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 September 23, 1999

Table of Contents

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

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76N-052N OTC Nasal Decongestants*
92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability *
96P-0342 CSP and all forms or silver marketed for human & animal con. *
97D-0433 In Vivo Bioequivalence Studies Based on Population *
98D-0077 Treatment of osteoarthritis/drugs, devices and biological pt *
98D-0814 Good manufacturing practice for blood and blood components *
98N-0673 Revisions to Requirements to Blood,Blood Components & Plasma *
98N-1215 Foreign Establishment Registration and Listing *
98P-0203 Eliminate Forced Molting of Laying Birds *
98P-0225 ANDA for omeprazole delayed-release tablets *
98P-0683 Soy Protein Containing Products*
98P-0858 ANDA for Cyclososporine Tablets 25mg, 50mg & 100mg *
98P-1219 Drug products containing oxycodone hydrocloride tablet suita *
99D-0557 Use of Nonhuman Primate Xenografts in Humans *
99D-1738 Bioavilability & Bioequivalence Studies for Nasal Aerosols *
99D-2096 Interpreting Sameness of Monoclonal Antibody Products *
99D-2638 Use of Medicated Feeds for Minor Species *
99D-2729 Industry on BA/BE studies orally administered drug products *
99M-4134 H990004; CardioSEAL Septal Occlusion System *
99N-0438 Contamination ready-to-eat foods associated food prepartion *
99N-1076 Foodborne Listeria Monocytogenes comments/scientific data *
99N-1307 Preliminary Regulatory Impact Analysis and Initial Regulatoy *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-0510 (ANDA) Ketorolac Tromethamine Injection, USP 30 mg/ml *
99P-0553 Anda Suitability Petition Levocarnitine Injection *
99P-1720 Variance from the labeling regulation for natural rubber *
99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast *
76N-052N OTC Nasal Decongestants

C 229 The Marshfield NeuroSciences Vol#: 73

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

C 5945 Chris Couture Vol#: 147

C 5946 Judy Lunde Vol#: 147

C 5947 Pauline M Doyle Vol#: 147

C 5948 Debbie Urben Vol#: 147

C 5949 Pam Lepper Vol#: 147

C 5950 Charles Behrens Vol#: 147

C 5951 Getchen S Dunham Vol#: 147

C 5952 Terri Lang Vol#: 147

C 5953 Sharon Cloonan & Betty Croll Vol#: 147

C 5954 Maria Carellla Vol#: 147

C 5955 Lydia Garvey Vol#: 147

C 5956 Marie Jermolowicz Vol#: 147

C 5957 Julie Pearson Vol#: 147

C 5958 Mercedes Sanbrailo Vol#: 147

C 5959 Kemmer Family Vol#: 147

C 5960 Anastasia Gourley Vol#: 147

C 5961 Carol Awad Vol#: 147

C 5962 Mr & Mrs V Mariano & Family Vol#: 147

C 5963 Dale & Karen Baldwin Vol#: 147

C 5964 Form Letter count 20 Vol#: 148

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

LET 44 The Honorable Mitch McConnell Vol#: 291

96P-0342 CSP and all forms or silver marketed for human & animal con.

PAV 1 HF-22 to Rosemary Jacobs Vol#: 2

97D-0433 In Vivo Bioequivalence Studies Based on Population

C 23 National Assn of Pharmaceutical Manuf Vol#: 1

98D-0077 Treatment of osteoarthritis/drugs, devices and biological pt

C 13 Bayer Corporation Vol#: 1

C 14 Pharmaceutical Res & Manuf of America Vol#: 1

C 15 Roache Pharmaceuticals Vol#: 1

98D-0814 Good manufacturing practice for blood and blood components

C 3 The Sacramento Medical Foundation Vol#: 2

98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

C 61 Katherine Fell Vol#: 2

C 62 Rebekah Bradshaw Vol#: 2

98N-0044 Effect of dietary supplement on structure/function of body

C 22398 Darlene E. Jewett Vol#: 876

98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;

C 154 Theresa Campbell Vol#: 19

C 155 Rush Msc Neurologic Consultants Vol#: 19

EC 1 Dan Sinclair Vol#: 19

98N-0337 Over the counter human drugs labeling requirements

APP 6 Zee Medica Inc Vol#: 3

LET 1 HFD-560 to Consumer HealthCare Prod Assn Vol#: 3

LET 2 HFD-560 to Cosmetic Toiletry & Frag Assn Vol#: 3

98N-0673 Revisions to Requirements to Blood,Blood Components & Plasma

C 1 Steven R. Pierce Vol#: 1

98N-1215 Foreign Establishment Registration and Listing

C 20 Royco Apparatus Ltd Vol#: 1

C 21 Canadian Hospital Specialties Ltd Vol#: 1

C 22 Parsons A. D. L. Inc Vol#: 1

98P-0203 Eliminate Forced Molting of Laying Birds

C 1832 Mary Jo Brooks Vol#: 45

C 1833 Elizabeth Kinnon & Richard Mitchell Vol#: 45

C 1834 Deniz Marie & 39 signatures Vol#: 45

C 1835 Molly J Fox Vol#: 45

C 1836 Robbie McCartney Vol#: 45

C 1837 Beth Duffy Vol#: 45

C 1838 Charles Locke Vol#: 45

C 1839 Tracey DeMartini Vol#: 45

98P-0225 ANDA for omeprazole delayed-release tablets

PDN 1 HFD-600 to Apdrx Pharmaceuticals, Inc. Vol#: 1

98P-0683 Soy Protein Containing Products

C 135 Valerie James Vol#: 19

C 136 Richard F. James Vol#: 19

C 137 National Food Processors Association Vol#: 19

C 138 American Soybean Association Vol#: 19

98P-0858 ANDA for Cyclososporine Tablets 25mg, 50mg & 100mg

PAV 1 HFD-600 to Apotex Corp Vol#: 1

98P-1219 Drug products containing oxycodone hydrocloride tablet suita

PAV 1 HFD-600 to King & Spalding Vol#: 1

99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 326 Susan Gensinger Vol#: 16

99D-1738 Bioavilability & Bioequivalence Studies for Nasal Aerosols

C 3 Sympatec, Inc Vol#: 1

C 4 Gem Laboratories, L. P. Vol#: 1

C 5 GlaxoWellcome Vol#: 1

C 6 Generic Pharmaceutical Industry Assn Vol#: 1

99D-2096 Interpreting Sameness of Monoclonal Antibody Products

C 1 Antisoma Vol#: 1

99D-2638 Use of Medicated Feeds for Minor Species

C 1 Kay Bushnell Vol#: 1

99D-2729 Industry on BA/BE studies orally administered drug products

EXT 1 National Assn of Pharmaceutical Manuf Vol#: 1

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

BRF 1 GCF-1 Vol#: 1

MO 1 Camp Oil Co.,dba Sav-A-ton Vol#: 1

99H-2708 Civil Money Penalty;Fuhr Enterprises Inc dba Sunray Amoco

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-2743 Civil Money Penalty;Service Energy LLC,dba Milford Mobile

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-2843 Civil Money Penalty;Underwood Convenience Stores Inc,dba Und

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99M-4134 H990004; CardioSEAL Septal Occlusion System

AAV 1 Nitinol Medical Technologies, Inc. Vol#: 1

99N-0438 Contamination ready-to-eat foods associated food prepartion

C 15 National Restaurant Assn Vol#: 5

C 16 University of Wisconsin-Madison Vol#: 5

99N-1076 Foodborne Listeria Monocytogenes comments/scientific data

C 3 International Dairy Foods Assn. Vol#: 1

99N-1174 Development of Strategy for Dietary Supplements

TR 2 Transcript of the 7/20/99 meeting Vol#: 7

99N-1307 Preliminary Regulatory Impact Analysis and Initial Regulatoy

C 1 U. S. Poultry & Egg Association Vol#: 1

99N-4004 Withdrawal of approval of several drug applications

LET 1 Vol#: 1

NWL 1 HFD-007 Vol#: 1

99N-4063 Positron emmission tomography drug products

BKG 1 Background material Vol#: 1

NAD 1 HFD-210 Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1572 Kay Stewart Vol#: 25

EC 101 Andrew C Millard Phd Vol#: 25

EC 102 Bill & Judy Webb Vol#: 25

EC 103 Raymond D Kuzmich Vol#: 25

EC 104 Mark Fraser Vol#: 25

EC 105 Unsigned Vol#: 25

EC 106 Susan Marks Roberts Vol#: 25

EC 107 Merita Trohimovich Pollard Vol#: 25

EC 108 Geoffry & Leah Levitt Vol#: 25

EC 109 Stephen Sanders Vol#: 25

EC 110 Paul Chang Vol#: 25

EC 111 Paul Chang Vol#: 25

EC 112 Susan Kulakowski Vol#: 25

EC 113 Jim & Pat Tucker Vol#: 25

99P-0510 (ANDA) Ketorolac Tromethamine Injection, USP 30 mg/ml

PAV 1 HFD-600 to Apotex Corp Vol#: 1

99P-0553 Anda Suitability Petition Levocarnitine Injection

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

99P-0683 ANDA for Ibuprofen 200mg tablets

WDL 1 HFD-600 to FPC Consulting Inc Vol#: 1

99P-1720 Variance from the labeling regulation for natural rubber

PAV 1 HFZ-1 to HIMA Vol#: 1

99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast

C 4 Hannah Sidofsky Vol#: 3

EC 11 Anne Levitt-Gruberger Vol#: 3

EC 12 Kelly D. Moran, Ph.D. Vol#: 3