DOCKETS ENTERED on 03/02/00

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 March 2, 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 ]

94P-0354 Certify Mercury/Silver (amalgam)-Classify & Issue Warning *
95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *
97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container *
98P-0561 Amend Labeling about Viagra to include warnings*
99D-5047 Industry on Pharmacokinetics in Patients with Impaired Hepat *
99N-2637 Public Information Regulations *
99N-4491 Reuse of Single Use Devices proposal*
99N-4784 Redacted Version of Substantially-Equivalent Premarket Notif *
99P-1267 ANDA Suitability for Clozapine tablets 12.5mg*
99P-1268 ANDA Suitability for Clozapine Tablets, 200mg*
99P-1589 Stay effective date of approval for NDA 20-932 Roxicodone *
99P-2778 Adopt a policy of publicizing on the internet certain info *
99P-4108 Exempt Performance Std Electrode Lead Wires & Patient Cables *
99P-5109 Stay filing or review of NDA for ferric hydroxy saccharate *
00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization *
00V-0877 Laser Light Show*
00V-0878 *

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

C 1544 Gabungan Pengusaha Kelapa Sawit Indonesi Vol#: 46

C 1545 Ann E. Barcus Vol#: 46

C 1546 Amy AC Salsgiver Vol#: 46

C 1547 Mr. & Mrs. M. Mercaldo Vol#: 46

C 1548 Lesley Raney Vol#: 46

C 1549 Edgar T. Busch Vol#: 46

C 1550 Christina J. Anderson Vol#: 46

C 1551 Assn of Public Hlth State & Territorial Vol#: 46

C 1552 J. Scott Stallings Vol#: 46

C 1553 William D. Anderson Vol#: 46

C 1554 Allan & Marla Farber Vol#: 46

C 1555 Jane Erickson Vol#: 46

C 1556 Elizabeth A. Factor Vol#: 46

C 1557 Ernest F. Low Vol#: 46

C 1558 Mrs. Julia Forrest Vol#: 46

C 1559 Walt & Susie Flora Vol#: 46

C 1560 R. E. James Vol#: 46

C 1561 Lanelle Montgomery Vol#: 46

C 1562 Doris Ludwig Vol#: 46

C 1563 Alan L. Dertinger Vol#: 46

C 1564 Joy Rialson Vol#: 46

C 1565 Sally Cancelmo Vol#: 46

C 1566 Helen Jean Mouat Maas Vol#: 46

C 1567 Kris Muller Vol#: 46

C 1568 Bruce Lerner Vol#: 46

C 1569 Walter F. Mays Vol#: 46

C 1570 Elsie H. Bogosian Vol#: 46

C 1571 Richard Schaeffer Vol#: 46

C 1572 Lois Buckley Vol#: 46

C 1573 Tia Streeter Vol#: 46

C 1574 Merry Blake Vol#: 46

C 1575 Maria Huerta Vol#: 46

C 1576 Inter-Tribal Council of Nevada Vol#: 46

C 1577 Avril S. Rose Vol#: 46

C 1578 Mark A. McGuire (11 Signatures) Vol#: 46

C 1579 Jeanne J. Fotorny Vol#: 46

C 1580 Dale Tillman Vol#: 46

C 1581 Dolores C. Myrick Vol#: 46

C 1582 Fred Miller Vol#: 46

C 1583 Elaine R. Langley Vol#: 46

C 1584 Lois Neher Vol#: 46

C 1585 Linda Filippi Vol#: 46

C 1586 Alicia Wong Vol#: 46

C 1587 Marion J. Franks Vol#: 46

C 1588 Jill Stoecker Vol#: 46

C 1589 Nancy Sebastian Vol#: 46

C 1590 Brigham & Womens Hospital Vol#: 46

C 1591 Mr. & Mrs. Daniel Demarta Vol#: 46

C 1592 Louise M. De Mar Vol#: 46

C 1593 Bill Cain Vol#: 46

C 1594 Mr. & Mrs. Thomas Weatherall Vol#: 46

C 1595 Bonnie H. King Vol#: 46

C 1596 Dorit Flowers Vol#: 46

C 1597 Donald V. Buttenhein Vol#: 46

C 1598 Ruth Harte Vol#: 46

C 1599 Lois Ericson Vol#: 46

C 1600 Anna E. Berardi Vol#: 46

C 1601 Lothar L. Kahn Vol#: 46

C 1602 Pusat Penelitian Kelapa Sawit (PPKS) Vol#: 46

C 1603 H. M. Hubrecht Vol#: 46

C 1604 Richard A. Reeves Vol#: 46

C 1605 Northwestern Michigan College Vol#: 46

C 1606 J. Prajapati Vol#: 46

C 1607 Timothy P. Morton Sr Vol#: 46

C 1608 Mary Cahill Vol#: 46

C 1609 Marguerite H. Watson Vol#: 46

C 1610 John R. Marinucci Vol#: 46

C 1611 Duane Bickell Vol#: 46

C 1612 Patrice A. Esse Vol#: 46

C 1613 Kathryn Surber Vol#: 46

C 1614 Beverly & William E. Plichts Vol#: 46

C 1615 Marilyn Zimmerman Vol#: 46

C 1616 Muriel Anderson Vol#: 46

C 1617 Departemen Kehutanan Perkebunan Vol#: 46

C 1618 Robert E. Roehrs, Ph.D Vol#: 46

C 1619 Bernice Schneider Vol#: 46

C 1620 Margaret Sprissler Vol#: 46

C 1621 Charles Urban Vol#: 46

C 1622 Robert A & Roberta L Cekay & M.E. Morin Vol#: 46

C 1623 Heidi Kammer Vol#: 46

C 1624 Kathleen Mullin Vol#: 46

C 1625 Karen Winters Vol#: 47

C 1626 H. L. Tuck Vol#: 47

C 1627 Ryan Rakonizay Vol#: 47

C 1628 Laura Kares Vol#: 47

C 1629 Natalie Ramon Vol#: 47

C 1630 Ilsemarie Caspar Vol#: 47

C 1631 Jennie Bahr Vol#: 47

C 1632 Southern Cotton Oil Co. Vol#: 47

C 1633 Marilyn J. Reese Vol#: 47

C 1634 Norman R. Lindskog Vol#: 47

C 1635 David & Sandy Prebenda Vol#: 47

C 1636 Paul Van Dyken Vol#: 47

C 1637 Lilli Lindsay Vol#: 47

C 1638 Janet Marsden Vol#: 47

C 1639 Kristine Asburry Vol#: 47

C 1640 Delta Oil Mill Vol#: 47

C 1641 Martha Walters Vol#: 47

C 1642 Wanda F. Cedar Vol#: 47

C 1643 Laura Schreiber Vol#: 47

C 1644 John M. Kirby Vol#: 47

C 1645 Emory University School of Medicine Vol#: 47

C 1646 Patricia Bason Vol#: 47

C 1647 The Center for Natural Medicine Vol#: 47

C 1648 American Dairy Science Assn Vol#: 47

C 1649 Sandra T. Cutter Vol#: 47

C 1650 PT. Amp Plantation Vol#: 47

C 1651 Virginia P. Hewes Vol#: 47

C 1652 Joanne C. Ray Vol#: 47

C 1653 Sister Leonore Britt Vol#: 47

C 1654 Thomas Renaud Vol#: 47

C 1655 Carol Baylous Vol#: 47

C 1656 Fay Wells Vol#: 47

C 1657 Jolynn Werner Vol#: 47

C 1658 Douglas Saltmarsh Vol#: 47

C 1659 June Linkous Parker Vol#: 47

C 1660 No Signature Vol#: 47

C 1661 Jean Leonard Vol#: 47

C 1662 R. Ley Vol#: 47

C 1663 Elise Felton Vol#: 47

C 1664 Selma M. King Vol#: 47

C 1665 Julius English Vol#: 47

C 1666 Mary H. Swartzmiller Vol#: 47

C 1667 Dieter & Ulrike Beck Vol#: 47

C 1668 Richard Ginkel Vol#: 47

C 1669 William J. Mason Vol#: 47

C 1670 Department of Health Vol#: 47

C 1671 Tammy Sinclair Vol#: 47

C 1672 Mary G. Hesse Vol#: 47

C 1673 Patricia Schopps Vol#: 47

C 1674 Harriet Korcek Vol#: 47

C 1675 Sonya Haimann Vol#: 47

C 1676 Southern Cotton Oil Vol#: 47

C 1677 Robert Renwick Vol#: 47

C 1678 V. L. Moore Vol#: 47

C 1679 R. A. Wallace Vol#: 47

C 1680 Malcolm & Carolyn Graham Vol#: 47

C 1681 Elaine Javetz Vol#: 47

C 1682 Andrea M. Mills Vol#: 47

C 1683 Betty J. Gustafson Vol#: 47

C 1684 Rennie Dorfman Vol#: 47

C 1685 Donna L. Rickerby Vol#: 47

C 1686 M. Bond Vol#: 47

C 1687 University of California Vol#: 47

C 1688 Lola Conrad Vol#: 47

C 1689 Sarah Shaw Vol#: 48

C 1690 Barbara Hudson Vol#: 48

C 1691 Bill Hague Vol#: 48

C 1692 Carol Field Vol#: 48

C 1693 Mary Jo & Bill Cornell Vol#: 48

C 1694 Maccabee Seed Company Vol#: 48

C 1695 Barbara Steinkraus Vol#: 48

C 1696 Regina Bock Vol#: 48

C 1697 Bobbie Flowers Vol#: 48

C 1698 Carolyn Grossman Vol#: 48

C 1699 Marian Anderson Vol#: 48

C 1700 Lois Biemiller Vol#: 48

C 1701 Richard L. Meagher Vol#: 48

C 1702 Bobbie D. Flowers Vol#: 48

C 1703 Elizabeth J. Anderson Vol#: 48

C 1704 Marguerite M. Smith Vol#: 48

C 1705 Phyllis Brocato Vol#: 48

C 1706 Evelyn Simms Vol#: 48

C 1707 Susan M Tumulty Vol#: 48

C 1708 Pat Sarknas Vol#: 48

C 1709 S. K. Coburn Vol#: 48

C 1710 Veronica Mayer Vol#: 48

C 1711 Francis C. Megaro Vol#: 48

C 1712 Rene Rannou Vol#: 48

C 1713 Andrew H. Duhaime Vol#: 48

C 1714 Philip H. Dolinsky Vol#: 48

C 1715 Dolores V. Boot Vol#: 48

C 1716 J. C. Rigney Vol#: 48

C 1717 Alice Terry Vol#: 48

C 1718 Jeannine Kriesel Vol#: 48

C 1719 Joan Allen Vol#: 48

C 1720 Richard H. Fleischer Vol#: 48

C 1721 Ruth & Bob Stephan Vol#: 48

C 1722 Vincent J. Cole Vol#: 48

C 1723 G. H. Hunter Vol#: 48

C 1724 William R. Lawson Vol#: 48

C 1725 Eunice P. Knott Vol#: 48

C 1726 David & Patricia Hall Vol#: 48

C 1727 Gertrude Moskowitz Vol#: 48

C 1728 Kathy, Wayne & Margaret Harper Vol#: 48

C 1729 Michael D. Payne Vol#: 48

C 1730 Carol A. Engle Vol#: 48

C 1731 Cheri Bergeron Vol#: 48

C 1732 Barbara K. Young Vol#: 48

C 1733 Red Oak Cardiovascular Center Vol#: 48

C 1734 Amanda Cheramie Vol#: 48

C 1735 Marcene Carre Vol#: 48

C 1736 Pamela J. Lane Vol#: 48

C 1737 Janice Chantland Vol#: 48

C 1738 Glenn Marshall Vol#: 48

C 1739 Lucy McManis Hickey Vol#: 48

C 1740 Maureen Stephenson Vol#: 48

C 1741 Hartsville Oil Mill Vol#: 48

C 1742 Pyco Industries, Inc Vol#: 48

C 1743 Kingsburg Cotton Oil Co. Vol#: 48

C 1744 Bobbi R. Lewis Nutrition Therapist Vol#: 48

C 1745 Rudelle Rand Vol#: 48

C 1746 Irene E. Ikeda Vol#: 48

EMC 335 Bill & Elaine Campbell Vol#: 47

EMC 336 Miller Vol#: 47

EMC 337 NaDara Holman Vol#: 47

EMC 338 Bonnie Wall Vol#: 47

EMC 339 Lyllis Ling Vol#: 47

EMC 340 Larry Jackson Vol#: 47

EMC 341 Roy P. Greene Vol#: 47

EMC 342 Tracee A. Knott Vol#: 47

EMC 343 Debra Holt Vol#: 47

EMC 344 Dianne Nagler Vol#: 47

EMC 345 Mary Alice Wetzel Vol#: 47

EMC 346 Tom Harvey Vol#: 47

EMC 347 Paul A. Vance, Jr. Vol#: 47

EMC 348 Kathryn M. Nudd Vol#: 47

EMC 349 Larry & Sarah Bartenstein Vol#: 47

EMC 350 Thurston Matthews Vol#: 47

EMC 351 No Name Vol#: 47

EMC 352 Cathy Achino Vol#: 47

EMC 353 George G. McKhann Jr Vol#: 47

EMC 354 Barbara Ulman Vol#: 47

EMC 355 Dr. Sugih Wanasuria Vol#: 47

EMC 356 Bev Ransom Vol#: 47

EMC 357 Pt. Smart Tbk Vol#: 48

EMC 358 PT. IVO MAS Vol#: 48

EMC 359 PT. TEGUH SEMPURNA Vol#: 48

EMC 360 PT. ANEKA INTIPERSADA Vol#: 48

EMC 361 PT. LANGGENG MUARAMAKMUR Vol#: 48

EMC 362 PT. INDOTRUBA TENGAH Vol#: 48

EMC 363 PT. LAGUNA MANDIRI Vol#: 48

EMC 364 PT. INDRIPLANT Vol#: 48

EMC 365 PT. Gunung Mas Raya Vol#: 48

EMC 366 PT. Cibaliung Tunggal Plantations Vol#: 48

EMC 367 PT. Bersama Sejahtera Sakti Vol#: 48

EMC 368 PT. Bina Sains Corporation Vol#: 48

EMC 369 PT. Indotruba Tengah Vol#: 48

EMC 370 PT. Lahan Tani Sakti Vol#: 48

EMC 371 PT. Kridatama Lancar Vol#: 48

EMC 372 PT. Paripurna Swakarsa Vol#: 48

EMC 373 PT. Swadaya Andika Vol#: 48

EMC 374 PT. Salim Ivomas Pratama Vol#: 48

EMC 375 PT. Tunggal Mitra Plantations Vol#: 48

EMC 376 PT. Serikat Putra Vol#: 48

EMC 377 Sonya Young Vol#: 48

EMC 378 Beth Ellen Ivens Vol#: 48

EMC 379 Lynn Sullivan Vol#: 48

EMC 380 Richard A. Neve, Ph. D. Vol#: 48

EMC 381 R. Charlton Johnson Vol#: 48

EMC 382 Lori Conner Vol#: 48

94P-0354 Certify Mercury/Silver (amalgam)-Classify & Issue Warning

C 4 Micahel A Tessier DDS Vol#: 1

95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

C 290 Judy S Weshil Vol#: 4

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

C 9621 National Pharmaceutical Alliance, GPIA Vol#: 197

98N-0562 Civil Money Penalties; Rajaram K Matkari

CS 5 HFA-305 Vol#: 3

OR 5 HF-3 Vol#: 3

98P-0561 Amend Labeling about Viagra to include warnings

ANS 1 HFD-1 to Hogan & Hartson Vol#: 1

PAV 1 HFD-1 to Public Citizen Vol#: 1

99D-5047 Industry on Pharmacokinetics in Patients with Impaired Hepat

C 1 Bristol-Myers Squibb Vol#: 1

C 2 Medical Products Agency Vol#: 1

C 3 PhRMA Vol#: 1

C 4 Procter & Gamble Pharamceuticals Vol#: 1

C 5 Astra Zeneca LP Vol#: 1

C 6 Merck & Co Inc Vol#: 1

99H-0051 Civil Money Penalties;Tosco Marketing Co Inc,d/b/a Circle

SET 1 GCF-1 Vol#: 1

99H-0055 Civil Money Penalties;Entrepreneur Inc,d/b/a Scotchman Store

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0058 Civil Money Penalties;Montgomery Foods Inc,d/b/a Food King

SET 1 GCF-1 Vol#: 1

99H-0059 Civil Money Penalties;Dunn's Auto Service Ctr Inc,d/b/a

SET 1 GCF-1 Vol#: 1

99H-0061 Civil Money Penalties; Carlie C'S Iga Inc.

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0062 Civil Money Penalties;Entrepreneur Inc,d/b/a Scotchman Store

SET 1 GCF-1 Vol#: 1

99H-0063 Civil Money Penalties; Toolland Inc, d/b/a Tool Shed Jr

SET 1 GCF-1 Vol#: 1

99H-0064 Civil Money Penalties; Food Lion Inc,d/b/a Food Lion #99

SET 1 GCF-1 Vol#: 1

99H-0065 Civil Money Penalties; Food Lion Inc, d/b/a Food Lion #272

SET 1 GCF-1 Vol#: 1

99H-0066 Civil Money Penalties;Food Lion Inc,d/b/a Food Lion #848

SET 1 GCF-1 Vol#: 1

99H-0181 Civil Money Penalties;Eric Swain & Steve Bradshaw,d/b/a Stop

SET 1 GCF-1 Vol#: 1

99H-0182 Civil Money Penalties;Hannaford Bros.Co,d/b/a Hannaford Food

SET 1 GCF-1 Vol#: 1

99H-0183 Civil Money Penalties;Hnnaford Bros Co,d/b/a hannaford Food

SET 1 GCF-1 Vol#: 1

99H-0195 Civil Money Penalties;Git-N-Go Convenience Stores Inc,d/b/a

SET 1 GCF-1 Vol#: 1

99H-0196 Civil Money Penalties;Tri Star Marketing Inc,d/b/a Super Gas

SET 1 GCF-1 Vol#: 1

99H-0197 Civil Money Penalties;Antonio Di Felice,d/b/a Garrett Hill

SET 1 GCF-1 Vol#: 1

99H-0198 Civil Money Penalties;Home Service Oil Co Inc,d/b/a Express

SET 1 GCF-1 Vol#: 1

99H-0350 Civil Money Penalty; Butch Hardy d/b/a/ Hardy's BP

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0351 Civil Money Penalty; Al Haytayan d/b/a Supershop Variety

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0352 Civil Money Penalty; Kroger Co d/b/a Kroger Food Store

SET 1 GCF-1 Vol#: 1

99H-1504 Civil Money Penalties;Susan Bresnaham & Steve Bresnaham

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1876 Civil Money Penalties;Weigel's Stores Inc,dba Weigel's Farm

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-4207 Civil Money Penalty;Union Leasing Corporation,dba Gingersnap

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-5100 Civil Money Penalty;South Arkansas Petroleum Company Inc,dba

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99N-2637 Public Information Regulations

C 1 Bristol-Myers Squibb Pharmacuetical Rese Vol#: 1

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

C 1872 Judith Sansone Vol#: 213

C 1873 Karen F Kelley Vol#: 213

C 1874 Steven T Smith Vol#: 213

C 1875 Barbara Loebel Vol#: 213

C 1876 Jonas Kron Vol#: 213

C 1877 Reva LeVires Vol#: 213

C 1878 Elizabeth R Vol#: 213

C 1879 Erin Hamernyik Vol#: 213

C 1880 Tanja Yuncich Vol#: 213

C 1881 Collette Marie Vol#: 213

C 1882 Anna Lee Laremore Vol#: 213

C 1883 Illegible Vol#: 213

C 1884 Diane Woyciichowski Vol#: 213

C 1885 S Steele Vol#: 213

C 1886 Jayme Curley Vol#: 213

C 1887 Christina Eisest Vol#: 213

C 1888 Naomi Kleinfeld Vol#: 213

C 1889 Carolyn Bninski Vol#: 213

C 1890 Catherine R Geary Vol#: 213

C 1891 Judith Mohling Vol#: 213

C 1892 Kathleen A Geary Vol#: 213

C 1893 Cecily Runge Vol#: 213

C 1894 Wayne Schweitzer Vol#: 213

C 1895 Jim Morris Vol#: 213

C 1896 Diana Stough Vol#: 213

C 1897 Mara L Vandershce Vol#: 213

C 1898 Robyn Autry Vol#: 213

C 1899 Shannon Byers Vol#: 213

C 1900 Beverly Baima Vol#: 213

C 1901 Anna Eckstein Vol#: 213

C 1902 W Grossman Vol#: 213

C 1903 Jean L Harrison Vol#: 213

C 1904 Helen H Frederick Vol#: 213

C 1905 Michelle Irene Vol#: 213

C 1906 Donna Berry Vol#: 213

C 1907 Patricia A Cassawey Vol#: 213

C 1908 Leslie Lomas Vol#: 213

C 1909 Ann Bingham Vol#: 213

C 1910 Christine Flannigan Vol#: 213

C 1911 Matthew Taylor Vol#: 213

C 1912 J Flannigan Vol#: 213

C 1913 M Cooke Vol#: 213

C 1914 Sylvia E Buselmeier Vol#: 213

C 1915 John G Klemmedson Vol#: 213

C 1916 John Gilpin Vol#: 213

C 1917 Constance Hall Vol#: 213

C 1918 Michael D Green Vol#: 213

C 1919 Eugene M Roark Vol#: 213

C 1920 Jonathan Strong Vol#: 213

C 1921 Paul Clare Vol#: 213

C 1922 Jeanne Templin Vol#: 213

C 1923 Shirley L Winnie Vol#: 213

C 1924 Kate Oser Vol#: 213

C 1925 Anne Sousanis Vol#: 213

C 1926 Angeliki V Keil Vol#: 213

C 1927 Judy McNally Vol#: 213

C 1928 Erica Bolliger Vol#: 213

C 1929 Susan M Myrces Vol#: 213

C 1930 Pamela J W Lauer Vol#: 213

C 1931 Erin M Gately Vol#: 213

C 1932 Michelle Hamilton & Brian Thornton Vol#: 213

C 1933 Mora Rogers Vol#: 213

C 1934 Nora Lee Falk Vol#: 213

C 1935 Richard B Pridham Vol#: 213

C 1936 Georgette Tumas Vol#: 213

C 1937 K Glasgow Vol#: 213

C 1938 Bruce Stephen Lewis Vol#: 213

C 1939 Janice Salinari Vol#: 213

C 1940 Nancy Shapiro Vol#: 213

C 1941 Sandy Robinson Vol#: 213

C 1942 Wade Burey Vol#: 213

C 1943 Marry L Chavers Vol#: 213

C 1944 Doug McGinnis Vol#: 213

C 1945 Eric Warner Vol#: 213

C 1946 Rebecca Ann Luna Vol#: 213

C 1947 Eric Reid Vol#: 213

C 1948 Scott Wilson Vol#: 213

C 1949 Sylvie Chevallier Vol#: 213

C 1950 A Geiser Vol#: 213

C 1951 John Zola Vol#: 213

C 1952 Janice Wall Vol#: 213

C 1953 Renee Geizy Vol#: 213

C 1954 Laura Olinger Vol#: 213

C 1955 Virginia Ruddell Vol#: 213

C 1956 Helen McDermott Vol#: 213

C 1957 Catherine Beeson Vol#: 213

C 1958 Kelly Shanafelt Vol#: 213

C 1959 Jurgen de Lemos Vol#: 213

C 1960 Linda Vandaveer Vol#: 215

C 1961 George D Piper Vol#: 215

C 1962 Bill Freese Vol#: 215

C 1963 April Schoenherr Vol#: 215

C 1964 Gloria J McGee Vol#: 215

C 1965 Earl J Brighthaupt Vol#: 215

C 1966 American Crop Protection Assoc (ACPA) Vol#: 215

C 1967 General Mills Vol#: 215

C 1968 S A McDaniel Vol#: 215

C 1969 Richard O'Neal & Family Vol#: 215

C 1970 Tanya Schwedler Vol#: 215

C 1971 Elizabeth Jennings Vol#: 215

C 1972 Foster Goodwill Vol#: 215

C 1973 Michael Beer Vol#: 215

C 1974 Chris Shadd Vol#: 215

C 1975 Gretchen Hagle Vol#: 215

C 1976 Brita A Johnson Vol#: 215

C 1977 Gary McDonald Vol#: 215

C 1978 Mary Spoerer Vol#: 215

C 1979 Barbara K Holisky Vol#: 215

C 1980 Ronewen Proust Vol#: 215

C 1981 Henry Lord Vol#: 215

C 1982 Harvey Ranzi Vol#: 215

C 1983 Scott Atthowe Vol#: 215

C 1984 Ry Thompson Vol#: 215

C 1985 Patricia Thomas Vol#: 215

C 1986 Barbara Foley & Brad Fregger Vol#: 215

C 1987 Jannie Wahl Vol#: 215

C 1988 Troy C Jones Vol#: 215

C 1989 Kari B Sammuels Vol#: 215

C 1990 Albert Fioretti Vol#: 215

C 1991 John d'Azzo & 7 signatures Vol#: 215

C 1992 Karen Ranzi Vol#: 215

C 1993 Pamela Todorovich Vol#: 215

C 1994 S Guggenheim Vol#: 215

C 1995 Paul Dokter Vol#: 215

C 1996 Brian D Duncan Vol#: 215

C 1997 Joan E Ross Vol#: 215

C 1998 Nancy K Waltrip Vol#: 215

C 1999 Evelyn Roppel Vol#: 215

C 2000 Wendy Lessard Vol#: 215

C 2001 Lorna B Estep Vol#: 215

C 2002 Judith A Turano Vol#: 215

C 2003 Catherine L Shorrick Vol#: 215

C 2004 Reena Fettner Vol#: 215

C 2005 James Bogac Vol#: 215

C 2006 James Sorensen Jr Vol#: 215

C 2007 Cliff Strom Vol#: 215

C 2008 Georgia Alexander Vol#: 215

C 2009 Shirely A Coon Vol#: 215

C 2010 Sal Mozza Vol#: 215

C 2011 Unsigned Vol#: 215

C 2012 Li Shen Vol#: 215

C 2013 Robert & Rita Mikel Vol#: 215

C 2014 Maile Johnson Vol#: 215

C 2015 Betha Gutsche Vol#: 215

C 2016 Alice W Hungate Vol#: 215

C 2017 Kathie Florsheim Vol#: 215

C 2018 Anne Halkedis Vol#: 215

C 2019 Judy Shull Vol#: 215

EC 1639 Ms. Katherine Metz Vol#: 202

EC 1640 Number Not Used Vol#: 202

EC 1641 Number Not Used Vol#: 202

EC 1642 Ms. Annabelle Clarke Vol#: 202

EC 1643 Mr. Dan Connor Vol#: 202

EC 1644 Mrs. Angela Church Vol#: 202

EC 1645 Ms. Patti Middleton Vol#: 202

EC 1646 Mr. Howard Weinstein Vol#: 202

EC 1647 Number Not Used Vol#: 202

EC 1648 Laughing Dog Farm Vol#: 202

EC 1649 Mr. Hoby Ebert Vol#: 202

EC 1650 Number Not Used Vol#: 202

EC 1651 Number Not Used Vol#: 202

EC 1652 Number Not Used Vol#: 202

EC 1653 Ms. Nicolette Krajewski Vol#: 202

EC 1654 Number Not Used Vol#: 202

EC 1655 Mr. Jack Bernens Vol#: 202

EC 1656 Number Not Used Vol#: 202

EC 1657 Number Not Used Vol#: 202

EC 1658 University of Michigan Vol#: 202

EC 1659 Mr. Larry Laverty Vol#: 202

EC 1660 Mr. Scott Roseman Vol#: 202

EC 1661 Number Not Used Vol#: 202

EC 1662 Ms. carmen cubillo Vol#: 202

EC 1663 Ms. Sarah Kaplan Vol#: 202

EC 1664 Number Not Used Vol#: 202

EC 1665 Mr. Michael Birch Vol#: 202

EC 1666 Mr. Steven Chostler Vol#: 202

EC 1667 Goodwin Biotechnology, Inc. Vol#: 202

EC 1668 Mr. H. Max Bock Vol#: 202

EC 1669 Mr. Daniel Mapel Vol#: 202

EC 1670 Ms. Erika Hoving Vol#: 202

EC 1671 Number Not Used Vol#: 202

EC 1672 Ms. Stephanie Kenney Vol#: 202

EC 1673 Mr. J. Marvin Seemann Vol#: 202

EC 1674 Mr. Keith Wehri Vol#: 202

EC 1675 Concerned Citizen Vol#: 202

EC 1676 Number Not Used Vol#: 202

EC 1677 Number Not Used Vol#: 202

EC 1678 Mr. Leonard Adame Vol#: 202

EC 1679 Federal Agricultural Research Centre Vol#: 202

EC 1680 Number Not Used Vol#: 202

EC 1681 The Letter Magazine Vol#: 202

EC 1682 Mr. Philip Quinn Vol#: 202

EC 1683 Number Not Used Vol#: 202

EC 1684 Ms. Zarah Kushner Vol#: 202

EC 1685 Bayerisches Staatsministerium fur Landes Vol#: 202

EC 1686 lse Vol#: 202

EC 1687 Number Not Used Vol#: 202

EC 1688 Mr. David Bloede Vol#: 202

EC 1689 Number Not Used Vol#: 202

EC 1690 Ms. Corrine Kupstas Vol#: 202

EC 1691 Mr. Hubert Ralls Vol#: 202

EC 1692 Mr. Gregory Kurdys Vol#: 202

EC 1693 Mr. Kerry Brethauer Vol#: 202

EC 1694 Mr. Steven Coultas Vol#: 202

EC 1695 Earthome, Inc. Vol#: 202

EC 1696 Number Not Used Vol#: 202

EC 1697 Ms. Lynne Durham Vol#: 202

EC 1698 Mr. Lance Davis Vol#: 202

EC 1699 Mr. Clark Furlong Vol#: 202

EC 1700 General Board of Global Ministries Vol#: 202

99N-4491 Reuse of Single Use Devices proposal

C 104 Assn of Disposable Device Manufacturers Vol#: 7

C 105 Medtronic Inc Vol#: 7

99N-4784 Redacted Version of Substantially-Equivalent Premarket Notif

ANS 1 HFZ-2 to Assn of the Nonwomen Fabrics In Vol#: 1

C 3 Dentsply International Vol#: 1

C 4 Terumo Medical Corporation Vol#: 1

EXT 1 Association of the Nonwomen Fabrics Ind Vol#: 1

99P-1267 ANDA Suitability for Clozapine tablets 12.5mg

PAV 1 HFD-600 Vol#: 1

99P-1268 ANDA Suitability for Clozapine Tablets, 200mg

PAV 1 HFD-600 Vol#: 1

99P-1589 Stay effective date of approval for NDA 20-932 Roxicodone

PAV 1 HFC-1 to Purdue Pharma LP Vol#: 1

99P-2778 Adopt a policy of publicizing on the internet certain info

LET 1 HFD-1 to Biovail Corporation Vol#: 1

99P-4108 Exempt Performance Std Electrode Lead Wires & Patient Cables

PDN 1 HFZ-1 Vol#: 1

99P-5109 Stay filing or review of NDA for ferric hydroxy saccharate

PDN 1 HFC-1 Vol#: 1

00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization

C 1 Medtronic Inc Vol#: 1

00H-0125 Civil Money Penalty;Cherokee Food Services,LLC;dba Power

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

00H-0476 Civil Money Penalty;Young Man Kim,dba Regal Cut Rate Liquors