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] 

DOCKETS ENTERED on January 6, 2000

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]  [ ITEM CODES ]

 
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability *
95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
97N-484S Human Cellular and Tissue-Based Products *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection) *
99N-4491 Reuse of Single Use Devices proposal*
99P-1340 Declared Eternity eau de Parfum Misbranded *
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 1039 USDA, Human Nutrition Research Ctr on Ag Vol#: 31

C 1040 Mary Barajikian + 2 names Vol#: 31

C 1041 cliff Stein Vol#: 31

C 1042 Pearl A Smith Vol#: 31

C 1043 Betty Marcus-Randle Vol#: 31

C 1044 Bertha C Rosenfeld Vol#: 31

C 1045 Elizabeth A Wuthrich Vol#: 31

C 1046 E E "Pete" Nicholls + 10 signatures Vol#: 31

C 1047 John B Slack Vol#: 31

C 1048 Jane Runnels Vol#: 31

C 1049 Joseph Richard Koelsch Vol#: 31

C 1050 Art Warshaw Vol#: 31

C 1051 David R Weiskotten Vol#: 31

C 1052 Terri R Joslyn Vol#: 31

C 1053 Ruth Wiley Vol#: 31

C 1054 Tom McIntyre Vol#: 31

C 1055 PA Citizens Consumer Council Vol#: 31

C 1056 Roslyn Arington Vol#: 31

C 1057 Peter Forte Vol#: 31

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

C 3698 Asa Hutchinson (CI) Vol#: 291

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

RPT 57 Nature's Marvel International Vol#: 38

97N-484S Human Cellular and Tissue-Based Products

C 300 Form letter count 73 Vol#: 14

C 301 Form letter count 5 Vol#: 15

C 302 Form letter count 12 Vol#: 16

C 303 Form letter count 5 Vol#: 17

C 304 Ralph Weinstein Vol#: 18

C 305 Margaret & Harrison Thom Vol#: 18

C 306 Mountian Neurological Center, PA. Vol#: 18

C 307 UNC School of Medicine Dept. of Orthopae Vol#: 18

C 308 WNJ, Wilson N. Jones Medical Center Vol#: 18

C 309 Emory Healthcare the Emory Clinic, Inc. Vol#: 18

C 310 Coastal Neurosurgical Assocs & Spine Ctr Vol#: 18

C 311 Piedmont Neurosurgery, P.A. Vol#: 18

C 312 illegible Vol#: 18

C 313 Daniel J. Sullivan, M.D. Vol#: 18

C 314 Section of Spinal Surgery the Neurosurgi Vol#: 18

C 315 University of Florida College of Medicin Vol#: 18

C 316 Louisville Orthopaedic Clinic Vol#: 18

C 317 Semmes Murphey Neurologic & Spine Instit Vol#: 18

C 318 Seth Rockman Vol#: 18

C 319 Center for Reproductive Health Vol#: 18

C 320 OC, Orthopedic Consultants LTD. Vol#: 18

C 321 Salem Spine & Scoliosis Center Vol#: 18

C 322 McFarland Clinic Assisted Reproductive P Vol#: 18

C 323 Atlanta Ctr for Reproductive Medicine,LL Vol#: 18

C 324 Conceptions Women's Hlth & Fertility Spe Vol#: 18

C 325 Conceptions Women's Hlth & Fertility Spe Vol#: 18

C 326 Kyle Greenfield Vol#: 18

C 327 Conceptions Women's Hlth & Fertility Spe Vol#: 18

C 328 Central Florida Lions Eye & Tissue Bank, Vol#: 18

C 329 Ctr for Reproductive Health Vol#: 18

C 330 Scott Roseff, M.D., FACOG, P.A. Vol#: 18

C 331 The Maryland Women's Center Vol#: 18

C 332 South Texas Orthopaedic & Spinal Surgery Vol#: 18

C 333 University of Colorado Hlth Sciences Ctr Vol#: 18

C 334 University of Tennessee Mephis Vol#: 18

C 335 Obstetrical & Gynecological Assocs P.A. Vol#: 18

C 336 Reproductive Health Specialists, LTD Vol#: 18

C 337 Tim Montileone Vol#: 18

C 338 Obstetrical & Gynecological Assocs P.A. Vol#: 19

C 339 Obstetrical & Gynecological Assocs P.A. Vol#: 19

C 340 Tim Koch Vol#: 19

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 4326 Food Science Corporation Vol#: 31

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 319 HFS-456 to Nutramax Laboratories Inc Vol#: 8

LET 320 HFS-456 to Standard Process Inc Vol#: 8

98N-0617 Treatment of Narcotic Dependence

C 119 Bazelon Center for Mental Health Law etc Vol#: 16

99H-0026 Civil Money Penalties;The Whalen Corp,d/b/a A & C Exxon

MO 1 GCF-1 Vol#: 1

99H-0415 Civil Money Penalties;Hattie Davis,d/b/a Buds Pick Up

MO 1 GCF-1 Vol#: 1

99H-1876 Civil Money Penalties;Weigel's Stores Inc,dba Weigel's Farm

MO 1 Weigel's Inc,dba Weigel's Farm Store #7 Vol#: 1

99H-4722 Civil Money Penalty;Jose L. Perez and Amanda Cruz,dba Contin

ANS 1 Continental Bar & Restaurant Vol#: 1

99H-4889 Civil Money Penalty;High's of Baltimore Incorporated,dba Hig

ANS 1 High's of Baltimore Inc Vol#: 1

99H-4973 Civil Money Penalty;Shelly Burgess;dba 45 One Stop

ANS 1 Shelley Burgess, dba 45 One Stop Vol#: 1

99H-4990 Civil Money Penalty;Orton Motor, Inc;dba Orton's Wadena Amoc

ANS 1 Orton Motor Inc Vol#: 1

99H-4995 Civil Money Penalty;Snow Hill Star, Inc;dba Your Stop

ANS 1 Snow Hill Star Inc Vol#: 1

99H-5025 Civil Money Penalty;Weigel's Inc,dba Weigel's #7

MO 1 Weigel's Inc,dba Weigel's Farm Store #7 Vol#: 1

99H-5054 Civil Money Penalty;Debbie Whaley;dba Chickaloon General Sto

ANS 1 Chickaloon General Store Vol#: 1

99H-5080 Civil Money Penalty;Pride Convience Inc,dba Pride

ANS 1 Pride Convenience Inc Vol#: 1

99H-5085 Civil Money Penalty;Wexford Bridge Corporation,dba Southern

ANS 1 Wexford Fridge Corp,dba Southern Liquors Vol#: 1

99H-5100 Civil Money Penalty;South Arkansas Petroleum Company Inc,dba

ANS 1 South Arkansas Petroleum Co Inc Vol#: 1

99H-5227 Civil Money Penalty;Go-Mart, Inc;dba Go-Mart #34

ANS 1 Go-Mart Inc, dba Go-Mart #44 Vol#: 1

99H-5272 Civil Money Penalty;Step 'N Fetch Um,Inc;dba Step 'N Fetch

ANS 1 Step 'N Fetchum Vol#: 1

99H-5405 Civil Money Penalty;A.T.M. Auto Plaza,Inc;dba Chevron Mini M

ANS 1 Chevron Mini Mart Vol#: 1

99H-5572 Civil Money Penalty;All American Discount Liquors, Inc;dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5573 Civil Money Penalty;Belmar Avenues, Inc;dba Columbine Wines

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5574 Civil Money Penalty;Carolyn Branch;dba Morgan City Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5575 Civil Money Penalty;Carmac Enterprises, Inc;dba Edray Kwik

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5577 Civil Money Penalty;Sung Nak;dba Hebron's Cut Rate

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5578 Civil Money Penalty;Parkridge Wine and Spirits, Ltd;dba Park

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5579 Civil Money Penalty;Joey and Tosha Adams;dba Adams Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5580 Civil Money Penalty;Donovan Woodburn, Jr;dba Hop & Sack #22

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

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

C 212 Sheldon Winnick MD Vol#: 24

C 213 unsigned Vol#: 24

C 214 Pamella Corvelli Vol#: 24

C 215 Carol Lopez-Bethel Vol#: 24

C 216 Caryle Katz Vol#: 24

C 217 J Reese J Walshor & Family Vol#: 24

C 218 C R Gneswgi Vol#: 24

C 219 Debbie Stahler Vol#: 24

C 220 Michael Steady Vol#: 24

C 221 Margaret Reavly Currin Vol#: 24

C 222 Miriam Stein Vol#: 24

C 223 Janet Brick Vol#: 24

C 224 Pearl Brick Vol#: 24

C 225 Barbara Brick Vol#: 24

C 226 Judith Lachner Vol#: 24

C 227 Karen Rasmussen Vol#: 24

C 228 Mara Steele Vol#: 24

C 229 Mark Schonbeck Vol#: 24

C 230 Larry Brooks Vol#: 24

C 231 Terri Middleton Vol#: 24

C 232 Nancy Bruns-Hall Vol#: 24

C 233 Alice Farber Vol#: 24

C 234 Amy Hutchinson Vol#: 24

C 235 Alex Jack Vol#: 24

C 236 John T McMahan MD Vol#: 24

C 237 Patricia Carey Vol#: 24

C 238 Michael McKinney Vol#: 24

C 239 Laura J Roys Vol#: 24

C 240 Steve Krasinsky Vol#: 24

C 241 Helen M Bourne Vol#: 24

C 242 Kathy Carter-White Vol#: 24

C 243 Annette Mills Vol#: 24

C 244 Lydia Gans Vol#: 24

C 245 Kathy Moore Vol#: 24

C 246 Dana Davis Vol#: 24

C 247 Sister Clare T Pelkey Vol#: 24

C 248 Patricia R Enloe Vol#: 24

C 249 Natural Cotton Colours Inc Vol#: 24

C 250 Judith L Katz Vol#: 24

C 251 Reina E Rabolt Vol#: 24

C 252 Gwenyth Arnold DeHetre Vol#: 24

C 253 Naomi Gunther Vol#: 24

EMC 645 Deborah C Waddell Vol#: 24

EMC 646 144 scientist from 27 countries Vol#: 24

EMC 647 Marie Falbo Vol#: 24

EMC 648 Erika Dreyer Vol#: 24

EMC 649 Lora MacKenzie Vol#: 24

EMC 650 Sjon Welters & 4 signatures Vol#: 24

EMC 651 Wilson Callan Vol#: 24

EMC 652 Sarah Huntington Vol#: 24

EMC 653 Steven G Rubenstein Vol#: 24

EMC 654 Paul Cohn Vol#: 24

EMC 655 Duke Skorich Vol#: 24

EMC 656 Mr & Mrs J N Winsor Vol#: 24

EMC 657 Senna Shanti Vol#: 24

EMC 658 Peter Rasmussen & family Vol#: 24

EMC 659 Laurie Dawson Vol#: 24

EMC 660 Steve Klintworth Vol#: 24

EMC 661 Laura L Monfore Vol#: 24

EMC 662 Clifford M Patterson Vol#: 24

EMC 663 Karolyn Redoutey Vol#: 24

EMC 664 Deborah LeSueur Vol#: 24

EMC 665 Lisa E Tishler Vol#: 24

EMC 666 Brandi Haigler Vol#: 24

EMC 667 Steve Bloom Vol#: 24

EMC 668 Eva B Olson Vol#: 24

EMC 669 Yehudit Lieberman Vol#: 24

EMC 670 David & Paula Behr Vol#: 24

EMC 671 V Richards Vol#: 24

EMC 672 Kim A Houghton Vol#: 24

EMC 673 Nicholas Malfitani Vol#: 24

99N-4491 Reuse of Single Use Devices proposal

C 27 Richard W Smith Vol#: 1

C 28 Michael J Newman Vol#: 1

C 29 John Macksood Vol#: 1

C 30 Milton T Smith, M.D. Vol#: 1

C 31 R Martin Bashir, M.D. Vol#: 1

C 32 Alan Plotner, M.D. Vol#: 1

C 33 Midwest Physician Centers Vol#: 1

C 34 A Saeed Fakhruddu Vol#: 1

C 35 MHG Endoscopy Clinic Vol#: 1

C 36 Boston Scientific Corp Vol#: 1

C 37 Surendra V Jain, M.D. Vol#: 1

C 38 Waring Trible, M.D. Vol#: 1

C 39 Gregory L Knech, M.D. Vol#: 1

C 40 Steve Harvey Vol#: 1

C 41 Gastrointestinal Associates of NE Tenn Vol#: 1

C 42 Melot Pun Vol#: 1

C 43 Alan G Y Chang Vol#: 1

C 44 E. Doran, M.D. Vol#: 1

C 45 Assocaited Gastroentorology Consultants Vol#: 1

C 46 Stanley Morris, M.D. Vol#: 1

C 47 Charles Lewis Vol#: 1

C 48 Bassett Healthcare Vol#: 1

C 49 Digestive Healthcare Associates, P.C. Vol#: 1

C 50 Michael S Taxier, M.D. Vol#: 1

C 51 Robert V Jao, M.D. Vol#: 1

C 52 D Wadlau Vol#: 1

C 53 The Greeley Mredical Clinic, P.C. Vol#: 1

C 54 Medical University of South Carolina Vol#: 1

C 55 Neal Winzelberg, M.D. Vol#: 1

C 56 Morrow C Corvasce, M.D. Vol#: 1

C 57 Kevin J Franklin Vol#: 1

C 58 Manoop Bhutenu, M.D. Vol#: 1

C 59 Girish Misitra Vol#: 1

C 60 Olympic Medical Corp. Vol#: 1

C 61 Medical Device Mfg Assn Vol#: 1

C 62 Guidant Corp Vol#:

C 63 American Society of Cataract & Refractiv Vol#: 1

C 64 Swedich Meical Ctr Vol#: 1

C 65 Illegible Vol#: 1

C 66 Pennsylvania Gastroenterology Consultant Vol#: 1

M 1 International Asson of Healthcare Centra Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

C 563 Mary C Larton Vol#: 12

C 564 Cancer Prevention Coalition Vol#: 12

EMC 32 Peggy L Davis Vol#: 12