Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on July 8, 2002

TABLE OF CONTENTS

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00D-1542 Electronic Signatures: Time Stamps *
01P-0350 Determine whether Sotradecol has been withdrawn from sale in *
01P-0549 Determination of Nitroglycerin Aerosol (sublingual) *
02D-0096 Nucleic Acid Tests on Samples from Blood Donors to Reduce Ri *
02N-0131 Generic FDA Rapid Response Surveys;Information Collection Ac *
02N-0152 Obtain Timely Pediatric Studies & Adequate Pediatric Labelin *
02N-0159 Focus Groups as used by the Food and Drug Administration *
02N-0204 Bar Code Label Requirements for human drug products *
02N-0209 Governing First Amendment Case Law *
02N-0215 Export Certificates *
02P-0013 Rescind GRAS Status for Aluminum-containing Food Additives *
02P-0043 Determine Pipracil Was Withdrawn For Safety Reasons *
02P-0170 ANDAs relaying Premax as reference listed drug not be appove *

76P-0500 Frozen Desserts

OB 543 Mrs. Martin T. Hullah Vol#: 14

OB 681 Chris V. Vol#: 15

WDL 1 Robert H. Harich, Jr. for Phil Bradley Vol#: 14

95V-0231 Laser Light Show

VRA 6 HFZ-300 to Production Design Intl., Inc. Vol#: 1

97V-0470 Lazer Light Show

VRA 2 HFZ-300 to Lazer Onyx Vol#: 1

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 5839 Judi I. Pulver Vol#: 241

C 5840 Diane M. Green Vol#: 241

C 5841 Laura Carver Vol#: 241

C 5842 Janice Emich Vol#: 241

C 5843 Weona Cleveland Vol#: 241

C 5844 Elizabeth Gingery Vol#: 241

C 5845 Janie Peto Vol#: 241

99D-1454 Nasal spray, inhalation solution, suspension&spray drug prod

GDL 2 GUIDANCE Vol#: 2

NAD 2 Vol#: 2

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 3501 Ms. Eva Altman Vol#: 21

C 3502 Paul Iannicelli Vol#: 212

C 3503 Elizabeth M. Read Vol#: 212

C 3504 Walter Z. & Wiltrud K. Miller Vol#: 212

00D-1542 Electronic Signatures: Time Stamps

C 9 GlaxoSmithKline Vol#: 6

00E-1347 Patent Extension AVELOX

EC 1 Number Not Used Vol#: 1

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

EMC 37 Anne Cecil Vol#: 78

00P-1322 Food Labeling and Allergen Contamination Control

EMC 488 Marie Waters Vol#: 20

EMC 489 Maureen Finsis Vol#: 20

01P-0350 Determine whether Sotradecol has been withdrawn from sale in

LET 2 HFD-1 to Omega Laboratories, Ltd Vol#: 1

01P-0549 Determination of Nitroglycerin Aerosol (sublingual)

LET 1 HFD-1 to Lachman Consultant Services, Vol#: 1

02D-0096 Nucleic Acid Tests on Samples from Blood Donors to Reduce Ri

C 4 New York Blood Center Vol#: 1

02N-0131 Generic FDA Rapid Response Surveys;Information Collection Ac

EC 2 National Association of Chain Drug Store Vol#: 1

02N-0152 Obtain Timely Pediatric Studies & Adequate Pediatric Labelin

C 25 University of Michigan Vol#: 1

C 26 Mercy Medical Group Vol#: 1

C 27 Baylor College of Medicine Vol#: 1

C 28 Ohio State Univeristy Vol#: 1

C 29 University of Florida Vol#: 1

C 30 University of Florida Vol#: 1

C 31 Health Sciences Center Vol#: 1

C 32 West Virginia University Vol#: 1

C 33 Children's Hospital of Philadelphia Vol#: 1

C 34 Cumberland Pediatric Foundation Vol#: 1

C 35 Children's Physicians Vol#: 1

C 36 University of Utah Vol#: 1

C 37 Schneider Children's Hospital Vol#: 1

C 38 Diane R. Edwards, M.D. Vol#: 1

C 39 Robert Wood Johson Medical School Vol#: 1

C 40 Society for Adolescent Medicine Vol#: 1

C 41 University of North Carolina Vol#: 1

C 42 Texas Children's Hospital Vol#: 1

C 43 Baylor College of Medicine Vol#: 1

C 44 University of Tennessee Vol#: 1

C 45 University of Rochester Vol#: 1

C 46 Strong Memorial Hospital Vol#: 1

C 47 Gerald S. Gilchrist, M.D., FAAP Vol#: 1

C 48 Saint Barnabas Medical Center Vol#: 1

C 49 Graham Children's Health Center Vol#: 1

C 50 James T. Christian, M.D. Vol#: 1

C 51 Children's Hospital of The King's Daught Vol#: 1

C 52 Hackensack University Medical Center Vol#: 1

C 53 American Pediatric Society Vol#: 1

C 54 Children's National Medical Center Vol#: 1

C 55 Hasbro Children's Hospital Vol#: 1

C 56 Texas Children's Health Plan, Inc. Vol#: 1

C 57 No signature Vol#: 1

C 58 American Academy of Pediatrics Vol#: 1

C 59 The Children's Cause Vol#: 1

C 60 Duke University Medical Center Vol#: 1

C 61 PhRMA Vol#: 1

C 62 Assn of American Physicians & Surgeons, Vol#: 2

EC 32 Maine Medical Center Vol#: 1

EC 33 American Academy of Pediatrics Vol#: 1

EC 34 University of Michigan Vol#: 1

EC 35 Albany Medical College Vol#: 1

EC 36 Dr. Regino Gonzalez-Peralta Vol#: 1

EC 37 Johns Hopkins Community Physicians Vol#: 1

EC 38 Dr. Laura Gibson Vol#: 1

EC 39 Dept. of Pediatrics, Univ of Kentucky Vol#: 1

EC 40 Group Health Permanente Vol#: 1

EC 41 Highlands Pediatrics Vol#: 1

EC 42 Clara Vista Medical Associates Vol#: 1

EC 43 Ms. Kristin Butterfield Vol#: 1

EC 44 Tulane University School of Medicine Vol#: 1

EC 45 Indiana University Vol#: 1

EC 46 Tulane University Health Sciences Center Vol#: 1

EC 47 University of Wisconsin's Children's Hos Vol#: 1

EC 48 Vanderbilt Vol#: 1

EC 49 Vanderbilt University Vol#: 1

EC 50 American Academy of Pediatrics Vol#: 1

EC 51 Eclipsys Corporation Vol#: 1

EC 52 Elizabeth Glaser Pediatric AIDS Foundati Vol#: 1

EC 53 Private Citizen Vol#: 1

EC 54 Pediatric Nephrology University of Kentu Vol#: 1

02N-0159 Focus Groups as used by the Food and Drug Administration

EC 3 az Vol#: 1

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

C 2 Aventis Pharmaceuticals Inc. Vol#: 1

EC 1 NRITLD Vol#: 1

02N-0209 Governing First Amendment Case Law

EC 144 Dr. David Laurentz Vol#: 2

EXT 5 American Feed Industry Assn Vol#: 2

02N-0215 Export Certificates

EC 2 AAP District 3 Resident Coordinator Vol#: 1

02N-0253 Withdrawal of 53 Guidances on Individual Product Labeling

NWL 1 Vol#: 1

02P-0013 Rescind GRAS Status for Aluminum-containing Food Additives

C 4 Alcoa Vol#: 1

02P-0043 Determine Pipracil Was Withdrawn For Safety Reasons

LET 1 HFD-7 to Michael Lisjak Vol#: 1

02P-0170 ANDAs relaying Premax as reference listed drug not be appove

SUP 1 Amarin Pharmaceuticals, Inc. Vol#: 1

02V-0214 Laser Light Show

VRA 1 HFZ-300 to Andrus Laser Research Vol#: 1

02V-0221

VRA 1 HFZ-300 to Mississippi Band of Choctaw I Vol#: 1

02V-0230 Laser Light Show, Laser Fantasy International-Rainbow I Proj

VRA 1 HFZ-300 to Montgomery County Memorial Ha Vol#: 1

02V-0286 Laser light show

VRA 1 HFZ-300 to Adams Audio Labs. Laser Div. Vol#: 1