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| Dockets Entered On
December 28, 2005
Table of Contents
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| Docket #
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| Title
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| 2000P-1275
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| Health Claim: Vegetable oil sterol esters & coronary heart d
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| 2000P-1276
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| Health Claim: Plant stanol esters and heart disease
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| 2004N-0439
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| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
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| 2004P-0110
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| Nutrient Content Claim: Carbohydrate Content of Foods
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| 2005M-0109
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| P040004 - ADVIA Centaur HBc Total ReadyPack Reagents and ADVIA Centaur HBc Total Quality Control Materials
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| 2005M-0504
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| P040045 - VISTAKON (senofilcon A) Contact Lens, Clear and Visibility Tinted with UV Blocker, Approved 12/20/05
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| 2005P-0265
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| Over-the Counter Sale of Modafinil
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| 2005P-0269
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| Amend 21 C.F.R. 101.12(b) Table 2 Reference Amount Customarily Consumed Per Eating Occasion: General Food Supply, by establishing a separate reference amount for fruitcake of 43 grams (1 1/2 ounces).
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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-0449
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| Amend existing regulations authorizing health claims relating beta-glucan soluble fiber from specific whole oat sources to reduced risk of coronary heart disease, to permit foods which exceed the nutr
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| 2005P-0458
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| Refrain from approving ANDA 77-271 until the three-year period of market exclusivity for the product has expired.
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| 2000P-1275
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| Health Claim: Vegetable oil sterol esters & coronary heart d
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| C
29
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| Heart Blend Foods, LLC
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| Vol #:
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| 22
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| 2000P-1276
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| Health Claim: Plant stanol esters and heart disease
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| C
33
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| Heart Blend Foods, LLC
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| Vol #:
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| 22
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| C
5
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| Michigan Milk Producers Association (MMPA)
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| Vol #:
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| 1
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| C
6
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| Honorable Rob Simmons
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| Vol #:
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| 1
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| C
506
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| Anamax Group
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| Vol #:
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| 40
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| C 507
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| Form letters
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| Vol #:
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| 42
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| 2003P-0132
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| Part 135 FDA regulations standard of identity frozen dessert
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| C
23
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| Fonterra (USA), Inc.
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| Vol #:
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| 2
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| C
24
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| National Farmers Union (NFU)
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| Vol #:
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| 2
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| C
25
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| Michigan Milk Producers Association (MMPA)
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| Vol #:
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| 2
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| C 26
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| D. Mugglin
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| Vol #:
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| 2
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| C 27
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| H. Weingart, Jr.
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| Vol #:
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| 2
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| C
28
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| Honorable Rob Simmons
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| Vol #:
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| 2
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| C 29
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| F. Baffie
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| Vol #:
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| 2
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| C 30
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| P. Hardin
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| Vol #:
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| 2
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| C
31
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| National Family Farm Coalition (NFFC)
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| Vol #:
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| 2
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| C 32
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| P. Cartwright
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| Vol #:
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| 2
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| C 33
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| Form letters
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| Vol #:
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| 3
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| 2004N-0439
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| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
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| C 5
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| D Rhoe
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| Vol #:
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| 1
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| 2004P-0110
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| Nutrient Content Claim: Carbohydrate Content of Foods
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| LET
6
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| Grocery Manufacturers Association (GMA)
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| Vol #:
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| 1
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| 2005M-0109
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| P040004 - ADVIA Centaur HBc Total ReadyPack Reagents and ADVIA Centaur HBc Total Quality Control Materials
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| CR
1
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| Bayer Healthcare, LLC
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| Vol #:
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| 1
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| 2005M-0504
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| P040045 - VISTAKON (senofilcon A) Contact Lens, Clear and Visibility Tinted with UV Blocker, Approved 12/20/05
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| AAV
1
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| Vistakon, Division of Johnson & Johnson Vision Care, Inc.
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| Vol #:
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| 1
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| 2005P-0265
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| Over-the Counter Sale of Modafinil
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| LET
1
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| FDA/CDER to J Salsman
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| Vol #:
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| 1
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| 2005P-0269
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| Amend 21 C.F.R. 101.12(b) Table 2 Reference Amount Customarily Consumed Per Eating Occasion: General Food Supply, by establishing a separate reference amount for fruitcake of 43 grams (1 1/2 ounces).
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| PDN
1
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| HFC-1 to Bell, Boyd & Lloyd LLC
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| Vol #:
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| 1
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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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| C 64
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| M. Glowacki
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| Vol #:
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| 2
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| C 65
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| J. Buning
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| Vol #:
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| 2
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| C 66
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| C. Grace
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| Vol #:
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| 2
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| C 67
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| S. Craig
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| Vol #:
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| 2
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| C 68
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| L. Lucas
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| Vol #:
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| 2
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| C 69
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| S. Frantz, MD
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| Vol #:
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| 2
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| C 70
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| J. Wood
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| Vol #:
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| 2
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| C 71
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| S. Sipko
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| Vol #:
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| 2
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| C 72
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| A. Barnes
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| Vol #:
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| 2
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| C 73
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| R. Roberts, D.O.
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| Vol #:
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| 2
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| C 74
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| L. Mendoza
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| Vol #:
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| 2
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| C 75
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| M. Classen
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| Vol #:
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| 2
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| C 76
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| N. Thomats
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| Vol #:
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| 2
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| C 77
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| Dr. J. Richards
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| Vol #:
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| 2
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| C 78
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| A. Woods
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| Vol #:
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| 2
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