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 June 23, 2000

Table of Contents

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

(Documents received by the Dockets Management Branch "MAY" be posted on the internet. Please do not include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence. )

[FDA DOCKETS PAGE][FDA HOME PAGE]  [ ITEM CODES ]

 
00N-1200 Dietary Supplements Containing Ephedrine Alkaloids *
00P-0092 ANDA Suitability for Thiotepa for Injection *
00P-0499 Review/Act on SKB '132 Form C & '423 Form A patent for NDA20 *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1292 Performance Standard for Electrode Lead Wires & Patient Cabl *
00P-1322 Food Labeling and Allergen Contamination Control *
00P-1365 ANDA be submitted for Fluoxetine Tablets/40 mg *
90P-0201 Optimum size & Style of print to be used to label OTC Drugs

N 3 Vol#: 8
 
 

95N-0259 Over the Counter Drug Labeling; Public Hearing

N 2 Vol#: 13
 
 

96N-0420 OTC Human Drugs; Proposed Labeling Requirements

N 2 Vol#: 25
 
 

98N-0337 Over the counter human drugs labeling requirements

N 1 Vol#: 6
 
 

99H-2397 Civil Money Penalty;Leigh Enterprises Ltd,dba Melrose Shell

SET 1 GCF-1 Vol#: 1
 
 

99H-2398 Civil Money Penalty;G & M Service Ctr Inc,dba G & M Serice

SET 1 GCF-1 Vol#: 1
 
 

99H-2399 Civil Money Penalty;Maxi Drug Inc,dba Brooks Pharmacy

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-2400 Civil Money Penalty;Daniel W Rose Sr,dba First Ave. Curb Sto

SET 1 GCF-1 Vol#: 1
 
 

99H-2452 Civil Money Penalty;Robert Klepaida,dba Munich Hofbrau

SET 1 GCF-1 Vol#: 1
 
 

99H-2453 Civil Money Penalty;Lucky Seven Food Stores Inc,dba Lucky Fo

SET 1 GCF-1 Vol#: 1
 
 

99H-2455 Civil Money Penalty;Small's Inc,dba John's Food Mart

SET 1 GCF-1 Vol#: 1
 
 

99H-2456 Civil Money Penalty;Super Mercado Torres Inc,dba Torres 3

SET 1 GCF-1 Vol#: 1
 
 

99H-2459 Civil Money Penalty;Ackie's Pioneer Inn Inc,dba Ackie's Pion

SET 1 GCF-1 Vol#: 1
 
 

99H-2460 Civil Money Penalty;Denise Armor,dba Smokin J's #3

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-2463 Civil Money Penalty;Robert D. Brownlow,dba Brownlow's Red Ow

SET 1 GCF-1 Vol#: 1
 
 

99H-2467 Civil Money Penalty;Eckerd Corporation,dba Eckerd Drugs #280

SET 1 GCF-1 Vol#: 1
 
 

99H-2469 Civil Money Penalty;Rod Hegna, Rick Lilla & Todd Thompson,db

SET 1 GCF-1 Vol#: 1
 
 

99H-2470 Civil Money Penalty;Paul Heidgerken,dba Paul's Par-A-Dice

SET 1 GCF-1 Vol#: 1
 
 

99H-2471 Civil Money Penalty;John Hickman & Lee Hickman,dba Hall's Fo

SET 1 GCF-1 Vol#: 1
 
 

99H-2472 Civil Money Penalty;Horkey Oil Company Inc,dba Friends 112

SET 1 GCF-1 Vol#: 1
 
 

99H-2475 Civil Money Penalty;Lab Marketing LC,dba Nothin' Butt Smokes

SET 1 GCF-1 Vol#: 1
 
 

99H-2476 Civil Money Penalty;Ken C. Lyles,dba BP Service Center

SET 1 GCF-1 Vol#: 1
 
 

99H-2477 Civil Money Penalty;Mclain Oil Company,dba Mclain Oil Compan

SET 1 GCF-1 Vol#: 1
 
 

99H-2480 Civil Money Penalty;Rite Aid Corporation,dba Rite Aid

SET 1 GCF-1 Vol#: 1
 
 

99H-4237 Civil Money Penalty;Calfee Co of Dalton Inc,dba Favorite Mar

WDL 1 GCF-1 Vol#: 1
 
 

99H-4603 Civil Money Penalty;Kwok Cheong Wong,dba Wing Cheong

SET 1 GCF-1 Vol#: 1
 
 

99H-4604 Civil Money Penalty;Rebel Oil Co Inc,dba Rebel Oil #56

SET 1 GCF-1 Vol#: 1
 
 

99H-4605 Civil Money Penalty;the Fallon R V Park Inc,dba The Fallon R

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-4608 Civil Money Penalty;Ranger Development Co,dba Sunrise Food

SET 1 GCF-1 Vol#: 1
 
 

99H-4610 Civil Money Penalty;AAA-Bangali Com Inc,dba Miracle Mart

SET 1 GCF-1 Vol#: 1
 
 

99H-4611 Civil Money Penalty;Lance Calvert,dba 7-Eleven

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-4612 Civil Money Penalty;Dana Franklin,dba West Addison General

SET 1 GCF-1 Vol#: 1
 
 

99H-4625 Civil Money Penalty;James Avery Brown,dba Brown's Outdoors

SET 1 GCF-1 Vol#: 1
 
 

99H-4628 Civil Money Penalty;Tony D'Angelo,dba Sam's Convenience

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-4630 Civil Money Penalty;Fraternal Order of Eagles Club Inc,dba

SET 1 GCF-1 Vol#: 1
 
 

99H-4632 Civil Money Penalty;Homeland Stores Inc,dba Homeland Store

SET 1 GCF-1 Vol#: 1
 
 

99H-4634 Civil Money Penalty;Krause Gentle Corp,dba Kum & Go #129

SET 1 GCF-1 Vol#: 1
 
 

99H-4636 Civil Money Penalty;Rashmi Lidher,dba Bubba-Doo's One Stop

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-4640 Civil Money Penalty;Paulinda Inc,dba Minit Mart #66

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-4641 Civil Money Penalty;R & M Foods Inc,dba Piggly Wiggly #117

SET 1 GCF-1 Vol#: 1
 
 

99H-4643 Civil Money Penalty;Roland Falls Service Station Inc,dba Fal

SET 1 GCF-1 Vol#: 1
 
 

99H-4645 Civil Money Penalty;Wade Taliaferro & Sonja L Taliaferro,dba

SET 1 GCF-1 Vol#: 1
 
 

99H-4650 Civil Money Penalty;Cumberland Farms Inc,dba Cumberland Farm

SET 1 GCF-1 Vol#: 1
 
 

99H-4651 Civil Money Penalty;Dollar World Inc,dba Dollar World

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-4652 Civil Money Penalty;Interstate Petroleum Ltd,dba Branson Wes

SET 1 GCF-1 Vol#: 1
 
 

99H-4653 Civil Money Penalty;Morris Marketers Inc,dba Finish Line She

SET 1 GCF-1 Vol#: 1
 
 

99H-4654 Civil Money Penalty;C K Smith & Co Inc,dba Holyoke United

SET 1 GCF-1 Vol#: 1
 
 

99H-4655 Civil Money Penalty;Ronald Swindle,dba Swindles Food Town

SET 1 GCF-1 Vol#: 1
 
 

99H-4656 Civil Money Penalty;Tony Tereso,dba Jenrose Wine & Liquors

CR 1 GCF-1 Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-4657 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart #1787

SET 1 GCF-1 Vol#: 1
 
 

99H-4658 Civil Money Penalty;Winn-Dixie Raleigh, Inc,dba Winn-Dixie

SET 1 GCF-1 Vol#: 1
 
 

99N-4166 Proposed Collection Electronic Records;Electronic Signature

NAL 1 OMB Vol#: 1

SS 1 Supporting Statement Vol#: 1
 
 

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

EC 3269 Ms. Lari Sahra Vol#: 415

EC 3270 Ms. constance roessler Vol#: 415
 
 

00N-0505 Animals Protein Prohibited in Ruminant Feed

N 2 Vol#: 1
 
 

00N-0726 General Licensing Provisions:Change to an Approved Applicati

N 2 OMB Vol#: 1

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

C 5 U. S. Small Business Administration Vol#: 1

C 6 United States Senate Vol#: 1

C 7 Congress of the United States Vol#: 1

00P-0092 ANDA Suitability for Thiotepa for Injection

PAV 1 HFD-600 to Gensia Sicor Pharmaceuticals Vol#: 1

00P-0499 Review/Act on SKB '132 Form C & '423 Form A patent for NDA20

C 2 SmithKline Beecham Corporation Vol#: 1

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

C 1565 Gloria DiBiase Vol#: 77

C 1566 Randi Barnes Vol#: 77

C 1567 Diane Dulken Vol#: 77

C 1568 Linn Cohen-Cole Vol#: 77

C 1569 Olivia James Vol#: 77

C 1570 Richard Hoch Vol#: 77

C 1571 Ricky & Betty Gibson Vol#: 77

C 1572 Kelli Helzerman Vol#: 77

C 1573 Charles M. Pipitone Vol#: 77

C 1574 Isaac Dostis Vol#: 77

C 1575 Adams Jeske Vol#: 77

C 1576 Janet Gordon Vol#: 77

C 1577 Karen Joen Vol#: 77

C 1578 John Spezia Vol#: 77

C 1579 Byron Whetzel Vol#: 77

C 1580 Jamie Harris Vol#: 77

C 1581 Karen Nott Vol#: 77

C 1582 Vidya Treat Vol#: 77

C 1583 Charlene Rowe Vol#: 77

C 1584 Liza Goldman Huertas Vol#: 77

C 1585 William Bailey Vol#: 77

C 1586 Judy Just Vol#: 77

C 1587 Katherine Hayden Vol#: 77

C 1588 S. Griffith Vol#: 77

C 1589 Michelle Voss Vol#: 77

C 1590 Nancy L. Navarra Vol#: 77

C 1591 Sujatha Raman Vol#: 77

C 1592 Francis Doughty Vol#: 77

C 1593 Allen Steffen Vol#: 77

C 1594 Peter L. Kantor Vol#: 77

C 1595 Elainer J. Parahus Vol#: 77

C 1596 Richard Robins Vol#: 77

C 1597 Sheryl Anderson Vol#: 77

C 1598 Lura B. Irish Vol#: 77

C 1599 Barb Roth Vol#: 77

C 1600 Peter & Anne Rogan Vol#: 77

C 1601 Carla Wright Vol#: 77

C 1602 Kathy Van Dame Vol#: 77

C 1603 Lois Montalbano Vol#: 77

C 1604 A. Hawkins Vol#: 77

C 1605 Jill & Shawn Waggener Vol#: 77

C 1606 Martin O'Connor Vol#: 77

C 1607 Li Hyun Vol#: 77

C 1608 Paul Senkin Vol#: 77

C 1609 David Visich Vol#: 77

C 1610 David Askin Vol#: 77

C 1611 Susie Karsky Vol#: 77

C 1612 S. Vice Vol#: 77

C 1613 George Odell Vol#: 77

C 1614 Annette Colin Vol#: 77

C 1615 Aimee Robertson Vol#: 77

C 1616 Frances M. Goodman Vol#: 77

C 1617 Diana Brinkman Vol#: 77

C 1618 Gerry Robinson Vol#: 77

C 1619 Bruce Robins Vol#: 77

C 1620 Laura Hoets Vol#: 77

C 1621 Scott McCandless Vol#: 77

C 1622 C. Kriss Vol#: 77

C 1623 Christine N. Weigand Vol#: 77

C 1624 Elsa Worth Vol#: 77

C 1625 Janet McLane Vol#: 77

C 1626 Thomas M. Miller Vol#: 77

C 1627 Robyn Greene Vol#: 77

C 1628 Ellen Levine Vol#: 77

C 1629 Ben Gouse Vol#: 77

C 1630 Barbara Trinidad Vol#: 77

C 1631 Vicki Hawse Vol#: 77

C 1632 Maureen Rafael Vol#: 77

C 1633 Joanne Carr Vol#: 77

C 1634 Troy Kaneshiro Vol#: 77

C 1635 Jill Koch Vol#: 77

C 1636 Norma Jean Sims Vol#: 77

C 1637 Loretta Anshutz Vol#: 77

C 1638 Diana Fogel Vol#: 77

C 1639 K. Van Every Vol#: 77

C 1640 Doreen Duff-Drys Vol#: 77

C 1641 Dana C. Nichols Vol#: 77

C 1642 Dale Helling Vol#: 77

C 1643 Judy Merrill-Smith Vol#: 77

C 1644 S. Vice Vol#: 77

C 1645 David Alexander Vol#: 77

C 1646 Louise Heath Vol#: 77

C 1647 Mae Sandler Vol#: 77

C 1648 Robert Williams Vol#: 77

C 1649 Joy Reese Vol#: 77

C 1650 Michaela Redden Vol#: 77

C 1651 Luanne Rowder Vol#: 77

C 1652 Susan Posch Vol#: 77

C 1653 Gary Sullivan Vol#: 77

C 1654 Msihi Posner Vol#: 77

C 1655 Robert Jereski Vol#: 77

C 1656 Alison Kelly Vol#: 77

C 1657 Jane Picardi Vol#: 77

C 1658 Betty Belcher Vol#: 77

C 1659 Beth S. Long Vol#: 77

C 1660 Jennifer Wolfsong Vol#: 77

C 1661 Bruce D. Olsen Vol#: 77
 
 

C 1662 Dorothy Boime Vol#: 77

C 1663 Karen van Meenen Vol#: 77

C 1664 Ruth Gallagher Vol#: 77

C 1665 Reinhold & Frankie Brooks Vol#: 77

C 1666 Diana Myndal Vol#: 77

C 1667 Laura Napoleon Vol#: 77

C 1668 Jill Block Vol#: 77

C 1669 Edith Cassidy Vol#: 77

C 1670 Nancy Loomis Eric Vol#: 77

C 1671 Helen Cruise Vol#: 77

C 1672 Chris Collmier Vol#: 77

C 1673 John Donlin Vol#: 77

C 1674 Susan S. Fairbanks Vol#: 78

C 1675 Janice Drexler Vol#: 78

C 1676 Justin Pohn Vol#: 78

C 1677 Thomas Reilly Vol#: 78

C 1678 Rich Yurman Vol#: 78

C 1679 Bobby Williamson Vol#: 78

C 1680 Tori Shearer Vol#: 78

C 1681 Victoria Powell Vol#: 78

C 1682 Robert H. Wagner Vol#: 78

C 1683 Emily J. Bender Vol#: 78

C 1684 No Signature Vol#: 78

C 1685 Judith Tuller Vol#: 78

C 1686 Susane Boukamel Vol#: 78

C 1687 Heather De Munn Vol#: 78

C 1688 Joyce Madden Vol#: 78

C 1689 Eugene Taubel Vol#: 78

C 1690 Lisa Deeley Vol#: 78

C 1691 Jean Parker Vol#: 78

C 1692 R. L. Tinkler Vol#: 78

C 1693 David Ingalsbe, Jr Vol#: 78

C 1694 Carl Recksiek Vol#: 78

C 1695 Larry Wingertsahn Vol#: 78

C 1696 Kimberlie Wilcox Vol#: 78

C 1697 Hana Khouri Vol#: 78

C 1698 B. B. Echols Vol#: 78

C 1699 Hannah Doress Vol#: 78

C 1700 JoAnn Corti Vol#: 78

C 1701 James & Barb Grann Vol#: 78

C 1702 David Cutler Vol#: 78

C 1703 Caroline Nelson Vol#: 78

C 1704 Dwight K. Harding Vol#: 78

C 1705 Pam Adair Vol#: 78

C 1706 April Sisk Vol#: 78

C 1707 Amy Wildey-McGill Vol#: 78

C 1708 P. Bryant Vol#: 78

C 1709 Lisa Deeley Vol#: 78

C 1710 Henry Schwab Vol#: 78

C 1711 Lisa Dougherty Vol#: 78

C 1712 Joseph P. Schmitt Vol#: 78

C 1713 Jane Yi Vol#: 78

C 1714 Arleen Dale Kirtland Vol#: 78

C 1715 Tasan Singleton Vol#: 78

C 1716 Thomas Weller Vol#: 78

C 1717 Cheryl Sellers Vol#: 78

C 1718 Pat Van Horn Vol#: 78

C 1719 Nina Silver Vol#: 78

C 1720 Merolyn Parker Vol#: 78

C 1721 Mary H. Daniels Vol#: 78

C 1722 Jeffrey Kirschner Vol#: 78

C 1723 Christine Jeske Vol#: 78

C 1724 Jessica L. Garrels Vol#: 78

C 1725 Susan Alexander Vol#: 78

C 1726 Laura Alvarez Vol#: 78

C 1727 John Carlton Vol#: 78

C 1728 Michele Asnari Vol#: 78

C 1729 Donald McLean Vol#: 78

C 1730 Jeanette Karren Vol#: 78

C 1731 Joyce C. Ehler Vol#: 78

C 1732 June Thompson Vol#: 78

C 1733 Frank & Melody Oxarart Vol#: 78

C 1734 Kathy Jarvis Vol#: 78

C 1735 John E. Kysar & Judith W. Davis Vol#: 78

C 1736 Mary Rubach Vol#: 78

C 1737 Stella B. Carson Vol#: 78

C 1738 Rich Bachtold Vol#: 78

00P-1292 Performance Standard for Electrode Lead Wires & Patient Cabl

PDN 1 HFZ-1 to Amrex-Zetron Inc Vol#: 1

00P-1322 Food Labeling and Allergen Contamination Control

C 1 CSPI Vol#: 2

00P-1365 ANDA be submitted for Fluoxetine Tablets/40 mg

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultants Services Inc Vol#: 1