Food and Drug Administration
Dockets Management Branch, 5630 Fishers Lane - Room
1061- HFA-305,
Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 DOCKETS ENTERED on August 10, 2000 TABLE OF CONTENTS Hyper links are part of the Docket title - not all dockets/documents are linked. NOTE: Documents received by the Dockets Management Branch "MAY" be posted on the Internet. PLEASE DO NOT include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence. |
91N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements * 96N-0393 MedWatch:FDA's Medical Prod Reporting Program Forms; Agency * 00D-1407 Safety Pharmacology Studies for Human Pharmaceuticals * 00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop * 00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods * 00P-1245 ANDA for Nizatidine Capsules, 75mg * 00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d * 00P-1443 Alendronate Sodium Tablets * 00V-0570 Laser Light Show * 00V-1442 * |
91N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements
THIS LINKED COMMENT DUPLICATES THOSE FOR 91N-0101, -0103, -0100H; AND 99D-5424, ALSO BELOW.
SUP 1 Emord & Associates P C Vol#: 20
91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement
SUP 2 Emord & Associates
P C Vol#: 40
91N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements
SUP 2 Emord & Associates
P C Vol#: 29
91N-100H Health Claims & Label Statements; Folate & Neural Tube Defec
SUP 1 Emord & Associates
P C Vol#: 11
96M-0311 Guideline on Infectious Disease Issues in Xenotransplantatio
C 168 Novartis Pharmaceuticals Corp Vol#: 20
96N-0393 MedWatch:FDA's Medical Prod Reporting Program Forms; Agency
C 25 FDA
New Jersey District Office Vol#: 1
97C-0415 Amend Regulations to Provide the Safe Use of Zinc Sulfide
BKG 1 BACKGROUND MATERIAL Vol#: 1
NFR 1 Vol#: 1
99D-5424 Health claims for Conventional Foods & Dietary Supplements
SUP 1 Emord & Associates
P C Vol#: 1
99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
C 14487 Deborah OKeefe Vol#: 438
C 14488 Edward & Janet Matza Vol#: 438
C 14489 Laurie Cook Vol#: 438
C 14490 Diana Webb Vol#: 438
C 14491 Hilary Hince Vol#: 438
C 14492 Earlene Webster Vol#: 438
C 14493 Patricia Olson Vol#: 438
C 14494 Marlene Campiott Vol#: 438
C 14495 Mary S. Martin Vol#: 438
C 14496 Cynthia Dott Vol#: 438
C 14497 Paul D. Guday Vol#: 438
C 14498 Carol Childs Vol#: 438
C 14499 Kelly A. Martin Vol#: 438
C 14500 Ron & Karen Holler Vol#: 438
C 14501 Rachel Brandenburg Vol#: 438
C 14502 Cynthia A. Uribe Vol#: 438
C 14503 Arlene A. Hallenbeck Vol#: 438
C 14504 Daniela Sylvia Adamezak Vol#: 438
C 14505 Phyllis A. Anderson Vol#: 438
C 14506 Annette & Mike Clark Vol#: 438
C 14507 Gordon Aitken Vol#: 438
C 14508 Jean Salisbury Vol#: 438
C 14509 Debbie Mahoney Vol#: 438
C 14510 Gertrud Aiken Vol#: 438
C 14511 Carole Grubb Vol#: 438
C 14512 Annie Lucky Vol#: 438
C 14513 Duke Stone Vol#: 438
C 14514 Marian Sample Vol#: 438
C 14515 Gregg & Roxanne Marble Vol#: 438
C 14516 Judith Hinckley Vol#: 438
C 14517 Timothy P. Brady Vol#: 438
C 14518 Dale V. & Bobby A. Sarkkinen Vol#: 438
C 14519 Sandra Aultman Vol#: 438
C 14520 David C. Barton Vol#: 438
C 14521 Pat A. Channell Vol#: 438
C 14522 Barbara Kirschenstein Vol#: 438
C 14523 Ruth R. Anderson Vol#: 438
C 14524 Bobby J. Davis Vol#: 438
C 14525 Carrie Cox Bedell Vol#: 438
C 14526 Gretchen Drilling Vol#: 438
C 14527 Stephanie Groll Vol#: 438
C 14528 D. A. Hayes Vol#: 438
C 14529 Edward A. Zink Vol#: 438
C 14530 Mr & Mrs Jeffrey Stoner & Family Vol#: 438
C 14531 William E. Norcott Vol#: 438
C 14532 Brent Anderson Vol#: 438
C 14533 Roland Dean Metcalf Vol#: 438
C 14534 Dolores J. Fincher Vol#: 438
C 14535 Margery Hunter Vol#: 438
C 14536 Jo Ann Miller Vol#: 438
C 14537 Darnell Heverey Vol#: 438
C 14538 Dona Grasseler Vol#: 438
C 14539 Dr. Guy Markham Vol#: 438
C 14540 Shannon D. Dobbins Vol#: 438
C 14541 Karena Youtz Vol#: 438
C 14542 Ann Anderson Vol#: 438
C 14543 Carol A. Deretchin Vol#: 438
C 14544 Edward M. Ames Vol#: 438
C 14545 Dianne R. Cristich Vol#: 438
C 14546 Darrell Wells Vol#: 438
C 14547 Suzanne L. Fournier Vol#: 438
C 14548 Pam Osborn Vol#: 438
C 14549 Keirsten Snoves Vol#: 438
C 14550 Billye Chandler Vol#: 438
C 14551 D. Petersen Vol#: 438
C 14552 Ilse S. Martz Vol#: 438
C 14553 Gail A. Horkman Vol#: 438
C 14554 John W. & Carol Smith Vol#: 438
C 14555 Ryan Holly Vol#: 438
99P-2630 Establish a Daily Value for "added sugars"
C 128 National Students Nurses' Assoc Inc(NSNA Vol#: 7
00D-1407 Safety Pharmacology Studies for Human Pharmaceuticals
EMC 1 Dennis
J Murphy PhD Vol#: 1
00F-0119 Safe Use of Calcium Disodium EDTA
BKG 1 BACKGROUND MATERIAL Vol#: 1
NFR 1 Vol#: 1
00M-1437 Premarket Approval QUS-2 Calcaneal Ultrasonometer
AAV 1 Metra Biosystems Vol#:
1
00N-1256 Over-the-Counter Drug Products;Public Hearing
CH 236 J C Willke, MD Vol#: 13
CH 237 American Medical Association Vol#: 13
CH 238 Mr. Robert Thompson Vol#: 13
CH 239 NFPRHA Vol#: 13
00N-1374 Revisions of Certain Food Chemicals Codex Monongraphs
N 1 Vol#: 1
00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
C 4093 Lucille Culpepper Vol#: 150
C 4095 Tatiana Wrenfeather Vol#: 150
C 4096 Deborah Natera Vol#: 150
C 4097 Kelly A. Schmidt Vol#: 150
C 4102 Ginger Metraux Vol#: 150
C 4103 Mary E. Anderson Vol#: 150
C 4104 Maxine Blaine Vol#: 150
C 4105 Dorothy Higdon Vol#: 150
C 4106 Diane Marie Kuc Vol#: 150
C 4109 Julia Kalamaras Vol#: 150
C 4110 Kristin Eggerling Vol#: 150
C 4112 D. Wayne Ratcliffe Vol#: 150
C 4114 Linda Gilmore Vol#: 150
C 4115 Doris M. Sullivan Vol#: 150
C 4116 Patricia McGill Vol#: 150
C 4117 Paula Hamilton Vol#: 150
C 4118 Mr & Mrs Francis J. Alberto Vol#: 150
C 4119 John H. Donahue Vol#: 150
C 4120 Elaine Congdon Vol#: 150
C 4121 Jeane Spada-Allgood Vol#: 150
C 4122 Eliza Vimmerstedt Vol#: 150
C 4124 Sharolyn Smidt Vol#: 150
C 4125 Maria Kniazeva Vol#: 150
C 4126 Danika Murray Vol#: 150
C 4128 Christine Krippene Vol#: 150
C 4129 Barbara Troutman Vol#: 150
C 4131 Alana Reynolds Vol#: 150
C 4132 Susan Wotring Vol#: 150
C 4133 Judith Lee Azaren Vol#: 150
C 4134 Gregory & Lorrie Curtis Vol#: 150
C 4135 M. L. Coleman Vol#: 150
C 4136 Jerry & Maggie Melnick Vol#: 150
C 4137 Jackie Sauriol Vol#: 150
C 4138 Juanita Zenus Vol#: 150
C 4139 Joseph & Donna Robertson Vol#: 150
C 4140 Mr & Mrs Joseph Beals Vol#: 150
C 4141 Jade Martinez Vol#: 150
C 4144 Janet Piggins Vol#: 150
C 4145 Georgia Rounsaville Vol#: 150
C 4146 Marga Madhuri Vol#: 150
C 4147 Willard B. Myers Vol#: 150
C 4148 Kate Gerritsen Vol#: 150
C 4149 Sharon Goodall Vol#: 150
C 4150 Elaine DeVore Vol#: 150
C 4151 Elizabeth Frost Vol#: 150
C 4153 Dr. George Eastman Vol#: 150
C 4154 Deanna Moritz Vol#: 150
C 4155 Marjorie Campaigne Vol#: 150
C 4156 Susan Sullivan Vol#: 150
C 4158 Jeremy Bowman Vol#: 150
C 4162 Michael Wheeler Vol#: 150
C 4165 Samanatha Ellis Vol#: 150
C 4167 Shirley O. Carroll Vol#: 150
C 4168 Gail Matthews Vol#: 150
C 4169 Lynn Mandaram Vol#: 150
C 4171 Mrs. Mary Nanos Vol#: 150
C 4172 Carola V. Cohn Vol#: 150
C 4174 Paula M. Castagna Vol#: 150
C 4175 Gina Sanchione Vol#: 150
C 4176 Christine Colasurdo Vol#: 150
C 4177 Mr & Mrs B. Bullington Vol#: 150
C 4183 Michael Garcia Vol#: 151
EMC 1765 Ligia Ercius-DiPaola Vol#: 151
EMC 1766 Hiren Patel Vol#: 151
EMC 1767 Amanda Mourant Vol#: 151
EMC 1768 Olivia Lehman Vol#: 151
EMC 1769 Irene C. Beard Vol#: 151
EMC 1770 Patrisha A. Lowder Vol#: 151
EMC 1771 Beth Baldino-Feehan Vol#: 151
00P-1245 ANDA for Nizatidine Capsules, 75mg
AMD 1 Lachman Consultant Services, inc. Vol#: 1
00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d
00P-1343 Reclassify Barium Enema Retention Catheter to Class II
N 1 Vol#: 1
00P-1443 Alendronate Sodium Tablets
PSA 1 Zenith Goldline Pharmaceuticals Vol#: 1