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 December 11, 2001

TABLE OF CONTENTS

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97N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood *
97P-0078 Recognized the Term "Soymilk" as the Established Common of U *
99P-1864 Reclassify Constrained Hip Prosthesis Metal/Polymer *
99P-2148 Label or Labeling of food ingredients and regulation *
99P-5198 Request amendment of the definition of milk *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
01D-0368 Submitting Marketing Applications according to ICH/CTD Forma *
01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm *
01N-0196 Phenylpropanolamine proposal to withdraw approval of NDA *
01N-0397 Transportation Safety & Potentially Sedating or Impairing *
01N-0450 Prescription Drug User Fee Act (PDUFA) *
01N-0464 Vaccine Adverse Event Reporting System *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
01P-0323 Not rely on non-public filings to approve an innovator NDA; *
01P-0443 Estrogen & progestin drug info available to the public is "M *
01P-0549 Determination of Nitroglycerin Aerosol (sublingual) *
01P-0560 Refrain Approval of Any Buprenorphine Product *

97N-0497 Allogeneic Peripheral and Placental/ Umbilical Cord Blood

C 15 American Association of Blood Banks Vol#: 4

97P-0078 Recognized the Term "Soymilk" as the Established Common of U

ANS 1 HFW-14 to Honorable Harry M. reid Vol#: 1

99P-1864 Reclassify Constrained Hip Prosthesis Metal/Polymer

C 2 Heller Ehrman White & McAuliffe, LLP Vol#: 3

C 3 American Academy of Orthopaedic Surgeons Vol#: 3

99P-2148 Label or Labeling of food ingredients and regulation

ANS 2 HFS-800 to Ms. Fran Stevens Vol#: 1

99P-5198 Request amendment of the definition of milk

C 4 David Lauer Vol#: 1

00D-1538 Electronic Records; Electronic Signatures, Validation

C 3 Genzyme Corporation Vol#: 5

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9176 Caitlin Bidinger Vol#: 401

C 9177 Aaron Infante-Levy Vol#: 401

00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz

C 29 David Lauer Vol#: 2

01D-0368 Submitting Marketing Applications according to ICH/CTD Forma

C 7 Hecker & Associates Vol#: 1

01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm

C 1 George Washington University Vol#: 1

01H-0065 Civil Money Penalty for First Check Home Drug Test Devices

MO 11 Worldwide Medical Corporation Vol#: 1

01N-0196 Phenylpropanolamine proposal to withdraw approval of NDA

C 10 Bayer Corporation Vol#: 1

01N-0397 Transportation Safety & Potentially Sedating or Impairing

C 6 Center for Disease Control & Prevention Vol#: 2

01N-0450 Prescription Drug User Fee Act (PDUFA)

APE 1 General Accounting Office Vol#: 2

APE 2 Patton Boggs, LLP Vol#: 2

APE 3 Vince Ventimiglia Vol#: 2

APE 4 Pharmaceutical Executive Magazine Vol#: 2

APE 5 National Breast Cancer Coalition Vol#: 2

APE 6 Children's Cause, Inc. Vol#: 2

APE 7 A.G. Edwards & Sons, Inc. Vol#: 2

APE 8 McNeil Consumer & Specialty Pharm Vol#: 2

APE 9 AstraZeneca Co. Vol#: 2

APE 10 Ovarian Cancer National Alliance Vol#: 2

APE 11 Video On Location, Inc. Vol#: 2

APE 12 Merck Research Laboratories Vol#: 2

APE 13 National Assn of Health Underwriters Vol#: 2

APE 14 Baxter Healthcare Vol#: 2

APE 15 BNA Health Care Policy Report Vol#: 2

APE 16 American Medical Assn Vol#: 2

APE 17 Washington Health Advocates Vol#: 2

APE 18 Philadelphia Distric Office Vol#: 2

APE 19 Bristol-Myers Squibb Vol#: 2

APE 20 Pharmaceutical Executive Magazine Vol#: 2

APE 21 FDA Vol#: 2

APE 22 BioCentury Publications Vol#: 2

APE 23 Gregory K. Frykman Vol#: 2

APE 24 Sigma-tau Research, Inc. Vol#: 2

APE 25 Patton Boggs, LLP Vol#: 2

APE 26 Johnson & Johnson Vol#: 2

APE 27 Tony Martin Vol#: 2

APE 28 Eli Lilly and Company Vol#: 2

LST 2 Vol#: 2

LST 3 Agenda for PDUFA Public Meeting 12/7/01 Vol#: 2

LST 4 PDUFA Registration for 12/7/01 meeting Vol#: 2

LST 5 PDUFA On-Site Registration 12/07/01 mtg Vol#: 2

TS 1 FDA Vol#: 2

TS 2 FDA Vol#: 2

TS 3 BlueCross BlueShield Assn Vol#: 2

TS 4 Biotechnology Industry Organization Vol#: 2

TS 5 Consumer Federation of America Vol#: 2

TS 6 National Organization for Rare Disorders Vol#: 2

TS 7 American Pharmaceutical Assn Vol#: 2

TS 8 National Center for Policy Research for Vol#: 2

TS 9 Academy of Managed Care Pharmacy Vol#: 2

TS 10 UAW Vol#: 2

TS 11 Tufts University Vol#: 2

TS 12 RxHealth Value Vol#: 2

TS 13 National Women's Health Network Vol#: 2

01N-0464 Vaccine Adverse Event Reporting System

C 1 Missouri Department of Health and Senior Vol#: 1

01N-0496 Patient Profile Viewer

N 1 Vol#: 1

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

LET 3 HFD-560 to David A. Grimes, M.D. Vol#: 10

01P-0323 Not rely on non-public filings to approve an innovator NDA;

C 1 Generic Pharmaceutical Assn Vol#: 1

01P-0443 Estrogen & progestin drug info available to the public is "M

PDN 1 HFD-001 to Gail Elbek Vol#: 1

01P-0549 Determination of Nitroglycerin Aerosol (sublingual)

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultant Services, Inc. Vol#: 1

01P-0560 Refrain Approval of Any Buprenorphine Product

ACK 1 HFA-305 Vol#: 1

CP 1 Hogan & Hartson, LLP Vol#: 1

01V-0457 XiScan Model 6000 diagnostic X-Ray System

VRA 1 HFZ-300 to XiTech, Inc. Vol#: 1