FDA Logo links to FDA home page
U.S. Food and Drug Administration
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | Dockets Home Page | Dockets Contacts and Location | Operating Status

horizonal rule

Dockets Management
Dockets Entered On October 6, 2004
Table of Contents
Docket # Title
1981N-0033P Antigingivitis & Antiplaque-Related Claims
1990N-0172 Revise Medical Device CGMP Regulation
1995S-0158 Community Disclosure of Institutional Review Boards
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
1996P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs
1997P-0197 Require that warning labels about risks of salmonella enteri
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
1998P-0203 Eliminate Forced Molting of Laying Birds
1999P-5106 Identify Sources of Natural Flavorings
2000N-0504 Egg Safety Action Plan
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
2003P-0479 Allow importation of Canadian versions of drugs that are approved to the United States
2003P-0548 Determination whether Dexamethasone Acetate Injection withdrawn for Safety Reasons
2004D-0193 Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
2004D-0414 FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
2004N-0081 BSE Risk Materials in Foods and Cosmetics
2004P-0148 ANDA Suitability for Oxycodone Hydrochloride 5 mg, 10 mg and 20 mg tablets
2004P-0152 ANDA Suitability for Hydromorphone Hydrochloride Tablets 2 mg and 4 mg dosage strengths
2004P-0195 ANDA Suitability for Divalproex Sodium Extended-Release Tablets, 750 mg
2004P-0452 Regulate the use of coding on food labels
1981N-0033P Antigingivitis & Antiplaque-Related Claims
C 25 Procter & Gamble Vol #: 88
C 26 Colgate-Palmolive Company Vol #: 90
SUP 4 Ciba Specialty Chemicals Corporation (Ciba) Vol #: 89
SUP 5 Ciba Speciality Chemicals Corporation (Ciba) Vol #: 86
1990N-0172 Revise Medical Device CGMP Regulation
ANS 6 HFW-1 to Honorable Slade Gorton Vol #: 18
BKG 5 Background material Vol #: 21
1995S-0158 Community Disclosure of Institutional Review Boards
SUP 30
Hospital Info. 		Northfield Laboratories Inc BB IND 10719 Vol #: 30
SUP 31
Hospital Info. 		Northfield Laboratories Inc BB IND 10719 Vol #: 35
SUP 32
Hospital Info. 		Northfield Laboratories Inc BB IND 10719 Vol #: 36
1995S-0316 75-Day Premarket Notifications for New Dietary Ingredients
RPT 236 Fuji Chemical Industry Co., Ltd Vol #: 170
RPT 237 U S Nutraceuticals, LLC Vol #: 172
1996P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs
C 828 R. Lavosky Vol #: 33
C 829 K. Hastings Vol #: 33
C 830 D. Cedar, RD Vol #: 33
1997P-0197 Require that warning labels about risks of salmonella enteri
C 853 R. Lavosky Vol #: 32
C 854 K. Hastings Vol #: 32
C 855 D. Cedar, RD Vol #: 32
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
C 7453 D. Brown Vol #: 319
C 7454 R. Capozzelli Vol #: 319
C 7455 K. Nguyen Vol #: 319
C 7456 J. Policoff Vol #: 319
C 7457 S and H Wyck Vol #: 319
1998P-0203 Eliminate Forced Molting of Laying Birds
C 1963 R. Lavosky Vol #: 47
C 1964 K. Hastings Vol #: 47
C 1965 D. Cedar, RD Vol #: 47
1999P-5106 Identify Sources of Natural Flavorings
C 69 Eligible Vol #: 3
2000N-0504 Egg Safety Action Plan
C 126 R. Lavosky Vol #: 10
C 127 K. Hastings Vol #: 10
C 128 D. Cedar, RD Vol #: 10
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
EXB 553 Center for Veterinary Medicine Vol #: 436
EXB 554 Center for Veterinary Medicine Vol #: 436
EXB 555 Center for Veterinary Medicine Vol #: 436
EXB 556 Center for Veterinary Medicine Vol #: 436
EXB 557 Center for Veterinary Medicine Vol #: 436
EXB 558 Center for Veterinary Medicine Vol #: 436
EXB 559 Center for Veterinary Medicine Vol #: 436
EXB 560 Center for Veterinary Medicine Vol #: 436
EXB 561 Center for Veterinary Medicine Vol #: 436
EXB 562 Center for Veterinary Medicine Vol #: 436
EXB 563 Center for Veterinary Medicine Vol #: 436
EXB 564 Center for Veterinary Medicine Vol #: 436
EXB 565 Center for Veterinary Medicine Vol #: 436
EXB 566 Center for Veterinary Medicine Vol #: 436
EXB 567 Center for Veterinary Medicine Vol #: 436
EXB 568 Center for Veterinary Medicine Vol #: 436
EXB 569 Center for Veterinary Medicine Vol #: 436
EXB 570 Center for Veterinary Medicine Vol #: 436
EXB 571 Center for Veterinary Medicine Vol #: 436
EXB 572 Center for Veterinary Medicine Vol #: 436
EXB 573 Center for Veterinary Medicine Vol #: 436
EXB 574 Center for Veterinary Medicine Vol #: 436
EXB 575 Center for Veterinary Medicine Vol #: 436
EXB 576 Center for Veterinary Medicine Vol #: 436
EXB 577 Center for Veterinary Medicine Vol #: 436
EXB 578 Center for Veterinary Medicine Vol #: 436
EXB 579 Center for Veterinary Medicine Vol #: 436
EXB 580 Center for Veterinary Medicine Vol #: 436
EXB 581 Center for Veterinary Medicine Vol #: 436
EXB 582 Center for Veterinary Medicine Vol #: 436
EXB 583 Center for Veterinary Medicine Vol #: 436
EXB 584 Center for Veterinary Medicine Vol #: 436
EXB 585 Center for Veterinary Medicine Vol #: 436
EXB 586 Center for Veterinary Medicine Vol #: 436
EXB 587 Center for Veterinary Medicine Vol #: 436
EXB 588 Center for Veterinary Medicine Vol #: 436
EXB 589 Center for Veterinary Medicine Vol #: 436
EXB 590 Center for Veterinary Medicine Vol #: 436
EXB 591 Center for Veterinary Medicine Vol #: 436
EXB 592 Center for Veterinary Medicine Vol #: 436
EXB 593 Center for Veterinary Medicine Vol #: 436
EXB 594 Center for Veterinary Medicine Vol #: 436
EXB 595 Center for Veterinary Medicine Vol #: 436
EXB 596 Center for Veterinary Medicine Vol #: 436
2003P-0479 Allow importation of Canadian versions of drugs that are approved to the United States
C 21 M. Piere Vol #: 1
C 22 A. Proehl Vol #: 1
C 23 Eligible Vol #: 1
C 24 A. Zoger Vol #: 1
C 25 L. Lupa Vol #: 1
C 26 P. Proehl Vol #: 1
2003P-0548 Determination whether Dexamethasone Acetate Injection withdrawn for Safety Reasons
ANS 1 HFD-7 to Gray Cary Vol #: 1
2004D-0193 Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
C 19 Alabama Eye Bank Vol #: 1
2004D-0414 FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
BKG 1 Background material Vol #: 2
2004N-0081 BSE Risk Materials in Foods and Cosmetics
C 40 D. Uhlman Vol #: 8
C 41 J. Aragon Vol #: 8
C 42 L. Dixon Vol #: 8
C 43 J. Shakman Vol #: 8
C 44 M. Prendergast Vol #: 8
C 45 S. Jarvi Vol #: 8
C 46 P. Dasgupta Vol #: 8
C 47 H. Thompson Vol #: 8
C 48 Farm Sanctuary Vol #: 8
C 49 S. Edmondson Vol #: 8
C 50 M. Moll Vol #: 8
C 51 Ginece Jones Vol #: 8
C 52 Eligible Vol #: 8
C 53 B. Frey Vol #: 8
C 54 K. Kindel Vol #: 8
C 55 N. Baumgardner Vol #: 8
C 56 J. Tolpin Vol #: 8
C 57 C. Clond Vol #: 8
C 58 S. Zill Vol #: 8
C 59 National Humane Education Society (NHES) Vol #: 8
C 60 S and H van Wyck Vol #: 8
C 61 R. Cluff Vol #: 8
C 62 Beautiful America Publishing Company Vol #: 8
C 63 L. Nissim Vol #: 8
C 64 T. Siegrist Vol #: 8
C 65 A. Blackwelder Vol #: 8
C 66 D. Bugliarelli Vol #: 8
C 67 B. Samuelson Vol #: 8
C 68 M. Neroes Vol #: 8
C 69 D. Uhlman Vol #: 8
C 70 K. Parker Vol #: 8
C 71 S and W Schwind Vol #: 8
C 72 V and R Bruce Vol #: 8
C 73 H and G Mroz Vol #: 8
C 74 M and G Warholak Vol #: 8
C 75 M Waidler and M Dunlop Vol #: 8
C 76 J and F Benedetto Vol #: 8
C 77 M. Goldman Vol #: 8
C 78 R. Snyder, PhD Vol #: 8
C 79 D. Brown Vol #: 8
C 80 J. Lampe Vol #: 8
C 81
Attachment 1, 2 		North American Natural Casing Assn Vol #: 12
C 82 K. Eicherl Vol #: 12
C 83 C. Cohill Vol #: 12
C 84 D. Bramyer Vol #: 12
C 85 A. Mathur Vol #: 12
C 86 S. Namboodin Vol #: 12
C 87 C. Young Vol #: 12
C 88 Y Hmon Vol #: 12
C 89 Y. Yum Vol #: 12
C 90 S. Aggarwal Vol #: 12
C 91 I Kiss Vol #: 12
C 92 H. Marshall Vol #: 12
C 93 S. Martin Vol #: 12
C 94 K.F. Emerick Vol #: 12
C 95 A. Kasper Vol #: 12
C 96 C. Richard Vol #: 12
C 97 W. Sims Vol #: 12
C 98 M. Yeary Vol #: 12
C 99 National Renderers Assn (NRA) and Animal Protein Producers Industry (APPI) Vol #: 12
C 100 D. Church Vol #: 12
2004P-0148 ANDA Suitability for Oxycodone Hydrochloride 5 mg, 10 mg and 20 mg tablets
PAV 1 HFD-600 to The Weinberg Group Inc. Vol #: 1
2004P-0152 ANDA Suitability for Hydromorphone Hydrochloride Tablets 2 mg and 4 mg dosage strengths
PAV 1 HFD-600 to The Weinberg Group Inc. Vol #: 1
2004P-0195 ANDA Suitability for Divalproex Sodium Extended-Release Tablets, 750 mg
PAV 1 HFD-600 to Lachman Consultant Services, Inc. Vol #: 1
2004P-0452 Regulate the use of coding on food labels
ACK 1 HFA-305 to Bunny Abraham Vol #: 1
CP 1 Bunny Abraham Vol #: 1

Page created on October 7, 2004 dp

horizonal rule

Dockets Home| Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | A-Z Index | Contact FDA | Privacy | Accessibility

FDA/Dockets Management