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 August 20, 1999

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 ]

 
92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
92P-0274 Determ Bendectin not withdrawn for safety/effective reasons *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
97P-0437 Anti-Nauseant Drug was withdrawn from Approved Drug List *
98A-0974 Interpret 807.85(b) where alternate mfg cannot be distribute *
98N-1038 Irradiation in the production, processing, &handling of food *
98P-0203 Eliminate Forced Molting of Laying Birds *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99D-0557 Use of Nonhuman Primate Xenografts in Humans *
99D-1576 Demonstrating the Effectiveness of Production Animal Drugs *
99D-1878 Good Manufacturing Practice for Blood and Blood Components: *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-2852 Condoms Packaging for both latex and non-latex condoms *
92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 5822 Mrs Doris Andrews Vol#: 142

C 5823 Kathryn Lerfald Vol#: 142

C 5824 Nancy Cross Vol#: 142

C 5825 Linda G Tiso Vol#: 142

C 5826 Daisy Kennedy Vol#: 142

C 5827 Lauren M Aklinski Vol#: 142

C 5828 Magaly Diaz Vol#: 142

C 5829 Karen Jones-Kolb Vol#: 142

C 5830 Lane Laughlin Vol#: 142

C 5831 George Fox Vol#: 142

C 5832 Lori Altman Vol#: 142

C 5833 Terri Drach Vol#: 142

C 5834 Don & Mary Burns Vol#: 142

C 5835 Leo Stone Vol#: 142

C 5836 Paul Michalofsky Vol#: 142

C 5837 Michael & Michele Zezima Vol#: 142

C 5838 Jeanna Gabellini Vol#: 142

C 5839 Mr & Mrs Lee Spinosa Vol#: 142

C 5840 Charlette M Hyde Vol#: 142

C 5841 Evelyn D Young Vol#: 142

C 5842 Diane R Gore Vol#: 142

C 5843 D Davis Vol#: 142

C 5844 Maureen Edwards Vol#: 142

C 5845 Ann Arnold Vol#: 142

EC 1 Patricia L Burnet Vol#: 141

92P-0274 Determ Bendectin not withdrawn for safety/effective reasons

PAV 1 HFD-7 to Townley & Updike Vol#: 1

96N-0417 CGMP in Packing or Holding Dietary Supplements

C 89 Mr & Mrs Joseph Urso Vol#: 3

C 90 Captek Softgel Int'l Inc Vol#: 3

C 91 Pure Encapsulations Inc; Dur Pearson Etc Vol#: 3

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

THESE COMMENTS DUPLICATE THOSE FOR 97P-0197 AND 98N-1230, ALSO BELOW

C 12 Sheila McLachlin Vol#: 2

C 13 Animal Place Vol#: 2

C 14 Cherie Maher Vol#: 2

97N-0074 President's National Food Safety Initiative

C 80 National Restaurant Assn Vol#: 10

C 81 Center for Science in the Public Interes Vol#: 10

97P-0197 Require that warning labels about risks of salmonella enteri

C 13 Sheila McLachlin Vol#: 1

C 14 Animal Place Vol#: 1

C 15 Cherie Maher Vol#: 1

97P-0437 Anti-Nauseant Drug was withdrawn from Approved Drug List

PAV 1 HFD-7 to Cato Research Vol#: 1

98A-0974 Interpret 807.85(b) where alternate mfg cannot be distribute

APA 1 HFZ-2 to Roger W Barnes Ltd Vol#: 1

98N-0617 Treatment of Narcotic Dependence

C 5 River Region Human Services Vol#: 1

98N-1038 Irradiation in the production, processing, &handling of food

C 4675 Terri Drach Vol#: 135

C 4676 Bonnie Thompson Vol#: 135

C 4677 Patricia A. Nail, M.S., C.C.N. Vol#: 135

C 4678 Audrey Maxwell Vol#: 135

C 4679 Marsha Cornman Vol#: 135

C 4680 Gary Douglas Vol#: 135

C 4681 Joanne Burch Vol#: 135

C 4682 Satomi Institute of Health (Japan) Vol#: 135

C 4683 Timothy L. Sampsel Vol#: 135

C 4684 Wanda S. Ballentine Vol#: 135

C 4685 M K T Matters Vol#: 135

C 4686 Mark Andrew Allen Vol#: 135

C 4687 Dawn Bizzarro Vol#: 135

C 4688 Caryle Katz Vol#: 135

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

C 12 Sheila McLachlin Vol#: 5

C 13 Animal Place Vol#: 5

C 14 Cherie Maher Vol#: 5

98P-0203 Eliminate Forced Molting of Laying Birds

C 1794 Suzi Wagner Vol#: 44

C 1795 Carola Hakkert Vol#: 44

C 1796 Jennifer Johnson Vol#: 44

C 1797 Douglas Lee Vol#: 44

C 1798 Lisanne Lee Feldman Vol#: 44

C 1799 P Hounsell Vol#: 44

C 1800 Sandra J Moss Vol#: 44

C 1801 Veronica Dickey Vol#: 44

C 1802 Christina Morin Vol#: 44

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 217 Terri Drach Vol#: 9

C 218 Kate Campion Vol#: 9

99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 284 J M Clark Vol#: 16

C 285 Philip Engel Vol#: 16

C 286 Denise M Dimino Vol#: 16

C 287 Lisanne Lee Feldman Vol#: 16

C 288 Unsigned Vol#: 16

C 289 Tina M Johnson Vol#: 16

99D-1576 Demonstrating the Effectiveness of Production Animal Drugs

MM 1 Minutes of 6/22/99 Mtg A.D.S.A. Vol#: 1

99D-1878 Good Manufacturing Practice for Blood and Blood Components:

C 8 Medical Center of Plano Vol#: 1

C 9 St. Francis Medical Center Vol#: 1

C 10 Baylor Medical Center-Ellis Country Vol#: 1

C 11 Freda Brown, MT(ASCP) Vol#: 1

C 12 Melinda Cokely, MT (ASCP) Vol#: 1

C 13 America's Blood Centers Vol#: 1

C 14 Baylor Medical Center at Grapevine Vol#: 1

C 15 American Association of Blood Banks Vol#: 1

C 16 Elizabeth T. Callais Vol#: 1

C 17 California Health Association Vol#: 1

C 18 Richard F. Roberts Vol#: 1

C 19 Peggy H. Dodson Vol#: 1

C 20 Regional Medical Laboratory, Inc Vol#: 1

99H-2696 Shore Stop Corporation,dba Shore Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2697 Civil Money Penalty;Oeu Ghov,dba Al's Donuts

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2698 Civil Money Penalty;Rick Lecrone & Billy Eubanks,dba B&R Dis

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2699 Civil Money Penalty;Toot 'N Totum food Stores Inc,dba Toot'N

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2700 Civil Money Penalty;Eagle Energy Inc,dba Eagle Express #240

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2721 Civil Money Penalty;Phillips Petroleum Company,dba Phillips

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2722 Civil Money Penalty;Lyndall Flowers,dba Wolflin Square Texac

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2723 Civil Money Penalty;EW James & Sons Inc,dba EW James & Sons

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2724 Civil Money Penalty;Clairbrooke Company & Barney Smith,dba

LET 1 Office of Tobacco Programs Vol#:

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2728 Civil Money Penalty;Velton Townsend,dba Townsend & Townsend

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1534 Susan Miller Vol#: 24

C 1535 Ilene Van Bruggen Vol#: 24

C 1536 Wayne D Gibbs Vol#: 24

C 1537 Bernard Beakman Vol#: 24

C 1538 Emil & Joanna Willimetz Vol#: 24

C 1539 Stacey Arnold Vol#: 24

C 1540 Pam Nordhof Vol#: 24

C 1541 Christopher & Deb Michaels Vol#: 24

C 1542 Cheryle Staley Vol#: 24

C 1543 Maria Elena Leahigh Vol#: 24

C 1544 Jon Gardner Vol#: 24

C 1545 Florence P Reeves Vol#: 24

C 1546 Scott Kravitz Vol#: 24

C 1547 Rachel L Johnson Vol#: 24

C 1548 Siobhan Hancock Vol#: 24

C 1549 C J Wishieska Vol#: 24

EC 42 Douglas Conwell Vol#: 24

EC 43 David O Bradshaw Vol#: 24

EC 44 Debra Haines Frantz Vol#: 24

EC 45 Elizabeth R Bernstein Vol#: 24

EC 46 Stephanie Hausman Vol#: 24

EC 47 Becky Dale Vol#: 24

EC 48 Tina Keller Vol#: 24

EC 49 Tina Fincher Vol#: 24

EC 50 Richard Gravrok Vol#: 24

EC 51 Ted Coskey Vol#: 24

EC 52 Diane H Spearly PhD Vol#: 24

EC 53 Steven Weiner Vol#: 24

EC 54 F E Baxter Vol#: 24

EC 55 Rhoby Cook Vol#: 24

EC 56 Pamela Koslyn Vol#: 24

EC 57 Paul Ruhlen Vol#: 24

EC 58 R Abdallah-Baran Vol#: 24

EC 59 Thadeus Dziekonski Vol#: 24

EC 60 Julia Grella Vol#: 24

EC 61 Eric Geoffroy Vol#: 24

EC 62 Paula Cenami Vol#: 24

EC 63 Patricia L Burnet Vol#: 24

99P-1340 Declared Eternity eau de Parfum Misbranded

C 260 Dorothy M. Skillings Vol#: 6

C 261 Lily Maxwell Vol#: 6

C 262 Patricia Woodland Vol#: 6

C 263 Eleanor Osmond Vol#: 6

C 264 Mark Taube Vol#: 6

C 265 Esther Le Sieur Vol#: 6

C 266 Ginny Cuny Vol#: 6

C 267 Karen Krusell Vol#: 6

C 268 Candice K. Paskey Vol#: 6

C 269 Alicia Wood Vol#: 6

C 270 Lily Maxwell Vol#: 6

C 271 Holy Cross Medical Group Vol#: 6

C 272 Diane Koerner Vol#: 6

C 273 Mary A. Thurn Vol#: 6

C 274 Madonna Burgess Vol#: 6

C 275 Ellen Melton Vol#: 6

EC 17 Kathy Reilly Vol#: 6

EC 18 William F. Taylor Vol#: 6

EC 19 Mary-Margaret Lytle Vol#: 6

EC 20 Jerold Block Vol#: 6

99P-2852 Condoms Packaging for both latex and non-latex condoms

ACK 1 HFA-305 Vol#: 1