Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870; TTY/TDD Users 1-800-735-2258 - [E-mail Us]

DOCKETS ENTERED on September 11, 2002

TABLE OF CONTENTS

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86F-0208 MYCO-PROTEIN DERIVED  FUSARIUM GRANINEARUM SOURCE PRO *
95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection) *
98N-0359 Program priorities/Center for Food Safety & Applied Nutritin *
01P-0120 Ban Unsafe IV Catheters and other Devices *
01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II *
02D-0124 Notifying FDA of Fatalities Related to Blood & Transfusion *
02D-0228 Implantable Middle Ear Hearing Device *
02N-0209 Governing First Amendment Case Law *

86F-0208 MYCO-PROTEIN DERIVED - FUSARIUM GRANINEARUM SOURCE PRO

EMC 7 CSPI Vol#: 1

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients

LET 7 HFS-820 to US Botanicals Vol#: 79

LET 8 HFS-820 to General Nutrition Corporation Vol#: 79

LET 9 HFS-820 to Nutramax Laboratories, Inc. Vol#: 79

RPT 102 PharmaSe, Inc. Vol#: 79

RPT 103 Takaro Shuzo Co., Ltd Vol#: 79

RPT 104 Scientific Medical Devices, Inc. Vol#: 79

RPT 105 AlphaNatural, Inc. Vol#: 79

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 632 HFS-810 to Dee Cee Laboratories, Inc Vol#: 18

LET 633 HFS-810 to Tabak's Health Products Vol#: 18

LET 634 HFS-810 to Crosslinks International, Inc Vol#: 18

LET 635 HFS-810 to Metagenics Vol#: 18

LET 636 HFS-810 to Pharmavite Corporation Vol#: 18

98D-0834 Non-Contraceptive Estrogen Class Labeling

NWL 1 Vol#: 1

98F-0196 Safe use of Selenium Yeast in Animal Feeds

EMC 1 B. Sachau Vol#: 1

98N-0359 Program priorities/Center for Food Safety & Applied Nutritin

EMC 12 National Food Processors Assn (NFPA) Vol#: 7

99F-5321 Food Safety & Inspection service safe use of ionizing radiai

EMC 242 Cal Hill Vol#: 5

EMC 243 Jeffrey Grayson Vol#: 5

EMC 244 Ave Torre-Bueno Vol#: 5

EMC 245 Lisa Yett Vol#: 5

EMC 246 Belinda Heaton Vol#: 5

EMC 247 Lydia Straus-Edwards Vol#: 5

EMC 248 Patricia Leavitt Vol#: 5

EMC 249 Cindy Stults-DiStasio Vol#: 5

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 241 Cal Hill Vol#: 4

EMC 242 Jeffrey Grayson Vol#: 4

EMC 243 Ave Torre-Bueno Vol#: 4

EMC 244 Lisa Yett Vol#: 4

EMC 245 Belinda Heaton Vol#: 4

EMC 246 Lydia Straus-Edwards Vol#: 4

EMC 247 Patricia Leavitt Vol#: 4

EMC 248 Cindy Stults-DiStasio Vol#: 4

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

EMC 244 Cal Hill Vol#: 4

EMC 245 Jeffrey Grayson Vol#: 4

EMC 246 Ave Torre-Bueno Vol#: 4

EMC 247 Lisa Yett Vol#: 4

EMC 248 Belinda Heaton Vol#: 4

EMC 249 Lydia Straus-Edwards Vol#: 4

EMC 250 Patricia Leavitt Vol#: 4

EMC 251 Cindy Stults-DiStasio Vol#: 4

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

EMC 3706 Jenny Holub Vol#: 512

EMC 3707 Cal Hill Vol#: 512

EMC 3708 Susan Levine Vol#: 512

EMC 3709 Jeffrey Grayson Vol#: 512

EMC 3710 Gloria Larkin Vol#: 512

EMC 3711 Jodie Leidecker Vol#: 512

EMC 3712 Belinda Heaton Vol#: 512

EMC 3713 Lydia Straus-Edwards Vol#: 512

EMC 3714 Kelli Gray Vol#: 512

EMC 3715 Patricia Leavitt Vol#: 512

EMC 3716 Linda Price Vol#: 512

EMC 3717 Janus Wilhelm Vol#: 512

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 883 Bernice Eaman Vol#: 212

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 398 No signature Vol#: 21

00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization

EMC 8 Jerry Lyons Vol#: 5

EMC 9 Lynn King Vol#: 5

EMC 10 Carmel Gulley Vol#: 5

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9830 Shawn B. Owen Vol#: 572

00N-1367 Postmarket Surveillance

EMC 2 Stephen Dolle Vol#: 1

01E-0365 Patent Term Extension Application, NEXIUM 4,738,974

ACK 1 HFA-305 Vol#: 1

PRC 1 Dr. Reddy's Laboratories, Ltd. Vol#: 1

01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked

EMC 341 Cal Hill Vol#: 6

EMC 342 Jeffrey Grayson Vol#: 6

EMC 343 Ave Torre-Bueno Vol#: 6

EMC 344 Lisa Yett Vol#: 6

EMC 345 Belinda Heaton Vol#: 6

EMC 346 Lydia Straus-Edwards Vol#: 6

EMC 347 Patricia Leavitt Vol#: 6

EMC 348 Cindy Stults-DiStasio Vol#: 6

01N-0067 Reclassification of Dental Mercury

C 49 DAMS, Inc. Vol#: 6

C 50 Jason J. Gehman Vol#: 6

EMC 319 Vanja Karlsson Vol#: 6

EMC 320 Sue Klein Vol#: 6

EMC 321 Bernard Windham Vol#: 6

EMC 322 Bernard Windham Vol#: 6

EMC 323 Bernard Windham Vol#: 6

EMC 324 Bernard Windham Vol#: 6

EMC 325 Bernard Windham Vol#: 6

EMC 326 Bernard Windham Vol#: 6

EMC 327 Bill Edwards Vol#: 6

EMC 328 Bernard Windham Vol#: 6

EMC 329 Bernard Windham Vol#: 6

EMC 330 Steve Savitz Vol#: 6

EMC 331 Mark Cree Jackson, MSE, MBA Vol#: 6

EMC 332 Owen Fonorow Vol#: 6

EMC 333 Dr. Jacques Imbeau, D.M.D Vol#: 6

EMC 334 Jim Gruber Vol#: 6

EMC 335 Richard Baynton Vol#: 6

EMC 336 Katherine Fry Vol#: 6

EMC 337 Jim Gruber Vol#: 6

EMC 338 Lawrence D. Cohen Vol#: 6

EMC 339 Jacques Imbeau, D.M.D. Vol#: 6

EMC 340 Michael V. Capizzi Vol#: 6

EMC 341 Mary Ann Newell Vol#: 6

EMC 342 Mary Robinson Vol#: 6

EMC 343 Lynne Locatell Vol#: 6

EMC 344 Therese Quinn Vol#: 6

EMC 345 Sandy Pittman Vol#: 6

EMC 346 Dawn M. Arthur Vol#: 6

EMC 347 S. Ward Eccles, D.D.S. Vol#: 6

EMC 348 No signature Vol#: 6

EMC 349 Jean Griffin Vol#: 6

EMC 350 Joseph W. Lyons Vol#: 6

EMC 351 Brandy Cravens Vol#: 6

EMC 352 Kathy Otterson Vol#: 6

EMC 353 Debbie Bevel Vol#: 6

EMC 354 Teresa McCuan Vol#: 6

EMC 355 Natalie Shuttleworth Vol#: 6

EMC 356 Geneva Robinson Vol#: 6

EMC 357 Gerhard & Barbara Bedding Vol#: 6

EMC 358 Mary Ann Newell Vol#: 6

EMC 359 Naoh Jenkins Vol#: 6

EMC 360 Marilyn Carter Vol#: 6

EMC 361 Linda Godsey Vol#: 6

EMC 362 Anna Harris Vol#: 6

EMC 363 Eleanor Lebrecht Vol#: 6

EMC 364 Charles Steinke Vol#: 6

EMC 365 Dale E. Foss II Vol#: 6

EMC 366 Adrian Chang Vol#: 6

EMC 367 Miriam Wingfield Vol#: 6

EMC 368 Franc Graham Vol#: 6

EMC 369 Franc Graham Vol#: 6

EMC 370 S. David Buck DDS Vol#: 6

EMC 371 Linda K. Kelly Vol#: 6

EMC 372 Phyllis Parun Vol#: 6

EMC 373 Molly Chidsey Vol#: 6

EMC 374 Mary Ann Newell Vol#: 6

EMC 375 Carol Blackman Vol#: 6

EMC 376 Mary Ann Newell Vol#: 6

EMC 377 Mary Ann Newell Vol#: 6

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

EMC 197 Randall Pittman Vol#: 2

01P-0120 Ban Unsafe IV Catheters and other Devices

LET 1 Hemapure AB Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 2339 Erin Denk Vol#: 220

EMC 2340 Rev. Nelson French Vol#: 220

EMC 2341 Rolfe McAfee Vol#: 220

EMC 2342 Bruce & Ruth Hawkins Vol#: 220

EMC 2343 Karen Issacson Vol#: 220

EMC 2344 Heather Schofield Vol#: 220

EMC 2345 Maria Debernardi Vol#: 220

EMC 2346 Rev. Laureen Smith Vol#: 220

EMC 2347 Cesar Goncalves Vol#: 220

EMC 2348 Sharon Grimm Vol#: 220

EMC 2349 Larissa Marantz Vol#: 220

EMC 2350 Rayma Pennington Vol#: 220

EMC 2351 Laurie Senauke Vol#: 220

EMC 2352 Sarah Kozak Vol#: 220

EMC 2353 Mary Anne O'Connor Vol#: 220

EMC 2354 Jim D. Fish Vol#: 220

EMC 2355 Barbara Baldock Vol#: 220

EMC 2356 Susan Woodruff Vol#: 220

EMC 2357 Robert Truax Vol#: 220

EMC 2358 Dean Beery Vol#: 220

EMC 2359 Frances T. Hecht Vol#: 220

EMC 2360 Howard Mainhart Vol#: 220

EMC 2361 Vicki Rae Harder-Thorne Vol#: 220

EMC 2362 G. Edward Shissler Vol#: 220

EMC 2363 Georgina Benoit Vol#: 220

EMC 2364 Mary Elizabeth Hollmann Vol#: 220

01P-0345 Listing the color additive yellow #5 for use in food/Drug

EMC 1109 Pauline Roufogalis Vol#: 5

EMC 1110 No Signature Vol#: 5

EMC 1111 Margaret Hartley Vol#: 5

EMC 1112 Paul Karch Vol#: 5

EMC 1113 Paul Karch Vol#: 5

EMC 1114 Kristy C. Vol#: 5

EMC 1115 Donna Koo Vol#: 5

EMC 1116 Kerry Peters Vol#: 5

EMC 1117 Dr. Robert M. Granger, II Vol#: 5

01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II

EMC 377 Michael R. Girard Vol#: 4

PAV 1 HF-11 to Russell E Dingle Vol#: 1

02D-0124 Notifying FDA of Fatalities Related to Blood & Transfusion

EMC 2 America's Blood Centers Vol#: 1

02D-0228 Implantable Middle Ear Hearing Device

C 5 Cryovascular System, Inc. Vol#: 1

02N-0204 Bar Code Label Requirements for human drug products

EMC 159 Craig K. Harmon Vol#: 5

EMC 160 Craig K. Harmon Vol#: 5

02N-0209 Governing First Amendment Case Law

C 23 Coalition of Healthcare Communication Vol#: 5

02V-0408 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Classic Computers, Inc. Vol#: 1