| | | | | | | | | | |
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| Dockets Entered
On June 27, 2005
Table of Contents
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| Docket #
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| Title
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|
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|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| 2000N-1396
|
| Bioengineered Foods Consumed By Humans or Animals
|
| |
|
|
| 2000P-1322
|
| Food Labeling and Allergen Contamination Control
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
| |
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
| |
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
| |
|
|
| 2002F-0160
|
| Safe use of Vitamin D3 in Calcium-Fortified Fruit Juices
|
| |
|
|
| 2002P-0166
|
| Print clear, legible & intelligible product expiration date
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| 2003D-0386
|
| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
|
| |
|
|
| 2003D-0554
|
| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| 2003P-0501
|
| Pyridostigmine Bromide Tablets, 30mg for the of myasthenia gravis (ANDA) voluntarily withdrawn from sale for safety or efficacy reasons
|
| |
|
|
| 2004N-0033
|
| Factor VIII Inhibitors
|
| |
|
|
| 2004N-0416
|
| Beverages: Bottled Water
|
| |
|
|
| 2004N-0456
|
| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
|
|
|
|
|
|
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
| |
|
|
| 2004N-0516
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
|
| |
|
|
| 2004P-0562
|
| Request immediate recall of all unapproved methacholine chloride products
|
| |
|
|
| 2005D-0068
|
| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System
|
| |
|
|
| 2005D-0106
|
| Guidance for Industry on Systemic Lupus Erythematosus Developing Drugs for Treatment
|
| |
|
|
| 2005D-0112
|
| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
|
| |
|
|
| 2005D-0174
|
| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
|
| |
|
|
| 2005D-0203
|
| Guidance for Industry on Safety Testing of Drug Metabolites
|
| |
|
|
| 2005N-0210
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Veterinary Feed Directive
|
| |
|
|
| 2005N-0231
|
| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
|
| |
|
|
| 2005P-0139
|
| withdrawal of approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
|
| |
|
|
| 2005P-0265
|
| Over-the Counter Sale of Modafinil
|
| |
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
| |
|
|
| RPT
274
|
| FCI Health Science Inc
|
| Vol #:
|
| 210
|
| |
|
|
| RPT
275
|
| Soft Gel Technologies, Inc
|
| Vol #:
|
| 211
|
|
| | | | | | | | |
| |
|
|
| RPT
276
|
| Japan Applied Microbiology Research Institute LTD
|
| Vol #:
|
| 213
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET
16285
|
| McLind Corporation
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16286
|
| McLind Corporation
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16287
|
| McLind Corporation
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16288
|
| Ortho Molecular Products
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16289
|
| Ortho Molecular Products
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16290
|
| Ortho Molecular Products
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16291
|
| Ortho Molecular Products
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16292
|
| Ortho Molecular Products
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16293
|
| Orotho Mlecular Products
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16294
|
| Nature's Way Products, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16295
|
| Dee Cee Laboratories,Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16296
|
| Dee Cee laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16297
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16298
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16299
|
| Dee Cee Laboratories,Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16300
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16301
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16302
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16303
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16304
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16305
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16306
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16307
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16308
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16309
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16310
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16311
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16312
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16313
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16314
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16315
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16316
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16317
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16318
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
|
| | | | | | | | |
| |
|
|
| LET
16319
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16320
|
| Dee Cee Laboratories,Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16321
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16322
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16323
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16324
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16325
|
| Dee Cee Laboratories, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16326
|
| Signa-Tau Pharmaceuticals, Inc.
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16327
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16328
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16329
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16330
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16331
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16332
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16333
|
| EnzymaticTherapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16334
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16335
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16336
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16337
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16338
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16339
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16340
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16341
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16342
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16343
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16344
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16345
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16346
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| LET
16347
|
| Enzymatic Therapy
|
| Vol #:
|
| 145
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| EMC 605
|
| R. Mattingly
|
| Vol #:
|
| 24
|
| |
|
|
| 2000N-1396
|
| Bioengineered Foods Consumed By Humans or Animals
|
| |
|
|
| EMC 11578
|
| R. Hammersley
|
| Vol #:
|
| 349
|
| |
|
|
| EMC 11579
|
| K. Carmona
|
| Vol #:
|
| 349
|
| |
|
|
| EMC 11580
|
| K. Carmona
|
| Vol #:
|
| 349
|
|
| | | | | | | | |
|
| |
|
| 2000P-1322
|
| Food Labeling and Allergen Contamination Control
|
| |
|
|
| EMC 544
|
| unsign
|
| Vol #:
|
| 30
|
| |
|
|
| EMC 545
|
| K. Baber
|
| Vol #:
|
| 30
|
|
| |
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| EMC 14461
|
| M. Scanlon, RN
|
| Vol #:
|
| 342
|
| |
|
|
| EMC 14462
|
| J. Null
|
| Vol #:
|
| 342
|
| |
|
|
| EMC 14463
|
| D. Beason
|
| Vol #:
|
| 342
|
| |
|
|
| EMC 14464
|
| R. Hoffman
|
| Vol #:
|
| 342
|
| |
|
|
| EMC 14465
|
| S. Matteson
|
| Vol #:
|
| 342
|
| |
|
|
| EMC 14466
|
| W. Snyder
|
| Vol #:
|
| 342
|
| |
|
|
| EMC 14467
|
| C. Cuccaro
|
| Vol #:
|
| 342
|
| |
|
|
| EMC 14468
|
| S. Santiago
|
| Vol #:
|
| 342
|
| |
|
|
| EMC 14469
|
| A. Maupin
|
| Vol #:
|
| 342
|
| |
|
|
| EMC 14470
|
| S. Deutsch
|
| Vol #:
|
| 342
|
| |
|
|
| EMC 14471
|
| A. Hanson
|
| Vol #:
|
| 342
|
| |
|
|
| EMC 14472
|
| C. Offutt
|
| Vol #:
|
| 342
|
| |
|
|
| EMC 14473
|
| V. Poster
|
| Vol #:
|
| 342
|
| |
|
|
| EMC 14474
|
| S. Weiner
|
| Vol #:
|
| 342
|
| |
|
|
| EMC 14475
|
| N. Earnhart
|
| Vol #:
|
| 342
|
| |
|
|
| EMC 14476
|
| D. Wetherhold
|
| Vol #:
|
| 342
|
|
| |
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
| |
|
|
| EMC 3171
|
| A. Sadowl
|
| Vol #:
|
| 261
|
| |
|
|
| EMC 3172
|
| L. Moccio
|
| Vol #:
|
| 261
|
| |
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
| |
|
|
| EMC 1268
|
| S. Stobaugh
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 1269
|
| J. Foy
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 1270
|
| A. Dadam
|
| Vol #:
|
| 5
|
| |
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
| |
|
|
| EMC 221
|
| S. Bonser
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 222
|
| S. Williams
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 223
|
| R. Johns
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 224
|
| M. Mitchell
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 225
|
| R. Davis
|
| Vol #:
|
| 4
|
| |
|
|
| 2002F-0160
|
| Safe use of Vitamin D3 in Calcium-Fortified Fruit Juices
|
|
| | | | | | | | |
|
| |
|
| BKG 2
|
| Reference 1
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0166
|
| Print clear, legible & intelligible product expiration date
|
| |
|
|
| C 3
|
| G. Mondrut
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 2
|
| J. Cornwell
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 3
|
| A. Mcgowan
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 4
|
| K. Anderson
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 5
|
| W. C. Rogers
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC
479
Attachment
|
| Calorie Control Council
|
| Vol #:
|
| 7
|
| |
|
|
| 2003D-0386
|
| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
|
| |
|
|
| EMC 4
|
| B. Sachau
|
| Vol #:
|
| 2
|
| |
|
|
| 2003D-0554
|
| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
|
| |
|
|
| EC
13
|
| Embassy of Japan
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| EMC 818
|
| J. Pasol
|
| Vol #:
|
| 11
|
| |
|
|
| EMC 819
|
| N. Taylor
|
| Vol #:
|
| 11
|
| |
|
|
| EMC 820
|
| B. Crow
|
| Vol #:
|
| 11
|
| |
|
|
| 2003N-0400
|
| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
| |
|
|
| EMC 58
|
| C. Evers
|
| Vol #:
|
| 15
|
| |
|
|
| 2003P-0501
|
| Pyridostigmine Bromide Tablets, 30mg for the of myasthenia gravis (ANDA) voluntarily withdrawn from sale for safety or efficacy reasons
|
| |
|
|
| LET
2
|
| HFD-7 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0033
|
| Factor VIII Inhibitors
|
| |
|
|
| EC 8
|
| American Bakers Association
|
| Vol #:
|
| 4
|
| |
|
|
| 2004N-0416
|
| Beverages: Bottled Water
|
| |
|
|
| EMC 3
|
| B. Sachau
|
| Vol #:
|
| 2
|
| |
|
|
| 2004N-0456
|
| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
|
|
|
|
|
|
|
|
|
| C
61
|
| Center for Science in the Public Interest
|
| Vol #:
|
| 5
|
| |
|
|
| EC
16
|
| American Heart Association
|
| Vol #:
|
| 4
|
| |
|
|
| EC
17
|
| Snack Food Association
|
| Vol #:
|
| 4
|
| |
|
|
| EC
18
|
| American Bakers Association
|
| Vol #:
|
| 4
|
|
| | | | | | | | |
| |
|
|
| EC
19
|
| General Mills
|
| Vol #:
|
| 4
|
| |
|
|
| EC
20
|
| National Yogurt Association
|
| Vol #:
|
| 4
|
| |
|
|
| EC
21
|
| Grocery Manufacturers Association
|
| Vol #:
|
| 4
|
| |
|
|
| EC
22
|
| International Dairy Foods Association
|
| Vol #:
|
| 4
|
| |
|
|
| EC
23
|
| The American Dietetic Association
|
| Vol #:
|
| 4
|
| |
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
| |
|
|
| EC 20
|
| American Heart Association
|
| Vol #:
|
| 4
|
| |
|
|
| EC
21
|
| American Heart Association
|
| Vol #:
|
| 4
|
| |
|
|
| EC
22
|
| Snack Food Association
|
| Vol #:
|
| 4
|
| |
|
|
| EC
23
|
| General Mills
|
| Vol #:
|
| 4
|
| |
|
|
| EC
24
|
| U.S. Canola Association
|
| Vol #:
|
| 4
|
| |
|
|
| EC
25
|
| International Dairy Foods Association
|
| Vol #:
|
| 4
|
| |
|
|
| EC
26
|
| Grocery Manufacturers Association
|
| Vol #:
|
| 5
|
| |
|
|
| EC
27
Attachment
|
| The American Dietetic Association
|
| Vol #:
|
| 5
|
| |
|
|
| EREG 1
|
| Ms. Jessica Bourne
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 2
|
| Mr. Jeff Dugal
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 3
|
| Ms. Misty Kruer
|
| Vol #:
|
| 4
|
| |
|
|
| 2004N-0516
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; 2005 Food Safety Survey
|
| |
|
|
| EMC 2
|
| B. Sachau
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0562
|
| Request immediate recall of all unapproved methacholine chloride products
|
| |
|
|
| LET
1
|
| HFD-005 to Lord Bissell Brook, LLP
|
| Vol #:
|
| 1
|
|
| |
|
| 2005D-0068
|
| Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System
|
| |
|
|
| EC 3
|
| Ms. Katharine Fogelgren
|
| Vol #:
|
| 1
|
| |
|
|
| 2005D-0106
|
| Guidance for Industry on Systemic Lupus Erythematosus Developing Drugs for Treatment
|
| |
|
|
| EMC
1
|
| Abbott Laboratories (Abbott)
|
| Vol #:
|
| 1
|
| |
|
|
| 2005D-0112
|
| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
|
| |
|
|
| EC
3
|
| Pfizer
|
| Vol #:
|
| 1
|
| |
|
|
| EC
4
|
| American Society of Clinical Oncology
|
| Vol #:
|
| 1
|
| |
|
|
| EC
5
|
| Cancer Leadership Council
|
| Vol #:
|
| 1
|
| |
|
|
| EC
6
|
| Colorectal Cancer Coalition
|
| Vol #:
|
| 1
|
| |
|
|
| EC 7
|
| Dr. Cheryl Anderson
|
| Vol #:
|
| 1
|
| |
|
|
| EC
8
|
| Eli Lilly and Company
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
1
|
| Merck & Co., Inc.
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2005D-0174
|
| Guidance on Expiration Dating of Unit-Dose Repackaged Drugs
|
| |
|
|
| EC 1
|
| Quincy Medical Center
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| Tomball Regional Hospital Pharmacy
|
| Vol #:
|
| 1
|
| |
|
|
| EC 3
|
| Carteret General Hospital
|
| Vol #:
|
| 1
|
| |
|
|
| 2005D-0203
|
| Guidance for Industry on Safety Testing of Drug Metabolites
|
| |
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 2
|
| Kraft Foods Global, Inc. (Kraft)
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0210
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Veterinary Feed Directive
|
| |
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0231
|
| Draft Report of the Threshold Working Group, Center for Food Safety and Applied Nutrition, Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food; Availability
|
|
|
|
|
|
|
|
|
| EC 1
|
| ELISA SYSTEMS Pty Ltd
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0139
|
| withdrawal of approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152
|
| |
|
|
| EMC 596
|
| D. McKee
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 597
|
| D. Trupiano
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 598
|
| B. Cloud
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 599
|
| B. Taylor
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 600
|
| S. Perry
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 601
|
| B. Goste
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 602
|
| B. Higgins
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 603
|
| G. Autumn
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 604
|
| S. Stecher
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 605
|
| L. Feldman
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 606
|
| T. Yates
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 607
|
| L. Lee
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 608
|
| K. Parker
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 609
|
| L. Novy
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 610
|
| P. Garcia
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 611
|
| L. Kehas
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 612
|
| G. Fritz
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 613
|
| M. Bushnell
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 614
|
| G. Holden
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 615
|
| J. Gaffney
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 616
|
| C. Howie
|
| Vol #:
|
| 3
|
|
| | | | | | | | |
| |
|
|
| EMC 617
|
| M. Albert, MSN, ARNP
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 618
|
| C. Connelly
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 619
|
| R. Cottage
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 620
|
| M. Rembold
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 621
|
| J. Higgins
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 622
|
| A. Franco
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 623
|
| K. Farrell
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 624
|
| J. Rivera
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 625
|
| L. Landstrom
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 626
|
| J. Kesich
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 627
|
| R. Courtmanch
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 628
|
| S. Light
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 629
|
| B. Abrams
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 630
|
| J. Fletcher
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 631
|
| M. Moutray
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 632
|
| J. Caruk
|
| Vol #:
|
| 3
|
| |
|
|
| 2005P-0265
|
| Over-the Counter Sale of Modafinil
|
| |
|
|
| ACK 1
|
| HFA-305 to James Salsman
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| James Salsman
|
| Vol #:
|
| 1
|
|
|
