Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870; TTY/TDD Users 1-800-735-2258 - [E-mail Us]

DOCKETS ENTERED on September 18, 2002

TABLE OF CONTENTS

Hyper links are part of the Docket  title - not all dockets/documents are linked

NOTE:  Documents received by the Dockets Management Branch "MAY" be posted on the Internet. PLEASE DO NOT include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence.

[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]

 
00D-0805 Requirements for Emergency Research *
00N-1663 Investigational New Drugs: Export Requirements *
01N-0067 Reclassification of Dental Mercury *
01P-0120 Ban Unsafe IV Catheters and other Devices *
02N-0114 Reclassification of Root-form Endosseous Dental Implants *
02N-0204 Bar Code Label Requirements for human drug products *
02N-0209 Governing First Amendment Case Law *
02P-0349 Amend product insert and/or label for Hemophilus Vaccines *
02P-0416 Highland VetPharma ANADA dosage form which differs from ANAD *

74N-0002 Action Level for Mercury In Fish and Shellfish

ANS 1 Office of Legislative Services Vol#: 2

ANS 2 Associate Commissioner for Compliance Vol#: 2

ANS 3 Office of Legislative Services Vol#: 2

BKG 1 Vol#: 1

C 1 Newman and Newman Vol#: 2

C 2 Associate Commissioner for Compliance Vol#: 2

C 3 Newman and Newman Vol#: 2

C 4 Vol#: 2

C 5 COOP Vol#: 2

C 6 Vol#: 2

C 7 Barbara K. Schumacher Vol#: 2

C 8 George Bilidas Vol#: 2

C 9 University of California, Berkeley Vol#: 2

C 10 Newman and Newman Vol#: 2

C 11 Leonard J. Goldwater Vol#: 2

C 12 Frances Strauss Vol#:

C 13 Fern Carr Vol#: 2

C 14 Mr. & Ms. George A. Gowen Vol#: 2

C 15 Vol#: 2

LET 1 U.S. Senate Vol#: 2

LET 2 Dept. of Health, Education, & Welfare Vol#: 2

NPR 1 Vol#: 1

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

EMC 339 Cal Hill Vol#: 5

EMC 340 Jeffrey Grayson Vol#: 5

EMC 341 Ave Torre-Bueno Vol#: 5

EMC 342 Lisa Yett Vol#: 5

EMC 343 Belinda Heaton Vol#: 5

EMC 344 Lydia Straus-Edwards Vol#: 5

EMC 345 Patricia Leavitt Vol#: 5

EMC 346 Cindy Stults-DiStasio Vol#: 5

EMC 347 Steve Huse Vol#: 5

EMC 348 Melissa Lombardo Vol#: 5

EMC 349 Jeremy Scott Vol#: 5

EMC 350 Megan Livingston Vol#: 5

EMC 351 Laida Aguirre Vol#: 5

EMC 352 Barbara Labrecque Vol#: 5

99F-5321 Food Safety & Inspection service safe use of ionizing radiai

EMC 250 Steve Huse Vol#: 5

EMC 251 Melissa Lombardo Vol#: 5

EMC 252 Jeremy Scott Vol#: 5

EMC 253 Megan Livingston Vol#: 5

EMC 254 Laida Aguirre Vol#: 5

EMC 255 Barbara Labrecque Vol#: 5

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 249 Steve Huse Vol#: 4

EMC 250 Melissa Lombardo Vol#: 5

EMC 251 Jeremy Scott Vol#: 4

EMC 252 Megan Livingston Vol#: 4

EMC 253 Laida Aguirre Vol#: 4

EMC 254 Barbara Labrecque Vol#: 4

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

EMC 252 Steve Huse Vol#: 4

EMC 253 Melissa Lombardo Vol#: 4

EMC 254 Jeremy Scott Vol#: 4

EMC 255 Megan Livingston Vol#: 4

EMC 256 Laida Aguirre Vol#: 4

EMC 257 Barbara Labrecque Vol#: 4

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 885 Denise Hewitt Vol#: 212

00D-0805 Requirements for Emergency Research

C 9 State University of New York Upstate Med Vol#: 1

00N-1663 Investigational New Drugs: Export Requirements

C 1 Merck & Co., Inc. Vol#: 1

C 2 PhRMA Vol#: 1

01N-0067 Reclassification of Dental Mercury

C 66 James E. Hardy, DDS Vol#: 8

C 67 Consumers for Dental Choice Vol#: 8

C 68 Jan McCoy Vol#: 8

C 69 Representative Hal Lynde Vol#: 8

C 70 Marilyn D. Kiefer, R.N. Vol#: 8

C 71 Cynthia Falkoff Vol#: 8

C 72 Stephen Deiss Vol#: 8

C 73 Consumers for Dental Choice Vol#: 8

EMC 512 Number Not Used Vol#: 10

EMC 513 Susan E. Marcus Vol#: 10

EMC 514 David W. Regiani, DDS, FIAOMT Vol#: 10

EMC 515 Pamela Cannon Vol#: 10

EMC 516 David G. Stahley Vol#: 10

EMC 517 Pat King Vol#: 10

EMC 518 Dr. and Mrs. Terry J. Lee Vol#: 10

EMC 519 Mary Ann Newell Vol#: 10

EMC 520 Eva Isacsson Vol#: 10

EMC 521 Eva Isacsson Vol#: 10

EMC 522 Marjorie H. Monteleon Vol#: 10

EMC 523 Marjorie H. Monteleon Vol#: 10

EMC 524 Connie Barnes Vol#: 10

EMC 525 James Guy Vol#: 10

EMC 526 Paul Lamon Vol#: 10

EMC 527 James D. Guy, Jr. Vol#: 10

EMC 528 Bob Finger Vol#: 10

EMC 529 Walter R. Schumm, PhD Vol#: 10

EMC 530 Anne O. Summers, PhD Vol#: 10

EMC 531 Consumers for Dental Choice Vol#: 10

EMC 532 American Academy of Biological Dentistry Vol#: 10

EMC 533 Lynne Campbell Vol#: 10

01P-0119 Reclass. Cyclosporine Diagnostic Test Devices from Class III

NFR 1 Vol#: 1

01P-0120 Ban Unsafe IV Catheters and other Devices

C 9 American Health Care Assn (AHCA) Vol#: 1

C 10 Dean Allgeyer, MD Vol#: 1

C 11 University of Iowa Hospitals and Clincs Vol#: 1

C 12 HemaMetrics Vol#: 1

C 13 American Academy of Pediatrics Vol#: 1

C 14 Premier, Inc. Vol#: 1

C 15 Canadian Intravenous Nurses Assn (NAPPSI Vol#: 1

C 16 Cook Inc Vol#: 1

C 17 ICU Medical, Inc. Vol#: 1

C 18 Cook, Inc. Vol#: 1

LET 2 HFZ-1 to Pblic Citizen's Health Research Vol#: 1

RPT 1 Ahrens Balwit & Associates,Inc. Vol#: 1

01P-0235 Reclassification of Cyclosporine Immunoassay

NFR 1 Vol#: 2

02D-0028 Cyclosporine & Tacrolimus Assays

GDL 2 Guidance for Industry and FDA Vol#: 1

NAD 2 Vol#: 1

02N-0109 Disemination information unapproved/new use for marketed dru

N 2 Vol#: 1

02N-0114 Reclassification of Root-form Endosseous Dental Implants

C 2 DENTSPLY International Vol#: 1

02N-0123 Food Canning Establishment Registration, Process Filling

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1

02N-0204 Bar Code Label Requirements for human drug products

C 19 GasRegs, Inc. Vol#: 6

02N-0209 Governing First Amendment Case Law

C 65 Congress of the United States Vol#: 16

C 66 BIO, Biotechnology Industry Organization Vol#: 16

C 67 CHPA, Consumer Healthcare Prods. Assn. Vol#: 16

C 68 CPR, National Ctr. for Policy Res. for W Vol#: 16

C 69 ANA, Assn. of National Advertisers, Inc. Vol#: 16

C 70 Abbott Laboratories Vol#: 16

C 71 Virginia Tech-Alexandria Vol#: 16

C 72 National Women's Health Network Vol#: 16

C 73 Freedom to Advertise Coalition Vol#: 18

C 74 Dorothy Dusek Vol#: 19

C 75 Congress of the United States Vol#: 19

EMC 148 Rhett Lawrence Vol#: 9

EMC 149 Martin, Jane & Clayton Kilmer Vol#: 9

EMC 150 Linda Patton Vol#: 9

EMC 151 Elsie Bagley Vol#: 9

EMC 152 David Rogers Vol#: 9

EMC 153 Wilderness Conservation Associate,OSPIRG Vol#: 9

EMC 154 Raymond Rowe Vol#: 9

EMC 155 Survive AIDS Vol#: 9

EMC 156 number not used Vol#: 9

EMC 157 W P Vol#: 9

EMC 158 Pure Encapsulations, Inc. et al Vol#: 20

SUP 1 AARP Vol#: 17

Page updated April 5, 2004 jb

02P-0349 Amend product insert and/or label for Hemophilus Vaccines

SUP 2 Clasen Immunotherapies, Inc. Vol#: 1

02P-0416 Highland VetPharma ANADA dosage form which differs from ANAD

ACK 1 HFA-305 Vol#: 1

CP 1 Shotwell & Carr, Inc. Vol#: 1