Dockets Entered On July 9, 2003

DOCKETS MANAGEMENT

Dockets Entered On July 9, 2003

Table of Contents (linked)

Docket #

Title

1978N-0064

OTC Antiperspirant

1995S-0117

Human Drugs Patent Term Extension & New Patents

2000N-1571

Enrofloxacin for Poultry: Opportunity for Hearing

2003P-0304

ANDA suitability for Carbamazepine Oral Suspension USP, 200 mg/mL based on the reference-listed drug

1978N-0064

OTC Antiperspirant

ACK 5

HFA-305 to CTFA

Vol #:

BKG 2

Background

Vol #:

PRC 1

CTFA

Vol #:

1995S-0117

Human Drugs Patent Term Extension & New Patents

LST 83

List as of April 30, 2003

Vol #:

LST 84

List as of July 7, 2003

Vol #:

2000D-1598

Voluntary Labeling for Bioengineered Foods

C 9876

Leta S. Armstrong

Vol #:

572

C 9877

Jerilyn Keyak

Vol #:

572

C 9878

Karen L. Pedler

Vol #:

572

C 9879

Dena Cassidy

Vol #:

572

C 9880

Mary R. Currier

Vol #:

572

C 9881

Karen Kerney

Vol #:

572

C 9882

Charles Ginsberg

Vol #:

572

C 9883

Bryan Bonfiglio

Vol #:

572

C 9884

Alisha Rett

Vol #:

572

C 9885

Lisa & Michael Derou

Vol #:

572

C 9886

Rose Marie Williams

Vol #:

572

C 9887

Justina Wiliams

Vol #:

572

C 9888

Phyllis I. Pereira

Vol #:

572

C 9889

The Fosters

Vol #:

572

C 9890

Lisa & Michael Derou

Vol #:

572

C 9891

Bea Moseley

Vol #:

572

C 9892

Paul Frehe

Vol #:

572

C 9893

R. Lucille Balukjian

Vol #:

572



C 9894	R. V. Ginther	Vol #:	572

C 9895	Elizabeth Hefner	Vol #:	572

C 9896	David & Barbara Starre	Vol #:	572

C 9897	Rose Marie Williams, MA	Vol #:	572

C 9898	Colleen Ostlund, C.H.	Vol #:	572

C 9899	Joy York	Vol #:	572

C 9900	Robert H. Fraser	Vol #:	572

C 9901	Laura L. Smoak	Vol #:	579

C 9902	Vanessa London	Vol #:	579

C 9903	Kelly Stoflet	Vol #:	579

C 9904	Patrick Newell	Vol #:	579

C 9905	Deborah Williams	Vol #:	579

C 9906	The Sierra Club	Vol #:	579

C 9907	Lester Crawford	Vol #:	579

C 9908	Cynthia Torges	Vol #:	579

C 9909	Anthony DelGreco	Vol #:	579

C 9910	Shawn Carney	Vol #:	579

C 9911	Michelle Hackett	Vol #:	579

C 9912	Kathy Kukla	Vol #:	579

C 9913	T. Jeffrey & Beatrice Mangin	Vol #:	579

C 9914	Janet Hitt	Vol #:	579

C 9915	awyn	Vol #:	579

C 9916	Ron Marsh	Vol #:	579

C 9917	Mr. Kris Kallmeyer	Vol #:	579

C 9918	Susan E. Wagner	Vol #:	579

C 9919	Donna Staggs	Vol #:	579

C 9920	Tim Stone	Vol #:	579

C 9921	10 signatures	Vol #:	579

C 9922	Andrew C. Schoeneman	Vol #:	479

C 9923	6 signatures	Vol #:	579

C 9924	Bob Segal	Vol #:	579

C 9925	Christi Oates	Vol #:	579

C 9926	Cliff & Janet Owen	Vol #:	579

2000N-1571	Enrofloxacin for Poultry: Opportunity for Hearing
CS 46	HFA-305	Vol #:	379

OR 48	HF-3	Vol #:	379



2002N-0277	Bioterrorism; Establishment & Maintenance of Records
2002N-0277	Bioterrorism; Establishment & Maintenance of Records
C 39	Performance Food Group (PFG)	Vol #:	8

C 40	Uniform Code Council, Inc.	Vol #:	8

C 41	American Forest & Paper Association	Vol #:	8

C 42	National Alcohol Beverage Control Assocaition (NABCA)	Vol #:	9

C 43	Truckload Carriers Association	Vol #:	9

C 44	McLane Company, Inc.	Vol #:	9

C 45	National Association for the Specialty Food Trade, Inc.	Vol #:	9

C 46	National Juice Products Association	Vol #:	9

C 47	Flavor and Extract Manufacturers Association of the United States	Vol #:	9

C 48	Procter & Gamble	Vol #:	9

C 49	American Spice Trade Association, Inc.	Vol #:	9

C 50	American Plastics Council, Polystyrene Packaging Council	Vol #:	9

C 51	Gate Gourmet Inc	Vol #:	10

C 52	Victory Wholesale Grocers	Vol #:	10

C 53	Paperboard Packaging Council	Vol #:	10

C 54	Assocaition for Dressings and Sauces	Vol #:	10

EMC 33	Kraft Foods	Vol #:	8

EMC 34	Celeste Industries	Vol #:	8

EMC 35	Iacobucci USA, Inc.	Vol #:	8

EMC 36	BASF Corporation	Vol #:	8

EMC 37	Mary Ann Dowd	Vol #:	8

EMC 38	International Custom Products, Inc.	Vol #:	8

EMC 39	The Fertilizer Institute	Vol #:	8

EMC 40	Swiss Government	Vol #:	8

EMC 41	Flying Food Group (FFG)	Vol #:	8

EMC 42	Flying Food Group (FFG)	Vol #:	8

EMC 43	Flying Food Group - JFK New York City	Vol #:	9

EMC 44	Instituto Peruano del Esparrago - IPE (Peruvian Asparagus Institute)	Vol #:	9

EMC 45	Indonesian Food and Beverage Association	Vol #:	9

EMC 46	Carriere Foods Inc.	Vol #:	9

EMC 47	Japan's Ministry of Foreign Affairs	Vol #:	9

EMC 48	Center for Science in the Public Interest (CSPI)	Vol #:	9

EMC 49	Australian Quarantine and Inspection Service	Vol #:	9

EMC 50	CIAA	Vol #:	9

EMC 51	Los Angeles Flying Food Group	Vol #:	9



EMC 52	Canadian Trucking Alliance	Vol #:	9

EMC 53	Flying Food Group	Vol #:	9

EMC 54	King Nut, Peterson Nut, Summer Harvest Brands USA	Vol #:	9

EMC 55	Fresh Express	Vol #:	9

EMC 56	Flying Food Service	Vol #:	9

EMC 57	American Wholesale Marketers Association	Vol #:	9

EMC 58	Flying Food Group	Vol #:	9

EMC 59	Canadian Produce Marketing Association	Vol #:	9

EMC 60	Ministry of Foreign Trade and Tourism, Peru	Vol #:	9	Attachment

EMC 61	Alpha Flight Services	Vol #:	9

EMC 62	National Tank Truck Carriers	Vol #:	9

EMC 63	Manitoba Division of the Animal Nutrition Association of Canada, ANAC	Vol #:	9

EMC 64	Snack Food Association	Vol #:	9

EMC 65	McGuire & Associates	Vol #:	9

EMC 66	Fepach A.G.	Vol #:	9

EMC 67	International Fresh-Cut Produce Association (IFPA)	Vol #:	9

EMC 68	Fepach A.G.	Vol #:	9

EMC 69	Grupo Bimbo	Vol #:	9

EMC 70	International In-Flight Catering Company Ltd.	Vol #:	9

EMC 71	Halong Services and Import Export	Vol #:	10

EMC 72	Federal of German Food and Drug Industries (BVE)	Vol #:	10

EMC 73	Delta Air Lines, Inc.	Vol #:	10

EMC 74	Embassy of Chile	Vol #:	10

EMC 75	Jugos del Valle, S.A. de C.V.	Vol #:	10

EMC 76	Brewers of Europe, The European Confederation of Sprits Producers, Comite europeen Ent	Vol #:	10	Attachment

EMC 77	Indonesian Food and Beverages manufacturers Association	Vol #:	10

EMC 78	Northern Border Customs Brokers Association, Inc.	Vol #:	10

EMC 79	Indonesian Food and Beverages Manufacturer Assocation	Vol #:	10

EMC 80	Scotch Whisky Association	Vol #:	10	Attachment

EMC 81	Delegation of the European Commission	Vol #:	10

EMC 82	British Embassy	Vol #:	10

EMC 83	Alpha Airports Group PLC	Vol #:	10

EMC 84	National Association of Convenience Stores	Vol #:	10

EMC 85	National Border Customs Brokers Association (NBCBA)	Vol #:	10

EMC 86	Product Marketing Association	Vol #:	10

EMC 87	Gobierno de Chile	Vol #:	10

EMC 88	Grupo Bimbo	Vol #:	10



EMC 89	Grupo Bimbo	Vol #:	10

EMC 90	ACCA International	Vol #:	10

EMC 91	International Mass Retail Association	Vol #:	10

EMC 92	Werner Enterprises, Inc.	Vol #:	10

EMC 93	International Dairy Foods Association	Vol #:	10

EMC 94	Nikko Inflight Catering Co.	Vol #:	10

EMC 95	Government of the Argentine Republic	Vol #:	10

EMC 96	e-gatematrix llc	Vol #:	10

EMC 97	The Kroger Co.	Vol #:	10

EMC 98	Pet Food Institute	Vol #:	10

EMC 99	Asociacion Mexicana de Industriales de Galletas y Pastas A.C. (AMEXIGAPA)	Vol #:	10

EMC 100	American Trucking Associations	Vol #:	10

EMC 101	Matson Navigation Company	Vol #:	10

EMC 102	Cara Operations Limited	Vol #:	10

EMC 103	Council for Responsible Nutrition	Vol #:	10

2003D-0209	Nitric Oxide Breath Test Special Controls Guidance document
2003D-0209	Nitric Oxide Breath Test Special Controls Guidance document
GDL 1	Guidance	Vol #:	1

NAD 1	FDA	Vol #:	1

NFR 1	FDA	Vol #:	1

2003P-0304	ANDA suitability for Carbamazepine Oral Suspension USP,200 mg/mL based on the reference-listed drug
ACK 1	HFA-305 to Taro Pharmaceuticals USA, Inc.	Vol #:	1

CP 1	Taro Pharmaceuticals USA, Inc.	Vol #:	1	Attachment 1, 2, 3

Contents

1978N-0064

OTC Antiperspirant

1995S-0117

Human Drugs Patent Term Extension & New Patents

2000N-1571

Enrofloxacin for Poultry: Opportunity for Hearing

2003P-0304

ANDA suitability for Carbamazepine Oral Suspension USP,200 mg/mL based on the reference-listed drug