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 21, 2000

Table of Contents

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98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA *
99D-4328 Antimicrobial Drugs to Treat Bloodstream Infection *
99N-0035 Medical Devices; Reclassification of 38 Preamendments *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-4613 Revoke the Regulation That Approved Posilac *
00D-1307 Parathyroid Hormone/Prevention & Treatment of Osteoporosis *
00N-1262 Improving Premarket Review/Approval of Food/Color Additives *
00N-1357 FDA Concept Paper:Demonstrably Difficult to Compound Drugs *
00P-1419 ANDA for Gabapentin Tablets 100 mg 300 mg and 400 mg *
00V-1423 Laser Light Show*
97N-0074 President's National Food Safety Initiative

C 254 Joel Hefley (CI) Vol#: 22

C 255 Wayne Allard (CI) Vol#: 22

98H-0734 Civil Money Penalties; A.T. Williams Oil Co,d/ba/ Wilco Gas

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 2314 Joan Frances Hanley Vol#: 67

99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA

C 43 PhRMA Vol#: 4

99D-4328 Antimicrobial Drugs to Treat Bloodstream Infection

C 3 Lifespan Vol#: 1
 
 

99H-0265 Civil Money Penalties;Eckerd Corp,d/b/a Eckerd Drugs #1037

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-0697 Civil Money Penalty; Southland Corp d/b/a 7-Eleven Food Stor

SET 1 GCF-1 Vol#: 1
 
 

99H-4255 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart Store

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-4345 Civil Money Penalty;Leach Enterprises Ltd,dba Your Country S

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-5414 Civil Money Penalty;Fry's Food Stores of Arizona,Inc;dba Fry

SET 1 GCF-1 Vol#: 1
 
 

99H-5415 Civil Money Penalty;Don Hopper;dba Big Al's Grocery

SET 1 GCF-1 Vol#: 1
 
 

99H-5416 Civil Money Penalty;Killinsworth Enterprises,Inc;dba Killins

SET 1 GCF-1 Vol#: 1
 
 

99H-5417 Civil Money Penalty;Arlene Lasker;dba C & G Community One St

SET 1 GCF-1 Vol#: 1
 
 

99H-5421 Civil Money Penalty;S & K Konvenience Stores,Inc;dba Chevron

SET 1 GCF-1 Vol#: 1
 
 

99H-5431 Civil Money Penalty;Rite Aid Corporation;dba Rite Aid Pharma

SET 1 GCF-1 Vol#: 1
 
 

99H-5433 Civil Money Penalty;Sheetz,Inc;dba Sheetz #136

SET 1 GCF-1 Vol#: 1
 
 

99H-5434 Civil Money Penalty;Ultramar Diamond Shamrock Corporation;

SET 1 GCF-1 Vol#: 1
 
 

99H-5437 Civil Money Penalty;Richard Cline;dba Richard's Quick Stop

SET 1 GCF-1 Vol#: 1
 
 

99H-5438 Civil Money Penalty;Daniel Custar;dba Red & White Grocery

SET 1 GCF-1 Vol#: 1
 
 

99H-5439 Civil Money Penalty;William Derasin; B & E 76

SET 1 GCF-1 Vol#: 1
 
 

99H-5443 Civil Money Penalty;Ingles Markets, Incorporated;dba Ingles

SET 1 GCF-1 Vol#: 1
 
 

99H-5454 Civil Money Penalty;Vern Foster and Alice Foster;dba Shopper

SET 1 GCF-1 Vol#: 1
 
 

99H-5459 Civil Money Penalty;ABH Development, L.L.C.;dba Wright Broth

SET 1 GCF-1 Vol#: 1
 
 

99H-5461 Civil Money Penalty;Canon Market, Inc;dba Canon Market

SET 1 GCF-1 Vol#: 1
 
 

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

SET 1 GCF-1 Vol#: 1
 
 

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

SET 1 GCF-1 Vol#: 1
 
 

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

SET 1 GCF-1 Vol#: 1
 
 

99H-5469 Civil Money Penalty;Eckerd Corporation;dba Eckerd Drug #6674

SET 1 GCF-1 Vol#: 1
 
 

99H-5472 Civil Money Penalty;Guttman Oil Company;dba Crossroad Food M

SET 1 GCF-1 Vol#: 1
 
 

99H-5474 Civil Money Penalty;Sun S. Hong;dba A & A Foods #2

SET 1 GCF-1 Vol#: 1
 
 

99H-5475 Civil Money Penalty;James M. Jacob and Gayle E. Jacob;dba G

SET 1 GCF-1 Vol#: 1
 
 

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

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

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

SET 1 GCF-1 Vol#: 1
 
 

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

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

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

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

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

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

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

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

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

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

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

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

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

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-5494 Civil Money Penalty;George W.Klein,Jr;dba Tylers Tackle Shop

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-5497 Civil Money Penalty;John M. Snow;dba Corner Stop #1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-5500 Civil Money Penalty;Shaw's Supermarkets,Inc;dba Shaw's Super

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-5501 Civil Money Penalty;L V Sumler;dba Town & Country Place

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-5508 Civil Money Penalty;Hole In The Wall,Inc;dba Hole In The Wal

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-5509 Civil Money Penalty;Houchens Industries,Inc;dba W.R.Houchens

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99N-0035 Medical Devices; Reclassification of 38 Preamendments

C 7 AdvaMed Advanced Medical Technology Assn Vol#: 2

C 8 AdvaMed Advanced Medical Technology Assn Vol#: 2

C 9 AdvaMed Advanced Medical Technology Assn Vol#: 2

99P-1340 Declared Eternity eau de Parfum Misbranded

C 639 Rachel Batunlot Vol#: 16

C 640 Nancy B Larsen, M.Ed. Vol#: 16

C 641 Richard Uhtenwoldt Vol#: 16

C 642 Danielle Bangs Vol#: 16

C 643 Kathy Chambers Vol#: 16

C 644 Barbara A. Bower Vol#: 16

C 645 Violette Nicholas Vol#: 16

C 646 Saundra Sharp Vol#: 16

C 647 J. Levins Vol#: 16

C 648 Marilyn Cleveland Vol#: 16

C 649 Janice Melfi Vol#: 16

C 650 Stephanie Roger Vol#: 16

C 651 Ariel Barfield Vol#: 16

EMC 137 Gordon C. Couger Vol#: 16

EMC 138 Jane B. Pannell, RN. Vol#: 16

EMC 139 Evelyn Hutchinson Vol#: 16

EMC 140 Charles Smith Vol#: 16

EMC 141 Joy Seibert Vol#: 16

EMC 142 E.S. & Diane Wall Vol#: 16

EMC 143 Anna Pawelczak-Zverev Vol#: 16

EMC 144 Linda McElver Vol#: 16

EMC 145 Suzyleone Vol#: 16

EMC 146 Julie Strickler Vol#: 16

99P-4613 Revoke the Regulation That Approved Posilac

C 568 no signature Vol#: 34

C 569 Darleen Meihel Vol#: 34

C 570 no signature Vol#: 34

C 571 Blake M. Vol#: 34

C 572 Trevor Storey Vol#: 34

C 573 Charvel Greene Vol#: 34

C 574 Kirsten Bush Vol#: 34

C 575 Russell S. Sobel Vol#: 34

C 576 Marion Sikora Vol#: 34

C 577 Lila Sprinx Vol#: 34

C 578 Jennie Finn Vol#: 34

C 579 Brian Peters Vol#: 34

C 580 Cynthea Ballard Vol#: 34

C 581 Tim Martin Vol#: 34

C 582 Bradley Scarbrough Vol#: 34

C 583 Lisa Vol#: 34

C 584 Nate Goss-Woliner Vol#: 34

C 585 Tim Schonholt Vol#: 34

C 586 Liv C. Vol#: 34

C 587 Katy Stewart Vol#: 34

C 588 no signature Vol#: 34

C 589 Vhett Picknell Vol#: 34

C 590 M. Davidson Vol#: 34

C 591 Brenda Vol#: 34

C 592 Jannis Burke Vol#: 34

C 593 Shelley H. Vol#: 34

C 594 no signature Vol#: 34

C 595 Michelle Vol#: 34

C 596 no signature Vol#: 34

C 597 Jacquire Bil, RN Vol#: 34

C 598 Rebecca Reimers Vol#: 34

C 599 Betsy Landers Vol#: 34

C 600 J. B. Vol#: 34

C 601 Susan L. Ternald Vol#: 34

C 602 Jason Maninger Vol#: 34

C 603 Keya Olson Vol#: 34

C 604 Jed Talbot Vol#: 34

C 605 Sara Pennoch Vol#: 34

C 606 David Vol#: 34

C 607 Jennie Finn Vol#: 34

C 608 Susan Palmer Vol#: 34

C 609 David Vol#: 34

C 610 Chris Vol#: 34

C 611 Roberta Vol#: 34

C 612 Nate Vol#: 34

C 613 Ed Vol#: 34

C 614 Tom Northrop Vol#: 34

C 615 Sharon Evans Vol#: 34

C 616 Clifton Scher Vol#: 34

C 617 Bradley Staples Vol#: 34

C 618 illegible Vol#: 34

C 619 Mackenzie Heimert Vol#: 34

C 620 F. Goodwin Vol#: 34

C 621 Dennis Vol#: 34

C 622 Ben Vol#: 34

C 623 Christopher K. Carter Vol#: 34


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

C 1 Lunar Vol#: 1

00N-1262 Improving Premarket Review/Approval of Food/Color Additives

C 3 Ecolab Inc Vol#: 1

C 4 American Plastics Council (APC) Vol#: 1

C 5 CTFA Assoc Vol#: 1

C 6 National Food Processors Assoc (NFPA) Vol#: 1

C 7 CSPI Vol#: 1

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

C 2 Shepherd Center Vol#: 1

0P-1419 ANDA for Gabapentin Tablets 100 mg 300 mg and 400 mg

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultant Services Inc Vol#: 1

0V-1423 Laser Light Show

VAR 1 Super Bowl Vol#: 1