DOCKETS ENTERED on APRIL 12, 1999

Updated as of 10:00 am, April 15, 1999.  The following documents were entered at the Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860 and are hyperlinked to the actual comments/letters/reports as indicated below.

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77N-0085 Saccharin and Its Salts

CA 27000 R J Huber Vol#: 424

CA 27001 M L Densmore Vol#: 424

CA 27002 E Keith Vol#: 424

CA 27003 F Dahl Vol#: 424

CA 27004 M L Sanders Jr. Vol#: 424

CA 27005 D E Andrews Vol#: 424

CA 27006 R S Dubrusson Vol#: 424

CA 27007 T Angelo Vol#: 424

CA 27008 E H Power Vol#: 424

CA 27009 N & H B Stanley Vol#: 424

CA 27010 R L Brown Vol#: 424

CA 27011 J Vannoy Vol#: 424

CA 27012 A J & P M Galloway Vol#: 424

CA 27013 L M Wilkinson Vol#: 424

CA 27014 S Muths Vol#: 424

CA 27015 H Richman Vol#: 424

CA 27016 L L Hart Vol#: 424

CA 27017 M F Weston Vol#: 424

CA 27018 L Butler Vol#: 424

CA 27019 R E Krol Vol#: 424

CA 27020 L K Schenck Vol#: 424

CA 27021 B R Albert Vol#: 424

CA 27022 J Browning Vol#: 424

CA 27023 R McDonnell Vol#: 424

CA 27024 P Pennington Vol#: 424

CA 27025 M Tippett et al Vol#: 424

CA 27026 D Salmon Vol#: 424

CA 27027 H M Nisoufer Vol#: 424

CA 27028 E E Olson Vol#: 424

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92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 4996 Ross Randrup Vol#: 77

C 4997 Nathen Hunt Vol#: 77

C 4998 Jeff Mayers Vol#: 77

C 4999 Marilee S. Williams Vol#: 77

C 5000 Hilary Lovett Vol#: 77

C 5001 Marjorie W. Chodack Vol#: 77

94F-0246 Safe Use of Ethylene-vinyl Acetate-vinyl Alcohol Copolymers

EA 1 Kuraray Company Ltd Vol#: 1

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

C 3687 Honorable Ralph M Hall (CI) Vol#: 291

96G-0096 Safe use of solin oil

NWL 1 Vol#: 1

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96N-0135 Protein Derived from Ruminants Prohibited in Ruminant Feed

C 1683 Evelyn Uselmann Vol#: 86

C 1684 Nancy Kanerick Vol#: 86

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97D-0483 Food-Effect Bioavailability and Bioequivalence Studies

C 11 PharmaKinetics Laboratories Inc Vol#: 1

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97V-0081 Laser Light Show

EXP 1 Vision Laser Vol#: 1

98D-0469 Labeling of OTC drug products/treatment of vaginal yeast inf

TR 1 September 11, 1998 meeting Vol#: 2

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98D-0994 Draft Guidance for Industry on BACPAC I

C 28 National Assn of Pharmaceutical Mfg Vol#: 1

C 29 Geneva Pharmaceuticals, Inc Vol#: 1

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98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

C 40 Illinois Stewardship Alliance Vol#: 2

C 41 National Turkey Federation Vol#: 2

C 42 Eric Gonder Vol#: 2

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98H-1137 Civil Money Penalties;Sky Chefs Inc,d/b/a LSG Sky Chefs

LET 2 Office of Tobacco Programs HF-11) Vol#:

WDL 1 GCF-1 Vol#: 1

98H-1202 Civil Money Penalties; Lake Sammamish Mini Mart Inc

ANS 1 LSMM Vol#: 1

98N-0583 Exports: Notification and Recordkeeping requirements

REF 1 OMB, OIRA Vol#: 1

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98N-0826 Dietary Supplements of Health Claims

C 16 American Herbal Products Association Vol#: 1

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

C 534 Gideon Porth Vol#: 11

C 535 Mr & Mrs George Landon Vol#: 11

C 536 Martha M. Kehl Vol#: 11

C 537 Michele L. DeAscentis Vol#: 11

C 538 Ronald E. DeAscentis Vol#: 11

C 539 Mary McDonald Vol#: 11

C 540 Yvonne Dunn Vol#: 11

C 541 Al Schwarz Vol#: 11

C 542 Holly Rose Vol#: 11

C 543 Richard L. Christie Vol#: 11

C 544 Charles M. Carletta Vol#: 11

C 545 No Signature Vol#: 11

C 546 M. Ruth Niswander Vol#: 11

C 547 Becky Schipper Vol#: 11

C 548 April Angelene Parker Vol#: 11

C 549 Laura E. Gibbons Vol#: 11

C 550 Sonia Siegel-Vexler Vol#: 11

C 551 Kenneth R. Niswander Vol#: 11

C 552 Mele Stokesberry Vol#: 11

C 553 Jay M. Gould Vol#: 11

C 554 Michael Shea Vol#: 11

C 555 J. W. Meredith Vol#: 11

C 556 Marie C. Davis Vol#: 11

C 557 Bonnie Buckner Vol#: 11

C 558 Chin Nook Vol#: 11

C 559 Sasha Albertini Vol#: 11

C 560 Tiffany DiMascio Vol#: 11

C 561 Linda Que Vol#: 11

C 562 P. J. Smith Vol#: 11

C 563 No Signature Vol#: 11

C 564 Kimberly Lesser Vol#: 11

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98N-1265 Distribution of Compounded Drug Products

C 930 Cynthia L. Wall Vol#: 58

C 931 Roger L. Kroeze Vol#: 58

C 932 Lee & Melanie Beasley Vol#: 58

C 933 Brian & Laurel Hines Vol#: 58

C 934 Carolyn N. Surknet Vol#: 58

C 935 Sharon Frazier Vol#: 58

C 936 Carolyn P. Shelburne Vol#: 58

C 937 Delores A. Shaw Vol#: 58

C 938 Kathleen Smith Vol#: 58

C 939 Ethel P. Thompson Vol#: 58

C 940 David R. Bonfiglio Vol#: 58

C 941 Carolee V. Thomson Vol#: 58

C 942 Dolores Brahms Vol#: 58

C 943 Dorothy Scholl Barclay Vol#: 58

C 944 Joan Lillevand Vol#: 58

C 945 Kathylyn Carroll Vol#: 58

C 946 Pat Dapice Vol#: 58

C 947 Karen Blum Vol#: 58

C 948 Patricia Preut Vol#: 58

C 949 Merrie Scully Vol#: 58

C 950 Pamela Anderegg Vol#: 58

C 951 Violla Orloff Vol#: 58

C 952 Ed & Cathie Khouri Vol#: 58

C 953 E. Vigh Vol#: 58

C 954 Barbara Rupp Vol#: 58

C 955 Diane Mason Vol#: 58

C 956 Sarah Sawyer Vol#: 58

C 957 Linda B. Parks Vol#: 58

C 958 Dianne J. Lynn Vol#: 58

C 959 Vicki A. Spicer Vol#: 58

C 960 Wava E. Markwardt Vol#: 58

C 961 Theresa Kuhn Vol#: 58

C 962 Teresa Rogers Vol#: 58

C 963 Joan K. McGee Vol#: 58

C 964 Diane Bailey Vol#: 58

C 965 Ethlie Ann Vare Vol#: 58

C 966 Deana Jourdan Vol#: 58

C 967 Carol Ann Reed Vol#: 58

C 968 Rosemary D. Amoroso Vol#: 58

C 969 Alison K. Hazelbaker Vol#: 58

C 970 Janelle McKinley Vol#: 58

C 971 Joan M Clark Vol#: 58

C 972 Jearette Carron Vol#: 58

C 973 Kathryn Wirtala Vol#: 58

C 974 Carla Paganelli Vol#: 58

C 975 Gladys Abbott Vol#: 58

C 976 Joan Gimbel Vol#: 58

C 977 Violet Allison James Vol#: 58

C 978 M. L. Ballweg Vol#: 58

C 979 Mary L. Lytle Vol#: 58

C 980 Jollene Slater Vol#: 58

C 981 Diana D. Matlack Vol#: 58

C 982 Alice E. Arrigo Vol#: 58

C 983 Dorothy Bacon Vol#: 58

C 984 Jody E. Bridges Vol#: 58

C 985 Chris Ziolkowski Vol#: 58

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98P-0043 Permit the label statement of "Supplement Facts"

C 6 American Herbal Products Association Vol#: 1

C 7 Council for Responsible Nutrition Vol#: 1

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98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 2072 Norma Nelson Vol#: 52

C 2073 Alice A. Crawford Vol#: 52

C 2074 Dawne Schulte Vol#: 52

C 2075 Linette Barker Vol#: 52

C 2076 Helene Dickard Vol#: 52

C 2077 Vera E. Larson Vol#: 52

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98P-0203 Eliminate Forced Molting of Laying Birds

C 817 Rachel Cole Vol#: 21

C 818 Julie Lutz Vol#: 21

C 819 Storm Kai Balchunas Vol#: 21

C 820 L. K. Davey Vol#: 21

C 821 Anne Kirkwood Vol#: 21

C 822 Amy Sullivan Vol#: 21

C 823 Kristy L. Boettler Vol#: 21

C 824 Mindy S. Kursban Vol#: 21

C 825 Christina J. Babst Vol#: 21

C 826 Natalie M. Diehl Vol#: 21

C 827 Pam Pepperell & Carl Scott Vol#: 21

C 828 Frances Jones Vol#: 21

C 829 Muriel J. King Vol#: 21

C 830 Beverly D. Conley Vol#: 21

C 831 Amrit C. Hansmeyer Vol#: 21

C 832 Nina Jacobsen Vol#: 21

C 833 Pamela H. Polcyn Vol#: 21

C 834 Juliet van Otteren Vol#: 21

C 835 Suzanna Hermans Vol#: 21

C 836 William V. Stewart Vol#: 21

C 837 Diane Terry Vol#: 21

C 838 David J. Gilbert Vol#: 21

C 839 Dione Kajieni Vol#: 21

C 840 Roger Montgomery Vol#: 21

C 841 Madonna Niles Vol#: 21

C 842 Lacey Levitt Vol#: 21

C 843 Susan Wilcock Vol#: 21

C 844 Roland Goyette Vol#: 21

C 845 Grace A. Golling Vol#: 21

C 846 Kelly Griffin Vol#: 21

C 847 Martine Sankari Vol#: 21

C 848 Nancy Kadas Vol#: 21

C 849 Richard Snyder Vol#: 21

C 850 Gayle Cowart Vol#: 21

C 851 Linda Scharf Vol#: 21

C 852 Wynne Jackson Vol#: 21

C 853 Margaret Sulla Vol#: 21

C 854 Juli Prue Vol#: 21

C 855 Bernard Caley Vol#: 21

C 856 Christine Ostopoff Vol#: 21

C 857 Tara Walker Vol#: 21

C 858 Destixee Clubb Vol#: 21

C 859 Karen Russell Vol#: 21

C 860 Jennifer Plyler Vol#: 21

C 861 Sid Shapiro Vol#: 21

C 862 Katrelya Angus Vol#: 21

C 863 Esther Wanning Vol#: 21

C 864 Elaine I. Woodriff Vol#: 21

C 865 Debora A. Kane & Tom Whitaker Vol#: 21

C 866 Florence L. Orth Vol#: 21

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98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 13 Public Voice for Food & Health Policy Vol#: 1

C 14 John Supan PhD Vol#: 1

C 15 Form Letter 117 Vol#: 3

C 16 Michael A. Marshall Vol#: 1

C 17 The Fisherman Harvest Vol#: 1

C 18 Washington St. Dept. of Natural Resource Vol#: 1

C 19 Premier Plastics div of Premier Ind.,Inc Vol#: 1

C 20 Harbor House Seafood, Inc. Vol#: 1

C 21 J. Kressel Vol#: 1

C 22 Iceberg Seafood Vol#: 1

C 23 Vicki R. Peal Vol#: 1

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98P-0659 Allow to Place a Sticker Listing the Dry Natural Rubber Warn

PAV 1 HFZ-1 Vol#: 1

98P-1121 Grated Parmesan Cheese Deviating from Identity standard

NTP 1 Vol#: 1

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98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 82 Barbara J. Brown Vol#: 3

C 83 Sarah Westwind Vol#: 3

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98P-1227 Extension of compliance date for Std for Electrode Lead Wire

PAV 1 HFZ-1 Vol#: 1

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99D-0236 Skin Irriation/Sensitization testing of generic transdermal

C 2 Novum Pharmaceutical Research Services Vol#: 1

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99D-0254 product name placement,size, & prominence in advertising

C 2 Jane Sinclair & Robert M Sinclair Vol#: 1

99D-0296 Fortmal Meetings with Sponsors/Applicant for PDUFA Products

NCR 1 Vol#: 1

99D-0297 Formal Dispute Resolution Appeals above the Division Level

NCR 1 Vol#: 1

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99D-0302 Mammography Quality Standards Act Final Regs,Document #2

C 1 Indian Health Service Vol#: 1

C 2 Institute for Mammography Research Inc Vol#: 1

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99D-0463 Adulteration involving hard or Sharp Foreign Objects

GDL 1 Vol#: 1

NAD 1 Vol#: 1

99D-0557 Use of Nonhuman Primate Xenografts in Humans

GDL 1 Vol#: 1

NAD 1 Vol#: 1

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99F-0187 Neotame - Filing of Food Additive Petition (FAP 9A4643)

C 1 H J Roberts MD Vol#: 1

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99F-0719 Safe use olestran place of fats and oils in prepackaged

EA 1 Vol#: 1

NFL 1 Procter & Gamble Co. Vol#: 1

99F-0720 Safe use hydrogenated aromatic petroleum hydrocarbon

EA 1 Vol#: 1

NFL 1 Arakawa Chemical Industries Vol#: 1

99H-0260 Civil Money Penalties;Bel Air Ent Inc,d/b/a Neptune's

ANS 1 Bel Air Ent. Inc. Vol#: 1

99H-0797 Civil Money Penalties;Wal-Mart Stores East Inc,d/b/a Wal Mar

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0798 Civil Money Penalties;Racetrac Petroleum Inc,d/b/a Racetrac

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0799 Civil Money Penalties;Anil Patel,d/b/a Shiv Food Mart

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0800 Civil Money Penalties;Rhadames Peguero,d/b/a Warren Super Ma

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0801 Civil Money Penalties;Kim Nguyn,d/b/a Rosemont Market

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0802 Civil Money Penalties;Deweese Ent Inc,d/b/a Super Stop #49

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0825 Civil Money Penalties;Lab Marketing,d/b/a Nothin' Butt Smoke

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0826 Civil Money Penalties;Wal-Mart Stores Inc,d/b/a Wal-Mart Sto

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0827 Civil Money Penalties;Angus I Hines Inc,d/b/a Sentry Food

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0828 Civil Money Penalties;Ultramar Diamond Shamrock Corp,d/b/a

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0829 Civil Money Penalties;The Southland Corp,d/b/a 7-Eleven

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0830 Civil Money Penalties;Cumberland Farms Inc,d/b/a Cumberland

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0831 Civil Money Penalties;Supervalu Inc,d/b/a Cub Foods

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0832 Civil Money Penalties;Walgreen Co,d/b/a Walgreens Drug Store

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0833 Civil Money Penalties;Action Petroleum Co Ltd,d/b/a Action

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0834 Civil Money Penalties;J W Brewer Tire Co Inc,d/b/a Quick Sav

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0835 Civil Money Penalties;E-Z Mart Store Inc,d/b/a E-Z Mart #251

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0836 Civil Moneoy Penalties;Wal-Mart Stores Inc,d/b/a Wal-Mart

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0857 Civil Money Penalties; Acme Markets of Virginia Inc,d/b/a

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0858 Civil Money Penalties;Angus I Hines Inc,d/b/a Sentry Food

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0859 Civil Money Penalties;Autry Geer & Sons Inc,d/b/a Greer's 30

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0860 Civil Money Penalties;Suk Bowman,d/b/a Evergreen Shores Groc

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0861 Civil Money Penalties;Shelly Cox,d/b/a Cox's Chevron

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0862 Civil Money Penalties;Maria Escobar,d/b/a Casa De Oro

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0863 Civil Money Penalties;Food Lion Inc,d/b/a Food Lion Store

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0864 Civil Money Penalties;Gibbs Oil Co Ltd,d/b/a Gibbs Oil

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0865 Civil Money Penalties;Tej Kaur,d/b/a Go Fer Supermarket

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0866 Civil Money Penalties;Asad Mohammadali & Farid Allana,d/b/a

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0867 Civil Money Penalties;Silva Pina,d/b/a El Frutero

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0868 Civil Money Penalties;Charles Scott,d/b/a Scott's IGA

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-0869 Civil Money Penalties;Lawrence Scott,d/b/a Scott's Variety

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

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99M-0870 PMA Urolume endoprosthesis for Detrusor Ext Sphincter Dyssyn

AAV 1 American Medical Systems, Inc Vol#: 1

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99M-0871 PMA Cypress Bioscience, Prosorba Column

AAV 1 Cyrpess Bioscience Inc Vol#: 1

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99M-0894 PMA Lumbar I/F Cage with VSP Spine System, P960025

AAV 1 DePuy AcroMed Inc Vol#: 1

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99N-0386 Talking with Stakeholders About FDA Modernization

EC 1 Ohio Dept of Agriculture Vol#: 1

EC 2 Robert M & Jane Sinclair Vol#: 1

99N-0670 Labeling Requirements for Color Additives and Petitions

N 1 Vol#: 1

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99P-0923 ANADA Suitability Petition for Miconazole Nitrate Cream 2%

ACK 1 HFA-305 Vol#: 1

CP 1 Pharmaderm, Veterinary Div. of Altana In Vol#: 1