Dockets Entered on November 4, 2003 kk

Dockets Management



Dockets Entered On November 3, 2003 Table of Contents



Docket #	Title

1994D-0025	Interim GDL/Labeling Milk & Milk Products from Cows w/rbST

1994V-0416	Laser Light Show

1997P-0329	Require Quantitative Labeling of Caffeine Content

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

1997S-0163	Dietary Supplements, Courtesy Letters (Letters of Objection)

1998D-0896	Medical Device Industry PMA shell development/modular review

1998P-0035	Exemption 21 CFR821 (b) Medical Device Tracking Requirements

1998P-0151	Introduction Of Downed Cattle Into The Food Supply

1998V-0817	Variance for emission delay for BioFlex Professional Laser

1999P-5106	Identify Sources of Natural Flavorings

2000N-1484	Safety Reporting Requirements Human Drug/Biological Products

2000P-1322	Food Labeling and Allergen Contamination Control

2002P-0294	Polymethylmethacrylate (PMMA) Bone Cement

2002V-0425	Laser Light Show

2003D-0165	Current Good Manufacturing Practices for Medical Gases

2003D-0380	Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability

2003D-0382	Draft Guidance: Sterile Drug Products Produced by Aseptic Processing

2003D-0412	International Conference on Harmonisation; Draft Guidance on E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting

2003N-0361	Anti-Counterfeit Drug Initiative

2003P-0090	Removing Serzone (nefazodone) from the market Bristol-Myers

2003P-0291	Enforce the law and prevent unlaw sale of contact lens

2003Q-0401	Qualified Health Claim (QHC) Omega-3 Fatty Acids and Coronoary Heart Disease Health Claim

2003V-0373	Laser Light Show

2003V-0377	Laser Light Show

2003V-0433	Laser Light Show

1994D-0025	Interim GDL/Labeling Milk & Milk Products from Cows w/rbST

C 8583	No signature	Vol #:	116

1994V-0416	Laser Light Show

VRA 2	HFZ-300 to Laserworks, Inc.	Vol #:	1

1997P-0329	Require Quantitative Labeling of Caffeine Content

C 245	No signature	Vol #:	8

C 246	No signature	Vol #:	8

C 247	No signature	Vol #:	8

C 248	No signature	Vol #:	8



C 249	No signature	Vol #:	8

C 250	No signature	Vol #:	8

C 251	No signature	Vol #:	8

C 252	No signature	Vol #:	8

C 253	No signature	Vol #:	8

C 254	No signature	Vol #:	8

C 255	No signature	Vol #:	8

C 256	No signature	Vol #:	8

C 257	No signature	Vol #:	8

C 258	No signature	Vol #:	8

C 259	No signature	Vol #:	8

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

LET 11405	Aboca Herbs and Health	Vol #:	87

LET 11406	Aboca Herbs and Health	Vol #:	87

LET 11407	Aboca Herbs and Health	Vol #:	88

LET 11408	Aboca Herbs and Health	Vol #:	88

LET 11409	Aboca Herbs and Health	Vol #:	88

LET 11410	Aboca Herbs and Health	Vol #:	88

LET 11411	Aboca Herbs and Health	Vol #:	88

LET 11412	Aboca Herbs and Health	Vol #:	88

LET 11413	Aboca Herbs and Health	Vol #:	88

LET 11414	Aboca Herbs and Health	Vol #:	88

LET 11415	Aboca Herbs and Health	Vol #:	88

LET 11416	Enzymatic Therapy Natural Medicines	Vol #:	88

LET 11417	PhytoPharmica Natural Medicines	Vol #:	88

LET 11418	Enzymatic Therapy Natural Medicines	Vol #:	88

LET 11419	Enzymatic Therapy Natural Medicines	Vol #:	88

LET 11420	Enzymatic Therapy Naural Medicines	Vol #:	88

LET 11421	Oregon's Wild harvest	Vol #:	88

LET 11422	PhytoPharmica Natural Medicines	Vol #:	88

LET 11423	PhytoPharmica Natural Medicines	Vol #:	88

LET 11424	Golden Temple of Oregon, Inc.	Vol #:	88

LET 11425	Herb Phrm	Vol #:	88

LET 11426	Herb Pharm	Vol #:	88

LET 11427	Herb Pharm	Vol #:	88

LET 11428	Generation Plus Inc.	Vol #:	88



LET 11429	PhytoPharmica Natural Medicines	Vol #:	88

LET 11430	PhytoPharmica Natural Medicines	Vol #:	88

LET 11431	Food Science of Vermont	Vol #:	88

LET 11432	Food Science of Vermont	Vol #:	88

LET 11433	FoodScience of Vermont	Vol #:	88

LET 11434	FoodScience of Vermont	Vol #:	88

LET 11435	FoodScience of Vermont	Vol #:	88

LET 11436	FoodScience of Vermont	Vol #:	88

LET 11437	Natural Organics Inc.	Vol #:	88

1997S-0163	Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 724	HFS-800 to Colorado Biolabs, Inc.	Vol #:	22

LET 725	HFS-800 to Highland Laboratories	Vol #:	22

LET 726	HFS-800 to Aboca USA, Inc	Vol #:	22

LET 727	HFS-800 to HerbsForever, Inc	Vol #:	22

LET 728	HFS-800 to Herbal Source	Vol #:	22

LET 729	HFS-800 to Pharmavite LLC	Vol #:	22

LET 730	HFS-800 to Michael's Naturopathic Programs	Vol #:	22

LET 731	HFS-800 to Lidtke Technologies Corporation	Vol #:	22

LET 732	HFS-800 to Crosslinks International, Inc	Vol #:	22

LET 733	HFS-800 to Peak Health Care Products, Inc.	Vol #:	22

1998D-0896	Medical Device Industry PMA shell development/modular review

GDL 2	Guideline	Vol #:	1

NAD 2	FDA	Vol #:	1

1998P-0035	Exemption 21 CFR821 (b) Medical Device Tracking Requirements

LET 1	HFZ-400 to Orthopedic Surgical Manufacturers Assn	Vol #:	1

1998P-0151	Introduction Of Downed Cattle Into The Food Supply

C 7198	Leona & David Doyle	Vol #:	303

C 7199	Stacy Fehl	Vol #:	303

C 7200	Cherie L. Holcomb, PhD	Vol #:	303

C 7201	Greta M. Bunting	Vol #:	303

C 7202	Gina Brunell	Vol #:	303

C 7203	Ruth Miller	Vol #:	303

C 7204	Susan Love	Vol #:	303

C 7205	Katie Desmond	Vol #:	303



C 7206	Beckie Doolan	Vol #:	303

C 7207	Michele Bencivinni	Vol #:	303

C 7208	Marianne Carnes	Vol #:	303

C 7209	Gladys R. Boss	Vol #:	303

C 7210	Susan B. Kay, MD	Vol #:	303

C 7211	Susan Riccobon	Vol #:	303

C 7212	Phil Versage	Vol #:	303

C 7213	Bentley Yeager	Vol #:	303

C 7214	Cathy Kreibich	Vol #:	303

C 7215	Ira Fishburn	Vol #:	303

C 7216	Michael R. Tenga	Vol #:	303

C 7217	Marguerite Tyler, RN	Vol #:	303

C 7218	Elisa Frey	Vol #:	303

C 7219	Jennifer Crimi	Vol #:	303

C 7220	Annette J. Prado	Vol #:	303

C 7221	Loretta Frediani	Vol #:	303

C 7222	Bill Frey	Vol #:	303

C 7223	Lisa Thomas Tucker	Vol #:	303

C 7224	Julie S. Lachman	Vol #:	303

C 7225	Eleanor Rosenthal	Vol #:	303

C 7226	Kim Griffin	Vol #:	303

1998V-0817	Variance for emission delay for BioFlex Professional Laser

VRA 1	HFZ-300 to Meditech International Inc.	Vol #:	1

1999P-5106	Identify Sources of Natural Flavorings

C 19	No signature	Vol #:	2

2000N-1484	Safety Reporting Requirements Human Drug/Biological Products

REF 1 Tab A, part 2, 3, 4, 5 Tab B, part 2, 3, 4, 5	OMB Review 3/14/2003	Vol #:	7

2000P-1322	Food Labeling and Allergen Contamination Control

C 539	No signature	Vol #:	30

C 540	No signature	Vol #:	30

C 541	No signature	Vol #:	30

C 542	No signature	Vol #:	30

2002P-0294	Polymethylmethacrylate (PMMA) Bone Cement

LET 1	HFZ-400 to Orthopedic Surgical Manufacturers Assn	Vol #:	5



2002V-0425	Laser Light Show

LET 1	HFZ-343 to MGM Grand Hotel & Casino	Vol #:	1

2003D-0165	Current Good Manufacturing Practices for Medical Gases

C 27	BOC Gases	Vol #:	1

C 28	Praxair, Inc. (Praxair)	Vol #:	1

C 29	Michigan Home Health Assn (MHHA)	Vol #:	1

C 30	Compressed Gas Assn (CGA)	Vol #:	1

C 31	AGA Gas, Inc.	Vol #:	1

2003D-0380	Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability

C 3	AstraZeneca Pharmaceuticals, LP	Vol #:	1

C 4	Umetrics, Inc.	Vol #:	1

C 5	Abbott Laboratories	Vol #:	1

C 6	Cambrex Corporation (Cambrex)	Vol #:	1

2003D-0382	Draft Guidance: Sterile Drug Products Produced by Aseptic Processing

C 5	VPCI, Inc.	Vol #:	1

C 6	Millipore Corporation (Millipore)	Vol #:	1

C 7	Alcon Laboratories, Inc.	Vol #:	1

C 8	Johnson-Johnson	Vol #:	1

C 9	Pfizer, Inc.	Vol #:	1

2003D-0412	International Conference on Harmonisation; Draft Guidance on E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting

C 5	Millennium Pharmaceuticals, Inc.	Vol #:	1

2003N-0361	Anti-Counterfeit Drug Initiative

C 5	PharmaDocs, LLC	Vol #:	3

C 6	InkShore Technologies	Vol #:	3

C 7	Plasma Protein Therapeutics Assn (PPTA)	Vol #:	3

C 8	DeLaRue	Vol #:	3

C 9	Isotech Laboratories, Inc.	Vol #:	3

C 10	DeKieffer & Horgan	Vol #:	3

2003P-0090	Removing Serzone (nefazodone) from the market Bristol-Myers

SUP 1	Public Citizen	Vol #:	1

2003P-0291	Enforce the law and prevent unlaw sale of contact lens

C 60	Dr. Helen Kim	Vol #:	2



2003Q-0401	Qualified Health Claim (QHC) Omega-3 Fatty Acids and Coronoary Heart Disease Health Claim

ACK 2	HFS-800 to Emord & Associates PC	Vol #:	2

C 2 Tab A, B, C	Ocean Nutrition Canada	Vol #:	3

LET 2	Emord & Associates, PC	Vol #:	2

LET 3	Oregon School of Medicine	Vol #:	2

LET 4	Enig Associates, Inc.	Vol #:	2

MM 1	Meeting Between Emord & Associates and FDA	Vol #:	2

SUP 1 Attachment, Reference 1, 18-20	Emord & Associates PC	Vol #:	2

2003V-0373	Laser Light Show

VRA 1	HFZ-300 to Eagle River Bowl, LLC	Vol #:	1

2003V-0377	Laser Light Show

VRA 1	HFZ-300 to Wild Country	Vol #:	1

2003V-0433	Laser Light Show

VRA 1	HFZ-300 to Vandenberg Community Center	Vol #:	1

Page created on November 4, 2003 kk
Page update on November 20, 2003 jb

FDA/Dockets Management