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 13, 2001

TABLE OF CONTENTS

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99P-1864 Reclassify Constrained Hip Prosthesis Metal/Polymer *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
01D-0475 Providing Regulatory Submissions in Electronic Format-ANDA's *
01D-0532 Food Code; 2001 Revision *
01N-0450 Prescription Drug User Fee Act (PDUFA) *
01N-0464 Vaccine Adverse Event Reporting System *
01N-0496 Patient Profile Viewer *

77N-0085 Saccharin and Its Salts

CA 25960 Number Not Used Vol#: 487

99P-1864 Reclassify Constrained Hip Prosthesis Metal/Polymer

EC 1 Heller Ehrman White & McAuliffe Vol#: 3

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9617 Phyllis Hallenbeck Vol#: 476

C 9618 Caitlin Bidinger Vol#: 476

C 9619 Aaron Infante-Levy Vol#: 476

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 12528 Elizabeth Hough Vol#: 773

C 12529 Karen Crowley Vol#: 773

C 12530 Lynda Roscoe Hartigan Vol#: 773

C 12531 Ann M OBrien Vol#: 773

C 12532 Malcolm Kenton Vol#: 773

C 12533 Mickey Woodcock Vol#: 773

C 12534 Dr M Warner Vol#: 773

C 12535 Marilyn Forman Vol#: 773

C 12536 Homer S White Vol#: 773

C 12537 Glenndle Myrick Vol#: 773

C 12538 Scott Mullen Vol#: 773

C 12539 Gary Van Warnsbeke Vol#: 773

C 12540 Lindsey Tuommen Vol#: 773

C 12541 Alyssa Herr Vol#: 773

C 12542 Karen Prentice Vol#: 773

C 12543 Karen M Klaczak Vol#: 773

C 12544 Anita Roll Vol#: 773

C 12545 Dr Peggy Green Vol#: 773

C 12546 Khary Simon Vol#: 773

C 12547 Laurel Licktiig Vol#: 773

C 12548 Rosemary Eller Vol#: 773

C 12549 Brenda Cramer Vol#: 773

C 12550 Mrs. V Rivers Vol#: 773

C 12551 Monroe Richards Vol#: 773

C 12552 Dr Nicole Cherok Vol#: 773

C 12553 Brenda Cramer Vol#: 773

C 12554 Mrs J Gordon Vol#: 773

C 12555 Mrs J Gordon Vol#: 773

C 12556 Joseph Mendelson III Vol#: 773

C 12557 Harold Parker Vol#: 773

C 12558 Shirley Davis Vol#: 773

C 12559 Robert Roethig Vol#: 773

C 12560 Joseph Mendelson III Vol#: 773

C 12561 Megan Smith Vol#: 773

C 12562 Natalie Roark Vol#: 773

C 12563 Tanya Bono Haro Vol#: 773

C 12564 Tabitha Solomon Vol#: 773

C 12565 Form Letter Count 805 Vol#: 8048

01D-0475 Providing Regulatory Submissions in Electronic Format-ANDA's

EC 1 Coltene/Whaledent Inc. Vol#: 1

01D-0532 Food Code; 2001 Revision

EC 1 Palm Beach County Health Department Vol#: 1

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

CS 9 HFA-305 Vol#: 1

OR 8 HF-3 Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

EC 206 Neuropathy Association Vol#: 4

EC 207 Mr. Richard Jones Vol#: 4

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

EC 5 The Annie Appleseed Project Vol#: 2

TR 1 Transcript of 12/7/01 meeting Vol#: 3

01N-0464 Vaccine Adverse Event Reporting System

EC 4 North Carolina Immunization Branch Vol#: 1

EC 5 Walter Reed Regional Vaccine Healthcare Vol#: 1

01N-0496 Patient Profile Viewer

EC 1 Berlex Laboratories Vol#: 1