Daily Dockets - 05/01/03

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DOCKETS ENTERED on May 1, 2003

Docket Number - Title

75N-0069 RADIOACTIVE DRUGS, INCLUDING BIOLOGICAL PRODUCTS

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

96N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

99D-1458 Enforcement Policy for FDA Personnel/Electronic Records& Sig

02D-0337 Liposome Drug Products:Chemistry, Manufacturing, and Control

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

02N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III]

02N-0534 Medical Device User Fee and Modernization Act of 2002

02P-0469 ANDA for Brimonidine Tartrate Ophthalmic Solution 0.2%

03D-0163 Blood Product Safety in Cases of Suspected SARS,Severe Acute

03P-0089 Loratadine in 10 Milligrams Orally Disintegrating Tablets

03P-0132 Part 135 FDA regulations standard of identity frozen dessert

03P-0160 FDA to send letter ruling refusing to approve loratadine tab

03P-0183 180 Day Tentative responses under 21CFR5.10/21CFR 10.30

03P-0184 Permit filing of ANDA for nafcillin for injection, USP, phar

75N-0069 RADIOACTIVE DRUGS, INCLUDING BIOLOGICAL PRODUCTS

C 1 ACNP, American College of Nuclear Physic Vol#: 1

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 2456 Mrs. Yvonne C. Ahern Vol#: 70

C 2457 Dawn Rohn Vol#: 70

C 2458 Nancy L. Weber Vol#: 70

C 2459 Jane Engel Vol#: 70

C 2460 Mrs. Christina Deichler Vol#: 70

C 2461 Ronnie Hostmeyer Vol#: 70

C 2462 Pamela Hosler Vol#: 70

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

C 4017 State of New Jersey Vol#: 348

C 4018 Presence Marketing/Dynamic Presence,Inc. Vol#: 348

C 4019 Ben R. Munguia Vol#: 348

C 4020 Robert Graham Vol#: 348

RPT 7 Sen Kennedy,Sen Durbin,Rep. Waxman Vol#: 348

95N-0309 CGMPs for the Production of Infant Formula

BKG 2 Background Material Vol#: 7

NEC 2 Vol#: 7

96N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements

EC 14 Enzyme Technical Association Vol#: 7

96V-0474 Variance Application for High Pressure Mercury Vapor Lamps

VRA 3 HFZ-300 to General Electric Co. Vol#: 1

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 10156 RKS, Inc. Vol#: 77

LET 10157 FoodScience Corporation Vol#: 77

LET 10158 Higher Nature Nutrional Excellence Vol#: 77

LET 10159 Northwest Natural Products Vol#: 77

LET 10160 TMG Industries Vol#: 77

LET 10161 Integrative Therapeutics Inc. Vol#: 77

LET 10162 Integrative Therapeutics Inc. Vol#: 77

LET 10163 Insight Pharmaceuticals Corp. Vol#: 77

LET 10164 Integrative Therapeutics Inc. Vol#: 77

LET 10165 Avon The Company for Women Vol#: 77

LET 10166 Avon The Company for Women Vol#: 77

LET 10167 Avon The Company for Women Vol#: 77

LET 10168 Avon The Cmpany for Women Vol#: 77

LET 10169 Avon The Company for Women Vol#: 77

LET 10170 Avon The Company for Women Vol#: 77

LET 10171 Perrigo Company of South Carolina Vol#: 77

LET 10172 Integrative Therapeutics Inc. Vol#: 77

LET 10173 Enzymatic Therapy Natural Medicines Vol#: 77

LET 10174 Enzymatic Therapy Natural Medicines Vol#: 77

LET 10175 Integrative Therapeutics Inc. Vol#: 77

LET 10176 Integrative Therapeutics Inc. Vol#: 77

LET 10177 Integrative Therapeutics Inc. Vol#: 77

LET 10178 Twin laboratories, Inc. Vol#: 77

LET 10179 Twin Laoratories, Inc. Vol#: 77

LET 10180 Enzymatic Therapy Natural Medicines Vol#: 77

LET 10181 Enzymatic Therapy Natural Medicines Vol#: 77

LET 10182 Enzymatic Therapy Natural Medicines Vol#: 77

LET 10183 Enzymatic Therapy Natural Medicines Vol#: 77

LET 10184 Enzymatic Therapy Natural Medicines Vol#: 77

LET 10185 PhytoPharmica Natural Medicines Vol#: 77

LET 10186 PhytoPharmica Natural Medicines Vol#: 77

LET 10187 Tabak's Health Products Vol#: 77

LET 10188 Enzymatic Therapy Natural Medicines Vol#: 77

LET 10189 Enzymatic Therapy natural Medicines Vol#: 77

LET 10190 Enzymatic Therapy Natural Medicines Vol#: 77

LET 10191 Enzymatic Therapy Natural Medicines Vol#: 77

LET 10192 Enzymatic Therapy Natural Medicines Vol#: 77

97V-0106 Laser Light Show

VRA 3 HFZ-300 to The Omnisphere - The Coca Col Vol#: 1

99D-1458 Enforcement Policy for FDA Personnel/Electronic Records& Sig

C 18 National Food Processors Assn (NFPA) Vol#: 1

C 19 Bectin, Dickinson & Company (BD) Vol#: 1

00D-1538 Electronic Records; Electronic Signatures, Validation

C 49 National Food Processors Assn (NFPA) Vol#: 9

C 50 Bectin, Dickinson & Company (BD) Vol#: 9

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

C 42 National Food Processors Assn (NFPA) Vol#: 9

C 43 Bectin, Dickinson & Company (BD) Vol#: 9

00D-1542 Electronic Signatures: Time Stamps

C 27 National Food Processors Assn (NFPA) Vol#: 7

C 28 Bectin, Dickinson & Company (BD) Vol#: 7

00D-1543 Electronic Signatures: Glossary of Terms

C 37 National Food Processors Assn (NFPA) Vol#: 7

C 38 Bectin, Dickinson & Company (BD) Vol#: 7

00E-1403 Patent Extension Prevnair, No. 5,360,897

N 1 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9538 Peter Miller Vol#: 408

C 9539 Udom Likhitwonnawut Vol#: 408

C 9540 Leilan Fintus Vol#: 408

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 1330 Ruth Miale Vol#: 233

02D-0324 Bioengineered Plants for Use in Humans and Animals

C 639 Joon L. Fitzsimmons Vol#: 13

C 640 Marilyn Cox Vol#: 13

C 641 Larrell R. Brown Vol#: 13

02D-0337 Liposome Drug Products:Chemistry, Manufacturing, and Control

C 10 Biologistic Services Vol#: 1

02E-0345 Patent Term Application for Aromanis No. 4,808,616

N 1 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

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

C 35 Trinity Health Vol#: 13

C 36 Allergy Laboratories, Inc. Vol#: 13

C 37 Michael C. Loftin, P.D. Vol#: 13

EC 41 Kaweah Delta District Hospital Vol#: 13

EC 42 St Joseph's/Candler Health System Vol#: 13

02N-0275 Bioterrorism Preparedness; Administrative Detention

C 22 Alpine Marketing Vol#: 3

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

EC 270 Mr. Carl Heckel Vol#: 11

02N-0278 Bioterrorism; Prior Notice of Imported Food Shipments

C 219 Assn of American Railroads Vol#: 14

02N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III]

C 6 McKesson Corporation Vol#: 2

EC 6 American Society of Health-System Pharma Vol#: 2

02N-0534 Medical Device User Fee and Modernization Act of 2002

C 29 MassMEDIC Vol#: 2

02P-0435 Effective Approval of Alphanate Antihemophilic Factor

C 15 Louis M. Aledort, MD Vol#: 1

02P-0469 ANDA for Brimonidine Tartrate Ophthalmic Solution 0.2%

LET 2 HFD-1 to Allergan, Inc. Vol#: 1

02V-0411 Laser light show

VRA 1 HFZ-300 to Live Bait Vol#: 1

02V-0504 Laser Light Show

VRA 1 HFZ-300 to Swinomish Northern Lights Cas Vol#: 1

03D-0060 Part11, Electronic records, electronic signatures scope

C 26 Karen Raskasky Vol#: 1

C 27 GlaxoSmithKline Vol#: 1

C 28 National Food Processors Assn (NFPA) Vol#: 1

C 29 Bectin, Dickinson & Company (BD) Vol#: 1

EC 18 APV e.V. Vol#: 1

EC 19 H. Lundbeck Vol#: 1

EC 20 Invensys Vol#: 1

EC 21 Number Not Used Vol#: 1

EC 22 Eli Lilly & Co. Vol#: 1

EC 23 Baxter Pharmaceutical Solutions LLC Vol#: 1

EC 24 Pharma Quality Europe Vol#: 1

EC 25 Consultant Vol#: 1

EC 26 National Food Processors Association Vol#: 5

EC 27 America's Blood Centers Vol#: 1

EC 28 Lipid Sciences, Inc. Vol#: 1

EC 29 PharmTech, Inc. Vol#: 1

03D-0163 Blood Product Safety in Cases of Suspected SARS,Severe Acute

C 2 San Diego Blood Bank Vol#: 1

EC 1 Community Blood Center Vol#: 1

EC 2 Mississippi Blood Services Vol#: 1

03F-0128 Permitted Use Concentration and to Expand pH Range for acidi

EC 1 Number Not Used Vol#: 2

03N-0059 Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach

EC 27 Ms. marti worth Vol#: 1

03N-0065 MDUFMA Small Business Qualification Certification

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1

03N-0066 Inspection by Accredited Persons Under MDUFMA

N 1 Vol#: 1

03N-0077 Recognition List Number 008

N 1 Vol#: 1

03N-0084 Electronic Records;Electronic Signatures;Agency Information

EC 3 none Vol#: 1

03P-0183 180 Day Tentative responses under 21CFR5.10/21CFR 10.30

ACK 1 HFA-305 Vol#:

CP 1 John Clark Vol#: 1

03P-0184 Permit filing of ANDA for nafcillin for injection, USP, phar

ACK 1 HFA-305 Vol#: 1

CP 1 Samson Medical Technologies, L.L.C. Vol#: 1

03V-0095 Laser Light Show

VRA 1 HFZ-300 to FX Unlimited Vol#: 1

03V-0127

VRA 1 HFZ-300 to Entertainment Service dba Ang Vol#: 1

03V-0185

ACK 1 HFA-305 to Creative Consultants Laser Im Vol#: 1

VAR 1 Creative Consultants, LLC Vol#: 1