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 December 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]

 
89V-0151 ONE PROJECTOR & MULTIPLE LIGHT SHOW PROJECTOR *
92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
94S-0120 510K Substantially Equivalent List *
95S-0117 Human Drugs Patent Term Extension & New Patents *
95V-0391 Laser Light Show*
98N-1038 Irradiation in the production, processing, &handling of food *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-4613 Revoke the Regulation That Approved Posilac *
99P-5328 ANADA suitability for prednisolone tablets *
99P-5329 ANADA suitability for furosemide tablets *
99P-5330 ANADA for enalapril maleate tablets *
99P-5331 ANADA suitability for Palabute (phenylbutazone) Pellets *
99P-5332 Amend limit Hydrogenated & partially Hydrogenated Menhaden O *
89V-0151 ONE PROJECTOR & MULTIPLE LIGHT SHOW PROJECTOR

EXP 1 MacShane Laser Art Productions Vol#: 1

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

C 6351 Lee Pettenger Vol#: 163

C 6352 Michelle Souliere Vol#: 163

C 6353 Sherrill Wilson Vol#: 162

C 6354 Jennifer Hall Vol#: 163

C 6355 Roberta Liebman Vol#: 163

C 6356 Jennifer L Parkinson Vol#: 163

C 6357 Kim Labarbera Vol#: 163

C 6358 A K Smiley Vol#: 163

C 6359 Paula I Long Vol#: 163

C 6360 Jeffrey Grayson Miller Vol#: 163

C 6361 Edward Sczesnak Vol#: 163

C 6362 Marguerite Ingalsbe Vol#: 163

C 6363 Charise Windley Vol#: 163

C 6364 Eric Gallagher Vol#: 163

C 6365 Suzanne Weinstein Vol#: 163

C 6366 Alice Everhart Page Vol#: 163

C 6367 Robert H Gallagher Vol#: 163

C 6368 Doris Goodwin Vol#: 163

C 6369 Theresa Kossow Vol#: 163

C 6370 Ruth Dickinson Vol#: 163

C 6371 Evan Stajduhar Vol#: 163

C 6372 Romona Richards Vol#: 163

C 6373 Melva Rooney Vol#: 163

C 6374 Eunice Lew Vol#: 163

C 6375 Mr & Mrs Courtney B Lawson Vol#: 163

C 6376 Donna Goldman Vol#: 163

C 6377 Michael Skidmore Vol#: 163

C 6378 Barbara Alweis Vol#: 163

C 6379 Marcia H Field Vol#: 163

C 6380 Mike O'Brien Vol#: 163

C 6381 Valerie L Weiss Vol#: 163

C 6382 Donna Zidek Vol#: 163

C 6383 Jean Hackworth Vol#: 163

C 6384 Margaret Bowman Vol#: 163

C 6385 Xzylia Davis Vol#: 163

C 6386 Unsigned Vol#: 163

C 6387 Ken Duvali Vol#: 163

C 6388 Phoebe Liebow Vol#: 163

C 6389 Nick & Jean Caizzo Vol#: 163

C 6390 Winona Ramsay Vol#: 163

C 6391 Betsy Sise Vol#: 163

C 6392 Kari Quandt Vol#: 163

C 6393 June Morrow Vol#: 163

C 6394 Wallace Sampson MD Vol#: 163

C 6395 Ann Vilesis Vol#: 163

C 6396 Michelle Lappa Vol#: 163

C 6397 Edward J Kaiser Vol#: 163

C 6398 Barbara Richardson Vol#: 163

C 6399 Carolyn R Whiting Vol#: 163

C 6400 Larry E Kulick Vol#: 163

C 6401 Nadine Schuster Vol#: 163

C 6402 Shirley G Warren Vol#: 163

C 6403 Frank L Warren Vol#: 163

C 6404 Alisa Stone Vol#: 163

94S-0120 510K Substantially Equivalent List

LST 89 November 1999 510k Monthly Vol#: 20

95S-0117 Human Drugs Patent Term Extension & New Patents

LST 49 List as of December 1, 1999 Vol#: 3

95V-0391 Laser Light Show

CR 1 HFA-305 Vol#: 1

EXP 1 Advanced Lighting Techniques Vol#: 1

96F-0293 Safe Use of 2-Methyl-4,5-Trimethylene-4-Isot...

NWL 1 Vol#: 1

98H-1202 Civil Money Penalties; Lake Sammamish Mini Mart Inc & Bruce

EXT 1 Lake Sammamish Mini Mart Inc Vol#: 1

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

C 4789 Edward J Kaiser Vol#: 138

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

CS 4 HFA-305 Vol#: 1

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

EXB 1 GCF-1 Vol#: 1

HER 2 Caldwell's Inc,dba Caldwell's Coastal Vol#: 1

99H-1354 Civil Money Penalty; Newcomb Oil Co & John L Newcomb Jr d/b/

CS 2 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-1619 Civil Money Penalty; Del Goebel dba G & S Gas

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-2632 Civil Money Penalty;Camp Oil Company,dba Sav-A-Ton

CS 3 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

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

LET 2 GCF-1 Vol#: 1

99H-3096 Civil Money Penalty;Honey Farms Inc,dba Honey Farms #31

LET 2 Office of Tobacco Programs Vol#: 1

99H-4012 Civil Money Penalty;Ingrams Market,dba Ingrams Market

CR 1 GCF-1 Vol#: 1

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-4188 Civil Money Penalty;Harold Hawkins,dba Hawkins Market

LET 2 Office of Tobacco Programs Vol#: 1

99H-4243 Civil Money Penalty;Honey Farms Inc,dba Honey Farms #77

LET 2 Office of Tobacco Programs Vol#: 1

99H-4424 Civil Money Penalty;A/C Stores Oil Co Inc,dba A/C Stores #3

ANS 1 AC Stores Oil Inc. Vol#: 1

99H-4457 Civil Money Penalty;Irvin F Lacoste,dba Waffles Plus Conoco

ANS 1 Irvin F Lacoste,dba Waffles Plus Inc Vol#: 1

99H-4497 Civil Money Penalty;Cato, Incorporated,dba Felton Goosecreek

ANS 1 Cato Inc, dba Felton Goose Creek Vol#: 1

99H-4633 Civil Money Penalty;Robert P Knudson,dba Valley Bait & Groce

ANS 1 Valley Bait & Grocery Vol#: 1

99H-4729 Civil Money Penalty;Aurora Petroleum Co,dba Fastgas II

ANS 1 Aurora Petroleum Co,dba Fastgas II Vol#: 1

99H-4730 Civil Money Penalty;Aurora Petroleum Co,dba Fatgas III

ANS 1 Aurora Petroleum Co,dba Fastgas III Vol#: 1

99H-4780 Civil Money Penalty;T T & E Inc,dba Texaco Food Mart

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-4794 Civil Money Penalty;Mark Roland,dba Mark's Texaco

ANS 2 Mark's Texaco Vol#: 1

99H-4917 Civil Money Penalty;Chong Choi,dba Little Joe's Pizzeria

ANS 1 Chong Choi Vol#:

99H-4919 Civil Money Penalty;Coborn's Incorporated,dba Cash Wise Food

ANS 1 Coborn's Inc,dba Cash Wise Vol#: 1

99H-4934 Civil Money Penalty;Rose Bryan,dba Bryan's Grocery

ANS 1 Rose Bryan Vol#: 1

99H-4939 Civil Money Penalty;Westover Food Mart Inc,dba Westover Food

ANS 1 Westover Food Mart Inc Vol#: 1

99H-4945 Civil Money Penalty;Legus Service Inc,dba Andy Legus' Shell

ANS 1 Legus Service Inc Vol#: 1

99N-1852 Status reports/postmarketing studies-human drugs&biological

REF 1 References Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1780 Jean Rhode Vol#: 163

C 1781 UK Vivisection Information Ser (UKAVIS) Vol#: 163

C 1782 Deborah M Boryenace Vol#: 163

C 1783 Jean Rhode Vol#: 163

C 1784 Susan Du Bois Vol#: 163

C 1785 Claudia M Trask Vol#: 163

C 1786 Jame B Campbell Vol#: 163

C 1787 Teresia E LaFleur Vol#: 163

C 1788 Dennis W Campbell Jr Vol#: 163

C 1789 Jennifer L Dunckley Vol#: 163

C 1790 Kimberly A Eger Vol#: 163

C 1791 Unsigned Vol#: 163

C 1792 Bruce & Tammy Barney Vol#: 163

C 1793 Nancy LaRoche Vol#: 163

C 1794 Marilyn R Warren Vol#: 163

C 1795 Brenda Neville Vol#: 163

C 1796 Peggy Suzuki Vol#: 163

C 1797 K Jake Gioffre Vol#: 163

C 1798 Corey Phillips Vol#: 163

C 1799 Jonathan Alan Agresta Vol#: 163

C 1800 Ryan Egnor-Keil Vol#: 163

C 1801 Katie Seiz Vol#: 163

C 1802 Diane M Stella Vol#: 163

C 1803 Arlene Malinosky Vol#: 163

C 1804 Louis J Tulino Vol#: 163

C 1805 Marcia Horn Vol#: 163

C 1806 Cindy Kasper Vol#: 163

C 1807 Kathy Scheidegger Vol#: 163

C 1808 Sydney Doherty Vol#: 163

C 1809 John O Jones Vol#: 163

C 1810 Mr & Mrs F Manigold Vol#: 163

C 1811 Mr & Mrs Bob Woods Vol#: 163

C 1812 Illegible Vol#: 163

C 1813 Paul Sewick & Beth Delaney Vol#: 163

C 1814 Stephanie Gipson Vol#: 163

C 1815 Goldie Sanoff Vol#: 163

C 1816 Janet Eisberner Vol#: 163

C 1817 Darla Garcia Vol#: 163

C 1818 Michelle Buzek Vol#: 163

C 1819 Kelly E Harden Vol#: 163

C 1820 Christina Craddock Vol#: 163

C 1821 Katie Piehl Vol#: 163

C 1822 Maya Vinoky & 14 signatures Vol#: 163

C 1823 Jennifer N Palmer Vol#: 163

C 1824 Susan Winters Vol#: 163

C 1825 Joanna Kirkpatrick Vol#: 163

C 1826 Unsigned Vol#: 163

C 1827 Laura A Danna Vol#: 163

C 1828 Alice M Mc Tague Vol#: 163

C 1829 Barbara & Vic Ulmer Vol#: 163

EMC 1 B A Campbell & P B Cook Vol#: 163

EMC 2 Valerie Madison PhD Vol#: 163

EMC 3 Lanai C Winter Vol#: 163

EMC 4 Crystal S Marshall Vol#: 163

99P-4613 Revoke the Regulation That Approved Posilac

EMC 62 Jim Eldon Vol#: 1

EMC 63 Scott Campbell Vol#: 1

EMC 64 John Hammell Vol#: 1

EMC 65 Karen Eck, M.T. (ASCP) Vol#: 1

MM 1 HFV-2 & Robert Cohen & Kimberley Gorall Vol#: 1

SUP 3 Robert Cohen Vol#: 1

99P-5328 ANADA suitability for prednisolone tablets

ACK 1 HFA-305 Vol#: 1

CP 1 Tyler Group Inc Vol#: 1

99P-5329 ANADA suitability for furosemide tablets

ACK 1 HFA-305 Vol#: 1

CP 1 Tyler Group Inc Vol#: 1

99P-5330 ANADA for enalapril maleate tablets

ACK 1 HFA-305 Vol#: 1

CP 1 Tyler Group Inc Vol#: 1

99P-5331 ANADA suitability for Palabute (phenylbutazone) Pellets

ACK 1 HFA-305 Vol#: 1

CP 1 PharmX Inc Vol#: 1

99P-5332 Amend limit Hydrogenated & partially Hydrogenated Menhaden O

ACK 1 HFA-305 Vol#: 1

CP 1 National Fish Meal & Oil Association Vol#: 1