approval for NDA 20-932 Roxicodone *
99P-2172 Reclassify ocular prosthetic (artificial eye) lubricant *
99P-2554 Aministrative Action Against E. Excel International *
92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 5682 Susan DuBois Vol#: 133

C 5683 Sandra Thomas Vol#: 133

C 5684 Ryan Nelson Vol#: 133

C 5685 Sherry Slade Vol#: 133

96N-0417 CGMP in Packing or Holding Dietary Supplements

TR 1 Transcript of the July 12, 1999 meeting Vol#: 4

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

C 10 Lorraine Nicotera Vol#: 2

C 11 Peggy Koteen Vol#: 2

97N-0074 President's National Food Safety Initiative

C 79 Assn of American Feed Control Officials Vol#: 10

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

C 11 Lorraine Nicotera Vol#: 1

C 12 Peggy Koteen Vol#: 1

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

C 22334 Kenneth A Little Vol#: 871

C 22335 Rita & Christopher Leydon Vol#: 871

EC 1 Stephen Morrissey OMD Vol#: 871

EC 2 Colorado Biolabs Inc Vol#: 871

EC 3 Erik Flatland Vol#: 871

EC 4 Jill Hups Vol#: 871

98N-0056 Sec 111(b)Pediatric Studies of list of Approved Drugs FDAMA

LET 8 HFD-1 to Genzyme Corp. Vol#: 3

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

C 4343 Victoria Casa-Egan Vol#: 107

C 4344 Dean Davison Vol#: 107

C 4345 Louise E. Bothstein Vol#: 107

C 4346 James D. McCullars, Jr Vol#: 107

C 4347 Sandra Lashuay Vol#: 107

C 4348 D. Harris Vol#: 107

C 4349 Georgina James Vol#: 107

C 4350 James C. Pierce Vol#: 107

C 4351 Lindsay Steven Vol#: 107

C 4352 Diane Pierce Vol#: 107

C 4353 A. Scott Vol#: 107

C 4354 Jacklyn H. Ack Vol#: 107

C 4355 Carrie L. Rausch Vol#: 107

C 4356 David M. Saxby, Jr. Vol#: 107

C 4357 Ellen Betz Vol#: 107

C 4358 J. Wertz Vol#: 107

C 4359 Victoria Parks Vol#: 107

C 4360 Jeff Watt Vol#: 107

C 4361 Carol Branscomb Vol#: 107

C 4362 Char. Dontoprulor Vol#: 107

C 4363 Edward D'Amato Vol#: 107

C 4364 Kris Shreffler Vol#: 107

C 4365 Ann Baird Speer Vol#: 107

C 4366 Russ Wacker Vol#: 107

C 4367 Amy Hall Vol#: 107

C 4368 Daphine Meimaridis Vol#: 107

C 4369 Linda Graff Vol#: 107

C 4370 Susan M. Selleck Vol#: 107

C 4371 Rae Walker Vol#: 107

C 4372 Jonna Vallance Vol#: 107

C 4373 G. Davis Vol#: 107

C 4374 Mr. & Mrs. Mark Glazman Vol#: 107

C 4375 Peter Heilemann Vol#: 107

C 4376 Barbara Clement Vol#: 107

C 4377 NNFA. National Nutritional Foods Assn. Vol#: 107

C 4378 Lynda M. Pitz Vol#: 107

C 4379 Ruth Sutherlin Vol#: 107

C 4380 Eric Goldsmith Vol#: 107

C 4381 Marsha Cederquest Vol#: 107

C 4382 Gloria J. Norris Vol#: 107

C 4383 Jodi B. Wever Vol#: 107

C 4384 Maria Rodreqalz Vol#: 107

C 4385 Jeanne Janson Vol#: 107

C 4386 Elizabeth Russell Vol#: 107

C 4387 Charlotte Brewer Vol#: 107

C 4388 Monique Salas Vol#: 107

C 4389 Michael M. Daily Vol#: 107

C 4390 A. G. Vol#: 107

C 4391 Stephanie Santiago Vol#: 107

C 4392 Ann E. Erbacher Vol#: 107

C 4393 Robert Dorman Vol#: 107

C 4394 Martha Anderson Vol#: 107

C 4395 Rita Whitcomb-Rutter Vol#: 107

C 4396 Dave Tully et al Vol#: 107

C 4397 Deborah Sanchez Vol#: 107

C 4398 Carl Williams Vol#: 107

C 4399 Ryan Nelson Vol#: 107

C 4400 Sherry Slade Vol#: 107

C 4401 Form letter count 13 Vol#: 108

C 4402 Bea Pirro Vol#: 109

C 4403 Ted Pirro Vol#: 109

C 4404 John A. Menz Vol#: 109

C 4405 Donna M. Freher-Lyons Vol#: 109

C 4406 Brunner-Orenshaw House Vol#: 109

C 4407 Diane Fontecchio Vol#: 109

C 4408 Sherine Toppozada-Tully Vol#: 109

C 4409 Y. M. Lee Vol#: 109

C 4410 Diane Ake Vol#: 109

C 4411 Jane Angulo Vol#: 109

C 4412 Charlotte Karotkin Vol#: 109

C 4413 Kally Conway Vol#: 109

C 4414 Felicia T. Vol#: 109

C 4415 Margaret Weston Vol#: 109

C 4416 Ruth Herrington Vol#: 109

98N-1215 Foreign Establishment Registration and Listing

ANS 1 HF-22 to Canadian Embassy Vol#: 1

C 6 Medical Devices Canada Vol#: 1

C 7 Abbott Laboratories Vol#: 1

C 8 Hoffmann-La Roche Inc Vol#: 1

C 9 Janssen Pharmaceutica Research Foundatio Vol#: 1

C 10 Precision BioLogic Inc Vol#: 1

C 11 Merck & Co Inc Vol#: 1

C 12 MDS Nordion Vol#: 1

C 13 Heller Ehrman White & McAuliff Vol#: 1

C 14 Erregierre SpA Vol#: 1

C 15 Asssociation Quebecoise des Fabricants d Vol#: 1

C 16 HFZ-300 Vol#: 1

EC 1 Stephen Brotherston Vol#: 1

EXT 1 Canadian Embassy Vol#: 1

MT 1 HF-23 to Embassy of Canada Vol#: 1

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

C 10 Lorraine Nicotera Vol#: 5

C 11 Peggy Koteen Vol#: 5

98N-1265 Distribution of Compounded Drug Products

C 4589 Evie Henderson Vol#: 149

C 4590 Diana Memme Vol#: 149

C 4591 Milan Delfosse Vol#: 149

C 4592 Cynthia Benben Vol#: 149

C 4593 Barbara L Olson Vol#: 149

C 4594 Shirley A Beaupre Vol#: 149

C 4595 Lynn Edelson Vol#: 149

C 4596 Nancy Baker Vol#: 149

C 4597 Ellen Tattersall Vol#: 149

C 4598 Misa Mihara Vol#: 149

C 4599 S Beattie Vol#: 149

C 4600 Nola Halverson Vol#: 149

C 4601 Suzanne D'Amore Vol#: 149

C 4602 Drew W Davis Vol#: 149

C 4603 Kathy Daigneau Vol#: 149

C 4604 Nancy E Lavatyer Vol#: 149

C 4605 Robert T Brucka Vol#: 149

C 4606 Mary B Sidwell Vol#: 149

C 4607 Ellen Marsden Vol#: 149

C 4608 A Piper Vol#: 149

C 4609 Caroline Blake Vol#: 149

C 4610 Mae Maloney Vol#: 149

C 4611 Darlene D Presser Vol#: 149

C 4612 Cecile Varieur Vol#: 149

C 4613 Rita M Versace PhD Vol#: 149

C 4614 Enid Stevens Vol#: 149

C 4615 Deborah Wencel Vol#: 149

C 4616 Marilu Harper Vol#: 149

C 4617 Maxine Lee Booth Vol#: 149

C 4618 Deborah J Petersen Vol#: 149

C 4619 Thelma J Piche Vol#: 149

C 4620 Pat Bingham Vol#: 149

C 4621 Dorothy Tinkham Vol#: 149

C 4622 Mary Ann Johnson Vol#: 149

C 4623 Della D Hamilton Vol#: 149

C 4624 Betty G Zimmerman Vol#: 149

C 4625 Michele F Beinder Vol#: 149

C 4626 Rosalie M Jones Vol#: 149

C 4627 Faith V Preston Vol#: 149

C 4628 Maria Valdivia Vol#: 149

C 4629 Karen D Fritts Vol#: 149

C 4630 Nancy J Gumm Vol#: 149

C 4631 Linda M Nisler Vol#: 149

C 4632 Hazel E Moore Vol#: 149

C 4633 Karen S Ryba Vol#: 149

C 4634 Gayle M Greco Vol#: 149

C 4635 Janis H Groves Vol#: 149

C 4636 Adrian B Cherney Vol#: 149

C 4637 Betty Radice Vol#: 149

C 4638 Rebecca Rizzo Vol#: 149

C 4639 Anita Dvorak Vol#: 149

C 4640 Ruth F Charlesworth Vol#: 149

C 4641 Linda L Miller Vol#: 149

C 4642 Barbara Nuvith Vol#: 149

C 4643 Marianne Mclaughlin Vol#: 149

C 4644 Deborah Mosca Vol#: 149

C 4645 Jeannine Cook Vol#: 149

C 4646 Sharon Kangas Vol#: 149

C 4647 Estrella L Richter Vol#: 149

C 4648 Carrol Sprouls Vol#: 149

C 4649 Betty B Norman Vol#: 149

C 4650 Drusilla C Vanzant Vol#: 149

C 4651 Pat Holly Vol#: 149

C 4652 Marty Buck Vol#: 149

C 4653 Linda Merkin Vol#: 149

C 4654 Elke Solheim Vol#: 149

C 4655 Elke Solheim Vol#: 149

C 4656 Roberta McIntosh Vol#: 149

C 4657 Regina A Beamer Vol#: 149

C 4658 Sharon Dawson Vol#: 149

C 4659 Nancy Shelly Vol#: 149

C 4660 Hope J Ehrman Vol#: 149

C 4661 L L Zumsteins Vol#: 149

C 4662 Lin Werner Vol#: 149

C 4663 Ron Sackman Vol#: 149

C 4664 Susan L Hommedren Vol#: 149

C 4665 Nancy Capitello Vol#: 149

C 4666 Phyllis J Degenhardt Vol#: 149

C 4667 Marcia Nielsen Vol#: 149

C 4668 Elizabeth C Bennett Vol#: 149

C 4669 Betty Christian-Piere Vol#: 149

C 4670 Deborah Tucker Vol#: 149

C 4671 Dorothy Jansen Vol#: 149

C 4672 Bonnie L Heydeman Vol#: 149

C 4673 Marsha Sprague Vol#: 149

C 4674 Charu Colorado Vol#: 149

C 4675 Nancy B Weinbrenner Vol#: 149

C 4676 Mary Ellen Amero Vol#: 149

C 4677 Susan B Bishop Vol#: 149

C 4678 Dolores M Nicholson Vol#: 149

C 4679 Louise Mathewson Vol#: 149

C 4680 Aymalee Vol#: 149

C 4681 Robin Monteris Vol#: 149

C 4682 Joyce A Reshki Vol#: 149

C 4683 Kathryn K Sullivan Vol#: 149

C 4684 Marti Wyse Vol#: 149

C 4685 Christine Stanfield Vol#: 149

C 4686 Beverly Haas Vol#: 149

C 4687 Kathryn Thomas Vol#: 149

C 4688 Connie Calaway Vol#: 149

C 4689 Eileen Adams Vol#: 149

C 4690 Laura L Vandegrift Vol#: 149

C 4691 Lois S Young Vol#: 149

C 4692 Sharon Watson Vol#: 149

C 4693 Gay Dust Vol#: 149

C 4694 Judy A Solenberger Vol#: 149

C 4695 Kathleen J Stiffler Vol#: 149

C 4696 Cheryl Manhowski Vol#: 149

C 4697 Ouida G Crozier Vol#: 149

C 4698 Carolyn Wiley Vol#: 149

98P-0752 Add Cerezyme (imiglucerase for inj) to pediatric priority li

PAV 1 HFD-1 to Genzyme Corp. Vol#: 1

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 186 Susan DuBois Vol#: 9

98P-1219 Drug products containing oxycodone hydrocloride tablet suita

AMD 3 King & Spalding Vol#: 1

99D-0239 Resolving scientific disputes concerning regulation Medical

C 1 HIMA Vol#: 1

C 2 Medical Device Manufacturers Association Vol#: 1

99D-0674 Investigational new drug applications for phase 2&3 of drugs

C 14 Procter & Gamble Pharmaceuticals Vol#: 1

99H-0769 Civil Money Penalty;James W Mathis,dba Wheel-In Grocery

CR 1 GCF-1 Vol#: 1

LET 3 GCF-1 Vol#: 1

99N-0386 Talking with Stakeholders About FDA Modernization

EC 25 DSM Anti-Infectives Vol#: 3

99N-1591 Animal Drug Availabililty Act; Veterinary Feed Directive

C 1 Purina Mills Inc Vol#: 1

99P-0189 Levlite Tablets

PAV 1 HFD-1 Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

C 207 Eleanor Malmo Vol#: 4

C 208 Joy Hahn Vol#: 4

C 209 Linda Giannoni Vol#: 5

C 210 Rebecca Widom Vol#: 5

C 211 Erin Gabriel Vol#: 5

C 212 Bernice M Celius Vol#: 5

C 213 Connie Sachs Vol#: 5

C 214 Ramma E Andre Vol#: 5

C 215 Yvonne Voigt Vol#: 5

C 216 Norma R Nielsen Vol#: 5

C 217 Alex Vaughan Vol#: 5

C 218 Mildred B Wells Vol#: 5

C 219 Paula Wells Vol#: 5

C 220 Barbara L Poehling Vol#: 5

C 221 Wendy Severinghaus Vol#: 5

C 222 Elaine M Caya Vol#: 5

C 223 John W Ulrich Vol#: 5

C 224 Nancy E Jackson Vol#: 5

EC 1 Pat Gallagher-Carlson Vol#: 5

EC 2 Peggy L Davis Vol#: 5

99P-1589 Stay effective date of approval for NDA 20-932 Roxicodone

C 1 Roxane Laboratories Inc Vol#: 1

SUP 1 Purdue Pharma LP Vol#: 1

99P-2172 Reclassify ocular prosthetic (artificial eye) lubricant

CR 1 HFA-305 Vol#: 1

99P-2554 Aministrative Action Against E. Excel International

ACK 1 HFA-305 Vol#: 1

CP 1 The Health Product Claims Alert Vol#: 1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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