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| Dockets Entered
On April 12, 2007
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1996V-0138
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| Laser Light Show
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| 1998N-0337C
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| Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
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| 1998N-1038
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| Irradiation in the production, processing, &handling of food
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| 2005N-0373
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| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
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| 2005P-0121
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| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
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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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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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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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| 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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| 2006D-0514
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| Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
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| 2006N-0036
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
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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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| 2006P-0212
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| Lasik due to the use of research from experiments conducted on human beings without proper basis to believe it is in the patients best interests and improper patient informed consent
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| 2006P-0213
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| enforce the single-use requirement for all Microkeratomes and their components used by Lasik
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| 2006P-0410
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| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 2006P-0428
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| Combivent (ipratropium bromide and albuterol sulfate)
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| 2007D-0040
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| Guidance for Industry on Developing Products for Weight Management
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| 2007N-0016
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| Sentinel Network To Promote Medical Product Safety
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| 2007N-0026
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| Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
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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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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 2007P-0116
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| Stay any additional Abbreviated New Drug Applications for generic Amlodipine products until after the Mylan Pharmaceuticals Inc. 180-day exclusivity expires on September 23, 2007
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| LET 13
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| FDA/CFSAN to Iwade Research Institute of Mycology Co., Ltd
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| Vol #:
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| 287
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| RPT 374
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| Simply Healthy LLC
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| Vol #:
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| 294
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| RPT 375
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| Croda Chemicals Europe Ltd
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| Vol #:
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| 295
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| 1996V-0138
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| Laser Light Show
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| VAR 2
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| FDA/CDRH to Strictly FX LLC
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| Vol #:
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| 1
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| 1998N-0337C
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| Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
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| M 2
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| FDA to Dockets Management
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| Vol #:
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| 1
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| 1998N-1038
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| Irradiation in the production, processing, &handling of food
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| C 5723
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| Z Stone
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| Vol #:
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| 193
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| EC 4620
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| Miss. Emma Jenny Taylor
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| Vol #:
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| 54
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| EC 4621
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| concerned citizen
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| Vol #:
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| 54
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| EC 4622
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| Mrs. Carol Sulanke
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| Vol #:
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| 54
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| EC 4623
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| Mrs. Alyson Brewer
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| Vol #:
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| 54
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| EC 4624
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| Mr. John Kelly
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| Vol #:
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| 54
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| EC 4625
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| Ms. L Gols
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| Vol #:
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| 54
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| EC 4626
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| Ms. Wendy Ebersberger
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| Vol #:
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| 54
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| EC 4627
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| Ms. Jamie Henneman
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| Vol #:
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| 54
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| EC 4628
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| Mrs. kristin godwin
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| Vol #:
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| 54
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| EC 4629
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| Mrs. Jessica Brown
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| Vol #:
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| 54
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| EC 4630
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| Oneida Tribe of Indians of Wisconsin
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| Vol #:
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| 54
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| EC 4631
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| Mrs. Debbie Blalock
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| Vol #:
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| 54
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| EC 4632
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| Miss. Rose Williams
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| Vol #:
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| 54
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| EC 4633
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| Mrs. Sandra Denninger
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| Vol #:
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| 54
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| EC 4634
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| Mrs. K Moeggenborg
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| Vol #:
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| 54
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| EC 4635
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| Dr. Annette Vollrath
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| Vol #:
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| 54
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| EC 4636
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| Mr. Greg Soboleski
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| Vol #:
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| 54
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| EC 4637
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| Ms. Kristin Bolton
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| Vol #:
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| 54
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| EC 4638
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| Miss. Aria Jackson
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| Vol #:
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| 54
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| EC 4639
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| Mrs. Jocelyn Hyers
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| Vol #:
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| 54
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| EC 4640
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| Ms. Barbara and Jim Dale
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| Vol #:
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| 54
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| EC 4641
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| Mrs. L Gray
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| Vol #:
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| 54
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| EC 4642
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| Mr. Gregory Huang-Dale
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| Vol #:
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| 54
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| EC 4643
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| Miss. Kate Husiow
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| Vol #:
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| 54
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| EC 4644
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| Miss. Christine Moon
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| Vol #:
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| 54
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| EC 4645
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| Ms. Judith Brain
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| Vol #:
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| 54
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| EC 4646
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| Mrs. Laura Loflin
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| Vol #:
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| 54
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| EC 4647
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| Private Citizen
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| Vol #:
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| 54
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| EC 4648
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| Ms. Teri Ewing
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| Vol #:
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| 54
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| EC 4649
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| Ms. Dorothy Bolton
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| Vol #:
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| 54
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| EC 4650
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| Ms. Kristin Martin
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| Vol #:
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| 54
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| EC 4651
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| The Hopland Inn
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| Vol #:
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| 54
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| EC 4652
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| Miss. Lindsey Larscheid
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| Vol #:
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| 54
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| EC 4653
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| Ms. judy lieblein
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| Vol #:
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| 54
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| EC 4654
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| Mr. Justin Riegsecker
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| Vol #:
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| 54
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| EC 4655
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| Dr. Lisa Iyer
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| Vol #:
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| 54
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| EC 4656
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| Mr. Kirk Peterson
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| Vol #:
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| 54
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| EC 4657
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| Ms. Marlies Wessbecher
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| Vol #:
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| 54
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| |
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| EC 4658
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| Mr. Nate Brundage
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| Vol #:
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| 54
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| EC 4659
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| Mrs. Kerri Cook-Descheene
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| Vol #:
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| 54
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| EC 4660
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| Mrs. Dolores Delgado
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| Vol #:
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| 54
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| EC 4661
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| Ms. Bonnie Baker
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| Vol #:
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| 54
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| EC 4662
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| Moreland Inc.
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| Vol #:
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| 54
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| EC 4663
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| Mr. richardt track
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| Vol #:
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| 54
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| EC 4664
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| Ms. Juliette Delfs
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| Vol #:
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| 54
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| EC 4665
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| Mr. kevin joines
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| Vol #:
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| 54
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| EC 4666
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| Mr. Zane Lewis
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| Vol #:
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| 54
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| EC 4667
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| Mr. Noah Rowell
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| Vol #:
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| 54
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| EC 4668
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| Miss. Lisa D'Antonio
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| Vol #:
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| 54
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| EC 4669
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| Ms. Ronda Styles
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| Vol #:
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| 54
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| EC 4670
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| private individual
|
| Vol #:
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| 54
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| EC 4671
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| Ms. Amber Leigh Thompson
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| Vol #:
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| 54
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| |
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| EC 4672
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| The Big Ox Farm
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| Vol #:
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| 54
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| |
|
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| EC 4673
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| ASPCA
|
| Vol #:
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| 54
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| |
|
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| EC 4674
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| Ms. Pamela Burke
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| Vol #:
|
| 54
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| |
|
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| EC 4675
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| Ms. Victoria King
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| Vol #:
|
| 54
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| |
|
|
| EC 4676
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| Ms. wendy marquardt
|
| Vol #:
|
| 54
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| |
|
|
| EC 4677
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| Mrs. Moseka Medlock
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| Vol #:
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| 54
|
|
| |
|
| 2005N-0272
|
| Irradiation in the Production, Processing, and Handling of Food
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| |
|
|
| C 2
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| G Tritsch
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| Vol #:
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| 1
|
| |
|
|
| C 3
|
| K Kern
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| Vol #:
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| 1
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| |
|
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| C 4
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| R Tracy
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| Vol #:
|
| 1
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| |
|
|
| C 5
|
| CS Symington
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| Vol #:
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| 1
|
| |
|
|
| C 6
|
| D Schut
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| Vol #:
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| 1
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| |
|
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| C 7
|
| Mississippi Market Natural Foods Co-op
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| Vol #:
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| 1
|
| |
|
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| C 8
|
| S Wright
|
| Vol #:
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| 1
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| |
|
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| C 9
|
| B Thatcher
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| Vol #:
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| 1
|
|
| | | | | | | |
|
| |
|
| C 10
|
| K Kern
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| Vol #:
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| 1
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| |
|
|
| C 11
|
| D Goldstein
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| Vol #:
|
| 1
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| |
|
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| C 12
|
| J Jonik
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| Vol #:
|
| 1
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| |
|
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| C 13
|
| K Smith
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| Vol #:
|
| 1
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| |
|
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| EMC 9
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| G. Gray
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| Vol #:
|
| 5
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| |
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| EREG 161
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| S. Lisowski
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| Vol #:
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| 4
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| |
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| EREG 162
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| C. Blower
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| Vol #:
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| 4
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| |
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| EREG 163
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| H. Cathro
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| Vol #:
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| 4
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| |
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| EREG 164
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| J. Pickard
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| Vol #:
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| 4
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| |
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| EREG 165
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| A. Laurie
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| Vol #:
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| 4
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| |
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| EREG 166
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| Portland Public Schools
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| Vol #:
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| 4
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| |
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| EREG 167
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| R. Bell
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| Vol #:
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| 4
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| |
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| EREG 168
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| M. Bar
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| Vol #:
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| 4
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| |
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| EREG 169
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| S. Cook
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| Vol #:
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| 4
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| |
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| EREG 170
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| University of Missouri-St. Louis
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| Vol #:
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| 4
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| |
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| EREG 171
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| Q. Montana
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| Vol #:
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| 4
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| |
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| EREG 172
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| L. White
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| Vol #:
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| 4
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| |
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| EREG 173
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| C. O'Loughlin
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| Vol #:
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| 4
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| |
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| EREG 174
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| L. Malinowski
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| Vol #:
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| 4
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| |
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| EREG 175
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| M. Sorchevich
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| Vol #:
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| 4
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| |
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| EREG 176
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| University of Michigan
|
| Vol #:
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| 4
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| |
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| EREG 177
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| S. Yearout
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| Vol #:
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| 4
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| |
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| EREG 178
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| L. Johnson
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| Vol #:
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| 4
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| |
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| EREG 179
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| M. Wonsidler
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| Vol #:
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| 4
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| |
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| EREG 180
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| E. Holbrook
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| Vol #:
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| 4
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| |
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| EREG 181
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| Photography By Desiree
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| Vol #:
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| 4
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| |
|
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| EREG 182
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| K. Lotts
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| Vol #:
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| 4
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| |
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| EREG 183
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| S. Horvath
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| Vol #:
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| 4
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| |
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| EREG 184
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| D. Durant
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| Vol #:
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| 4
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| |
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| EREG 185
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| C. Williams
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| Vol #:
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| 4
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| |
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| EREG 186
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| D. Munk
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| Vol #:
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| 4
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| |
|
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| EREG 187
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| M. Allen
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| Vol #:
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| 4
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| |
|
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| EREG 188
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| Union of Concerned Scientists
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| Vol #:
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| 4
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| |
|
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| EREG 189
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| U. C. S.
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| Vol #:
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| 4
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| |
|
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| EREG 190
|
| R. Barker
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| Vol #:
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| 4
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| |
|
|
| EREG 191
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| J. Bacica
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| Vol #:
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| 4
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| |
|
|
| EREG 192
|
| S. Dennis-Martineau
|
| Vol #:
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| 4
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|
| | | | | | | |
|
| |
|
| EREG 193
|
| C. Wolcott
|
| Vol #:
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| 4
|
| |
|
|
| EREG 194
|
| J. Hadcroft
|
| Vol #:
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| 4
|
| |
|
|
| EREG 195
|
| D. Sebesta
|
| Vol #:
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| 4
|
| |
|
|
| EREG 196
|
| S. Heitzenrater
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| Vol #:
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| 4
|
| |
|
|
| EREG 197
|
| P. Ambrose
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 198
|
| J. Tallis
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| Vol #:
|
| 4
|
| |
|
|
| EREG 199
|
| Air Studio
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 200
|
| A. Strong
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| Vol #:
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| 4
|
| |
|
|
| EREG 201
|
| L. Foster
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 202
|
| L. Wilbur
|
| Vol #:
|
| 4
|
| |
|
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| EREG 203
|
| J. Thompson
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| Vol #:
|
| 4
|
| |
|
|
| EREG 204
|
| G. Borst
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 205
|
| R. E. C. Solar
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 206
|
| VegMichigan
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 207
|
| A. Stavropoulos
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 208
|
| N. Zett
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 209
|
| K. Peck
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 210
|
| S. Boyd
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 211
|
| J. Rocheleau
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 212
|
| FDA
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 213
|
| Paradox Arts
|
| Vol #:
|
| 4
|
| |
|
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| EREG 214
|
| D. Rowland
|
| Vol #:
|
| 4
|
| |
|
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| EREG 215
|
| Griswold Family
|
| Vol #:
|
| 4
|
| |
|
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| EREG 216
|
| G. Wolf
|
| Vol #:
|
| 4
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| |
|
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| EREG 217
|
| J. Denison
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 218
|
| G. Allerton
|
| Vol #:
|
| 4
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| |
|
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| EREG 219
|
| S. Pew
|
| Vol #:
|
| 4
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| |
|
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| EREG 220
|
| K. Carbonneau
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 221
|
| J. Rinehart
|
| Vol #:
|
| 4
|
| |
|
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| EREG 222
|
| M. Flowers
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 223
|
| S. & R. Newberg
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 224
|
| P. Hosler
|
| Vol #:
|
| 4
|
| |
|
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| EREG 225
|
| R. van Heuvein
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 226
|
| M. Sorensen
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 227
|
| W. Schmidt
|
| Vol #:
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| 4
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| EREG 228
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| Medford Environmental Alliance
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| Vol #:
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| 4
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| EREG 229
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| R. Cooper
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| Vol #:
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| 4
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| EREG 230
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| U. C. S.
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| Vol #:
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| 4
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| EREG 231
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| J. Zaitlin
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| Vol #:
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| 4
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| EREG 232
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| T. Brown
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| Vol #:
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| 4
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| EREG 233
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| E. Koivisto
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| Vol #:
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| 4
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| EREG 234
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| Ag Futures Alliance
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| Vol #:
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| 4
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| EREG 235
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| B. Lee
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| Vol #:
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| 4
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| EREG 236
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| C. Bostick
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| Vol #:
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| 4
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| EREG 237
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| T. Ahring
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| Vol #:
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| 4
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| |
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| EREG 238
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| Retired
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| Vol #:
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| 4
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| EREG 239
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| D. Rismoen
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| Vol #:
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| 4
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| EREG 240
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| M. Swyers
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| Vol #:
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| 4
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| EREG 241
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| W. Gibbs
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| Vol #:
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| 4
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| EREG 242
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| E. Fernandez
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| Vol #:
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| 4
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| EREG 243
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| S. Milone
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| Vol #:
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| 4
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| EREG 244
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| B. Linner
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| Vol #:
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| 4
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| EREG 245
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| C. Flewitt
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| Vol #:
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| 4
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| EREG 246
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| C. Blacklock
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| Vol #:
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| 4
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| EREG 247
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| D. Hennessey
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| Vol #:
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| 4
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| |
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| EREG 248
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| G. Thompson
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| Vol #:
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| 4
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| EREG 249
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| O. Eielson
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| Vol #:
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| 4
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| |
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| EREG 250
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| M. Lawrence
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| Vol #:
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| 4
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| |
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| EREG 251
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| B. Goetz
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| Vol #:
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| 4
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| |
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| EREG 252
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| M. Phillips
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| Vol #:
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| 4
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| |
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| EREG 253
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| H. Heaney
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| Vol #:
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| 4
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| |
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| EREG 254
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| U. C. S.
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| Vol #:
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| 4
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| |
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| EREG 255
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| C. West
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| Vol #:
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| 4
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| |
|
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| EREG 256
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| L. Huddlestone
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| Vol #:
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| 4
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| |
|
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| EREG 257
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| Berkshire Medical Center
|
| Vol #:
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| 4
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| |
|
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| EREG 258
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| V. Perkins
|
| Vol #:
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| 4
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| |
|
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| EREG 259
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| S. McLean
|
| Vol #:
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| 4
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| |
|
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| EREG 260
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| Citizens For A Safe Food Supply
|
| Vol #:
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| 4
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| |
|
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| EREG 261
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| J. Riley
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| Vol #:
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| 4
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| |
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| EREG 262
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| B. Wessel
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| Vol #:
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| 4
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| |
|
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| EREG 263
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| D. Borgeson
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| Vol #:
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| 4
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| |
|
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| EREG 264
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| B. Thomas
|
| Vol #:
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| 4
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| |
|
|
| EREG 265
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| S. Micheal
|
| Vol #:
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| 4
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| |
|
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| EREG 266
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| J. Brockman
|
| Vol #:
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| 4
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|
| | | | | | | |
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| |
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| EREG 267
|
| A. Higbee
|
| Vol #:
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| 4
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| |
|
|
| EREG 268
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| N. Idol
|
| Vol #:
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| 4
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| |
|
|
| EREG 269
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| A. Hanser
|
| Vol #:
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| 4
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| |
|
|
| EREG 270
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| T. Weems
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| Vol #:
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| 4
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| |
|
|
| EREG 271
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| R. Leigh
|
| Vol #:
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| 4
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| |
|
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| EREG 272
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| E. Foley
|
| Vol #:
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| 4
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| |
|
|
| EREG 273
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| B. Fankhauser
|
| Vol #:
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| 4
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| |
|
|
| EREG 274
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| D. Hupert
|
| Vol #:
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| 4
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| |
|
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| EREG 275
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| Royal Palm Academy
|
| Vol #:
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| 4
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| |
|
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| EREG 276
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| L. Hutchings
|
| Vol #:
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| 4
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| |
|
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| EREG 277
|
| M. Servais
|
| Vol #:
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| 4
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| |
|
|
| EREG 278
|
| Retired Pathologist
|
| Vol #:
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| 4
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| |
|
|
| EREG 279
|
| S. Lowenthal
|
| Vol #:
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| 4
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| |
|
|
| EREG 280
|
| D. Scarl
|
| Vol #:
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| 4
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| |
|
|
| EREG 281
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| J. Lerman
|
| Vol #:
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| 4
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| |
|
|
| EREG 282
|
| J. May
|
| Vol #:
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| 4
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| |
|
|
| EREG 283
|
| L. Bradshaw
|
| Vol #:
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| 4
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| |
|
|
| EREG 284
|
| U. C. S.
|
| Vol #:
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| 4
|
| |
|
|
| EREG 285
|
| M. Ross
|
| Vol #:
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| 4
|
| |
|
|
| EREG 286
|
| Union of Concerned Scientists
|
| Vol #:
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| 4
|
| |
|
|
| EREG 287
|
| A. Stavis
|
| Vol #:
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| 4
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| |
|
|
| EREG 288
|
| W. Mauceri
|
| Vol #:
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| 4
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| |
|
|
| EREG 289
|
| W. Sternman
|
| Vol #:
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| 4
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| |
|
|
| EREG 290
|
| M. Anderson
|
| Vol #:
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| 4
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| |
|
|
| EREG 291
|
| A. Schwartz
|
| Vol #:
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| 4
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| |
|
|
| EREG 292
|
| S. Federman
|
| Vol #:
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| 4
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| |
|
|
| EREG 293
|
| F. Costa
|
| Vol #:
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| 4
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| |
|
|
| EREG 294
|
| L. Horst
|
| Vol #:
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| 4
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| |
|
|
| EREG 295
|
| Vineyard Nursery Supplies, Inc.
|
| Vol #:
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| 4
|
| |
|
|
| EREG 296
|
| Union of Concerned Scientisis
|
| Vol #:
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| 4
|
| |
|
|
| EREG 297
|
| Meat Packers Consolidated
|
| Vol #:
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| 4
|
| |
|
|
| EREG 298
|
| P. Kehn
|
| Vol #:
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| 4
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| |
|
|
| EREG 299
|
| C. Trevino
|
| Vol #:
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| 4
|
| |
|
|
| EREG 300
|
| J. Goldman
|
| Vol #:
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| 4
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| |
|
|
| EREG 301
|
| A. Ritchey
|
| Vol #:
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| 4
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| |
|
|
| EREG 302
|
| M. Bakatsa
|
| Vol #:
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| 4
|
| |
|
|
| EREG 303
|
| J. Affonso
|
| Vol #:
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| 4
|
|
| | | | | | | |
|
| |
|
| EREG 304
|
| Allen E. Lavee, M. D., Inc.
|
| Vol #:
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| 4
|
| |
|
|
| EREG 305
|
| R. Kosta
|
| Vol #:
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| 4
|
| |
|
|
| EREG 306
|
| S. Wicmann
|
| Vol #:
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| 4
|
| |
|
|
| EREG 307
|
| U. N. M.
|
| Vol #:
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| 4
|
| |
|
|
| EREG 308
|
| D. Luehrmann
|
| Vol #:
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| 4
|
| |
|
|
| EREG 309
|
| D. Randolph
|
| Vol #:
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| 4
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| |
|
|
| EREG 310
|
| S. Hall
|
| Vol #:
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| 4
|
| |
|
|
| EREG 311
|
| S. Inabinet
|
| Vol #:
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| 4
|
| |
|
|
| EREG 312
|
| Tucson Optical Engineering, Inc.
|
| Vol #:
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| 4
|
| |
|
|
| EREG 313
|
| K. Jueds
|
| Vol #:
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| 4
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| |
|
|
| EREG 314
|
| V. Prichodko
|
| Vol #:
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| 4
|
| |
|
|
| EREG 315
|
| B. Buckley
|
| Vol #:
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| 4
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| |
|
|
| EREG 316
|
| C. Snively
|
| Vol #:
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| 4
|
| |
|
|
| EREG 317
|
| M. Delmestre
|
| Vol #:
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| 4
|
| |
|
|
| EREG 318
|
| R. Kuljian
|
| Vol #:
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| 4
|
| |
|
|
| EREG 319
|
| D. Schall
|
| Vol #:
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| 4
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| |
|
|
| EREG 320
|
| F. Aaron
|
| Vol #:
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| 4
|
| |
|
|
| EREG 321
|
| P. Lundell
|
| Vol #:
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| 4
|
| |
|
|
| EREG 322
|
| J. Norman
|
| Vol #:
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| 4
|
| |
|
|
| EREG 323
|
| J. Wolff
|
| Vol #:
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| 4
|
| |
|
|
| EREG 324
|
| Johns Hopkins
|
| Vol #:
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| 4
|
| |
|
|
| EREG 325
|
| Mofga
|
| Vol #:
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| 4
|
| |
|
|
| EREG 326
|
| D. Strong
|
| Vol #:
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| 4
|
| |
|
|
| EREG 327
|
| D. Engisch-Platt
|
| Vol #:
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| 4
|
| |
|
|
| EREG 328
|
| M. Cosgriff
|
| Vol #:
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| 4
|
| |
|
|
| EREG 329
|
| L. Southworth
|
| Vol #:
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| 4
|
| |
|
|
| EREG 330
|
| University of Pennsylvania
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 331
|
| R. Walton
|
| Vol #:
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| 4
|
| |
|
|
| EREG 332
|
| F. Dg
|
| Vol #:
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| 4
|
| |
|
|
| EREG 333
|
| L. Kirby
|
| Vol #:
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| 4
|
| |
|
|
| EREG 334
|
| K. Trepes
|
| Vol #:
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| 4
|
| |
|
|
| EREG 335
|
| K. Pemberton
|
| Vol #:
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| 4
|
| |
|
|
| EREG 336
|
| A. Balboa
|
| Vol #:
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| 4
|
| |
|
|
| EREG 337
|
| L. Haner
|
| Vol #:
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| 4
|
| |
|
|
| EREG 338
|
| R. Graham-Gardner
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 339
|
| B. Staelens
|
| Vol #:
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| 4
|
| |
|
|
| EREG 340
|
| J. Johnson
|
| Vol #:
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| 4
|
|
| | | | | | | | |
|
| |
|
| EREG 341
|
| D. Saperia
|
| Vol #:
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| 4
|
| |
|
|
| EREG 342
|
| R. McMillan
|
| Vol #:
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| 4
|
| |
|
|
| EREG 343
|
| S. Spears
|
| Vol #:
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| 4
|
| |
|
|
| EREG 344
|
| Private Citizen
|
| Vol #:
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| 4
|
| |
|
|
| EREG 345
|
| N. Gilkyson
|
| Vol #:
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| 4
|
| |
|
|
| EREG 346
|
| P. Tomasello
|
| Vol #:
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| 4
|
| |
|
|
| EREG 347
|
| D. Rodriguez
|
| Vol #:
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| 4
|
| |
|
|
| EREG 348
|
| Currituck Farm
|
| Vol #:
|
| 4
|
| |
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
| |
|
|
| EREG 56
|
| K. Clark
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 57
|
| R. Bittker
|
| Vol #:
|
| 32
|
| |
|
|
| EREG 58
|
| American Academy of Pediatriacs
|
| Vol #:
|
| 32
|
| |
|
|
| 2005N-0373
|
| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
|
| |
|
|
| C 15
|
| Becton, Dickinson and Company
|
| Vol #:
|
| 9
|
| |
|
|
| 2005P-0121
|
| Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II
|
| |
|
|
| C 15
|
| Shapiro Clinical Center
|
| Vol #:
|
| 7
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C 18294
|
| J. Larson
|
| Vol #:
|
| 198
|
| |
|
|
| 2005P-0459
|
| To enforce ban on carbon monoxide gas in fresh meat packaging
|
| |
|
|
| EMC 12
|
| V. Benn
|
| Vol #:
|
| 7
|
| |
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
| |
|
|
| C 16
|
| Baylor College of Medicine
|
| Vol #:
|
| 3
|
| |
|
|
| 2006D-0480
|
| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
|
| |
|
|
| EMC 2
|
| D. Friesen
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 3
|
| M. Urciuoli
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0514
|
| Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
|
|
|
|
|
|
|
| |
|
|
| C 2
|
| St. Louis Cord Blood Bank, SSM Cardinal Glennon Children's Hospital
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0036
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
|
|
|
|
|
|
| | |
|
|
| EMC 29
|
| A. Sander
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0069
|
| Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
|
|
| | | | | | | | |
|
| |
|
| EREG 1
|
| American Academy of Pediatrics
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0212
|
| Lasik due to the use of research from experiments conducted on human beings without proper basis to believe it is in the patients best interests and improper patient informed consent
|
| |
|
|
| LET 1
|
| FDA/CDRH to M Patterson
|
| Vol #:
|
| 1
|
|
| |
|
| 2006P-0213
|
| enforce the single-use requirement for all Microkeratomes and their components used by Lasik
|
| |
|
|
| LET 1
|
| FDA/CDRH to M Patterson
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0410
|
| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
|
| |
|
|
| RC 1
|
| MedImmune Oncology Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0415
|
| Petition Seeking Regulation of Cloned Animals
|
| |
|
|
| EMC 121
|
| B. Flowers
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 122
|
| L. Gray
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 123
|
| E. Smith
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 124
|
| J. Schuyler
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 125
|
| J. MacCallum
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 126
|
| L. Lee
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 127
|
| J. Payne
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 128
|
| B. Coleman
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 129
|
| C. Barnes
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 130
|
| R. Stambaugh
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 131
|
| S. Ottendorf
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 132
|
| K. Cummings
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 133
|
| M. McLean
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 134
|
| V. McAfee
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 135
|
| M. Kerwit
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 136
|
| C. Collier
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 137
|
| P. Rozek
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 138
|
| B. Dardzinski
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 139
|
| M. DiPalma
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 140
|
| S. Shaffer
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 141
|
| M. Thrantell
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 142
|
| S. Soares
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 143
|
| D. Kirchof-Glazier
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 144
|
| S. Heath
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 145
|
| D. Lamb
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 146
|
| W. Schmidt
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| Vol #:
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| 6
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|
| | | | | | | |
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| |
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| EMC 147
|
| C. del Castillo
|
| Vol #:
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| 6
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| |
|
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| EMC 148
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| J. & B. Ballantyne
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| Vol #:
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| 6
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| |
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| EMC 149
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| L. Congo
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| Vol #:
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| 6
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| |
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| EMC 150
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| D. Umhofer
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| Vol #:
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| 6
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| |
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| EMC 151
|
| G. Nicholson
|
| Vol #:
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| 6
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| |
|
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| EMC 152
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| C. Mesec
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| Vol #:
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| 6
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| |
|
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| EMC 153
|
| A. Frankel
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| Vol #:
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| 6
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| |
|
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| EMC 154
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| L. Dakin-Salomonson
|
| Vol #:
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| 6
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| |
|
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| EMC 155
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| J. Rebara
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| Vol #:
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| 6
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| |
|
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| EMC 156
|
| T. Mosley
|
| Vol #:
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| 6
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| |
|
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| EMC 157
|
| J. Jiosi
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| Vol #:
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| 6
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| |
|
|
| EMC 158
|
| M. Carpenter
|
| Vol #:
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| 6
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| |
|
|
| EMC 159
|
| L. Campbell
|
| Vol #:
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| 6
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| |
|
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| EMC 160
|
| D. Wood
|
| Vol #:
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| 6
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| |
|
|
| EMC 161
|
| T. & J. Carlson
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| Vol #:
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| 6
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| |
|
|
| EMC 162
|
| M. McNeill
|
| Vol #:
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| 6
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| |
|
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| EMC 163
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| R. Wayne
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| Vol #:
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| 6
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| |
|
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| EMC 164
|
| P. Wayne
|
| Vol #:
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| 6
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| |
|
|
| EMC 165
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| A. Fehman
|
| Vol #:
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| 6
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| |
|
|
| EMC 166
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| J. Stege
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| Vol #:
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| 6
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| |
|
|
| EMC 167
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| J. Shiloh
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| Vol #:
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| 6
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| |
|
|
| EMC 168
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| Z. Walden
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| Vol #:
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| 6
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| |
|
|
| EMC 169
|
| G. Patton
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| Vol #:
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| 6
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| |
|
|
| EMC 170
|
| R. Perez
|
| Vol #:
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| 6
|
| |
|
|
| EMC 171
|
| M. Suarez
|
| Vol #:
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| 6
|
| |
|
|
| EMC 172
|
| K. Scott
|
| Vol #:
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| 6
|
| |
|
|
| EMC 173
|
| E. Eyzatia
|
| Vol #:
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| 6
|
| |
|
|
| EMC 174
|
| W. Boyd
|
| Vol #:
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| 6
|
| |
|
|
| EMC 175
|
| D. Shelton
|
| Vol #:
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| 6
|
| |
|
|
| EMC 176
|
| L. Hluhan
|
| Vol #:
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| 6
|
| |
|
|
| EMC 177
|
| C. Wallace
|
| Vol #:
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| 6
|
| |
|
|
| EMC 178
|
| A. Gore
|
| Vol #:
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| 6
|
| |
|
|
| EMC 179
|
| M. Westrick
|
| Vol #:
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| 6
|
| |
|
|
| EMC 180
|
| L. Marshall
|
| Vol #:
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| 6
|
| |
|
|
| EMC 181
|
| J. Grossman
|
| Vol #:
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| 6
|
| |
|
|
| EMC 182
|
| D. Kolditz
|
| Vol #:
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| 6
|
| |
|
|
| EMC 183
|
| R. Pessin
|
| Vol #:
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| 6
|
|
| | | | | | | | |
|
| |
|
| EMC 184
|
| B. Mihopulos
|
| Vol #:
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| 6
|
| |
|
|
| EMC 185
|
| T. Mandala
|
| Vol #:
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| 6
|
| |
|
|
| EMC 186
|
| G. Phelps
|
| Vol #:
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| 6
|
| |
|
|
| EMC 187
|
| K. Widmer
|
| Vol #:
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| 6
|
| |
|
|
| EMC 188
|
| B. Jennings
|
| Vol #:
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| 6
|
| |
|
|
| EMC 189
|
| R. Carricaburu
|
| Vol #:
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| 6
|
| |
|
|
| EMC 190
|
| L. Polo
|
| Vol #:
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| 6
|
| |
|
|
| EMC 191
|
| T. Garnett
|
| Vol #:
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| 6
|
| |
|
|
| EMC 192
|
| A. Linton
|
| Vol #:
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| 6
|
| |
|
|
| EMC 193
|
| M. Sanders
|
| Vol #:
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| 6
|
| |
|
|
| EMC 194
|
| D. Heilman
|
| Vol #:
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| 6
|
| |
|
|
| EMC 195
|
| M. Aurilio
|
| Vol #:
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| 6
|
| |
|
|
| EMC 196
|
| D. Tucker
|
| Vol #:
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| 6
|
| |
|
|
| EMC 197
|
| T. Perkins
|
| Vol #:
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| 6
|
| |
|
|
| EMC 198
|
| C. Symington
|
| Vol #:
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| 6
|
| |
|
|
| EMC 199
|
| Y. Hansen
|
| Vol #:
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| 6
|
| |
|
|
| EMC 200
|
| I. Uphoff
|
| Vol #:
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| 6
|
| |
|
|
| EMC 201
|
| S. Suzelis
|
| Vol #:
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| 6
|
| |
|
|
| EMC 202
|
| H. Gregar
|
| Vol #:
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| 6
|
| |
|
|
| EMC 203
|
| C. Schuett
|
| Vol #:
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| 6
|
| |
|
|
| EMC 204
|
| T. Doherty
|
| Vol #:
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| 6
|
| |
|
|
| EMC 205
|
| M. Pryslak
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 206
|
| W. Ballentine
|
| Vol #:
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| 6
|
| |
|
|
| EMC 207
|
| C. Kamin
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 208
|
| M. Hyde
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 209
|
| E. Hudson
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 210
|
| M. Gerhardy
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 211
|
| H. Landry
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 212
|
| K. McKee
|
| Vol #:
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| 6
|
| |
|
|
| EMC 213
|
| L. Henselman
|
| Vol #:
|
| 6
|
| |
|
|
| 2006P-0428
|
| Combivent (ipratropium bromide and albuterol sulfate)
|
| |
|
|
| C 2
|
| American Association for Respiratory Care (AARC)
|
| Vol #:
|
| 1
|
| |
|
|
| 2007D-0040
|
| Guidance for Industry on Developing Products for Weight Management
|
| |
|
|
| C 2
|
| Bristol-Myers Squibb Company
|
| Vol #:
|
| 1
|
| |
|
|
| C 3
|
| NAASO The Obesity Society
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EC 1
|
| Dr. Richard Atkinson
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| The University of Alabama at Birmingham
|
| Vol #:
|
| 1
|
| |
|
|
| EC 3
|
| Pennington Biomedical Research Center
|
| Vol #:
|
| 1
|
| |
|
|
| EC 4
|
| Obecure, Ltd.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 5
|
| Globe Institute of Technology
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0016
|
| Sentinel Network To Promote Medical Product Safety
|
| |
|
|
| C 2
|
| MITA Medical Imaging & Technology Alliance
|
| Vol #:
|
| 6
|
| |
|
|
| C 3
|
| American Academy of Orthopaedic Surgeons
|
| Vol #:
|
| 6
|
| |
|
|
| C 4
|
| American College of Clinical Pharmacy (ACCP)
|
| Vol #:
|
| 6
|
| |
|
|
| 2007N-0026
|
| Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
|
| |
|
|
| EREG 1
|
| N. Schwartz
|
| Vol #:
|
| 1
|
| |
|
|
| EREG 2
|
| Arizona State University
|
| Vol #:
|
| 4
|
| |
|
|
| EREG 3
|
| Retired High School Science Teacher
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0114
|
| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
|
| |
|
|
| EAPE 43
|
| Fava, Jamie
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 44
|
| Bass, Steven
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 45
|
| Caniglia, Jacqueline
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 46
|
| Hopkins, John
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 47
|
| Greer, Kelly
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 48
|
| Spearmon, Jo Ann
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 49
|
| Young, Donna
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 50
|
| Cantu, Tom
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 51
|
| Wechsler, Jill
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 52
|
| Werble, Cole
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 53
|
| Jenkins-Showalter, Janet
|
| Vol #:
|
| 1
|
| |
|
|
| 2007N-0121
|
| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
|
| |
|
|
| EAPE 25
|
| Young, Karen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 26
|
| Tesch, Dianne
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 27
|
| Dal Pan, Gerald
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 28
|
| Moncavage, Melissa
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 29
|
| Saini, Sandeep
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 30
|
| Taylor, Kellie
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 31
|
| Van Syckel, Lisa
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 32
|
| Pierce, William
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EAPE 33
|
| Cumber, Nicole
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 34
|
| Dormitzer, Catherine
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 35
|
| Strickland, Dennis
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 36
|
| Coster, John
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 37
|
| Bishop, Susan
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 38
|
| Miller, Kristen
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 39
|
| Hassner Sharav, Vera
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 40
|
| Nazir, Nabila
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 41
|
| Stifano, Toni M.
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 42
|
| Greer, Kelly
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 43
|
| Hilfiker, David
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 44
|
| Chuen, Michelle
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 45
|
| Spearmon, Jo Ann
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 46
|
| Young, Donna
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 47
|
| Mathis, Lisa
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 48
|
| Avant, Deb
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 49
|
| St. Amand, Keith
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 50
|
| Mills, Sharon
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 51
|
| Jenkins-Showalter, Janet
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 1
|
| G. & R. Meysenburg
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 2
|
| Congress of the U.S. House of Representatives
|
| Vol #:
|
| 3
|
| |
|
|
| 2007P-0116
|
| Stay any additional Abbreviated New Drug Applications for generic Amlodipine products until after the Mylan Pharmaceuticals Inc. 180-day exclusivity expires on September 23, 2007
|
|
|
| | |
|
|
|
|
|
| EMC 2
|
| Synthon Pharmaceuticals, Inc.
|
| Vol #:
|
| 2
|
|
|
