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DOCKETS ENTERED on April 23, 2003
Docket Number - Title
76N-0377Certain Drugs Containing
Fluoxymesterone & Ethinyl Estrad
80N-0280Vaginal
Contraceptive Drug Products for OTC Use
95N-0304Ephedrine
Alkaloids: Reports of Adverse Events; Availability
97S-016230-Day
Structure Function Claim Notification Letters Dietary
97S-0163Dietary
Supplements, Courtesy Letters (Letters of Objection)
98N-0718Withdrawal
of3 NDA for Estrogen-Androgen Combination Drugs
99D-1458Enforcement
Policy for FDA Personnel/Electronic Records& Sig
02N-0204Bar
Code Label Requirements for human drug products
02N-0528Risk
Management Workshop, April 9-11, 2003 [PDUFA III
02N-0534Medical
Device User Fee and Modernization Act of 2002
02P-0419Amiodarone
Hydrochloride Injection 50mg/mL
03N-0069FDA
Task Force on Consumer Health Info for Better Nutrition\
03P-0109Promulgate
regulation mandating adverse reporting for dietar
76N-0377 Certain Drugs Containing
Fluoxymesterone & Ethinyl Estrad
LET 5HFA-305Vol#: 1 MM3HFD-130Vol#:
1
80N-0280 Vaginal Contraceptive Drug
Products for OTC Use
C55ARMKEL, LLCVol#: 12C56Global Campaign for MicrobicidesVol#: 12
EC138Global Campaign
for Microbicides Vol#: 14
EC139Planned
Parenthood Federation of AmericaVol#: 14
EC140National
Women's Health NetworkVol#: 14
EC141Mr. Gary YinglingVol#: 14
EC142ARMKEL,
LLCVol#: 14
EC143Family Health
InternationalVol#: 14
EC144The Alan
Guttmacher InstituteVol#: 14
EC145Ibis
Reproductive HealthVol#: 14
EC146American Social
Health AssociationVol#: 14
EC147Number Not UsedVol#: 14
EC148Ibis
Reproductive HealthVol#: 14
EMC 6Family Planning
Assn (United Kingdom)Vol#: 12
EMC 7APhA, American
Pharmacists Assn.Vol#: 12
EMC 8NFPRHA, Nat.
Family Planning & ReproductVol#: 12
85N-0145Use of Acrylonitrile Copolymers
NI1Vol#: 1
85N-0241HEMATOLOGY & PATHOLOGY
DEV/PMA/AUTOMOTED BLOOD CELL SEPER
NI1Vol#: 1
86N-0077NDA'S: PROPOSED CLARIFICATION OF
REQUIREMENTS FOR APP
NI1Vol#: 1
86N-0445QUALITY STD FOR FOOD WITH NO
IDENTITY STD BOTTLED WATER
NI1Vol#: 1
86P-0338AMEND STANDARDS OF IDENTITY &
QUALITY FOR PINEAPPLE JUICE
NI1Vol#: 1
88N-0413CGMP for Blood and Blood Components;
Proficiency Testing req
NI1Vol#: 1
88P-0224AMEND STANDARDS FOR CANNED PINEAPPLE
RE:WHOLE PINEAPPLE
NI1Vol#: 1
89N-0106Shellac and Shellac Wax
NI1Vol#: 1
89N-0378Erythromycin Capsules; Proposed
Amendment of Dissolution Std
NI1Vol#: 1
89P-0208Establish standard of identity for
frozen yogurt
NI1Vol#: 2
89P-0314Exemption from Preemption on Hearing
Aids
NI1Vol#: 10
89P-0320Amend Animal Care Regulations
NI1Vol#: 1
89P-0444Amend Standards of Identity for
Yogurt, Lowfat Yogurt et al
NI1Vol#: 2
90N-361MName Declaration for Protein
Hydrolysates & Vegetable Broth
NI1Vol#: 12
91N-0074Aseptic Process/Terminal
Sterilization of Pharmaceuticals
NI1Vol#: 3
91N-0245Cosmetic Products Containing Certain
Hormone Ingredients
NI1Vol#: 2
91N-0313Food Additive Status of Food-Contact
Articles
NI1Vol#: 1
94P-0036Req labeling of trans fatty acid
& prohibit deceptive claims
C2302Richard G. WoodVol#: 68
C2303Alan CourtneyVol#: 68
C2304Joann HeronVol#: 68
C2305Sarah Walker, MS, MPH, RDVol#: 68
C2306Jean Ann WheelockVol#: 68
C2307Madonna MajernikVol#: 68
C2308Bard Cosman, M.D.Vol#: 68
C2309Ingrid EggeVol#: 68
C2310Barbara & Jim HazardVol#: 68
C2311Mrs. Melinda CaterVol#: 68
C2312Thelma SegalVol#: 68
C2313Irene RogersVol#: 68
C2314Beth O'NeillVol#: 68
C2315Marjorie M. MartinVol#: 68
C2316Christine MiotkeVol#: 68
C2317Harlene Warner Vol#: 68
C2318Joanne & Bob HedgesVol#: 68
C2319Karen Synell, Ph.D.Vol#: 68
C2320Margaret S. MiddletonVol#: 68
C2321Margot EbyVol#: 68
C2322Vince BroemelingVol#: 68
C2323Ms. Peggy McGrathVol#: 68
C2324Ms. Helen IrtnerVol#: 68
95N-0304 Ephedrine Alkaloids: Reports of
Adverse Events; Availability
C4001CSPIVol#: 348C4002Acupuncture
Society of New YorkVol#: 348
C4003Mary Schomer,RNCVol#: 348
C4004Durk Pearson & Sandy ShawVol#: 348
EMC 755Mary Schomer, RNCVol#: 346
EMC 756Jeffrey ArwoodVol#: 346
EMC 757Micah D. StoneVol#: 346
EMC 758Douglas W. PalladinoVol#: 346
EMC 759Russell AldrichVol#: 346
SUP 2Ephedra
Education Council (EEC)Vol#: 348
96N-0417CGMP in Mfg. Packing or Holding
Dietary Supplements
EC10Mr. Mark BurtonVol#: 7
97S-0162 30-Day Structure Function Claim
Notification Letters Dietary
LET 9785Nutritionals, Inc.Vol#: 75LET 9786Aboca USAVol#: 75
LET
9787Dolisos LaboratoriesVol#: 75
LET
9788Source NaturalsVol#: 75
LET
9789Flora Inc.Vol#: 75
LET
9790Flora, Inc.Vol#: 75
LET
9791Flora, inc.Vol#: 75
LET
9792NOW FoodsVol#: 75
LET
9793NOW FoodsVol#: 75
LET
9794Apex Fitness GroupVol#: 75
LET
9795Apex Fitness GroupVol#: 75
LET
9796Apex Fitness GroupVol#: 75
LET
9797Apex Fitness GroupVol#: 75
LET
9798Apex Fitness GroupVol#: 75
LET
9799Herbsforever, Inc.Vol#: 75
LET
9800Northwest Natural ProductsVol#: 75
LET
9801Solstice Medicine CompanyVol#: 75
LET
9802Solstice Medicine CompanyVol#: 75
LET
9803Enzymatic Therapy Natural MedicinesVol#: 75
LET
9804Your VitaminsVol#: 75
LET
9805Your VitaminsVol#: 75
LET
9806Nutrition Now, Inc.Vol#: 75
LET
9807NBTYVol#: 75
LET
9808NBTYVol#: 75
LET 9809NBTYVol#:
75
LET
9810NBTYVol#: 75
LET
9811NBTYVol#: 75
LET
9812NBTYVol#: 75
LET
9813NBTYVol#: 75
LET
9814NBTYVol#: 75
LET
9815NBTYVol#: 75
LET
9816NBTYVol#: 75
LET
9817NBTYVol#: 75
LET
9818NBTYVol#: 75
LET
9819NBTYVol#: 75
LET
9820NBTYVol#: 75
LET
9821NBTYVol#: 75
LET
9822NBTYVol#: 75
LET
9823NBTYVol#: 75
LET
9824NBTYVol#: 75
LET
9825NBTYVol#: 75
LET
9826NBTYVol#: 75
LET
9827NBTYVol#: 75
LET
9828NBTYVol#: 75
LET
9829NBTYVol#: 75
LET
9830NBTYVol#: 75
LET
9831NBTYVol#: 75
LET
9832NBTYVol#: 75
LET
9833NBTYVol#: 75
LET
9834NBTYVol#: 75
LET
9835NBTYVol#: 75
LET
9836NBTYVol#: 75
LET
9837NBTYVol#: 75
LET
9838NBTYVol#: 75
LET
9839NBTYVol#: 75
LET 9840NBTYVol#:
75
LET
9841NBTYVol#: 75
LET
9842NBTYVol#: 75
LET
9843NBTYVol#: 75
LET
9844NBTYVol#: 75
LET
9845NBTYVol#: 75
LET
9846NBTYVol#: 75
LET
9847NBTYVol#: 75
LET
9848NBTYVol#: 75
LET
9849NBTYVol#: 75
LET
9850ProcLab NutritionVol#: 75
LET
9851Natrol, Inc.Vol#: 75
LET
9852Enzymatic Therapy Nutural MedicinesVol#: 75
LET
9853Biotech CorporationVol#: 75
LET
9854Biotech CorporationVol#: 75
LET
9855Biotech CorporationVol#: 75
LET
9856Biotech CorporationVol#: 75
LET
9857Biotech CorporationVol#: 75
LET
9858Biotech CorporationVol#: 75
LET
9859Biotech CorporationVol#: 75
LET
9860Amerifit NutritionVol#: 75
LET
9861Amerifit NutritionVol#: 75
97S-0163
Dietary Supplements, Courtesy Letters (Letters of Objection)
LET 688HFS-800 to AuMed, Inc.Vol#: 20LET 689HFS-800 to Novartis OphthalmicsVol#: 20
LET
690 HFS-800 to National Vitamin Company, IncVol#: 20
LET
691HFS-800 to Herbalist & Alchemist, Inc.Vol#: 20
LET
692HFS-800 to Prostate Rx, Inc.Vol#: 20
LET
693HFS-800 to Oregon's Wild HarvestVol#: 20
98N-0718
Withdrawal of3 NDA for Estrogen-Androgen Combination Drugs
LET 2HFA-305Vol#: 1 98P-1041Withdrawn
from sale of Tylosterone Tablets
BKG 1Background MaterialVol#: 2
99D-1458 Enforcement Policy for FDA
Personnel/Electronic Records& Sig
C4Bristol-Myers SquibbVol#: 199N-4282Biotechnology
in the Year 2000 and Beyond; Public Meetings
EMC 3976Patricia McMonagleVol#: 514
EMC 3977Charles AlvarezVol#: 514
99P-2630Establish a Daily Value for
"added sugars"
EMC 479Gregory QuirozVol#: 32
00D-1538Electronic Records; Electronic
Signatures, Validation
C35Bristol-Myers SquibbVol#: 8
00D-1539Electronic Records & Signatures,
Retention of Electronic Rec
C28Bristol-Myers SquibbVol#: 8
00D-1542Electronic Signatures: Time Stamps
C13Bristol-Myers SquibbVol#: 6
00D-1598Voluntary Labeling for Bioengineered
Foods
C9851Form Letter Count 11Vol#: 577
C9852Form Letter Count 162Vol#: 578
00P-1211Establish Mandatory Pre-Market
Safety Testing for GE Foods
EMC 5599Patricia McMonagleVol#: 788
EMC 5600Charles AlvarezVol#: 788
00P-1411Set a regulatory limit for
methylmercury in seafood
C1Janice StangerVol#: 2
C2Dennis De MotsVol#: 2
01P-0345Listing the color additive yellow #5
for use in food/Drug
C5Stephen CottrellVol#: 3
EMC 1172Cristina ColanardiVol#: 5
EMC 1173Heather Anne OsborneVol#: 5
02D-0402Field offices on "Regulatory
Procedures Manual, Chapter 9"
EC5Number Not UsedVol#: 1
02N-0204 Bar Code Label Requirements for
human drug products
EC20Mr. James
RinehartVol#: 13 EC21Stony Brook
HospitalVol#: 13
EC22Roosevelt
InstituteVol#: 13
EC23Brigham and
Women's HospitalVol#: 13
EC24Rapid City
Regional HospitalVol#: 13
EC25Brattleboro
Memorial HospitalVol#: 13
EC26Computpye,
Inc.Vol#: 13
02N-0276Bioterrorism
Preparedness;Registration of Food Facilities
EC258Vieira de Castro - Produtos AlimentaresVol#: 11
EC259Fuji Food Products, Inc.Vol#: 11
02N-0278Bioterrorism; Prior Notice of
Imported Food Shipments
EC307Mr. David GirouxVol#: 14
EC308Southern Methodist UniversityVol#: 14
02N-0434Withdrawel of Certain Proposed rules
& other propose action
NI1Vol#: 1
02N-0528 Risk Management Workshop, April
9-11, 2003 [PDUFA III]
TS1Risk Management CDER/CBER ExecutiveVol#: 2TS2CDER/CBER Pharmacovigilance Working GrouVol#: 2
TS3CDER, Good
Pharmacovigilance PracticesVol#: 2
TS4RCN Associates,
IncVol#: 2
TS5Stephen A Goldman
Consulting Services LLVol#: 2
TS6Pharmaceutical
Safety AssessmentsVol#: 2
TS7Watson
PharmaceuticalsVol#: 2
TS8PhRMAVol#: 2
TS9CRF Box IncVol#: 2
TS10PhRMAVol#: 2
TS11CDER,
Pharmacoepidemiologic AssessmentVol#: 2
TS12Pharmacovigilance
& Risk Management, IncVol#: 2
TS13ISPE Membership
CommitteeVol#: 2
02N-0534
Medical Device User Fee and Modernization Act of 2002
02P-0419
Amiodarone Hydrochloride Injection 50mg/mL
WDL 1Bioniche Pharma Group LimitedVol#: 102P-0434Exemption
from premarket notification; class II devices
NFR 1Vol#: 1
02P-0494CEREC Ceramic Dental Restoration
Systems
NFR 1Vol#: 1
02V-0410Variance for Q-Beam Series
VRA 1HFZ-300 to Richards Audio VisualVol#: 1
03D-0060Part11, Electronic records,
electronic signatures scope
C4Bristol-Myers SquibbVol#: 1
C5Yamatake CorporationVol#: 1
C6F.Hoffmann-La Roche LtdVol#: 1
C7Boehringer IngelheimVol#: 1
EC12Ministry ofHealthVol#: 1
EC13Number Not UsedVol#: 1
EC14Johnson & JohnsonVol#: 1
EC15Chemgineering GmbHVol#: 1
EMC 5IBM CorporationVol#: 1
EMC 6CRF Box, LtdVol#: 1
03D-0092Food and Cosmetic Security Guidances
EC3Number Not UsedVol#: 1
03D-0141Optical Impression Systems for
Computer Assisted Design
GDL 1GUIDANCEVol#: 1
NAL 1Vol#: 1
03N-0069 FDA Task Force on Consumer Health
Info for Better Nutrition
EC47Mr. tony
romareoVol#: 1 EC48Number Not UsedVol#: 1
EC49MannatechVol#: 1
03N-0084Electronic Records;Electronic
Signatures;Agency Information
EC2Packard Hospital, Stanford UniversityVol#: 1
03P-0109
Promulgate regulation mandating adverse reporting for dietar
LET 1HF-40 to AHPAVol#: 1 03V-0073A laser display
device VRA 1HFZ-300 to Mr. Alex TsengVol#: 1