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| Dockets Entered
On April 13, 2004
Table of Contents
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| Docket
#
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| Title
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| 1978N-0036L
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| OTC Laxative
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| 1978N-0038
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| Sunscreen Drug Products
|
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| 1978N-0064
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| OTC Antiperspirant
|
|
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|
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| 1995F-0221
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| Safe Use of Natamycin
In Broiler Chicken Feed
|
|
|
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| 1995S-0316
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| 75-Day Premarket Notifications
for New Dietary Ingredients
|
|
|
|
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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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| 1998N-0337
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| Over the counter human
drugs labeling requirements
|
|
|
|
|
| 1998N-1109
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| Mercury Compounds
in Drugs and Food
|
|
|
|
|
| 1999D-2335
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| Guidance for Medical
Gloves A workshop Manual
|
|
|
|
|
| 2001P-0075
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| Switch Status of Emergency Contraceptives
from Rx to OTC
|
|
|
| 2002E-0342
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| Lea's Shield, U.S.
Patent No. 4,703,752
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|
|
|
|
| 2002N-0466
|
| Safety, Clinical and
Immune Response of Dryvax
|
|
|
|
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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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| 2003N-0397
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| Agency Information
Collection Activities: Proposed Collection; Comment Request; Extension;
Threshold of Regulation for Substances used in Food-Contact Articles
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| 2003N-0424
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| Agency Information
Collection Activities: Proposed Collection; Comment Request;
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|
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| 2003N-0482
|
| Agency Information
Collection Activities: Proposed Collection; Comment Request; Mammography
Facilities, Standards, and Lay Summaries for Patients
|
|
|
|
|
| 2003P-0159
|
| Venlafaxine Hydrochloride
Extended-Release Tablets
|
|
|
|
|
| 2003P-0196
|
| Switch Nicotrol Inhaler
(nicotine Inhalation System) From Prescription to Over the Counter
Status
|
|
|
|
|
| 2003P-0270
|
| Prohibit False and
Misleading Labeling
|
|
|
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive
Therapy Device in Class III for All Indications
|
|
|
|
|
| 2004D-0002
|
| Guidance for Industry
and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
|
|
|
|
| 2004D-0027
|
| Guidance for Industry on Time
and Extent Applications
|
|
|
| 2004D-0028
|
| Draft Consumer Advisory
regarding Advice for Subgroups of a Population regarding Mercury in
Fish and Shellfish
|
|
|
|
|
| 2004D-0035
|
| Guidance for Industry
on the Preclinical and Clinical Evaluation of Agents Used in the Prevention
or Treatment of Postmenopausal Osteoporosis
|
|
|
|
|
| 2004N-0154
|
| Medical Devices; Semi-critical
Reprocessed Single-Use Devices; Termination of Exemptions from Premarket
Notification; Requirement for Submission of Validation Data
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|
|
|
|
| 2004P-0004
|
| Correct of FDA's advice
for women who are pregnant, or might become pregnant, and nursing
mother, about avoiding harm to your baby or young child from mercury
in fish and shellfish
|
|
|
|
|
| 2004P-0173
|
| ANDA for Cefprozil
Tablets for Oral Suspension, 125 mg and 250 mg
|
|
|
|
|
| 2004Q-0097
|
| Qualified Health Claim:
Calcium and various cancers
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|
|
|
|
| 2004Q-0100
|
| Qualified Health Claim:
Calcium and bone fractures
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|
|
|
|
| 2004Q-0102
|
| Qualified Health Claim:
Calcium and Kidney/urinary stones
|
|
|
|
|
| 2004Q-0144
|
| Qualified Health Claim
(QHC): Chromium picolinate and Diabetes
|
|
|
|
|
| 2004V-0095
|
| Laser Light Show
|
|
|
|
|
| 2004V-0104
|
| Laser Light Show
|
|
|
|
|
| 1978N-0036L
|
| OTC Laxative
|
|
|
|
|
| ACK
30
|
| HFA-305 to Purdue
Frederick Company
|
| Vol #:
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| 134
|
|
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|
|
| CP
29
|
| Purdue Frederick Company
|
| Vol #:
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| 134
|
|
|
|
|
| 1978N-0038
|
| Sunscreen Drug
Products
|
|
| | | | | | | | |
|
|
|
|
| LET
177
|
| HFD-1 to The Cosmetic, Toiletry and Fragrance Association
|
| Vol #:
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| 150
|
|
|
|
|
| LET
178
|
| HFD-1 to The Cosmetic, Toiletry and Fragrance Association
|
| Vol #:
|
| 150
|
|
| |
|
| 1978N-0064
|
| OTC Antiperspirant
|
|
|
|
|
| LET
22
|
| HFD-1 to Covington & Burling
|
| Vol #:
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| 51
|
|
|
|
|
| LET
23
|
| HFD-1 to Cosmetic, Toiletry and Fragrance Association
|
| Vol #:
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| 51
|
|
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|
|
| 1993D-0398
|
| Microbiological Testing Antimicrobial Drug Residues in Foods
|
|
|
|
|
| EC 5
|
| Active Access
|
| Vol #:
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| 1
|
|
|
|
|
| 1995F-0221
|
| Safe Use of Natamycin In Broiler Chicken Feed
|
|
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 9
|
|
|
|
|
| 1995S-0316
|
| 75-Day Premarket Notifications for New Dietary Ingredients
|
|
|
|
|
| RPT 172
|
| PhytoMedica, LLC
|
| Vol #:
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| 127
|
|
|
|
|
| RPT 173
|
| Care & Health Limited
|
| Vol #:
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| 128
|
|
|
|
|
| RPT 174
|
| EGN Pharma, Inc
|
| Vol #:
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| 129
|
|
|
|
|
| RPT 175
|
| MicroBio Co., LTD
|
| Vol #:
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| 130
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|
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| RPT 176
|
| Kyowa Hakko USA Inc
|
| Vol #:
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| 131
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| LET
13560
|
| The House of Yin Yang (BVI) Ltd.
|
| Vol #:
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| 113
|
|
|
|
|
| LET
13561
|
| The House of Yin Yang
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13562
|
| The House of Yin Yang
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13563
|
| The House of Yin Yang
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13564
|
| The House of Yin Yang
|
| Vol #:
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| 113
|
|
|
|
|
| LET
13565
|
| Arbonne International
|
| Vol #:
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| 113
|
|
|
|
|
| LET
13566
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13567
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13568
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13569
|
| Cell Tech International Incorporated
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13570
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13571
|
| PhytoPharmica Natural Medicines
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13572
|
| Leiner Health Products
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13573
|
| Leiner Health Products
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13574
|
| Leiner Health Products
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13575
|
| Leiner Health Products
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13576
|
| Leiner Health Products
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13577
|
| Leiner Health Products
|
| Vol #:
|
| 113
|
|
| | | | | | | | |
|
|
|
|
| LET
13578
|
| Leiner Health Products
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13579
|
| Leiner Health Products
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13580
|
| Leiner Health Products
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13581
|
| Leiner Health Products
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13582
|
| General Vitamin Corporation
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13583
|
| General Vitamin Corporation
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13584
|
| General Vitamin Corporation
|
| Vol #:
|
| 113
|
|
|
|
|
| LET
13585
|
| General Vitamin Corporation
|
| Vol #:
|
| 113
|
|
|
|
|
| 1998N-0337
|
| Over the counter human drugs labeling requirements
|
|
|
|
|
| ANS
21
|
| HFD-560 to HHS Supply Service Center
|
| Vol #:
|
| 9
|
|
|
|
|
| 1998N-1109
|
| Mercury Compounds in Drugs and Food
|
|
|
|
|
| LET 5
|
| Physicians Total Care
|
| Vol #:
|
| 3
|
|
| |
|
| 1999D-2335
|
| Guidance for Medical Gloves A workshop Manual
|
|
|
|
|
| GDL
2
|
| Guidance
|
| Vol #:
|
| 2
|
|
|
|
|
| NAD
2
|
| FDA
|
| Vol #:
|
| 2
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| EC 707
|
| Mr. Patrick Vogel
|
| Vol #:
|
| 163
|
|
|
|
|
| EC 708
|
| Lovelace Health Systems
|
| Vol #:
|
| 163
|
|
|
|
|
| EC 709
|
| Mrs. cheryl mcdonough
|
| Vol #:
|
| 163
|
|
|
|
|
| EC 710
|
| Miss. Tara Seyfer
|
| Vol #:
|
| 163
|
|
|
|
|
| EC 711
|
| Mr. Joe Poss
|
| Vol #:
|
| 163
|
|
|
|
|
| EC 712
|
| Mrs. Karen Suarez
|
| Vol #:
|
| 163
|
|
| |
|
| 2002E-0342
|
| Lea's Shield, U.S. Patent No. 4,703,752
|
|
|
|
|
| AMD 1
|
| Shlomo Gabbay
|
| Vol #:
|
| 1
|
|
|
|
|
| 2002N-0466
|
| Safety, Clinical and Immune Response of Dryvax
|
|
|
|
|
| C 50
|
| K. Tennant
|
| Vol #:
|
| 5
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| EMC 158
|
| Dr. F. Kummerow
|
| Vol #:
|
| 3
|
|
|
|
|
| EXT
6
|
| National Food Processors Assn (NFPA)
|
| Vol #:
|
| 3
|
|
|
|
|
| 2003N-0397
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Extension; Threshold of Regulation for Substances used in Food-Contact Articles
|
|
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
| 2003N-0424
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
| |
|
| 2003N-0482
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Mammography Facilities, Standards, and Lay Summaries for Patients
|
|
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0159
|
| Venlafaxine Hydrochloride Extended-Release Tablets
|
|
|
|
|
| C
2
|
| Wyeth Pharmaceuticals (Wyeth)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0196
|
| Switch Nicotrol Inhaler (nicotine Inhalation System) From Prescription to Over the Counter Status
|
|
|
|
|
| PDN
1
|
| HF-22 to Pharmacists Planning Service, Inc. (PPSI)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
|
|
|
|
| C 67
|
| D. Somers
|
| Vol #:
|
| 6
|
|
|
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
|
|
|
|
| C 1
|
| T. Harvey
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 17
|
| PAIMI Board Member
|
| Vol #:
|
| 2
|
|
| |
|
| 2004D-0002
|
| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
|
|
|
|
|
| C
7
Attachment C, D
|
| American Society of plastic Surgeons (ASPS)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
8
Attachment
|
| Autoimmune Technologies, LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| C
9
|
| Mentor Corporation (Mentor)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
10
|
| William E. Katzin,MD,PhD
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 7
|
| Mrs. Lale Goddard
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
8
Attachment
|
| National Women's Health Network
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
9
Attachment
|
| Our Bodies Ourselves
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 10
|
| Dr. George Landis
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 11
|
| Dr. Rpberta Gartsode
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 12
|
| Dr. Neal Reisman
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 13
|
| Dr. William Adams
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 14
|
| Chemically Associated Neurological Disorders
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 15
|
| Mrs. J B
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0027
|
| Guidance for Industry on Time and Extent Applications
|
|
|
|
|
| EC
1
|
| Ciba Specialty Chemicals Corporation (Ciba)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0028
|
| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
|
|
| | | | | | | | |
|
|
|
|
| C 31
|
| C. Minhoto
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0035
|
| Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
|
|
|
|
|
| C
2
|
| Eli Lilly and Company (Lilly)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
3
|
| National Osteoporosis Foundation (NOF)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
4
|
| American Society for Bone and Mineral research (ASBMR)
|
| Vol #:
|
| 1
|
|
|
|
|
| C
5
References
|
| Novartis Pharmaceuticals Corporation (Novartis)
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 2
|
| Organon Pharmaceuticals Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
3
Attachment
|
| Wyeth Pharmaceuticals Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 4
|
| Procter and Gamble Pharmaceuticals
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0042
|
| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
|
|
|
|
|
| EC 1
|
| Miss. Joan Biren
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 2
|
| Slippery Rock University
|
| Vol #:
|
| 1
|
|
| |
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
|
|
|
|
| EC 21
|
| Mr. Hugh Eckert
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 22
|
| Dr. Phillip Cushman
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 23
|
| Dr. ABBEY STRAUSS
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 24
|
| NONE
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 25
|
| Dr. emanuel newmark
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0154
|
| Medical Devices; Semi-critical Reprocessed Single-Use Devices; Termination of Exemptions from Premarket Notification; Requirement for Submission of Validation Data
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0004
|
| Correct of FDA's advice for women who are pregnant, or might become pregnant, and nursing mother, about avoiding harm to your baby or young child from mercury in fish and shellfish
|
|
|
|
|
|
|
|
|
| LET
1
|
| HFS-006 to Environmental Working Group
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0173
|
| ANDA for Cefprozil Tablets for Oral Suspension, 125 mg and 250 mg
|
|
|
|
|
| ACK
1
|
| HFA-305 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004Q-0097
|
| Qualified Health Claim: Calcium and various cancers
|
|
|
|
|
| ACK
2
|
| HFS-200 to Emord & Associates PC
|
| Vol #:
|
| 15
|
|
| |
|
| 2004Q-0100
|
| Qualified Health Claim: Calcium and bone fractures
|
|
|
|
|
| ACK
2
|
| HFS-200 to Emord & Associates, PC
|
| Vol #:
|
| 6
|
|
|
|
|
| 2004Q-0102
|
| Qualified Health Claim: Calcium and Kidney/urinary stones
|
|
|
|
|
| C
1
|
| Southwestern Medical Center, University of Texas
|
| Vol #:
|
| 6
|
|
