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| Dockets Entered
On November 1, 2005
Table of Contents
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| Docket #
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| Title
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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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| 1999P-0033
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| Combat the spread of transmissible spongiform encephalopathy
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| |
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| |
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| |
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| |
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| |
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| |
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| |
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| |
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| |
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| 2005D-0261
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| Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
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| 2005D-0385
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| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
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| |
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| 2005D-0412
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| Guidance for Industry: A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicle
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| 2005M-0435
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| P960040/S028 - VENTAK PRIZM AVT System, Approved 3/27/03
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| |
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| 2005N-0311
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| Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop
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| |
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| |
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| 2005N-0404
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| Solicitation of Public Review and Comment on Research Protocol:
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| 2005N-0426
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation
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| 2005P-0267
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| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
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| 2005P-0323
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| Immediately remove Adderall and Adderall XR from the market for safety reasons
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| 2005P-0436
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| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
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| 2005P-0440
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| To deny approval of Smith & Nephew's premarket approval application (PMA) for the Birmingham hip resurfacing system (P040033) based on the data currently submitted in support of the PMA
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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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| LET
16709
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| DMD Pharmaceuticals
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| Vol #:
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| 150
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| LET
16710
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| WTSmed
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| Vol #:
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| 150
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| LET
16711
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| Mediainfo
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| Vol #:
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| 150
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| LET
16712
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| ProCaps Laboratories
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| Vol #:
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| 150
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| LET
16713
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| Nutramax Laboratories, Inc.
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| Vol #:
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| 150
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| LET
16714
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| Herbalist Alchemist
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| Vol #:
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| 150
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| LET
16715
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| Cadbury Adams USA LLC
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| Vol #:
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| 150
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| |
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| LET
16716
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| Caudill Seed Company
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| Vol #:
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| 150
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| |
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| LET
16717
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| Nature's Way Products, Inc.
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| Vol #:
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| 150
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| | | | | | | | |
| |
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| LET
16718
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| FoodScience Corporation
|
| Vol #:
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| 150
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| LET
16719
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| Childlife Nutrition for Kids!
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| Vol #:
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| 150
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| LET
16720
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| Childlife Nutrition for Kids!
|
| Vol #:
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| 150
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| |
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| LET
16721
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| Now Foods
|
| Vol #:
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| 150
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| |
|
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| LET
16722
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| Univera, Inc.,d.b.a Oasis LifeSciences
|
| Vol #:
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| 150
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| |
|
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| LET
16723
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| Pharmavite LLC
|
| Vol #:
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| 150
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| |
|
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| LET
16724
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| Pharmavite LLC
|
| Vol #:
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| 150
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| |
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| LET
16725
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| EX3 Energy
|
| Vol #:
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| 150
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| |
|
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| LET
16726
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| Pharmavite LLC
|
| Vol #:
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| 150
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| |
|
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| LET
16727
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| Pharmavite LLC
|
| Vol #:
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| 150
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| |
|
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| LET
16728
|
| Pharmavite LLC
|
| Vol #:
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| 150
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| |
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| LET
16729
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| Pharmavite LLC
|
| Vol #:
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| 150
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| LET
16730
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| Pharmavite LLC
|
| Vol #:
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| 150
|
| |
|
|
| 1999P-0033
|
| Combat the spread of transmissible spongiform encephalopathy
|
| |
|
|
| EMC 7
|
| A. Stapleton
|
| Vol #:
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| 9
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| |
|
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| EMC 8
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| K. Borek
|
| Vol #:
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| 9
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| |
|
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| EMC 9
|
| B. Freese
|
| Vol #:
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| 9
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| |
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| EMC 10
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| D. Wichar
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| Vol #:
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| 9
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| |
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| EMC 11
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| F. Jakobcic
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| Vol #:
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| 9
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| |
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| EMC 12
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| S. Wellman
|
| Vol #:
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| 9
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| |
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| EMC 13
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| K. Lipiatos
|
| Vol #:
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| 9
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| EMC 613
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| S. Bondi
|
| Vol #:
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| 24
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| |
|
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| EMC 614
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| E. Reid
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| Vol #:
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| 24
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| |
|
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| EMC 615
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| D. Dudish
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| Vol #:
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| 24
|
| |
|
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| 2000P-1491
|
| Amend Definition & Standard of Identy for Parmesan Cheese
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| |
|
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| EMC 2
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| J. Deni, II
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| Vol #:
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| 1
|
| |
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
| |
|
|
| EMC 1293
|
| M. Miracle
|
| Vol #:
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| 6
|
| |
|
|
| EMC 1294
|
| S. Gruber
|
| Vol #:
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| 6
|
|
| |
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
| |
|
|
| EMC 231
|
| M. Marler
|
| Vol #:
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| 4
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| |
|
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| EMC 232
|
| M. Wilson
|
| Vol #:
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| 4
|
|
| | | | | | | | |
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| |
|
| 2002N-0273
|
| Animal Proteins Prohibited in Ruminant Feed
|
| |
|
|
| EC
35
|
| Mrs. Carla Yelkovan
|
| Vol #:
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| 4
|
| |
|
|
| EMC 59
|
| L. Aaron
|
| Vol #:
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| 14
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| |
|
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| EMC 60
|
| J. Cooley
|
| Vol #:
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| 14
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| |
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| EMC 61
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| J. Turk
|
| Vol #:
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| 14
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| |
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| EMC 62
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| L. Henri
|
| Vol #:
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| 14
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| |
|
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| EMC 63
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| J. Spruce
|
| Vol #:
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| 14
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| |
|
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| EMC 64
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| C. Getz
|
| Vol #:
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| 14
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| |
|
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| EMC 65
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| J. Tatum Jr.
|
| Vol #:
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| 14
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| |
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| EMC 66
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| M. Uze
|
| Vol #:
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| 14
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| |
|
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| EMC 67
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| K. Sgamma
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| Vol #:
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| 14
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| |
|
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| EMC 68
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| C. Mizerany
|
| Vol #:
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| 14
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| EMC 69
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| C. Fisch
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| Vol #:
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| 14
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| |
|
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| EMC 70
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| W. Ballentine
|
| Vol #:
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| 14
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| |
|
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| EMC 71
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| V. Engle
|
| Vol #:
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| 14
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| |
|
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| EMC 72
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| S. Brahmbhatt
|
| Vol #:
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| 14
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| |
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| EMC 73
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| L. Friedman
|
| Vol #:
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| 14
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| |
|
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| EMC 74
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| D. Shively
|
| Vol #:
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| 14
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| |
|
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| EMC 75
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| A. Egbert
|
| Vol #:
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| 14
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| |
|
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| EMC 76
|
| C. Clark
|
| Vol #:
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| 14
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| |
|
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| EMC 77
|
| J. Ballard
|
| Vol #:
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| 14
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| |
|
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| EMC 78
|
| M. Smith
|
| Vol #:
|
| 14
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| |
|
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| EMC 79
|
| J. Ballard
|
| Vol #:
|
| 14
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| |
|
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| EMC 80
|
| J. Ertel
|
| Vol #:
|
| 14
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| |
|
|
| EMC 81
|
| K. Miller
|
| Vol #:
|
| 14
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| |
|
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| EMC 82
|
| M. Budd
|
| Vol #:
|
| 14
|
| |
|
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| EMC 83
|
| D. Blanken
|
| Vol #:
|
| 14
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| |
|
|
| EMC 84
|
| D. Isaacson
|
| Vol #:
|
| 14
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| |
|
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| EMC 85
|
| G. Camhi
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 86
|
| H. Gordon
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 87
|
| S. Harrison
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 88
|
| S. Stout
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 89
|
| S. Dobbelaere
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 90
|
| K. Althiser
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 91
|
| B. Atkinson
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 92
|
| L. Lambeth
|
| Vol #:
|
| 14
|
|
| | | | | | | | |
| |
|
|
| EMC 93
|
| J. Wyrick
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 94
|
| R. Herbin
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 95
|
| J. Armstrong
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 96
|
| E. Walsingham
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 97
|
| C. SMith
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 98
|
| H. Cohen
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 99
|
| B. Jones
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 100
|
| P. Herron
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 101
|
| C. Dronzkowski
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 102
|
| W. Brown
|
| Vol #:
|
| 14
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| |
|
|
| EMC 103
|
| C. Wedding
|
| Vol #:
|
| 14
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| |
|
|
| EMC 104
|
| N. Wedding
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 105
|
| T. O'Neil
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 106
|
| W. Davis
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 107
|
| R. Tolleson
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 108
|
| B. Fitzpatrick
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 109
|
| B. Flowers
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 110
|
| K. Pence
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 111
|
| C. Frechette
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 112
|
| T. Schram
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 113
|
| S. Hall
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 114
|
| H and M Wood
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 115
|
| E. Honey
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 116
|
| L. Pike
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 117
|
| P. DesChene
|
| Vol #:
|
| 14
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC 546
|
| Mission Possible International
|
| Vol #:
|
| 8
|
| |
|
|
| EMC 547
|
| Mission Possible International
|
| Vol #:
|
| 8
|
| |
|
|
| EMC
548
|
| Calorie Control Council
|
| Vol #:
|
| 8
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC 1147
|
| J. Olivo
|
| Vol #:
|
| 11
|
| |
|
|
| EMC 1148
|
| J. Hubbard
|
| Vol #:
|
| 11
|
| |
|
|
| EMC 1149
|
| L. Jacobs
|
| Vol #:
|
| 11
|
| |
|
|
| EMC 1150
|
| K. Bryan
|
| Vol #:
|
| 11
|
| |
|
|
| 2003P-0132
|
| Part 135 FDA regulations standard of identity frozen dessert
|
|
| | | | | | | | |
| |
|
|
| EMC 2
|
| J. Deni, II
|
| Vol #:
|
| 1
|
| |
|
|
| 2004H-0322
|
| Civil Money Penalty Re: Ecumed Health Group, Inc.
|
| |
|
|
| MO 13
|
| Ecumed Health Group, Amador Reyes, Juan Carrai and Richard Stone, M.D.
|
| Vol #:
|
| 2
|
|
| |
|
| 2005D-0261
|
| Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
|
|
|
|
|
|
|
| |
|
|
| EMC
3
Attachment
|
| Blood Systems, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| 2005D-0385
|
| Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
|
| |
|
|
| EC
2
|
| FDAReady Consulting
|
| Vol #:
|
| 1
|
| |
|
|
| 2005D-0412
|
| Guidance for Industry: A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicle
|
|
|
|
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005M-0435
|
| P960040/S028 - VENTAK PRIZM AVT System, Approved 3/27/03
|
| |
|
|
| AAV
1
|
| Guidant CRM Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0311
|
| Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop
|
| |
|
|
| EC
1
|
| American Society of Clinical Oncology
|
| Vol #:
|
| 1
|
| |
|
|
| EC
2
|
| Pfizer
|
| Vol #:
|
| 1
|
| |
|
|
| EC
3
|
| American Society of Clinical Oncology
|
| Vol #:
|
| 1
|
| |
|
|
| EC
4
|
| AstraZeneca
|
| Vol #:
|
| 1
|
| |
|
|
| EC
5
|
| Amer Soc for Clinical Pharmacology & Therapeutics
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0345
|
| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
|
| |
|
|
| EC
2205
|
| Mr. David Benfell
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 217
|
| C. Rubin
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 218
|
| B. Sanders
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 219
|
| A. Hicka
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 220
|
| D. King
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 221
|
| M. Rich
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 222
|
| A. Bruce
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 223
|
| V. Richards
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 224
|
| S. Staley
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 225
|
| No signature
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 226
|
| S. Manewith
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 227
|
| E. Feldman, MD
|
| Vol #:
|
| 3
|
|
| | | | | | | |
| |
|
|
| EMC 228
|
| L. Howery
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 229
|
| W. Fegenhols
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 230
|
| C. Blum
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 231
|
| S. Sakoutis
|
| Vol #:
|
| 3
|
| |
|
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| EMC 232
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| A. Winton
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| EMC 233
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| S. Cohen
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| EMC 234
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| A. Chatterjee
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| EMC 235
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| Q. Lippmann
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| EMC 236
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| R. Hall
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| EMC 237
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| M. Palm, RN
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| EMC 238
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| S. Conklin
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| EMC 239
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| E. Raether
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| EMC 240
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| M. Johnson
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| EMC 241
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| S. Romich
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| EMC 242
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| K. Abrams
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| EMC 243
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| K. Scott
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| EMC 244
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| S. Pfleeger
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| EMC 245
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| M. Corry
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| EMC 246
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| L. Schultz
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| EMC 247
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| N. Sharp
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| EMC 248
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| P. Gianino
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| EMC 249
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| D. Horan
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| 3
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| EMC
250
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| Planned Parenthood Affiliates of Washington state
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| 3
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| EMC 251
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| J. Daley
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| EMC 252
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| R. Heuertz
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| EMC 253
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| L. Messner
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| EMC 254
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| A. Gibson
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| EMC 255
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| R. Ray
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| EMC 256
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| L. Sullivan
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| EMC 257
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| F. Ettinger
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| EMC 258
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| M. Fassberg
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| EMC 259
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| M. Lyda
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| 3
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| EMC 260
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| C. Edquist
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| 3
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| EMC 261
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| A. Kapner
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| 3
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| EMC 262
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| M. Abiett
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| 3
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| EMC 263
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| M. McBride
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| 3
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| EMC 264
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| K. SMith
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| 3
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| EMC 265
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| C. Thompson
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| 3
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| EMC 266
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| R. Miller
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| EMC 267
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| C. McDonnell
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| 3
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| EMC 268
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| J. Jorgensen
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| 3
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| EMC 269
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| P. Gutherie
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| 3
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| EMC 270
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| S. Downes
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| 3
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| EMC 271
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| J. Stannard
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| 3
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| EMC 272
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| M. Hannon
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| 3
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| EMC 273
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| J. Coffey
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| 3
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| EMC 274
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| J. Glenn
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| 3
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|
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| EMC 275
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| P. Stancil
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| 3
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| EMC 276
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| J. Dezsofi
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| 3
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| EMC 277
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| A. Audette
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| 3
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| |
|
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| EMC 278
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| E. Voeller
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| 3
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| |
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| EMC 279
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| C. Flanigan
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| Vol #:
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| 3
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| |
|
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| EMC 280
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| J. Miner
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| 3
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| |
|
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| EMC 281
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| J. Richter
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| Vol #:
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| 3
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| |
|
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| EMC 282
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| C. Wilke
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| Vol #:
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| 3
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|
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| EMC 283
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| L. Falk
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| Vol #:
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| 3
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| |
|
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| EMC 284
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| P. Wylie
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| Vol #:
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| 3
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| |
|
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| EMC 285
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| A. Stavis
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| Vol #:
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| 3
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| |
|
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| EMC 286
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| S. Trejo
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| Vol #:
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| 3
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| |
|
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| EMC 287
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| S. Marcus
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| Vol #:
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| 3
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| |
|
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| EMC 288
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| A. Tuttle
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| Vol #:
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| 3
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| |
|
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| EMC 289
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| R. Youdelman
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| Vol #:
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| 3
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| |
|
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| EMC 290
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| L. Quinet
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| 4
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| |
|
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| EMC 291
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| A. Butts
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| Vol #:
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| 3
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| |
|
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| EMC 292
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| Z. Ziemer
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| Vol #:
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| 3
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| |
|
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| EMC 293
|
| M. Mathias
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| Vol #:
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| 3
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| |
|
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| EMC 294
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| J. Mitchell
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| Vol #:
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| 3
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| |
|
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| EMC 295
|
| F. Farkas
|
| Vol #:
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| 3
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| |
|
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| EMC 296
|
| L. Shrier
|
| Vol #:
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| 3
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| |
|
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| EMC 297
|
| P. King
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| Vol #:
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| 3
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| |
|
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| EMC 298
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| A. Lawler
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| Vol #:
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| 3
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| |
|
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| EMC 299
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| N. Stephani
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| Vol #:
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| 3
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| |
|
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| EMC 300
|
| D. Gould
|
| Vol #:
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| 3
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| |
|
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| EMC 301
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| J. Lewis
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| Vol #:
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| 3
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| |
|
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| EMC 302
|
| S. Trego
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| Vol #:
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| 3
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| |
|
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| EMC 303
|
| J. Greene
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| Vol #:
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| 3
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| |
|
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| EMC 304
|
| K. Haun
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| Vol #:
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| 3
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| |
|
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| EMC 305
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| J. Tomczyk
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| Vol #:
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| 3
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| |
|
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| EMC 306
|
| K. Schoemer
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| Vol #:
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| 3
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| |
|
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| EMC 307
|
| R. Moyer
|
| Vol #:
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| 3
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| |
|
|
| EMC 308
|
| D. Voorhes
|
| Vol #:
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| 3
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| |
|
|
| EMC 309
|
| V. Swenson
|
| Vol #:
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| 3
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| |
|
|
| EMC 310
|
| S. Needham
|
| Vol #:
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| 3
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| |
|
|
| EMC 311
|
| P. Yates
|
| Vol #:
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| 3
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| |
|
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| EMC 312
|
| D. Smatana
|
| Vol #:
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| 3
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| |
|
|
| EMC 313
|
| A. Huberman
|
| Vol #:
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| 3
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| |
|
|
| EMC 314
|
| L. Martel
|
| Vol #:
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| 3
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| |
|
|
| EMC 315
|
| T. Hill
|
| Vol #:
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| 3
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| |
|
|
| EMC 316
|
| M. Goodmn
|
| Vol #:
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| 3
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| |
|
|
| EMC 317
|
| C. Falnnery
|
| Vol #:
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| 3
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| |
|
|
| EMC 318
|
| A. Hansel
|
| Vol #:
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| 3
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| |
|
|
| EMC 319
|
| S. McComas
|
| Vol #:
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| 3
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| |
|
|
| EMC 320
|
| M. Yacobucci
|
| Vol #:
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| 3
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| |
|
|
| EMC 321
|
| J. Hooper
|
| Vol #:
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| 3
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| |
|
|
| EMC 322
|
| C. Hemphill
|
| Vol #:
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| 3
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| |
|
|
| EMC 323
|
| C. Knapp
|
| Vol #:
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| 3
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| |
|
|
| EMC 324
|
| M. Aronson
|
| Vol #:
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| 3
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| |
|
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| EMC 325
|
| S. Lyon
|
| Vol #:
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| 3
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| |
|
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| EMC 326
|
| M. Coronado
|
| Vol #:
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| 3
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| |
|
|
| EMC 327
|
| A. Aleman
|
| Vol #:
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| 3
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| |
|
|
| EMC 328
|
| C. Johnson
|
| Vol #:
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| 3
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| |
|
|
| EMC 329
|
| C. Hunt
|
| Vol #:
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| 3
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| |
|
|
| EMC 330
|
| D. Jacobson
|
| Vol #:
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| 3
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| |
|
|
| EMC 331
|
| F. Roseberry
|
| Vol #:
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| 3
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| |
|
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| EMC 332
|
| F. Wesley
|
| Vol #:
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| 3
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| |
|
|
| EMC 333
|
| L. Pettyjohn
|
| Vol #:
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| 3
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| |
|
|
| EMC 334
|
| D. Deagona
|
| Vol #:
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| 3
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| |
|
|
| EMC 335
|
| K. McConnell
|
| Vol #:
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| 3
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| |
|
|
| EMC 336
|
| S. Barwell
|
| Vol #:
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| 3
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| |
|
|
| EMC 337
|
| C. Popcheff
|
| Vol #:
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| 3
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| |
|
|
| EMC 338
|
| K. McQuaid
|
| Vol #:
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| 3
|
|
| | | | | | | |
| |
|
|
| EMC 339
|
| M. Brophy
|
| Vol #:
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| 3
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| |
|
|
| EMC 340
|
| J. Black
|
| Vol #:
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| 3
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| |
|
|
| EMC 341
|
| T. Minow
|
| Vol #:
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| 3
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| |
|
|
| EMC 342
|
| R. Unger
|
| Vol #:
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| 3
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| |
|
|
| EMC 343
|
| J. Blaz
|
| Vol #:
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| 3
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| |
|
|
| EMC 344
|
| K. Jordan
|
| Vol #:
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| 3
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| |
|
|
| EMC 345
|
| A. Grandov
|
| Vol #:
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| 3
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| |
|
|
| EMC 346
|
| S. Clay
|
| Vol #:
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| 3
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| |
|
|
| EMC 347
|
| C. Heinecke
|
| Vol #:
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| 3
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| |
|
|
| EMC 348
|
| D. Ostenkamp
|
| Vol #:
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| 3
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| |
|
|
| EMC 349
|
| R. Chanon
|
| Vol #:
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| 3
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| |
|
|
| EMC 350
|
| E. Winter
|
| Vol #:
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| 3
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| |
|
|
| EMC 351
|
| H. Shiller
|
| Vol #:
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| 3
|
| |
|
|
| EMC 352
|
| R. Ruggieri, Jr.
|
| Vol #:
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| 3
|
| |
|
|
| EMC 353
|
| C. Crocker
|
| Vol #:
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| 3
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| |
|
|
| EMC 354
|
| S. Freel
|
| Vol #:
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| 3
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| |
|
|
| EMC 355
|
| J. Temple
|
| Vol #:
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| 3
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| |
|
|
| EMC 356
|
| S. Stewart
|
| Vol #:
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| 3
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| |
|
|
| EMC 357
|
| M. O'Brien
|
| Vol #:
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| 3
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| |
|
|
| EMC 358
|
| C. Butlien
|
| Vol #:
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| 3
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| |
|
|
| EMC 359
|
| M. Barrett
|
| Vol #:
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| 3
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| |
|
|
| EMC 360
|
| M. Ballard
|
| Vol #:
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| 3
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| |
|
|
| EMC 361
|
| A, Newcomb
|
| Vol #:
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| 3
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| |
|
|
| EMC 362
|
| K. King
|
| Vol #:
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| 3
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| |
|
|
| EMC 363
|
| S. Tornheim
|
| Vol #:
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| 3
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| |
|
|
| EMC 364
|
| J. Murray
|
| Vol #:
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| 3
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| |
|
|
| EMC 365
|
| B. Johnson
|
| Vol #:
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| 3
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| |
|
|
| EMC 366
|
| B. Bernard
|
| Vol #:
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| 3
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| |
|
|
| EMC 367
|
| S. Zaslaw
|
| Vol #:
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| 3
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| |
|
|
| EMC 368
|
| M. Syed
|
| Vol #:
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| 3
|
| |
|
|
| EMC 369
|
| M. Clark
|
| Vol #:
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| 3
|
| |
|
|
| EMC 370
|
| L. Franklin
|
| Vol #:
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| 3
|
| |
|
|
| EMC 371
|
| A. Fusco
|
| Vol #:
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| 3
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| |
|
|
| EMC 372
|
| K. Shaw
|
| Vol #:
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| 3
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| |
|
|
| EMC 373
|
| P. Tadeo
|
| Vol #:
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| 3
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| |
|
|
| EMC 374
|
| S. Thames
|
| Vol #:
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| 3
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| |
|
|
| EMC 375
|
| S. Stigleman
|
| Vol #:
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| 3
|
|
| | | | | | | |
| |
|
|
| EMC 376
|
| P. Loeff
|
| Vol #:
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| 3
|
| |
|
|
| EMC 377
|
| A. Roman
|
| Vol #:
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| 3
|
| |
|
|
| EMC 378
|
| D. Fairbairn
|
| Vol #:
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| 3
|
| |
|
|
| EMC 379
|
| L. Vest
|
| Vol #:
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| 3
|
| |
|
|
| EMC 380
|
| A. Green
|
| Vol #:
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| 3
|
| |
|
|
| EMC 381
|
| G. Robbins
|
| Vol #:
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| 3
|
| |
|
|
| EMC 382
|
| G. Robbins
|
| Vol #:
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| 3
|
| |
|
|
| EMC 383
|
| A. Babalola
|
| Vol #:
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| 3
|
| |
|
|
| EMC 384
|
| M. Dudek
|
| Vol #:
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| 3
|
| |
|
|
| EMC 385
|
| S. Martinez
|
| Vol #:
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| 3
|
| |
|
|
| EMC 386
|
| M. McFarland
|
| Vol #:
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| 3
|
| |
|
|
| EMC 387
|
| E. Cerda
|
| Vol #:
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| 3
|
| |
|
|
| EMC 388
|
| R. Richardson
|
| Vol #:
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| 3
|
| |
|
|
| EMC 389
|
| P. Freismuth
|
| Vol #:
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| 3
|
| |
|
|
| EMC 390
|
| T. Hogle
|
| Vol #:
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| 3
|
| |
|
|
| EMC 391
|
| T. Bell
|
| Vol #:
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| 3
|
| |
|
|
| EMC 392
|
| D. Parker
|
| Vol #:
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| 3
|
| |
|
|
| EMC 393
|
| T. Bell
|
| Vol #:
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| 3
|
| |
|
|
| EMC 394
|
| F. Dahir
|
| Vol #:
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| 3
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| |
|
|
| EMC 395
|
| K. May
|
| Vol #:
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| 3
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| |
|
|
| EMC 396
|
| M. Logeland
|
| Vol #:
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| 3
|
| |
|
|
| EMC 397
|
| T. Vu
|
| Vol #:
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| 3
|
| |
|
|
| EMC
398
|
| Planned Parenthood Federation of America, Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 399
|
| S. Carroll
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 400
|
| R. Hall
|
| Vol #:
|
| 3
|
| |
|
|
| EMC
401
|
| American Society for Reproductive Medicine
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 402
|
| J. Grim
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 403
|
| A. Fermoyle
|
| Vol #:
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| 33
|
| |
|
|
| EMC 404
|
| S. Magee
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 405
|
| C. Spotts
|
| Vol #:
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| 33
|
| |
|
|
| EMC 406
|
| M. Holston
|
| Vol #:
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| 33
|
| |
|
|
| EMC 407
|
| S. Morgan
|
| Vol #:
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| 33
|
| |
|
|
| EMC 408
|
| C. Watloms
|
| Vol #:
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| 33
|
| |
|
|
| EMC 409
|
| G. Robbins
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 410
|
| W. Wilson
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 411
|
| L. Schiffer
|
| Vol #:
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| 33
|
| |
|
|
| EMC
412
|
| Honorable Joseph Crowley and Honorable Carolyn B. Maloney
|
| Vol #:
|
| 33
|
|
| | | | | | | | |
| |
|
|
| EMC
413
|
| Honorable Louise M. Slaughter et al.
|
| Vol #:
|
| 33
|
| |
|
|
| EMC
414
|
| The City of New York
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 415
|
| J. James
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 416
|
| S. Prowell
|
| Vol #:
|
| 33
|
| |
|
|
| EMC 417
|
| L. O'Shea
|
| Vol #:
|
| 33
|
| |
|
|
| EMC
418
|
| National Partnership for Women & Families
|
| Vol #:
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| 33
|
| |
|
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
| |
|
|
| EMC
7
|
| American College of Physicians
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 8
|
| J. Metrock
|
| Vol #:
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| 2
|
| |
|
|
| EMC 9
|
| No signature
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 10
|
| A. Murray
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 11
|
| K. Anderson
|
| Vol #:
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| 2
|
| |
|
|
| EMC 12
|
| H. Church
|
| Vol #:
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| 2
|
| |
|
|
| EMC 13
|
| B. Erickson
|
| Vol #:
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| 2
|
| |
|
|
| EMC 14
|
| P. Sprague
|
| Vol #:
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| 2
|
| |
|
|
| EMC 15
|
| J. Paynter
|
| Vol #:
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| 14
|
| |
|
|
| EMC 16
|
| R. Roast
|
| Vol #:
|
| 14
|
| |
|
|
| EMC 17
|
| J. Fallat
|
| Vol #:
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| 2
|
| |
|
|
| EMC 18
|
| J. Foster
|
| Vol #:
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| 2
|
| |
|
|
| EMC 19
|
| M. Sumrall
|
| Vol #:
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| 2
|
| |
|
|
| EMC 20
|
| S. Young
|
| Vol #:
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| 2
|
| |
|
|
| EMC 21
|
| J. Sughrue
|
| Vol #:
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| 2
|
| |
|
|
| EMC 22
|
| P. Fiscella
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 23
|
| W. Wood
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 24
|
| D. Girard
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 25
|
| L. Adler
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 26
|
| E. Gallagher
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 27
|
| D. Schleckser
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 28
|
| B. Deckard
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 29
|
| J. Travis
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 30
|
| B. Wishingrad
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 31
|
| S. Daughtry
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 32
|
| P. Harrell
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 33
|
| B. Massie
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 34
|
| D. O'Connor
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 35
|
| C. Berardo
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
| |
|
|
| EMC 36
|
| J. Whitlow
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 37
|
| C. Roane
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 38
|
| S. Porcaro
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 39
|
| P. Schroeder
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 40
|
| B. Tower
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 41
|
| E. Elgin
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 42
|
| K. Murray
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 43
|
| J and W Davies
|
| Vol #:
|
| 2
|
| |
|
|
| 2005N-0404
|
| Solicitation of Public Review and Comment on Research Protocol:
|
| |
|
|
| EC
1
|
| Ms. Susan Hayward
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0426
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2005P-0267
|
| Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
|
| |
|
|
| EC
106
|
| Dr. Dennis Mc Intosh
|
| Vol #:
|
| 3
|
| |
|
|
| EC
107
|
| Mr. Frank Maziarski, CRNA, MS
|
| Vol #:
|
| 3
|
| |
|
|
| EC
108
|
| Dr. William Simpson
|
| Vol #:
|
| 3
|
| |
|
|
| EC
109
|
| SurgiCare of Jacksonville
|
| Vol #:
|
| 3
|
| |
|
|
| EC
110
|
| Hammonton Anesthesia Associates
|
| Vol #:
|
| 3
|
| |
|
|
| EC
111
|
| Dr. Craig Brener
|
| Vol #:
|
| 3
|
| |
|
|
| EC
112
|
| Ms. Leigh Gushea
|
| Vol #:
|
| 3
|
| |
|
|
| EC
113
|
| Mr. James Hawes, ARNP-CRNA
|
| Vol #:
|
| 3
|
| |
|
|
| EC
114
|
| AANA
|
| Vol #:
|
| 3
|
| |
|
|
| EC
115
|
| Kentucky Association of Nurse Anesthetists
|
| Vol #:
|
| 3
|
| |
|
|
| EC
116
|
| Mrs. Miriam Talley CRNA
|
| Vol #:
|
| 3
|
| |
|
|
| EC
117
|
| Mr. Robert Hitt
|
| Vol #:
|
| 3
|
| |
|
|
| EC
118
|
| Dr. howard reynolds
|
| Vol #:
|
| 3
|
| |
|
|
| EC
119
|
| Member of AANA
|
| Vol #:
|
| 3
|
| |
|
|
| EC
120
|
| Saint Vincent Memorial Hospital
|
| Vol #:
|
| 3
|
| |
|
|
| EC
121
|
| Mr. James Neblett III
|
| Vol #:
|
| 3
|
| |
|
|
| EC
122
|
| altru hospital
|
| Vol #:
|
| 3
|
| |
|
|
| EC
123
|
| University Anesthesiologists, Inc
|
| Vol #:
|
| 3
|
| |
|
|
| EC
124
|
| Mrs. Misty Montellano
|
| Vol #:
|
| 3
|
| |
|
|
| EC
125
|
| Mrs. kim thomas
|
| Vol #:
|
| 3
|
| |
|
|
| EC
126
|
| anesthesia medical group of santa cruz, inc.
|
| Vol #:
|
| 3
|
| |
|
|
| EC
127
|
| Mrs. Karenn Hall
|
| Vol #:
|
| 3
|
|
| | | | | | | | |
| |
|
|
| EC
128
|
| Dr. Alan Angel
|
| Vol #:
|
| 3
|
| |
|
|
| EC
129
|
| Wichita Falls Endoscopy Center
|
| Vol #:
|
| 3
|
| |
|
|
| EC
130
|
| Dr. Kevin Pace
|
| Vol #:
|
| 3
|
| |
|
|
| EC
131
|
| Digestive
|
| Vol #:
|
| 3
|
| |
|
|
| EC
132
|
| UW School of Medicine
|
| Vol #:
|
| 3
|
| |
|
|
| EC
133
|
| University of Rochester
|
| Vol #:
|
| 3
|
| |
|
|
| EC
134
|
| Dr. Maurizio Solca
|
| Vol #:
|
| 3
|
| |
|
|
| EC
135
|
| Mr. Nick Hill
|
| Vol #:
|
| 3
|
| |
|
|
| EC
136
|
| Dr. LUCIA CAPELLARO
|
| Vol #:
|
| 3
|
| |
|
|
| EC
137
|
| Dr. Roger Mattison
|
| Vol #:
|
| 3
|
| |
|
|
| EC
138
|
| Dr. Jonathan Radin
|
| Vol #:
|
| 3
|
| |
|
|
| EC
139
|
| None
|
| Vol #:
|
| 3
|
| |
|
|
| EC
140
|
| Huntsville Hospital Systems
|
| Vol #:
|
| 3
|
| |
|
|
| EC
141
|
| University of Udine, Italy
|
| Vol #:
|
| 3
|
| |
|
|
| EC
142
|
| UAB Medical Center
|
| Vol #:
|
| 3
|
| |
|
|
| EC
143
|
| Dr. James McKenna
|
| Vol #:
|
| 3
|
| |
|
|
| EC
144
|
| Dr. Lynn Mishkel
|
| Vol #:
|
| 3
|
| |
|
|
| EC
145
|
| Children's Anesthesiologists, PC
|
| Vol #:
|
| 3
|
| |
|
|
| EC
146
|
| Mrs. Lynn Coyne
|
| Vol #:
|
| 3
|
| |
|
|
| EC
147
|
| Dartmouth Hitchcock Medical Center
|
| Vol #:
|
| 3
|
| |
|
|
| EC
148
|
| Tejas Anesthesia, PA/Texas Society of Anes.
|
| Vol #:
|
| 3
|
| |
|
|
| EC
149
|
| Dr. Richard Siegenfeld
|
| Vol #:
|
| 3
|
| |
|
|
| EC
150
|
| Dr. james dooley
|
| Vol #:
|
| 3
|
| |
|
|
| EC
151
|
| CHESHIRE MEDICAL CENTER
|
| Vol #:
|
| 3
|
| |
|
|
| 2005P-0323
|
| Immediately remove Adderall and Adderall XR from the market for safety reasons
|
| |
|
|
| EC
2
|
| The Oaks Treatment Center
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0436
|
| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
|
| |
|
|
| ACK
1
|
| HFA-305 to Frommer Lawrence & Haug LLP
|
| Vol #:
|
| 1
|
|
| |
|
| 2005P-0440
|
| To deny approval of Smith & Nephew's premarket approval application (PMA) for the Birmingham hip resurfacing system (P040033) based on the data currently submitted in support of the PMA
|
|
|
|
|
|
|
|
| |
|
| ACK
1
|
| HFA-305 to Wright Medical Technology, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
|
| Wright Medical Technology, Inc.
|
| Vol #:
|
| 1
|
|
|
