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 November 10, 1999

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]
 
92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
97D-0433 In Vivo Bioequivalence Studies Based on Population *
98N-1038 Irradiation in the production, processing, &handling of food *
98P-0203 Eliminate Forced Molting of Laying Birds *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99M-4810 H980007; Shelhigh Pulmonic Valve Conduit Model NR-4000 *
99P-0794 ANADA PropoFlo Propofol Anesthetic Injection-10 mg/ml *
99P-1589 Stay effective date of approval for NDA 20-932 Roxicodone *
99P-4581 Add Triiodo-L-Thyronine, T3 SR to "Bulk Drug Substances" *
83N-0118 CERTAIN PRESCRIPTION DRUGS TO RELIEF COUGH/COLD/ALLERGY

WDL 1 SmithKline Beecham Pharmaceuticals Vol#: 3

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

C 6249 Buster Duck Vol#: 159

C 6250 Paul S Lipton Vol#: 159

C 6251 Stuart & Beth Sackman Vol#: 159

C 6252 Dorothy Dalessandro Vol#: 159

C 6253 Lucy Cesar-Jedacek Vol#: 159

C 6254 Jessica Chover Vol#: 159

C 6255 Mark Oshinskic Vol#: 159

C 6256 M Ruth Niswander Vol#: 159

C 6257 Judy Downing Vol#: 159

C 6258 Millard A Murphy Vol#: 159

C 6259 Jennifer Webster Vol#: 159

C 6260 Kimberly J Geisler Vol#: 159

C 6261 Courtney Barrick & 14 signatures Vol#: 159

C 6262 Dan Steinberg Vol#: 159

C 6263 M Hersey Vol#: 159

97D-0433 In Vivo Bioequivalence Studies Based on Population

C 25 Anapharm, Inc. Vol#: 2

97N-0074 President's National Food Safety Initiative

C 159 Jill Schmndt Vol#: 11

C 160 Jennifer Johnson Vol#: 11

C 161 Brenda Shoss Vol#: 11

C 162 Diana Saxton Vol#: 11

98N-0562 Civil Money Penalties; Rajaram K Matkari

MO 3 GCF-1 Vol#: 2

98N-0581 Requirements for Testing Human Blood Donors

NM 1 Vol#: 5

98N-0607 General Requirements for Blood,Blood Components and Derivati

NM 1 Vol#: 2

98N-0815 Plasma Derivatives & Other Blood-Derived Products

NM 1 Vol#: 1

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

C 4779 Step Vol#: 138

98P-0203 Eliminate Forced Molting of Laying Birds

C 1885 Sherry Horton Vol#: 45

C 1886 Donna Brigham Vol#: 45

C 1887 Joanne Douglas Vol#: 45

C 1888 Laurie Jidon Vol#: 45

C 1889 Elinore B Gordon Vol#: 45

C 1890 Gail Dotson Vol#: 45

C 1891 Dorothy C Ramsaier Vol#: 45

C 1892 Amrit & Chris Hansmeyer Vol#: 45

C 1893 Jessica Lee Orestano Vol#: 45

C 1894 Marie C Beltz Vol#: 45

C 1895 Diana Etzler Vol#: 45

C 1896 Rita Flygar Vol#: 45

C 1897 Robin Jacobson Vol#: 45

C 1898 Ruta M Klimas Vol#: 45

C 1899 Lisa Koester Vol#: 45

C 1900 Edward M Castellano Vol#: 45

C 1901 Michael & Ingrid Alexander Vol#: 45

C 1902 Karen Biesiada Vol#: 45

C 1903 Rosemary Berg Vol#: 45

98P-0683 Soy Protein Containing Products

BKG 3 BACKGROUND MATERIAL Vol#: 22

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 694 Paul S Lipton Vol#: 23

99F-4694 2-methyl-4-isothiazolin-3-one as an antimicrobial

NFL 1 Rohm and Haas Co Vol#: 1

99H-1137 Civil Money Penalties;Harold Flora,d/b/a Harold Flora Amoco

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1165 Civil Money Penalties;Walco Oil co,d/b/a Walco Mart #156

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1184 Civil Money Penalties;Salama Market 5 Inc,d/b/a Salama Super

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1192 Civil Money Penalties;Pak Associates Inc,d/ba/ Amoco Food &

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1227 Civil Money Penalties;Robert Tennie,d/b/a 16th Ave Shell

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1578 Civil Money Penalty; Billy's Seafood Inc dba T J's Gas & Gri

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2804 Civil Money Penalty;Citizen's Fuel Co,dba Citizens Food Stor

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-4230 Civil Money Penalty;Duckwall-Alco Stores Inc,dba Alco Discou

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4399 Civil Money Penalty;Atlantic Financial Group Corp,dba Check

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4400 Civil Money Penalty;Bells' Food Market Inc,dba Bells' Food

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4401 Civil Money Penalty;Jack Blanton,dba New Smithville Road She

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4402 Civil Money Penalty;Broadway General Store Inc,dba Broad

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4403 Civil Money Penalty;Freddy Cabral,dba Center Grocery Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4404 Civil Money Penalty;Martha Campbell,dba Long's Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4405 Civil Money Penalty;Alexis Cruz,dba Alex Mini Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4406 Civil Money Penalty;Foersters Market Inc,dba Foerster's Mark

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4407 Civil Money Penalty;Rolston Friday,dba Friday's Ent

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4408 Civil Money Penalty;Delores Glenn,dba Delores Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4409 Civil Money Penalty;Stanley Hatoff,dba Stan Hatoff's Numbers

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4410 Civil Money Penalty;Home Ent Inc,dba South Hadley Shell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4411 Civil Money Penalty;James Filandrianos Inc,dba Oak Square Su

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4412 Civil Money Penalty;K & S of Hamlet Inc,dba Kirkley's Amoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4413 Civil Money Penalty;Yamileth Lopez,dba River Street Mini Mak

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4414 Civil Money Penalty;M L & R Ent Inc,dba R & R Express

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4415 Civil Money Penalty;Maxi Drug Inc,dba Brooks Pharmacy #871

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4416 Civil Money Penalty;Peter Johnson & Mike Donohoe,dba The Fou

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4417 Civil Money Penalty;Feliz B Perez Peguero,dba Dr Perez Groce

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4418 Civil Money Penalty;Jewel Redmond,dba Jewel's Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4419 Civil Money Penalty;Rhea Drugstore Inc,dba Rhea Drug Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4420 Civil Money Penalty;Gladys Santana,dba El Nuevo Monte Carlo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4421 Civil Money Penalty;Sita Ram Inc,dba Corner Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4422 Civil Money Penalty;Iris B Tejada,dba Evelyn's Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4423 Civil Money Penalty;Sang Y Yoo,dba Yoo Shell Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4573 Civil Money Penalty;Gibbs Oil Co Ltd Partnership,dba Gibbs

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4574 Civil Money Penalty;Mustafa Uwainat,dba B-52 Market #2

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99M-4810 H980007; Shelhigh Pulmonic Valve Conduit Model NR-4000

AAV 1 Shelhigh, Inc. Vol#: 1

99P-0794 ANADA PropoFlo Propofol Anesthetic Injection-10 mg/ml

PDN 1 HFV-100 to Veterinary Research Assocs, I Vol#: 1

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

LET 2 HFD-1 to Purdue Pharma L.P. Vol#: 1

99P-2733 ANADA for Ketanil 200 (Ketamine Hydrochloride Inj.

PDN 1 HFV-100 to Wildlife Labs, Inc. Vol#: 1

99P-4581 Add Triiodo-L-Thyronine, T3 SR to "Bulk Drug Substances"

PDN 1 HFC-1 to Beverly J. Warns Vol#: 1