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Dockets Management

Dockets Entered On January 30, 2007
Docket # Title
2003N-0573 Draft Animal Cloning Risk Assessment
2005D-0202 Guidance for Industry on Bar Code Label Requirements; Questions and Answers
2005N-0105 Proposal to Debar James T. Kimball; Notice of Opportunity for Hearing
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
2006D-0363 Guidance for Industry and Food and Drug Administration Staff; Draft Class II Special Controls Guidance Document: Absorbable Hemostatic Device
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
2006D-0400 Global Harmonization Task Force, Study Groups 1, 2, 4, and 5; New Proposed and Final Documents; Availability
2006D-0408 Guidance for Industry and Food and Drug Administration Staff; Annual Reports for Approved Premarket Approval Applications
2006D-0463 Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
2006N-0362 General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
2006N-0421 Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A
2006P-0307 To amend 21CFR 201.17 regarding expiration dates
2006P-0365 Urge FDA to Take Regulatory Action to Safeguard the Public from Violative Dental Devices Distributed by Five Companies, Including Devices Manufactured in Unregistered Facilities and
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0415 Petition Seeking Regulation of Cloned Animals
2007N-0016 Sentinel Network To Promote Medical Product Safety
2007N-0029 Indevus Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application
2007V-0038 Laser Light Show
2003N-0573 Draft Animal Cloning Risk Assessment
EC 3168 Ms. Beth Edwards Vol #: 17
EC 3169 Mr. Jerry Pierson Vol #: 17
EC 3170 Mrs. dale durland Vol #: 17
EC 3171 Ms. Elaina Davis Vol #: 17
EC 3172 Miss. Eugenia Washington Vol #: 17
EC 3173 Ms. Christianna Nelson Vol #: 17
EC 3174 Mrs. Lynette Donnelly Vol #: 17
EC 3175 Medical Social Worker Vol #: 17
EC 3176 Mr. Bruce Barrett Vol #: 17
EC 3177 Miss. Leah Karaffa Vol #: 17
EC 3178 Ms. Tamara Vivian Vol #: 17
EC 3179 college student Vol #: 17
EC 3180 Dr. Ronald Bergman Vol #: 17
EC 3181 Ms. Aggie Hertel Vol #: 17
EC 3182 Mr. Shaun Hummell Vol #: 17
EC 3183 Mr. Daniel Solomon Vol #: 17
EC 3184 Dr. Patricia F. Neyman Vol #: 17
EC 3185 FIRE Vol #: 17
EC 3186 Ms. J Alley Vol #: 17
EC 3187 Mr. John Sasso Vol #: 17
EC 3188 Mrs. Joan Klein Vol #: 17
EC 3189 Ms. Rentia Humphries Vol #: 17
EC 3190 Mrs. Katherine Godwin Vol #: 17
EC 3191 Ms. Meggie Ferreira Vol #: 17
EC 3192 Mrs. charlea craig Vol #: 17
EC 3193 Ms. Suellen Jones Vol #: 17
EC 3194 Ms. Karla Mosley Vol #: 17
EC 3195 Ms. Alexandrea Hickey Vol #: 17
EC 3196 Mr. lucas golden Vol #: 17
EC 3197 Ms. Kelly lyons Vol #: 17
2005D-0202 Guidance for Industry on Bar Code Label Requirements; Questions and Answers
EC 8 Mr. Darnlen Williams Vol #: 1
2005N-0105 Proposal to Debar James T. Kimball; Notice of Opportunity for Hearing
ND 1 FDA Vol #: 1
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
EC 1569 Mrs. Lauren Dauphinais Vol #: 24
EC 1570 Mrs. Rebecca Lawson Vol #: 24
EC 1571 Ms. Valerie Caskey Vol #: 24
EC 1572 Glens Falls Regional Celiac Support Group Vol #: 24
EC 1573 Mrs. Nicka Pohl Vol #: 24
EC 1574 Mr. Alan Hann Vol #: 24
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
C 73 Wyeth Pharmaceuticals, Inc. (Wyeth) Vol #: 8
C 74 L. Perrigo Company (Perrigo) Vol #: 8
C 75 Antigen Laboratories, Inc. Vol #: 8
C 76 Machine & Welding Supply Company Vol #: 8
C 77 Superior Weldinh Supply, Inc. Vol #: 8
C 78 United States Welding, Inc. Vol #: 8
C 79 AWESCO Vol #: 8
2006D-0363 Guidance for Industry and Food and Drug Administration Staff; Draft Class II Special Controls Guidance Document: Absorbable Hemostatic Device
C 1 St. Jude Medical (SJM) Vol #: 1
C 2 Ferrosan A/S, Sydmarken 5, DK-2860 Soeborg Vol #: 1
C 3 Duke University Medical Center Vol #: 1
C 4 Ethicon, Inc. (Ethicon) Vol #: 1
EC 3 Vascular Solutions Vol #: 1
EC 4 Pfizer Vol #: 1
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
C 1586 E. Janak Vol #: 46
C 1587 A. Clark Vol #: 46
C 1588 M. Pezzimenti Vol #: 46
C 1589 T. Graham Vol #: 46
2006D-0400 Global Harmonization Task Force, Study Groups 1, 2, 4, and 5; New Proposed and Final Documents; Availability
C 2 Advanced Medical Technology Association (AdvaMed) Vol #: 1
2006D-0408 Guidance for Industry and Food and Drug Administration Staff; Annual Reports for Approved Premarket Approval Applications
C 4 Abbott Laboratories Vol #: 1
C 5 Medtronic, Inc. Vol #: 1
C 6 Cook Group Incorporated (COOK) Vol #: 1
C 7 Roche Molecular Systems, Inc. Vol #: 1
2006D-0463 Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability
C 3 Naryx Pharma, Inc. Vol #: 2
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
SUP 29 Consumers for Dental Choice Vol #: 37
2006N-0362 General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
C 1 Jefferson University Vol #: 1
C 2 Ferrosan A/S, Sydmarken 5, DK-2860 Soeborg Vol #: 1
C 3 Duke University Medical Center Vol #: 1
C 4 Ethicon, Inc. (Ethicon) Vol #: 1
EC 2 Vascular Solutions Vol #: 1
2006N-0421 Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A
N 2 FDA Vol #: 1
2006P-0307 To amend 21CFR 201.17 regarding expiration dates
LET 1 FDA/CDER to Royal Medical Group Vol #: 1
2006P-0365 Urge FDA to Take Regulatory Action to Safeguard the Public from Violative Dental Devices Distributed by Five Companies, Including Devices Manufactured in Unregistered Facilities and
LET 1 FDA/CDRH to Kerr Corporation Vol #: 2
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 41 J. Salazar Vol #: 6
C 42 V. Knight Vol #: 6
C 43 C. White Vol #: 6
C 44 M. Hass Vol #: 6
C 45 J. Denison Vol #: 6
C 46 T. O'Neill Vol #: 6
C 47 P and M Hlavacka Vol #: 6
C 48 E. Fettman Vol #: 6
C 49 L. Nunes Vol #: 6
EC 994 Mrs. Tracey Zack Vol #: 8
EC 995 Miss. Andria Harrold Vol #: 8
EC 996 Mrs. Nicola Grobe Vol #: 8
EC 997 Miss. CHRISTINE CARON Vol #: 8
2006P-0415 Petition Seeking Regulation of Cloned Animals
EC 911 Mrs. Stephanie Gilbert Vol #: 4
EC 912 Mr. Seth Bailey Vol #: 4
EC 913 Ms. Elizabeth Karpinski Vol #: 4
2007N-0016 Sentinel Network To Promote Medical Product Safety
EAPE 91 Goldman, Stephen A. Vol #: 1
2007N-0029 Indevus Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application
NWL 1 FDA Vol #: 1
2007V-0038 Laser Light Show
ACK 1 FDA / DDM to Lasersmith Light Show Systems, LLC Vol #: 1
VAR 1 Lasersmith Light Show Systems, LLC Vol #: 1

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