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 October 8, 1999

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]
 
75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products *
85N-0214 Drug Price Competition & Patent Term Restoration ACT 1984 *
92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
93N-0040 Levo-Alpha-Acetyl-Methadol Revise Conditions for Use *
97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD *
98N-0313 Sugeons's and Patient Examination Gloves Reclassification *
98N-1215 Foreign Establishment Registration and Listing *
99D-1738 Bioavilability & Bioequivalence Studies for Nasal Aerosols *
99D-2013 Cooperative Manufacturing Arrangements for Licensed *
99D-2096 Interpreting Sameness of Monoclonal Antibody Products *
99D-2638 Use of Medicated Feeds for Minor Species *
99N-1591 Animal Drug Availabililty Act; Veterinary Feed Directive *
99N-2549 Cosmetic Product Voluntary Reporting Program *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-2148 Label or Labeling of food ingredients and regulation *
99P-2630 Establish a Daily Value for "added sugars" *
99V-4005 Laser Light Show *
99V-4332 Laser Light Show Projector*
99V-4362 Laser Light Show, Mobolazer ML10-200,ML10-300,ML,10*
75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

PR 5 Ciba Specialty Chemicals Corporation Vol#: 65

77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products

C 236 McNeil Consumer Healthcare Vol#: 234

85N-0214 Drug Price Competition & Patent Term Restoration ACT 1984

C 51 Alfred B. Engelberg Vol#: 24

C 52 Andrx Pharmaceuticals, Inc Vol#: 24

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

C 5965 Ann Thiery Vol#: 151

C 5966 Joann Fleming Vol#: 151

C 5967 Lea Wood Vol#: 151

C 5968 Sandra Carrillo Vol#: 151

C 5969 Betty L Wrigley Vol#: 151

C 5970 Christina Pasley Vol#: 151

C 5971 Vivian Schueler Vol#: 151

C 5972 Mrs Robert C Stevens Vol#: 151

C 5973 Kesha Glaser Vol#: 151

C 5974 Aileen Bernardo Vol#: 151

C 5975 P Bierman Vol#: 151

C 5976 Susan R Barber Vol#: 151

C 5977 Kit Howe Vol#: 151

C 5978 Maureen Joyce Vol#: 151

C 5979 Jenny Nelson Vol#: 151

C 5980 Senator Janet Munt Vol#: 11

C 5981 Abigail A Kenny Vol#: 151

C 5982 Heather Middaugi Vol#: 151

C 5983 Mrs John C Tuten Jr Vol#: 151

C 5984 Mr & Mrs Norman H Jaquin Vol#: 151

C 5985 Roman Weber Vol#: 151

C 5986 Eihway Su Vol#: 151

C 5987 Carole Giehl Vol#: 151

EC 40 Conrad Miller MD Vol#: 151

93N-0040 Levo-Alpha-Acetyl-Methadol Revise Conditions for Use

C 9 Virginia Commonwealth University Vol#: 1

97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD

C 5 Sacramento Medical Foundation Vol#: 1

97N-0074 President's National Food Safety Initiative

C 115 Morray B. Cohen Vol#: 10

C 116 Sarah Forbes Vol#: 10

98H-1115 Civil Money Penalties;Milo Jackson,d/b/a MJ's Corner Store

SUB 1 GCF-,1 Vol#: 1

98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;

LET 5 Intl Academy of Compounding Pharmacists Vol#: 19

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

C 5 Joint Council of Allergy Asthma & Immuno Vol#: 5

EXT 1 Ansell Healthcare Products Inc Vol#: 5

98N-1215 Foreign Establishment Registration and Listing

C 24 Walsh Medical Devices Inc Vol#: 1

C 25 Medionics International Inc Vol#: 1

C 26 Mui Scientific Vol#: 1

C 27 Cool Eyes Vol#: 1

99D-1651 Chemistry,Mfging/Control Changes to an approved NADA/ANADA

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

99D-1738 Bioavilability & Bioequivalence Studies for Nasal Aerosols

C 13 3M Pharmaceuticals Vol#: 1

C 14 Anapharm Vol#: 1

99D-2013 Cooperative Manufacturing Arrangements for Licensed

C 4 America's Blood Centers Vol#: 1

C 5 Procter & Gamble Pharmaceuticals Vol#: 1

99D-2096 Interpreting Sameness of Monoclonal Antibody Products

C 2 Centocor Vol#: 1

99D-2638 Use of Medicated Feeds for Minor Species

C 2 Purina Mills, Inc Vol#: 1

99H-0047 Civil Money Penalties;Mary Obranovich,d/b/a M & G Store

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-0207 Civil Money Penalties; Center Street Foods Inc,d/b/a Giant

LET 2 Office of Tobacco Programs Vol#: 1

99H-0663 Civil Money Penalty; Spaceway Oil Co Inc d/b/a Spaceway Oil

LET 2 Office of Tobacco Programs Vol#: 1

99H-0666 Civil Money Penalty; Tomick Inc d/b/a/ Tomick Shell

ANS 1 Tomick Shell Vol#: 1

99H-0699 Civil Money Penalties;Nancy Adkins,d/b/a Nancy's Restaurant

LET 2 Office of Tobacco Programs Vol#: 1

99H-0878 Civil Money Penalties; Dell Oil Ltd,d/b/a Dell Oil

LET 2 Office of Tobacco Programs Vol#: 1

99H-0938 Civil Money Penalties;Dahir Brothers Inc,d/b/a Triangle

ANS 1 Dahir Brothers Inc,dba Lewis Grocery Vol#: 1

99H-1032 Civil Money Penalties;Bert Malone,d/b/a Lazy Lee's One Stop

MO 2 GCF-1 Vol#: 1

99H-1035 Civil Money Penalties;Gil Sullivan,d/b/a Sullivan Amoco

ANS 1 Sullivan Amoco Vol#: 1

99H-1121 Civil Money Penalties;Paks Inc,d/b/a Paks West Convenience

ANS 1 Paks Inc Vol#: 1

99H-1330 Civil Money Penalties;Caldwell's Inc,d/b/a Caldwell's Coasta

LET 2 Office of Tobacco Programs Vol#: 1

99H-1725 Civil Money Penalty;Joseph Finkelpearl,dba Melwood Drug Co

LET 2 Office of Tobacco Programs Vol#: 1

99H-2185 Civil Money Penalty;Ruggiano Ent Inc,dba Grantville Amoco

LET 2 Office of Tobacco Programs Vol#: 1

99H-2257 Civil Money Penalty;James Hudson,dba Hudco Superette

ANS 1 Hudco Superette Vol#: 1

99H-2320 Civil Money Penalty;Jimmy D Griffin,dba Tobacco Shoppe

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-2474 Civil Money Penalty;Kroger Limited Partnership I,dba King So

ANS 1 Kroger Corp. dba King Soopers Vol#: 1

99H-2494 Civil Money Penalty;IMS Group Inc,dba Quik Mart

LET 2 Office of Tobacco Programs Vol#: 1

99H-2520 Civil Money Penalty;Endicott Pharmacy Inc,dba Endicott Pharm

LET 2 Office of Tobacco Programs Vol#: 1

99H-2573 Civil Money Penalty;Ports Petroleum Company Inc,dba Fuel Mar

LET 2 Office of Tobacco Programs Vol#: 1

99H-2589 Civil Money Penalty;MFA Petroleum Company.dba Marston Fuel

LET 3 Office of Tobacco Programs Vol#: 1

99H-2658 Civil Money Penalty;Thigpen Inc,dba Night Rider Mart

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-2666 Civil Money Penalty;Dennis Yourczek,dba Newsette

ANS 1 Dennis Yourczek, dba Newsette Vol#: 1

99H-2687 Civil Money Penalty;Mohammad Butt,dba Ashna Getty Service St

LET 2 Office of Tobacco Programs Vol#: 1

99H-2689 Civil Money Penalty;Breezy Hill Enterprises Inc,dba Breezy

LET 2 Office of Tobacco Programs Vol#: 1

99H-2731 Civil Money Penalty;Tobacco Superstores Inc,dba Tobacco Supe

ANS 2 Tobacco Superstores Inc Vol#: 1

99H-2756 Civil Money Penalty;Preston Harden,dba Presto Food Store

ANS 1 Preston Harden, dba Presto Food Store Vol#: 1

99H-2761 Civil Money Penalty;Irvin Kohn & Juanita Kohn,dba North Pros

ANS 1 North Prosser Market Vol#: 1

99H-2765 Civil Money Penalty;Sixty One Quick Stop Inc,dba 61 Quick

ANS 1 Sixty One Quick Stop Inc Vol#: 1

99H-2772 Civil Money Penalty;Kellduff 5 and 10 Inc,dba Kellduff 5 &10

ANS 1 Killduff 5 & 10 Vol#: 1

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

99H-2780 Civil Money Penalty;Coastal Energy Co of Mississippi Inc

LET 2 Office of Tobacco Programs Vol#: 1

99H-2785 Civil Money Penalty;GMG Inc,dba Midlothia Citgo

LET 2 Office of Tobacco Programs Vol#: 1

99H-2804 Civil Money Penalty;Citizen's Fuel Co,dba Citizens Food Stor

MO 1 Citizens Fuel Co Vol#: 1

RMO 1 GCF-1 Vol#: 1

99H-2829 Civil Money Penalty;Mike Desmond,dba Desmond Deli

ANS 2 Mike Desmond Vol#: 1

99H-2843 Civil Money Penalty;Underwood Convenience Stores Inc,dba Und

ANS 1 Underwood Convenience Stores Inc Vol#: 1

99H-2848 Civil Money Penalty;Gas-N Grub Inc,dba Gas-N Grub

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

99H-2902 Civil Money Penalty;Pearson Lane & Stephanie Lane,dba Silver

ANS 1 Silverdale Grocery Vol#: 1

99H-2940 Civil Money Penalty;Azhar Shaikh,dba East Boston Shell

ANS 1 East Boston Shell Vol#: 1

99H-2981 Civil Money Penalty;Ekelund Enterprises Inc,dba Trout Liquor

ANS 1 Ekelund Ent Inc, dba Trout Liquors Vol#: 1

99H-2982 Civil Money Penalty;Ewing Oil Co inc,dba Williamsport Shell

ANS 1 Ewing Oil Co Inc, dba Williamsport Shell Vol#: 1

99H-3006 Civil Money Penalty;Dixie Pak-A-Sak Inc,dba Dixie Pak-A-Sak

ANS 1 Disie Pak-A-Sak Inc Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

99H-3008 Civil Money Penalty;Jerry Drake,dba Pak-A-way Food Mart

ANS 1 Jerry Drake, dba Pak-A-Way Food Mart Vol#: 1

99H-3014 Civil Money Penalty;Roswil Inc,dba Ramey's Supermarket

EXT 1 Roswil Inc,dba Ramey's Supermarket Vol#: 1

99H-3036 Civil Money Penalty;Detroit Auto Service Inc,dba Frederick

ANS 1 Frederick Sunoco Vol#: 1

99H-3048 Civil Money Penalty;Kevin Mick,dba Mick's Main Street Bar

ANS 1 Micki's Main Street Bar Vol#: 1

99H-3062 Civil Money Penalty;Billy L. Eckstine,dba Myersville Exxon

ANS 1 Myersville Exxon Vol#: 1

99H-3073 Civil Money Penalty;NAN Corporation,dba Kwik Way Store

ANS 1 NAN Corp Vol#: 1

99H-4008 Civil Money Penalty;Young Hee Choi,dba I Like Deli & Sundrie

LET 2 Office of Tobacco Programs Vol#: 1

99H-4072 Civil Money Penalty;Bell Ent Inc & Colais Foodstore Inc,dba

NPH 1 HHS/FDA/CDER Vol#: 1

99N-1415 Supplements and other changes to aproved NADA

NPR 1 Vol#: 1

99N-1502 Quality Mammography Standards

NFR 2 Vol#: 1

99N-1591 Animal Drug Availabililty Act; Veterinary Feed Directive

C 8 National Grain & Feed Association Vol#: 1

99N-2099 Classify subcutaneous implanted,intravascular infusion port

BKG 1 Background Vol#: 1

NPR 1 Vol#: 1

99N-2549 Cosmetic Product Voluntary Reporting Program

C 2 The Cosmetic, Toiletry & Fragrance Assn Vol#: 1

99N-4166 Proposed Collection Electronic Records;Electronic Signature

N 1 Vol#: 1

99N-4235 Practices in the dietary supplement industry survey

N 1 HFA-250 Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

ANS 3 HFV-12 to Ms Smith & Friends Vol#: 163

ANS 4 HFV-12 to Ted Leybold Vol#: 163

C 1704 Aliess Brady Vol#: 162

C 1705 Linda K Frances Vol#: 162

C 1706 Charles & Ann Burch Vol#: 162

C 1707 E B Morales Vol#: 162

C 1708 William R Hale MD Vol#: 162

C 1709 Sister Marcella Steffes Vol#: 162

C 1710 Madeline Sone & 6 signatures Vol#: 162

C 1711 Skijs Robinson & 4 signatures Vol#: 162

C 1712 Bernadette K Covach Vol#: 162

C 1713 Scott Crawford Vol#: 162

C 1714 Julie R Lassotovitch Vol#: 162

C 1715 Dr Paul C Schattauer Vol#: 162

C 1716 Robin Denman Vol#: 162

C 1717 Isabel Moore Vol#: 162

C 1718 Paula J Olch Vol#: 162

C 1719 Nancy Strong Vol#: 162

C 1720 Arleen Fraser Vol#: 162

C 1721 Judith P Edwards Vol#: 162

C 1722 Kathleen M Phelan Vol#: 162

C 1723 Mark M Giese Vol#: 162

C 1724 Shameem K Ghauri MD Vol#: 162

C 1725 Devera Black Vol#: 162

C 1726 Greg Edblom Vol#: 162

C 1727 Sue Juhre Vol#: 162

C 1728 Jill Kelly PhD Vol#: 162

C 1729 Lynn Olson Vol#: 162

C 1730 Beth Connor Vol#: 162

C 1731 Barbara Warner Vol#: 162

C 1732 Dorothea Harrington Vol#: 162

C 1733 Ms Cheri J Lager-Niewiara Vol#: 162

C 1734 Helen Howard Vol#: 162

C 1735 Julia Dashe Vol#: 162

C 1736 Sally Young Vol#: 162

C 1737 Susannah Fiering Vol#: 162

C 1738 Josephine Sippie-Gora Vol#: 162

C 1739 Laurie Donegan Vol#: 162

C 1740 Bobbie Potsic Vol#: 162

C 1741 Liz Tapp Vol#: 162

C 1742 Kathy Ivory Vol#: 162

C 1743 Susan Steffenhagen Vol#: 162

C 1744 Rosemarie H Tucker Vol#: 162

C 1745 Myrna Brown Vol#: 162

C 1746 R Howell Vol#: 162

C 1747 Virginia Townsend Vol#: 162

C 1748 M Sanderling & Robert Michels Vol#: 162

C 1749 Ramma Andre' Vol#: 162

C 1750 Irma B Roth Vol#: 162

C 1751 Clare Cahalan Vol#: 162

C 1752 Sherri Detweiler Vol#: 163

C 1753 Jennifer Latham & Jared Cvetas Vol#: 163

C 1754 Rochelle Golosman Vol#: 163

C 1755 Elizabeth Kinnon & Richard Mitchell Vol#: 163

C 1756 Christine Ziemnik Vol#: 163

C 1757 Maryanne Cramer Vol#: 163

C 1758 Federation of Animal Science Societies Vol#: 163

C 1759 Reba Bumble Vol#: 163

C 1760 Linda Jean Smith & Friends Vol#: 163

C 1761 Matthew A Roman Vol#: 163

C 1762 Howard Donovan Vol#: 163

C 1763 Ted Leybold Vol#: 163

C 1764 Linda Smith & S W Gregy Vol#: 163

C 1765 American Assoc of Bovine Practitioners Vol#: 163

EC 185 Lynne Parette Vol#: 163

EC 186 George Voellmer Vol#: 163

EC 187 Slaskoo Vol#: 163

EC 188 Joseph Bertulfo Vol#: 163

EC 189 Hannah MacLaren Vol#: 163

EC 190 Paula Cenami Vol#: 163

EC 191 Jeffrey A Brasch Vol#: 163

99P-2148 Label or Labeling of food ingredients and regulation

C 4 Lidia Pino Vol#: 1

99P-2630 Establish a Daily Value for "added sugars"

C 70 Judith Lytez Vol#: 1

C 71 Wena Dows Vol#: 1

C 72 Margaret Emerson Vol#: 1

C 73 Fred & Merrily Davies Vol#: 1

99V-4005 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Four Corners Entertainment, Inc. Vol#: 1

99V-4332 Laser Light Show Projector

ACK 1 HFA-305 Vol#: 1

VAR 1 United Laser Artists Inc. Vol#: 1

99V-4362 Laser Light Show, Mobolazer ML10-200,ML10-200,ML10-300,ML,10

ACK 1 HFA-305 Vol#: 1