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Dockets Management
Dockets Entered On July 12, 2004
Table of Contents
Docket # Title
1982N-0166 OTC Drug Products for Overindulgence of Alcohol
1994P-0390 Adopt Amendments Governing Health Claims & Nutrient Claims
1995P-0241 Implied Nutrient Content Claim 'Healthy' & Health Claims
1997S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)
1998P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC
1999P-5106 Identify Sources of Natural Flavorings
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003D-0206 Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability
2003D-0290 Compounding of Drugs for Use in Animals Compliance Policy Guide
2003D-0571 Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
2003E-0249 Patent Extension for Elitek (rasburicase) 5,382,518
2003P-0291 Enforce the law and prevent unlaw sale of contact lens
2003P-0505 ANDA for Acetaminophen, Caffeine and Orphenadrine Citrate Tablets
2004D-0182 Guidance for Industry on Combination Products, Timeliness of Premarket Review, Dispute Resolution
2004D-0187 Guidance for Industry on Premarketing Risk Assessment
2004D-0188 Guidance for Industry on Development and Use of Risk Minimization Action Plans
2004D-0189 Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
2004N-0049 Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
2004N-0103 Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment
2004N-0132 Agency Information Collection Activities: Proposed Collection; Comment Request: Premarket Approval of Medical Devices
2004N-0133 Part 11, Electronic Record; Electronic Signatures; Public Meeting
2004N-0161 Agency Information Collection Activities: Proposed Collection; Comment Request; Information from U.S. Processors that Export to the European Community
2004N-0181 Critical Path Initiative
2004N-0234 Annual Guidance Agenda
2004N-0275 Agency Emergency Processing Under OMB Review; Application for Participation in the Medical Device Fellowship Program; Form FDA 3608
2004P-0013 Review safety of Nutropin Depot Injection, issue direction to Genentech Inc. to add warnings regarding diabetes in their safety literature, and consider amending 21 CFR 314.80(e) Postmarketing studies
2004P-0015 Deny approval of any New Drug Application ( NDA ) for recombinant salmon calcitonin (rsCT ) nasal spray
2004P-0056 ANDA for Ondansetron Orally Disintegrating Tablets
2004P-0069 Declare that Fentanyl Transdermal Systems, in strengths of 37.5 mcg/hr, 62.5 mcg/hr, and 87.5 mcg/hr are suitable for submission in an ANDA
2004P-0123 Glimepiride Tablets, 3mg and 6mg for an Abbreviated new drug application ( ANDA )
2004P-0293 Carbohydrate Labeling - Remove Dietary Fiber from Total Carbohydrates
2004P-0294 Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
2004P-0295 To determine whether Zyvox (linezolid) tablets 400mg (NDA 20-130) has been withdrawn for safety or effectiveness reasons as outlined below.
2004Q-0097 Qualified Health Claim: Calcium and various cancers
2004Q-0098 Qualified Health Claim: Calcium and hypertension
2004Q-0099 Qualified Health Claim: Calcium and menstrual disorders
2004Q-0100 Qualified Health Claim: Calcium and bone fractures
2004Q-0102 Qualified Health Claim: Calcium and Kidney/urinary stones
2004Q-0180 Qualified Health Claim (QHC): Lutein and Eye Diseases
2004S-0170 Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
1982N-0166 OTC Drug Products for Overindulgence of Alcohol
SUP 4 Procter & Gamble Company (P&G) Vol #: 22
1994P-0390 Adopt Amendments Governing Health Claims & Nutrient Claims
EMC 2 National Nutritional Foods Assn (NNFA) Vol #: 7
EMC 3
Attachment
American Feed Industry Assn (AFIA) Vol #: 7
EMC 4 American Heart Assn Assn Vol #: 7
EMC 5 Kellogg's Vol #: 7
EMC 6 Natonal Dairy Council (NDC) Vol #: 7
1995P-0241 Implied Nutrient Content Claim 'Healthy' & Health Claims
EMC 2 National Nutritional Foods Assn (NNFA) Vol #: 9
EMC 3
Attachment
American Feed Industry Assn (AFIA) Vol #: 9
EMC 4 American Heart Assn Vol #: 9
EMC 5 Kellogg Vol #: 9
EMC 6 National Dairy Council (NDC) Vol #: 9
1997S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)
LET 760 HFS-800 to Banks of Eden LLC Vol #: 23
LET 761 HFS-800 to Herb Pharm Vol #: 23
LET 762 HFS-800 to Waleda Inc Vol #: 23
1998P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC
EMC 102 Wellpoint Vol #: 6
1999P-5106 Identify Sources of Natural Flavorings
EMC 163 E. Leckar Vol #: 2
2000N-1571 Enrofloxacin for Poultry: Opportunity for Hearing
EXB 244 Center for Veterinary Medicine Vol #: 419
EXB 245 Center for Veterinary Medicine Vol #: 419
EXB 246 Center for Veterinary Medicine Vol #: 419
EXB 247 Center for Veterinary Medicine Vol #: 419
EXB 248 Center for Veterinary Medicine Vol #: 419
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
EMC 182 C. Eubank Vol #: 3
2002N-0278 Bioterrorism; Prior Notice of Imported Food Shipments
C 351 Japan Airlines International Co., Ltd (JAL) Vol #: 29
C 352 Scotch Whisky Assn Vol #: 29
EMC 211
Attachment
Canadian Maufacturers & Exporters Vol #: 29
EMC 212 Baskets By Geri's Eatin' Centre Vol #: 29
MM 13 Meeting Between FDA and CBP,CFIA and Canadian Boeder Services Agency Vol #: 29
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 342 Mission Possible Intl. Vol #: 6
EMC 343 R. Murray Vol #: 6
EMC 344 J. Bowen, MD Vol #: 6
EMC 345 Mission Possible International Vol #: 6
EMC 346 Mission Possible International Vol #: 6
2003D-0206 Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability
C 9 Australian Government Vol #: 1
EC 8 Digestive Care, Inc. Vol #: 1
EC 9 Digestive Care, Inc. Vol #: 1
EC 10 Digestive Care, Inc. Vol #: 1
EC 11 Digestive Care, Inc. Vol #: 1
EC 12 Digestive Care, Inc. Vol #: 1
EC 13 Cystic Fibrosis Foundation Vol #: 1
EC 14 Cystic Fibrosis Foundation Vol #: 1
EC 15 MERISTEM Therapeutics Vol #: 1
EC 16 CanReg Inc. on behalf of Axcan Scandipharm Inc. Vol #: 1
EC 17 KV Pharmaceutical Company Vol #: 1
2003D-0290 Compounding of Drugs for Use in Animals Compliance Policy Guide
C 10 American Veterinary Medical Assn (AVMA) Vol #: 1
2003D-0571 Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
C 25 Pharmaceuticals Research and Manufacturers of America (PhRMA) Vol #: 2
EMC 3 Merck & Co., Inc. Vol #: 2
2003E-0249 Patent Extension for Elitek (rasburicase) 5,382,518
N 1 FDA Vol #: 1
2003P-0291 Enforce the law and prevent unlaw sale of contact lens
PDN 1 HFZ-1 to Timothy Milburn O.D. Vol #: 2
2003P-0505 ANDA for Acetaminophen, Caffeine and Orphenadrine Citrate Tablets
WDL 1 Lachman Consultant Services, Inc. Vol #: 1
2004D-0182 Guidance for Industry on Combination Products, Timeliness of Premarket Review, Dispute Resolution
C 3 Pharmaceutical Research and Manfacturers of America (PhRMA) Vol #: 1
2004D-0187 Guidance for Industry on Premarketing Risk Assessment
C 9 ISPE Vol #: 1
C 10 Bristol-Myers Squibb Company Vol #: 1
EMC 3 Centers for Education & research on Therapeutics (CERTs) Vol #: 1
EMC 4 Merck & Co., Inc. Vol #: 1
EMC 5
Attachment
Johnson and Johnson Vol #: 1
2004D-0188 Guidance for Industry on Development and Use of Risk Minimization Action Plans
C 9 ISPE Vol #: 1
C 10 Bristol-Myers Squibb Company Vol #: 1
EMC 5 American Medical Assn (AMA) Vol #: 1
EMC 6 Centers for Education & Research on Therapeutics (CERTs) Vol #: 1
EMC 7 J. Kramer,MD,MS Vol #: 1
EMC 8 Merck & Co., Inc. Vol #: 1
EMC 9
Attachment
Johnson and Johson Vol #: 1
EMC 10 American Pharmacists Assn (APhA) Vol #: 1
2004D-0189 Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
C 8 ISPE Vol #: 1
C 9 Bristol-Myers Squibb Company Vol #: 1
EMC 3 Centers for Education & research on therapeutics (CERTs) Vol #: 1
EMC 4 Merck & Co., Inc. Vol #: 1
EMC 5
Attachment
Johnson and Johnson Vol #: 1
2004N-0049 Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
N 2 FDA Vol #: 1
2004N-0103 Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment
N 2 FDA Vol #: 1
2004N-0132 Agency Information Collection Activities: Proposed Collection; Comment Request: Premarket Approval of Medical Devices
N 2 FDA Vol #: 1
2004N-0133 Part 11, Electronic Record; Electronic Signatures; Public Meeting
C 16 National Grain and Feed Assn (NGFA) Vol #: 4
C 17 United Parcel Service, Inc. (UPS) Vol #: 4
C 18 ABB Process Solutions Vol #: 4
C 19 Wyeth Pharmaceuticals Vol #: 4
C 20 EduQuest, Inc. Vol #: 4
C 21 Assn of Clinical Research Organizations (ACRO) Vol #: 4
C 22 Dow Chemical Company (Dow) Vol #: 4
C 23 Gas Regs, Inc. Vol #: 4
C 24 Pfizer, Inc. Vol #: 4
C 25 Land O'Lakes Farmland Feed, LLC Vol #: 5
C 26 Cosmetic, Toiletry and Fragrance Assn (CTFA) Vol #: 5
C 27 Pharmaceutical Research and Manufacturers of America (PhRMA) Vol #: 5
C 28 Advanced Medical Technology Assn (AdvaMed) Vol #: 5
C 29 Compressed Gas Assn (CGA) Vol #: 5
C 30 F. Hoffmann-La Roche Ltd. Vol #: 5
C 31 Society of Quality Assurance (SQA) Vol #: 5
C 32 Bristol-Myers Squibb Company Vol #: 5
C 33 GlaxoSmithKline (GSK) Vol #: 5
EMC 48
Attachment 1, 2
ISPE Vol #: 4
EMC 49 PDA of Japan Vol #: 4
EMC 50 International Assn for Pharmaceutical Technology (APV) Vol #: 4
EMC 51 J. Rosendal Vol #: 4
EMC 52 J. Rosendal Vol #: 4
EMC 53 National Food Processors Assn (NFPA) Vol #: 4
EMC 54 PDA of Japan Vol #: 4
EMC 55 Janssen Pharmaceutica Vol #: 4
EMC 56 American Assn of Blood Banks (AABB) Vol #: 4
EMC 57 Merck & Co., Inc. Vol #: 4
EMC 58 Assn of Clinical Research Organizations (ACRO) Vol #: 4
2004N-0161 Agency Information Collection Activities: Proposed Collection; Comment Request; Information from U.S. Processors that Export to the European Community
N 2 FDA Vol #: 1
2004N-0181 Critical Path Initiative
C 2 MicroCal, LLC Vol #: 1
2004N-0234 Annual Guidance Agenda
N 1 FDA Vol #: 1
2004N-0275 Agency Emergency Processing Under OMB Review; Application for Participation in the Medical Device Fellowship Program; Form FDA 3608
N 1 FDA Vol #: 1
2004P-0013 Review safety of Nutropin Depot Injection, issue direction to Genentech Inc. to add warnings regarding diabetes in their safety literature, and consider amending 21 CFR 314.80(e) Postmarketing studies
LET 1 HFD-005 to Edward Odland Vol #: 1
2004P-0015 Deny approval of any New Drug Application ( NDA ) for recombinant salmon calcitonin (rsCT ) nasal spray
LET 1 HFD-005 to Buc & Beardsley Vol #: 1
2004P-0056 ANDA for Ondansetron Orally Disintegrating Tablets
PAV 1 HFD-600 to Lachman Consultant Services, Inc. Vol #: 1
2004P-0069 Declare that Fentanyl Transdermal Systems, in strengths of 37.5 mcg/hr, 62.5 mcg/hr, and 87.5 mcg/hr are suitable for submission in an ANDA
PAV 1 HFD-600 to Lachman Consultant Services, Inc. Vol #: 1
2004P-0123 Glimepiride Tablets, 3mg and 6mg for an Abbreviated new drug application ( ANDA )
PAV 1 HFD-600 to Lachman Consultant Services, Inc. Vol #: 1
2004P-0293 Carbohydrate Labeling - Remove Dietary Fiber from Total Carbohydrates
ACK 1 HFA-305 Vol #: 1
CP 1 National Starch and Chemical Company Vol #: 1
2004P-0294 Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose
CP 1
Attachments
McNeil Nutritionals, Div. of McNeil - PPC, Inc. Vol #: 1
ACK 1 HFS-832 to McNeil Nutritionals Vol #: 2
LET 1 McNeil Nutritionals Vol #: 2
LET 2 HFS-800 to McNeil Nutritionals Vol #: 2
SUP 1 McNeil Nutritionals Vol #: 2
2004P-0295 To determine whether Zyvox (linezolid) tablets 400mg (NDA 20-130) has been withdrawn for safety or effectiveness reasons as outlined below.
ACK 1 HFA-305 to - Lachman Consultant Services Inc. Vol #: 1
CP 1 Lachman Consultant Services Inc. Vol #: 1
2004Q-0097 Qualified Health Claim: Calcium and various cancers
LET 3 Emord & Associates PC Vol #: 15
2004Q-0098 Qualified Health Claim: Calcium and hypertension
LET 5 Emord & Associates PC Vol #: 9
2004Q-0099 Qualified Health Claim: Calcium and menstrual disorders
LET 3 Emord & Associates PC Vol #: 4
2004Q-0100 Qualified Health Claim: Calcium and bone fractures
LET 3 Emord & Associates PC Vol #: 6
2004Q-0102 Qualified Health Claim: Calcium and Kidney/urinary stones
LET 3 Emord & Associates PC Vol #: 6
2004Q-0180 Qualified Health Claim (QHC): Lutein and Eye Diseases
C 1 United Egg Producers Vol #: 5
C 2 United States Department of Agriculture Vol #: 5
2004S-0170 Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
EMC 24 Pfizer Global Pharmaceuticals Vol #: 3

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