Dockets Entered on August 9, 2004

Dockets Management



Dockets Entered On August 9, 2004 Table of Contents



Docket #	Title

1985V-0284	Starlight series one laser light show

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

1998P-0610	Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

1999P-5106	Identify Sources of Natural Flavorings

2001P-0075	Switch Status of Emergency Contraceptives from Rx to OTC

2003N-0338	Obesity

2003P-0029	Remove metered-dose inhalers (MDI) containing moiety albuter

2003P-0064	Withhold Approval of Generic Lovenox (enoxaparin sodium inje

2003P-0479	Allow importation of Canadian versions of drugs that are approved to the United States

2003P-0574	Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth

2004D-0042	Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products

2004N-0181	Critical Path Initiative

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

2004N-0257	Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle

2004N-0264	Federal Measures to Mitigate BSE Risks: Considerations for Further Action

2004P-0074	oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin

2004P-0110	Nutrient Content Claim: Carbohydrate Content of Foods

2004P-0357	determination lthat an advisory opinion or exemption is not needed in accorance with FDA regulations

2004P-0359	Suitability Petition for (New Strength) Methacholine Chloride 1280 mg/vial

2004S-0233	Stimulating Innovation in Medical Technologies

2004V-0318	Laser Light Show

2004V-0358	Projector for a Laser Light Show

1985V-0284	Starlight series one laser light show
VRA 10	HFZ-300 to Starlasers	Vol #:	1

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

LET 14190	Perrigo Company of South Carolina	Vol #:	123

LET 14191	Perrigo Company of South Carolina	Vol #:	123

LET 14192	Perrigo Company of South Carolina	Vol #:	123

LET 14193	Enzymatic Therapy	Vol #:	123

LET 14194	Enzymatic Therapy	Vol #:	123

LET 14195	Enzymatic Therapy	Vol #:	123

LET 14196	Enzymatic Therapy	Vol #:	123

LET 14197	Enzymatic Therapy	Vol #:	123

LET 14198	Enzymatic Therapy	Vol #:	123

LET 14199	Inverness Medical Nutritionals Group	Vol #:	123



LET 14200	Pure Encapsulations, Inc.	Vol #:	123

LET 14201	Purdue Products L.P.	Vol #:	123

LET 14202	Loders Croklaan Lipid Nutrition	Vol #:	123

LET 14203	Loders Croklaan Lipid Nutrition	Vol #:	123

LET 14204	Loders Croklaan Lipid Nutrition	Vol #:	123

LET 14205	Loders Croklaan Lipid Nutrition	Vol #:	123

LET 14206	Natural Factors Nutritional Products, Inc.	Vol #:	123

LET 14207	Natural Factors Nutritional Products Inc.	Vol #:	123

LET 14208	Natural Factors Nutritional Products Inc.	Vol #:	123

LET 14209	Natural Factors Nutritional Products Inc.	Vol #:	123

LET 14210	Natural Factors Nutritional Products Inc.	Vol #:	123

LET 14211	Perrigo Company of South Carolina	Vol #:	123

LET 14212	Perrigo Company of South Carolina	Vol #:	123

LET 14213	Perrigo Company of South Carolina	Vol #:	123

LET 14214	Perrigo Company of South Carolina	Vol #:	123

LET 14215	Perrigo Company of South Carolina	Vol #:	123

LET 14216	Perrigo Company of South Carolina	Vol #:	123

LET 14217	Perrigo Company of South Carolina	Vol #:	123

LET 14218	Perrigo Company of South Carolina	Vol #:	123

LET 14219	Perrigo Company of South Carolina	Vol #:	123

LET 14220	Perrigo Company of South Carolina	Vol #:	123

LET 14221	Perrigo Company of South Carolina	Vol #:	123

LET 14222	Perrigo Company of South Carolina	Vol #:	123

LET 14223	Perrigo Company of South Carolina	Vol #:	123

LET 14224	Perrigo Company of South Carolina	Vol #:	123

LET 14225	Perrigo Company of South Carolina	Vol #:	123

LET 14226	Enzymatic Therapy	Vol #:	123

1998P-0610	Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

ANS 2	HFD-1 to Wellpoint	Vol #:	6

1999P-5106	Identify Sources of Natural Flavorings

C 56	N. Caplan	Vol #:	2

C 57	R. Flygar	Vol #:	2

C 58	D. Oder	Vol #:	2

2001P-0075	Switch Status of Emergency Contraceptives from Rx to OTC

C 1876	Gilda De Ferrari	Vol #:	281



C 1877	D. Scala	Vol #:	281

C 1878	L. Lafono	Vol #:	281

C 1879	L. Miles Bourne	Vol #:	281

C 1880	D. Constantine	Vol #:	281

C 1881	W. Alexander	Vol #:	281

C 1882	R. Scala	Vol #:	281

C 1883	N. Scala	Vol #:	281

C 1884	L. Ardire	Vol #:	281

C 1885	D. W. Hiltz	Vol #:	281

C 1886	W. J. Small	Vol #:	281

C 1887	M. Lodise	Vol #:	281

C 1888	C. Tymon	Vol #:	281

C 1889	P. D. Eixenberger	Vol #:	281

C 1890	C. Keyl	Vol #:	281

C 1891	P. Fredrick	Vol #:	281

C 1892	E. Talamonti	Vol #:	281

C 1893	P. A. Johnston	Vol #:	281

C 1894	J. Gyllenborg	Vol #:	281

C 1895	B. Laughlin	Vol #:	281

C 1896	R. A. Weber	Vol #:	281

C 1897	B. Cheeseman	Vol #:	281

C 1898	P. McGinley	Vol #:	281

C 1899	Anonymous	Vol #:	281

C 1900	C. Birkey	Vol #:	281

C 1901	K. Sligav	Vol #:	281

C 1902	C. M. St. Jean	Vol #:	281

C 1903	E. Hepner	Vol #:	281

C 1904	L. Miles Bourne	Vol #:	281

C 1905	L.V. M. Kane	Vol #:	281

C 1906	L. E. Gensel	Vol #:	281

C 1907	D. W. & C. A. Hiltz	Vol #:	281

C 1908	N. K. Finn	Vol #:	281

C 1909	R. Axelrod	Vol #:	281

C 1910	S. Flach	Vol #:	281

C 1911	M. Kerr	Vol #:	281

C 1912	N. Curtis	Vol #:	281

C 1913	D. Warren	Vol #:	281



C 1914	M. B. Stewart	Vol #:	281

C 1915	R. Fyfe	Vol #:	281

C 1916	K. Funabashi	Vol #:	281

C 1917	D. Zuckerman & J. M. Follows	Vol #:	281

C 1918	B. Martin	Vol #:	281

C 1919	J. McKeown	Vol #:	281

C 1920	W. Hibberd	Vol #:	281

C 1921	M. DiMarco-Temkin	Vol #:	281

C 1922	E. A. Farnham	Vol #:	281

C 1923	B. Mosedale	Vol #:	281

C 1924	K. Sullivan	Vol #:	281

C 1925	M. Mandel	Vol #:	281

C 1926	S. Davoody	Vol #:	281

C 1927	D. M. Stewart	Vol #:	281

C 1928	B. Neilan	Vol #:	281

C 1929	R. & T. Walter	Vol #:	281

C 1930	M. McColgan	Vol #:	281

C 1931	J. P. McLaughlin	Vol #:	281

C 1932	M. & E. Byer	Vol #:	281

C 1933	R. & B. Knievel	Vol #:	281

C 1934	L. Manarte	Vol #:	281

C 1935	E. McDonald	Vol #:	281

C 1936	M. Ashenfelter	Vol #:	288

C 1937	S. Splichal	Vol #:	288

C 1938	J. E. Walsh	Vol #:	288

C 1939	J. G. Hyland	Vol #:	288

C 1940	M. C. Hospador	Vol #:	288

C 1941	A. Hsi	Vol #:	288

C 1942	J. Rooney	Vol #:	288

C 1943	J. O'Donnell	Vol #:	288

C 1944	E. Angeles	Vol #:	288

C 1945	J. Pirolli	Vol #:	288

C 1946	A. Vetter	Vol #:	288

C 1947	W. M. Gallagher	Vol #:	288

C 1948	T. Early	Vol #:	288

C 1949	A. T. D'Imperio	Vol #:	288

C 1950	T. Perkins	Vol #:	288



C 1951	T. McGurk	Vol #:	288

C 1952	J. P. Williamson	Vol #:	288

C 1953	J. A. Wittingen	Vol #:	288

C 1954	A. Andino	Vol #:	288

C 1955	K. Hays	Vol #:	288

C 1956	J. W.H. Glasser	Vol #:	288

C 1957	R. Longoria	Vol #:	288

C 1958	B. Thrasher	Vol #:	288

C 1959	K. Lam	Vol #:	288

C 1960	R. E. Batie, D.O., Inc.	Vol #:	288

C 1961	J. P. Curlin	Vol #:	288

C 1962	L. J. Kooima	Vol #:	288

C 1963	M. Mawn	Vol #:	288

C 1964	J. Kremer	Vol #:	281

C 1965	E. Hand	Vol #:	288

C 1966	M. Mawn	Vol #:	288

C 1967	E. L. Hand	Vol #:	288

C 1968	F. W. Munzer	Vol #:	288

C 1969	J. A. Dewms	Vol #:	288

C 1970	J. Minsk	Vol #:	288

C 1971	V. Andrade	Vol #:	288

C 1972	S. Weary	Vol #:	288

C 1973	J. Rivard	Vol #:	288

C 1974	E. Cowley	Vol #:	288

C 1975	S. Cohen	Vol #:	288

C 1976	M. Anand	Vol #:	288

C 1977	L. A. Wallace	Vol #:	288

C 1978	B. J. Penfield	Vol #:	288

C 1979	T. R. Frieden	Vol #:	288

C 1980	J. Shafer	Vol #:	288

C 1981	J. A. Hudkins	Vol #:	288

C 1982	T. Coufal	Vol #:	288

2003N-0338	Obesity

C 21 Enclosure	Pennington Biomedical Research Center	Vol #:	12

2003P-0029	Remove metered-dose inhalers (MDI) containing moiety albuter



SUP 8	Honeywell	Vol #:	2

2003P-0064	Withhold Approval of Generic Lovenox (enoxaparin sodium inje

C 3	Hyman, Phelps & McNamara, PC	Vol #:	3

2003P-0479	Allow importation of Canadian versions of drugs that are approved to the United States

PDN 1	HF-22 to Honorable Charlie Ryan	Vol #:	1

PDN 2	HF-22 to Sate of Vermont	Vol #:	1

2003P-0574	Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth

C 3	Assn for Dressings and Sauces (ADS)	Vol #:	2

C 4	Alliance for Listeriosis Prevention (Alliance)	Vol #:	2

C 5	National Frozen Pizza Institute (NFPI)	Vol #:	2

2004D-0042	Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products

SUP 2	Pfizer, Inc.	Vol #:	3

2004N-0181	Critical Path Initiative

C 50	United States Bone and Joint Decade (USBJD)	Vol #:	3

C 51	Lymphoma Research Foundation	Vol #:	3

C 52	Scleroderma Foundation	Vol #:	3

C 53	W M Kelly	Vol #:	3

C 54	National Coalition for Cancer Survivorship	Vol #:	3

C 55	American Society of Clinical Oncology	Vol #:	3

C 56	Prostate Cancer Foundation	Vol #:	3

C 57	I Ross	Vol #:	3

EMC 14	Number not used	Vol #:	3

EMC 15	Johnson & Johnson	Vol #:	3

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

EXT 2	American Frozen Food Institute	Vol #:	1

2004N-0257	Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle

EXT 1	China WTO/TBT	Vol #:	2

2004N-0264	Federal Measures to Mitigate BSE Risks: Considerations for Further Action

C 13	Baker Commodities, Inc.	Vol #:	7

C 14	Dr. M. Laderoute	Vol #:	7

C 15	Pet Food Institute (PFI)	Vol #:	7

C 16	M. Cornette	Vol #:	7



C 17	C. Hughes	Vol #:	7

C 18	S. Mellinger	Vol #:	7

C 19	F. McKee	Vol #:	7

C 20	Form Letters	Vol #:	10

C 21	Form Letters	Vol #:	11

EXT 20	Advanced Medical Technology Assn (AdvaMed)	Vol #:	7

LET 1	HF-11	Vol #:	7

2004P-0074	oxandrolone and widely used anti-coagulant durgs containing the active drug warfarin

C 1 Tab A, B, C	Heller Ehrman	Vol #:	1

2004P-0110	Nutrient Content Claim: Carbohydrate Content of Foods

LET 4	Grocery Manufacturers of America (GMA)	Vol #:	1

2004P-0357	determination lthat an advisory opinion or exemption is not needed in accorance with FDA regulations

ACK 1	City of Arlington Texas	Vol #:	1

AP 1	City of Arlington Texas	Vol #:	1

2004P-0359	Suitability Petition for (New Strength) Methacholine Chloride 1280 mg/vial

ACK 1	HFA-305 to Methapharm Inc.	Vol #:	1

CP 1 Attachment 1, 2	Methapharm Inc.	Vol #:	1

2004S-0233	Stimulating Innovation in Medical Technologies

C 2	American Assn for Clinical Chemistry (AACC)	Vol #:	1

EC 5	American Academy of Orthopaedic Surgeons	Vol #:	1

2004V-0318	Laser Light Show

VRA 1	HFZ-300 to Sun on the Beach	Vol #:	1

2004V-0358	Projector for a Laser Light Show

ACK 1	HFA-305 to Guitar Center #220	Vol #:	1

VAR 1	Guitar Center #220	Vol #:	1

Page created on August 9, 2004 dp

FDA/Dockets Management