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 Us]

DOCKETS ENTERED on August 22, 2000

TABLE OF CONTENTS

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88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE *
92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992 *
98N-1038 Irradiation in the production, processing, &handling of food *
99F-0187 Neotame - Filing of Food Additive Petition (FAP 9A4643) *
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal *
00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1468 ANDA for Sertraline Hydrochloride Capsules 25mg, 50mg & 100m *
00V-1469 Laser Light Show *

88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

C 137 Kelly's Medical Equipment & Supply Vol#: 5

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

C 122 Kelly's Medical Equipment & Supply Vol#: 5

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

C 5184 Adriana Valencoa Vol#: 151

C 5185 Terry Bruegger Vol#: 151

C 5186 Zola Cranford Vol#: 151

C 5187 Susan Robin Vol#: 151

C 5188 Hunter Lewis Vol#: 151

EMC 214 Danaandjen Vol#: 151

EMC 215 Elle Griswold Vol#: 151

EMC 216 Borge Hojlund Jensen Vol#: 151

EMC 217 Dr. Elsa & Walter Verderber Vol#: 151

EMC 218 Ann Fonfa Vol#: 151

EMC 219 Tom Vol#: 151

EMC 220 Dolores Tippett Vol#: 151

EMC 221 Patris1234 Vol#: 151

EMC 222 David A. Harbster Vol#: 151

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

C 4 Hartman & Craven LLp Vol#: 1

00N-1256 Over-the-Counter Drug Products;Public Hearing

CH 395 Paula Spoem Vol#: 17

CH 396 Christie Joachim Vol#: 17

CH 397 Christie Joachim Vol#: 17

CH 398 Margo McNeil Vol#: 17

CH 399 Jill Rosenthal Vol#: 17

CH 400 Maryann Russell Vol#: 17

CH 401 Mike Shannon Vol#: 17

CH 402 Karen L. Tatum Vol#: 17

CH 403 Scott Miller Vol#: 17

CH 404 Karen Lin Vol#: 17

CH 405 Suzan Hudak Vol#: 17

CH 406 Elizabeth T. Weiss, MD Vol#: 17

CH 407 Meredith Perkins Vol#: 17

CH 408 Eva M. Downs Vol#: 17

CH 409 Andy Meyer Vol#: 17

CH 410 Planned Parenthood Vol#: 17

CH 411 Yael Swica Vol#: 17

CH 412 Rose Moore Vol#: 17

00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal

C 13 Global Resource Action Ctr for the Envir Vol#: 4

C 14 Produce Marketing Assoc (PMA) Vol#: 4

C 15 Tropicana Products Inc Vol#: 4

C 16 Stanislaus Food Products Vol#: 4

C 17 Minute Maid Co Vol#: 4

C 18 American Bakers Assoc (ABA) Vol#: 4

C 19 Fresh Juice Company Vol#: 5

C 20 National Fisheries Institute Vol#: 4

C 21 National Consumers League (NCL & CFA) Vol#: 4

C 22 Consumers United for Food Safety (CUFFS) Vol#: 4

EMC 36 Robert N Carr Jr Vol#: 4

EMC 37 Alison S Johnson Vol#: 4

EMC 38 Imbroglio Cures Inc Vol#: 4

EMC 39 Lorelle Guentz Vol#: 4
 

0N-1364 Prescription Drug User Fee Act (PDUFA) Public Meeting

EAPE33 Consumer Federation of America Vol#: 1

EAPE34 Komen Foundation Vol#: 1

EAPE35 Baxter Healthcare Vol#: 1

EAPE36 Aventis Pharmaceticals Vol#: 1

EAPE37 Animal Health Institute Vol#: 1

EAPE38 Health Policy Consultant Vol#: 1

EAPE39 American Society of Health-System Pharma Vol#: 1

EAPE40 Bayer Vol#: 1

EAPE41 Y-ME National Breast Cancer Organization Vol#: 1

EAPE42 R.W. Johnson Pharmaceutical Research Ins Vol#: 1

EAPE43 R.W.Johnson Pharmaceutical Research Inst Vol#: 1

EAPE44 Pharmacia Vol#: 1

00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair

C 21 Dept of Orthopaedic Surgery Vol#: 1

EXT 3 King & Spalding Vol#: 1

EXT 4 Orthopedic Surgical Manufacturers Assoc Vol#: 1

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 4772 Connie O'Strand Vol#: 194

C 4773 Jasen Worden Vol#: 194

C 4774 Maureen Mulcrone Vol#: 194

C 4775 Doris & Gene Peters Vol#: 194

C 4776 Jeff Evensen Vol#: 194

C 4777 Ms. Madelaine Gray Vol#: 194

C 4778 Rupert Bullard Vol#: 194

C 4779 Lisa St. Clair Haney Vol#: 194

C 4780 Katherine Herndon Vol#: 194

C 4781 Consumer Vol#: 194

C 4782 Marcia Gale Vol#: 194

C 4783 Heike I. Albers Vol#: 194

C 4784 Marian Porter Vol#: 194

C 4785 Heather Winkel Vol#: 194

C 4786 Chris Dyess Vol#: 194

C 4787 Karen Russell Vol#: 194

C 4788 Mrs. W. Pangman Vol#: 194

C 4789 Susannah Fisherman-Phillips Vol#: 194

C 4790 Valerie Morris Vol#: 194

C 4791 Mr & Mrs W. Kienzle Vol#: 194

C 4792 Bob Smith Vol#: 194

C 4793 Hal R. Helms Vol#: 194

C 4794 Laurie Stern Vol#: 194

C 4795 Arline Savage Vol#: 194

C 4796 Iris Uhlar Vol#: 194

C 4797 Jamie Badmura Vol#: 194

C 4798 Lea Reppart Vol#: 194

C 4799 Carol Underwood Vol#: 194

C 4800 Andrew Belco Vol#: 194

C 4801 Carrie Sark Vol#: 194

C 4802 Rev. L. Smith Vol#: 194

C 4803 Lisa Clark Vol#: 194

C 4804 Christine Spix Vol#: 194

C 4805 Marlene August Vol#: 194

C 4806 Nancy Kinwen Vol#: 194

C 4807 Fianula Trainer Vol#: 194

C 4808 Maureen Weilard Vol#: 194

C 4809 Kirklin Morris Vol#: 194

C 4810 Gerald F. Lampe Vol#: 194

C 4811 Cathy Kijek Vol#: 194

C 4812 Anthony S. Weiland Vol#: 194

C 4813 Lois Lampe Vol#: 194

C 4814 Kenneth J. Raspberry Vol#: 194

C 4815 Jennifer L. Ardis Vol#: 194

C 4816 Elizabeth Wayne Vol#: 194

C 4817 Matt Smith Vol#: 194

C 4818 Leslie Crowe Vol#: 194

C 4819 Gwen Redd Vol#: 194

C 4820 Brandy Copeland Vol#: 194

C 4821 Tim Brouhard Vol#: 194

C 4822 Peter Kalroda Vol#: 194

C 4823 Colleen Daley Vol#: 194

C 4824 Sky Mikinak Vol#: 194

C 4825 Cynthia Klose Vol#: 194

C 4826 Kaidi Lee Miller Vol#: 194

C 4827 S. Edwards Vol#: 194

C 4828 Moudian Larryetti Vol#: 194

C 4829 Diane Nabor Vol#: 194

C 4830 Dennis Nabor Vol#: 194

C 4831 Elizabeth Coletti Vol#: 194

C 4832 Kristine Grey Vol#: 194

C 4833 Michelle Grzyuacz Vol#: 194

C 4834 Renee & Andria Philippe Vol#: 194

C 4835 R. Boehorer Vol#: 194

C 4836 Peggy R. Vaughn Vol#: 194

C 4837 Anne Evensen Vol#: 194

C 4838 Kelly Cortilias Vol#: 194

C 4839 Cathie Courter Vol#: 194

C 4840 Ronald Barone Vol#: 194

C 4841 Patricia R. Low Vol#: 194

C 4842 Josephine T. Shore Vol#: 194

C 4843 Amy Doran Vol#: 194

C 4844 Rebecca Amyot Vol#: 194

C 4845 Bill Henderson Vol#: 194

C 4846 S. Finnigan Vol#: 194

C 4847 Diane Henderson Vol#: 194

EMC 1805 Jo Hayward-Haines Vol#: 194

EMC 1806 Dolly Shaffner Vol#: 194

EMC 1807 Jodi Hesse Vol#: 194

EMC 1808 Christine Thuau Vol#: 194

EMC 1809 Leona Brandwene Vol#: 194

EMC 1810 Bette Rice Vol#: 194

EMC 1811 Jennifer Dillon Vol#: 194

EMC 1812 Susan Frikken Vol#: 194

EMC 1813 Cathy Sinclair Vol#: 194

EMC 1814 Patti See Vol#: 194

EMC 1815 Barbara Armstrong Vol#: 194

EMC 1816 Bryna Dunn Vol#: 194

EMC 1817 Lauryn Fischer Vol#: 194

EMC 1818 Maryan Moon Vol#: 194

EMC 1819 Luanna Barnett Vol#: 194

EMC 1820 Joe Dalessandro Vol#: 194

EMC 1821 Riett Jacks Vol#: 194

EMC 1822 Inese Holte Vol#: 194

EMC 1823 Myrna Kitchens Vol#: 194

EMC 1824 Roxanne Robbin Vol#: 194

EMC 1825 Rita Chapple Vol#: 194

EMC 1826 Erik Frye Vol#: 194

EMC 1827 Debra & Timothy Smith Vol#: 194

EMC 1828 Kathryn Gordon Vol#: 194

EMC 1829 Portia Mottola Vol#: 194

EMC 1830 Eliz Terplan Vol#: 194

EMC 1831 Katie Saylor Vol#: 194

EMC 1832 Scholl Bernard Vol#: 194

EMC 1833 David Freyer Vol#: 194

EMC 1834 Katherine Manville Vol#: 194

EMC 1835 Dale Albertson Vol#: 194

EMC 1836 Joseph G. McCool Vol#: 194

EMC 1837 Summer Jarvis Vol#: 194

EMC 1838 Lanora Kelley Vol#: 194

EMC 1839 Lydia LaFleur Vol#: 194

EMC 1840 Cheryl Dunn Vol#: 194

EMC 1841 Michelle Smith Vol#: 194

EMC 1842 Michelle Van Gores Vol#: 194

EMC 1843 Adrian Smith Vol#: 194

EMC 1844 Sara Tashker Vol#: 194

EMC 1845 B. R. Brown Vol#: 194

EMC 1846 Jill Rosenthal Vol#: 194

EMC 1847 Emily Bartok Vol#: 194

EMC 1848 Mary Ann Cunningham Vol#: 194

EMC 1849 Nota Lucas Vol#: 194

EMC 1850 Dick Burrows Vol#: 194

EMC 1851 Alisa Pronovost Vol#: 194

EMC 1852 Marco Ramos Vol#: 194

EMC 1853 Tamera Flores Vol#: 194

EMC 1854 Donna Hoaglin Vol#: 194

EMC 1855 Jen Sarkisian Vol#: 194

EMC 1856 Michelle Avolio Vol#: 194

EMC 1857 James Austin Vol#: 194

EMC 1858 Yvonne Rousseau Vol#: 194

EMC 1859 Shirley Emerson Vol#: 194

EMC 1860 Linda Schiller-Hanna Vol#: 194

EMC 1861 Leanne Dalderis Vol#: 194

EMC 1862 Gregg Izzo Vol#: 194

EMC 1863 Kat Bradley-Bennett Vol#: 194

EMC 1864 Rodijah Peters Vol#: 194

EMC 1865 Dr. Andrew C. Millard Vol#: 194

EMC 1866 Thomas Kiernan Vol#: 194

EMC 1867 Jesse Gore Vol#: 194

EMC 1868 Barbara Esposito Vol#: 194

EMC 1869 Tibor Flothmann Vol#: 194

EMC 1870 Becky Greenhalgh Vol#: 194

EMC 1871 Gene Derig Vol#: 194

EMC 1872 Jennifer Baccellieri Vol#: 194

EMC 1873 Sandy Smith Vol#: 194

EMC 1874 Celeste Nicolls Vol#: 194

EMC 1875 Dawn Wrench Vol#: 194

EMC 1876 Thomas Farnam Vol#: 194

EMC 1877 Glenn Giddings Vol#: 194

EMC 1878 Andrea Tietmeyer Vol#: 194

EMC 1879 Christine Nye Vol#: 194

EMC 1880 Ginny Hodgkins Vol#: 194

EMC 1881 Kelly Morris Vol#: 194

EMC 1882 Edwin Lainhart Vol#: 194

EMC 1883 Jacqueline Rosine Vol#: 194

EMC 1884 Jason Hardy Vol#: 194

EMC 1885 Kathy Davey Vol#: 194

EMC 1886 Julie Dempsey Vol#: 194

EMC 1887 Ruth Giorgis Vol#: 194

EMC 1888 Diane Hanzel Vol#: 194

EMC 1889 Judith L. Bourne Vol#: 194

EMC 1890 Margaret Reed Vol#: 194

EMC 1891 Sanford Roen Vol#: 194

EMC 1892 Cheryl Vallone Vol#: 194

EMC 1893 Russell Engebretson Vol#: 194

EMC 1894 Anne Pearson Vol#: 194

EMC 1895 Sarah Caldwell Vol#: 194

EMC 1896 Billy Otten Vol#: 194

EMC 1897 Lynn Hays Vol#: 194

EMC 1898 Sam Tsembides Vol#: 194

EMC 1899 Stacy Wolff Vol#: 194

EMC 1900 Alan Shalloway Vol#: 194

00P-1468 ANDA for Sertraline Hydrochloride Capsules 25mg, 50mg & 100m

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultant Services, Inc. Vol#: 1

00V-1469 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 ZooBar,Inc Vol#: 1
 
 
Page Updated January 6, 2005