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DOCKETS ENTERED on 3/18/03

Docket Number - Title

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98N-1038 Irradiation in the production, processing, &handling of food *
98N-1109 Mercury Compounds in Drugs and Food *
00N-1571 Enrofloxacin for Poultry: Opportunity for Hearing *
01P-0190 Fountain Diet Coca-Cola and Bottled Diet Coca-Cola *
02D-0492 Clinical Trials for Therapeutics in Adult Healthy Volunteers *
02P-0436 ANDA for ribavirin, USP in a water soluble film-coated table *
02P-0498 ANDA Warfarin Sodium Tablets, USP 0.5 mg. (Coumadin tablets) *
02P-0505 Labeling nuts & eligible nut containing products reduce risk *
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

C 3749 Angela Olson Vol#: 299

C 3750 Evelyn Nuckles Vol#: 299

C 3751 Associates in Orthodontics, P.A. Vol#: 299

C 3752 Karen Campbell Vol#: 299

C 3753 Valentines Eneterprises, Inc. Vol#: 299

C 3754 Valerie Young, PhD Vol#: 299

C 3755 Isabel Burk Vol#: 299

C 3756 Natural Partners, Inc. Vol#: 299

C 3757 Marian Burk Wood Vol#: 299

C 3758 James R. Lewis Vol#: 299

C 3759 Grace L. Shessler Vol#: 299

C 3760 National Organization for Rare Disorders Vol#: 299

C 3761 Thomas N. Tiedt, PhD Vol#: 299

C 3762 Ann Burns Vol#: 299

C 3763 Marilyn Overly Vol#: 299

C 3764 TaosHerb, Co. Vol#: 299

C 3765 Form Letters 15 Vol#: 303

C 3766 Form Letters 16 Vol#: 304

C 3767 Form Letters 15 Vol#: 305

C 3768 Form Letters 2 Vol#: 306

97N-0505 Chorionic Gonadotropin

EXB 1 EXHIBIT E Vol#: 3

97P-0078 Recognized the Term "Soymilk" as the Established Common of U

C 162 Vincent & Carol Malnati Vol#: 2

97P-0130 Require Percentage Ingredient Labeling

C 163 John Bak Vol#: 5

C 164 Joan Johnson Vol#: 5

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 9650 Doctor's Best Inc. Vol#: 74

LET 9651 NF Formulas, Inc. Vol#: 74

LET 9652 NF Formulas, Inc. Vol#: 74

LET 9653 NF Formulas, Inc. Vol#: 74

LET 9654 NF Formulas, Inc. Vol#: 74

LET 9655 NF Formulas, Inc. Vol#: 74

LET 9656 NF Formulas, Inc. Vol#: 74

LET 9657 NF Formulas, Inc. Vol#: 74

LET 9658 NF Formulas, Inc. Vol#: 74

LET 9659 NF Formulas, Inc. Vol#: 74

LET 9660 NF Formulas, Inc. Vol#: 74

LET 9661 NF Formulas, Inc. Vol#: 74

LET 9662 NF Formulas, Inc. Vol#: 74

LET 9663 NF Formulas, Inc. Vol#: 74

LET 9664 NF Formulas, Inc. Vol#: 74

LET 9665 NF Formulas, Inc. Vol#: 74

LET 9666 NF Formulas, Inc. Vol#: 74

LET 9667 NF Formulas, Inc. Vol#: 74

LET 9668 NF Formulas, Inc. Vol#: 74

LET 9669 NF Formulas, Inc. Vol#: 74

LET 9670 NF Formulas, Inc. Vol#: 74

LET 9671 NF Formulas, Inc. Vol#: 74

LET 9672 NF Formulas, Inc. Vol#: 74

LET 9673 NF Formulas, Inc. Vol#: 74

LET 9674 NF Formulas, Inc. Vol#: 74

LET 9675 NF Formulas, Inc. Vol#: 74

LET 9676 NF Formulas, Inc. Vol#: 74

LET 9677 NF Formulas, Inc. Vol#: 74

LET 9678 NF Formulas, Inc. Vol#: 74

LET 9679 NF Formulas, Inc. Vol#: 74

LET 9680 NF Formulas, Inc. Vol#: 74

LET 9681 NF Formulas, Inc. Vol#: 74

LET 9682 NF Formulas, Inc. Vol#: 74

LET 9683 NF Formulas, Inc. Vol#: 74

LET 9684 NF Formulas, Inc. Vol#: 74

LET 9685 NF Formulas, Inc. Vol#: 74

LET 9686 NF Formulas, Inc. Vol#: 74

LET 9687 NF Formulas, Inc. Vol#: 74

LET 9688 NF Formulas, Inc. Vol#: 74

LET 9689 NF Formulas, Inc. Vol#: 74

LET 9690 NF Formulas, Inc. Vol#: 74

LET 9691 NF Formulas, Inc. Vol#: 74

LET 9692 NF Formulas, Inc. Vol#: 74

LET 9693 NF Formulas, Inc. Vol#: 74

LET 9694 ZeaVision, LLC Vol#: 74

LET 9695 Enzymatic Therapy, Inc. Vol#: 74

LET 9696 Enzymatic Therapy, Inc. Vol#: 74

LET 9697 Enzymatic Therapy, Inc. Vol#: 74

LET 9698 Enzymatic Therapy, Inc. Vol#: 74

LET 9699 Enzymatic Therapy, Inc. Vol#: 74

LET 9700 Enzymatic Therapy, Inc. Vol#: 74

LET 9701 Enzymatic Therapy, Inc. Vol#: 74

LET 9702 Enzymatic Therapy, Inc. Vol#: 74

LET 9703 Enzymatic Therapy, Inc. Vol#: 74

LET 9704 Enzymatic Therapy, Inc. Vol#: 74

LET 9705 Enzymatic Therapy, Inc. Vol#: 74

LET 9706 Enzymatic Therapy, Inc. Vol#: 74

LET 9707 Enzymatic Therapy, Inc. Vol#: 74

LET 9708 Enzymatic Therapy, Inc. Vol#: 74

LET 9709 Enzymatic Therapy, Inc. Vol#: 74

LET 9710 Enzymatic Therapy, Inc. Vol#: 74

LET 9711 Enzymatic Therapy, Inc. Vol#: 74

LET 9712 Enzymatic Therapy, Inc. Vol#: 74

LET 9713 Enzymatic Therapy, Inc. Vol#: 74

LET 9714 Enzymatic Therapy, Inc. Vol#: 74

LET 9715 Enzymatic Therapy, Inc. Vol#: 74

LET 9716 Enzymatic Therapy, Inc. Vol#: 74

LET 9717 Enzymatic Therapy, Inc. Vol#: 74

LET 9718 Enzymatic Therapy, Inc. Vol#: 74

LET 9719 Enzymatic Therapy, Inc. Vol#: 74

LET 9720 Enzymatic Therapy, Inc. Vol#: 74

LET 9721 Enzymatic Therapy, Inc. Vol#: 74

LET 9722 Enzymatic Therapy, Inc. Vol#: 74

LET 9723 Enzymatic Therapy, Inc. Vol#: 74

LET 9724 Enzymatic Therapy, Inc. Vol#: 74

LET 9725 Enzymatic Therapy, Inc. Vol#: 74

LET 9726 Enzymatic Therapy, Inc. Vol#: 74

LET 9727 Enzymatic Therapy, Inc. Vol#: 74

LET 9728 Enzymatic Therapy, Inc. Vol#: 74

LET 9729 PhytoPharmica Vol#: 74

LET 9730 Pharmavite Corporation Vol#: 74

LET 9731 Pharmavite Corporation Vol#: 74

LET 9732 Natrol, Inc. Vol#: 74

LET 9733 Prolab Nutrition, Inc. Vol#: 74

LET 9734 Enzymatic Therapy, Inc. Vol#: 74

LET 9735 PhytoPharmica Vol#: 74

LET 9736 PhytoPharmica Vol#: 74

LET 9737 PhytoPharmica Vol#: 74

LET 9738 PhytoPharmica Vol#: 74

LET 9739 PhytoPharmica Vol#: 74

LET 9740 PhytoPharmica Vol#: 74

LET 9741 PhytoPharmica Vol#: 74

LET 9742 PhytoPharmica Vol#: 74

LET 9743 PhytoPharmica Vol#: 74

LET 9744 PhytoPharmica Vol#: 74

LET 9745 PhytoPharmica Vol#: 74

LET 9746 PhytoPharmica Vol#: 74

LET 9747 PhytoPharmica Vol#: 74

LET 9748 PhytoPharmica Vol#: 74

LET 9749 PhytoPharmica Vol#: 74

LET 9750 PhytoPharmica Vol#: 74

LET 9751 PhytoPharmica Vol#: 74

LET 9752 PhytoPharmica Vol#: 74

LET 9753 PhytoPharmica Vol#: 74

LET 9754 Enzymatic Therapy Inc Vol#: 74

LET 9755 Enzymatic Therapy Inc Vol#: 74

LET 9756 PhytoPharmica Vol#: 74

LET 9757 PhytoPharmica Vol#: 74

LET 9758 PhytoPharmica Vol#: 74

LET 9759 PhytoPharmica Vol#: 74

LET 9760 PhytoPharmica Vol#: 74

LET 9761 PhytoPharmica Vol#: 74

LET 9762 PhytoPharmica Vol#: 74

LET 9763 PhytoPharmica Vol#: 74

LET 9764 PhytoPharmica Vol#: 74

LET 9765 PhytoPharmica Vol#: 74

LET 9766 PhytoPharmica Vol#: 74

LET 9767 PhytoPharmica Vol#: 74

LET 9768 Enzymatic Therapy, Inc. Vol#: 74

LET 9769 Enzymatic Therapy, Inc. Vol#: 74

LET 9770 NF Formulas, Inc. Vol#: 74

LET 9771 NF Formulas, Inc. Vol#: 74

LET 9772 NF Formulas, Inc. Vol#: 74

LET 9773 NF Formulas, Inc. Vol#: 74

LET 9774 NF Formulas, Inc. Vol#: 74

LET 9775 NF Formulas, Inc. Vol#: 74

LET 9776 NF Formulas, Inc. Vol#: 74

LET 9777 NF Formulas, Inc. Vol#: 74

LET 9778 NF Formulas, Inc. Vol#: 74

LET 9779 NF Formulas, Inc. Vol#: 74

LET 9780 NF Formulas, Inc. Vol#: 74

LET 9781 NF Formulas, Inc. Vol#: 74

LET 9782 NF Formulas, Inc. Vol#: 74

LET 9783 Perrigo Company of South Carolina Vol#: 74

LET 9784 Tabak's Health Products Vol#: 74

98E-0849 Patent Extension 4,490,351 VITREON

N 2 Vol#: 1

98E-0851 Patent Extension #4,291,708, T-SCAN

LET 5 HFD-005 to U.S. Patent & Trademark Offi Vol#: 1

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

C 5697 Ms. Monica Ryder Vol#: 193

C 5698 Carole & Dean David Vol#: 193

C 5699 Giles Erickson Vol#: 193

C 5700 no signature Vol#: 193

C 5701 Rebecca Andrus Vol#: 193

C 5702 Gary McDaniel Vol#: 193

C 5703 Martha Dudley Vol#: 193

C 5704 Andrew R. Grey Vol#: 193

C 5705 Eva Mazur Vol#: 193

C 5706 Julie B. Whittaker Vol#: 193

C 5707 Ms. Lana H. Davidson Vol#: 193

C 5708 Vanessa McMahan Vol#: 193

C 5709 Allergy Elimination Clinic Vol#: 193

C 5710 Ann Bigay Ridenhour Vol#: 193

C 5711 Birgit Whitelaw Vol#: 193

C 5712 Bob Chambers Vol#: 193

LET 13 USDA/Office of the Secretary Vol#: 193

98N-1109 Mercury Compounds in Drugs and Food

LET 2 Merck & Co., Inc. Vol#: 2

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

C 71 April Schoenherr Vol#: 7

C 72 Joy Reese Vol#: 7

C 73 Raj & Helen Desai Vol#: 7

C 74 Deborah Cady Vol#: 7

C 75 Laura Mantle Vol#: 7

C 76 Elias W. Keim Vol#: 7

99F-5321 Food Safety & Inspection service safe use of ionizing radiai

C 69 April Schoenherr Vol#: 7

C 70 Joy Reese Vol#: 7

C 71 Raj & Helen Desai Vol#: 7

C 72 Deborah Cady Vol#: 7

C 73 Laura Mantle Vol#: 7

C 74 Elias W. Keim Vol#: 7

99F-5322 Ionizing Radiation for the Treatment of Food

C 68 April Schoenherr Vol#: 5

C 69 Joy Reese Vol#: 5

C 70 Raj & Helen Desai Vol#: 5

C 71 Deborah Cady Vol#: 5

C 72 Laura Mantle Vol#: 5

C 73 Elias W. Keim Vol#: 5

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

C 71 April Schoenherr Vol#: 5

C 72 Joy Reese Vol#: 5

C 73 Raj & Helen Desai Vol#: 5

C 74 Deborah Cady Vol#: 5

C 75 Laura Mantle Vol#: 5

C 76 Elias W. Keim Vol#: 5

C 77 Rita Flygar Vol#: 5

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9845 Nancy Delaplane Vol#: 572

C 9846 Debra Barringer Vol#: 572

00E-1348 Patent Extension PROTONIX, No. 4,758,579

LET 3 HFD-005 to U.S. Patent & Trademark Offi Vol#: 1

00E-1402 Patent Extension for Betaxon, No. 4,911,920

LET 1 HFD-005 to U.S. Patent & Trademark Offi Vol#: 1

00N-1463 Labeling Requirements for Systemic Antibacterial Drug Produc

NCR 1 Vol#: 1

00N-1484 Safety Reporting Requirements Human Drug/Biological Products

BKG 1 BACKGROUND Vol#: 2

NPR 1 Vol#: 1

00N-1571 Enrofloxacin for Poultry: Opportunity for Hearing

FF 1 Center for Veterinary Medicine Vol#: 363

FF 2 Bayer Corporation & AHI Vol#: 364

MO 39 Center for Veterinary Medicine Vol#: 362

01E-0029 Patent Extension for Trileptal, No. 4,559,174

LET 4 HFD-005 to U.S. Patent & Trademark Offi Vol#: 1

01E-0089 Kaletra, Patent Extension Application No.5,886,036

LET 4 HFD-005 to U.S. Patent & Trademark Offi Vol#: 1

01E-0092 Rescula, Patent Extension Application No. 5,221,763

LET 4 HFD-005 to U.S. Patent & Trademark Offi Vol#: 1

01E-0366 Patent Term Extension Application, PEG-Intron No. 5,951,974

LET 4 HFD-005 to U.S. Patent & Trademark Offi Vol#: 1

01E-0404 Patent Term Extension Application; No. 5,444,106

LET 4 HFD-005 to U.S. Patent & Trademark Offi Vol#: 1

01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked

C 67 April Schoenherr Vol#: 7

C 68 Joy Reese Vol#: 7

C 69 Raj & Helen Desai Vol#: 7

C 70 Deborah Cady Vol#: 7

C 71 Laura Mantle Vol#: 7

C 72 Elias W. Keim Vol#: 7

01P-0190 Fountain Diet Coca-Cola and Bottled Diet Coca-Cola

C 60 Agnes L. King Vol#: 1

C 61 Amanda Newman Vol#: 1

C 62 Carol Miller Vol#: 1

C 63 Shannon Cartmill Vol#: 1

C 64 Judy Bridger Vol#: 1

C 65 Irving Birnbaum Vol#: 1

C 66 Meghan Gradert Vol#: 1

C 67 Charlene Ratcliffe Vol#: 1

C 68 Linzi Stephens Vol#: 1

C 69 J.A. Morthup Vol#: 1

C 70 Debby Zeinberg Vol#: 1

C 71 Chris Rye Vol#: 1

C 72 Connie B. Beck Vol#: 1

C 73 Lisa Edgar Vol#: 1

C 74 Samesa Teston Vol#: 1

LET 3 State of Michigan Attorney General Vol#: 1

LET 4 USDA Vol#: 1

01P-0320 Establish Format Standards for Ingredient Labels on Food Pro

C 179 Laura Lencioni Vol#: 6

C 180 Rae Pullen Alexakos Vol#: 6

C 181 John A. Carley Vol#: 6

C 182 Sunny D. Manahow Vol#: 6

C 183 Ms. Marybelle Eggert Vol#: 6

C 184 Justin Steurich Vol#: 6

C 185 Page S. Morahan, Ph.D. Vol#: 6

C 186 Robert & Judith Steurich Vol#: 6

C 187 Nancy Betcher, RD Vol#: 6

C 188 Michele Mormando, RD, CDE Vol#: 6

02D-0492 Clinical Trials for Therapeutics in Adult Healthy Volunteers

C 7 Schering-Plough Vol#: 1

C 8 Abbott Laboratories Vol#: 1

C 9 AstraZeneca Vol#: 1

02E-0019 Patent Term Application for Axert No. 5,565,447

LET 4 HFD-005 to U.S. Patent & Trademark Offi Vol#: 1

02E-0023 Patent Term Application for Definity No. 5,527,521

LET 4 HFD-005 to U.S. Patent & Trademark Offi Vol#: 1

02N-0077 Emergency Medical Device Shortage Program Survey

N 3 Vol#: 1

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

C 43 Kraft Foods Vol#: 7

C 44 Fisheries Council of Canada Vol#: 7

C 45 PennAg Industries Association Vol#: 7

02N-0278 Bioterrorism; Prior Notice of Imported Food Shipments

C 51 Kraft Foods Vol#: 7

C 52 Fresh Produce Assn of the Americas Vol#: 7

C 53 Flegenheimer International, Inc. Vol#: 7

02N-0319 Blood Establishment Registration/Product Listing,formFDA2830

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1

02N-0496 Large & Small Volume Parenterals Used in Total Parenteral Nu

N 2 Vol#: 1

02N-0532 Nonclinical Datasets; Notice of Pilot Project

APE 1 Lilly Research Laboratories Vol#: 1

02P-0013 Rescind GRAS Status for Aluminum-containing Food Additives

LET 4 HFS-265 to Colin G. Meyer, D.V.M., Ph.D. Vol#: 1

02P-0436 ANDA for ribavirin, USP in a water soluble film-coated table

WDL 1 BioPartners GmbH Vol#: 1

02P-0498 ANDA Warfarin Sodium Tablets, USP 0.5 mg. (Coumadin tablets)

AMD 1 Taro Pharmaceuticals USA, Inc. Vol#: 1

02P-0505 Labeling nuts & eligible nut containing products reduce risk

C 7 Tufts University Vol#: 4

03E-0033 Patent Extension Application for DERMAGRAFT No. 4,963,489

LET 2 HFD-005 to U.S. Patent & Trademark Offi Vol#: 1

03N-0075 Administrative Detention and Banned Medical Devices

N 1 Vol#: 1

03N-0085 Environmental Impact Considerations

N 1 Vol#: 1

03P-0097 Unithroid as reference listed drug for levothyroxine sodium

ACK 1 HFA-305 Vol#: 1