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Dockets Management

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Dockets Entered On October 31, 2006
Docket # Title
1995N-0294 Quality/fill container; common or unusual name regulations
2000E-1252 Patent Extension Alamast #5,034,230
2003F-0535 Chlorine Dioxide (FAP 4A4751)
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-0331 Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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
2006N-0107 FDA-Regulated Products Containing Nanotechnology Materials
2006N-0184 Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
2006N-0220 Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices
2006N-0239 Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation
2006N-0292 Unique Device Identification
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
2006N-0426 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602)
2006P-0394 Revise the labeling requirements for eggs sold in the United States
1995N-0294 Quality/fill container; common or unusual name regulations
ACK 1 FDA/DDM to the Grocery Manufacturers Association Vol #: 6
CP 1 Grocery Manufacturers Association Vol #: 6
2000E-1252 Patent Extension Alamast #5,034,230
LET 4 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2003F-0535 Chlorine Dioxide (FAP 4A4751)
LET 1 FDA/CFSAN Vol #: 1
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
NEC 1 FDA Vol #: 3
2006D-0331 Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
C 9 Federation of American Hospitals Vol #: 3
C 10 Council on Governmental Relations Vol #: 3
EC 48 Society for Academic Emergency Medicine Vol #: 2
EC 49 Novo Nordisk Inc Vol #: 2
EC 50 University of Pennsylvania Dept. of Emerg. Med Vol #: 2
EC 51 Federation of American Hospitals Vol #: 3
EC 52 University of Washington Vol #: 3
EC 53 Columbia University Vol #: 3
2006D-0363 Guidance for Industry and Food and Drug Administration Staff; Draft Class II Special Controls Guidance Document: Absorbable Hemostatic Device
GDL 1 Guidance Vol #: 1
NAD 1 FDA 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
EC 4 Ms. Margot Hird Vol #: 1
2006N-0107 FDA-Regulated Products Containing Nanotechnology Materials
C 13 Our Bodies, Ourselves Vol #: 12
2006N-0184 Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
N 2 FDA Vol #: 1
2006N-0220 Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices
N 2 FDA Vol #: 1
2006N-0239 Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation
N 2 FDA Vol #: 1
2006N-0292 Unique Device Identification
EC 30 Sonitor Technologies, Inc. Vol #: 1
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
EC 127 Dental Care Vol #: 3
EC 128 Rockland COunty Conservation Association, Inc. Vol #: 3
EC 129 Dental Care Vol #: 3
EC 130 Mr. Gary Takata Vol #: 3
EC 131 Dental Care Vol #: 3
EC 132 Women's Voices for the Earth Vol #: 3
EC 133 Self Employed Vol #: 3
EC 134 Dental Care Vol #: 3
EC 135 Dental Care Vol #: 3
EC 136 Dental Care Vol #: 3
2006N-0362 General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
NPR 1 FDA Vol #: 1
REF 1 Reference Vol #: 2
REF 2 Reference Vol #: 2
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 1 FDA Vol #: 1
2006N-0426 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602)
N 1 FDA Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
EC 373 Mrs. Jana Peck Vol #: 2
EC 374 Public Citizen Vol #: 2
EC 375 Mrs. Linda Calbreath Vol #: 2

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