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 Us]

DOCKETS ENTERED on February 8, 2001

TABLE OF CONTENTS

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98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00N-1669 Electronic filing of drug registration and listing informati *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1411 Set a regulatory limit for methylmercury in seafood *
01D-0025 Guidance for Industry - Yellow Corn & Dry-Milled *
01P-0068 Revoke the ban set on implementation of prosthetic hair fibe *

98D-0969 Effects of antimicrobial new animal drugs/use in food-produc

C 28 John C Garvey Vol#: 16

98N-0337 Over the counter human drugs labeling requirements

APP 13 Arnall Golden & Gregory, LLP Vol#: 6

APP 14 CHPA, Consumer Healthcare Products Assn. Vol#: 6

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 3739 Kady Lane Vol#: 117

C 3740 Nicole Groote Vol#: 117

C 3741 no signature Vol#: 117

C 3742 Albanese Vol#: 117

C 3743 Valdez Vol#: 117

C 3744 Sheffer Vol#: 117

C 3745 Scuderi Vol#: 117

C 3746 Henry Vol#: 117

C 3747 Marshall Vol#: 117

C 3748 Moe Vol#: 117

C 3749 Mariana Vol#: 117

C 3750 Parks Vol#: 117

C 3751 Lowis Vol#: 117

C 3752 Schaefer, M.D. Vol#: 117

C 3753 Woodruff Vol#: 117

C 3754 Savage Vol#: 117

C 3755 MacNerland Vol#: 117

C 3756 Polich Vol#: 117

C 3757 Walker Vol#: 117

C 3758 Swann Vol#: 117

C 3759 Koon Vol#: 117

C 3760 Perez Vol#: 117

C 3761 Caso Vol#: 117

C 3762 Dering Vol#: 117

C 3763 Baroni Vol#: 117

C 3764 Siracusa Vol#: 117

C 3765 Savage Vol#: 117

C 3766 Brogle Vol#: 117

C 3767 Malatino Vol#: 117

C 3768 Garabedian Vol#: 117

C 3769 Smith Vol#: 117

C 3770 Tober Vol#: 117

EMC 923 Parrott Vol#: 117

EMC 924 Jorgens Vol#: 117

EMC 925 Henwood Vol#: 117

EMC 926 Hensler Vol#: 117

EMC 927 Lori G. I. Vol#: 117

EMC 928 Zimmerman Vol#: 117

EMC 929 Jacobson Vol#: 117

EMC 930 Clark Vol#: 117

EMC 931 Morris Vol#: 117

EMC 932 MacFhearghuis Vol#: 117

EMC 933 d'Affonseca Vol#: 117

EMC 934 Furlong Vol#: 117

EMC 935 Welch Vol#: 117

EMC 936 Masturzo Vol#: 117

EMC 937 Thomas Vol#: 117

EMC 938 Smith Vol#: 117

EMC 939 Kuhn Vol#: 117

EMC 940 Parnes Vol#: 117

EMC 941 Westler Vol#: 117

EMC 942 Carter Vol#: 117

EMC 943 Flaherty Vol#: 117

EMC 944 Jade Vol#: 117

EMC 945 Hogle Vol#: 117

EMC 946 Hughes, Ph.D., RN Vol#: 117

EMC 947Shearer Vol#: 117

EMC 948 Greene Vol#: 117

EMC 949 Bowers Vol#: 117

EMC 950 Sternberg Vol#: 117

EMC 951 Kots Vol#: 117

EMC 952 Williams Vol#: 117

EMC 953 Gleason Vol#: 117

EMC 954 Mattia Vol#: 117

EMC 955 Schmit Vol#: 117

EMC 956 Sutherlin Vol#: 117

EMC 957 Veterinary Healthcare Communications Vol#: 117

EMC 958 Darlene Brannen Synopsys, Inc. Vol#: 117

EMC 959 House Vol#: 117

EMC 960 Gausling Vol#: 117

EMC 961 Jessler Vol#: 117

EMC 962 Oba Vol#: 117

EMC 963 Jeddi Vol#: 117

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 346 Canman Vol#: 198

EMC 347 Smith Vol#: 198

EMC 348 Lent Vol#: 198

EMC 349 Levy Vol#: 198

EMC 350 Smith Vol#: 198

EMC 351 Valerie T Vol#: 198

EMC 352 Gemer Vol#: 198

EMC 353 Hubert Vol#: 198

EMC 354 Peairs Vol#: 198

EMC 355 C Anderson Vol#: 198

EMC 356 Skumanich PhD Vol#: 198

EMC 357 Smith Vol#: 198

EMC 358 Dumas PhD Vol#: 198

EMC 359 Cerier Vol#: 198

EMC 360 Stewart Vol#: 198

EMC 361 Betcher Vol#: 198

EMC 362 Weinberg MD Vol#: 198

EMC 363 Warren Vol#: 198

EMC 364 Lievow Vol#: 198

EMC 365 Cavanaugh Vol#: 198

EMC 366 Riehle Vol#: 198

EMC 367 Rothfusz Vol#: 198

EMC 368 Horton Vol#: 198

EMC 369 Fox Vol#: 198

EMC 370 Wilczek Vol#: 198

EMC 371 Kirschbaum Vol#: 198

EMC 372 Wooliever Vol#: 198

EMC 373 Kuehlwein Vol#: 198

EMC 374 M Kirch Vol#: 198

EMC 375 Wallin Vol#: 198

EMC 376 Buckner Vol#: 198

EMC 377 Arbogast Vol#: 198

EMC 378 Sobel Vol#: 198

EMC 379 Leiken Vol#: 198

EMC 380 Riley Vol#: 198

EMC 381 Masonick Vol#: 198

EMC 382 Skinner Vol#: 198

EMC 383 Bruce Vol#: 198

EMC 384 Osornio Vol#: 198

EMC 385 Prokope Vol#: 198

EMC 386 Thompson Vol#: 198

EMC 387 Heyman Vol#: 198

EMC 388 Gausling Vol#: 198

EMC 389 Alspector Vol#: 198

00D-1598 Voluntary Labeling for Bioengineered Foods

C 130 Form Letter Vol#: 14

C 131 Vahey Vol#: 10

C 132 Taiani Vol#: 10

C 133 Ledet Vol#: 10

C 134 Schonbeck, Ph.D. Vol#: 10

C 135 Fitzell Vol#: 10

C 136 Pouder Vol#: 10

C 137 Mello Vol#: 10

C 138 McNulty Vol#: 10

C 139 ALerenzo Vol#: 10

C 140 Smith Vol#: 10

C 141 Duram Vol#: 10

C 142 Tarres Vol#: 10

C 143 Urszula Vol#: 10

C 144 Keller Vol#: 10

C 145 Eckart Vol#: 10

C 146 K. Doolittle Vol#: 10

C 147 Fishburn Vol#: 10

C 148 Pophal Vol#: 10

C 149 Cline Vol#: 10

C 150 Meetzer Vol#: 10

C 151 Curry Vol#: 10

C 152 Peaff Vol#: 10

C 153 Johuson Vol#: 10

C 154 Moreau Vol#: 10

C 155 Colvin Vol#: 10

C 156 M. J. Vol#: 10

C 157 Shire Vol#: 10

C 158 Caton-Garcia Vol#: 10

C 159 Mata Vol#: 10

C 160 Dennis F. Vol#: 10

C 161 Sara B. Vol#: 10

C 162 Wright Vol#: 10

C 163 Schiller Vol#: 10

C 164 R.L. Vol#: 10

C 165 M.A. Vol#: 10

C 166 Melissa B. Vol#: 10

C 167 Alhott Vol#: 10

C 168 T Marshall Vol#: 10

C 169 Daitz Vol#: 10

C 170 Niswander Vol#: 10

C 171 Dumouchelle Vol#: 10

C 172 Rucker Vol#: 10

C 173 Timothy A. Vol#: 10

EMC 487 Cathy Balken Vol#: 14

00D-1651 Inspection of Medical Device Manufacturers

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

00D-1662 Use of Xenotransplantation Products in Humans

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

EMC 2 Miller Vol#: 9


00N-1669 Electronic filing of drug registration and listing informati

LET 15 Alcon Laboratories Inc Vol#: 1

LET 16 Banner Pharmacaps Vol#: 1

LET 17 S S T Corporation Vol#: 1

LET 18 Aventis Pasteur Inc Vol#: 1

LET 19 Merc & Co Inc Vol#: 1

LET 20 Allergan Vol#: 1

LET 21 Perrigo Vol#: 1

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

C 8763 Murawski Vol#: 683

C 8764 Zubow Vol#: 683

C 8765 Fehribach Vol#: 683

C 8766 Pratt Vol#: 683

C 8767 Uzzle, Jr. Vol#: 683

C 8768 August, M.A. Vol#: 683

C 8769 Howard Vol#: 683

C 8770 Tanebaum Vol#: 683

C 8771 Schut Vol#: 683

C 8772 Ruth Vol#: 683

C 8773 Baker Vol#: 683

C 8774 Pullan Vol#: 683

C 8775 Perry Vol#: 683

C 8776 Lansdowne Vol#: 683

C 8777 Herm Vol#: 683

C 8778 L. Armstrong Vol#: 683

C 8779 Stephens Vol#: 683

C 8780 Slama Vol#: 683

C 8781 Krippene Vol#: 683

C 8782 Iopea Vol#: 684

C 8783 Ritter Vol#: 684

C 8784 Chatas Vol#: 684

C 8785 Fad Vol#: 684

C 8786 Fenko Vol#: 684

C 8787 Zupas Vol#: 684

C 8788 Gonzakz Vol#: 684

C 8789 Scott Vol#: 684

C 8790 Barbett Vol#: 684

C 8791 Gomez Vol#: 684

C 8792 McKenzie Vol#: 684

C 8793 Donnelly Vol#: 684

C 8794 Lerner Vol#: 684

C 8795 Freedman Vol#: 684

C 8796 Khalsa Vol#: 684

C 8797 Vernon Vol#: 684

C 8798 Fick Vol#: 684

C 8799 Gluck Vol#: 684

C 8800 Skillman Vol#: 684

C 8801 McKenzie Vol#: 684

C 8802 Betz-Zall Vol#: 684

C 8803 Stern Vol#: 684

C 8804 Carter Vol#: 684

C 8805 Warren Vol#: 684

C 8806 Schultz Vol#: 684

C 8807 Brown Vol#: 684

C 8808 Prince Vol#: 684

C 8809 Smith Vol#: 684

C 8810 Safstrom Vol#: 684

C 8811 Slucki Vol#: 684

C 8812 Miller Vol#: 684

C 8813 Bithell Vol#: 684

C 8814 Rushforth Associates Vol#: 684

C 8815 Haug Vol#: 684

C 8816 Clark Vol#: 684

C 8817 Taylor Vol#: 684

C 8818 White Vol#: 684

C 8819 Barrett, MD Vol#: 684

C 8820 Reber Vol#: 684

C 8821 Skowron Vol#: 684

C 8822 Faerber Vol#: 684

C 8823 Fightlin Vol#: 684

EMC 4248 Melnick Vol#: 684

EMC 4249 Rice Vol#: 684

EMC 4250 Fuchs Vol#: 684

EMC 4251 Richter Vol#: 684

EMC 4252 Rice Vol#: 684

EMC 4253 Blaine Vol#: 684

EMC 4254 Foote Vol#: 684

EMC 4255 West Vol#: 684

EMC 4256 Meredith Vol#: 684

EMC 4257 Colht Vol#: 684

EMC 4258 Smith Vol#: 684

EMC 4259 Patti Vol#: 684

EMC 4260 Young Vol#: 684

EMC 4261 Wallitt Vol#: 684

EMC 4262 Kresky Vol#: 684

EMC 4263 Rachele Vol#: 684

EMC 4264 Hauser Vol#: 684

EMC 4265 Sterling Vol#: 684

EMC 4266 Stephens Vol#: 684

EMC 4267 Collins Vol#: 684

EMC 4268 Dickinson Vol#: 684

EMC 4269 Pociask Vol#: 684

EMC 4270 Considine Vol#: 684

EMC 4271 Mason Vol#: 684

EMC 4272 Graham Vol#: 684

EMC 4273 Koenig Vol#: 684

EMC 4274 Knight Vol#: 684

EMC 4275 Mitchell Vol#: 684

EMC 4276 Schwartz Vol#: 684

EMC 4277 Dodds Vol#: 684

EMC 4278 Cahn Vol#: 684

EMC 4279 Gould Vol#: 684

EMC 4280 Anton Vol#: 684

EMC 4281 Ramsay Vol#: 684

EMC 4282 Gerald Vol#: 684

EMC 4283 Campopiano Vol#: 684

EMC 4284 Duffy Vol#: 684

EMC 4285 Gabria Vol#: 684

EMC 4286 Potter Vol#: 684

EMC 4287 Potter Vol#: 684

EMC 4288 Kerstein Vol#: 684

EMC 4289 Doane Vol#: 684

EMC 4290 Wilkie Vol#: 684

EMC 4291 Redmon Vol#: 684

EMC 4292 Eusebio Vol#: 684

00P-1411 Set a regulatory limit for methylmercury in seafood

EMC 1 Form Letter Vol#: 2

01D-0025 Guidance for Industry - Yellow Corn & Dry-Milled

EMC 1 Form Letter Vol#: 2

01P-0068 Revoke the ban set on implementation of prosthetic hair fibe

ACK 1 HFA-305 Vol#: 1

CP 1 Medicap Ltd. (Italy) Vol#: 1