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DOCKETS ENTERED on July 2, 2002

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75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
81N-0033 Oral Health Care Drug Products for OTC Human Use *
97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection) *
99N-2079 Assessment of Preclinical Reproductive Toxicity Data *
99P-5332 Amend limit Hydrogenated & partially Hydrogenated Menhaden O *
01N-0322 Institutional Review Boards *
01P-0495 Determine Ultram's safety or effectiveness reasons *
02D-0096 Nucleic Acid Tests on Samples from Blood Donors to Reduce Ri *
02N-0101 Amfepramone(diethylpropion) Amineptine; Burprenorphine *
02N-0131 Generic FDA Rapid Response Surveys;Information Collection Ac *
02N-0152 Obtain Timely Pediatric Studies & Adequate Pediatric Labelin *
02P-0191 Request for immediate final approval of tramadol Hydrochlori *
02P-0252 Seek immediate final approval of generic tramadol hydrochlor *

75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

LET 25 HFD-001 to Intnat'l Lab Technology Corp Vol#: 60

LET 26 HFD-001 to Woodward Laboratories, Inc. Vol#: 60

LET 27 HFD-001 to CFTA Vol#: 60

LET 28 HFD-001 to CFTA Vol#: 60

76P-0500 Frozen Desserts

C 453 J. Luther Snyder Vol#: 6

80N-0042 Anticaries Drug Products for OTC Human Use

LET 51 Pfizer, Inc. Vol#: 36

81N-0033 Oral Health Care Drug Products for OTC Human Use

LET 54 Pfizer, Inc. Vol#: 70

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 603 HFS-810 to Herbmax Inc Vol#: 17

LET 604 HFS-810 to Sweet Aloha Farms Vol#: 17

LET 605 HFS-810 to Colin Worldwide Corporation Vol#: 17

LET 606 HFS-810 to M K Health Food Distributor's Vol#: 17

LET 607 HFS-810 to Shanti Herbs Vol#: 17

LET 608 HFS-810 to Infinity2, Inc. Vol#: 17

LET 609 HFS-810 to Maxluck Biotechnology Corpora Vol#: 17

98N-0359 Program priorities/Center for Food Safety & Applied Nutritin

N 4 Vol#: 7

99N-2079 Assessment of Preclinical Reproductive Toxicity Data

C 14 Schering-Plough Research Inst. Vol#: 3

99P-5332 Amend limit Hydrogenated & partially Hydrogenated Menhaden O

SUP 3 National Fish Meal & Oil Assn Vol#: 1

01E-0363 Patent Term Extension Application, MIFEPREX No. 4,386,085

LET 6 Population Council Vol#: 1

LET 7 Concept Therapeutics, Inc. Vol#: 1

01N-0322 Institutional Review Boards

C 27 Med-Tox Group Vol#: 1

01P-0495 Determine Ultram's safety or effectiveness reasons

ACK 2 HFA-305 Vol#: 2

PRC 1 Ortho-McNeil Vol#: 2

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

C 3 Stanford Medical School Vol#: 1

02M-0235 PMA IntraCoil Self-expanding Peripheral Stent, P000033

AAV 1 Sulzer IntraTherapeutics Inc Vol#: 1

02M-0250 PMA LAP-Band Adjustable Gastric Banding (LAGB) System

AAV 1 BioEnterics Corporation Vol#: 1

02M-0255 PMA On-X Prosthetic Heart Valve, Models ONXM & ONXMC

AAV 1 Medical Carbon Research Institute LLC Vol#: 1

02N-0101 Amfepramone(diethylpropion) Amineptine; Burprenorphine

LET 2 HFD-009 Vol#: 1

02N-0102 Notification of a health claim based Authoritative Statement

N 2 Vol#: 1

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

C 2 GlaxoSmithKline Vol#: 1

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

C 3 Kathleen Graham Lomax, MD, FAAP Vol#: 1

C 4 David Center for Children's Vol#: 1

C 5 University of Florida Vol#: 1

C 6 William B. Weil, MD Vol#: 1

C 7 Louis Trachtman, MD Vol#: 1

C 8 University of Minnesota Vol#: 1

C 9 Wake Forest University Baptist Medical c Vol#: 1

C 10 University of Chicago Children's Hospita Vol#: 1

C 11 Children's Mercy Hospitals & Clinics Vol#: 1

C 12 Randy A. Hock, MD, PhD Vol#: 1

C 13 Indiana University Vol#: 1

C 14 Peter Dawson, MD, MPH Vol#: 1

C 15 Michael J. Coogan, MD, FAAP Vol#: 1

C 16 Bruce P. Meyer, MD Vol#: 1

C 17 Douglas K. Mitchell, MD Vol#: 1

C 18 Penobscot Pediatrics, P.A. Vol#: 1

C 19 Advanced Pediatrics Vol#: 1

02P-0191 Request for immediate final approval of tramadol Hydrochlori

ACK 2 HFA-305 Vol#: 1

PRC 1 Ortho-McNeil Vol#: 1

02P-0252 Seek immediate final approval of generic tramadol hydrochlor

ACK 2 HFA-305 Vol#: 1

PRC 1 Ortho-McNeil Vol#: 1

02V-0304 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Valentino Vol#: 1