Dockets Entered on December 14, 2005

Dockets Management



Dockets Entered On December 14, 2005 Table of Contents



Docket #	Title

1990S-0308	Generic Drug Speeches & Policy and Procedure Guides

1994F-0153	Safe use of n-octanol, Synthetic Fatty Alcohols

1995S-0158	Community Disclosure of Institutional Review Boards

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

1999P-1340	Declared Eternity eau de Parfum Misbranded

2001P-0345	Listing the color additive yellow #5 for use in food/Drug

2002N-0273	Animal Proteins Prohibited in Ruminant Feed

2002P-0317	Recall Aspartame as a Neurotoxic Drug

2003N-0076	Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

2004N-0556	Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant

2004P-0009	to clarify the use of the terms "100% Natural" and "Fat Free" in food product packages

2004P-0448	DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)

2005D-0340	Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment

2005N-0329	Designation of New Animal Drugs for Minor Uses or Minor Species

2005N-0343	Agency Emergency Processing Under OMB Review; Guidance for Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006

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-0364	Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting

2005N-0410	Prescription Drug User Fee Act (PDUFA): Public Meeting

2005N-0447	Possible Changes to Regulatory Jurisdiction of Certain Food Products Containing Meat and Poultry. Notice of Public Meeting

2005P-0048	Professional labeling for aspirin dosing in order to specify the morefavorable benefit/risk profile of aspirin doses of 75-150 mg/day for secondary cardiovascular prevention, 5-=150 mg/day for seconda


2005P-0116	To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations

2005P-0273	Add Calcium to the Mandatory List

2005P-0433	Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512

2005V-0489	Laser Light Show

1990S-0308	Generic Drug Speeches & Policy and Procedure Guides

RPT 761	Statistical Report - Month of November 2005	Vol #:	54

1994F-0153	Safe use of n-octanol, Synthetic Fatty Alcohols

OB 1	B. Sachau	Vol #:	1

1995S-0158	Community Disclosure of Institutional Review Boards

SUP 46 Detriot Attachment	Northfield Laboratories BB IND #10719	Vol #:	49

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

LET 17031	AdvoCare International, L.P.	Vol #:	154



LET 17032	AdvoCare International, L.P.	Vol #:	154

LET 17033	AdvoCare International, L.P.	Vol #:	154

LET 17034	AdvoCare International, L.P.	Vol #:	154

LET 17035	Neways International, Inc.	Vol #:	154

LET 17036	Enzymatic Therapy	Vol #:	154

LET 17037	Enzymatic Therapy	Vol #:	154

LET 17038	Enzymatic Therapy	Vol #:	154

LET 17039	Enzymatic Therapy	Vol #:	154

LET 17040	Enzymatic Therapy	Vol #:	154

LET 17041	Enzymatic Therapy	Vol #:	154

LET 17042	New Chapter, Inc.	Vol #:	154

LET 17043	New Chapter, Inc.	Vol #:	154

LET 17044	Matagenics, Inc.	Vol #:	154

LET 17045	Miracle Breakthrough lab, Inc.	Vol #:	154

LET 17046	Herb Pharm	Vol #:	154

LET 17047	Herb Pharm	Vol #:	154

LET 17048	Herb Pharm	Vol #:	154

LET 17049	Herb Pharm	Vol #:	154

LET 17050	Herb Pharm	Vol #:	154

LET 17051	Herb Pharm	Vol #:	154

LET 17052	Herb Pharm	Vol #:	154

LET 17053	Natrol, Inc.	Vol #:	154

1999P-1340	Declared Eternity eau de Parfum Misbranded

EMC 620	J. Jallo	Vol #:	24

2001P-0345	Listing the color additive yellow #5 for use in food/Drug

EMC 1295	B. Entringer	Vol #:	6

EMC 1296	S. Meredith	Vol #:	6

EMC 1297	L. Cosgrave	Vol #:	6

2002N-0273	Animal Proteins Prohibited in Ruminant Feed

C 384	E. Herndon, Sr.	Vol #:	35

C 385	M. Martin	Vol #:	35

C 386	M. Cramer	Vol #:	35

C 387	M. Miller	Vol #:	35

C 388	H and J Howbaher	Vol #:	35

C 389	P. Olsen	Vol #:	35



C 390	J. Manion	Vol #:	35

C 391	R. Travis	Vol #:	35

C 392	C. Cheeks	Vol #:	35

C 393	R. Gilbo	Vol #:	35

C 394	G. Russell	Vol #:	35

C 395	J. Schnobrich	Vol #:	35

C 396	D. Teeter	Vol #:	35

C 397	J. Shand	Vol #:	35

C 398	M. Yohe	Vol #:	35

C 399	S. Twitchell	Vol #:	35

C 400	L. Taylor	Vol #:	35

C 401	T. Amato	Vol #:	35

C 402	C. Schultz	Vol #:	35

C 403	Gibson County Courthouse	Vol #:	35

C 404	D. Diaz	Vol #:	35

C 405	E. Burkholder	Vol #:	35

C 406	J. Harker	Vol #:	36

C 407	R. Williams	Vol #:	36

C 408	S. Reneau	Vol #:	36

C 409	Giles Couny, Tennessee	Vol #:	36

C 410	J. Tyler	Vol #:	36

C 411	M. Lukasiewicz	Vol #:	36

C 412	Honorable Randy Neugebauer	Vol #:	36

EC 165	New Zealand Embassy Washington DC	Vol #:	34

EC 166	Ms. Diane Weinstein	Vol #:	34

EC 167	Mr. Dwight Ward	Vol #:	34

EC 168	Mrs. Teresa Russo	Vol #:	34

EC 169	Ms. Jennifer Otway	Vol #:	34

EC 170	Mrs. Ursula Pelka	Vol #:	34

EC 171	Miss. Erin Maupin	Vol #:	34

EC 172	Mr. Marvin Huyser	Vol #:	34

EC 173	Williamson Co. Cattlemen	Vol #:	34

EC 174	Ms. Kelly Flood	Vol #:	34

EC 175	Mrs. James Denison	Vol #:	34

EC 176	Farm Sanctuary	Vol #:	34

EC 177	Ms. Jo Tyler	Vol #:	34



2002P-0317	Recall Aspartame as a Neurotoxic Drug

EMC 562	Mission Possible International	Vol #:	8

EMC 563	Mission Possible International	Vol #:	8

EMC 564	Mission Possible International	Vol #:	8

EMC 565	Calorie Control Council	Vol #:	8

EMC 566	Mission Possible International	Vol #:	8

EMC 567	Mission Possible International	Vol #:	8

EMC 568	Mission Possible International	Vol #:	8

2003N-0076	Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

EMC 1165	S. Murray	Vol #:	12

EMC 1166	C. Launt	Vol #:	12

EMC 1167	C. Hott	Vol #:	12

EMC 1168	S. Gallagher	Vol #:	12

EMC 1169	S. Robinson	Vol #:	12

EMC 1170	D. DiGiacinto	Vol #:	12

EMC 1171	J. Chromey	Vol #:	12

EMC 1172	T. Biediger, MD	Vol #:	12

EMC 1173	L. Hooper	Vol #:	12

EMC 1174	A. Liao	Vol #:	12

2004N-0556	Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant

EC 20	United States Agency for International Development	Vol #:	1

2004P-0009	to clarify the use of the terms "100% Natural" and "Fat Free" in food product packages

PDN 1	HFC-1 to Antonio Zamora	Vol #:	1

2004P-0448	DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)

AMD 1	Hill Dermaceuticals, Inc.	Vol #:	1

2005D-0340	Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment

EC 1	Global Alliance to Improve Outcomes in Acne	Vol #:	1

2005N-0329	Designation of New Animal Drugs for Minor Uses or Minor Species

C 3	Keep Antibiotics Working (KAW)	Vol #:	1

EMC 3	Keep Antibiotics Working (KAW)	Vol #:	1

EMC 4	B. Raez	Vol #:	1

2005N-0343	Agency Emergency Processing Under OMB Review; Guidance for Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006



LET 1	AMerican Licorice Co.	Vol #:	1

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

C 493	M. Sadowski	Vol #:	165

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

EC 392	Mr. Craig Beutler	Vol #:	5

EC 393	Mrs. Annette Davidson	Vol #:	5

EC 394	Mrs. Noosheen Hakimi	Vol #:	5

EC 395	Mr. jack Hennessy	Vol #:	5

EC 396	Ms. Rita Aberg	Vol #:	5

EC 397	Mrs. Lisa Doughty	Vol #:	5

TR 1	Transcript of the November 1, 2005 Public Hearing	Vol #:	7

2005N-0364	Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002; Public Meeting

TR 1	Transcript of November 17, 2005 Meeting	Vol #:	2

2005N-0410	Prescription Drug User Fee Act (PDUFA): Public Meeting

C 1	Blue Cross Blue Shield Association	Vol #:	1

EC 6	American Society of Health-System Pharmacists	Vol #:	1

EC 7	Academy of Managed Care Pharmacy	Vol #:	1

EC 8	Blue Cross Blue Shield Association	Vol #:	1

2005N-0447	Possible Changes to Regulatory Jurisdiction of Certain Food Products Containing Meat and Poultry. Notice of Public Meeting

EMC 1	M. Dunker	Vol #:	1

2005P-0048	Professional labeling for aspirin dosing in order to specify the morefavorable benefit/risk profile of aspirin doses of 75-150 mg/day for secondary cardiovascular prevention, 5-=150 mg/day for seconda


C 7	Preventive Cardiovascular Nurses Association (PCNA)	Vol #:	3

2005P-0116	To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations

C 10	Sepracor, Inc. (Sepracor)	Vol #:	3

2005P-0273	Add Calcium to the Mandatory List

SUP 1	Rutgers University	Vol #:	2

2005P-0433	Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512

C 7	D. Marquardt	Vol #:	1

2005V-0489	Laser Light Show

ACK 1	HFA-305 to Fullhouse Productions L.L.C.	Vol #:	1



VAR 1	Fullhouse Productions L.L.C.	Vol #:	1

Page created on December 27, 2005 RSC

FDA/Dockets Management