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 September 14, 1999

Table of Contents

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

[FDA DOCKETS PAGE] [FDA HOME PAGE]

 
78N-0038 Sunscreen Drug Products*
80N-0042 Anticaries Drug Products for OTC Human Use *
80N-0295 OTC drug review policy statement*
84N-0102 Orphan Product Designations*
92N-0139 Statement Policy: Foods Derived from New Plant Varieties*
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability*
95S-0158 Community Disclosure of Institutional Review Boards*
96N-0244 Food Labeling; Declaration of Free Glutamate in Food*
96P-0215 Withdrawal Norplant's approval for sale in the United States*
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs*
97D-0318 Revised Precautionary Measure to Reduce Transmission ofCJD *
98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding*
98N-0581 Requirements for Testing Human Blood Donors *
98N-0607 General Requirements for Blood,Blood Components and Derivati*
98N-1215 Foreign Establishment Registration and Listing *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-0203 Eliminate Forced Molting of Laying Birds *
98P-0680 Amend reg re: sale & distribution of turtles & viable eggs *
98P-1121 Grated Parmesan Cheese Deviating from Identity standard*
99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA*
99D-1273 Medical Devices: Draft Guidance for FDA Staff on Civil Money*
99D-1718 Monoclonal Antibodies Used in Reagents in Drug Mfg *
99D-1878 Good Manufacturing Practice for Blood and Blood Components:*
99D-2213 Invalidation of test results when using licensed & 510(k)*
99D-2335 Guidance for Medical Gloves A workshop Manual *
99N-0193 Supplements and Other Changes to an Approved Application*
99N-1737 Clinical Trials for Invest Devices Intended to Treat Threat*
99N-2075 Reporting of Use Errors With Medical Devices *
99P-0301 Amend the Peanut Spread Regulations*
99P-0389 Abbreviated new drug application/topical dematological drug*
99P-1041 Temporary Marketing Permit Salad Dressing *
99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast*
99P-4064 Class II 510(K) Exemption Petition for Vascular Tunnelers*
99V-4005 Mobolazer ML10-200,ML10-300,ML10-300W, *
99V-4028 Laser Light Show Ar/kr LP1-1001, Ar - LP2 1002 *
99V-4065 Variance Application for Range Finder *
77N-094A Internal analgesic, antipyretic & antirheumatic drug

NCR 2 Vol#: 13

78N-0038 Sunscreen Drug Products

ANS 6 HFD-560 Vol#: 131

80N-0042 Anticaries Drug Products for OTC Human Use

PDN 5 HFD-560 Vol#: 31

80N-0295 OTC drug review policy statement

MM 118 HFD-560 & CTFA, CHCPA, Covington & Burli Vol#: 3

84N-0102 Orphan Product Designations

LST 88 August 1999 Vol#: 2

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

C 5874 Roger & Moinque Mendelson Vol#: 142

C 5875 Brigitte Capalbo Vol#: 142

C 5876 D G Kenny Vol#: 142

C 5877 Carol Holland Vol#: 142

C 5878 Arlene G Patterson Vol#: 142

C 5879 Anel Molina Vol#: 142

C 5880 Sharon M Schott Vol#: 142

C 5881 Richard Tren Vol#: 142

C 5882 A Very Concerned American Vol#: 142

C 5883 Yvette Ferreira Vol#: 142

C 5884 Jody Gordon Vol#: 142

C 5885 Deborah Vittner Vol#: 142

C 5886 Lynne Michalak Vol#: 142

C 5887 Sonja Anderson Vol#: 142

C 5888 Lucy Regan Vol#: 142

C 5889 Liza Molina Vol#: 146

C 5890 Leslyn M Dorris Vol#: 146

C 5891 Ed Gutierrez Vol#: 146

C 5892 Lauren Smith Vol#: 146

C 5893 Joseph F & Diane M Williams Vol#: 146

C 5894 Kelli & Eric Domke Vol#: 146

C 5895 Chholing P Taha Vol#: 146

C 5896 Leslie Taha Vol#: 146

C 5897 Mahatma Gandhi Vol#: 146

C 5898 Bonnie Dervin Vol#: 146

C 5899 Paul Patrick Vol#: 146

C 5900 Mario & Marion Sauling Vol#: 146

C 5901 Consumer Right to Know Vol#: 146

C 5902 John R Long Vol#: 146

C 5903 Barbara Atherton Vol#: 146

C 5904 Dr Maureen McNulty Vol#: 146

C 5905 Lucille S Blakely Vol#: 146

C 5906 D E Sache Vol#: 146

C 5907 Julie Anderson Vol#: 146

C 5908 Lise Nodeau Vol#: 146

C 5909 May Jennings & 5 signatures Vol#: 146

C 5910 Edward L Mass Vol#: 146

C 5911 Sarah E Pierce Vol#: 146

C 5912 Roxie S Volk & & signatures Vol#: 146

C 5913 Victoria Johnson Vol#: 146

C 5914 Arthur L Lazarovitz Vol#: 146

C 5915 Jacqueline Ross Vol#: 146

C 5916 Laura Rojas Vol#: 146

C 5917 Jodi Walter Vol#: 146

C 5918 Howard Spivak Vol#: 146

C 5919 Karen McCarthy Vol#: 146

EC 2 Crystal Siembida Vol#: 142

EC 3 Sheri Hartsfield Vol#: 142

EC 4 Janice & Christine Vol#: 142

EC 5 Suzanne Romey Vol#:

EC 6 Elizabeth Hamilton Vol#: 142

EC 7 Tracey Johnson Vol#: 142

EC 8 Elaine Kaufmann Vol#: 142

EC 9 Keith McGlone Vol#: 142

EC 10 Ronnie Cummins Vol#: 142

EC 11 Jeanine Cardella Vol#: 142

EC 12 Bob Loftus Vol#: 142

EC 13 Jack & Laurie Tepe Vol#: 142

EC 14 Dhymitruy Bouryiotis Vol#: 142

EC 15 Kathi Kibbel Vol#: 142

EC 16 Adventure Cruises Vol#: 142

EC 17 Adrienne Weller Vol#: 142

EC 18 Lisa Joire Vol#: 142

EC 19 Kay Stoltz Vol#: 142

EC 20 Sonja Vol#: 142

EC 21 Robin Rowe-Seifert Vol#: 142

EC 22 Karen Song Vol#: 142

EC 23 Adrianne Cook Vol#: 142

EC 24 Manus Dennison Vol#: 142

EC 25 George Bardosh Vol#: 146

EC 26 Starla Vol#: 146

EC 27 Jenifer G Kalamian Vol#: 146

EC 28 Karen Helser Thiry Vol#: 146

EC 29 Gordon Gagliano & Ursula Hegi Vol#: 146

EC 30 Michael Johnson Vol#: 146

EC 31 Christina Farsalas Vol#: 146

EC 32 Jaime M Vega Vol#: 146

EC 33 Hillary Hoffman Vol#: 146

EC 34 T Lee Vol#: 146

EC 35 Thomas R Schwerdt Vol#: 146

EC 36 Elka Oliver Vol#: 146

EC 37 Monica Thomas Vol#: 146

EC 38 Clark Hays Vol#: 146

EC 39 Joseph C Cerny Vol#: 146

94S-0120 510K Substantially Equivalent List

LST 86 August 1999 510k Monthly Vol#: 20

95F-0130 Safe Use of Polyethylene Terephthalate Polymers

EA 3 Shell Chemical Company Vol#: 1

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

C 3696 Rex A. Bryant, Sr & Annmarie F. Bryant Vol#: 291

95S-0158 Community Disclosure of Institutional Review Boards

SUP 20 Baxter INDA#6859 Vol#: 14

96N-0244 Food Labeling; Declaration of Free Glutamate in Food

C 612 Adrienne Samuels, Ph.D. Vol#: 17

96P-0215 Withdrawal Norplant's approval for sale in the United States

C 210 Melissa Burrows Vol#: 5

C 211 Stephen K. Carter Vol#: 5

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

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

C 229 Renee Spaziante Vol#: 9

C 230 Ruth H. Sosis Vol#: 9

C 231 Social Awarenesscom Vol#: 9

C 232 Social Awarenesscom Vol#: 9

C 233 Joe Miele Vol#: 9

C 234 Edith M. Jenkins Vol#: 9

C 235 Terence J. Simons Vol#: 9

C 236 Melissa & Larry O'Brien Vol#: 9

C 237 Joseph Mangine Vol#: 9

C 238 Nancy Koschmann Vol#: 9

C 239 Raina M. Spaziani Vol#: 9

C 240 Jo-Ann Polce Vol#: 9

C 241 Ms. J. Heller Vol#: 9

C 242 Ms. J. Heller Vol#: 9

C 243 Betty Rand Vol#: 9

C 244 Ms. Betsy Lampl Vol#: 9

C 245 Jamie Schaefer Vol#: 9

C 246 Allison E. Kirkpatrick Vol#: 10

C 247 Lisanne Lee Feldman Vol#: 10

C 248 Jamie Schaefer Vol#: 10

C 249 Saint John's Retreat Center Vol#: 10

C 250 Jessica R. Rogers Vol#: 10

C 251 Breitman Vol#: 10

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

C 2 University of Cambridge Vol#: 1

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

C 230 Renee Spaziante Vol#: 8

C 231 Ruth H. Sosis Vol#: 8

C 232 Social Awarenesscom Vol#: 8

C 233 Social Awarenesscom Vol#: 8

C 234 Joe Miele Vol#: 8

C 235 Edith M. Jenkins Vol#: 8

C 236 Terence J. Simons Vol#: 8

C 237 Melissa & Larry O'Brien Vol#: 8

C 238 Joseph Mangine Vol#: 8

C 239 Nancy Koschmann Vol#: 8

C 240 Raina M. Spaziani Vol#: 8

C 241 Jo-Ann Polce Vol#: 8

C 242 Ms. J. Heller Vol#: 8

C 243 Ms. J. Heller Vol#: 8

C 244 Betty Rand Vol#: 8

C 245 Ms. Betsy Lampl Vol#: 8

C 246 Jamie Schaefer Vol#: 8

C 247 Allison E. Kirkpatrick Vol#: 9

C 248 Lisanne Lee Feldman Vol#: 9

C 249 Jamie Schaefer Vol#: 9

C 250 Saint John's Retreat Center Vol#: 9

C 251 Jessica R. Rogers Vol#: 9

C 252 Breitman Vol#: 9

98D-0656 Abbreviated Rpts & Synopses in Support of Mktg Applications

GDL 2 HFD-6 Vol#: 1

NAD 2 Vol#: 1

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

C 150 Edelson Ctr for Environ & Prev Med Inc Vol#: 19

C 151 Edelson Ctr for Environ & Prev Med Inc Vol#: 19

C 152 Jana Nestlerode Vol#: 19

C 153 Edelson Ctr for Environ & Prev Med Inc Vol#: 19

98N-0572 Letters of Interest & Food Safety Data by Retail Operators

N 2 Vol#: 1

98N-0581 Requirements for Testing Human Blood Donors

C 1 Dartmouth-Hitchcock Medical Center Vol#: 1

C 2 Blood Bank Vol#: 1

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

C 1 Dartmounth-Hitchcock Medical Center Vol#: 1

98N-1215 Foreign Establishment Registration and Listing

C 19 Thomson & Nielsen Electronics Ltd Vol#: 1

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

C 229 Renee Spaziante Vol#: 12

C 230 Ruth H. Sosis Vol#: 12

C 231 Social Awarenesscom Vol#: 12

C 232 Social Awarenesscom Vol#: 12

C 233 Joe Miele Vol#: 12

C 234 Edith M. Jenkins Vol#: 12

C 235 Terence J. Simons Vol#: 12

C 236 Melissa & Larry O'Brien Vol#: 12

C 237 Joseph Mangine Vol#: 12

C 238 Nancy Koschmann Vol#: 12

C 239 Raina M. Spaziani Vol#: 12

C 240 Jo-Ann Polce Vol#: 12

C 241 Ms. J. Heller Vol#: 12

C 242 Ms. J. Heller Vol#: 12

C 243 Betty Rand Vol#: 12

C 244 Ms. Betsy Lampl Vol#: 12

C 245 Jamie Schaefer Vol#: 12

C 246 Allison E. Kirkpatrick Vol#: 13

C 247 Lisanne Lee Feldman Vol#: 13

C 248 Jamie Schaefer Vol#: 13

C 249 Saint John's Retreat Center Vol#: 13

C 250 Jessica R. Rogers Vol#: 13

C 251 Breitman Vol#: 13

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

C 2238 Peter & Pamela Sabatini Vol#: 64

98P-0203 Eliminate Forced Molting of Laying Birds

C 1811 April Hosty Vol#: 44

C 1812 Healther Sweeting Vol#: 44

C 1813 Des & Lorraine Smithson Vol#: 44

C 1814 Donna Matthews Vol#: 44

C 1815 Kim Kramer Vol#: 44

C 1816 Dale Anne Carter Vol#: 44

C 1817 K Mailly & B A Hons Vol#: 44

C 1818 Suzanne House Vol#: 44

C 1819 Karen Porter Vol#: 44

C 1820 Karl (Ireland) Vol#: 44

C 1821 James P Jones Vol#: 44

C 1822 D M Hulme Vol#: 44

C 1823 Chris Lucy Vol#: 44

C 1824 Robert Mahon Vol#: 44

C 1825 Jo Billings Vol#: 44

C 1826 Dona Schiava Vol#: 44

C 1827 The Johnson Family Vol#: 44

C 1828 Mrs Muriel Wall Vol#: 44

C 1829 R Thompson Vol#: 44

C 1830 Stacey D Leichman Vol#: 44

C 1831 Ms N J Nokes Vol#: 44

EC 1 Arian B Royer Vol#: 44

98P-0680 Amend reg re: sale & distribution of turtles & viable eggs

C 21 Richard Fife Vol#: 1

98P-1121 Grated Parmesan Cheese Deviating from Identity standard

C 1 Kraft Foods, Inc. Vol#: 1

99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA

C 30 National Assn of Pharmaceutical Manuf Vol#: 3

C 31 Intl Pharmaceutical Excipients Council Vol#: 3

C 32 HEALTHPOINT Vol#: 3

C 33 GlaxoWellcome Vol#: 3

C 34 The R.W. Johnson Pharmaceutical Res Inst Vol#: 3

99D-1273 Medical Devices: Draft Guidance for FDA Staff on Civil Money

C 1 Health Industry Manuf Assn Vol#: 1

99D-1718 Monoclonal Antibodies Used in Reagents in Drug Mfg

C 1 Lilly Research Laboratories Vol#: 1

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

C 27 Baptist Health Vol#: 1

99D-2213 Invalidation of test results when using licensed & 510(k)

C 1 Dartmouth-Hitchcock Medical Center Vol#: 1

99D-2335 Guidance for Medical Gloves A workshop Manual

C 1 NAMSA Vol#: 1

99F-2997 Filing of Food Additive Petition

NFL 1 Engelhard Corp. Vol#: 1

99F-3087 Sodium Stearoyl Lactylate

NFL 1 American Ingredietns Co. Vol#: 1

99H-0675 Civil Money Penalties;Hamrick's Inc,d/b/a Carousel Liquor

LET 3 Hamrick's Inc. Vol#: 1

99H-1448 Civil Money Penalties;Donald German,d/b/a The Alibi

CS 2 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2596 Civil Money Penalty;Clinkoco Inc,dba Clinkoco #5

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-2597 Civil Money Penalty;Clinkoco Inc,dba Clinkoco #6

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-2602 Civil Money Penalty;David James,dba James Grocery & Service

ANS 1 James Grocery & Service Station Vol#: 1

99H-2693 Civil Money Penalty;Frankie Wayne Jordan,dba Lucern Country

ANS 1 Lucern Country Store Vol#: 1

99H-2749 Civil Money Penalty;Andlar Ent Inc,dba Fast Break Food Mart

ANS 1 Andlar Enterprises Incrams Vol#: 1

99H-2855 Civil Money Penalty;Coloradopongas Inc,dba Coloradopongas

ANS 1 Coloradopongas Vol#: 1

99H-2903 Civil Money Penalty;Pearsons Supermarket Inc,dba Pearsons Su

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2904 Civil Money Penalty;Speedway Superamerica LLC,dba Superameri

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-2905

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99N-0193 Supplements and Other Changes to an Approved Application

C 12 Daniel Kearns Vol#: 2

99N-1174 Development of Strategy for Dietary Supplements

C 59 Institute of Food Technologists Vol#: 6

99N-1737 Clinical Trials for Invest Devices Intended to Treat Threat

C 12 Steven Peckman Vol#: 1

C 13 Oklahoma State Dept of Health Vol#: 1

99N-2075 Reporting of Use Errors With Medical Devices

C 1 Zymed Inc Vol#: 1

99P-0301 Amend the Peanut Spread Regulations

C 4 The State University of N.J. Rutgers Vol#: 1

LET 1 HFS-151 to The Proctor & Gamble Company Vol#: 1

99P-0389 Abbreviated new drug application/topical dematological drug

LET 1 HFD-001 to Glaxo Wellcome Inc Vol#: 1

99P-1041 Temporary Marketing Permit Salad Dressing

LET 7 Kraft Foods, Inc. Vol#: 1

99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast

C 2 Marjory Donn Vol#: 3

EC 3 Trudy Kazlov Vol#: 3

EC 4 Douglas E. Wingeier Vol#: 3

99P-4064 Class II 510(K) Exemption Petition for Vascular Tunnelers

ACK 1 HFA-305 Vol#: 1

CP 1 IMPRA, Inc. Vol#: 1

99V-4005 Mobolazer ML10-200,ML10-300,ML10-300W, ML10-1000ML10-1.G, ML

ACK 1 HFA-305 Vol#: 1

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

99V-4028 Laser Light Show Ar/kr LP1-1001, Ar - LP2 1002

ACK 1 HFA-305 Vol#: 1

99V-4065 Variance Application for Range Finder

ACK 1 HFA-305 Vol#: 1

VAR 1 FLIR Systems Boston Vol#: 1