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 April 9, 2002

TABLE OF CONTENTS

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94S-0120 510K Substantially Equivalent List *
95N-0308 Inapplicability of the Dietary Supplement Health & Ed. Act 
99D-0392 Seafood HACCP transition guidance *
99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast *
01P-0323 Not rely on non-public filings to approve an innovator NDA; *
02N-0063 Consumer Surveys on Food & Dietary Supplement Labeling *

94S-0120 510K Substantially Equivalent List

LST 113 List of March 2002 Vol#: 27

95N-0308 Inapplicability of the Dietary Supplement Health & Ed. Act

C 8 Sue Olmos Vol#: 1

C 9 Jackie Lucius Vol#: 1

C 10 Lisa M. Repa Vol#: 1

C 11 Gail Tucker Vol#: 1

C 12 Gina Palmer Vol#: 1

C 13 Trudi A. Kimm Vol#: 1

C 14 Pamela S. Klonaris Vol#: 1

C 15 Nora Dickins Vol#: 1

C 16 Nancy Cullinan Vol#: 1

C 17 Spring Farm Cares Vol#: 1

C 18 June L. Willoughby Vol#: 1

C 19 Lori Garrison Vol#: 1

C 20 Jennifer Vol#: 1

C 21 Maxine Brinker Vol#: 1

C 22 Hieidi L. Dumas Vol#: 1

C 23 Tereasa Steinberg Vol#: 1

C 24 Patricia M. Aussem Vol#: 1

C 25 OtterTail Farm Vol#: 1

C 26 Lara Cottrell-Springfield Vol#: 1

C 27 Barbara Renkosiewicz Vol#: 1

C 28 Yvonne M. Welz Vol#: 1

C 29 Lara Cottrell-Stringfield Vol#: 1

C 30 Diane M. Lanigan Vol#: 1

C 31 Dorothy W. Riley Vol#: 1

C 32 Ellen S. Kohn Vol#: 1

C 33 Susan Cole Vol#: 1

C 34 Rosamaria Carbonell Vol#: 1

C 35 Pet Health & Nutrition Ctr. Vol#: 1

C 36 Kristi Billinger Vol#: 1

C 37 Sharon D. Stein Vol#: 1

C 38 Karla Gunderson Vol#: 1

C 39 Diana R. Liebich Vol#: 1

C 40 Fred Liebich Vol#: 1

C 41 Elaine Burn Vol#: 1

99D-0392 Seafood HACCP transition guidance

ACK 1 HFA-305 Vol#: 1

CP 1 United Fishing Agency, Ltd. Vol#: 1

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

EMC 11 Health Care Without Harm et al Vol#: 3

PDN 2 HFZ-1 to Health Care Without Harm Vol#: 3

00E-1238 Patent Extension Temodar (temozolomide), #5,260,291

LET 2 U.S. Patent & Trademark Office Vol#: 1

M 1 HFD-7 Vol#: 1

00E-1348 Patent Extension PROTONIX, No. 4,758,579

LET 2 U.S. Patent & Trademark Office Vol#: 1

M 1 HFD-7 Vol#: 1

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

C 12615 Ann Dillenutin Vol#: 783

C 12616 Eleanor Wilson Vol#: 783

C 12617 Donald DeBona Vol#: 783

C 12618 Jeremy Marks Vol#: 783

C 12619 L Bangent Vol#: 783

C 12620 Shellie Willet Vol#: 783

EMC 5229 Andy Metrick Vol#: 783

EMC 5230 Andy Metrick Vol#: 783

EMC 5231 Edward Triska Vol#: 783

EMC 5232 Holly Owens Vol#: 783

00V-0610 Infrared Laser Aiming Light

LET 1 HFZ-300 to Insight Technology Inc. Vol#: 1

01E-0366 Patent Term Extension Application, PEG-Intron No. 5,951,974

LET 3 U.S. Patent & Trademark Office Vol#: 1

M 2 HFD-7 Vol#: 1

01E-0404 Patent Term Extension Application; No. 5,444,106

LET 3 U.S. Patent & Trademark Office Vol#: 1

M 2 HFD-7 Vol#: 1

01P-0320 Establish Format Standards for Ingredient Labels on Food Pro

C 161 Sita Halperin Vol#: 6

C 162 Sheila Peskin Vol#: 6

C 163 Roy, Lyn & Russell Johnson Vol#: 6

C 164 Victoria A. Karabinus Vol#: 6

C 165 Ms. Dolores A. La Piana Vol#: 6

C 166 Diane Mowry Vol#: 6

C 167 James S. Gilliland Vol#: 6

C 168 Charles R. Vocke Vol#: 6

C 169 Ann Barkley Macalusoo Vol#: 6

C 170 Mrs. L. Delloff Vol#: 6

C 171 Jane Wilson Vol#: 6

C 172 Allan & RuthAnn Boersma Vol#: 6

C 173 Mr. & Mrs. George Herman Vol#: 6

C 174 Lubov Mandel Vol#: 6

C 175 Catherine Modre Vol#: 6

C 176 Sheere Tucker Vol#: 6

C 177 Joanne Hedges Vol#: 6

C 178 Form Letter count 55 Vol#: 9

01P-0323 Not rely on non-public filings to approve an innovator NDA;

LET 2 Pfizer Inc. & Pharmacia Corp. Vol#: 1

02D-0094 IND exemptions studies lawfully marketed Cancer drug biologi

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

02D-0096 Nucleic acid tests samples donors whole blood component HIV1

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

02E-0019 Patent Term Application for Axert No. 5,565,447

LET 3 U.S. Patent & Trademark Office Vol#: 1

M 2 HFD-7 Vol#: 1

02E-0023 Patent Term Application for Definity No. 5,527,521

LET 3 U.S. Patent & Trademark Office Vol#: 1

M 2 HFD-7 Vol#: 1

02N-0037 Public Informational meeting on Antimicrobial Resistance

NM 1 Vol#: 1

02N-0054 Labeling Requirements for Color Additives

NCR 1 Vol#: 1

02N-0063 Consumer Surveys on Food & Dietary Supplement Labeling

EMC 7 Jarrows Formulas, Inc. Vol#: 1

EMC 8 American Herbal Prods. Assn. Vol#: 1

02N-0101 Amfepramone(diethylpropion) Amineptine; Burprenorphine

N 1 Vol#: 1

02V-0146 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Electro Magic Vol#: 1