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Dockets Management

Dockets Entered On April 4, 2007
Table of Contents
Docket # Title
1996V-0210 Variance for Laser Light Show
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2003N-0573 Draft Animal Cloning Risk Assessment
2005N-0272 Irradiation in the Production, Processing, and Handling of Food
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2007N-0114 Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
2007N-0123 Amlodipine Abbreviated New Drug Application Approvals
1996V-0210 Variance for Laser Light Show
AMD 2 Lasersmith Light Show Systems, LLC Vol #: 1
LET 1 FDA/DDM to Lasersmith Light Show Systems, LLC Vol #: 1
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 19819 Bio-Botanica Inc Vol #: 174
LET 19820 Garden of Life, Inc. Vol #: 174
LET 19821 Herbalife International of America, Inc. Vol #: 174
LET 19822 NBTY Inc. Vol #: 174
LET 19823 NBTY Inc. Vol #: 174
LET 19824 NBTY Inc. Vol #: 174
LET 19825 NBTY Inc. Vol #: 174
LET 19826 NBTY Inc. Vol #: 174
LET 19827 NBTY Inc. Vol #: 174
LET 19828 NBTY Inc. Vol #: 174
LET 19829 NBTY Inc. Vol #: 174
LET 19830 NBTY Inc. Vol #: 174
LET 19831 NBTY Inc. Vol #: 174
LET 19832 NBTY Inc. Vol #: 174
LET 19833 NBTY Inc. Vol #: 174
LET 19834 NBTY Inc. Vol #: 174
LET 19835 NBTY Inc. Vol #: 174
LET 19836 NBTY Inc. Vol #: 174
LET 19837 New Paradigm Health Systems, Inc. Vol #: 174
LET 19838 Brownwood Acres Foods, Inc. and Flavonoid Sciences Vol #: 174
LET 19839 Melaleuca, Inc. Vol #: 174
LET 19840 Melaleuca, Inc. Vol #: 174
LET 19841 Next Proteins, Inc. Vol #: 174
LET 19842 Chattem, Inc. Vol #: 174
LET 19843 Bodyhealth.com Corporation Vol #: 174
LET 19844 Specialty Nutrition Products, LLC. Vol #: 174
LET 19845 Ajinomoto USA, Inc. Vol #: 174
LET 19846 Ajinomoto USA, Inc. Vol #: 174
LET 19847 Novartis Consumer Health Vol #: 174
LET 19848 Planetary Herbals Vol #: 175
LET 19849 Enzymatic Therapy, Inc. Vol #: 175
LET 19850 Natural Factors Nutritional Products, Inc. Vol #: 175
LET 19851 Natural Factors Nutritional Products, Inc. Vol #: 175
2003N-0573 Draft Animal Cloning Risk Assessment
C 539 D. Hix Vol #: 46
C 540 L. Goldfine Vol #: 46
C 541 D. Jones Vol #: 46
C 542 L. Nelson Vol #: 46
C 543 D. Show Vol #: 46
C 544 P. Valentine Vol #: 46
C 545 J. Corpus Vol #: 46
C 546 G. Kaskel Vol #: 46
C 547 K. Guman Vol #: 46
C 548 C. Holt Vol #: 46
C 549 J. Bianco Vol #: 46
C 550 K. Domenico Vol #: 46
C 551 no signature Vol #: 46
C 552 N. Frazier Vol #: 46
C 553 L. Cappelli Vol #: 46
C 554 R. Bianco Vol #: 46
C 555 J. Conwell Vol #: 46
C 556 P. Albert Vol #: 46
C 557 A. Leinenkugel Vol #: 46
C 558 B. Butler Vol #: 46
C 559 C. Ketelle Vol #: 46
C 560 L. Johnson Vol #: 46
C 561 R. Ali Vol #: 46
C 562 J. McNeill Vol #: 46
C 563 S. Phelps Vol #: 46
C 564 J. Jaworski Vol #: 46
C 565 K. Glover Vol #: 46
C 566 T. Hunt III Vol #: 46
C 567 J. Barnard Vol #: 46
C 568 P. Hughes Vol #: 46
C 569 S. Leisey Vol #: 46
C 570 S. Miller Vol #: 46
C 571 C. Miller Vol #: 46
C 572 B. Bortner Vol #: 46
C 573 J. Faust Vol #: 46
C 574 C. Gemmill Vol #: 46
C 575 S. Yeager Vol #: 46
C 576 K. Dixon Vol #: 46
C 577 A. Memisevic Vol #: 46
C 578 R. Murphy Vol #: 46
C 579 D. Hayden Vol #: 46
C 580 B. Hersh Vol #: 46
C 581 A. Bizzarri Jr Vol #: 46
C 582 N. Hooper Vol #: 46
C 583 N. Hooper Vol #: 46
C 584 D. Gowin Vol #: 46
C 585 K. Cullen Vol #: 46
C 586 A. Ammons Vol #: 46
C 587 C. Rye Vol #: 46
C 588 G. Baur Vol #: 46
C 589 M. Honors Vol #: 46
C 590 P. Ensign Vol #: 46
C 591 S. Carlson Vol #: 46
C 592 N. Barin Vol #: 46
C 593 M. Hennessey Vol #: 46
C 594 G. Bernard Vol #: 46
C 595 B. Carpenter Vol #: 46
C 596 J. Swift Vol #: 46
C 597 I. Callan Vol #: 46
C 598 no signature Vol #: 46
C 599 N. Wittman Vol #: 46
C 600 L. Vol #: 46
C 601 L. Traglia Vol #: 46
C 602 F. Sciacca Vol #: 46
C 603 no signature Vol #: 46
C 604 M. Austin Vol #: 46
C 605 F. Traglia Vol #: 46
C 606 F. Schaller Jr. Vol #: 46
C 607 no signature Vol #: 46
C 608 L. Klingeman Vol #: 46
C 609 J. Wiseman Vol #: 46
C 610 R. Neider Vol #: 46
C 611 M. Belcastro Vol #: 46
C 612 J. Mann Vol #: 46
C 613 T. Gerhard Vol #: 46
C 614 S. Valente Vol #: 46
C 615 no signature Vol #: 46
C 616 no signature Vol #: 46
C 617 R. Batalden Vol #: 46
C 618 no signature Vol #: 46
C 619 T. Adams Vol #: 46
C 620 no signature Vol #: 46
C 621 F. Sawyer Vol #: 46
C 622 J. leiberman Vol #: 46
C 623 L. Schley Vol #: 46
C 624 P. Dorster Vol #: 46
C 625 K. Pela Vol #: 46
C 626 Form Letter Count 105 Vol #: 51
C 627 T. Weis Vol #: 46
C 628 K. Owen Vol #: 46
C 629 L. McGrath Vol #: 46
C 630 A. McGrath Vol #: 46
C 631 L. Carson Vol #: 46
C 632 J.Verde Vol #: 46
C 633 Caldwell County Hospital Vol #: 46
C 634 J.W. Vol #: 46
C 635 J. Koerner Vol #: 46
C 636 C. Willison Vol #: 46
C 637 D. Risucci Vol #: 46
C 638 A. Murray Vol #: 46
C 639 P. Reiners Vol #: 46
C 640 M. Lipsitz Vol #: 46
C 641 J. Sipley Vol #: 46
C 642 V. Henderson Vol #: 46
C 643 J. Greir Vol #: 46
C 644 Form Letter Count 10 Vol #: 52
EC 4233 Eat For Life Vol #: 50
EC 4234 Mrs. Jamie Knispel Vol #: 50
EC 4235 Mr. James Gilland Vol #: 50
EC 4236 Ms. Laura Reisdorph Vol #: 50
EC 4237 Miss. Allison Matthews Vol #: 50
EC 4238 Mr. carl schuh Vol #: 50
EC 4239 Mrs. Michel Gigante Vol #: 50
EC 4240 Ms. Teri Hitt Vol #: 50
EC 4241 Mrs. Lidia Capazzi Vol #: 50
EC 4242 Mr. lynn mckee Vol #: 50
EC 4243 Mrs. Linda Howe Vol #: 50
EC 4244 Mr. Gary Hagy Vol #: 50
EC 4245 Ms. Michelle Mollet Vol #: 50
EC 4246 Ms. p Grindle Vol #: 50
EC 4247 Ms. Joyce Nicotera Vol #: 50
EC 4248 Mr. David Bray Vol #: 50
EC 4249 Ms. sandy watson Vol #: 50
EC 4250 Registered Voter Vol #: 50
EC 4251 Salvere Farm Vol #: 50
EC 4252 Mrs. Amy Lausterer Vol #: 50
EC 4253 Mrs. Jean Smith Vol #: 50
EC 4254 Ms. Thomas Heasley Vol #: 50
EC 4255 Mrs. kelsey Bostan Vol #: 50
EC 4256 Mrs. Mary Gomez-Rettie Vol #: 50
EC 4257 Mr. Arthur Saiz Vol #: 50
EC 4258 Dr. Marni Gauthier Vol #: 50
EC 4259 Ms. Sky DeMuro Vol #: 50
EC 4260 Ms. Donna Prizgintas Vol #: 50
EC 4261 Oreyana Vol #: 50
EC 4262 Ms. Louise Smith Vol #: 50
EC 4263 Ms. Denise Bohl Vol #: 50
EC 4264 Say NO to to animal cloning Vol #: 50
EC 4265 East Carolina University Vol #: 50
EC 4266 Mrs. Ann Mallek Vol #: 50
EC 4267 Mr. James Schuman Vol #: 50
EC 4268 Mr. Joseph Martinez Vol #: 50
EC 4269 The Farm School Vol #: 50
EC 4270 Miss. Robin Southworth Vol #: 50
EC 4271 Mr. Stephen Bruno Vol #: 50
EC 4272 Mr. chuck b Vol #: 50
EC 4273 Mr. Joseph Souliere Vol #: 50
EC 4274 Mr. Felice Pace Vol #: 50
EC 4275 Ms. Jan Yager Vol #: 50
EC 4276 Mr. henry ferrini Vol #: 50
EC 4277 Mr. Steven Robert Vol #: 50
EC 4278 Ms. Cheryl Costigan Vol #: 50
EC 4279 Ms. Kristin Schu Vol #: 50
EC 4280 Mrs. Rachel Winograd Bollenbecker Vol #: 50
EC 4281 none Vol #: 50
EC 4282 Mr. Michael Stachura Vol #: 50
EC 4283 Ms. Audrey Pitigliano Vol #: 50
EC 4284 Mrs. Valerie Fein Vol #: 50
EC 4285 Miss. Kristy Mucci Vol #: 50
EC 4286 Ms. MaryKelly Meader Vol #: 50
EC 4287 Saint Peter Damian Fraternity Secular Franciscan Vol #: 50
EC 4288 Mrs. Sharrel Swanson Vol #: 50
EC 4289 Ms. Leslie Chaffin Vol #: 50
EC 4290 Mr. Kevin Crupi Vol #: 50
EC 4291 Ms. Louise Crawford Vol #: 50
EC 4292 Mrs. Brenda Elizondo Vol #: 50
EC 4293 Ms. rebecca broeske Vol #: 50
EC 4294 Mrs. Lynda Scott Vol #: 50
EC 4295 Miss. Dana Pinkston Vol #: 50
EC 4296 Uganda Coffee Development Authority Vol #: 50
EC 4297 Mr. james sabbatini Vol #: 50
EC 4298 Mrs. A. B. Armstrong Vol #: 50
EC 4299 Miss. Kara Cannon Vol #: 50
EC 4300 Mr. Dennis Yurich Vol #: 50
EC 4301 Mr. s roescher Vol #: 50
EC 4302 Mrs. Kaara Smith Vol #: 50
EC 4303 All veggie Vol #: 50
EC 4304 Quarry Brook Farms Vol #: 50
EC 4305 Mrs. Deborah Dill Vol #: 50
EC 4306 American Citizen Vol #: 50
EC 4307 Ms. Kim Edgerton Vol #: 50
EC 4308 Mr. Marc Fortier Vol #: 50
EC 4309 Ms. Agnes Niemiec Vol #: 50
2005N-0272 Irradiation in the Production, Processing, and Handling of Food
NPR 1 FDA Vol #: 1
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
EC 1881 Mrs. Dee Comber Vol #: 31
EC 1882 Miss. Sandra Ahrens Vol #: 31
EC 1883 Mrs. Judy Lake Vol #: 31
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 18286 C. & N. Salvi Vol #: 198
C 18287 L. Llabrrs Vol #: 198
C 18288 A. Dehner Vol #: 198
C 18289 A. Ehlers Vol #: 198
C 18290 J. Ehlers Vol #: 198
2007N-0114 Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
EAPE 13 Bizzaro, Thomas Vol #: 1
EAPE 14 Craddock, Marissa Vol #: 1
EAPE 15 Hoane, Krysty Vol #: 1
EAPE 16 Brennan, RPh, Colleen Vol #: 1
2007N-0123 Amlodipine Abbreviated New Drug Application Approvals
C 2 Daiichi Sankyo, Inc. Vol #: 1
C 3 Mutual Pharmaceutical Co. Inc. Vol #: 1
EMC 1 Daiichi Sankyo Inc. Vol #: 1
EMC 2 Orchid Healthcare (Orchid) Vol #: 1
EMC 3 Medco Health Solutions, Inc, (Medco) Vol #: 1
EMC 4 Apotex, Inc. (formerly TorPharm) Vol #: 1
EMC 5 Pfizer Vol #: 1

Page created on May 21, 2007 ue

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