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| Dockets Entered
On June 11, 2007
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| Docket #
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| Title
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| 1995N-0294
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| Quality/fill container; common or unusual name regulations
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| |
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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| 1999N-1415
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| Supplements and other changes to aproved NADA
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| |
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| 2000D-0109
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| Assessment of Antimicrobial Susceptibility Devices
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| |
|
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| 2002P-0483
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| Actions re: exceptive drug products, ex release guaifenesin
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| |
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| |
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| 2003V-0550
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| Laser Light Show
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| |
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| 2004N-0382
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| Food Labeling: Safe Handling Statements: Labeling of Shell Eggs
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| |
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| 2004P-0006
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| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| |
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| |
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| |
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| |
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| 2006D-0480
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| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
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| |
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| 2006N-0238
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| Debarment of Maria Anne Kirkman Campbell
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| 2006N-0362
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| General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
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| |
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| 2006P-0069
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| Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
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| |
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| 2006P-0334
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| Reclassification Petition fo Bone Heterografts
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| |
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| 2007D-0106
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| Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection
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| |
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| 2007D-0117
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| Guidance for Industry on Orally Disintegrating Tablets
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| |
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| 2007M-0108
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| P060019 - Therapy Cool Path Ablation Catheter and IBI 1500T9 RF Ablation Generator
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| |
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| 2007N-0114
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| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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| |
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| 2007N-0208
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| Interim Melamine and Melamine Analogues Safety/Risk Assessment; Availability
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| |
|
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| 2007P-0177
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| ANADA Suitability for generic new animal drug meloxicam which differs from the pioneer product, Metacam 1.5 mg/mL Oral Suspension
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| |
|
| 1995N-0294
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| Quality/fill container; common or unusual name regulations
|
| |
|
|
| REF 1
|
| OMB Review
|
| Vol #:
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| 7
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET 19994
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 19995
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 19996
|
| Enzymatic Therapy, Inc.
|
| Vol #:
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| 175
|
| |
|
|
| LET 19997
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
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| |
|
|
| LET 19998
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 19999
|
| M. Santana, LLC
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20000
|
| Source Naturals
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20001
|
| Source Naturals
|
| Vol #:
|
| 175
|
|
| | | | | | | |
|
| |
|
| LET 20002
|
| T & Tea Company
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20003
|
| T & Tea Company
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20004
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20005
|
| NewMark: A Division of New Chapter, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20006
|
| New Chapter, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20007
|
| New Chapter, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20008
|
| New Chapter, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20009
|
| New Chapter, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20010
|
| New Chapter, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20011
|
| New Chapter, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20012
|
| New Chapter, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20013
|
| New Chapter, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20014
|
| Hillestad Pharmaceuticals
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20015
|
| Attogram Corp.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20016
|
| Inverness Medical Nutritionals Group
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20017
|
| Inverness Medical Nutritionals Group
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20018
|
| Inverness Medical Nutritionals Group
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20019
|
| Inverness Medical Nutritionals Group
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20020
|
| Inverness Medical Nutritionals Group
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20021
|
| Inverness Medical Nutritionals Group
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20022
|
| Inverness Medical Nutritionals Group
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20023
|
| Inverness Medical Nutritionals Group
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20024
|
| Leland Cherry Company
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20025
|
| HERB PHARM
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20026
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20027
|
| Lativio LLP
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20028
|
| JOL Management
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20029
|
| Bee-Alive Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20030
|
| Swanson Health Products
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20031
|
| Futurebiotics LLC
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20032
|
| KHONG GUAN CORPORATION
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20033
|
| Medtech Products, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20034
|
| Pharmavite LLC
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20035
|
| Univera LifeSciences, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20036
|
| ZeaVision, LLC
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20037
|
| HERB PHARM
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20038
|
| CParmax, Inc.
|
| Vol #:
|
| 175
|
|
| | | | | | | | |
|
| |
|
| LET 20039
|
| Iovate Health Sciences U.S.A. Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20040
|
| Nutramax Laboratories, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20041
|
| Peak Health Care Products, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20042
|
| StoneBridge Pharma
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20043
|
| Savvier, LP
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20044
|
| FreeLife International, Inc.
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20045
|
| Leiner Health Products, LLC
|
| Vol #:
|
| 175
|
| |
|
|
| LET 20046
|
| Futurebiotics LLC
|
| Vol #:
|
| 175
|
| |
|
|
| 1999N-1415
|
| Supplements and other changes to aproved NADA
|
| |
|
|
| REF 3
|
| OMB Review
|
| Vol #:
|
| 2
|
| |
|
|
| 2000D-0109
|
| Assessment of Antimicrobial Susceptibility Devices
|
| |
|
|
| ACK 1
|
| FDA/DDM to Clinical and Laboratory Standards Institute
|
| Vol #:
|
| 2
|
| |
|
|
| CP 1
|
| Clinical and Laboratory Standards Institute
|
| Vol #:
|
| 2
|
| |
|
|
| 2002P-0483
|
| Actions re: exceptive drug products, ex release guaifenesin
|
| |
|
|
| PAV 1
|
| FDA/ORA
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
| |
|
|
| C 1456
|
| J. Ardizzone
|
| Vol #:
|
| 207
|
| |
|
|
| C 1457
|
| B. Pavey
|
| Vol #:
|
| 207
|
| |
|
|
| C 1458
|
| L. Graff
|
| Vol #:
|
| 207
|
| |
|
|
| C 1459
|
| C. Smead
|
| Vol #:
|
| 207
|
| |
|
|
| C 1460
|
| K. Rienks
|
| Vol #:
|
| 207
|
| |
|
|
| C 1461
|
| K. Ray
|
| Vol #:
|
| 207
|
| |
|
|
| C 1462
|
| J. Call
|
| Vol #:
|
| 207
|
| |
|
|
| C 1463
|
| J. Reeds
|
| Vol #:
|
| 207
|
| |
|
|
| C 1464
|
| B. Truman
|
| Vol #:
|
| 207
|
| |
|
|
| C 1465
|
| P. Polizzi
|
| Vol #:
|
| 207
|
| |
|
|
| C 1466
|
| M. Bann
|
| Vol #:
|
| 207
|
| |
|
|
| C 1467
|
| M. Bautel
|
| Vol #:
|
| 207
|
| |
|
|
| C 1468
|
| S. Lonsbury
|
| Vol #:
|
| 207
|
| |
|
|
| C 1469
|
| J. E. Young
|
| Vol #:
|
| 207
|
| |
|
|
| C 1470
|
| M. D. Chapman
|
| Vol #:
|
| 207
|
| |
|
|
| C 1471
|
| S. Perez
|
| Vol #:
|
| 207
|
| |
|
|
| C 1472
|
| K. Inman
|
| Vol #:
|
| 207
|
| |
|
|
| C 1473
|
| B. Paolucci
|
| Vol #:
|
| 207
|
|
| | | | | | | |
|
| |
|
| C 1474
|
| R. Sorenson
|
| Vol #:
|
| 207
|
| |
|
|
| C 1475
|
| A. Ainsworth
|
| Vol #:
|
| 207
|
| |
|
|
| C 1476
|
| J. Barrios
|
| Vol #:
|
| 207
|
| |
|
|
| C 1477
|
| L. Jaeger
|
| Vol #:
|
| 207
|
| |
|
|
| C 1478
|
| SFC P. Pierce
|
| Vol #:
|
| 207
|
| |
|
|
| C 1479
|
| M. Rivas
|
| Vol #:
|
| 207
|
| |
|
|
| C 1480
|
| A. Fierke
|
| Vol #:
|
| 207
|
| |
|
|
| C 1481
|
| J. Thompson
|
| Vol #:
|
| 207
|
| |
|
|
| C 1482
|
| M. H.
|
| Vol #:
|
| 207
|
| |
|
|
| C 1483
|
| C. Roth
|
| Vol #:
|
| 207
|
| |
|
|
| C 1484
|
| T. Warner
|
| Vol #:
|
| 207
|
| |
|
|
| C 1485
|
| D. Lacey
|
| Vol #:
|
| 207
|
| |
|
|
| C 1486
|
| M. Peek
|
| Vol #:
|
| 207
|
| |
|
|
| C 1487
|
| K. Angus
|
| Vol #:
|
| 207
|
| |
|
|
| C 1488
|
| K. Yoshida
|
| Vol #:
|
| 207
|
| |
|
|
| C 1489
|
| J. Prescott
|
| Vol #:
|
| 207
|
| |
|
|
| C 1490
|
| A. Herrington
|
| Vol #:
|
| 207
|
| |
|
|
| C 1491
|
| J. Preslar
|
| Vol #:
|
| 207
|
| |
|
|
| C 1492
|
| S. Jung
|
| Vol #:
|
| 207
|
| |
|
|
| C 1493
|
| J. Jackson
|
| Vol #:
|
| 207
|
| |
|
|
| C 1494
|
| R. & S. Pearson
|
| Vol #:
|
| 207
|
| |
|
|
| C 1495
|
| D. Mahnke
|
| Vol #:
|
| 207
|
| |
|
|
| C 1496
|
| S. G. Borrillo
|
| Vol #:
|
| 207
|
| |
|
|
| C 1497
|
| J. Walsh
|
| Vol #:
|
| 207
|
| |
|
|
| C 1498
|
| K. Blaser
|
| Vol #:
|
| 207
|
| |
|
|
| C 1499
|
| M. Watters
|
| Vol #:
|
| 207
|
| |
|
|
| C 1500
|
| T. Jones
|
| Vol #:
|
| 207
|
| |
|
|
| C 1501
|
| P. Petruccelli
|
| Vol #:
|
| 207
|
| |
|
|
| C 1502
|
| C. Breedlove
|
| Vol #:
|
| 207
|
| |
|
|
| C 1503
|
| M. Fitzgerald
|
| Vol #:
|
| 207
|
| |
|
|
| C 1504
|
| L. Iachetta
|
| Vol #:
|
| 207
|
| |
|
|
| C 1505
|
| M. Reardon
|
| Vol #:
|
| 207
|
| |
|
|
| C 1506
|
| J. Campbell
|
| Vol #:
|
| 207
|
| |
|
|
| C 1507
|
| S. Sarno
|
| Vol #:
|
| 207
|
| |
|
|
| C 1508
|
| R. Hassinger
|
| Vol #:
|
| 207
|
| |
|
|
| C 1509
|
| E. McCormick
|
| Vol #:
|
| 207
|
| |
|
|
| C 1510
|
| L. Bostic
|
| Vol #:
|
| 207
|
|
| | | | | | | |
|
| |
|
| C 1511
|
| H. Ryan
|
| Vol #:
|
| 207
|
| |
|
|
| C 1512
|
| P. Lopez
|
| Vol #:
|
| 207
|
| |
|
|
| C 1513
|
| K. Logsdon
|
| Vol #:
|
| 207
|
| |
|
|
| C 1514
|
| E. Harry
|
| Vol #:
|
| 207
|
| |
|
|
| C 1515
|
| G. Mercury
|
| Vol #:
|
| 207
|
| |
|
|
| C 1516
|
| K. Moore
|
| Vol #:
|
| 207
|
| |
|
|
| C 1517
|
| T. Le
|
| Vol #:
|
| 207
|
| |
|
|
| C 1518
|
| A. Baggett
|
| Vol #:
|
| 207
|
| |
|
|
| C 1519
|
| R. Potter
|
| Vol #:
|
| 207
|
| |
|
|
| C 1520
|
| E. Monsay
|
| Vol #:
|
| 207
|
| |
|
|
| C 1521
|
| M. Royse
|
| Vol #:
|
| 207
|
| |
|
|
| C 1522
|
| P. Rich
|
| Vol #:
|
| 207
|
| |
|
|
| C 1523
|
| C. Patrick
|
| Vol #:
|
| 207
|
| |
|
|
| C 1524
|
| P. Elsheimer
|
| Vol #:
|
| 207
|
| |
|
|
| C 1525
|
| P. Sellers
|
| Vol #:
|
| 207
|
| |
|
|
| C 1526
|
| W. Gilligan
|
| Vol #:
|
| 207
|
| |
|
|
| C 1527
|
| M. Minard
|
| Vol #:
|
| 207
|
| |
|
|
| C 1528
|
| R. Pastrana
|
| Vol #:
|
| 207
|
| |
|
|
| C 1529
|
| W. L. Riviere
|
| Vol #:
|
| 207
|
| |
|
|
| C 1530
|
| V. Hodge
|
| Vol #:
|
| 207
|
| |
|
|
| C 1531
|
| S. Wheeler
|
| Vol #:
|
| 207
|
| |
|
|
| C 1532
|
| M. J. Eberle
|
| Vol #:
|
| 207
|
| |
|
|
| C 1533
|
| A. Leamon
|
| Vol #:
|
| 207
|
| |
|
|
| C 1534
|
| G. Riker
|
| Vol #:
|
| 207
|
| |
|
|
| C 1535
|
| M. Zoch
|
| Vol #:
|
| 207
|
| |
|
|
| C 1536
|
| A. Tirrell
|
| Vol #:
|
| 207
|
| |
|
|
| C 1537
|
| C. J. Miles
|
| Vol #:
|
| 207
|
| |
|
|
| C 1538
|
| B. L. Wagoner
|
| Vol #:
|
| 207
|
| |
|
|
| C 1539
|
| J. Fajardo
|
| Vol #:
|
| 207
|
| |
|
|
| C 1540
|
| M. Hallisey
|
| Vol #:
|
| 207
|
| |
|
|
| C 1541
|
| M. Cline
|
| Vol #:
|
| 207
|
| |
|
|
| C 1542
|
| H. Stewart
|
| Vol #:
|
| 207
|
| |
|
|
| C 1543
|
| V. Rogers
|
| Vol #:
|
| 207
|
| |
|
|
| C 1544
|
| E. Vega
|
| Vol #:
|
| 207
|
| |
|
|
| C 1545
|
| T. C. Yang
|
| Vol #:
|
| 207
|
| |
|
|
| C 1546
|
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| Laser Light Show
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| ACK 2
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| FDA / DDM to Whatergy, Inc.
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| 1
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| VAR 2
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| Whatergy, Inc.
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| 1
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| 2004N-0382
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| Food Labeling: Safe Handling Statements: Labeling of Shell Eggs
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| |
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| REF 2
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| OMB Review
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| Vol #:
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| 4
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| | | | | | | | |
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| 2004P-0006
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| Stay approval of abbreviated new drug applications for controlled release oxycodone hydrochloride products that list OxyContin oxycodone HCI controlled-release
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| |
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| FDA/DDM to Kleinfeld, Kaplan and Becker, LLP
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| 1
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| ACK 3
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| FDA/DDM to Kleinfeld, Kaplan and Becker, LLP
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| 1
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| |
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| CP 1
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| Kleinfeld, Kaplan and Becker, LLP
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| Vol #:
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| 2
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| Kleinfeld, Kaplan and Becker, LLP
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| T. Florczak
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| 1
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| C. Flaherty
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| 1
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| K. Yuhas
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| 1
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| D. Block
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| 1
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| |
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| C 49
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| L. Greub
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| Vol #:
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| 1
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| N. & R. Gott
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| 1
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| S. Knoploh-Odole
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| Vol #:
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| 1
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| K. Svet
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| 1
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| A. Colonna
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| 1
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| L. Lewis
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| 8
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| D. Ellenberg
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| 8
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| |
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| P. Michaels
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| Vol #:
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| 8
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| |
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| C 57
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| G. Field
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| 8
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| |
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| E. Wanning
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| 8
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| E. Pasquesi
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| 8
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| M. Zinn
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| 8
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| J. Abbey
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| 8
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| A. Adams
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| S. Somes
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| A. Vietor
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| M. Franco
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| C 66
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| J. Whatford
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| Harvard Club of New York City
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| Center for Neuromuscular Massage Therapy
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| Vol #:
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| 8
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| C 69
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| D. Lalani
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| 8
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| K. Little
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| G. DiSpigno
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| J. Jennings
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| C 73
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| A. Adams
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| C 74
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| P. Viethaler
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| 8
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| C 75
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| L. Bronstein
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| 8
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| C 76
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| N. Ross
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| 8
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| C 77
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| California Natural Products
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| 8
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| C 78
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| J. Mueller
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| S. Mikolajczak
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| 8
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| C 80
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| K. Colebrook
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| 8
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| C 81
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| Rainbow Grocery Cooperative, Inc.
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| Vol #:
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| 8
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| C 82
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| D. & D. Luxern
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| 8
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| C 83
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| R. & J. Raleigh
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| Vol #:
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| 8
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| C 84
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| L. Colacurcio
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| 8
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| C 85
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| F. Hilton
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| 8
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| C 86
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| G. Barello
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| A. Lewis
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| 8
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| J. Duncan
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| 8
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| C 89
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| M. Harris & J. Apodaca
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| Vol #:
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| 8
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| C 90
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| C. Cannon
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| 8
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| P. Shaia
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| 8
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| C 92
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| L. Black
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| 8
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| K. Wilkison
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| 8
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| C 94
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| S. Henderson
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| 8
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| C 95
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| Form Letter Count 77
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| 10
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| |
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| C 96
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| Form Letter Count 7
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| Vol #:
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| 11
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| |
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| C 97
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| Form Letter Count 16
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| Vol #:
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| 12
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| |
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| C 98
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| N. Brown
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| 8
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| C 99
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| P. Pokorny
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| 8
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| |
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| C 100
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| W. Kobylarz
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| Vol #:
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| 8
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| C 101
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| Illegible
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| 8
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| |
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| C 102
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| J. Busch
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| Vol #:
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| 8
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| |
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| C 103
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| S. George
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| 8
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| |
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| EC 297
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| Ms. Gail Coffey
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| Vol #:
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| 6
|
| |
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| EC 298
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| Ms. Valerie Guinan
|
| Vol #:
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| 6
|
| |
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|
| EC 299
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| Ms. Nancy Davenport
|
| Vol #:
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| 6
|
| |
|
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| EC 300
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| Mrs. Linda Nedderman-Eaton
|
| Vol #:
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| 6
|
| |
|
|
| EC 301
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| Mr. David Purdy
|
| Vol #:
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| 6
|
| |
|
|
| EC 302
|
| Ms. Laura Smith
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| Vol #:
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| 6
|
| |
|
|
| REF 1
|
| OMB Review
|
| Vol #:
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| 9
|
|
| | | | | | | | |
|
| |
|
| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| |
|
|
| REF 1
|
| OMB Review
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| Vol #:
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| 37
|
| |
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|
| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| |
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| C 18316
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| R. Birckbichler
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| Vol #:
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| 198
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| |
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|
| C 17
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| American Clinical Laboratory Association (ACLA)
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| Vol #:
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| 1
|
| |
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| 2006D-0480
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| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
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| |
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| EC 212
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| individual consumer/grower
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| Vol #:
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| 6
|
| |
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| EC 213
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| Mrs. Laurie Schober
|
| Vol #:
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| 6
|
| |
|
|
| EC 214
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| Mr. Jeffrey Murrah
|
| Vol #:
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| 6
|
| |
|
|
| EC 215
|
| Mrs. Patricia Michael
|
| Vol #:
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| 6
|
| |
|
|
| EC 216
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| Dr. Laurence Smith
|
| Vol #:
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| 6
|
| |
|
|
| EC 217
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| Mr. Douglas Cook
|
| Vol #:
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| 6
|
| |
|
|
| EC 218
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| Mr. Barry Corbett
|
| Vol #:
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| 6
|
| |
|
|
| EC 219
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| Mrs. Desiree Passantino
|
| Vol #:
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| 6
|
| |
|
|
| EC 220
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| Mr. Gerald Smagacz
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| Vol #:
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| 6
|
| |
|
|
| EC 221
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| Ms. Donna Guardino
|
| Vol #:
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| 6
|
| |
|
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| EC 222
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| Ms. Elaine La Rochelle
|
| Vol #:
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| 6
|
| |
|
|
| EC 223
|
| Mr. Hal Grisham
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| Vol #:
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| 6
|
| |
|
|
| EC 224
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| Finding Inner Peace Yoga School
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| Vol #:
|
| 6
|
| |
|
|
| EC 225
|
| none
|
| Vol #:
|
| 6
|
| |
|
|
| EC 226
|
| Ms. Carol Hanson
|
| Vol #:
|
| 6
|
| |
|
|
| EC 227
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| Mrs. Nova ferguson
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| Vol #:
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| 6
|
| |
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| EC 228
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| Mr. Peter Freer
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| Vol #:
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| 6
|
| |
|
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| EC 229
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| Ms. claudia gehlhaart
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| Vol #:
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| 6
|
| |
|
|
| EC 230
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| Mr. Eric Wernli
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| Vol #:
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| 6
|
| |
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| EC 231
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| Unique Logic
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| Vol #:
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| 6
|
| |
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|
| EC 232
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| Ms. Ann Zavala
|
| Vol #:
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| 6
|
| |
|
|
| EC 233
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| Miss. Catherine Shaffer
|
| Vol #:
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| 6
|
| |
|
|
| EC 234
|
| On Behalf of my family and me
|
| Vol #:
|
| 6
|
| |
|
|
| EC 235
|
| Mr. Daniel Walsh
|
| Vol #:
|
| 6
|
| |
|
|
| EC 236
|
| Mr. Richard Molini
|
| Vol #:
|
| 6
|
| |
|
|
| EC 237
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| Ms. A Fry
|
| Vol #:
|
| 6
|
| |
|
|
| EC 238
|
| Ms. Lisa Thompson
|
| Vol #:
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| 6
|
| |
|
|
| EC 239
|
| Mr. Jerome Smith
|
| Vol #:
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| 6
|
|
| | | | | | | | |
|
| |
|
| EC 240
|
| Mrs. Catherine Comis
|
| Vol #:
|
| 6
|
| |
|
|
| EC 241
|
| Mrs. Josephine Guardino
|
| Vol #:
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| 6
|
| |
|
|
| EC 242
|
| Mr. Richard Gray
|
| Vol #:
|
| 6
|
| |
|
|
| EC 243
|
| Miss. Hannah Burns
|
| Vol #:
|
| 6
|
| |
|
|
| EC 244
|
| Mr. Randall Bryant
|
| Vol #:
|
| 6
|
| |
|
|
| EC 245
|
| Mrs. Kay Andresen
|
| Vol #:
|
| 6
|
| |
|
|
| EC 246
|
| Mr. john nelson
|
| Vol #:
|
| 6
|
| |
|
|
| EC 247
|
| Anti-Aging Clinic Assoc, Inc.
|
| Vol #:
|
| 6
|
| |
|
|
| EC 248
|
| Ms. Leanne Wylet
|
| Vol #:
|
| 6
|
| |
|
|
| 2006N-0238
|
| Debarment of Maria Anne Kirkman Campbell
|
| |
|
|
| LET 3
|
| FDA/CDER to Maria Anne Kirkman Campbell, M.D.
|
| Vol #:
|
| 1
|
|
| |
|
| 2006N-0362
|
| General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
|
| |
|
|
| C 27
|
| B. Ceverha
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0069
|
| Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
|
| |
|
|
| REF 1
|
| OMB Review
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0334
|
| Reclassification Petition fo Bone Heterografts
|
| |
|
|
| SUP 1
|
| Regeneration Technologies Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007D-0106
|
| Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection
|
| |
|
|
| C 3
|
| Consortium of Independent Review Boards
|
| Vol #:
|
| 1
|
| |
|
|
| 2007D-0117
|
| Guidance for Industry on Orally Disintegrating Tablets
|
| |
|
|
| C 7
|
| Wyeth Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007M-0108
|
| P060019 - Therapy Cool Path Ablation Catheter and IBI 1500T9 RF Ablation Generator
|
| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0114
|
| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
|
| |
|
|
| TR 1
|
| Transcript of April 27, 2007 Hearing
|
| Vol #:
|
| 3
|
|
| |
|
| 2007N-0208
|
| Interim Melamine and Melamine Analogues Safety/Risk Assessment; Availability
|
| |
|
|
| EC 1
|
| B ACHAU
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0177
|
| ANADA Suitability for generic new animal drug meloxicam which differs from the pioneer product, Metacam 1.5 mg/mL Oral Suspension
|
| |
|
|
| C 1
|
| Boehringer Ingelheim Vetmedica, Inc.
|
| Vol #:
|
| 1
|
|
|
