Dockets Entered on August 21, 2007

Dockets Management



Dockets Entered On August 21, 2007



Docket #	Title

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

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

1998N-0359	Program priorities/Center for Food Safety & Applied Nutrition

2003D-0044	Reporting Results for Studies Evaluating Diagnostic Tests

2003P-0409	Reclassification for Moblie Bearing Knees from Class III and Class II

2004N-0226	Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010

2004N-0382	Food Labeling: Safe Handling Statements: Labeling of Shell Eggs

2005D-0112	Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics

2005N-0272	Irradiation in the Production, Processing & Handling of Food

2005P-0411	Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

2006F-0059	Safe Use of Polydextrose as a Bulking Agent, Formulation Aid, Humectant and Texturizer in All Foods, except Meat and Poultry (FAP 6A4763)

2006N-0104	Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format

2006N-0238	Debarment of Maria Anne Kirkman Campbell

2006N-0454	Use of Ozone-Depleting Substances; Removal of Essential-Use Designations

2006P-0281	Determination of Orudis KT (ketoprofen, 12.5 mg) Oral Tablet

2006P-0379	To urge the FDA's prompt action to cancel the GRAS desgnation for diacetyl

2006P-0505	ANDA for Ursodial Capsules USP, 100 mg 200 mg, and 400 mg

2007D-0125	Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims

2007D-0168	Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations

2007D-0173	Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators

2007N-0236	Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Applications and Supporting Regulations, and Form FDA 356V

2007N-0264	Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule

2007N-0317	Agency Information Collection Activities; Proposed Collection; Comment Request, Guidance for Industry on Pharmacogenomic Data Submissions; Extension

2007P-0065	To increase print size of direct-to-consumer advertisements

2007V-0222	Projector for a Laser Light Show

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

LET 20616	NBTY	Vol #:	180

LET 20617	NBTY	Vol #:	180

LET 20618	NBTY	Vol #:	180

LET 20619	NBTY	Vol #:	180

LET 20620	NBTY	Vol #:	180

LET 20621	NBTY	Vol #:	180

LET 20622	NBTY	Vol #:	180

LET 20623	NBTY	Vol #:	180

LET 20624	Enzmatic	Vol #:	180



LET 20625	Enzmatic	Vol #:	180

LET 20626	Enzmatic	Vol #:	180

LET 20627	Enzmatic	Vol #:	180

LET 20628	Enzmatic	Vol #:	180

LET 20629	Enzmatic	Vol #:	180

LET 20630	Enzmatic	Vol #:	180

LET 20631	Enzmatic	Vol #:	180

LET 20632	Enzmatic	Vol #:	180

LET 20633	Josefino Gonzales	Vol #:	180

LET 20634	Sciff Nutrition International Inc.	Vol #:	180

LET 20635	Sciff Nutrition International Inc.	Vol #:	180

LET 20636	Sciff Nutrition International Inc.	Vol #:	180

LET 20637	Sciff Nutrition International Inc.	Vol #:	180

LET 20638	Sciff Nutrition International Inc.	Vol #:	180

LET 20639	Sciff Nutrition International Inc.	Vol #:	180

LET 20640	Sciff Nutrition International Inc.	Vol #:	180

LET 20641	Sciff Nutrition International Inc.	Vol #:	180

LET 20642	Sciff Nutrition International Inc.	Vol #:	180

LET 20643	Sciff Nutrition International Inc.	Vol #:	180

LET 20644	Sciff Nutrition International Inc.	Vol #:	180

LET 20645	Sciff Nutrition International Inc.	Vol #:	180

LET 20646	The EFA Focus Company	Vol #:	180

LET 20647	Bayer HealthCare	Vol #:	180

LET 20648	Golden Temple	Vol #:	180

LET 20649	HERB PHARM	Vol #:	180

LET 20650	The Coromega Company, Inc.	Vol #:	180

LET 20651	Applied Cognitive Sciences LLC	Vol #:	180

LET 20652	NBTY	Vol #:	180

LET 20653	NBTY	Vol #:	180

LET 20654	NBTY	Vol #:	180

LET 20655	NBTY	Vol #:	180

LET 20656	NBTY	Vol #:	180

LET 20657	NBTY	Vol #:	180

LET 20658	NBTY	Vol #:	180

LET 20659	NBTY	Vol #:	180

LET 20660	NBTY	Vol #:	180

LET 20661	MOLEAC	Vol #:	180



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

LET 945	FDA/CSFAN to Wellness International Network, Ltd	Vol #:	28

LET 946	FDA/CFSAN to Hansen Beverage Company	Vol #:	28

LET 947	FDA/CFSAN to Microgravity Enterprises, Inc.	Vol #:	28

LET 948	FDA/CFSAN to University Lab Technologies	Vol #:	28

LET 949	FDA/CFSAN to Konsyl Phatmaceuticals, Inc.	Vol #:	28

LET 950	FDA/CFSAN to Technical Marketing Manager	Vol #:	28

LET 951	FDA/CFSAN to Herbal Extract Company of North America	Vol #:	28

LET 952	FDA/CFSAN to Cardiac Wellness Supplements	Vol #:	28

1998N-0359	Program priorities/Center for Food Safety & Applied Nutrition

EC 406	American Frozen Food Institute	Vol #:	12

2003D-0044	Reporting Results for Studies Evaluating Diagnostic Tests

EC 7	Miracle 2 Soaps	Vol #:	1

2003P-0409	Reclassification for Moblie Bearing Knees from Class III and Class II

LET 1	FDA/CDRH to Orthopedic Surgicla Manufacturers Association (OSMA)	Vol #:	6

2004N-0226	Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010

EC 27	Mrs. Vonda Clerke	Vol #:	1

EC 28	Mr. Luis Perez	Vol #:	1

EC 29	Dr. Sara Stebbins	Vol #:	1

2004N-0382	Food Labeling: Safe Handling Statements: Labeling of Shell Eggs

NFR 1	FDA	Vol #:	1

2005D-0112	Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics

EC 44	Miss. karen kistler	Vol #:	1

2005N-0272	Irradiation in the Production, Processing & Handling of Food

C 3746	David Peters	Vol #:	61

2005P-0411	Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

C 18335	G. McKillop	Vol #:	198

2006F-0059	Safe Use of Polydextrose as a Bulking Agent, Formulation Aid, Humectant and Texturizer in All Foods, except Meat and Poultry (FAP 6A4763)

BKG 2	Background Material	Vol #:	1

EA 2	Environmental Assessment	Vol #:	1

FONS 1	Finding of No Significant Impact	Vol #:	1



NFR 1	FDA	Vol #:	1

2006N-0104	Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format



EC 7	Imgenex.corp	Vol #:	1

2006N-0238	Debarment of Maria Anne Kirkman Campbell

LET 5	FDA to Maria Anne Kirkman Campbell, M.D.	Vol #:	1

2006N-0454	Use of Ozone-Depleting Substances; Removal of Essential-Use Designations

C 1246	N. Rexford	Vol #:	15

C 1247	K. Wells	Vol #:	15

C 1248	P. Gandolfi	Vol #:	15

C 1249	G. Sharpless	Vol #:	15

C 1250	R. Compton	Vol #:	15

C 1251	J. Meadows	Vol #:	15

C 1252	S. Parker	Vol #:	15

C 1253	J Kline	Vol #:	15

C 1254	R. Jones	Vol #:	15

C 1255	H. Frye	Vol #:	15

C 1256	R. Gillespie	Vol #:	15

C 1257	C Kuppenbender	Vol #:	15

C 1258	J. Mingel	Vol #:	15

C 1259	D. Farough	Vol #:	15

C 1260	J. Williams	Vol #:	15

C 1261	S. Proctor	Vol #:	15

C 1262	K. Evans	Vol #:	15

C 1263	G. Aspenwall	Vol #:	15

C 1264	J Johnson Jr	Vol #:	15

C 1265	B Wright	Vol #:	15

C 1266	G Hackett	Vol #:	15

C 1267	M LaFluer	Vol #:	15

C 1268	A Redmond	Vol #:	15

C 1269	H. Hancock	Vol #:	15

C 1270	J. Johnson	Vol #:	15

C 1271	D. O'Connell	Vol #:	15

C 1272	C. Bowers	Vol #:	15

C 1273	E. DeFaleo	Vol #:	15



C 1274	R. Szada	Vol #:	15

C 1275	B. Groh	Vol #:	15

C 1276	P. Porath	Vol #:	15

C 1277	M. Vandenberg	Vol #:	15

C 1278	F. Tedrick	Vol #:	15

C 1279	J. Menga	Vol #:	15

C 1280	D. Goodin	Vol #:	15

C 1281	M. Sauvveur	Vol #:	15

C 1282	B. Haywood	Vol #:	15

C 1283	H. Van Horn	Vol #:	15

C 1284	J. Hartwell	Vol #:	15

C 1285	D Dixon	Vol #:	15

C 1286	J. Nunez	Vol #:	15

C 1287	B Mills	Vol #:	15

C 1288	J. Reynolds	Vol #:	15

C 1289	M. Meyer	Vol #:	15

C 1290	R. Smith	Vol #:	15

C 1291	J O'Brien	Vol #:	15

C 1292	J Salva	Vol #:	15

C 1293	G. Vayles	Vol #:	15

C 1294	G. Pike	Vol #:	15

C 1295	M. O'Connor	Vol #:	15

C 1296	C. Smith	Vol #:	15

C 1297	M. Hagle	Vol #:	15

C 1298	E Peet	Vol #:	15

C 1299	H. Warren	Vol #:	15

C 1300	E. Butcher	Vol #:	15

C 1301	D Wilkerson	Vol #:	15

C 1302	M Tomerlin	Vol #:	15

C 1303	K. Hill	Vol #:	15

C 1304	C Walker	Vol #:	15

C 1305	P Hobart	Vol #:	15

C 1306	D Barough	Vol #:	15

C 1307	C. Smole	Vol #:	15

C 1308	N. Gilmore	Vol #:	15

C 1309	R Lepczyk	Vol #:	15

C 1310	D. McKamie	Vol #:	15



C 1311	G Sherman	Vol #:	15

C 1312	T Lewis	Vol #:	15

C 1313	S Ramos	Vol #:	15

C 1314	J Morgan	Vol #:	15

C 1315	W Head	Vol #:	15

C 1316	S Harrison	Vol #:	15

C 1317	J Kanoff	Vol #:	15

C 1318	P Vella	Vol #:	15

C 1319	A Landis Jr	Vol #:	15

C 1320	J Colon	Vol #:	15

C 1321	G. Powell	Vol #:	15

C 1322	E Kroah	Vol #:	15

C 1323	W Oestrick	Vol #:	15

C 1324	A. Basler	Vol #:	15

C 1325	M. Lange	Vol #:	1

C 1326	G. McLees	Vol #:	15

C 1327	T Copeland	Vol #:	15

C 1328	F Palumbo	Vol #:	15

C 1329	J Sarsfield	Vol #:	15

C 1330	C Kelley	Vol #:	15

C 1331	C DeFusco	Vol #:	15

C 1332	M. Connors	Vol #:	15

C 1333	E Altman	Vol #:	15

C 1334	R Reese	Vol #:	15

C 1335	V Sonon	Vol #:	15

C 1336	D Pester	Vol #:	15

C 1337	D Spittgerber	Vol #:	15

C 1338	H Sanger	Vol #:	15

C 1339	W. Gerst	Vol #:	15

C 1340	F Berttand	Vol #:	15

C 1341	C. Fulton	Vol #:	15

C 1342	B Snodgress	Vol #:	15

C 1343	L Maddox	Vol #:	15

C 1344	E Schmitt	Vol #:	15

C 1345	S. Copeland	Vol #:	15

C 1346	J Lane	Vol #:	15

C 1347	R Estes	Vol #:	15



C 1348	B Davidson	Vol #:	15

C 1349	M. Burton	Vol #:	15

C 1350	A Wieland	Vol #:	15

C 1351	M Turner	Vol #:	15

C 1352	H McGuire	Vol #:	15

C 1353	E Watson	Vol #:	15

C 1354	V Mitchell	Vol #:	15

C 1355	B Short	Vol #:	15

C 1356	N Wood	Vol #:	15

C 1357	B Mikton	Vol #:	15

C 1358	L Huff	Vol #:	15

C 1359	E Gilbertson	Vol #:	15

C 1360	V. Plantico	Vol #:	15

EC 28	Mrs. Deborah Singleton	Vol #:	16

EC 29	none	Vol #:	16

EC 30	None	Vol #:	16

EC 31	Ms. Nancy Spuhler	Vol #:	16

EC 32	Mrs. Kathryn West	Vol #:	16

EC 33	Ms. carol swindell	Vol #:	16

EC 34	Mrs. lois brachman	Vol #:	16

2006P-0281	Determination of Orudis KT (ketoprofen, 12.5 mg) Oral Tablet

LET 2	FDA/CDER to Camargo Pharmaceutical Services, LLC	Vol #:	1

2006P-0379	To urge the FDA's prompt action to cancel the GRAS desgnation for diacetyl

LET 2	NATIONAL JEWISH Medical and Research Center	Vol #:	2

2006P-0505	ANDA for Ursodial Capsules USP, 100 mg 200 mg, and 400 mg

AMD 1	Lachman Consultant Services, Inc.	Vol #:	1

2007D-0125	Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims

EC 1892	Mrs. Lisa Walker	Vol #:	5

EC 1893	Mr. john kropp	Vol #:	5

EC 1894	Mrs. Viviane Paolini	Vol #:	5

EC 1895	Ms. jacqueline wurn	Vol #:	5

EC 1896	Mrs. Donna Spears	Vol #:	5

EC 1897	Mr. Douglas Smith	Vol #:	5

EC 1898	Ms. Lisa Whalen	Vol #:	5



EC 1899	Mr. Sean McKenna	Vol #:	5

EC 1900	Mr. Benjamin Hestley	Vol #:	5

EC 1901	Ms. Evelyn Harvey	Vol #:	5

EC 1902	Mr. William Hillier	Vol #:	5

EC 1903	Mr. Gary Radman	Vol #:	5

EC 1904	Ms. Brenda Varrasso	Vol #:	5

EC 1905	New Era Health LLC	Vol #:	5

EC 1906	Miss. Jill Murphy	Vol #:	5

EC 1907	Mr. W. Clement	Vol #:	5

EC 1908	Ms. Gillian Drake	Vol #:	5

EC 1909	Mr. William Shelton	Vol #:	5

EC 1910	Mr. Hugh Howard	Vol #:	5

EC 1911	Ms. Filomena Concia	Vol #:	5

EC 1912	Mr. Ryan Carson	Vol #:	5

EC 1913	Ms. Ginger Corbett	Vol #:	5

EC 1914	Mr. John Grisaffi	Vol #:	5

EC 1915	Jacobi Group Ltd.	Vol #:	5

EC 1916	Ms. Kathleen Martin	Vol #:	5

EC 1917	Ms. Cynthia Frey	Vol #:	5

EC 1918	Ms. Christina Howle	Vol #:	5

EC 1919	Mrs. Connie Helms	Vol #:	5

EC 1920	Mrs. Suzanne Schmidt	Vol #:	5

EC 1921	Mrs. Ann Garcia	Vol #:	5

EC 1922	None	Vol #:	5

EC 1923	Mr. Mark Romano	Vol #:	5

EC 1924	Quantum Injury	Vol #:	5

EC 1925	Ms. Sherry Sullivan	Vol #:	5

EC 1926	Ms. C J Anderson	Vol #:	5

EC 1927	Mr. Albert Glover	Vol #:	5

EC 1928	Mrs. Frances Merriott	Vol #:	5

EC 1929	Ms. Karen Caldwell	Vol #:	5

EC 1930	Ms. Faith Pardue	Vol #:	5

EC 1931	Ms. Mars Wall	Vol #:	5

EC 1932	Ms. Ruth Mills	Vol #:	5

EC 1933	Mr. Beverley Tierney	Vol #:	5

EC 1934	Health Freedom Alliance	Vol #:	5

EC 1935	Mr. Eddie Braun	Vol #:	5



EC 1936	Mrs. Barbara Boyden	Vol #:	5

EC 1937	Ms. Marie Green	Vol #:	5

EC 1938	Essex Bay Photography	Vol #:	5

EC 1939	Mr. Donald gage	Vol #:	5

EC 1940	Mrs. s berdan	Vol #:	5

EC 1941	Ms. Nancy Armstrong	Vol #:	5

EC 1942	Miss. Sara DRISCOLL	Vol #:	5

EC 1943	Mr. Patrick Rowe	Vol #:	5

EC 1944	Mrs. Sharon Ratzlaff	Vol #:	5

EC 1945	Mrs. Sue Carroll	Vol #:	5

EC 1946	Dr. Debra Tranberg	Vol #:	5

EC 1947	Dr. Jeremy Kaslow	Vol #:	5

EC 1948	Mrs. Dorothy Hall	Vol #:	5

EC 1949	FDA	Vol #:	5

EC 1950	Mr. alan mesher	Vol #:	5

EC 1951	Ms. brittney kecxon	Vol #:	5

EC 1952	Mr. Michael Young	Vol #:	5

EC 1953	Ms. Karen Traber	Vol #:	5

EC 1954	Miss. sesame fowler	Vol #:	5

EC 1955	Dr. Joshi Franks	Vol #:	5

EC 1956	Distributor of Nutritional Supplements	Vol #:	5

EC 1957	Mrs. Mary Hunter	Vol #:	5

EC 1958	Ms. Nancy Hesse	Vol #:	5

EC 1959	Mr. Ted Harrison	Vol #:	5

EC 1960	Ms. Diana Whery	Vol #:	5

EC 1961	Living Water Wellness	Vol #:	5

EC 1962	Ms. Dorothy Vadnais	Vol #:	5

EC 1963	Ms. Paula Weisman	Vol #:	5

EC 1964	Ms. Eleanor Hayes	Vol #:	5

EC 1965	Ms. Theresa DiTullio	Vol #:	5

EC 1966	Mrs. Cinda Kavurt	Vol #:	5

EC 1967	Mr. David Optekar	Vol #:	5

EC 1968	Mrs. Eleanor Smith	Vol #:	5

EC 1969	Mr. Aaron Thomas	Vol #:	5

EC 1970	None	Vol #:	5

EC 1971	Ms. Diana Gillis	Vol #:	5

EC 1972	Mrs. Julie Bennett	Vol #:	5



EC 1973	Ms. Linda Broadhead	Vol #:	5

EC 1974	Mr. Francisco Becerra	Vol #:	5

EC 1975	Ms. Andrea Peterson	Vol #:	5

EC 1976	Mr. Arthur Hoover	Vol #:	5

EC 1977	Mr. michael regis	Vol #:	5

EC 1978	Miss. Carolyn Pontikas	Vol #:	5

EC 1979	Ms. Pearlann Singleton	Vol #:	5

EC 1980	Mr. Barry Laub	Vol #:	5

EC 1981	Miss. karen kistler	Vol #:	5

EC 1982	Mr. John Moffitt	Vol #:	5

EC 1983	Miss. karen kistler	Vol #:	5

EC 1984	Mrs. Loretta Browning	Vol #:	5

EC 1985	RN	Vol #:	5

EC 1986	Mr. Jeff Allen	Vol #:	5

EC 1987	Ms. Helen Preston	Vol #:	5

EC 1988	Mr. William Stoner	Vol #:	5

EC 1989	Mrs. Alene Lindstrand	Vol #:	5

EC 1990	Ms. Julie Halpin	Vol #:	5

EC 1991	Mr. Bradley Collins	Vol #:	5

EC 1992	Mr. Buzz Marcus	Vol #:	5

EC 1993	Mrs. Yvette Diaz	Vol #:	5

EC 1994	Mr. david Flynn	Vol #:	5

EC 1995	Ms. Rose M. Berkowitz	Vol #:	5

EC 1996	member of health FreedomFoundation	Vol #:	5

EC 1997	Mr. robert rosenfield	Vol #:	5

EC 1998	Ms. Margaret Stocking	Vol #:	5

EC 1999	Mrs. Deborah La Place	Vol #:	5

EC 2000	Dr. Ken Knott	Vol #:	5

EC 2001	Mr. mario castaldini	Vol #:	5

EC 2002	Mr. mario castaldini	Vol #:	5

EC 2003	Dr. Rick Kirschner	Vol #:	5

EC 2004	Mr. David George	Vol #:	5

EC 2005	Health Freedom Action	Vol #:	5

EC 2006	Health Freedom Action	Vol #:	5

EC 2007	Ms. Barbara Roberts	Vol #:	5

EC 2008	Mr. Brian Fraser	Vol #:	5

EC 2009	Ms. Marianne Sonntag	Vol #:	5



EC 2010	American	Vol #:	5

EC 2011	Mr. James Asmus	Vol #:	5

EC 2012	Mrs. Lori Asmus	Vol #:	5

EC 2013	Mr. Ken Galitello	Vol #:	5

EC 2014	Ms. Claire Libby	Vol #:	5

EC 2015	Mrs. Tammy Gardner	Vol #:	5

EC 2016	Ms. Barbara Elmore	Vol #:	5

EC 2017	Mrs. Peggy Kilgore	Vol #:	5

EC 2018	Ms. Genette Henderson	Vol #:	5

EC 2019	Ms. Lucille Gordon	Vol #:	5

EC 2020	Dr. Peggy Miller	Vol #:	5

EC 2021	Mrs. Lorene Marchioli	Vol #:	5

EC 2022	Miss. GerneyLee Carter	Vol #:	5

EC 2023	Mrs. June McElroy	Vol #:	5

EC 2024	Ms. Peneloope Jank	Vol #:	5

EC 2025	Mrs. Karen Smith	Vol #:	5

EC 2026	Mr. ken bueller	Vol #:	5

EC 2027	Ms. Julee Tappero	Vol #:	5

EC 2028	Dr. Kristine Taylor	Vol #:	5

EC 2029	Mrs. corrina carfizzi	Vol #:	5

EC 2030	Mr. Peter Glickman	Vol #:	5

EC 2031	Mr. Paul Roberts	Vol #:	5

EC 2032	Mr. joe storc	Vol #:	5

EC 2033	Mrs. Edythe Shaw	Vol #:	5

EC 2034	Ms. Nicole Green	Vol #:	5

EC 2035	Mr. Roger Effa	Vol #:	5

EC 2036	Miss. Patricia Furness	Vol #:	5

EC 2037	Bauman College	Vol #:	5

EC 2038	Ms. Christine Lewis	Vol #:	5

EC 2039	Mrs. Harriett Campbell	Vol #:	5

EC 2040	Mrs. Judith Martz	Vol #:	5

EC 2041	Fordham University	Vol #:	5

EC 2042	Ms. Lauri Pratt	Vol #:	5

EC 2043	Mrs. Elizabeth Zarzycki	Vol #:	5

EC 2044	Mrs. Patricia Lammers	Vol #:	5

EC 2045	Ms. Kathy Hutchins	Vol #:	5

EC 2046	Mrs. joyce baker	Vol #:	5



EC 2047	Ms. Tina Brown	Vol #:	5

EC 2048	Ms. Virginia Shaknis	Vol #:	5

EC 2049	Ms. Christine Allsup	Vol #:	5

EC 2050	Mrs. Linda Phillips	Vol #:	5

EC 2051	Arbonne International	Vol #:	5

EC 2052	Mrs. JOAN FAVORITE	Vol #:	5

EC 2053	Mrs. Sarah Yao	Vol #:	5

EC 2054	Daniel O'Connnor, Nuticeutical Consultant	Vol #:	5

EC 2055	Ms. Victoria Morton	Vol #:	5

EC 2056	Ms. Nancy Peregrine NC	Vol #:	5

EC 2057	Mrs. Christa Barnickel	Vol #:	5

EC 2058	Mr. Peter Goodwin	Vol #:	5

EC 2059	Ms. Diane K. Watson	Vol #:	5

EC 2060	Mrs. J.G. Punga	Vol #:	5

EC 2061	Mr. James F Smith	Vol #:	5

EC 2062	Ms. Catherine Greene	Vol #:	5

EC 2063	Ms. Catherine Greene	Vol #:	5

EC 2064	Ms. Mary Gonnella	Vol #:	5

EC 2065	Bauman College	Vol #:	5

EC 2066	Ms. Laura Braggiotti	Vol #:	5

EC 2067	Ms. Bevel Somotun	Vol #:	5

EC 2068	Ms. LOUISE GILMAN	Vol #:	5

EC 2069	Mr. EDWARD ANDERSON	Vol #:	5

EC 2070	Mr. William Gist	Vol #:	5

EC 2071	Ms. Andrea Freeman	Vol #:	5

EC 2072	Mrs. Twila Rawson	Vol #:	5

EC 2073	Ms. Ann Capotosto	Vol #:	5

EC 2074	Miss. Jacqueline Mornan	Vol #:	5

EC 2075	Ms. Lynn Ravazzini	Vol #:	5

EC 2076	Mrs. JoEllen DeNicola	Vol #:	5

EC 2077	Mrs. Lilly Nozinski	Vol #:	5

EC 2078	Mrs. Marsha Kidd	Vol #:	5

EC 2079	Mrs. Susan Weems	Vol #:	5

EC 2080	Mr. Donald Carey-Shaw	Vol #:	5

EC 2081	Mr. Vincent J. Young	Vol #:	5

EC 2082	Mr. Brent Harshberger	Vol #:	5

EC 2083	Ms. Ina Brennan	Vol #:	5



EC 2084	Ms. Carol Lutra-Johns	Vol #:	5

EC 2085	Ms. Victoria Dickinson	Vol #:	5

EC 2086	Ms. aLISA Battaglia	Vol #:	5

EC 2087	Ms. N Schulz	Vol #:	5

EC 2088	Mrs. Pamela Wellborn	Vol #:	5

EC 2089	Ms. Ellen Amba Caldwell	Vol #:	5

EC 2090	Ms. Sue Acer	Vol #:	5

EC 2091	Mr. Rod Peirson	Vol #:	5

EC 2092	Ms. Linda K	Vol #:	5

EC 2093	Mrs. M Wood	Vol #:	5

EC 2094	Mr. Richard Johnson	Vol #:	5

EC 2095	Mr. Bruce Gardner	Vol #:	5

EC 2096	Mr. William Hedal	Vol #:	5

EC 2097	Ms. Bea Workman	Vol #:	5

2007D-0168	Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations

LET 1	Natco Pharma Limited	Vol #:	1

2007D-0173	Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators

C 6	PhRMA	Vol #:	1

2007N-0236	Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Applications and Supporting Regulations, and Form FDA 356V

EC 1	Mrs. Janice Carey	Vol #:	1

2007N-0264	Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule

EREG 1	Y.Yogi	Vol #:	1

2007N-0317	Agency Information Collection Activities; Proposed Collection; Comment Request, Guidance for Industry on Pharmacogenomic Data Submissions; Extension

N 1	FDA	Vol #:	1

2007P-0065	To increase print size of direct-to-consumer advertisements

LET 2	FDA/CDER to Pharmacists Planning Service, Inc.	Vol #:	1

2007V-0222	Projector for a Laser Light Show

VRA 1	FDA/CDRH to Tempest International LLC	Vol #:	1

Page created on August 21, 2007 ue

FDA/Dockets Management