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| Dockets Entered
On July 29, 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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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| 2004P-0223
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| Whole Grain Descriptive Claims
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| 2004P-0294
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| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
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| 2005D-0183
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| Guidance for Industry on Antiviral Drug Development Conducting Virology Studies and Submitting the Data to the Agency
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| 2005D-0195
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| Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
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| 2005N-0147
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| Sprout Safety Public Meeting
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| 2005P-0300
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| Determine that the drug Phenergan (promethazine hydrochloride) 12.5 mg and 50 mg tablets (NDA 07-935) was voluntarily withdrawn from sale for reasons other than safety or effectiveness
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| 2005V-0301
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| Laser Light Show
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
16400
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| Hillestad Pharmaceuticals
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| Vol #:
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| 146
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| LET
16401
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| Hillestad Pharmaceuticals
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| Vol #:
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| 146
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| LET
16402
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| Metagenics, Inc.
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| Vol #:
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| 146
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| LET
16403
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| Emzyamtic Therapy
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| Vol #:
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| 146
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| LET
16404
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| Geni Herbs
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| Vol #:
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| 146
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| LET
16405
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| Enzymatic Therapy
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| Vol #:
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| 146
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| LET
16406
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| Nutriceutical Innovations, Inc.
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| Vol #:
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| 146
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| LET
16407
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| Leiner Health Products
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| Vol #:
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| 146
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| LET
16408
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| Theralife, Inc.
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| Vol #:
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| 146
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| LET
16409
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| InteMedica, LLC
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| Vol #:
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| 146
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| LET
16410
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| Intelligent Nutrients
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| Vol #:
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| 146
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| LET
16411
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| NBTY Inc.
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| Vol #:
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| 146
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| LET
16412
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| NBTY Inc.
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| Vol #:
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| 146
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| LET
16413
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| NBTY Inc.
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| Vol #:
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| 146
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| LET
16414
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| NBTY Inc.
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| Vol #:
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| 146
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| LET
16415
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| NBTY Inc.
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| Vol #:
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| 146
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| LET
16416
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| Corta-FLX, Inc.
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| Vol #:
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| 146
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| LET
16417
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| Perrigo Company of South Carolina
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| Vol #:
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| 146
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| LET
16418
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| Perrigo Company of South Carolina
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| Vol #:
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| 146
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| LET
16419
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| NBTY Inc.
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| Vol #:
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| 146
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| LET
16420
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| NBTY Inc.
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| Vol #:
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| 146
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| LET
16421
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| NBTY Inc.
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| Vol #:
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| 146
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| LET
16422
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| NBTY Inc.
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| Vol #:
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| 146
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutritin
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| EMC
21
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| Food Products Association
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| Vol #:
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| 9
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| C 62
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| F. Levin
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| Vol #:
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| 5
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| EMC
783
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| Breadfarm
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| Vol #:
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| 4
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| 2004P-0223
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| Whole Grain Descriptive Claims
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| C
24
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| Roman Meal Company
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| Vol #:
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| 5
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| 2004P-0294
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| Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
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| EMC
2
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| McNeil Nutritionals LLC
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| Vol #:
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| 2
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| 2005D-0183
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| Guidance for Industry on Antiviral Drug Development Conducting Virology Studies and Submitting the Data to the Agency
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| EMC
1
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| Abbott
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| Vol #:
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| 1
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| 2005D-0195
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| Guidance for Industry and FDA Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9
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| EC
1
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| State of Wisconsin
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| Vol #:
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| 1
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| 2005N-0147
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| Sprout Safety Public Meeting
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| EMC
4
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| U S Department of Agriculture, ARS, ERRC, FSITRU
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| Vol #:
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| 3
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| EC 3
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| none
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| Vol #:
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| 1
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
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| EC
5
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| Ms. Susan Sheehan
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| Vol #:
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| 1
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| EC
6
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| Mrs. Jennifer Hutson
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| Vol #:
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| 1
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| EC
7
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| Mrs. kay jee
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| Vol #:
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| 1
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| 2005P-0300
|
| Determine that the drug Phenergan (promethazine hydrochloride) 12.5 mg and 50 mg tablets (NDA 07-935) was voluntarily withdrawn from sale for reasons other than safety or effectiveness
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| ACK
1
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| HFA-305 to Amide Pharmaceutical, Inc.
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| Vol #:
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| 1
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| CP
1
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| Amide Pharmaceutical, Inc.
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| Vol #:
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| 1
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| 2005V-0301
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| Laser Light Show
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| ACK
1
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| HFA-305 to Club Element
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| Vol #:
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| 1
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| VAR
1
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| Club Element
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| Vol #:
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| 1
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