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Dockets Management
Dockets Entered On November 28, 2003
Table of Contents
Docket # Title
1981N-0033P Antiplaque & Antiplaque-Related Claims
1995N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability
1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
1998D-0173 PMA/510(K)Expedited Review Guidance for Industry
1998D-1146 Microbial effects of antimicrobial new animal drugs/human sa
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
1999N-2637 Public Information Regulations
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
1999P-1340 Declared Eternity eau de Parfum Misbranded
1999P-2630 Establish a Daily Value for "added sugars"
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2001P-0298 Permit Use of Symbols on In-Vitro Diagnostic Labeling
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
2002E-0099 Patent Term Extension Application for XIGRIS No. 4,775,624
2002E-0184 Patent Extension Application for XIGRIS, No. 5,681,932
2002N-0276 Bioterrorism Preparedness; Registration of Food Facilities
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
2003D-0229 Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
2003D-0382 Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
2003D-0383 Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability
2003D-0385 Guidance for Industry: Comparability Protocols b
2003D-0386 Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
2003D-0504 Bundling Multiple Devices in a Single Application; Draft Guidance for Industry and FDA; Availability
2003E-0150 Patent extension ABILIFY (aripiprazole) Patent No. 5,006,528
2003E-0255 Patent Extension for Xigris (drotrecogin alpha), 4,775,624 and 5,009,889, and 5,681,932
2003N-0169 Dental Amalgam; Request for Information
2003N-0338 Obesity
2003N-0344 Consumer-Directed Promotion; Public Meeting
2003N-0361 Anti-Counterfeit Drug Initiative
2003N-0400 Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
2003N-0472 Statement of Work for the Evaluation of First Cycle Review Performance; Availability
2003N-0496 Food Labeling: Health Claims; Dietary Guidance
2003N-0513 Electronic Submissions of Food Contact Notifications; Notice of Pilot Project
2003P-0166 Revoke Approval for Marketing of Menstrual Cups
2003P-0274 In re Tier 1 initial Approval Program
2003P-0276 Establish Interim Acceptable Levels for Acrylamide In Major Food Sources
2003P-0362 Over-the-counter Hearing Aids
2003P-0511 refrain from completing the review of the PMA submitted by Inamed Corporation(Inamed) for McGhan silicone gel-filled breast implants
2003P-0530 Silicone Gel-filled Breast Implants
2003V-0541 Laser Light Show
1981N-0033P Antiplaque & Antiplaque-Related Claims
C 13 WhiteHill Oral Technologies, Inc. Vol #: 78
C 14 Procter & Gamble Company Vol #: 81
C 15 Colgate-Palmolive Company (Colgate-Palmolive) Vol #: 82
C 16
Attachment
Colgate-Palmolive Company (Colgate-Palmolive) Vol #: 84
C 17
Appendix 1, 2, 3
Consumer Healthcare Products Assn (CHPA) Vol #: 85
C 18 Access Business Group (ABG) Vol #: 86
C 19
Summary, Attachment 1, 2, 3
Johnson & Johnson Vol #: 86
C 20 Pfizer, Inc. Vol #: 86
1995N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability
EMC 945 Steve Truett Vol #: 375
1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
EMC 258 No signature Vol #: 41
1998D-0173 PMA/510(K)Expedited Review Guidance for Industry
GDL 2 Guideline Vol #: 1
NAD 2 FDA Vol #: 1
1998D-1146 Microbial effects of antimicrobial new animal drugs/human sa
EMC 702 Kathleen Eastman Vol #: 62
1998P-0151 Introduction Of Downed Cattle Into The Food Supply
C 7286 Evelyn Marks Vol #: 305
C 7287 Kym Barnes Vol #: 305
C 7288 Eva J. Crowe Vol #: 305
C 7289 Susan Dressen Vol #: 305
C 7290 Eligible Vol #: 305
C 7291 Jenny S. Ercolino Vol #: 305
C 7292 Bob Hartwig Vol #: 305
C 7293 Joan M. Raymond Vol #: 305
C 7294 Marita Treat Vol #: 305
C 7295 Donna Grulke Vol #: 305
C 7296 Barbara Jones Vol #: 305
C 7297 Joline Bettendorf Vol #: 305
C 7298 AK Morro Masonis Vol #: 305
1999N-2637 Public Information Regulations
NCR 1 FDA Vol #: 1
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
C 18223 Virginia Williams Vol #: 514
EMC 4082 Richard Phillips Vol #: 514
1999P-1340 Declared Eternity eau de Parfum Misbranded
EMC 490 Nancy Doing Vol #: 21
1999P-2630 Establish a Daily Value for "added sugars"
EMC 704 Katherine Larrabee Vol #: 32
EMC 705 Matthew Tom Vol #: 32
EMC 706 L. Sieffert Vol #: 32
EMC 707 Cynthia Cavallaro Vol #: 32
EMC 708 Jennifer Mitchell Vol #: 32
EMC 709 Tandy Boynton Vol #: 32
EMC 710 William D. Bartlett Vol #: 32
EMC 711 William Fisher Vol #: 32
EMC 712 Anna Jacus Vol #: 32
EMC 713 Kathy Bowden Vol #: 32
EMC 714 Jennifer Leister Vol #: 32
EMC 715 Alison Brantley Vol #: 32
EMC 716 John P. Stoltenberg, PE Vol #: 32
EMC 717 J. Richard Maritt Vol #: 32
EMC 718 Peter C. Reilly and Maureen A. Flannery Vol #: 32
EMC 719 Christina Gleason Vol #: 32
EMC 720 Karen Janda Vol #: 32
EMC 721 Deborah Smith Vol #: 32
EMC 722 Julio Contreras Vol #: 32
EMC 723 Laureen Berdofe Vol #: 32
EMC 724 Marta Simmons Vol #: 32
EMC 725 Veneita Mullins Vol #: 32
EMC 726 Victoria Cole Vol #: 32
EMC 727 Duy Nguyen Vol #: 32
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
NM 1 FDA Vol #: 39
2001P-0298 Permit Use of Symbols on In-Vitro Diagnostic Labeling
PAV 1 HFZ-1 to Bio-Rad Laboratories Vol #: 1
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
EMC 1209 Penny Edler Vol #: 5
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
EMC 136 J. Walters Vol #: 3
2002E-0099 Patent Term Extension Application for XIGRIS No. 4,775,624
N 1 FDA Vol #: 1
2002E-0184 Patent Extension Application for XIGRIS, No. 5,681,932
N 1 FDA Vol #: 1
2002N-0276 Bioterrorism Preparedness; Registration of Food Facilities
C 167 Uniform Code Council, Inc. (UCC) Vol #: 15
C 168 ATOFINA Chemicals, Inc. Vol #: 15
LST 2 Satellite Teleconference Attendees Vol #: 15
LST 3 10/28/2003 List of Attendees Vol #: 15
LST 4 Participant List for the Houston BT Downlink Vol #: 15
LST 5 BT Downlink Registration Vol #: 15
LST 6 10/28 Satellite Conference Participants Vol #: 15
LST 7 Memphis, TN BT Downsite 10/28/2003 Vol #: 15
LST 8 Denver site of the 10/28 downlink Vol #: 15
LST 9 List for the Minneapolis Formal Downlink on 10/28 Vol #: 15
LST 10 List of Wisconsin Dowlink Vol #: 15
LST 11 List of attendees for 10/28th Conference in Portland, Oregon Vol #: 15
LST 12 BT downlink list of attendees in Baton Rouge, LA Vol #: 15
LST 13 List regarding BT Downlink Vol #: 15
LST 14 List that attended the 10/28/03 Satellite Downlink in Cincinnati District Vol #: 15
LST 15 New York District registration list from 10/28 Downlink Vol #: 15
LST 16 List for BT Downlink held in Washington Vol #: 15
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
LST 2 Satellite Teleconference Attendees Vol #: 17
LST 3 10/28/2003 List of Attendees Vol #: 17
LST 4 Participant List for the Houston BT Downlink Vol #: 17
LST 5 BT Downlink Registration Vol #: 17
LST 6 10/28 Satellite Conference Participants Vol #: 17
LST 7 Memphis, TN BT Downsite 10/28/2003 Vol #: 17
LST 8 Denver site of the 10/28 downlink Vol #: 17
LST 9 List for the Minneapolis Formal Downlink on 10/28 Vol #: 17
LST 10 List of Wisconsin Dowlink Vol #: 17
LST 11 List of attendees for 10/28th Conference in Portland, Oregon Vol #: 17
LST 12 BT downlink list of attendees in Baton Rouge, LA Vol #: 17
LST 13 List regarding BT Downlink Vol #: 17
LST 14 List that attended the 10/28/03 Satellite Downlink in Cincinnati District Vol #: 17
LST 15 New York District registration list from 10/28 Downlink Vol #: 17
LST 16 List for BT Downlink held in Washington Vol #: 17
2003D-0229 Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
N 2 FDA Vol #: 1
NCR 1 Number not used Vol #: 1
2003D-0382 Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
LET 1 Organon, Inc. Vol #: 3
2003D-0383 Draft Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Availability
C 2 Dade Behring, Inc. Vol #: 1
C 3 Invitrogen, Corporation Vol #: 1
2003D-0385 Guidance for Industry: Comparability Protocols b
EMC 1 Eli Lilly and Company (Lilly) Vol #: 1
2003D-0386 Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
C 2 Thomas Layloff, PhD et al. Vol #: 1
2003D-0504 Bundling Multiple Devices in a Single Application; Draft Guidance for Industry and FDA; Availability
GDL 1 Guideline Vol #: 1
NAD 1 FDA Vol #: 1
2003E-0150 Patent extension ABILIFY (aripiprazole) Patent No. 5,006,528
N 1 FDA Vol #: 1
2003E-0255 Patent Extension for Xigris (drotrecogin alpha), 4,775,624 and 5,009,889, and 5,681,932
N 1 FDA Vol #: 1
2003N-0169 Dental Amalgam; Request for Information
SUP 10 American Dental Assn (ADA) Vol #: 4
2003N-0338 Obesity
C 9 Atkins Nutritionals, Inc. Vol #: 6
C 10 Donald K. Layman, PhD Vol #: 6
C 11 Mount Sinai Medical Center Vol #: 6
EMC 24 Capitol Policy Institute Vol #: 6
EMC 25 Girl Scouts of the USA Vol #: 6
NM 2 FDA Vol #: 6
TS 17 National Dairy Council (NDC) Vol #: 6
2003N-0344 Consumer-Directed Promotion; Public Meeting
C 2 Kristin A. Altar, RN,BSN Vol #: 2
SUP 2 Catalina Health Resource (CHR) Vol #: 2
2003N-0361 Anti-Counterfeit Drug Initiative
C 42 Healthcare Distribution Management Assn (HDMA) Vol #: 5
2003N-0400 Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
C 18 Lorraine Hanes Vol #: 3
C 19 Tracy Wills Vol #: 3
C 20 Tracy Wills Vol #: 3
C 21 5 signatures Vol #: 3
C 22 6 signatures Vol #: 3
C 23 5 signatures Vol #: 3
C 24 W.B. "Bill" McCaslin Vol #: 3
2003N-0472 Statement of Work for the Evaluation of First Cycle Review Performance; Availability
C 1 Pharmaceutical Research and Manufacturers of America (PhRMA) Vol #: 1
2003N-0496 Food Labeling: Health Claims; Dietary Guidance
NPR 1 FDA Vol #: 1
REF 1
Tab A, B, C
OMB Review March 13, 2003 Vol #: 1
2003N-0513 Electronic Submissions of Food Contact Notifications; Notice of Pilot Project
N 1 FDA Vol #: 1
2003P-0166 Revoke Approval for Marketing of Menstrual Cups
ANS 1 HFZ-1 to Associated Pharmacologists & Toxicologis Vol #: 1
2003P-0274 In re Tier 1 initial Approval Program
C 10 Colon Cancer Alliance Vol #: 1
2003P-0276 Establish Interim Acceptable Levels for Acrylamide In Major Food Sources
LET 1 HFS-300 to Center for Science in the Public Interest Vol #: 1
2003P-0362 Over-the-counter Hearing Aids
C 3 Rancho Bernardo Hearing Services, Inc. Vol #: 1
C 4 Active Hearing and Balance CenterRichard Navarro, PhD Vol #: 1
EMC 6 Susan Sykes, MS/CCC/SLP Vol #: 1
EMC 7 Anthony Mercadante, MA,CCC-A Vol #: 1
2003P-0511 refrain from completing the review of the PMA submitted by Inamed Corporation(Inamed) for McGhan silicone gel-filled breast implants
C 1 Inamed Corporation (Inamed) Vol #: 1
2003P-0530 Silicone Gel-filled Breast Implants
EMC 1 Bridgitte V. Engler Vol #: 1
EMC 2 Lori Hackett Vol #: 1
EMC 3 Margaret Rath Vol #: 1
EMC 4 April Lassetter Vol #: 1
EMC 5 George J. Gottwald Vol #: 1
EMC 6 Bernard M. Patten,MD,FACP,FRSM,FTNS Vol #: 1
2003V-0541 Laser Light Show
ACK 1 HFA-305 to Crobar Vol #: 1

Page created December 1, 2003 jb
Page updated December 24, 2003 jb

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