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 November 7, 2000

TABLE OF CONTENTS

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95S-0117 Human Drugs Patent Term Extension & New Patents *
95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
97P-0329 Require Quantitative Labeling of Caffeine Content *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
00D-1392 Guidance for Industry on Botanical Drug Products *
00N-0930 Nominations for Working Groups: Pharmaceutical Science AC *
00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair *
00N-1399 Presubmission Conferences *
00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz *
00P-1276 Health Claim: Plant stanol esters and heart disease *
00P-1607 Revoke Implantation of Silicone Gel-Filled Breast Implants *

95S-0117 Human Drugs Patent Term Extension & New Patents

LST 57 List as of October 31, 2000 Vol#: 4

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients

RPT 81 Roche Vitamins Inc Vol#: 55

97P-0329 Require Quantitative Labeling of Caffeine Content

C 240 Alicia Lopez Vol#: 4

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

C 2544 Jerome Glassman Vol#: 78

C 2545 Sally Triggs Vol#: 78

C 2546 Virginia L. Dekker Vol#: 78

C 2547 Liane Rainer Vol#: 78

C 2548 Mr. Booth K. Bender Vol#: 78

C 2549 Beth Brozle Vol#: 78

C 2550 Billie Ralston Vol#: 78

C 2551 no signature Vol#: 78

C 2552 D. Smith Vol#: 78

C 2553 Barbara Eisenberg Vol#: 78

C 2554 Yvette G. Schueler Vol#: 78

C 2555 Darren Edwards Vol#: 78

C 2556 Kimberly DeWees Vol#: 78

C 2557 Kathy M. Dye Vol#: 78

C 2558 Mr. & Mrs. Ed Mettler Vol#: 78

C 2559 Thomas P. Verlin Vol#: 78

C 2560 Cathy Morris Vol#: 78

C 2561 Mary Jo Brooks Vol#: 78

C 2562 Elizabeth Muellers Vol#: 78

C 2563 Nancy Baumgardner Vol#: 78

C 2564 Damon R. Phillips Vol#: 79

EMC 197 Raven Vol#: 78

EMC 198 Mrs. E. Rossman Vol#: 78

EMC 199 Jessica Peterson Vol#: 78

EMC 200 Julie Bond Vol#: 78

EMC 201 Katrina Ferrell Lee Vol#: 78

EMC 202 Carole A. Daniels Vol#: 78

EMC 203 Rufus Storm Vol#: 78

EMC 204 Nancy L. Gowani Vol#: 78

EMC 205 Sid Shapiro & Linda Kelson Vol#: 78

EMC 206 Darren & Kristi Brown Vol#: 78

EMC 207 Mrs. Barbara Hybner Vol#: 78

EMC 208 Prof. Gale Edgerton Vol#: 78

EMC 209 Peggy Swain Vol#: 78

EMC 210 Michael W. Terry Vol#: 78

EMC 211 Pat Williams Vol#: 78

EMC 212 Valerie Howell Vol#: 78

EMC 213 Michael & Michele Zezima Vol#: 78

EMC 214 Patricia McCurdy Vol#: 78

EMC 215 Laura & Myles Corey Vol#: 78

EMC 216 Abigail S. Boxman Vol#: 78

EMC 217 Barb Watts Vol#: 78

EMC 218 Kristi Dunkle Vol#: 78

EMC 219 Jennifer Hillman Vol#: 78

EMC 220 Jennifer A. Goolsby Vol#: 78

EMC 221 Colette Dupont Vol#: 78

EMC 222 J. Lissauer Vol#: 78

EMC 223 Judith Tobin Vol#: 78

EMC 224 Merna Bishop Vol#: 78

EMC 225 Geoffrey E. Doman Vol#: 78

EMC 226 Joe Sacchi Vol#: 78

EMC 227 Kristine MacDonald Vol#: 78

EMC 228 Carol Lipper Vol#: 78

EMC 229 Anne McAuliffe Vol#: 78

EMC 230 Jennifer LaRocque Vol#: 78

EMC 231 Donald Shaw Vol#: 78

EMC 232 Patricia McM. Reber Vol#: 78

EMC 233 L. Booker Vol#: 78

EMC 234 Wanda J. Cole Vol#: 78

EMC 235 Harry Nutting Vol#: 78

EMC 236 Pam Borres & Jay Christianson Vol#: 78

99H-1032 Civil Money Penalties;Bert Malone,d/b/a Lazy Lee's One Stop

LET 7 Lazy Lee's One Stop Inc. Vol#: 2

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

C 15973 Flora E. Dooley Vol#: 467

C 15974 Doris P. Jones Vol#: 467

C 15975 Frank Allen Vol#: 467

C 15976 Cindy Kay Morgan Vol#: 467

C 15977 Martha W. MacLaren Vol#: 467

C 15978 Ruby M. Pettitt Vol#: 467

C 15979 Janet H. Heer Vol#: 467

C 15980 Liesel Orend & Jan Sultan Vol#: 467

C 15981 Rob Birmingham Vol#: 467

C 15982 A. Joyce Zabka Vol#: 467

C 15983 Mark Schwartz Vol#: 467

C 15984 Patricia S. Springer Vol#: 467

C 15985 Mrs. Margaret Childers Vol#: 467

C 15986 Christina Layman Vol#: 467

C 15987 Noel Logan Vol#: 467

C 15988 Hiyian Caprar Vol#: 467

C 15989 Rebecca Lee Finster Vol#: 467

C 15990 Shauna Scott Vol#: 467

C 15991 Pat Gstalder Vol#: 467

C 15992 Dora E. Stroops Vol#: 467

C 15993 Mark & Betty J. Schmidt Vol#: 467

C 15994 Helena Kotary Vol#: 467

C 15995 Georgene F. Meyer Vol#: 467

C 15996 Robert C. Russell Vol#: 467

C 15997 Carmella P. Payne Vol#: 474

C 15998 Dawn E. Shultz Vol#: 474

C 15999 Tammy Broyles Vol#: 474

C 16000 Cynthia A. Hunter Vol#: 474

C 16001 Jennifer L. Broyles Vol#: 474

C 16002 Taffy Pearson Vol#: 474

C 16003 Mande Pool Vol#: 474

C 16004 Rebecca D. Payne Vol#: 474

C 16005 Barbara Keman Vol#: 474

C 16006 Dianna DeLong Vol#: 474

C 16007 George A. Soroka Vol#: 474

C 16008 Rick & Jamie Casolar Vol#: 474

C 16009 Mrs. Rosemary L. Conn Vol#: 474

C 16010 Karyn White Vol#: 474

C 16011 Frances Sullentrop Vol#: 474

C 16012 Joan L. Mathews Vol#: 474

C 16013 Troy Shinn Vol#: 474

C 16014 Judith Skovlin Vol#: 474

C 16015 Teresa Thompson Vol#: 474

C 16016 Susan Sielbenmorgen Vol#: 474

C 16017 Christine Lessifore Vol#: 474

C 16018 Hans H. Stahl Vol#: 474

C 16019 Richard R. Rossi Vol#: 474

C 16020 Ann Anthony Vol#: 474

C 16021 James L. Word Vol#: 474

C 16022 Ms. Marianne Bourke Vol#: 474

C 16023 Kristi Apperson Vol#: 474

C 16024 Jennifer Page & David McDonald Vol#: 474

C 16025 Lee & Susan Tyler Vol#: 474

C 16026 Armandine F. Kelly Vol#: 474

C 16027 Joseph J. Horton Vol#: 474

C 16028 Michele & Dan Zboralski Vol#: 474

C 16029 Eugene & Elizabeth Schweitzer Vol#: 474

C 16030 Robin Dan Vol#: 474

C 16031 Mary E. Hull Vol#: 474

C 16032 Curtis M. Smith Vol#: 474

C 16033 Janet Brinkman Vol#: 474

C 16034 Mrs. Helen Wakefield Vol#: 474

C 16035 Jan Robinson Vol#: 474

C 16036 Mrs. Carroll J. Lemas Vol#: 474

C 16037 Marsha L. Scott Vol#: 474

C 16038 Rachel Marie Burton Vol#: 474

C 16039 James & Theres Coombs Vol#: 474

C 16040 Deborah Weiss Vol#: 474

C 16041 Jacqueline Lynch Vol#: 474

C 16042 Virginia Mohler Vol#: 474

C 16043 Lee M. Jones Vol#: 474

C 16044 I. J. Barrett Vol#: 474

C 16045 Sharon Wehmeier Vol#: 474

C 16046 Tracy DeRusha Vol#: 474

C 16047 John E. Carroll Vol#: 474

C 16048 Kay E. Mahaffey Vol#: 474

C 16049 Frances E. Cooper Vol#: 474

C 16050 George Keller Vol#: 474

C 16051 Ms. Peggy G. Wagner Vol#: 474

C 16052 Pamela A. Lamparella Vol#: 474

C 16053 Peter Staniewicz Vol#: 474

C 16054 Robert & Dale Kelly Vol#: 474

C 16055 Ms. Bernadette J. Sumen Vol#: 474

C 16056 Kathy Otten Vol#: 474

C 16057 Elena Gomez Vol#: 474

C 16058 Walter L. Rutledge Vol#: 474

C 16059 Shirley Kainey Vol#: 474

C 16060 Rhonda Resnick Vol#: 474

C 16061 Frances K. Mazvrek Vol#: 474

C 16062 Robert & Nella Ebert Vol#: 474

C 16063 Peggy W. Denton Vol#: 474

C 16064 Ruby L. Puckett Vol#: 474

C 16065 Michele Hanrahan Vol#: 474

C 16066 Mr. E. H. Dunbar Vol#: 474

C 16067 Claude VanderVeen Vol#: 474

C 16068 Georgia M. Walker Vol#: 474

C 16069 Lorlie Esterly Vol#: 474

C 16070 Betty Orner Vol#: 474

C 16071 Marion I. Fischbach Vol#: 474

C 16072 Yvonne LeFever/Albert Zuppo Vol#: 474

C 16073 Eugene P. Feury Vol#: 474

EMC 3268 Test Vol#: 474

EMC 3269 Jennifer R. Stock Vol#: 474

EMC 3270 Teri Zuckerman Vol#: 474

EMC 3271 Kathleen A. Bohde Vol#: 474

EMC 3272 Rainer Hildenbrand Vol#: 474

EMC 3273 Joe Melanese Vol#: 474

EMC 3274 Terren Suydam Vol#: 474

EMC 3275 Sal Quartuccio Vol#: 474

EMC 3276 Adam Kriney Vol#: 474

EMC 3277 Jane Gerald Vol#: 474

EMC 3278 Claudia Morris Vol#: 474

EMC 3279 Debbie Dunbar Ortman Vol#: 474

EMC 3280 Scott James Vol#: 474

EMC 3281 Elizabeth Cottle Vol#: 475

EMC 3282 Sean Bradway Vol#: 475

EMC 3283 Maryann B. Kane Vol#: 475

00D-1392 Guidance for Industry on Botanical Drug Products

C 22 State Drug Administration, China Vol#: 2

00E-1608 Patent Extension for Minimed 2007, No. 4,373,527

APP 1 Johns Hopkins Univerity Vol#: 1

LET 1 US Dept of Commerce, Patent & Trademark Vol#: 1

00N-0930 Nominations for Working Groups: Pharmaceutical Science AC

NOM 1 NCTR Vol#: 2

NOM 2 American Heart Association Vol#: 2

NOM 3 American Association of Immunologists Vol#: 2

NOM 4 Bioscience Products, Agilent Technologie Vol#: 2

NOM 5 Natl Institute of Environmental Hlth Sci Vol#: 2

NOM 6 Schering-Plough Research Institute Vol#: 2

NOM 7 Schering-Plough Research Institute Vol#: 2

NOM 8 CDER Vol#: 2

NOM 9 University of Minnesota Vol#: 2

NOM 10 Glaxo Wellcome Vol#: 2

NOM 11 Abbott Laboratoires Vol#: 2

NOM 12 Pfizer Global Research & Development Vol#: 2

NOM 13 Pfizer Global Research & Development Vol#: 2

NOM 14 Boehringer Ingelheim Pharmaceuticals Inc Vol#: 2

NOM 15 CDER Vol#: 3

NOM 16 Eugene Herman Vol#: 3

NOM 17 NCTR Vol#: 3

NOM 18 Internat'l Soc for the Study of Xenobiot Vol#: 3

NOM 19 Glaxo Wellcome Inc Vol#: 3

NOM 20 Glaxo Wellcome Inc Vol#: 3

NOM 21 Abbott Pharmaceutical Products Division Vol#: 3

NOM 22 CDER Vol#: 3

NOM 23 William D Kerns DVM MS ACVP Vol#: 3

NOM 24 Julia H Riley DVM Vol#: 3

NOM 25 Pharmacia Corp Vol#: 3

NOM 26 Pfizer Global Research & Development Vol#: 3

00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair

LET 1 Hyman Phelps & McNamara Vol#: 1

LET 2 King & Spalding Vol#: 1

00N-1399 Presubmission Conferences

M 1 HF-26 Vol#: 1

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

C 7 First District Assn Vol#: 1

00P-1276 Health Claim: Plant stanol esters and heart disease

C 2 Physicians Committee for Responsible Med Vol#: 11

00P-1607 Revoke Implantation of Silicone Gel-Filled Breast Implants

ACK 1 HFA-305 Vol#: 1

CP 1 Chemically Associated Neurological Disor Vol#: 1

00V-1605 Laser Light Show

ACK 1 HFA-305 Vol#: 1

00V-1606

ACK 1 HFA-305 Vol#: 1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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