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| Dockets Entered
On July 7, 2004
Table of Contents
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| Docket
#
|
| Title
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|
| 1998D-1146
|
| Microbial effects
of antimicrobial new animal drugs/human sa
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed
Cattle Into The Food Supply
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity
eau de Parfum Misbranded
|
|
|
|
|
| 1999P-2630
|
| Establish a Daily
Value for "added sugars"
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry:
Opportunity for Hearing
|
|
|
|
|
| 2001P-0345
|
| Listing the color
additive yellow #5 for use in food/Drug
|
|
|
|
|
| 2002D-0325
|
| Polyvinychloride using
Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration
of Food Facilities
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior
Notice of Imported Food Shipments
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as
a Neurotoxic Drug
|
|
|
|
|
| 2003D-0206
|
| Draft Guidance for Industry
on Exocrine Pancreatic Insufficiency Drug Products; Availability
|
|
|
| 2003D-0554
|
| Compliance Policy Guide Sec.
110.310 Prior Notice of Imported Food Under the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002
|
|
|
| 2003N-0076
|
| Food Labeling: Trans
Fatty Acids in Nutrition Labeling; Consumer research to consider possible
footnote statements
|
|
|
|
|
| 2003N-0338
|
| Obesity
|
|
|
|
|
| 2003N-0400
|
| Control of Communicable
Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain
Other Animals
|
|
|
|
|
| 2003N-0539
|
| Over-the-Counter Drug
Products; Safety and Efficacy Review
|
|
|
|
|
| 2003P-0029
|
| Remove metered-dose
inhalers (MDI) containing moiety albuter
|
|
|
|
|
| 2004D-0187
|
| Guidance for Industry
on Premarketing Risk Assessment
|
|
|
|
|
| 2004D-0188
|
| Guidance for Industry
on Development and Use of Risk Minimization Action Plans
|
|
|
|
|
| 2004D-0189
|
| Guidance for Industry
on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
|
|
|
|
|
| 2004N-0133
|
| Part 11, Electronic
Record; Electronic Signatures; Public Meeting
|
|
|
|
|
| 2004N-0181
|
| Critical Path Initiative
|
|
|
|
|
| 2004N-0184
|
| Requirements Pertaining
to Sampling and Private Laboratories Used in Connection With Importing
Food
|
|
|
|
|
| 2004N-0221
|
| Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
|
|
|
|
|
| 2004N-0230
|
| Food; Current Good
Manufacturing Practice Regulations; Public Meetings
|
|
|
|
|
| 2004P-0075
|
| Prohibit the marketing
and distribution of Authorized Generics until the expiraration of
the first generic applicant's exclusivity period.
|
|
|
|
|
| 2004P-0227
|
| Adhere to the statutory
limitations of section 505(j)(5)(B)(iv) of the Act in issuing final
approvals to ANDA applicants
|
|
|
|
|
| 2004P-0261
|
| Prevent Pfizer Inc.
from marketing a generic version of Accupril until after the expiration
of Teva's 180-day exclusivity period
|
|
|
|
|
| 2004P-0266
|
| Take immediate action
to cease the unlawful distribution of misbranded, adulterated and
unlabeled cosmetics.
|
|
|
|
|
| 2004P-0280
|
| ANDA for Nicotine
Polacrilex, 2 mg base per 240 mL oral solution
|
|
|
|
|
| 2004P-0281
|
| Nicotine Base Oral
Solution 2 mg base per 240 mL oral solution and 4 mg base per 240
mL oral solution in bottles
|
|
|
|
|
| 2004P-0282
|
| Nicotine Bitartrate
Oral solution 2 mg base per 240 mL oral solution and 4 mg base 240
mL oral solution in bottles
|
|
|
|
|
| 2004S-0170
|
| Medicare Prescription Drug,
Improvement, and Modernization Act of 2003, Section 1013: Suggest
Priority Topics for Research
|
|
|
| 2004S-0233
|
| Stimulating Innovation
in Medical Technologies
|
|
|
|
|
| 1998D-1146
|
| Microbial effects
of antimicrobial new animal drugs/human sa
|
|
|
| EMC 713
|
| P. Corcoran
|
| Vol #:
|
| 62
|
|
|
|
|
| EMC 714
|
| J. Green
|
| Vol #:
|
| 62
|
|
|
|
|
| EMC 715
|
| N. Volkers
|
| Vol #:
|
| 62
|
|
|
|
|
| 1998P-0151
|
| Introduction Of
Downed Cattle Into The Food Supply
|
|
| | | | | | | | |
|
|
|
|
| EMC 4241
|
| W. Nowicki
|
| Vol #:
|
| 304
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
|
|
| EMC 543
|
| E. Kleemichen
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC
544
|
| EHN
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC
545
|
| EHN
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC
546
|
| EHN
|
| Vol #:
|
| 24
|
|
|
|
|
| EMC 547
|
| R. Lewis
|
| Vol #:
|
| 24
|
|
|
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
|
|
|
|
| EMC 788
|
| A. Dowd
|
| Vol #:
|
| 33
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
| EMC 794
|
| Reyanna Vosberg
|
| Vol #:
|
| 271
|
|
|
|
|
| EMC 795
|
| Richard Artley
|
| Vol #:
|
| 271
|
|
|
|
|
| LET
16
|
| Woodruff & Howe Environmental Engineering, Inc.
|
| Vol #:
|
| 444
|
|
| |
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
|
|
| EMC 1241
|
| G. Owen
|
| Vol #:
|
| 5
|
|
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| EMC 180
|
| S. Cho
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 181
|
| E. Kennedy
|
| Vol #:
|
| 3
|
|
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
|
|
| EC 386
|
| Mr. Michael Petro
|
| Vol #:
|
| 28
|
|
|
|
|
| EC 387
|
| NM Border Authority
|
| Vol #:
|
| 28
|
|
|
|
|
| EC 388
|
| Mr. Richard Fuller
|
| Vol #:
|
| 28
|
|
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
| EMC
206
|
| National Customs Brokers and Forwarders Assn of America, Inc. (NCBFAA)
|
| Vol #:
|
| 29
|
|
|
|
|
| EMC
207
|
| Process Systems Consulting
|
| Vol #:
|
| 29
|
|
|
|
|
| EMC
208
|
| Royal Mail
|
| Vol #:
|
| 29
|
|
|
|
|
| EMC
209
|
| Australian Government
|
| Vol #:
|
| 29
|
|
|
|
|
| EMC
210
|
| La Ferme Martinette
|
| Vol #:
|
| 29
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| EMC
336
|
| Mission Possible Intl.
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
337
|
| Mission Possible Intl.
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
338
|
| Mission Possible Intl.
|
| Vol #:
|
| 6
|
|
| | | | | | | | |
|
|
|
| 2003N-0539
|
| Over-the-Counter Drug Products; Safety and Efficacy Review
|
|
|
|
|
| EMC
1
|
| Polymedica Pharmaceuticals
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
2
|
| Kirkpatrick & Lockhart, LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
3
|
| Consumer Healthcare Products Assn (CHPA)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0029
|
| Remove metered-dose inhalers (MDI) containing moiety albuter
|
|
|
|
|
| EMC 17
|
| A. King, RN
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 18
|
| R. Shaw
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 19
|
| K. Hartley
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004D-0187
|
| Guidance for Industry on Premarketing Risk Assessment
|
|
|
|
|
| EC 1
|
| FDA/OPaSS
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
2
|
| Eli Lilly and Company
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 3
|
| University of Pennsylvania School of Medicine
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
2
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 1
|
|
| |
|
| 2004D-0188
|
| Guidance for Industry on Development and Use of Risk Minimization Action Plans
|
|
|
|
|
| EC
1
|
| Eli Lilly and Company
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
4
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0189
|
| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
|
|
|
|
|
| EMC
2
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
|
|
|
|
| EMC
42
|
| The Dow Chemical Company
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC
43
|
| LogicaCMG
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC
44
|
| Triangle PEERS
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC
45
|
| National Electrical Manufacturers Assn (NEMA)
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC
46
|
| Society of Quality Assurance (SQA)
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC
47
|
| Society of Quality Assurance (SQA)
|
| Vol #:
|
| 4
|
|
|
|
|
| 2004N-0181
|
| Critical Path Initiative
|
|
|
|
|
| EMC
1
|
| Facility Automation Management Engineering (FAME) Systems
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0184
|
| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
|
|
|
|
|
| EMC
2
|
| American Assn for Laboratory Accreditation (A2LA)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
3
|
| ADPEN LAboratories, Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
4
|
| KFDA
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
5
|
| KFDA
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
|
|
| 2004N-0221
|
| Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
|
|
|
|
|
| EC 12
|
| iVoice, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 13
|
| National federation of the Blind
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 14
|
| National Federation of the Blind
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 15
|
| Mrs. Catherine Gaffney
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 16
|
| National Federation of the Blind
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 17
|
| National Federation of the Blind
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 18
|
| National Federation of the Blind
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 19
|
| NFB
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 20
|
| National federation of the blind
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 21
|
| Lighthouse International
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 22
|
| Talking Rx, Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 23
|
| National Federation of the Blind
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 24
|
| National Federation of the Blind
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 25
|
| National Federation of the Blind
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
6
|
| Talking RX, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 7
|
| B. Pierce
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
8
|
| Blinded Veterans Assn (BVA)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 9
|
| E. Meskys
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 10
|
| S. Stanzel
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 11
|
| D. Stayer
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
12
|
| American Academy of Ophthalmology
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 13
|
| R. Walhof
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 14
|
| C. Clark
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 15
|
| P. Chong
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 16
|
| C. Carlson
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 17
|
| J. Halverson
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 18
|
| B. Jones
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 19
|
| B. Kimbro
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 20
|
| R. Gaffney
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
21
|
| National Federation of the Blind (NFB)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 22
|
| M. Fliegelman
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 23
|
| D. Stein
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
24
|
| American Foundation of the Blind
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0230
|
| Food; Current Good Manufacturing Practice Regulations; Public Meetings
|
|
|
|
|
| EMC 2
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
|
| EMC 3
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0075
|
| Prohibit the marketing and distribution of Authorized Generics until the expiraration of the first generic applicant's exclusivity period.
|
|
|
|
|
| PDN 1
|
| HF-22 to Mylan Pharmaceuticals Inc
|
| Vol #:
|
| 1
|
|
| |
|
| 2004P-0227
|
| Adhere to the statutory limitations of section 505(j)(5)(B)(iv) of the Act in issuing final approvals to ANDA applicants
|
|
|
|
|
| PDN
1
|
| HF-22 to Wiley Rein & Fielding LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0261
|
| Prevent Pfizer Inc. from marketing a generic version of Accupril until after the expiration of Teva's 180-day exclusivity period
|
|
|
|
|
| PDN 1
|
| HF-22 to White & McAuliffe LLP
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004P-0266
|
| Take immediate action to cease the unlawful distribution of misbranded, adulterated and unlabeled cosmetics.
|
|
|
|
|
| EMC
1
|
| EHN
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0280
|
| ANDA for Nicotine Polacrilex, 2 mg base per 240 mL oral solution
|
|
|
|
|
| CP
1
|
| Nico Worldwide, LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0281
|
| Nicotine Base Oral Solution 2 mg base per 240 mL oral solution and 4 mg base per 240 mL oral solution in bottles
|
|
|
|
|
| CP
1
|
| Nico Worldwide, LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0282
|
| Nicotine Bitartrate Oral solution 2 mg base per 240 mL oral solution and 4 mg base 240 mL oral solution in bottles
|
|
|
|
|
| CP
1
|
| Nico Worldwide, LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004S-0170
|
| Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
|
|
|
|
|
| EC
47
Attachment
1, 2, 3,
4
|
| Opt-e-scrip, Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| EC
48
|
| Alzheimer's Association
|
| Vol #:
|
| 2
|
|
|
|
|
| EC
49
|
| Resource Group, Ltd.
|
| Vol #:
|
| 2
|
|
|
|
|
| EC
50
Attachment
1, 2
|
| Dr. Raymond Hakim
|
| Vol #:
|
| 2
|
|
|
|
|
| EC
51
Attachment
|
| Medicaid/SCHIP Dental Program Representatives Assn
|
| Vol #:
|
| 2
|
|
|
|
|
| EC
52
Attachment
|
| Centers for Education
|
| Vol #:
|
| 2
|
|
|
|
|
| EC
53
Attachment
|
| Biotechnology Industry Organization
|
| Vol #:
|
| 2
|
|
|
|
|
| EC
54
|
| American Music Therapy Association
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
14
Attachment
|
| Social HMO Consortium
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
15
|
| CDC Health Systems Research Work Group
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
16
|
| Juvenile Diabetes Research Foundation International (JDRF) et al.
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
17
Attachment
1, 2, 3,
4
|
| Opt-e-Scrip, Inc.
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
18
|
| American Dental Assn
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
19
|
| Wyeth Pharmaceuticals (Wyeth)
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
20
|
| BlueCross BlueShield Assn (BCBSA)
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
21
|
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|
| Vol #:
|
| 3
|
|
