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 28, 1999 Table of Contents(Hyper links are part of the Docket title - not all dockets/documents are linked) |
87V-0388 Benedum natural science theater light show * 92N-0139 Statement Policy: Foods Derived from New Plant Varieties * 92S-0251 Electronic Submissions; Establishment of Public Docket * 97N-0511 Procedures the safe and sanitary processing/importing juice * 98D-0388 Dermatological Drug Product NDA's and ANDA's * 98N-1038 Irradiation in the production, processing, &handling of food * 99P-1340 Declared Eternity eau de Parfum Misbranded * 99P-4613 Revoke the Regulation That Approved Posilac * 99V-5524 Laser Light Show* 99V-5525 * 99V-5526 * |
92N-0139 Statement Policy: Foods Derived from New Plant Varieties
C 6412 Judith Shotwell Vol#: 163
C 6413 J. Morley Schloss Vol#: 163
C 6414 Marjorie W. Spencer Vol#: 163
92S-0251 Electronic Submissions; Establishment of Public Docket
M 8 CBER, CFR 601.2, 314.50 BLA, PLA, ELA, N Vol#: 1
96N-0277 Eligibility Criteria for Considering Additional Condition
BKG 1 Background Vol#: 2
97N-0511 Procedures the safe and sanitary processing/importing juice
C 252 Deborah Silvers Vol#: 14
C 253 Anna Falcone & Family Vol#: 14
C 254 Crystal Anne Earwood Vol#: 14
C 255 Clayton Hopkins Vol#: 14
C 256 Donald W Frazier Vol#: 14
C 259 Pamela McDaniel Vol#: 14
C 260 Fl Dept of Agriculture & Consumer Servic Vol#: 14
C 263 CLF, Conservation Law Foundation Vol#: 14
C 264 Suzanne Harkness Vol#: 14
C 265 Magical Mavericks Movement Vol#: 14
C 268 Robert C Parker, Joan W Parker Vol#: 14
C 269 American Fresh Juice Council Vol#: 14
C 272 Katros Groves/Citrus Direct Vol#: 14
EMC 12 Cullende Windt Vol#: 14
EMC 13 Kathryn S Meredith Vol#: 14
EMC 16 Michael J Brown Sr Vol#: 14
TR 4 Transcript of December 9, 1999 meeting Vol#: 16
TR 5 ranscript
of December 10, 1999 meeting Vol#: 17
98D-0388 Dermatological Drug Product NDA's and ANDA's
CP 3 Bristol-Myers Squibb Company Vol#: 1
98D-0969 Effects of antimicrobial new animal drugs/use in food-produc
BKG 1 BACKGROUND Vol#: 1
GDL 2 GUIDANCE Vol#: 1
NAD 2 Vol#: 1
NAD 3 Vol#: 1
98F-1201 Pigment Dispersants
NFR 1 Vol#: 1
98N-1038 Irradiation in the production, processing, &handling of food
C 4815 Milton Shapiro Vol#: 139
C 4816 William J. Pearson Vol#: 139
C 4817 Paul & Connie Bang Vol#: 139
C 4818 Anna M. Kramer Vol#: 139
C 4819 Alice Giovanella Vol#: 139
C 4821 Michael Durell Vol#: 139
C 4822 Naomi B. Isler Vol#: 139
C 4823 Mrs. Trudie Laster Vol#: 139
C 4824 Erasmus Brancato Vol#: 139
C 4825 Gray Panthers of Sacramento Vol#: 139
C 4826 Zelda Kreuter Vol#: 139
C 4827 Dr. & Mrs. M. Shore Vol#: 139
C 4828 Joan Phillips Vol#: 139
C 4829 Clifford Browder Vol#: 139
C 4833 Harold Warner Vol#: 139
C 4834 Albert & Elizabeth Watrous Vol#: 139
C 4835 Mrs. Lorraine Katen Vol#: 139
C 4836 Warren & Olive Wilson Vol#: 139
C 4837 John B. Drachman Vol#: 139
C 4838 Helen M. Stailey Vol#: 139
C 4839 Edward J. Lawrence Vol#: 139
C 4841 Marjorie Caruso Vol#: 139
C 4842 Cynthia Weets Vol#: 139
C 4843 Dorothea Sotiros Vol#: 139
C 4844 Rachel Blumenthal Vol#: 139
C 4845 Shirley R. Kupferberg Vol#: 139
C 4846 Dr. & Mrs. Nicholas Gura Vol#: 139
C 4847 Ruth Louise Granick Vol#: 139
C 4848 Stephanie Bekooy Vol#: 139
C 4849 Judith Shotwell Vol#: 139
C 4850 J. Morley Schloss Vol#: 139
C 4851 Marjorie W. Spencer Vol#: 139
C 4853 Linda Lee Bong Vol#: 139
C 4855 Elliot S. Pierce Vol#: 140
C 4856 Action for a Clean Environment Vol#: 140
C 4857 Richard A. Olson Vol#: 140
C 4859 William E. Smith Vol#: 140
C 4862 Gary A. Schwartz Vol#: 140
C 4863 Jerry & Elaine Amos Vol#: 140
C 4864 Mary B. Smith Vol#: 140
C 4866 Keith Johnson Vol#: 140
C 4867 N. C. Overton Vol#: 140
C 4869 Fredrick & Lenore Dusold Vol#: 140
C 4870 Nancy Boomgaarden Vol#: 140
C 4872 Joan D. Levin Vol#: 140
C 4873 Norma Smith-Cost, MT(ASCP) Vol#: 140
C 4876 Michael Compain, M.D. Vol#: 140
C 4878 Jennifer Halpen Vol#: 140
C 4881 Individual Consumer Vol#: 140
C 4882 Ford Motor Co. Vol#: 140
C 4883 Sara & David Rothfeld et al Vol#: 140
C 4884 Matthew W. Ponzar Vol#: 140
C 4885 Cindy A. Krueger Vol#: 140
C 4887 William E. Holland Vol#: 140
C 4888 Brendan Miller Vol#: 140
EMC 6 Phyllis J. Raynor Vol#: 139
99F-1421 Tetradecanoic Acid, Lithium Salt as a Stabilizer
NFR 1 Vol#: 1
99F-1457 High Density Polyethylene & Polypropylene Resins
NFR 1 Vol#: 1
99H-1298 Civil Money Penalties;MFA Petroleum Co,d/b/a Break Time
LET 2 Office of Tobacco Programs Vol#: 1
99H-1468 Civil Money Penalties;MFA Petroleum Co,d/b/a Break Timem
LET 2 Office of Tobacco Programs Vol#: 1
99H-1695 Civil Money Penalty;John Allen Bybel dba Day & Nite Convenie
LET 2 Office of Tobacco Programs Vol#: 1
SET 1 GCF-1 Vol#: 1
99H-4621 Civil Money Penalty;Neil Ainley,dba A J's of Perryville
LET 2 Office of Tobacco Programs Vol#: 1
99H-4639 Civil Money Penalty;Omega Beverages Inc,dba Super Soda Cente
LET 2 Office of Tobacco Programs Vol#: 1
99H-4738 Civil Money Penalty;Bret Delchambre,dba Mardi Gras Gift Shop
LET 2 Office of Tobacco Programs Vol#: 1
WDL 1 GCF-1 Vol#: 1
99H-4778 Civil Money Penalty;May's Drug Stores, Inc;The Drug Warehous
ANS 1 May's Drug Stores Inc Vol#: 1
99H-5141 Civil Money Penalty;Fleming Brothers Oil Company;dba Southto
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5268 Civil Money Penalty;Ramco,Inc;dba 7-Eleven #19677B
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5269 Civil Money Penalty;Karl Savokinas;dba Kulture Shock Smoke S
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5270 Civil Money Penalty;Abraham Schiff;dba Pioneer Club Gift Sho
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5271 Civil Money Penalty;William Skvarca and Annette Skvarca;dba
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5272 Civil Money Penalty;Step 'N Fetch Um,Inc;dba Step 'N Fetch
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5273 Civil Money Penalty;Steve Stonebreaker;dba Zeigler's Gulf
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5274 Civil Money Penalty;The Great Atlantic and Pacific Tea Compa
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5275 Civil Money Penalty;Three Tee's Leasing and Development,Inc
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5276 Civil Money Penalty;Kenneth Wade and Gary Wade;dba Stop 'N S
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5277 Civil Money Penalty;Wal-Mart Stores,Inc;dba Wal-Mart Neighbo
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5278 Civil Money Penalty;Windsor's E-Z Stop,Inc;dba Windsor's E-Z
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5279 Civil Money Penalty;Duk Yang;dba No. 1 Food Store
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5280 Civil Money Penalty;Dave Nyberg;dba Cold Spring Super Valu
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5281 Civil Money Penalty;Equilon Enterprises L.L.C.;dba Texaco St
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5282 Civil Money Penalty;Excel Marketing,Inc;dba Pennsylvania Ave
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5283 Civil Money Penalty;Franklin Road Amoco,Inc;dba Franklin Roa
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5284 Civil Money Penalty;Janak Enterprises,Inc;dba Mountair Liquo
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5285 Civil Money Penalty;Key Chau;dba Jimmy's Mobil Station
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5286 Civil Money Penalty;Lance Riggs,Ralph Riggs,and Stephen Rigg
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5287 Civil Money Penalty;Marvin E. March;dba Foothills Liquors
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5288 Civil Money Penalty;Potter and Sims Foods,Inc;dba Super Valu
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5289 Civil Money Penalty;Rite Aid Corporation;dba Rite Aid Pharma
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5290 Civil Money Penalty;Seung S. Shin;dba Honey Carry Out
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5291 Civil Money Penalty;Sherri P. Brown;dba Paul's Pastry Shop
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5292 Civil Money Penalty;Southwest Liquor Corporation;Dave Studda
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5293 Civil Money Penalty;Teodorico B. Sazon,Jr;dba Riverside Mobi
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5294 Civil Money Penalty;University Conoco, L.L.C.;dba University
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5295 Civil Money Penalty;Wawa, Inc.;dba Wawa Food Market #535
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5296 Civil Money Penalty;William B. Michel,Jr;dba Ken Caryl Liquo
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5307 Civil Money Penalty;Carol Campbell;dba Conoco Travel Shop
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5308 Civil Money Penalty;Jerry Lawley & Darlene Lawley;dba Ardmor
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5309 Civil Money Penalty;Krebsbach Oil Company;dba Super America
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5310 Civil Money Penalty;Leon Thomas & Joanne Thomas;dba The Coun
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5311 Civil Money Penalty;Love's Country Stores,Inc;dba Love's Cou
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5312 Civil Money Penalty;Nadeen Donnelly;dba Owl Grocery & Sundry
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5313 Civil Money Penalty;Noel Powell;dba Noel's Food Mart #2
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5314 Civil Money Penalty;Rich Heinze;dba Rick's Oil Company
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5315 Civil Money Penalty;Vik, Inc;dba Westminster Hess
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5316 Civil Money Penalty;Wal-Mart Stores,Inc;dba Wal-Mart Store #
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5391 Civil Money Penalty;K-Mart Corp;dba Big Kmart #3717
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5392 Civil Money Penalty;Maurice C.Hardesty;dba Hardesty's Grocer
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5393 Civil Money Penalty;Phillips Petroleum Company;dba Phillips
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5394 Civil Money Penalty;Robert Fowler and Joyce Fowler;dba Rober
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5395 Civil Money Penalty;Sanjay Gupta;dba Sameer Crown
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5396 Civil Money Penalty;Sue Chun and Jun I.Chun;dba Poks Grocery
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5397 Civil Money Penalty;Wal-Mart Stores,Inc;dba Wal-Mart Store #
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5398 Civil Money Penalty;Yong Koo Lee and Min Ja Lee;dba L & M Li
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5399 Civil Money Penalty;Ali Kazemezadeh;dba Mittie's Food Mart
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5400 Civil Money Penalty;B & K Foods, Inc;dba B & K Foods
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5401 Civil Money Penalty; Sayle Oil Company,Inc;dba Texaco Gas Ma
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5402 Civil Money Penalty;The Gott Company; Fastop 6
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5403 Civil Money Penalty;Kang K. Young;dba Geo Deli
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5404 Civil Money Penalty;Texaco, Inc;dba Texaco Stations Self Ser
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5405 Civil Money Penalty;A.T.M. Auto Plaza,Inc;dba Chevron Mini M
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5409 Civil Money Penalty;Carl Akey;dba The Plaza Market
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5410 Civil Money Penalty;Albertson's,Inc;dba Albertson's #952
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5411 Civil Money Penalty;J Bailes, LLC;dba J B'S Country Store
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5412 Civil Money Penalty;William Bellamy;dba Bellamy's Grocery
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5413 Civil Money Penalty;Kathleen M.Staden,Scott L.Frank & Randal
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5414 Civil Money Penalty;Fry's Food Stores of Arizona,Inc;dba Fry
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5415 Civil Money Penalty;Don Hopper;dba Big Al's Grocery
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5416 Civil Money Penalty;Killinsworth Enterprises,Inc;dba Killins
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5417 Civil Money Penalty;Arlene Lasker;dba C & G Community One St
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5418 Civil Money Penalty;Kenny Lee;dba Hibiscus Gift Shop
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5419 Civil Money Penalty;Lynnfield Drug, Inc;dba Freedom Drug
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5420 Civil Money Penalty;McGee & Cowen Enterprises Inc;dba Canyon
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5421 Civil Money Penalty;S & K Konvenience Stores,Inc;dba Chevron
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5422 Civil Money Penalty;Sheetz,Inc;dba Sheetz Convenience Store
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99H-5423 Civil Money Penalty;Town & Country Grocers of Fredericktown
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/CDER/FDA Vol#: 1
99N-4461 WDL of Guidance Document on Selegiline Hydrochloride Tablets
NWL 1 Vol#: 1
99N-5222 Notice Claim for GRAS Exemption Based on GRAS determination
N 1 Vol#: 1
99P-1340 Declared Eternity eau de Parfum Misbranded
C 551 Bridget Holdar MS PT Vol#: 12
C 552 Mary R Hassinger Vol#: 12
EMC 25 Claudia Rosa-Bienenfeld, MSW, LCSW Vol#: 12
EMC 26 Meg Kallman Feeley Vol#: 12
EMC 27
Daniel Unsworth and Family Vol#: 12
99P-4613 Revoke the Regulation That Approved Posilac
EMC 211 David Dashiells Vol#: 3
EMC 212 Justin Sharber Vol#: 3
EMC 213 Linda Mieczkowski Vol#: 3
EMC 214 Nanette Grace Taska Vol#: 3
EMC 215 Burton Goldberg Vol#: 3
EMC 216 Patty Faussett Vol#: 3
EMC 217 Patricia Panitz Vol#: 3
EMC 219 Nedra Lynell Roman Vol#: 3
EMC 223 Josey Sprocket (Rex Tyler) Vol#: 3
EMC 225 Barbara Hodges Vol#: 3
EMC 227 Arnie Kushnick Vol#: 3
EMC 230 Timothy G. Sikora Vol#: 3
EMC 232 Justin Sharber Vol#: 3
EMC 233 Virginia Heick Vol#: 3
EMC 238 Linda Nitzschke Vol#: 3
EMC 239 L.Emery-Jacobs Vol#: 3
EMC 242 James Biddle MD Vol#: 3
EMC 243 Sharon Mullane Vol#: 3
EMC 244 Freeda Cathcart Vol#: 3
EMC 247 Daniel Blacklock, Colleen Blacklock, Ben Vol#: 3
EMC 251 Arjuna da Silva Vol#: 3
EMC 258 Jaron Ben-Shalom Vol#: 3
EMC 261 Justin Sharber Vol#: 3
EMC 262 Justin Sharber Vol#: 3
EMC 263 Nanette Grace Taska Vol#: 3