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| Dockets Entered
On December 16, 2003
Table of Contents
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| Docket #
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| Title
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| 1995V-0312
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| Laser Light Show
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| 1997D-0530
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| Use of IEC 60601 Standards; Medical Electrical;
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| 2000N-1652
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| Human Prescripton Drugs/Biologics in Electronic Format
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2003D-0092
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| Food and Cosmetic Security Guidances
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| 2003N-0142
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| Submitting & Reviewing Complete Responses for Clinical Holds
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| 2003N-0506
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| Agency Emergency Processing Request Under OMB Review; Experimental Study of Possible Footnotes and Cuing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Pa
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| 2003N-0513
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| Electronic Submissions of Food Contact Notifications; Notice of Pilot Project
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| 2003N-0542
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| Agency Information Collection Activities: Proposed Collection; Proposed Collection; Premarket Notification Submission 510(K),
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| 2003P-0238
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| ANDA Suitability Petition for Clarithromycin Extended-Release Tablets
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| 2003P-0288
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| Health Center, be deemed a ' pharmacy of an other health care entity'
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2003P-0363
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| Professional and Patient Labeling for Hearing Aid Devices
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| 2003P-0564
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| 513(f) Reclassification Petition for In Vitro Diagnostics for Anti-Hepatitis A Virus IgM and Total Antibodies
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| 2003V-0563
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| Laser Light Show
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| 1995V-0312
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| Laser Light Show
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| AMD
1
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| Laseronics Design Interstellar
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| Vol #:
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| 1
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| 1997D-0530
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| Use of IEC 60601 Standards; Medical Electrical;
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| NAD
8
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| FDA
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| Vol #:
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| 1
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| NCR
1
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| FDA
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| Vol #:
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| 1
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| NCR
2
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| FDA
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| Vol #:
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| 1
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| 2000N-1652
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| Human Prescripton Drugs/Biologics in Electronic Format
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| EMC 707
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| S Christiansen
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| Vol #:
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| 120
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| EMC 708
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| E Duffy
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| Vol #:
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| 120
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| EMC 709
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| S Asbury
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| Vol #:
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| 120
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| EMC 710
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| D Lambertson
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| Vol #:
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| 120
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| EMC 711
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| S Kennedy
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| Vol #:
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| 120
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| EMC 712
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| S Puleo
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| Vol #:
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| 120
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| C 33
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| D Ellis
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| Vol #:
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| 2
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| C 34
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| L Deyarmund
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| Vol #:
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| 2
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| C 35
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| C Brayden
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| Vol #:
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| 2
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| C 36
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| S Waser
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| Vol #:
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| 2
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| C 37
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| E Drury
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| Vol #:
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| 2
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| C 38
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| K Hand
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| Vol #:
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| 2
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| C 39
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| S Scown
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| Vol #:
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| 2
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| C 40
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| E Robinson
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| Vol #:
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| 2
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| C 41
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| R Hutchinson
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| Vol #:
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| 2
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| EC 7
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| Hanlon, Linda
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| Vol #:
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| 1
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| EC 8
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| Smith, Diane
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| Vol #:
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| 1
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| EC 9
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| Taylor, Scott
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| Vol #:
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| 1
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| EC 10
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| Waser, Susette
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| Vol #:
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| 1
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| EC 11
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| Perkins, Donna
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| Vol #:
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| 1
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| EC 12
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| Schurr, Judith
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| Vol #:
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| 1
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| EMC 15
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| D Bullthwait
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| Vol #:
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| 1
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| 2003N-0142
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| Submitting & Reviewing Complete Responses for Clinical Holds
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2003N-0506
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| Agency Emergency Processing Request Under OMB Review; Experimental Study of Possible Footnotes and Cuing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Pa
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| C
1
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| National Food Processors Association
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| Vol #:
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| 1
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| 2003N-0513
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| Electronic Submissions of Food Contact Notifications; Notice of Pilot Project
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| C
1
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| Keller & Heckman LLP
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| Vol #:
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| 1
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| EC 1
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| Heckman, Jerome
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| Vol #:
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| 1
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| 2003N-0542
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| Agency Information Collection Activities: Proposed Collection; Proposed Collection; Premarket Notification Submission 510(K),
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| N
1
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| FDA
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| Vol #:
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| 1
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| 2003P-0238
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| ANDA Suitability Petition for Clarithromycin Extended-Release Tablets
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| SUP
1
Attachment
1, 2
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| The Weinberg Group Inc
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| Vol #:
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| 1
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| 2003P-0288
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| Health Center, be deemed a ' pharmacy of an other health care entity'
|
|
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| PAV
1
|
| HFC-1 to Family Care Health Centers
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| Vol #:
|
| 1
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| 2003P-0362
|
| Over-the-counter Hearing Aids
|
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| C
6
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| Hogan & Hartson, LLP
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| Vol #:
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| 1
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