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 October 17, 2000

TABLE OF CONTENTS

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[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]
 
78N-036L OTC Laxative *
95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *
99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease *
99P-4375 Health Claim: Vitamin E and Heart Disease *
00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers *
00D-1392 Guidance for Industry on Botanical Drug Products *
00N-0506 Safety Issues Associated With Dietary Supplements *
00P-1084 Diabetes Drugs Troglitazone,rosiglitazone,pioglitazone *
00P-1276 Health Claim: Plant stanol esters and heart disease *
00P-1432 Pregnancy Warning Language on OTC Nicotine Products *
78N-036L OTC Laxative

LET 183 HFD-560 to Arent, Fox, Kintner, Plotkin Vol#: 107

88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

NFR 3 Vol#: 5

95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

EMC 80 Colleen Murphy MD Vol#: 5

EMC 81 David M Husak Vol#: 5

98N-0044 Effect of dietary supplement on structure/function of body

PDN 1 HFD-6 to Grocery Mfrs of America Vol#: 882

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

C 15552 Richard A. Lambriegger Vol#: 462

C 15553 Raymond L. Kemp Vol#: 462

C 15554 Juana b. McCann Vol#: 462

C 15555 Lisa J. Webb Vol#: 462

C 15556 Erin A. Haeussler Vol#: 462

C 15557 Lucille M. Hohnstein Vol#: 462

C 15558 Shirley Espig Vol#: 462

C 15559 Carol McCarrey Vol#: 462

C 15560 Winnie R. Greenaway Vol#: 462

C 15561 Barbara Garrett Vol#: 462

C 15562 Carrie Lewis Vol#: 462

C 15563 Melton & Janice Boulware Vol#: 462

C 15564 Vicki Rippeto Vol#: 462

C 15565 Nancy & Robert Hutchins Vol#: 462

C 15566 Eve Gate Vol#: 462

C 15567 Sheila Pricur Vol#: 462

C 15568 Mr & Mrs Joseph Major Vol#: 462

C 15569 Carol Frye Vol#: 462

C 15570 Beverley Kipp Vol#: 462

C 15571 Selin Strait Vol#: 462

C 15572 Heidi Brown Vol#: 462

C 15573 Dewitt Kennemy Vol#: 462

C 15574 Ray VanBlarcom Vol#: 462

C 15575 Jean Marie Howell Vol#: 462

C 15576 Carol S. Heape Vol#: 462

C 15577 Patricia A. Merryman Vol#: 462

C 15578 Richard Loos Vol#: 462

C 15579 Kathleen Cortlund Vol#: 462

C 15580 Carl Adametz Vol#: 462

C 15581 Lori Granberg Vol#: 462

C 15582 Guy Louis Sferlazza Vol#: 462

C 15583 Richard Kaplan Vol#: 462

C 15584 Joseph E. Gladney Vol#: 462

C 15585 Rhesa Eckelberry Vol#: 462

C 15586 Stephanie A. Serrell-Conant Vol#: 462

C 15587 Peter Hewitt Vol#: 462

C 15588 Guy W. Baker Vol#: 462

C 15589 Mrs. C. Cuiklinski Vol#: 462

C 15590 Freda Ann Prelitz Vol#: 462

C 15591 Stanley Welaish Vol#: 462

C 15592 Madeline Matz Vol#: 462

C 15593 Marie Piaskowski Vol#: 462

C 15594 Sheri Miranda Vol#: 462

C 15595 Katherine L. Kane Vol#: 462

C 15596 Quintin & Gail Molina Vol#: 462

C 15597 Laura B. Irish Vol#: 462

C 15598 Judith Keist Vol#: 462

C 15599 Joan Breit Vol#: 462

C 15600 Mark J. Byron Vol#: 462

C 15601 Margaret A. Pavlik Vol#: 462

C 15602 Patricia Bigelow Vol#: 462

C 15603 Diana L. Painter Vol#: 462

C 15604 Michele Holzman Vol#: 462

C 15605 Mary A. Wallen Vol#: 462

C 15606 Daniel L. Murphy Vol#: 462

C 15607 Heidi & Audie Morris Vol#: 462

C 15608 Louanna Banks Vol#: 462

C 15609 John P. Capp, Jr. Vol#: 462

C 15610 Mrs. Geoufranco Frittelli Vol#: 462

C 15611 Harold Wampler Vol#: 462

C 15612 George Schroeder Vol#: 462

C 15613 Gayle M. Acord Vol#: 462

C 15614 Lorraine Fast Vol#: 462

C 15615 Donald Kops Vol#: 462

C 15616 Joanna Buck Vol#: 462

C 15617 Nancy Bradshaw Vol#: 462

C 15618 George Pacanovsky Vol#: 462

C 15619 Carol Davis Vol#: 462

C 15620 Lee Ann Stewart Vol#: 462

C 15621 Joseph Schultz Vol#: 462

C 15622 Doris Hayden Vol#: 462

C 15623 Suzanne L. Saphr Vol#: 462

C 15624 Christina Alliod Vol#: 462

C 15625 Robert A. Sokol Vol#: 462

C 15626 Deana Dobler Vol#: 462

C 15627 Bonnie Jae Vol#: 462

C 15628 Regis & Connie Gmuer Vol#: 462

C 15629 Charles M. Schaffer Vol#: 462

C 15630 Linda Kathleen & Raul Cordova Vol#: 462

C 15631 Paula Hickman Vol#: 462

C 15632 Ieda Darnell Vol#: 462

C 15633 Terry Anderson Vol#: 462

C 15634 Don Beach Vol#: 462

C 15635 Evan Hunter Wright Vol#: 462

C 15636 Linda Leonard Vol#: 462

C 15637 Mr & Mrs Cecil Morris Vol#: 462

C 15638 Janet T. Crow Vol#: 462

C 15639 Maria Vernescy Vol#: 462

C 15640 Ellen Wallner Vol#: 462

C 15641 Gary Tower Vol#: 462

C 15642 Linda M. Proper Vol#: 462

C 15643 Robyn Bucking Vol#: 462

C 15644 Susan M. Kunashea Vol#: 462

C 15645 Tom Fredette Vol#: 463

C 15646 Jerry W. Weise Vol#: 463

C 15647 Florence P. Shanner Vol#: 463

C 15648 Mary Catherine True Vol#: 463

C 15649 Rosemary Schmitz Vol#: 463

C 15650 Kara Weiss Vol#: 463

C 15651 Debra P. Baer Vol#: 463

C 15652 Jasmine Julia Jacobsen Vol#: 463

C 15653 Anna Joyce Barker Vol#: 463

C 15654 Lorraine A. Spencer Vol#: 463

C 15655 Henry C. Gresham Vol#: 463

C 15656 Amy Stirling Vol#: 463

C 15657 Norman & Mary Heintz Vol#: 463

C 15658 Thomas & Sally Price Vol#: 463

C 15659 R. C. Chene Vol#: 463

C 15660 Joe Myslinski Vol#: 463

C 15661 Mrs. Lucile Vining Vol#: 463

C 15662 Wilfred L. Yorks Vol#: 463

C 15663 Nello Allegrezza Vol#: 463

C 15664 Reba W. Pritchelt Vol#: 463

C 15665 Shirley Lytle Vol#: 463

C 15666 Mr & Mrs Don Marshall Vol#: 463

C 15667 Frances L. Shaw Vol#: 463

C 15668 Janet B. Ashmun Vol#: 463

C 15669 Peria Commander Vol#: 463

C 15670 Mr & Mrs Robert F. Brandt Vol#: 463

C 15671 Frances M. Cooley Vol#: 463

C 15672 Joyce M. Drake Vol#: 463

C 15673 Justine Drake Vol#: 463

C 15674 William C. Sawyer Vol#: 463

C 15675 Betty Hutchinson Vol#: 463

C 15676 Shirley Prins Vol#: 463

C 15677 Sara MacCracken Vol#: 463

C 15678 Cameron T. & Tammy J. Wlodarski Vol#: 463

C 15679 Mrs. A. M. Mitchell Vol#: 463

C 15680 Richard Stygar Vol#: 463

C 15681 Joyce A. Termini Vol#: 463

C 15682 William Reed Vol#: 463

C 15683 LaVerne L. Whaley Vol#: 463

C 15684 Della Colman Vol#: 463

C 15685 Doris Bancroft Vol#: 463

99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease

SUP 4 Julian M Whitaker and others Vol#: 11

99P-4375 Health Claim: Vitamin E and Heart Disease

SUP 3 Emord & Associates & others Vol#: 5

00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers

C 11 Pharmaceutical Research Institute Vol#: 1

00D-1392 Guidance for Industry on Botanical Drug Products

C 3 Guangzhou Intl. Bioisland Development Co Vol#: 1

C 4 Tsumura & Co. Vol#: 1

C 5 Ancile Pharmaceutical Vol#: 1

C 6 Pfizer Inc. Vol#: 1

C 7 Indena s.p.a. (Italy) Vol#: 1

C 8 PharmaPrint Vol#: 1

C 9 Botanical Ent. Inc. Vol#: 1

C 10 Andes Pharmaceuticals Inc. Vol#: 1

C 11 PhytoCeutica Inc. Vol#: 1

C 12 Oxford Natural Products Plc Vol#: 1

C 13 Banner Pharmacaps Inc. Vol#: 1

C 14 Consumer Healthcare Prod Asson. (CHPA) Vol#: 2

C 15 CV Technologies Inc. (Canada) Vol#: 2

C 16 NIH Vol#: 2

C 17 Bundesfachverband der Arzneimittel-Herst Vol#: 2

C 18 Zhao Lili Vol#: 2

EXT 2 Star Scientific Inc. Vol#: 1

00N-0506 Safety Issues Associated With Dietary Supplements

PDN 1 HFD-6 to Grocery Mfrs of America Vol#: 1

00P-1084 Diabetes Drugs Troglitazone,rosiglitazone,pioglitazone

LET 1 HFD-7 to Sidney M Wolfe MD Vol#: 1

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

C 1 Meyer Texon MD Vol#: 11

00P-1432 Pregnancy Warning Language on OTC Nicotine Products

SUP 1 Lexington Law Group Vol#: 1