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95S-0316:
75-Day Premarket Notifications for New Dietary Ingredients
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| RPT226
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| 04/08/2004
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| 04/08/2004
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| Private Industry
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| Altai, LLC
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| pdf1,
pdf2,
pdf4
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| Buckthorn Extract
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| Signature:
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| John Geier
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| RPT227
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| 04/08/2004
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| 04/08/2004
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| Private Industry
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| Outsource Product
Manufacture LLC
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| pdf1,
pdf2,
pdf3,
pdf4,
pdf5
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| VI-28
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| Signature:
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| Robert DeWitty,
Esq
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| RPT228
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| 04/29/2004
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| 04/29/2004
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| International Industry
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| Bioriginal Food
& Science Corporation
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| pdf1,
pdf2
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| Echium Oil
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| Signature:
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| Rakesh Kapoor PhD
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| RPT229
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| 04/29/2004
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| 04/29/2004
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| International Industry
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| Conseco Sea Buckthorn
Co., Ltd
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| pdf1,
pdf2
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| Conseco
Brand Sea Buckthorn Seed Oil
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| Signature:
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| Han Xu, MD
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| RPT230
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| 04/29/2004
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| 04/29/2004
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| International Industry
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| Conseco Sea Buckthorn
Co., Ltd
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| pdf1,
pdf2
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| Conseco
Brand Sea Buckthorn Fruit Oil
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| Signature:
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| Han Xu, MD
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| RPT231
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| 04/29/2004
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| 04/29/2004
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| Private Industry
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| Seven Tortoise
Co., Ltd
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| pdf
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| Essence of Mulberry
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| Signature:
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| David S W Fang
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| RPT232
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| 05/21/2004
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| 05/21/2004
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| Private Industry
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| Omega Bio-Pharma
(USA) LLC
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| pdf1,
pdf2,
pdf3
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| 2-aminoethanethiol HCL (cysteamine HCL) (S-BI II)
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| Signature:
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| Gary Wong Kwan
Po
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| RPT233
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| 05/21/2004
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| 05/21/2004
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| Private Industry
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| Stage II Enterprises
LLC
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| pdf1,
pdf2,
pdf3
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| Cortinine
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| Signature:
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| Jim Prochnow
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| RPT234
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| 06/04/2004
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| 06/04/2004
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| Private Industry
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| Nano Port (USA),
Inc.
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| pdf1,
pdf2,
pdf3,
Attachments: 1,
2,
3
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| Nano
Red Elemental Selenium (Nano-Se)
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| Signature:
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| Yu Har Fei
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| RPT235
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| 08/04/2004
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| 08/04/2004
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| International Industry
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| Hormos Medical
Corporation
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| pdf1,
pdf2,
pdf3,
pdf4,
Conents,
Tab1:
Append.1,2,3,4,5
Tab
2:
Append.1,2,3,4,5
Tab
3:
Append.1,2,3,4,5
Tab
4:
Append.1,2,3,4,5
Tab
5:
Append.1,2,3,4,5
Tab
6:
Append.2,3,4,5
Tab
7:
Append.1,2,3,4,5
Tab
8:
Append.1,2,3,4,5
Tab
9:
Attachments 1,2,3
Tab
10:
Attachments 1,2
Tab
11:
Append. 1,2
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| 7-hydroxymatairesinol
(HMR)
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| Signature:
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| Lars Pellas
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| RPT236
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| 08/04/2004
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| 08/04/2004
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| Private Industry
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| Fuji Chemical
Industry Co., Ltd
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| pdf1,
pdf2,
pdf3,
pdf4,
pdf5,
pdf6,
pdf7,
pdf8,
pdf9,
pdf9a,
pdf10a,
pdfb,
pdf11a,
padfb,
padf12a,
pdf12b,
pdf13a,
padf13b,
pdf14a,
padf14b,
pdf15a,
pdf15b,
pdf16a,pdf16b,
pdf17a,
pdf17b,
pdf18a,
pdf18b,
pdf19a,
pdf19b,
pdf20a,
pdf20b,
pdf21a,
pdf21b,
pdf22a,
pdf22b,
pdf23a,
pdf23b,
pdf24a,
pdf24b,
pdf25a,
pdf25b,
pdf26
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| Astaxanthin,
extracted from the Haematococcus pulvialis algae
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| Signature:
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| Marc S. Ullman
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| RPT237
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| 08/04/2004
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| 08/04/2004
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| Private Industry
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| U S Nutraceuticals,
LLC
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| pdf1, pdf2, Tabs: A,
B,
C,
D,
E,
F,
G,
H,
I,
Ja,
Jb,
Jc,
Jd
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| Zanthine
extract Astaxanthin Complex, extract of the algae, Haematococcus
pluvialis
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| Signature:
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| Anthony L Young
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| RPT238
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| 08/04/2004
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| 08/04/2004
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| Private Industry
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| Awareness Corporation
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| pdf
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| Hoodia gordonii
Powder
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| Signature:
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| Susan D Brienza
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| RPT239
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| 08/04/2004
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| 08/04/2004
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| Private Industry
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| Quinta Naturaceuticals,
Inc
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| pdf
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| Hypoestes
rosea dried leaf powder (P. Beauv.)
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| Signature:
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| Howard B Cottam
PhD
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| RPT240
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| 08/04/2004
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| 08/04/2004
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| Private Industry
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| Soft Gel Technologies
Incorporated
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| pdf,
Amendments: 1,
2,
05-Udell,12-Hoang,
24-Oryza-Oil-Fat-Chemical-Co-LTD,
26-Richeux,
28-Szweda
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| Phyto-derived Ceramides, Cennamides
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| Signature:
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| Susan D Brienza
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| RPT241
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| 08/04/2004
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| 08/04/2004
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| Private Industry
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| BTR Group Incorporated
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| pdf
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| Maximum D3
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| Signature:
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| James Grote MD
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| RPT242
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| 08/04/2004
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| 08/04/2004
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| International Industry
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| Ingredia
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| 01-Appendix-08
01-pdf
02-Appendix-08-GB
02-pdf
03-Appendix-08-F
03-pdf
04-Appendix-09-GB
04-df
05-Appendix-09-F
05-pdf
06-Appendix-10-10-GB
07-Appendix-10
07-pdf
08-Appendix-10-GB
08-pdf
09-Appendix-01
10-Appendix-02
10-Appendix-12
11-Appendix-03
11-Appendix-12
12-Appendix-04
12-Appendix-13
13-Appendix-05
13-Appendix-13
14-Appendix-06
14-Appendix-14
15-Appendix-07-01
15-Appendix-07-02
15-Appendix-14
16-Appendix-15-GB&F
17-Appendix-15-GB
18-Appendix-15-F
19-Appendix-16-GB
20-Appendix-16-GB
21-Appendix-16-F
22-Appendix-17
25-Appendix-20
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| lactium,
a milk protein hydrolysate
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| Signature:
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| Jean-Francois Boudier
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| RPT243
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| 09/28/2004
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| 09/28/2004
|
| Private Industry
|
| Outsource Products
Manufacture LLC
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| 01-pdf,
02-pdf
03-pdf,
04-pdf
05-pdf,
06-pdf
07-pdf
08-Meyer
09-pdf
10-Monograph
11-Antler
12-Batchelder
13-Wang
4-Suttie
15-FDA-CFSAN
16-CDC-Belay
17-Raymond
18-pdf
19-NPAG-Data
20-Hsieh
21-Goldberg
22-Cuscuta-Seed
23-Matsuda
24-Premarket-Notification-Kaempferiae
25-Vimala
26-Kiuchi
27-Farhat-GN
28-Sunesson-AL
29-Canada-AT
30-Othman
31-DeWitty
32-Shek
33-Anti-Ageing-Study
34-Test-Report
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| VI-28
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| Signature:
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| Robert DeWitty,
Esq
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| RPT244
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| 09/28/2004
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| 09/28/2004
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| International Industry
|
| Conseco Sea Buckthorn
Co., Ltd
|
|
|
|
|
|
|
| pdf1,
pdf2
|
| Conseco
Brand Sea Buckthorn Seed Oil
|
|
|
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| Signature:
|
| Han Xu, MD
|
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| Top
| Up | Back | Next
Most Recent
Page last updated
August 2, 2005
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