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DOCKETS ENTERED on
April 25 and April 26, 2003
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability
97S-0162 30-Day Structure Function Claim Notification Letters Dietary
99D-1458 Enforcement Policy for FDA Personnel/Electronic Records& Sig
99D-4809 Applications Covered by Section 505(b)(2)
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
02N-0204 Bar Code Label Requirements for human drug products
02N-0475 Financial Relationships & Interest in Research Involving Hum
02N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III]
02P-0317 Recall Aspartame as a Neurotoxic Drug
03N-0069 FDA Task Force on Consumer Health Info for Better Nutrition
03N-0094 Annual Guidance Agenda
03P-0176 Follow-Up Approval of Therapeutic Protein Products
03P-0178 ANDA Suitability for Divalproex Sodium Extended-Release Tabs
00N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
95N-0304 Ephedrine Alkaloids: Reports of Adverse
Events; Availability
C 4005 National Nutritional Food Asn (NNFA) Vol#: 348
C 4006 Alkemists Pharmaceuticals et al. Vol#: 348
EMC
760 Angela Cooper Vol#: 346
EMC 761 United
Sports Technologies Vol#:
346
EMC
762 Norah K. McIntire, L.Ac. Vol#: 346
96N-0417 CGMP in Mfg. Packing or Holding Dietary
Supplements
C 106
Enzyme Technical Assn (ETA) Vol#: 7
EC 11
Missouri Botanical Garden Vol#: 7
EC 12
Missouri Botanical Garden Vol#: 7
EC 13
Number Not Used Vol#: 7
EMC
18 Colonial Dames Co. Vol#: 7
97S-0162 30-Day Structure Function Claim Notification
Letters Dietary
LET 9931
Enzymatic Therapy Natural Medicines Vol#: 75
LET 9932
Solgar Vitamin and Herb Vol#: 75
LET 9933
Source Naturals Vol#: 75
LET 9936
Nutrition Now, Inc. Vol#: 75
LET 9937
Nutrition Now, Inc. Vol#: 75
LET 9938
24-7 Nutritionals, Inc. Vol#: 75
LET 9939
Solgar Vitamin and Herb Vol#: 75
LET 9940
Nutrition Now, Inc. Vol#: 75
LET 9949
Zhishin, LLC Vol#: 75
LET 9950
Zhishin, LLC Vol#: 75
LET 9952
Baniatrix International Inc. Vol#: 75
LET 9953
Sunrider International Vol#: 75
LET 9954
Enzymatic Therapy Natural Medicines Vol#: 75
LET 9955
PhytoPharmica natural Medicines Vol#: 75
LET 9956
PhytoPharmica Natural Medicines Vol#: 75
LET 9957
Enzymatic Therapy natural Medicines Vol#: 75
LET 9958
Enzymatic Therapy Natural Medicines Vol#: 75
LET 9959
Functional Integratd Therapies, LLC Vol#: 75
LET 9960
Enzymatic Therapy Natural Medicines Vol#: 75
LET 9961
Maharishi Ayur-Ved Products, Int.,Inc. Vol#: 75
LET 9962
Maharishi Ayur-Ved Products Int.,Inc. Vol#: 75
LET 9963
Maharishi Ayur-Ved Products Int., Inc. Vol#: 75
LET 9964
Maharishi Ayur-Ved Products Int., Inc. Vol#: 75
LET 9965
Maharishi Ayur-Ved Products Int., Inc. Vol#: 75
LET 9966
Maharishi Ayur-Ved Products Int., Inc. Vol#: 75
LET 9967
Maharishi Ayur-Ved Products Int., Inc. Vol#: 75
LET 9968
Maharishi Ayur-Ved Products Int., Inc. Vol#: 75
LET 9969
Maharishi Ayur-Ved Products Int., Inc. Vol#: 75
LET 9970
Maharishi Ayur-Ved Products Int., Inc. Vol#: 75
LET 9971
Maharishi Ayur-Ved Products Int., Inc. Vol#: 75
LET 9972
PhytoPharmica Natural Medicines Vol#: 75
LET 9973
Nature's Sunshine Products, inc. Vol#: 75
LET
9974 NOW Foods Vol#: 75
LET 9975
Vitaline Formulas Vol#: 75
LET 9976
Vitaline Formulas Vol#:
LET 9977
Herbalife International of America, Inc. Vol#: 75
LET 9978
PhytoPharmica Natural Medicines Vol#: 75
LET 9979
PhytoPharmica natural Medicines Vol#: 75
LET 9980
PhytoPharmica Natural Medicines Vol#: 75
98N-1038 Irradiation in the production, processing,
&handling of food
EMC
1112 Debbie Ortman Vol#: 198
98P-0610 Convert
Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC
EMC
79 Donald L. Brison Vol#: 5
EMC
80 Chris Terrazas Vol#: 5
EMC
81 Beverly Roland Vol#: 5
EMC
82 The Broaster Company Vol#: 5
EMC
83 John H. Schoeberlein Vol#: 5
EMC
84 Eric Howard Vol#: 5
EMC
85 Sarah Phipps Vol#: 5
EMC
86 Sarah Phipps Vol#: 5
EMC
87 Shirley Cherry Vol#: 5
99D-1458 Enforcement Policy for FDA
Personnel/Electronic Records& Sig
C 7
Experimental Pathology Laboratories, Inc Vol#: 1
99D-4809 Applications Covered by Section 505(b)(2)
C 12 Biotechnology Industry Organization Vol#: 2
99N-4282 Biotechnology in the Year 2000 and Beyond;
Public Meetings
EMC
3978 Claudette Griffith Vol#: 514
EMC
3979 Elizabeth Mather Vol#: 514
EMC
3980 Frances O' Halloran Vol#: 514
99P-1340 Declared Eternity eau de Parfum Misbranded
EMC
443 Denise Vol#: 21
EMC
444 Leah Potts Vol#: 21
00D-1538 Electronic Records; Electronic Signatures,
Validation
C 38
Experimental Pathology Laboratories, Inc Vol#: 8
00D-1539 Electronic Records & Signatures,
Retention of Electronic Rec
C 31
Experimental Pathology Laboratories, Inc Vol#: 8
00D-1542 Electronic Signatures: Time Stamps
C 16
Experimental Pathology Laboratories, Inc Vol#: 6
00D-1543 Electronic Signatures: Glossary of Terms
C 26
Experimental Pathology Laboratories, Inc Vol#: 7
00D-1598 Voluntary Labeling for Bioengineered Foods
EMC
12009 Shannon Walker Vol#: 574
01D-0583 Food Security Guidance
EC 5
Number Not Used Vol#: 1
01P-0075 Switch Status of Emergency Contraceptives
from Rx to OTC
EMC
301 No signature Vol#: 10
EMC 302 Heritage
of Kentucky Vol#:
10
01P-0345 Listing the color additive yellow #5 for use
in food/Drug
EMC
1174 Don A. Werner Vol#: 5
02D-0325 Polyvinychloride using Plasticier
di-(2-ethyhexyl)phthalate
EMC
108 Jeanne Medina Vol#: 3
02D-0525 Medical Devices; Chemical Indicators
Premarket Notification
EMC
1 George S. Mills Vol#: 1
02N-0204 Bar Code Label Requirements for human drug
products
EC 27
Private Citizen Vol#: 13
EC 28 Lehigh Valley Hospital Vol#: 13
EC 29 University of Wisconsin Hospital &
Clini Vol#: 13
EC 30 St. Lukes Regional Medical Center Vol#: 13
EC 31 Hunterdon Medical Center Family
Practice Vol#: 13
EC 32 Wyoming County Community Hospital Vol#: 13
EC 33 University of Louisville Hospital Vol#: 13
EC 34 University Hospital Louisville
Kentucky Vol#: 13
EC 35
Mrs. Debbie Baker Vol#: 13
EC 36
Dr. Timothy Buffey Vol#: 13
EC 37 INTEGRIS HEALTH S.W. Vol#: 13
EC 38 Children's Hospital Vol#: 13
EC 39 Children's Hospital Vol#: 13
EC 40 Children's Hospital Pharmacy Vol#: 13
EMC 174 The Neuenschwander Company Vol#: 13
02N-0276 Bioterrorism Preparedness;Registration of
Food Facilities
EC 260
Northland Cranberries, Inc. Vol#: 11
EC 261
Number Not Used Vol#: 11
EC 262
Number Not Used Vol#: 11
EC 263
Number Not Used Vol#: 11
EC 264
Number Not Used Vol#: 11
EC 265
Number Not Used Vol#: 11
EC 266
Miss Patricia Maya Vol#: 11
EC 267
PhelpsTek Vol#: 11
EC 268
Department of Agriculture Republic of So Vol#: 11
EC 269
TIN THINH CO., LTD Vol#: 11
02N-0454 Notice of a Claim for GRAS Exemption Based
on GRAS Determin
SS 1
Supporting Statement Vol#: 1
02N-0475 Financial Relationships & Interest in
Research Involving Hum
EC 3 Tourette Syndrome Association Vol#: 1
EMC
3 George Ubogy, MD Vol#: 1
02N-0528 Risk Management Workshop, April 9-11, 2003
[PDUFA III]
C 2 Pharmaceutical Printed Literature
Assn Vol#: 2
C 3 Watson Laboratories, Inc. Vol#: 2
TS 27 HFD-6,
Office of Executive Programs Vol#: 2
TS 28 HFD-102,
ODE II / OND / CDER Vol#: 2
TS 30 The
Degge Group, ISP Vol#: 2
TS 31 HFD-40,
Medical Policy Vol#: 2
TS 32 Institute
for Safe Medication Practices Vol#: 2
TS 33 Watson
Pharmaceuticals Vol#:
2
TS 34 HFM-576,
CBER, Div. of Clinical Trial Vol#: 2
TS 35 Pharmacia
Corporation, PhRMA Vol#: 2
TS 36 Pharmacovigilance
& Risk Management, In. Vol#: 2
TS 37 Biotechnology
Industry Organization (BIO Vol#: 2
TS 38 Public
Citizen's Health Research Group Vol#: 2
TS 39 American
Society of Health-System Pharma Vol#: 2
TS 40 First
Genetic Trust Vol#: 2
02N-0534 Medical Device User Fee and Modernization
Act of 2002
C 28
Business Support International Vol#: 2
02P-0009 Amend 21 CFR 120.24 concentrated and
shelf-stable juice
GDL
2 Guideline Vol#: 1
NAD
2
Vol#: 1
02P-0317 Recall Aspartame as a Neurotoxic Drug
EMC
244 Mission Possible International
Vol#: 5
EMC
245 Mission Possible International
Vol#: 5
03D-0060 Part11, Electronic records, electronic
signatures scope
C 11
Baxter Healthcare Corporation Vol#: 1
C 12
E.I. du Pont de Nemours and Company Vol#: 1
C 13
Experimental Pathology Laboratories, Inc Vol#: 1
EC 16
Business Performance Associates Vol#: 1
EC 17 Syngenta CTL Vol#: 1
EMC
7 F.Hoffmann-La Roche Ltd Vol#: 1
EMC
8 Japan Pharmaceutical
Manufacturers Assn Vol#: 1
03D-0061 Comparability Protocols Chemistry
Manufacturing and controls
EMC 1 GlaxoSmithKline Vol#: 1
EMC
2 Triangle PEERS Vol#: 1
03D-0163 Blood Product Safety in Cases of Cases of
Suspecte SARS
C 1
Community Blood Center/Community Tissue Vol#: 1
GDL 1 Guideline Vol#: 1
NAD
1 Vol#: 1
03F-0128 Permitted Use Concentration and to Expand pH
Range for acidi
EA 1
Environmental Assessment Vol#: 1
NFL
1 Alcide Corp. Vol#: 1
03M-0173 PMA Healthtronics OssaTron, P990086/S003
AAV
1 Healthtronics Surgical Services,
Inc. Vol#: 1
03M-0174 PMA, TECHNOLAS 217A Excimer Laser System,
P990027/S004
AAV
1 Bausch & Lomb Surgical Vol#: 1
03M-0175 PMA Essure System, P020014
AAV
1 Conceptus, Inc. Vol#: 1
03N-0069 FDA Task Force on Consumer Health Info for
Better Nutrition
EMC
2 Wellness Lifestyles, Inc. Vol#: 1
03N-0094 Annual Guidance Agenda
EMC
1 Instrumentarium Corp. Vol#: 1
03N-0142 Submitting & Reviewing Complete
Responses for Clinical Holds
EC 1
self Vol#: 1
03P-0176 Follow-Up Approval of Therapeutic Protein
Products
ACK
1 HFA-305 to BIO Vol#: 1
CP 1 Biotechnology
Industry Organization Vol#: 1
03P-0178 ANDA Suitability for Divalproex Sodium
Extended-Release Tabs
ACK 1 HFA-305 to Lachman Consultant
Services Vol#: 1
CP 1 Lachman
Consultant Services, Inc. Vol#: 1
03V-0177 Laser Light Show
ACK
1 HFA-305 to Lighting & Sound
Consultants Vol#: 1
VAR
1 Lighting & Sound
Consultants Vol#: 1
DOCKETS
ENTERED on April 26, 2003
00N-1571 Enrofloxacin for Poultry: Opportunity for
Hearing
MO 43 Center
for Veterinary Medicine Vol#: 362
03D-0117 Implementation of Inspection by Accredited
Persons Program
BKG
1 Background Material Vol#: 1
GDL
1 Guidance Vol#: 3
NAD
1 Vol#: 3