Dockets Entered on November 3, 2005

Dockets Management



Dockets Entered On November 3, 2005 Table of Contents
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Note: Due to the size of this file, we have divided it into sections.

Docket #	Title

1975N-0256	Food Labeling & Label Declaration of Ingredient Requireme

1975N-0331	X-Ray Field Limitation & Alignment, Beam & Exposure

1975P-0305	NSN 6545-00-999-6449 Med Equip Set, Med Field Treatment F

1976N-0289	Methadone

1977N-0221	Safety of Certain Food Ingredients

1977P-0020	Labeling of All Waxed Fruits & Vegetables

1977P-0057	Classification of Continuous ph Monitor

1977P-0191	Amend Compliance Date 1250.51 Discharge of Wastes

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

2004N-0230	Food; Current Good Manufacturing Practice Regulations; Public Meetings

2004N-0458	Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994

2005D-0219	Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals

2005D-0240	Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability

2005D-0348	Guidance for Industry and Food and Drug Administration: Procedures for Handling Post-Approval Studies Imposed by PMA Order

2005D-0412	Guidance for Industry: A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicle


2005N-0345	Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product

2005N-0354	Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing

2005N-0394	FDAs Communication of Drug Safety Information; Public Hearing

2005N-0404	Solicitation of Public Review and Comment on Research Protocol:

1975N-0256	Food Labeling & Label Declaration of Ingredient Requireme

RET 1	088-06-0017 Boxes 1 & 2	Vol #:	9

1975N-0331	X-Ray Field Limitation & Alignment, Beam & Exposure

RET 1	Transfer No. 088-06-0017 Box 2	Vol #:	1

1975P-0305	NSN 6545-00-999-6449 Med Equip Set, Med Field Treatment F

RET 1	Transfer No. 088-06-0017 Box 2	Vol #:	1

1976N-0289	Methadone

RET 1	Transfer No. 088-06-0017 Box 2	Vol #:	1

1977N-0221	Safety of Certain Food Ingredients

RET 1	Transfer No. 088-06-0017 Box 2	Vol #:	2

1977P-0020	Labeling of All Waxed Fruits & Vegetables

RET 1	Transfer No. 088-06-0017	Vol #:	1

1977P-0057



	Classification of Continuous ph Monitor

RET 1	Transfer No. 088-06-0017 Box 2	Vol #:	1

1977P-0191	Amend Compliance Date 1250.51 Discharge of Wastes

RET 1	Transfer No. 088-06-0017 Box 2	Vol #:	1

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

LET 16753	Hillestad Pharmaceuticals	Vol #:	151

LET 16754	Hansen Beverage Company	Vol #:	151

LET 16755	Enzymatic Therapy	Vol #:	151

LET 16756	Enzymatic Therapy	Vol #:	151

LET 16757	Enzymatic Therapy	Vol #:	151

LET 16758	Enzymatic Therapy	Vol #:	151

LET 16759	Enzymatic Therapy	Vol #:	151

LET 16760	Enzymatic Therapy	Vol #:	151

LET 16761	Enzymatic Therapy	Vol #:	151

LET 16762	Enzymatic Therapy	Vol #:	151

LET 16763	Gene Biotechnology, Inc. d/b/a Natural Bio Care	Vol #:	151

LET 16764	NBTY Inc.	Vol #:	151

LET 16765	NBTY Inc.	Vol #:	151

LET 16766	NBTY Inc.	Vol #:	151

LET 16767	NBTY Inc.	Vol #:	151

LET 16768	NBTY Inc.	Vol #:	151

LET 16769	NBTY Inc.	Vol #:	151

LET 16770	NBTY Inc.	Vol #:	151

LET 16771	NBTY Inc.	Vol #:	151

LET 16772	NBTY Inc.	Vol #:	151

LET 16773	NBTY Inc.	Vol #:	151

LET 16774	NBTY Inc.	Vol #:	151

LET 16775	NBTY Inc.	Vol #:	151

LET 16776	NBTY Inc.	Vol #:	151

LET 16777	NBTY Inc.	Vol #:	151

LET 16778	NBTY Inc.	Vol #:	151

LET 16779	NBTY Inc.	Vol #:	151

LET 16780	NBTY Inc.	Vol #:	151

LET 16781	NBTY Inc.	Vol #:	151

LET 16782	NBTY Inc.	Vol #:	151



2004N-0230	Food; Current Good Manufacturing Practice Regulations; Public Meetings

RPT 1	Food CGMP Modernization - A Focus on Food Safety	Vol #:	4

2004N-0458	Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994

EC 44	Ms. Nicolle Singer	Vol #:	1

EC 45	Cryonic Life Insurance Company	Vol #:	1

2005D-0219	Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals

EC 3	Mr. Karl Nagel	Vol #:	1

EC 4	Mr. ROBERT A. ADELAAR	Vol #:	1

2005D-0240	Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability

EC 7	Indiana University	Vol #:	1

EC 8	Indiana University-Purdue University Fort Wayne	Vol #:	1

EC 9	Tufts School Of Dental Medicine	Vol #:	1

EC 10	CHPA and CTFA	Vol #:	1

EC 11	American Dental Association	Vol #:	1

EC 12	Tufts School of Dental Medicine	Vol #:	1

EC 13	Indiana State Department of Health	Vol #:	1

2005D-0348	Guidance for Industry and Food and Drug Administration: Procedures for Handling Post-Approval Studies Imposed by PMA Order

EC 1	AdvaMed	Vol #:	1

2005D-0412	Guidance for Industry: A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicle


EC 1	Miss. Stephanie So	Vol #:	<

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FDA/Dockets Management