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| Dockets Entered
On June 23, 2004
Table of Contents
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| Docket #
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| Title
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| 1995S-0117
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| Human Drugs Patent Term
Extension & New Patents
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| 2002N-0278
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| Bioterrorism; Prior Notice of
Imported Food Shipments
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| 2003D-0571
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| Guidance for Industry on Drug
Substance; Chemistry, Manufacturing, and Controls Information
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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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| 2003P-0274
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| In re Tier 1 initial
Approval Program
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| 2003P-0574
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| Regulatory limit for
Listeria monocytogenes in ready-to-eat foods that do not support its
growth
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| 2004D-0188
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| Guidance for Industry
on Development and Use of Risk Minimization Action Plans
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| 2004N-0086
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| Diabetes: Targeting
Safe and Effective Prevention and Treatment; Public Meeting
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| 2004N-0115
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| Prescription Drug Importation
Study
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| 2004N-0133
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| Part 11, Electronic
Record; Electronic Signatures; Public Meeting
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| 2004N-0221
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| Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
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| 2004P-0171
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| Standards for 'Similarity'
or 'Sameness' of Biotechnology-Derived Products
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| 1995S-0117
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| Human Drugs Patent
Term Extension & New Patents
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| LST
93
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| List as of June 22,
2004
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| Vol #:
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| 7
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| 2001P-0075
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| Switch Status of
Emergency Contraceptives from Rx to OTC
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| EC 802
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| N/A
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| Vol #:
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| 163
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| 2002N-0278
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| Bioterrorism; Prior
Notice of Imported Food Shipments
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| EC 489
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| Mrs. Pilar Guerrero
Roldan
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| Vol #:
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| 29
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| EC 490
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| Mr. Rob Pounds
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| Vol #:
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| 29
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| EC
491
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| Always Canadian, LLC
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| Vol #:
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| 29
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| EC
492
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| Alaska Marine Lines,Inc.
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| Vol #:
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| 29
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| 2003D-0476
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| Guidance for Industry
on Product Recalls, Including Removals and Corrections; Availability
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| EC 4
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| Mr. Steve Dotson
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| Vol #:
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| 1
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| 2003D-0571
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| Guidance for Industry
on Drug Substance; Chemistry, Manufacturing, and Controls Information
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| EC
3
Attachment
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| SCHWARZ PHARMA AG
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| Vol #:
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| 1
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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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| EC 29
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| none
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| Vol #:
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| 7
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| EC 30
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| Dr. Ted Labuza
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| Vol #:
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| 7
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| EC 31
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| Ms. Mary Jo Shank
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| Vol #:
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| 7
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| EC 32
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| Mr. Joseph Wetzel
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| Vol #:
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| 7
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| EC 33
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| Mrs. Elizabeth Dehart
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| Vol #:
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| 7
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| EC
34
Attachment
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| Frito-Lay, North America
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| Vol #:
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| 1
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| EMC
228
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| National Dairy Council
(NDC)
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| Vol #:
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| 7
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| 2003P-0274
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| In re Tier 1 initial
Approval Program
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| | | | | | | | |
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| EMC
40
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| Abigail Alliance
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| Vol #:
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| 4
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| 2003P-0574
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| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
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| EMC 3
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| C. Hornback
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| Vol #:
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| 2
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| 2004D-0188
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| Guidance for Industry on Development and Use of Risk Minimization Action Plans
|
|
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| EMC
3
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| CenterFIRST
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| Vol #:
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| 1
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| 2004N-0086
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| Diabetes: Targeting Safe and Effective Prevention and Treatment; Public Meeting
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|
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| EMC 17
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| I. Robinett,RN,BSN,CDE,CPT
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| Vol #:
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| 1
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| EMC 18
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| G. Lorenzi, RN, CDE
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| Vol #:
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| 1
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| EMC 19
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| G. Lorenzi, RN, CDE
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| Vol #:
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| 1
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| EMC 20
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| J. Byers
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| Vol #:
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| 1
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| EMC 21
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| S. Strosnider
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| Vol #:
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| 1
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| EMC 22
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| M. Schenk
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| Vol #:
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| 1
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| 2004N-0115
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| Prescription Drug Importation Study
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|
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| EMC
21
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| Pharmaceutical Security Institute (PSI)
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| Vol #:
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| 19
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| EMC
22
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| META Solutions, Inc.
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| Vol #:
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| 19
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| 2004N-0133
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| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
|
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| EC
16
Attachment
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| AstraZeneca plc
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| Vol #:
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| 1
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| EC 17
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| CRF inc.
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| Vol #:
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| 1
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| EMC
40
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| Syngenta Limited, Alderley Park
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| Vol #:
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| 4
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| EMC
41
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| PHT Corporation
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| Vol #:
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| 4
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|
|
|
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| 2004N-0221
|
| Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
|
|
|
|
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| EMC 4
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| T. Florence
|
| Vol #:
|
| 1
|
|
|
|
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| EMC
5
|
| MINOPS ProjectJudith Taylor
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0171
|
| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
|
|
|
|
|
| EMC
1
|
| Biotechnology Industry Organization
(BIO)
|
| Vol #:
|
| 1
|
|
