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| Dockets Entered
On January 7, 2005
Table of Contents
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| Docket #
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| Title
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| 1978N-0036L
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| OTC Laxative
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| 1981N-0033
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| Oral Health Care Drug Products for OTC Human Use
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| 1994G-0237
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| Safe Use In Food Triglyceride Containing Caprylic & Capric
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| 1997N-0484P
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| Current Good Tissue Practice for Mfrs. of Human Cellular
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2000N-0504
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| Egg Safety Action Plan
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2001P-0340
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| Regulate Reprocessed Single Use Medical Devices as Reusable
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| 2002P-0013
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| Rescind GRAS Status for Aluminum-containing Food Additives
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| 2003N-0191
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| Agency Emergency Processing Under OMB Review; Submission of Validation Data for Reprocessed Single Use Devices
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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| 2003P-0564
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| 513(f) Reclassification Petition for In Vitro Diagnostics for Anti-Hepatitis A Virus IgM and Total Antibodies
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| 2004D-0198
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004D-0377
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| International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
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| 2004D-0378
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| International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
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| 2004D-0385
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| Class II Special Controls Guidance Document: Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus
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| 2004D-0440
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| Guidance for Industry on Computerized Systems Used in Clinical Trials
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| 2004N-0115
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| Prescription Drug Importation Study
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| 2004N-0154
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| Medical Devices; Semi-critical Reprocessed Single-Use Devices; Termination of Exemptions from Premarket Notification; Requirement for Submission of Validation Data
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| 2004P-0070
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| Withhold approval of any abbreviated New Drug Application ( ANDA) for a generic version of Ferrlecit( sodium ferric gluconate complex in sucrose ) until the conditions set forth in this petition are s
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| 2004P-0271
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| Determine that Drying Lotion, a Topical Acne Drug Products for Over the Counter Human Use, can contain in combination both Sulfur (10.0%) and Salicylic Acid (2.0%) as the active
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| 2004P-0285
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| To determine whether Aciphex (rabeprazole sodium) delayed-release tablets, 10mg (NDA 20-973) has been voluntarily withdrawn or withheld from sale for safety or effectiveness reasons
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| 2004P-0290
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| Refrain from approving any ANDA for a topical mupirocin calcium product containing the amorphous form of the active ingredient
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| 2004P-0294
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| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
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| 2004Q-0072
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| QHC Eggs w/Enhanced omega-3 fatty acid content and reduced risk of heart disease and sudden fatal heart attack
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| 2004Q-0097
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| Qualified Health Claim: Calcium and various cancers
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| 2004Q-0098
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| Qualified Health Claim: Calcium and hypertension
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| 2004Q-0099
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| Qualified Health Claim: Calcium and menstrual disorders
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| 2004Q-0102
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| Qualified Health Claim: Calcium and Kidney/urinary stones
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| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
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| 2005P-0008
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| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
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| 1978N-0036L
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| OTC Laxative
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|
| | | | | | | | |
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| C
342
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| Jewish Vegetarians of North America (JVNA)
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| Vol #:
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| 27
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| C 343
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| S. Nataline
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| Vol #:
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| 27
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| C 344
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| J. Horn
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| Vol #:
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| 27
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| C 345
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| Dr. L and B Pizzini
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| Vol #:
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| 27
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| C
346
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| Farm Animal Welfare Network
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| Vol #:
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| 27
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| C
347
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| Humane Society of the United States (USUS)
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| Vol #:
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| 27
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| C
348
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| Sparboe Summit Farm, Inc.
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| Vol #:
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| 26
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| C 349
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| C. Bradley
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| Vol #:
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| 27
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| C
350
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| PennAg Industries Assn
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| Vol #:
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| 27
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| C 351
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| C. Lininger
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| Vol #:
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| 27
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| C 352
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| M. Lieberman
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| Vol #:
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| 27
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| C
353
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| Luoma Egg Ranch, Inc.
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| Vol #:
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| 27
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| C 354
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| M. Ciano
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| Vol #:
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| 27
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| C
355
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| Florida Department of Agriculture & Consumer Services
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| Vol #:
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| 27
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| C 356
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| J. Miller
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| Vol #:
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| 27
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| C 357
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| D. Reuben
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| Vol #:
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| 27
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| C 358
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| J. Dyne
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| Vol #:
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| 27
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| C
359
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| State of California
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| Vol #:
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| 27
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| C 360
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| A. Lopez, Jr.
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| Vol #:
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| 27
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| C 361
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| N. Orr
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| Vol #:
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| 27
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| C 362
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| D. Shaffer
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| Vol #:
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| 27
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| C 363
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| Form Letters
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| Vol #:
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| 28
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| TR
4
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| Transcript of Proposed Rule for Prevention of Salmonella Enteritidis in Shell Eggs During Production
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| Vol #:
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| 29
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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|
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|
|
| EXB 822
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| Bayer Corporation
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| Vol #:
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| 471
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|
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| EXB 823
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| Bayer Corporation
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| Vol #:
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| 471
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| EXB 824
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| Bayer Corporation
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| Vol #:
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| 471
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|
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| EXB 825
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| Bayer Corporation
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| Vol #:
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| 471
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| EXB 826
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| Bayer Corporation
|
| Vol #:
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| 471
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|
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| EXB 827
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| Bayer Corporation
|
| Vol #:
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| 471
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|
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|
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| EXB 828
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| Bayer Corporation
|
| Vol #:
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| 471
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|
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|
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| EXB 829
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| Bayer Corporation
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| Vol #:
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| 471
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| EXB 830
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| Bayer Corporation
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| Vol #:
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| 471
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| EXB 831
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| Bayer Corporation
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| Vol #:
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| 471
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|
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| EXB 832
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| Bayer Corporation
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| Vol #:
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| 471
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| |
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| 2001P-0340
|
| Regulate Reprocessed Single Use Medical Devices as Reusable
|
|
| | | | | | | | |
|
| |
|
| PDN
1
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| HFZ-1 to Assn of Disposable Device Manufacturers
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| Vol #:
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| 1
|
|
|
|
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| 2002P-0013
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| Rescind GRAS Status for Aluminum-containing Food Additives
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|
|
|
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| PDN
1
Enclosure
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| HFC-1 to Food Analysis and Diagnostic Laboratory
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| Vol #:
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| 1
|
|
| |
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| 2003N-0191
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| Agency Emergency Processing Under OMB Review; Submission of Validation Data for Reprocessed Single Use Devices
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|
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|
|
| C
1
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| Hyman, Phelps & McNamara, PC
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| Vol #:
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| 1
|
|
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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|
|
|
|
| C
9
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| Association of American Feed Control Officials (AAFCO)
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| Vol #:
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| 4
|
|
|
|
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| 2003P-0270
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| Prohibit False and Misleading Labeling
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|
|
|
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| C 83
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| J. Peters, MSW, LCSW
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| Vol #:
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| 9
|
|
|
|
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| 2003P-0564
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| 513(f) Reclassification Petition for In Vitro Diagnostics for Anti-Hepatitis A Virus IgM and Total Antibodies
|
|
|
|
|
| C
1
|
| Abbott Laboratories
|
| Vol #:
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| 1
|
|
|
|
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| 2004D-0198
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| Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
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|
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|
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| C
8
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| AABB Donor History Task Force
|
| Vol #:
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| 1
|
|
|
|
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| 2004D-0343
|
| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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|
|
|
|
| C
17
|
| Huntleigh Healthcare Limited
|
| Vol #:
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| 2
|
|
|
|
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| C
18
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| Kinetic Concepts Inc (KCI)
|
| Vol #:
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| 2
|
|
|
|
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| C
19
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| Sunrise Medical Inc
|
| Vol #:
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| 2
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|
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|
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| C
20
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| Carolinas HealthCare System
|
| Vol #:
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| 2
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|
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|
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| C
21
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| Intermountain Health Care
|
| Vol #:
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| 2
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|
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|
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| C
22
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| Boone Hospital
|
| Vol #:
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| 2
|
|
|
|
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| C
23
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| Summit Medical Center
|
| Vol #:
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| 2
|
|
|
|
|
| C
24
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| Mercy Medical Center
|
| Vol #:
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| 2
|
|
|
|
|
| C
25
|
| Bay Regional Medical Center
|
| Vol #:
|
| 2
|
|
|
|
|
| C
26
|
| Bay Regional Medical Center
|
| Vol #:
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| 2
|
|
|
|
|
| C
27
|
| American College of Clinical Engineering (ACCE)
|
| Vol #:
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| 2
|
|
|
|
|
| C
28
|
| Baretich Engineering
|
| Vol #:
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| 2
|
|
|
|
|
| C
29
|
| American Health Care Association
|
| Vol #:
|
| 2
|
|
|
|
|
| C
30
|
| Wellmont Health System
|
| Vol #:
|
| 2
|
|
|
|
|
| C
31
|
| Memorial Medical Center
|
| Vol #:
|
| 2
|
|
|
|
|
| C
32
|
| ARAMARK Healthcare Management Services
|
| Vol #:
|
| 2
|
|
|
|
|
| C
33
|
| Thompson Health
|
| Vol #:
|
| 2
|
|
|
|
|
| C
34
|
| Jupiter Medical Center
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
| |
|
| EMC 455
|
| E Evans
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 456
|
| J Judge
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 457
|
| G de la Carrera
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 458
|
| J Spring
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 459
|
| J Wagner
|
| Vol #:
|
| 8
|
|
|
|
|
| 2004D-0377
|
| International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
|
|
|
|
|
|
|
|
|
| C
10
|
| AstraZeneca. LP
|
| Vol #:
|
| 1
|
|
|
|
|
| C
11
|
| Johnson & Johnson Pharmaceutical Research & Development, LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| C
12
|
| Wyeth Pharmaceuticals
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0378
|
| International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
|
|
|
|
|
|
|
|
|
| C
8
|
| Wyeth Pharmaceuticals
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0385
|
| Class II Special Controls Guidance Document: Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus
|
|
|
|
|
| C
1
Attachment
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0440
|
| Guidance for Industry on Computerized Systems Used in Clinical Trials
|
|
|
|
|
| C
9
|
| PDA Japan
|
| Vol #:
|
| 1
|
|
|
|
|
| C
10
|
| Purdue Pharma, L.P.
|
| Vol #:
|
| 1
|
|
|
|
|
| C
11
|
| Becton, Dickinson and Company (BD)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
12
|
| Society for Clinical Data Management, Inc. (SCDM)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
13
|
| AstraZeneca Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| C
14
|
| F. Hoffman-LaRoche Ltd
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
|
|
|
|
| REF 2
|
| Reference Material
|
| Vol #:
|
| 25
|
|
|
|
|
| 2004N-0154
|
| Medical Devices; Semi-critical Reprocessed Single-Use Devices; Termination of Exemptions from Premarket Notification; Requirement for Submission of Validation Data
|
|
|
|
|
| C
1
|
| Assn of Disposable Device Manufacturers
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0070
|
| Withhold approval of any abbreviated New Drug Application ( ANDA) for a generic version of Ferrlecit( sodium ferric gluconate complex in sucrose ) until the conditions set forth in this petition are s
|
|
|
|
|
|
|
|
|
| C
2
|
| Watson Pharma, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0271
|
| Determine that Drying Lotion, a Topical Acne Drug Products for Over the Counter Human Use, can contain in combination both Sulfur (10.0%) and Salicylic Acid (2.0%) as the active
|
|
|
|
|
|
|
|
|
|
|
| PDN
1
|
| HFC-1 to D'ARCY Skincare
|
| Vol #:
|
| 1
|
|
| |
|
| 2004P-0285
|
| To determine whether Aciphex (rabeprazole sodium) delayed-release tablets, 10mg (NDA 20-973) has been voluntarily withdrawn or withheld from sale for safety or effectiveness
|
|
| | | | | | | | |
|
| |
|
| reasons
|
|
|
|
|
| LET
1
|
| HFD-5 to Lachman Consultant Services, Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0290
|
| Refrain from approving any ANDA for a topical mupirocin calcium product containing the amorphous form of the active ingredient
|
|
|
|
|
| LET
1
|
| HFD-5 to GlaxoSmithKline Research & Development
|
| Vol #:
|
| 1
|
|
|
|
|
| SUP
1
|
| GlaxoSmithKline
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0294
|
| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
|
|
|
|
|
| LET
3
|
| McNeil Nutritionals
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004Q-0072
|
| QHC Eggs w/Enhanced omega-3 fatty acid content and reduced risk of heart disease and sudden fatal heart attack
|
|
|
|
|
| LET
3
|
| AAC Consulting Group
|
| Vol #:
|
| 4
|
|
|
|
|
| 2004Q-0097
|
| Qualified Health Claim: Calcium and various cancers
|
|
|
|
|
| LET
6
|
| Marine Bio Co. Ltd
|
| Vol #:
|
| 15
|
|
|
|
|
| 2004Q-0098
|
| Qualified Health Claim: Calcium and hypertension
|
|
|
|
|
| LET
8
|
| Marine Bio Co. Ltd.
|
| Vol #:
|
| 9
|
|
|
|
|
| 2004Q-0099
|
| Qualified Health Claim: Calcium and menstrual disorders
|
|
|
|
|
| LET
6
|
| Marine Bio Co. Ltd
|
| Vol #:
|
| 4
|
|
|
|
|
| 2004Q-0102
|
| Qualified Health Claim: Calcium and Kidney/urinary stones
|
|
|
|
|
| LET
6
|
| Marine Bio Co Ltd
|
| Vol #:
|
| 6
|
|
| |
|
| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
|
|
|
|
|
| EMC
16
|
| Weston A Price Foundation
|
| Vol #:
|
| 5
|
|
|
|
|
| 2005P-0008
|
| simvastatin tablets 5mg, 10mg, 20mg, and 40 mg
|
|
|
|
|
| ACK
1
|
| Ivax Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Ivax Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
|
