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 Us]

DOCKETS ENTERED on August 18, 2000

TABLE OF CONTENTS

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85N-0214 Drug Price Competition & Patent Term Restoration ACT 1984 *
97N-0436 Methods informing consumers of contents of bottle water *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
00D-1307 Parathyroid Hormone/Prevention & Treatment of Osteoporosis *
00N-0504 Egg Safety Action Plan *
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1422 Suitability Petition (OTC),Famotidine Orally Disintegrating *
00P-1466 Non-Approvable Letters for Neurontin *
00V-1464 Laser Light Show *
00V-1465 *

85N-0214 Drug Price Competition & Patent Term Restoration ACT 1984

C 71 Hyman Phelps & McNamara Vol#: 27

97N-0436 Methods informing consumers of contents of bottle water

C 214 Ivene Seth Vol#: 7

EMC 61 R. Shiro Vol#: 7

97V-0230 Laser Light Show re: Gemini Lasers

M 1 HFZ-343 Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 2575 H Eubanks Vol#: 188

C 2576 J Johnson Vol#: 188

C 2577 D Wells Vol#: 188

C 2578 S Sandstrom Vol#: 188

C 2579 J Tonietto Vol#: 188

C 2580 R Weber Vol#: 188

C 2581 R Keenan Vol#: 188

C 2582 M Miller Vol#: 188

C 2583 D Clark Vol#: 188

C 2584 D Pearson Vol#: 188

C 2585 D Gokhman Vol#: 188

C 2586 J McCarthy Vol#: 188

C 2587 J Oler Vol#: 188

C 2588 G Stenstad Vol#: 188

C 2589 P Hall Vol#: 188

C 2590 D Fenimore Vol#: 188

C 2591 A Hawryluk Vol#: 188

C 2592 S Mottet Vol#: 188

C 2593 M Schallau Vol#: 188

C 2594 R Luce Vol#: 188

C 2595 T Fairchild Vol#: 188

C 2596 A Joy Vol#: 188

C 2597 E Thamalis Vol#: 188

C 2598 C Martineau Vol#: 188

C 2599 J Healey Vol#: 188

C 2600 C Hoffman Vol#: 188

C 2601 R Westcott Vol#: 188

C 2602 L Slama Vol#: 188

C 2603 F Guerrero Vol#: 188

C 2604 K Berg Vol#: 188

C 2605 V Bavisotto Vol#: 188

C 2606 L Blum Vol#: 188

C 2607 D Guenther Vol#: 188

C 2608 W Elder Vol#: 188

C 2609 M Gray Vol#: 188

C 2610 J Potochnik Vol#: 188

C 2611 M Wallner Vol#: 188

C 2612 S Clarkson Vol#: 188

C 2613 V Sullivan Vol#: 188

C 2614 R Rou Vol#: 188

C 2615 D Herold Vol#: 188

C 2616 D Mitrani Vol#: 188

C 2617 J Mosser Vol#: 188

C 2618 F McKenzie Vol#: 188

C 2619 L Roselyn Vol#: 188

C 2620 Form Letter Count (37) Vol#: 189

00D-1307 Parathyroid Hormone/Prevention & Treatment of Osteoporosis

C 9 National Osteoporosis Foundation Vol#: 2

00N-0504 Egg Safety Action Plan

EMC 131 P Patek Vol#: 6

EMC 132 G Carlsen Vol#: 6

EMC 133 The Riley Family Vol#: 6

EMC 134 C Fong Vol#: 6

EMC 135 C Beal Vol#: 6

EMC 136 S Trout Vol#: 6

EMC 137 E Ehrhardt Vol#: 6

EMC 138 N H. Vol#: 6

EMC 139 D Smith Vol#: 6

EMC 140 B Biel Vol#: 6

EMC 141 D Abbott Vol#: 6

EMC 142 M Parks Vol#: 6

EMC 143 S Gaertner Vol#: 6

EMC 144 M Kelner Vol#: 6

EMC 145 G Beatty Vol#: 6

EMC 146 C Krueger Vol#: 6

EMC 147 M Peppercorn Vol#: 6

EMC 148 C. Repeta Vol#: 6

EMC 149 E Zimmerman Vol#: 6

EMC 150 L Meyer et al Vol#: 6

EMC 151 C Steele Vol#: 6

EMC 152 L Muck Vol#: 6

EMC 153 S Seiler Vol#: 6

EMC 154 J Mensch Vol#: 6

EMC 155 R Chase Vol#: 6

EMC 156 A Podgorny Vol#: 6

EMC 157 S Coyle Vol#: 6

EMC 158 S Fallander Vol#: 6

EMC 159 N Blankenship Vol#: 6

EMC 160 K Axtell Vol#: 6

EMC 161 S Dilallo Vol#: 6

EMC 162 R Reed Vol#: 6

EMC 163 D Soriano Vol#: 6

EMC 164 M Genser Vol#: 6

EMC 165 J Stone Vol#: 6

00N-1256 Over-the-Counter Drug Products;Public Hearing

CH 374 C Weaver Vol#: 16

CH 375 M Laquatra Vol#: 16

CH 376 S Zablotny Vol#: 16

CH 377 L Martin Vol#: 16

CH 378 A Daily Vol#: 16

CH 379 P Dora Vol#: 16

CH 380 L Klemm Vol#: 16

CH 381 S Olverson Vol#: 16

CH 382 A Jayme Vol#: 16

CH 383 K Shannon Vol#: 16

CH 384 K Leach Vol#: 16

CH 385 M Voiland Vol#: 16

CH 386 C Leed Vol#: 16

CH 387 L Herman Vol#: 16

CH 388 J Zweiman Vol#: 16

CH 389 J Terradotter Vol#: 16

CH 390 M Yanasak Vol#: 16

CH 391 S Srinivas Vol#: 16

CH 392 C Pluim Vol#: 16

CH 393 E Kitlas Vol#: 16

CH 394 K Anderson Vol#: 16

00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal

C 12 Flow International Corporation Vol#: 4

00N-1357 FDA Concept Paper:Demonstrably Difficult to Compound Drugs

C 10 C Tamorria Vol#: 1

C 11 Pathogenesis Corporation Vol#: 1

EMC 3 Memorial Hermann Healthcare System Vol#: 1

EMC 4 American Society of Health-System Pharma Vol#: 1

EMC 5 S Gardner Vol#: 1

00N-1364 Prescription Drug User Fee Act (PDUFA) Public Meeting

APE 1 J Center Vol#: 1

APE 2 T Calandra Vol#: 1

APE 3 K Holcombe Vol#: 1

APE 4 L Ripper Vol#: 1

APE 5 J Bennett Vol#: 1

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 4528 B Masck Vol#: 179

C 4529 D England Vol#: 179

C 4530 A Hartfelder Vol#: 179

C 4531 R Lester Vol#: 179

C 4532 C Gumban Vol#: 179

C 4533 R Hickman Vol#: 179

C 4534 J Nutter Vol#: 179

C 4535 F Francis Vol#: 179

C 4536 J Erdmann Vol#: 179

C 4537 J Hering Vol#: 179

C 4538 S Kozosky Vol#: 179

C 4539 G Barning Vol#: 179

C 4540 D Begg Vol#: 179

C 4541 R Roschko Vol#: 179

C 4542 B Christian Vol#: 179

C 4543 M Gould Vol#: 179

C 4544 B Adams Vol#: 179

C 4545 E Kaplan Vol#: 179

C 4546 S Redinger Vol#: 179

C 4547 J Salandre Vol#: 179

C 4548 K Fox Vol#: 179

C 4549 C Langille Vol#: 179

C 4550 P Siddall Vol#: 179

C 4551 G Barker Vol#: 179

C 4552 S Nelson Vol#: 179

C 4553 V Schreiber Vol#: 179

C 4554 F Scobbo Vol#: 179

C 4555 R Schwabe Vol#: 179

C 4556 J Cooper Vol#: 179

C 4557 R Cyries Vol#: 179

C 4558 A Bunch Vol#: 179

C 4559 J Rasor Vol#: 179

C 4560 S Ruby Vol#: 179

C 4561 W Bower Vol#: 179

C 4562 R Peebles Vol#: 179

C 4563 K Wright Vol#: 179

C 4564 D Taylor Vol#: 179

C 4565 M Butler Vol#: 179

C 4566 K Krusenklaus Vol#: 179

C 4567 F Knoblich Vol#: 179

C 4568 J Quinn Vol#: 179

C 4569 J Gadsden Vol#: 179

C 4570 D Bulder Vol#: 179

C 4571 J Scott Vol#: 179

C 4572 B Surratt Vol#: 179

C 4573 D Amodei Vol#: 179

C 4574 L Markey Vol#: 179

C 4575 P Tan Vol#: 179

C 4576 C Popsecu Vol#: 179

C 4577 E Popsecu Vol#: 179

C 4578 R Clark Vol#: 179

C 4579 M Richardson Vol#: 179

C 4580 G Woest Vol#: 179

C 4581 S Hickok Vol#: 179

C 4582 S Malloy Vol#: 179

C 4583 E McKinney Vol#: 179

C 4584 D Lubold Vol#: 179

C 4585 P Gillemot Vol#: 179

C 4586 M Stokes, Jr. Vol#: 179

C 4587 E Phail Vol#: 179

C 4588 B Peirce Vol#: 179

C 4589 B Peirce Vol#: 179

C 4590 R Stone Vol#: 179

C 4591 B Gould Vol#: 179

C 4592 G Peirce Vol#: 179

C 4593 J. Aguisewicz Vol#: 179

C 4594 I Hoenig Vol#: 179

C 4595 G Jackson Vol#: 179

C 4596 S Gill Vol#: 179

C 4597 N Powers Vol#: 179

C 4598 R Perdicon Vol#: 179

C 4599 B Saul Vol#: 179

C 4600 K Fitzsimmons Vol#: 179

C 4601 E Peliz Vol#: 179

C 4602 C Pelic Vol#: 179

C 4603 F Kovac Vol#: 179

C 4604 D Smith Vol#: 179

C 4605 G Dengle Vol#: 179

C 4606 L Applegate Vol#: 179

C 4607 L Oakes Vol#: 179

C 4608 M Diazgranatos Vol#: 179

C 4609 T Beaver Vol#: 179

C 4610 J Brugger Vol#: 179

C 4611 D Noal Vol#: 179

C 4612 P Haberfeld Vol#: 179

C 4613 G Wilson Vol#: 179

C 4614 F Lamb Vol#: 179

C 4615 R Mitchell Vol#: 179

C 4616 H Hedrick Vol#: 179

C 4617 K Briggs Vol#: 179

C 4618 N Weiweb Vol#: 180

C 4619 J Gordon Vol#: 180

C 4620 S Kennedy Vol#: 180

C 4621 P Wolfson Vol#: 180

C 4622 R Walp Vol#: 180

C 4623 M Gray Vol#: 180

C 4624 L Pinney Vol#: 180

C 4625 H Smith Vol#: 180

C 4626 A Perouthy Vol#: 180

C 4627 J Russell Vol#: 180

C 4628 V Gilcrease Vol#: 180

C 4629 E Holley Vol#: 180

C 4630 V Franio Vol#: 180

C 4631 S Hui Vol#: 180

C 4632 L Konczal Vol#: 180

C 4633 J August Vol#: 180

C 4634 R Glaser Vol#: 180

C 4635 S Kanyur Vol#: 180

C 4636 R Kanyur Vol#: 180

C 4637 M Villamil Vol#: 180

C 4638 J Weissman Vol#: 180

C 4639 N Hamilton Vol#: 180

C 4640 M Herrick Vol#: 180

C 4641 D Waxman Vol#: 180

C 4642 A Hobbs Vol#: 180

C 4643 M. Robinson Vol#: 180

C 4644 P Moseley Vol#: 180

C 4645 C Herrick Vol#: 180

C 4646 R Smith Vol#: 180

C 4647 J Kerr Vol#: 180

C 4648 E. Maddaus Vol#: 180

C 4649 D Gage Vol#: 180

C 4650 M Murphy Vol#: 180

C 4651 A Melendez Vol#: 180

C 4652 B deGero Vol#: 180

C 4653 M Mendez Vol#: 180

C 4654 P. May Vol#: 180

C 4655 L Howell Vol#: 180

C 4656 P Hodgson Vol#: 180

C 4657 D Eckstein Vol#: 180

C 4658 J Wood Vol#: 180

C 4659 K. Howell Vol#: 180

C 4660 R Baranowski Vol#: 180

C 4661 J DeRuiter Vol#: 180

C 4662 R Hughes Vol#: 180

C 4663 K Paxton Vol#: 180

C 4664 H Dieter Vol#: 180

C 4665 H March Vol#: 180

C 4666 W Winder Vol#: 180

C 4667 N Trisler Vol#: 180

C 4668 K Hejl Vol#: 180

C 4669 B Miller Vol#: 180

C 4670 K Williams Vol#: 180

C 4671 S Hall Vol#: 180

C 4672 J Miles Vol#: 180

C 4673 M McCarthy Vol#: 180

C 4674 K Ellis Vol#: 180

C 4675 T Raouf Vol#: 180

C 4676 L Shifre Vol#: 180

C 4677 L Summers Vol#: 180

C 4678 Brandt Vol#: 180

C 4679 B S Vol#: 180

C 4680 K Belt Vol#: 180

C 4681 B Sartain Vol#: 180

C 4682 J Matheny Vol#: 180

00P-1422 Suitability Petition (OTC),Famotidine Orally Disintegrating

CR 1 HFA-305 Vol#: 1

LET 1 Yamanouchi Pharma Technologies, Inc. Vol#: 1 
 

00P-1433 ANDA for OTC drug product Famotidine orally disintegrating t

CR 1 HFA-305 Vol#: 1

LET 1 Yamanouchi Pharma Technologies, Inc. Vol#: 1

00P-1466 Non-Approvable Letters for Neurontin

ACK 1 HFA-305 Vol#: 1

CP 1 Pfizer, Inc. Vol#: 1

00V-1464 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Candyman Productions Vol#: 1

00V-1465

ACK 1 HFA-305 Vol#: 1

VAR 1 Family Bowling Center Vol#: 1