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 12, 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 ]

 
78N-036L OTC Laxative*
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
97N-0511 Procedures the safe and sanitary processing/importing juice *
98N-0313 Surgeons's and Patient Examination Gloves Reclassification *
98N-0581 Requirements for Testing Human Blood Donors *
98N-0607 General Requirements for Blood,Blood Components and Derivati *
98N-0815 Plasma Derivatives & Other Blood-Derived Products *
99D-5347 Transmission of Zoonoses By Blood and Blood Products *
99N-1415 Supplements and other changes to aproved NADA *
99N-4491 Reuse of Single Use Devices proposal *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-4613 Revoke the Regulation That Approved Posilac *
76N-052N OTC Nasal Decongestants

WDL 2 The Proctor & Gamble Company Vol#: 73

78N-036L OTC Laxative

C 200 University of South Alabama Vol#: 107

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

EMC 12 Amy Smith Vol#: 31

97N-0511 Procedures the safe and sanitary processing/importing juice

EMC 30 John S. Fohl Vol#: 18

98N-0313 Surgeons's and Patient Examination Gloves Reclassification

C 43 Marianne G McAndrew RN BSN CDE Vol#: 8

C 44 Colleen M Baker BS RN Vol#: 8

98N-0581 Requirements for Testing Human Blood Donors

C 11 Fujirebio America Inc Vol#: 5

C 12 University Hospitals Health System Vol#: 5

C 13 Hartford Hospital Vol#: 5

C 14 Puget Sound Blood Center Vol#: 5

C 15 University of Rochester, Medical Center Vol#: 5

C 16 American Association of Blood Banks Vol#: 5

C 17 Long Beach Memorial Medical Center Vol#: 5

C 18 America's Blood Centers Vol#: 5

C 19 American Red Cross Vol#: 5

C 20 Olympus America Inc Vol#: 5

C 21 Committee of Ten Thousand Vol#: 5

C 22 San Diego Blood Bank Vol#: 5

C 23 Interstate Blood Bank Inc Vol#: 5

98N-0607 General Requirements for Blood,Blood Components and Derivati

C 8 Puget Sound Blood Center Vol#: 2

C 9 American Association of Blood Banks Vol#: 2

C 10 America's Blood Centers Vol#: 2

C 11 Greater New York Hospital Association Vol#: 2

C 12 Committee of Ten Thousand Vol#: 2

C 13 San Diego Blood Bank Vol#: 2

98N-0815 Plasma Derivatives & Other Blood-Derived Products

C 4 Novartis Pharmaceuticals Corporation Vol#: 1

C 5 National Hemophilia Foundation Vol#: 1

C 6 FFF Enterprises Inc Vol#: 1

C 7 American Red Cross Vol#: 1

C 8 Committee of Ten Thousand Vol#: 1

C 9 International Plasma Products Industry A Vol#: 1

EMC 1 Caremark Inc Vol#: 1

99D-5347 Transmission of Zoonoses By Blood and Blood Products

EMC 4 Patricia Wright Vol#: 1

99N-1415 Supplements and other changes to aproved NADA

C 5 Animal Drug Alliance Vol#: 2

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

C 314 Mark & Ellen Oslinskie Vol#: 35

C 315 J M Kreimer Vol#: 35

C 316 Vennessa R Pustek Vol#: 35

C 317 Diane L Beres Vol#: 35

C 318 Nadi N S & Oleh Maczaj Vol#: 35

C 319 Nell Lancaster Vol#: 35

C 320 Jennifer Sheffield Vol#: 35

C 321 Daniel Oswald & Gina Erickson Vol#: 35

C 322 Kendall Dunnigan Vol#: 35

C 323 Kristan E Johnson Vol#: 36

C 324 Laura Huth Vol#: 36

C 325 Lois Engelman Vol#: 36

C 326 Kathleen M Phelan Vol#: 36

C 327 Renee Wade Vol#: 36

C 328 Kazue Kishima Vol#: 36

C 329 Peter T Kerwin Vol#: 36

C 330 Jan Holt Vol#: 36

C 331 Janet Hoagland Vol#: 36

C 332 Theodore Kisner Vol#: 36

C 333 Roy A Sletson Vol#: 36

C 334 Catherine E Warren Vol#: 36

C 335 Gladys Schmitz & 14 signatures Vol#: 36

C 336 Brian Pellerin Vol#: 36

C 337 Alice de Angnera Vol#: 36

C 338 Ruth Anne Muller Vol#: 36

C 339 Robin Arutt Vol#: 36

C 340 Kay Chassie Vol#: 36

C 341 Heather Stouder Vol#: 36

C 342 Brian Hannagan Vol#: 36

C 343 Hannah Burton Vol#:

C 344 Mary K Priem Vol#: 36

C 345 Ivan Maluski Vol#: 36

C 346 Mark Des Marcfs Vol#: 36

C 347 Jazmin Rollin Vol#: 36

C 348 Steve M Chase Vol#: 36

C 349 Everett J Dietrick Vol#: 36

C 350 Janet Kaji Vol#: 36

C 351 Susan Heroudorfer Vol#: 36

C 352 Ayden Bremner Vol#: 36

C 353 Joseph Katroscik Vol#: 36

C 354 Derek D Severson Vol#: 36

C 355 Gail DM Giavonini Vol#: 36

C 356 Willard Rutschman & Jerry L Rutschman Vol#: 36

C 357 Sister Janet Corcoran Vol#: 36

C 358 Musie Eisenberg Vol#: 36

C 359 Cindy Jednak Vol#: 36

C 360 Jack Brown Vol#: 36

C 361 Giora Panigel Vol#: 36

C 362 J Nicole De Fever Vol#: 36

C 363 Audrey N Fernandez Vol#: 36

C 364 Zoe Whitehurst Vol#: 36

C 365 Stephen J Allen Vol#: 36

C 366 Jeffery Garcia Vol#: 36

C 367 Betty Chapman Vol#: 36

C 368 Louis Russell Vol#: 36

C 369 Rio Thomas Vol#: 36

C 370 Linda Edwards Vol#: 36

EMC 736 Theresa H Fort Vol#: 35

EMC 737 Jody Bussell Vol#: 35

EMC 738 Deidre Regan Vol#: 35

EMC 739 Maria Christina Blanco Vol#: 35

EMC 740 Ron C Hardman Vol#: 35

EMC 741 Marilyn Borchardt Vol#: 35

EMC 742 Katherine M McBride Vol#: 35

EMC 743 Anthony Peters Vol#: 35

EMC 744 Dawn K Piper Vol#: 35

EMC 745 Beverly Cade Vol#: 35

EMC 746 Joyce Kauffman Vol#: 35

EMC 747 Judy Spadoni Vol#: 35

EMC 748 Ted Purdy Vol#: 35

EMC 749 Ardys De Lu Vol#: 35

EMC 750 Claudia Tomaso Vol#: 35

EMC 751 Claudia Tomaso Vol#: 35

EMC 752 R Dale Vol#: 35

EMC 753 D Schuelke Vol#: 35

EMC 754 Rose Glickman Vol#: 35

EMC 755 S Jacobse Vol#: 35

EMC 756 Nancy B Spears Vol#: 35

EMC 757 Jane Doro Vol#: 35

EMC 758 Nicole Maron Vol#: 35

EMC 759 Andy S Boyle Vol#: 35

EMC 760 Andy S Boyle Vol#: 35

EMC 761 Karl Hanf Vol#: 35

EMC 762 Robert J Howard Vol#: 35

EMC 763 Anne Whitefield Vol#: 35

EMC 764 Vivienne Verdon-Roe Vol#: 35

EMC 765 Beth J Shlifer Vol#: 35

EMC 766 Ray Couture Vol#: 35

EMC 767 Betty Rack Vol#: 35

EMC 768 Elaine Shirron Vol#: 35

EMC 769 Angeleen Campra Vol#: 35

EMC 770 231 scientists from 31 counties Vol#: 35

EMC 771 Chad L Skinner Vol#: 35

EMC 772 Stephen Hoyt Vol#: 36

EMC 773 Kate E Kaemerle Vol#: 36

EMC 774 Jorge Gutman Vol#: 36

EMC 775 Anne Connolly Vol#: 36

EMC 776 Joanna Rogers Vol#: 36

EMC 777 Jennet Grover Vol#: 36

EMC 778 Josh Shiver Vol#: 36

EMC 779 Elizabeth Doak Vol#: 36

EMC 780 John Halbert Vol#: 36

EMC 781 Richard A Biggert Vol#: 36

EMC 782 David Melly Vol#: 36

EMC 783 Martin Lemke Vol#: 36

EMC 784 Carmen Nogales Vol#: 36

EMC 785 Abigail Breuer Vol#: 36

EMC 786 Aileen Ford Vol#: 36

EMC 787 Matthew O Latham Vol#: 36

EMC 788 Read Vanderbilt Vol#: 36

EMC 789 Laura Sanchez Vol#: 36

EMC 790 George Hallahan Vol#: 36

EMC 791 Bob Slawson Vol#: 36

EMC 792 Donna Gesualdo Vol#: 36

EMC 793 Monnie Efross Vol#: 36

EMC 794 Greta Larson Vol#: 36

EMC 795 Amanda N Brown Vol#: 36

EMC 796 Susan Baumgart Vol#: 36

EMC 797 Barbara Docs Vol#: 36

EMC 798 Joey Green Vol#: 36

EMC 799 Janice Foss Vol#: 36

EMC 800 Eliana Uretsky Vol#: 36

EMC 801 Detlef R Bartsch PhD Vol#: 36

EMC 802 David Charles Vol#: 36

EMC 803 William B Crouch Vol#: 36

EMC 804 Micah Lubensky Vol#: 36

EMC 805 Jennifer Erbsen Vol#: 36

EMC 806 Mary Ann Williamson Vol#: 36

EMC 807 Shawn McDougal Vol#: 36

EMC 808 Michael Mills Vol#: 36

EMC 809 Kathy Gammon Vol#: 36

EMC 810 Briana Rose Vol#: 36

EMC 811 Michael Irving Vol#: 36

EMC 812 Kevin Tewart Vol#: 36

EMC 813 R A Martin Vol#: 36

EMC 814 Richard West Vol#: 36

EXT 2 American Frozen Institute Vol#: 36

EXT 3 Sustain Vol#: 36

99N-4491 Reuse of Single Use Devices proposal

C 67 Form Letter Count 321 Vol#: 4

C 68 Dept of Veterans Affairs Vol#: 7

C 69 Kaiser Permanente Vol#: 7

C 70 American Hospital Asson Vol#: 7

C 71 Medical College of Virginia Vol#: 7

C 72 American College of Surgeons Vol#: 7

C 73 Ortho Cycle Co Inc Vol#: 7

C 74 Johnny Baird Vol#: 7

C 75 State of New Jersey Dept of Health Vol#: 7

C 76 Concord Hopital, N.H. Vol#: 7

C 77 Concord Hopital, N.H. Vol#: 7

C 78 Manohester Hospital, N.H. Vol#: 7

C 79 Harvard Medical School Vol#: 7

C 80 Robert V Jao, M.D. Vol#: 7

C 81 University of Maryland School of Medicin Vol#: 7

C 82 Ron Ah Loy Vol#: 7

C 83 Daniel A Meline, M.D. Vol#: 7

C 84 Harvard Medical School Vol#: 7

C 85 Ronald Feldman, M.D. Vol#: 7

C 86 Robert A Brenner, M.D. Vol#: 7

C 87 Yuma Regional Medical Center Vol#:

C 88 Valley Hospital Vol#: 7

C 89 Dept of Veterans Affairs Vol#: 7

C 90 Robert Meichner Vol#: 7

C 91 Eugene Gastroenterology Consultants Vol#: 7

C 92 Dept of Veterans Affairs Vol#: 7

C 93 Dept of Veterans Affairs Vol#: 7

C 94 Dept of Veterans Affairs Vol#: 7

C 95 Bassett Healthcare Vol#: 7

C 96 Digestive Healthcare Associates Vol#: 7

C 97 American Society for Gastrointestinal Vol#: 7

C 98 Abbott Laboratories Vol#: 7

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 34 Lucy T Maltby Vol#: 12

99P-4613 Revoke the Regulation That Approved Posilac

EMC 276 Derek Goodwin Vol#: 4

EMC 277 Felix Bock Cubillo Vol#: 4

00H-0003 Civil Money Penalty;Hassen Agha;dba Wood Plus

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0004 Civil Money Penalty;American Drug Stores,Inc;dba Osco Drug #

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0006 Civil Money Penalty;Aspen Park Wine & Spirits LLC;dba Aspen

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0007 Civil Money Penalty;Eugene Ball;dba Park City Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0008 Civil Money Penalty;Keith Bush and Chom Bush;dba Bush's Gas

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0009 Civil Money Penalty;Casey's Marketing Company;dba Casey's Ge

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0010 Civil Money Penalty;Q Tian Chen;dba Cheung Wah aka State Gar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0011 Civil Money Penalty;Commonwealth Service & Supply Corporatio

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0012 Civil Money Penalty;Sien Van Dang;dba One A Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0014 Civil Money Penalty;Alex Dar;dba Ashland #35378

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0016 Civil Money Penalty;Frattaroli's Beer & Soda Outlet,Inc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0017 Civil Money Penalty;Clarence Haugh;dba Cal's Valley Inn

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0018 Civil Money Penalty;Sam Hodrage;dba Sam's Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0019 Civil Money Penalty;Hulse & Hulse,Inc;dba King's Korner

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0020 Civil Money Penalty;Inner City Oil Company,Inc;dba Service

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0021

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0022 Civil Money Penalty;K.W. Quickie Mart,Inc;dba K.W. Quickie

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0023 Civil Money Penalty;John Kelley;dba Nikals Smokes & Photo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0024 Civil Money Penalty;Jeanette Khamarji;dba A & G Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0025 Civil Money Penalty;Charlotte Knutson;dba Markette Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0026 Civil Money Penalty;Charles McKenzie and Regina McKenzie

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0027 Civil Money Penalty;Ibrahim Mustafa;dba Lena Super Valu

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0028 Civil Money Penalty;Panaro's Pizzeria Inc;dba Panaro's Pizze

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0029 Civil Money Penalty;Babulal Tendel;dba Fremont Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0030 Civil Money Penalty;Bill Trevathan;dba Bill's Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0031 Civil Money Penalty;Uni-Marts,Inc;dba Uni-Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0032 Civil Money Penalty;W W Smoke Shop L.L.C.;dba W W Smoke Shop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1