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| Dockets Entered
On June 10, 2004
Table of Contents
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| Docket
#
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| Title
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| 1980N-0145B
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| Safety & Efficacy
Review for OTC Ophthalmic Drug Prod.
|
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| 1994P-0343
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| Revoke the use of
rBGH, BST and Prosilac
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| 1995S-0158
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| Community Disclosure
of Institutional Review Boards
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|
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|
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| 2000N-1571
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| Enrofloxacin for Poultry:
Opportunity for Hearing
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|
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| 2000P-0177
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| Request that FDA not
Approve Upjohn's Bovine Growth Hormone
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| 2001P-0075
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| Switch Status of Emergency
Contraceptives from Rx to OTC
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|
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| 2002N-0275
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| Bioterrorism Preparedness;
Administrative Detention
|
|
|
|
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| 2003D-0060
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| Part11, Electronic records,
electronic signatures scope
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|
|
| 2003D-0204
|
| Guidance for Industry: IRB Review
of Stand-Alone HIPAA Authorizations; Availability
|
|
|
| 2003D-0206
|
| Draft Guidance for Industry
on Exocrine Pancreatic Insufficiency Drug Products; Availability
|
|
|
| 2003D-0537
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| Guidance for Industry
and FDA Staff; User Fees and Refunds for Premarket Notification Submissions
(510(k)s);
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|
|
|
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| 2003D-0545
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| Questions and Answers Regarding
Registration of Food Facilities
|
|
|
| 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
|
|
|
|
|
| 2003N-0324
|
| New Animal Drugs; Removal of
Obsolete and Redundant Regulations
|
|
|
| 2003N-0360
|
| Agency Info Collection:
Information Program on Clinical Trials for Serious or Life-Threatening
Diseases: Maintaining a Databank
|
|
|
|
|
| 2003N-0481
|
| Agency Information
Collection Activities; Proposed Collection; Comment Request; Food
Additive Petitions
|
|
|
|
|
| 2003P-0159
|
| Venlafaxine Hydrochloride
Extended-Release Tablets
|
|
|
|
|
| 2003P-0296
|
| Romano Cheese for
Manufacturing Deviating From Identity Standard; Temporary Permit for
Market Testing
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|
|
|
|
| 2003P-0479
|
| Allow importation
of Canadian versions of drugs that are approved to the United States
|
|
|
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive
Therapy Device in Class III for All Indications
|
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|
| 2003P-0574
|
| Regulatory limit for Listeria
monocytogenes in ready-to-eat foods that do not support its growth
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|
|
| 2004D-0001
|
| Global Harmonization Task Force,
Study Group 1, 2, 3 and 4; New Proposed and Final Documents; Availability
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|
| 2004D-0042
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| Guidances for Industry on Improving
Direct-to-Consumer Advertising for Medical Products
|
|
|
| 2004D-0065
|
| Guidance for Industry: Prior
Notice of Imported Food Questions and Answers
|
|
|
| 2004D-0117
|
| International Conference on
Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning
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|
|
| 2004D-0118
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| International Conference on
Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological
Products Subject to Changes in Their Manufacturing Process
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| 2004N-0133
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| Part 11, Electronic
Record; Electronic Signatures; Public Meeting
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| 2004N-0166
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| Agency Information Collection
Activities: Proposed Collection; Comment Request; Infant Feeding Practices
Study II
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| 2004N-0181
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| Critical Path Initiative
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| 2004N-0184
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| Requirements Pertaining
to Sampling and Private Laboratories Used in Connection With Importing
Food
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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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|
| 2004N-0244
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| Agency Information
Collection Activities: Proposed Collection; Comment Request;
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| 2004P-0059
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| Health Claim Petition:
Glucosamine and Chondroitin Sulfate and Osteoarthritis
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| 2004P-0067
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| Revoke the regulation
that approved Posilac, Monsanto's bovine growth hormone
|
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|
|
| 2004P-0127
|
| ANADA suitability
for ANTIROBE (clindamycin hydrochloride) capsules for dogs and cats
(NADA 120-161)
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| 2004P-0261
|
| Prevent Pfizer Inc.
from marketing a generic version of Accupril until after the expiration
of Teva's 180-day exclusivity period
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| 2004P-0262
|
| Withdraw approval of ANDA suitability
petition
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| 2004Q-0144
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| Qualified Health Claim (QHC):
Chromium picolinate and Diabetes
|
|
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| 2004S-0233
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| Stimulating Innovation
in Medical Technologies
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|
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|
|
| 1980N-0145B
|
| Safety & Efficacy
Review for OTC Ophthalmic Drug Prod.
|
|
|
|
|
| MT
1
|
| HFD-560
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| Vol #:
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| 1
|
|
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|
|
| 1994P-0343
|
| Revoke the use
of rBGH, BST and Prosilac
|
|
|
|
|
| PDN
1
|
| HFC-1 to Robert Cohen
|
| Vol #:
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| 1
|
|
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| 1994P-0390
|
| Adopt Amendments
Governing Health Claims & Nutrient Claims
|
|
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|
|
| EC 1
|
| Mr. Joseph Ouellette
|
| Vol #:
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| 5
|
|
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|
| 1995S-0158
|
| Community Disclosure
of Institutional Review Boards
|
|
|
|
|
| SUP
27
Attachments
|
| Northfield Laboratories
Inc BB IND 10719
|
| Vol #:
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| 27
|
|
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|
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| 2000N-1571
|
| Enrofloxacin for
Poultry: Opportunity for Hearing
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|
| | | | | | | | |
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| |
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| EMC 788
|
| Robin Justus
|
| Vol #:
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| 271
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| EMC 789
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| John & Lucy Perko
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| Vol #:
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| 271
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| EMC 790
|
| David Randall
|
| Vol #:
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| 271
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| EXB 84
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| Center for Veterinary Medicine
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| Vol #:
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| 410
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| EXB 85
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| Center for Veterinary Medicine
|
| Vol #:
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| 410
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|
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| EXB 86
|
| Center for Veterinary Medicine
|
| Vol #:
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| 410
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|
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| EXB 87
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| Center for Veterinary Medicine
|
| Vol #:
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| 410
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| EXB 88
|
| Center for Veterinary Medicine
|
| Vol #:
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| 410
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|
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| EXB 89
|
| Center for Veterinary Medicine
|
| Vol #:
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| 410
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| EXB 90
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| Center for Veterinary Medicine
|
| Vol #:
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| 410
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| EXB 91
|
| Center for Veterinary Medicine
|
| Vol #:
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| 410
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|
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| EXB 92
|
| Center for Veterinary Medicine
|
| Vol #:
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| 410
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| EXB 93
|
| Center for Veterinary Medicine
|
| Vol #:
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| 410
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| EXB 94
|
| Center for Veterinary Medicine
|
| Vol #:
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| 410
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| EXB 95
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| Center for Veterinary Medicine
|
| Vol #:
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| 410
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|
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| EXB 96
|
| Center for Veterinary Medicine
|
| Vol #:
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| 410
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|
|
|
|
| EXB 97
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 410
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|
|
|
|
| EXB 98
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 410
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|
|
|
|
| EXB 99
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 410
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|
|
|
|
| EXB 100
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 410
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|
|
|
|
| EXB 101
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 410
|
|
|
|
|
| EXB 102
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 410
|
|
|
|
|
| EXB 103
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 410
|
|
|
|
|
| EXB 104
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 410
|
|
|
|
|
| 2000P-0177
|
| Request that FDA not Approve Upjohn's Bovine Growth Hormone
|
|
|
|
|
| PDN
1
|
| HFC-1 to Robert Cohen
|
| Vol #:
|
| 1
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| EC 770
|
| Ms. Angela Lalley
|
| Vol #:
|
| 163
|
|
|
|
|
| EC 771
|
| Ms. Sally Roach
|
| Vol #:
|
| 163
|
|
|
|
|
| EC 772
|
| Ibis Reproductive Health
|
| Vol #:
|
| 163
|
|
|
|
|
| EC 773
|
| Mr. Henry Honigfort
|
| Vol #:
|
| 163
|
|
|
|
|
| EC 774
|
| Dr. Jeffrey Baden
|
| Vol #:
|
| 163
|
|
|
|
|
| EC 775
|
| Mr. Matthew Shipp
|
| Vol #:
|
| 163
|
|
|
|
|
| EC 776
|
| Ms. Jennifer Alber
|
| Vol #:
|
| 163
|
|
|
|
|
| EC 777
|
| Miss. Teena Parker
|
| Vol #:
|
| 163
|
|
| | | | | | | | |
|
|
|
|
| EMC 7107
|
| B. Taylor
|
| Vol #:
|
| 237
|
|
|
|
|
| EMC 7108
|
| N. Guardreau
|
| Vol #:
|
| 237
|
|
|
|
|
| EMC 7109
|
| J. Berkson
|
| Vol #:
|
| 237
|
|
|
|
|
| EMC 7110
|
| K. L. Cunningham
|
| Vol #:
|
| 237
|
|
|
|
|
| EMC 7111
|
| M. Capello
|
| Vol #:
|
| 237
|
|
|
|
|
| EMC 7112
|
| J. Brigham
|
| Vol #:
|
| 237
|
|
|
|
|
| EMC 7113
|
| K. Popplewell
|
| Vol #:
|
| 237
|
|
|
|
|
| EMC 7114
|
| S. Schoorl
|
| Vol #:
|
| 237
|
|
|
|
|
| 2002N-0275
|
| Bioterrorism Preparedness; Administrative Detention
|
|
|
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 10
|
|
|
|
|
| 2003D-0060
|
| Part11, Electronic records, electronic signatures scope
|
|
|
|
|
| EC 30
|
| Aslan Consulting Services, LLC
|
| Vol #:
|
| 1
|
|
| |
|
| 2003D-0204
|
| Guidance for Industry: IRB Review of Stand-Alone HIPAA Authorizations; Availability
|
|
|
|
|
| EC 1
|
| First Clinical Research, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0206
|
| Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability
|
|
|
|
|
| EC 1
|
| Women and Children's Hospital of Buffalo
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0319
|
| Guidance for Industry and FDA Staff; Draft; Premarket Assessment of Pediatric Medical Devices
|
|
|
|
|
| EC 1
|
| Mr. Robert Jr Perocchi
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0537
|
| Guidance for Industry and FDA Staff; User Fees and Refunds for Premarket Notification Submissions (510(k)s);
|
|
|
|
|
| GDL
1
|
| Guidance
|
| Vol #:
|
| 1
|
|
|
|
|
| NAD
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003D-0545
|
| Questions and Answers Regarding Registration of Food Facilities
|
|
|
|
|
| EC 9
|
| CONSULTORES INTERNACIONALES DE MERCADOTECNIA, S.A.
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 10
|
| CONSULTORES INTERNACIONALES
|
| Vol #:
|
| 1
|
|
| |
|
| 2003D-0571
|
| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
|
|
|
|
|
| EC 1
|
| German Assoc. of Research-Based Pharm. Companies
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| LET
1
|
| HFS-830 to Fran L. Rivard, B.A., LPN
|
| Vol #:
|
| 7
|
|
|
|
|
| 2003N-0312
|
| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
|
|
|
|
|
| EC 7
|
| Ms. laura berke
|
| Vol #:
|
| 4
|
|
| | | | | | | | |
|
|
|
|
| 2003N-0324
|
| New Animal Drugs; Removal of Obsolete and Redundant Regulations
|
|
|
|
|
| EC 1
|
| Meridian Pharmacy
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003N-0360
|
| Agency Info Collection: Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Databank
|
|
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0481
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions
|
|
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0539
|
| Over-the-Counter Drug Products; Safety and Efficacy Review
|
|
|
|
|
| EC 4
|
| Mr. VERNHET Marc
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0159
|
| Venlafaxine Hydrochloride Extended-Release Tablets
|
|
|
|
|
| CR
1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0296
|
| Romano Cheese for Manufacturing Deviating From Identity Standard; Temporary Permit for Market Testing
|
|
|
|
|
| LET
2
|
| Kerry, Inc. and Mullins Cheese, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0479
|
| Allow importation of Canadian versions of drugs that are approved to the United States
|
|
|
|
|
| LET
2
|
| HFD-005 to State of Vermont
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0555
|
| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
|
|
|
|
|
| C 20
|
| R. Hinman
|
| Vol #:
|
| 2
|
|
|
|
|
| C 21
|
| B. Cody, BS, RN
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 20
|
| Patients Rights Abvocacy
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 21
|
| Ms. Cynthia Rossetti
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 22
|
| global greens usgp
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 23
|
| Dr. paul weiner
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 24
|
| Ms. Wendy Rosen
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 25
|
| Rehabilitation Services
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 26
|
| Mr. Jack Pealer
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003P-0574
|
| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
|
|
|
|
|
| EC 1
|
| Norben Ltd.
|
| Vol #:
|
| 2
|
|
| |
|
| 2004D-0001
|
| Global Harmonization Task Force, Study Group 1, 2, 3 and 4; New Proposed and Final Documents; Availability
|
|
|
|
|
| EC 1
|
| Cook Group Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0042
|
| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
|
|
|
|
|
| EC 5
|
| National Women's Health Network
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 6
|
| VA Outcomes Group (White River Jct., VT)
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
|
| EC 7
|
| VA Outcomes Group (White River Jct., VT)
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 8
|
| VA Outcomes Group (White River Jct., VT)
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 9
|
| Federal Trade Commission
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 10
|
| Kaiser Permanente
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0065
|
| Guidance for Industry: Prior Notice of Imported Food Questions and Answers
|
|
|
|
|
| EC 1
|
| Evelina Hwang CHB
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 2
|
| Sherry Renya Miller
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 3
|
| TLR-Total Logistics Resource Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 4
|
| P.S. Clearance Co., Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 5
|
| Horizon Air
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 6
|
| Ms. Chrystal Smith
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 7
|
| Ms. Jo Carter
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 8
|
| Ontario Commercial Fisheries' Association
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 9
|
| Keith's Variety Store
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 10
|
| Korea Food and Drug Administration
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 11
|
| San-Ei Gen F.F.I., Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 12
|
| Southern Waters Marine Products pty/ltd
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 13
|
| Blueberry Sales L.P.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0082
|
| Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems; Availability
|
|
|
|
|
| EC 3
|
| Mr. David Queen
|
| Vol #:
|
| 1
|
|
| |
|
| 2004D-0117
|
| International Conference on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning
|
|
|
|
|
| EC 1
|
| Genentech
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 2
|
| Pfizer Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 3
|
| Novartis Pharmaceuticals Corp.
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 4
|
| Novartis Pharmaceuticals Corp
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0118
|
| International Conference on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
|
|
|
|
|
| EC 1
|
| Brighton Collaboration
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 2
|
| Johnson
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
|
|
|
|
| C
9
|
| Boehringer Ingelheim Corporation
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 13
|
| NOTOCORD Systems
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 14
|
| NOTOCORD Systems
|
| Vol #:
|
| 2
|
|
|
|
|
| EC 15
|
| Chiron
|
| Vol #:
|
| 2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 2004N-0166
|
| Agency Information
Collection Activities: Proposed Collection; Comment Request; Infant
Feeding Practices Study II
|
|
|
|
|
| EC
2
|
| Bureau of Medicine and Surgery
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 3
|
| Mrs. Maria Elena Gomez-Herbert
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
4
|
| Madigan Army Medical Center
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0179
|
| Agency Information
Collection Activities: Proposed Collection; Comment Request; New Animal
Drug Application, FDA Form 356 V, 21 CFR Part 514
|
|
|
|
|
| EC 1
|
| Ms. barb sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0181
|
| Critical Path Initiative
|
|
|
|
|
| EC
1
|
| Musella Foundation For Brain
Tumor Research & Info
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0184
|
| Requirements Pertaining
to Sampling and Private Laboratories Used in Connection With Importing
Food
|
|
|
|
|
| C
2
|
| Foreign Trade Service Corp.
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004N-0205
|
| Furan in food;
thermal treatment
|
|
|
|
|
| EC 1
|
| Dr. James Coughlin
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004N-0221
|
| Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
|
|
|
|
|
| C
2
|
| Northeastern Assn of the Blind
at Albany (NABA)
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
1
|
| National Federation of the Blind
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
2
|
| Atlanta VA Medical Center
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
3
|
| Helen Keller National Center
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
4
|
| Helen Keller National Center
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0244
|
| Agency Information
Collection Activities: Proposed Collection; Comment Request;
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0059
|
| Health Claim Petition:
Glucosamine and Chondroitin Sulfate and Osteoarthritis
|
|
|
|
|
| SUP 6
|
| Weider Nutrition International,
Inc.
|
| Vol #:
|
| 16
|
|
|
|
|
| 2004P-0067
|
| Revoke the regulation
that approved Posilac, Monsanto's bovine growth hormone
|
|
|
|
|
| LET
1
|
| HFV-1 to Robert Cohen
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0127
|
| ANADA suitability
for ANTIROBE (clindamycin hydrochloride) capsules for dogs and cats
(NADA 120-161)
|
|
|
|
|
| PRC
1
|
| Smart Drug Systems Inc.
|
| 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
|
|
|
|
|
| ACK
1
|
| HFA-305 to Heller Ehrman Attorneys
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Teva Pharmaceuticals USA, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0262
|
| Withdraw approval
of ANDA suitability petition
|
|
