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| Dockets Entered
On June 29, 2006
Table of Contents
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| Docket #
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| Title
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| 1997S-0163
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| Dietary Supplements,
Courtesy Letters (Letters of Objection)
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| 2000D-1306
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| Content & Format
of the Adverse Reactions Section of Labeling
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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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| 2005P-0398
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| ANDA Suitability for
Carboplatin Injection, 10 mg/mL in a 1000 mg/100 mL multiple-dose
vial
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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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| 2006D-0191
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| Guidance for Industry
and Food and Drug Administration; Guidance for the Use of Bayesian
Statistics in Medical Device Clinical Trials
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| 2006E-0040
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| Patent Extension Application
for ROZEREM (ramelteon), U.S. Patent No. 6,034,239
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| 2006N-0109
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| General and Plastic
Surgery Devices; Reclassification of the Topical Oxygen Chamber for
Extremities
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| 2006P-0147
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| Determine whether
Risperdal M Tab (Risperidone) Orally Disintegrating Tablets, 3 mg
and 4 mg (NDA No. 21-444), was voluntarily withdrawn or withheld from
sale for safety or efficacy reasons
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| 2006P-0151
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| Stay the current approvable
letter with conditions of any and all Premarket Applications for silicone
gel-filled breast implants
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| 2006P-0178
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| Immediately ban fluoroquinolone
antibiotic gatifloxacin in humans
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| 2006P-0224
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| Take appropriate remedial
action against the apparent misbranding of generic azithromycin marketed
by Pliva, Inc.
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| 2006P-0243
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| Qualified Health Claim:
(QHC) Corn oil and corn oil containing foods and heart disease
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| 2006V-0194
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| Laser Light Show
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| 1997S-0163 |
| Dietary Supplements,
Courtesy Letters (Letters of Objection)
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| LET 885
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| FDA/CFSAN to C Humphrey
& Associates PA
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| Vol #:
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| 27
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| LET 886
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| FDA/CFSAN to Beulah
Land Corporation
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| Vol #:
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| 27
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| LET 887
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| FDA/CFSAN to Arkopharma,
LLC
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| Vol #:
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| 27
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| LET 888
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| FDA/CFSAN to New Chapter,
Inc
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| Vol #:
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| 27
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| LET 889
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| FDA/CFSAN to New Chapter,
Inc
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| Vol #:
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| 27
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| LET 890
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| FDA/CFSAN to Immunotec
Research Inc
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| Vol #:
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| 27
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| LET 891
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| FDA/CFSAN to Gindan
Neutra-Ceuticals Inc
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| Vol #:
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| 27
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| LET 892 Attachments
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| FDA/CFSAN to Pure
Research Products LLC
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| Vol #:
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| 27
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| LET 893
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| FDA/CFSAN to Nutra
Nano Tech Inc
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| Vol #:
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| 27
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| 2000D-1306
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| Content & Format
of the Adverse Reactions Section of Labeling
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| EC 11
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| EC 12
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| Mr. Dave Lowe
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| Vol #:
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| 1
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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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| EC 11
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2005P-0398
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| ANDA Suitability
for Carboplatin Injection, 10 mg/mL in a 1000 mg/100 mL multiple-dose
vial
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| AMD 1
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| Lachman Consultant
Services, Inc.
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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 13839
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| M. Veabelt
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| Vol #:
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| 159
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| 2006D-0191
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| Guidance for Industry
and Food and Drug Administration; Guidance for the Use of Bayesian
Statistics in Medical Device Clinical Trials
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| EC 3
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| Dr. Michael Messner
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| Vol #:
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| 1
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| EC 4
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| Johns Hopkins Bloomberg SPH
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| Vol #:
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| 1
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| EC 5
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| Dr. ANDREW HARTLEY
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| Vol #:
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| 1
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| 2006E-0040
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| Patent Extension
Application for ROZEREM (ramelteon), U.S. Patent No. 6,034,239
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| EC 1
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2006N-0109
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| General and Plastic
Surgery Devices; Reclassification of the Topical Oxygen Chamber for
Extremities
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| C 2
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| GWR Medical, Inc. (GWR)
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| Vol #:
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| 1
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| 2006P-0147
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| Determine
whether Risperdal M Tab (Risperidone) Orally Disintegrating Tablets,
3 mg and 4 mg (NDA No. 21-444), was voluntarily withdrawn or withheld
from sale for safety or efficacy reasons
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| WDL 1
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| Lachman Consultant Services,
Inc.
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| Vol #:
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| 1
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| 2006P-0151
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| Stay the current
approvable letter with conditions of any and all Premarket Applications
for silicone gel-filled breast implants
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| EC 3
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| University of Nebraska
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| Vol #:
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| 1
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| EC 4
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| SF COSW
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| Vol #:
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| 1
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| EC 5
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| National Organization for Women
(Colorado)
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| Vol #:
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| 1
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| EC 6
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| MDRC
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| Vol #:
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| 1
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| EC 7
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| Dr. Beatrice Greenwald
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| Vol #:
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| 1
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| EC 8
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| Ms. candi clouse
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| Vol #:
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| 1
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| EC 9
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| Ms. Carolyn Greer
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| Vol #:
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| 1
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| EC 10
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| Miss. Rakefet Abergel
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| Vol #:
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| 1
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| EC 11
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| Mr. Barry Saltzman
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| Vol #:
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| 1
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| EC 12
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| Mr. David Boyle
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| Vol #:
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| 1
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| EC 13
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| Mr. Doug Noble-Hodge
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| Vol #:
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| 1
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| EC 14
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| Ms. Connie Schaefer
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| Vol #:
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| 1
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| EC 15
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| Ms. brianna smith
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| Vol #:
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| 1
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| EC 16
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| Ms. Catherine Critz
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| Vol #:
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| 1
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| EC 17
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| Ms. Sara Behmerwohld
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| Vol #:
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| 1
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| EC 18
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| Ms. Brenda Brynildsen
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| Vol #:
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| 1
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| EC 19
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| NOW
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| Vol #:
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| 1
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| EC 20
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| National Organization for Women
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| Vol #:
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| 1
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| EC 21
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| Mrs. Joanna Kenney
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| Vol #:
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| 1
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| EC 22
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| Ms. Candace King
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| Vol #:
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| 1
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| EC 23
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| Ms. Deborah Hemlock
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| Vol #:
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| 1
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| EC 24
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| Ms. Seana Blake
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| Vol #:
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| 1
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