Dockets Entered on January 11, 2007

Dockets Management



Dockets Entered On January 11, 2007



Docket #	Title

1978N-0065	Skin Bleaching Drug Products

1999F-5522	Ionizing radiation /control of Food-borne pathogens safe use

2001E-0365	Patent Term Extension Application, NEXIUM 4,738,974

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

2003N-0573	Draft Animal Cloning Risk Assessment

2004E-0011	Patent Term Extention of U.S. patent No. 5,198,533 for Cetrotide (cetrorelix acetate)

2004E-0393	Patent Extension for Uroxatral (Alfuzosin hydrochloride), U.S. Patent No. 4,661,491

2004E-0396	Patent Extension for TAXUS EXPRESS (Paclitaxel-Eluting Coronary Stent System)

2004E-0413	Patent Term Extension for CIALIS (tadalafil), U.S. Patent No. 5,859, 006

2004P-0464	Vitamin D & Calcium & Reduced Risk of Osteoporosis

2005N-0373	Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants

2005P-0384	Deficient Peripheral Metabolism of Thyroxine to Triiodothyronine

2006D-0463	Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability

2006E-0025	Patent Extension Application for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent No. 5,681,814

2006E-0040	Patent Extension Application for ROZEREM (ramelteon), U.S. Patent No. 6,034,239

2006E-0042	Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243

2006E-0043	Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,529,990

2006N-0493	International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization Scheduling Recommendations for Dronabinol (INN) and its Stereoisome

2006N-0517	Medical Devices; Immunology and Microbiology Devices; Classification of Quality Control Material for Cystic Fibrosis Nucleic Acid Assays

2006P-0271	Amend practice of assessing the performance of medical devices for determining in vitro susceptibility of bacteria or fungi to included CLSI.

2006P-0394	Revise the labeling requirements for eggs sold in the United States

2006P-0415	Petition Seeking Regulation of Cloned Animals

2006P-0535	Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products

2007N-0005	Prescription Drug User Fee Act (PDUFA): Public Meeting

1978N-0065	Skin Bleaching Drug Products

C 78	M. Wallis, MD	Vol #:	20

1999F-5522	Ionizing radiation /control of Food-borne pathogens safe use

C 99	Gray Star, Inc.	Vol #:	10

2001E-0365	Patent Term Extension Application, NEXIUM 4,738,974

LET 6	FDA/CDRH to Budd Larner, P.C.	Vol #:	1

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

C 1404	M. Czech	Vol #:	262

2003N-0573	Draft Animal Cloning Risk Assessment



C 33	S. Cull	Vol #:	9

C 34	Law Offices of Theodore W. Robinson	Vol #:	9

C 35	M. Robinson	Vol #:	9

C 36	A. Flores	Vol #:	9

C 37	S. Szanderek	Vol #:	9

C 38	D. Littleton	Vol #:	9

C 39	Dr. J Wilson	Vol #:	9

C 40	A. Donajkowski	Vol #:	9

C 41	K. Kimmel	Vol #:	9

C 42	N. Vehar	Vol #:	9

C 43	L. MArie	Vol #:	9

C 44	D. Savre	Vol #:	9

C 45	R. Crosley et al	Vol #:	9

C 46	S. Duerkop	Vol #:	9

C 47	No signature	Vol #:	9

C 48	K. Caldwell	Vol #:	9

C 49	S. Sheppard	Vol #:	9

C 50	A. Brown	Vol #:	9

C 51	Form Letters	Vol #:	12

C 52	G. McMillen	Vol #:	9

C 53	Form letters	Vol #:	13

C 54	Form letters	Vol #:	14

EC 2137	Mrs. Iena Robinson	Vol #:	10

EC 2138	Mr. Lonnie Kelley	Vol #:	10

EC 2139	Mr. Gregory Marlow	Vol #:	10

EC 2140	Mrs. christina dabbraccio	Vol #:	10

EC 2141	Ms. Stephanie Richter	Vol #:	10

EC 2142	Mr. gabriel perkins	Vol #:	10

EC 2143	Ms. Patty Nolan	Vol #:	10

EC 2144	Mr. Patrick Trimble	Vol #:	10

EC 2145	Mrs. Janelle O'Rourke	Vol #:	10

EC 2146	Mrs. Judy Burnley	Vol #:	10

EC 2147	Mr. Zack Covell	Vol #:	10

EC 2148	Mr. Jon Giaimo	Vol #:	10

EC 2149	WeAreAllGreen.com	Vol #:	10

EC 2150	Ms. Jessica Basile	Vol #:	10

EC 2151	Mr. Donald Mosbrucker	Vol #:	10



EC 2152	Mr. Jason Pelszynski	Vol #:	10

EC 2153	Mrs. Joanna Peterson	Vol #:	10

EC 2154	Ms. Lydia Medici	Vol #:	10

EC 2155	Ms. Ellen Diamond	Vol #:	10

EC 2156	Mr. Ray Armstrong	Vol #:	10

EC 2157	Mr. Clay Woodruff	Vol #:	10

EC 2158	Mrs. Heidi Wise	Vol #:	10

EC 2159	Ms. adeladie basped	Vol #:	10

EC 2160	Mrs. pam snell	Vol #:	10

EC 2161	Mr. Aviv Cohn	Vol #:	10

EC 2162	Ms. FloAnn Beaver	Vol #:	10

EC 2163	Mr. Toby Schwartz Schwartz	Vol #:	10

EC 2164	Mr. Gerald Layne	Vol #:	10

EC 2165	Mrs. Pamela Shields	Vol #:	10

EC 2166	Mr. John Pierce	Vol #:	10

EC 2167	Mrs. celeste hollingsead	Vol #:	10

EC 2168	Mrs. Angela Boicheff	Vol #:	10

EC 2169	Ms. S Fron	Vol #:	10

EC 2170	Mr. Adeolu Adejokun	Vol #:	10

EC 2171	Mrs. Robin Cabaniss	Vol #:	10

EC 2172	Mr. Ken Danis	Vol #:	10

EC 2173	Miss. Bianca Sams	Vol #:	10

EC 2174	Mrs. Diana Howard	Vol #:	10

EC 2175	Mr. Robert Nicoson	Vol #:	10

EC 2176	Mrs. Amy McAbeer	Vol #:	10

EC 2177	Ms. Julie Euseppi	Vol #:	10

EC 2178	Mr. Evan Sforza	Vol #:	10

EC 2179	Mr. Matteo Paris	Vol #:	10

EC 2180	Mrs. Richard Hollingsead	Vol #:	10

EC 2181	Mr. Daniel Garcia	Vol #:	10

EC 2182	Mr. Jay Smith	Vol #:	10

EC 2183	Mr. greg Hervey	Vol #:	10

EC 2184	Mr. Andrew Goodman	Vol #:	10

EC 2185	Mr. thomas matera	Vol #:	10

EC 2186	Ms. Susan Smith	Vol #:	10

EC 2187	Ms. Carol Black	Vol #:	10

EC 2188	Mr. Lewis Schwartz	Vol #:	10



EC 2189	Mrs. Kylene Grell	Vol #:	10

EC 2190	Mr. D REYNOLDS	Vol #:	10

EC 2191	Mr. Mark Johnson	Vol #:	10

EC 2192	Mr. Timothy Edwards	Vol #:	10

EC 2193	Mr. Damen Jackson	Vol #:	10

EC 2194	Ms. Joan M. Konold	Vol #:	10

EC 2195	Mrs. Beverly Gardner	Vol #:	10

EC 2196	Mrs. Carol Haden	Vol #:	10

EC 2197	Ms. Jessica Keyes	Vol #:	10

EC 2198	Mr. David Schalliol	Vol #:	10

EC 2199	Miss. Mary Jones	Vol #:	10

EC 2200	Mrs. Whitney DeCillis	Vol #:	10

EC 2201	University of Maine	Vol #:	10

EC 2202	Mr. Court Lewis	Vol #:	10

EC 2203	Mr. Michael Czaplewski	Vol #:	10

EC 2204	Mr. Toral Kale	Vol #:	10

EC 2205	Mrs. Gina Fields	Vol #:	10

EC 2206	Well-Path	Vol #:	10

EC 2207	Mrs. Brittany King	Vol #:	10

EC 2208	Mr. BILL HITCHCOCK	Vol #:	10

EC 2209	Miss. Samantha Grant	Vol #:	10

EC 2210	Mr. Jakob Wettman	Vol #:	10

EC 2211	Mrs. Debbie McClure	Vol #:	10

EC 2212	Mrs. Patricia Fulton	Vol #:	10

EC 2213	Mrs. natalie lawrie	Vol #:	10

EC 2214	Ms. Molly Desrosiers	Vol #:	10

EC 2215	Mr. Bill Grady	Vol #:	10

EC 2216	Ms. Beverly Saul	Vol #:	10

EC 2217	Mrs. Wendy Shipman	Vol #:	10

EC 2218	Mr. John H Jones.Jr	Vol #:	10

EC 2219	Mrs. Heather Valero	Vol #:	10

EC 2220	Mrs. Janet Reisdorff	Vol #:	10

EC 2221	Ms. Donna Dugan	Vol #:	10

EC 2222	Mrs. Rebecca Lewis	Vol #:	10

EC 2223	Mrs. Barbara Roy	Vol #:	10

EC 2224	Ms. L. Baker	Vol #:	10

EC 2225	Ms. Sara Palmer	Vol #:	10



EC 2226	Miss. Christina Ciotola	Vol #:	10

EC 2227	Miss. Christina Ciotola	Vol #:	10

EC 2228	N/A	Vol #:	10

EC 2229	Mrs. cindi dishron	Vol #:	10

EC 2230	N/A	Vol #:	10

EC 2231	Mr. Josh Miller	Vol #:	10

EC 2232	Miss. Dana Chi	Vol #:	10

EC 2233	Mrs. Corinna Seelmann	Vol #:	10

EC 2234	Ms. Jacqueline Zielenski	Vol #:	10

EC 2235	Mrs. stacy carney	Vol #:	10

EC 2236	Ms. Laura Steiermann	Vol #:	10

EC 2237	Mr. Andrew Perkins	Vol #:	10

EC 2238	Ms. Raven Athene	Vol #:	10

EC 2239	Mr. Gregory Lester	Vol #:	10

EC 2240	Ms. Erin McLaughlin	Vol #:	10

EC 2241	Mr. Matthew Nansel	Vol #:	10

EC 2242	Mr. Vincent Wu	Vol #:	10

EC 2243	Miss. Cynthia Armenta	Vol #:	10

EC 2244	Mr. E. Smith	Vol #:	10

EC 2245	Blair Communications	Vol #:	10

EC 2246	Mr. Bert Blair	Vol #:	10

EC 2247	Mrs. Monique Williams Little	Vol #:	10

EC 2248	Ms. Lisa Wargo	Vol #:	10

EC 2249	Mrs. Jessica Kaplan	Vol #:	10

EC 2250	Ms. Melody Burgess	Vol #:	10

EC 2251	Ms. Josie Bonskowski	Vol #:	10

EC 2252	Mrs. Christina Normand	Vol #:	10

EC 2253	Mr. Joel Kingery	Vol #:	10

EC 2254	Mrs. Shiloh Turner	Vol #:	10

EC 2255	Mrs. Ruth Schulte	Vol #:	10

EC 2256	Miss. anne WETTMAN	Vol #:	10

EC 2257	Ms. Jo Ann Cardwell	Vol #:	10

EC 2258	Ms. Paige Delbridge	Vol #:	10

EC 2259	Mr. Edward Ruiz	Vol #:	10

EC 2260	Dr. Sandy Hunter	Vol #:	10

EC 2261	Mrs. Donna Niles	Vol #:	10

EC 2262	Mr. B Dershaw	Vol #:	10



EC 2263	Mrs. Romey Ritter	Vol #:	10

EC 2264	Ms. Laurie Mangum	Vol #:	10

EC 2265	Ms. Ralph Panaro	Vol #:	10

EC 2266	Miss. Jacqueline Shardo	Vol #:	10

EC 2267	Ms. Patricia A Rogers	Vol #:	10

EC 2268	Mr. Jeffrey Irving	Vol #:	10

EC 2269	Ms. Emily Marcinko	Vol #:	10

EC 2270	Mrs. Theresa Rogelstad	Vol #:	10

EC 2271	Ms. Lynn Thomas	Vol #:	10

EC 2272	Mrs. Mary Whitehead	Vol #:	10

EC 2273	Mrs. jill bozarth	Vol #:	10

EC 2274	Ms. Jean McKelvey	Vol #:	10

EC 2275	Mr. John Reilly	Vol #:	10

EC 2276	Ms. Molly Hesson	Vol #:	10

EC 2277	Home	Vol #:	10

EC 2278	Ms. Lisa Algarin	Vol #:	10

EC 2279	Miss. Katie Johnson	Vol #:	10

EC 2280	Mr. Mike Kinney	Vol #:	10

EC 2281	Miss. Tracey Sheffer	Vol #:	10

EC 2282	Mrs. Elizabeth Cantrell	Vol #:	10

EC 2283	Ms. Patricia Dorfman	Vol #:	10

EC 2284	Mrs. Jessica Sweeney	Vol #:	10

EC 2285	Mrs. Carole Allen	Vol #:	10

EC 2286	Ms. blythe Blue	Vol #:	10

EC 2287	Ms. Barbara Stickle	Vol #:	10

EC 2288	Mr. Thomas Williams	Vol #:	10

EC 2289	Ms. Carol Plante	Vol #:	10

EC 2290	Mrs. Amber Muller	Vol #:	10

EC 2291	Mrs. JAMIE CARPENTER	Vol #:	10

EC 2292	Mrs. Betty Hudson	Vol #:	10

EC 2293	Ms. Kate Holohan	Vol #:	10

EC 2294	Mrs. Martha DiVincenzo	Vol #:	10

EC 2295	Mrs. Persis Nacks	Vol #:	10

EC 2296	Dr. Linda Stern	Vol #:	10

EC 2297	Ms. Michael Norris	Vol #:	10

EC 2298	Mr. K Buckley	Vol #:	10

EC 2299	Mr. Martin Niles	Vol #:	10



EC 2300	Miss. tracie charles	Vol #:	10

EC 2301	Mr. Greg Esterlund	Vol #:	10

EC 2302	Ms. Bobbie Jones	Vol #:	10

EC 2303	Mrs. Michele lee	Vol #:	10

EC 2304	Mr. Art Hanson	Vol #:	10

EC 2305	Ms. B McClintock	Vol #:	10

EC 2306	Dr. Steven Zabronsky	Vol #:	10

EC 2307	Mrs. Cheryl W Grossman	Vol #:	10

EC 2308	Mrs. Tammy Ryan	Vol #:	10

EC 2309	Mrs. Lissa Bell	Vol #:	10

EC 2310	Ms. Christine Balint	Vol #:	10

EC 2311	The Enright-Down Family	Vol #:	10

EC 2312	Ms. Sasha Sicks	Vol #:	10

EC 2313	Mr. Arran Thomson	Vol #:	10

EC 2314	Miss. courtney lucansky	Vol #:	10

EC 2315	Mr. Jerry Usery	Vol #:	10

EC 2316	Mr. Andrew Cameron	Vol #:	10

EC 2317	Mrs. Linda Hall	Vol #:	10

EC 2318	Miss. Katie Washick	Vol #:	10

EC 2319	Mrs. lucy weatherly	Vol #:	10

EC 2320	Mr. John Adamski	Vol #:	10

EC 2321	Mrs. veranice sanchez	Vol #:	10

EC 2322	Mrs. Dawn Gotha	Vol #:	10

EC 2323	Mr. john pilgrim	Vol #:	10

EC 2324	Mr. Jason Bays	Vol #:	10

EC 2325	Mrs. Nancy Reeves	Vol #:	10

EC 2326	Ms. Kathryn Vitarelli	Vol #:	10

EC 2327	Mrs. Debra Johnson	Vol #:	10

EC 2328	Ms. stephanie saccone	Vol #:	10

EC 2329	Mrs. Debra Siegel-Furlin	Vol #:	10

EC 2330	Ms. Eva Lobel	Vol #:	10

EC 2331	Mr. John McGrath	Vol #:	10

EC 2332	Ms. barbara Meyer	Vol #:	10

EC 2333	self	Vol #:	10

EC 2334	Mr. Morty Newmark	Vol #:	10

EC 2335	Mrs. Joyce Cook	Vol #:	10

EC 2336	Mrs. Melody LeBaron	Vol #:	10



EC 2337	EarthSave International	Vol #:	10

EC 2338	N/a	Vol #:	10

EC 2339	Ms. Tracy Centorbi	Vol #:	10

EC 2340	Mr. Randall Fopma	Vol #:	10

EC 2341	Mrs. Heather Dupuy	Vol #:	10

EC 2342	Mrs. Sarah Johnston	Vol #:	10

EC 2343	Ms. Rose Harkey	Vol #:	10

EC 2344	Mr. C. Alexander Cohen	Vol #:	10

EC 2345	Mr. Ravi Grover	Vol #:	10

EC 2346	Mr. scott anderson	Vol #:	10

EC 2347	Mrs. Sue Garrison	Vol #:	10

EC 2348	Mr. Brian Adams	Vol #:	10

EC 2349	Mrs. Virginia Macey-Schuette	Vol #:	10

EC 2350	Mrs. Holly Willis	Vol #:	10

EC 2351	Ms. Pat Gibson	Vol #:	10

EC 2352	Ms. Judith Poxon	Vol #:	10

EC 2353	Mr. William Daniels	Vol #:	10

EC 2354	Ms. Pam Hembree	Vol #:	10

EC 2355	Ms. Barbara Thueringer	Vol #:	10

EC 2356	Mr. Joshua Eckels	Vol #:	10

EC 2357	Ms. Kimberly Rowlett	Vol #:	10

EC 2358	Mrs. Kay Williams	Vol #:	10

EC 2359	Mrs. Pamela Crawford	Vol #:	10

EC 2360	Mr. Michael Dimas	Vol #:	10

EC 2361	Ms. jennifer hayes	Vol #:	10

EC 2362	consumer and citizen of US	Vol #:	10

EC 2363	Mrs. Pamela Ramey	Vol #:	10

EC 2364	Ms. Melissa Patterson	Vol #:	10

EC 2365	Mrs. Lori Rowley	Vol #:	10

EC 2366	Mrs. Alice Paulsen	Vol #:	10

EC 2367	Ms. deb belcore	Vol #:	10

EC 2368	Ms. F.B. Weldon	Vol #:	10

EC 2369	Mrs. Karen Saggio	Vol #:	10

EC 2370	US CITIZEN	Vol #:	10

EC 2371	Ms. Debra Chapman	Vol #:	10

EC 2372	Mrs. Kyna Mackey	Vol #:	10

EC 2373	Ms. Suzanne Stapler	Vol #:	10



EC 2374	Mrs. Christine Nauman	Vol #:	10

EC 2375	na	Vol #:	10

EC 2376	Mr. John Russo	Vol #:	10

EC 2377	Mrs. L Tatum	Vol #:	10

EC 2378	Mr. Bryan Keeler	Vol #:	10

EC 2379	Ms. JUANITA JOHNSON	Vol #:	10

EC 2380	Dr. Lizette Eckert	Vol #:	10

EC 2381	Mr. Daniel Miller	Vol #:	10

EC 2382	Mr. David Hudson	Vol #:	10

EC 2383	Mrs. Lori Lett	Vol #:	10

EC 2384	Ms. Vicki Holland	Vol #:	10

EC 2385	Ms. Tammy Huffman	Vol #:	10

EC 2386	Mr. Tom Hedgepeth	Vol #:	10

EC 2387	Ms. ursula ceballos	Vol #:	10

EC 2388	Ms. Jeane Bakassoulas	Vol #:	10

EC 2389	Mr. David Bonham	Vol #:	10

EC 2390	Mrs. Maria Lugar	Vol #:	10

EC 2391	Mrs. Elizabeth Hughes	Vol #:	10

EC 2392	Mr. John Jackson	Vol #:	10

EC 2393	Mr. Charles Bailey	Vol #:	10

EC 2394	Mrs. Karen Hill	Vol #:	10

EC 2395	Miss. C Keller	Vol #:	10

EC 2396	Ms. Lynda Thomas	Vol #:	10

EC 2397	none	Vol #:	10

EC 2398	Ms. C Rodwell	Vol #:	10

EC 2399	Mrs. Rebecca Daniel	Vol #:	10

EC 2400	Mrs. Tatanya Winter	Vol #:	10

EC 2401	Mr. William Petschel	Vol #:	10

EC 2402	Mrs. Sharon Wiksten	Vol #:	10

EC 2403	Ms. Belinda Chandler	Vol #:	10

EC 2404	Ms. CJ Downs	Vol #:	10

EC 2405	Mr. John Eddy	Vol #:	10

EC 2406	Mr. Doug White	Vol #:	10

EC 2407	Mr. Brett Sheppard	Vol #:	10

EC 2408	Mr. John Smith	Vol #:	10

EC 2409	Mr. Sid Sattler	Vol #:	10

EC 2410	Ms. Diane Fuchs	Vol #:	10



EC 2411	Ms. Jessica Abeita	Vol #:	10

EC 2412	Ms. Kezia Willingham	Vol #:	10

EC 2413	Ms. Amanda Yonas	Vol #:	10

EC 2414	Ms. Heather Garland	Vol #:	10

EC 2415	Ms. Amy Rosenthal	Vol #:	10

EC 2416	Mrs. Sandra Flannigan	Vol #:	10

EC 2417	Ms. Sara Todd	Vol #:	10

EC 2418	Ms. Charlene Cerridwen	Vol #:	10

EC 2419	Mrs. Maria Kochis	Vol #:	10

EC 2420	Ms. Dottie Glenn	Vol #:	10

EC 2421	Ms. Meredith Wibby	Vol #:	10

EC 2422	Mr. Damian Parr	Vol #:	10

EC 2423	Ms. Ashley McKenzie	Vol #:	10

EC 2424	Mr. Ed Sabo	Vol #:	10

EC 2425	Oak Park Middle School	Vol #:	10

EC 2426	Ms. Elizabeth Basescu	Vol #:	10

EC 2427	Mrs. Maria Pak	Vol #:	10

EC 2428	Mr. walter antin	Vol #:	10

EC 2429	Miss. Mareika Kardum	Vol #:	10

EC 2430	Ms. MarBeth Dunn	Vol #:	10

EC 2431	Mr. Mark Sgaggio	Vol #:	10

EC 2432	Ms. Linda McAllister	Vol #:	10

EC 2433	Ms. jackie schwartz	Vol #:	10

EC 2434	UC Davis	Vol #:	10

EC 2435	Mr. Nicholas O'Neil	Vol #:	10

EC 2436	Ms. Denise Arndt	Vol #:	10

EC 2437	Ms. Laura Mallinak	Vol #:	10

EC 2438	Mr. BENJAMIN RICE	Vol #:	10

EC 2439	Ms. Judith Fisher	Vol #:	10

EC 2440	Ms. ANNA MARIE JACKSON	Vol #:	10

EC 2441	Ms. Joanne Moore	Vol #:	10

EC 2442	Ms. Lorraine McGuinness	Vol #:	10

EC 2443	Ms. lenora pruitt	Vol #:	10

EC 2444	Mrs. N. Tenen	Vol #:	10

EC 2445	Mrs. Theresa Mymo	Vol #:	10

EC 2446	Ms. Sarah Stanwood	Vol #:	10

EC 2447	Mr. Joseph Dishron	Vol #:	10



EC 2448	Mrs. Lisa Clark	Vol #:	10

EC 2449	Mr. johnathan feelgo	Vol #:	10

EC 2450	Miss. Aneesa Shahid	Vol #:	10

EC 2451	Ms. Angela Fishman	Vol #:	10

EC 2452	Ms. Kimberly Dohms	Vol #:	10

EC 2453	Mr. James Jackson	Vol #:	10

EC 2454	Mrs. arkay o'malley	Vol #:	10

EC 2455	Mrs. Cristina Brito	Vol #:	10

EC 2456	Miss. Cindi Hunt	Vol #:	10

EC 2457	Mr. Damion Waltermeyer	Vol #:	10

EC 2458	Miss. Laura Guziak	Vol #:	10

EC 2459	Public Health Nursing	Vol #:	10

EC 2460	Mrs. Christine Castellon	Vol #:	10

EC 2461	Ms. Donna Waugh Campbell	Vol #:	10

EC 2462	Miss. Ejatu Jalloh	Vol #:	10

EC 2463	KASH4	Vol #:	10

EC 2464	Ms. Nata Hurst	Vol #:	10

EC 2465	Mrs. Marcia Jackson	Vol #:	10

EC 2466	Mrs. Beth Orth	Vol #:	10

EC 2467	Mrs. Jan Thomas	Vol #:	10

EC 2468	Mr. James Lemon	Vol #:	10

EC 2469	Mrs. Lisa Clark	Vol #:	10

EC 2470	Ms. Jennifer Moore	Vol #:	10

EC 2471	Mrs. Mary Camara	Vol #:	10

EC 2472	Mr. Matt Richard	Vol #:	10

EC 2473	Miss. Lisa Tilley	Vol #:	10

EC 2474	Mr. John B	Vol #:	10

EC 2475	Mr. Tommie Birge	Vol #:	10

EC 2476	Ms. Carmen Moreno	Vol #:	10

EC 2477	Ms. Breanne Gearheart	Vol #:	10

EC 2478	Mrs. Maureen Hanson	Vol #:	10

EC 2479	Ms. Michelle Jordan	Vol #:	10

EC 2480	Miss. Courtney Puig	Vol #:	10

EC 2481	Mrs. carol tuskan	Vol #:	10

EC 2482	Mr. Nicholas Bruno	Vol #:	10

EC 2483	Ms. Timothy Cockrell	Vol #:	10

EC 2484	Miss. Varsenik Khloyan	Vol #:	10



EC 2485	Miss. Varsenik Khloyan	Vol #:	10

2004E-0011	Patent Term Extention of U.S. patent No. 5,198,533 for Cetrotide (cetrorelix acetate)

LET 4	FDA/CDER to the U.S. Patent and Trademark Office	Vol #:	1

2004E-0393	Patent Extension for Uroxatral (Alfuzosin hydrochloride), U.S. Patent No. 4,661,491

LET 5	FDA/CDER to the U.S. Patent and Trademark Office	Vol #:	1

2004E-0396	Patent Extension for TAXUS EXPRESS (Paclitaxel-Eluting Coronary Stent System)

LET 5	FDA/CDER to the U.S. Patent and Trademark Office	Vol #:	1

2004E-0413	Patent Term Extension for CIALIS (tadalafil), U.S. Patent No. 5,859, 006

LET 5	FDA/CDER to the U.S. Patent and Trademark Office	Vol #:	1

2004P-0464	Vitamin D & Calcium & Reduced Risk of Osteoporosis

EC 3	Mrs. Cheryl White	Vol #:	9

2005N-0373	Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants

BKG 1	Background Material	Vol #:	2

2005P-0384	Deficient Peripheral Metabolism of Thyroxine to Triiodothyronine

SUP 2	E. Pritchard	Vol #:	1

2006D-0463	Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability

C 2	Accentia BioPharmaceuticals	Vol #:	1

2006E-0025	Patent Extension Application for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent No. 5,681,814

LET 5	FDA/CDER to the U.S. Patent and Trademark Office	Vol #:	1

2006E-0040	Patent Extension Application for ROZEREM (ramelteon), U.S. Patent No. 6,034,239

LET 5	FDA/CDER to the U.S. Patent and Trademark Office	Vol #:	1

2006E-0042	Patent Extension Application for CUBICIN (daptomycin for injection), U.S. Patent No. 4,885,243

LET 5	FDA/CDER to U.S. Patent and Trademark Office	Vol #:	1

2006E-0043	Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,529,990

LET 5	FDA/CDER to the U.S. Patent and Trademark Office	Vol #:	1

2006N-0493	International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization Scheduling Recommendations for Dronabinol (INN) and its Stereoisome


EC 1	Echo Pharmaceuticals BV	Vol #:	1

2006N-0517	Medical Devices; Immunology and Microbiology Devices; Classification of Quality Control Material for Cystic Fibrosis Nucleic Acid Assays



BKG 1	Back Ground Information	Vol #:	1

2006P-0271	Amend practice of assessing the performance of medical devices for determining in vitro susceptibility of bacteria or fungi to included CLSI.

C 2	American Society for Microbiology (ASM)	Vol #:	1

LET 1	FDA to Clinical and Laboratory Standards Institute (CLSI)	Vol #:	1

2006P-0394	Revise the labeling requirements for eggs sold in the United States

EC 474	Mr. John Cacka	Vol #:	7

2006P-0415	Petition Seeking Regulation of Cloned Animals

C 27	T. Tyler	Vol #:	5

C 28	J. McDonald	Vol #:	5

C 29	M. Boime	Vol #:	5

C 30	K. Miller, MPH	Vol #:	5

C 31	E. Hunter	Vol #:	5

C 32	M. Troge	Vol #:	5

C 33	Dr. K. Lowey	Vol #:	5

C 34	D. Parsons	Vol #:	5

C 35	J and J Rush	Vol #:	5

C 36	J and W Weich	Vol #:	5

C 37	M. McGowan	Vol #:	5

C 38	C. Schurer	Vol #:	5

C 39	A. Ito	Vol #:	5

C 40	J. Kramer	Vol #:	5

C 41	D. Keyser	Vol #:	5

EC 760	Mr. Sid Lambert	Vol #:	4

EC 761	Mr. Kenneth Duke	Vol #:	4

EC 762	Mrs. Ann-Marie Gunn	Vol #:	4

EC 763	Ms. Leah Targon	Vol #:	4

EC 764	Mr. Ronald Johnson	Vol #:	4

EC 765	Ms. kathleen paulsen	Vol #:	4

EC 766	Mrs. Jennifer Kelly	Vol #:	4

EC 767	Mrs. Margaret Sladek	Vol #:	4

EC 768	Mrs. Jennifer O'Leary	Vol #:	4

EC 769	Mrs. Sheila Shepardson	Vol #:	4

EC 770	Mr. Rodney Davidson	Vol #:	4

EC 771	Mr. Stephen Burgio	Vol #:	4

EC 772	Total Health Solutions	Vol #:	4



EC 773	Mr. John Donahoo	Vol #:	4

EC 774	Mrs. Erin Currin	Vol #:	4

EC 775	Ms. Sue Ann Wales	Vol #:	4

EC 776	Ms. Christine A. Gembica	Vol #:	4

EC 777	Mrs. Brenda Mitchell	Vol #:	4

EC 778	Ms. Twila Nelson	Vol #:	4

EC 779	Mr. Terry Davis	Vol #:	4

EC 780	Mr. Eddie Gonzalez	Vol #:	4

EC 781	Ms. Donna Grant	Vol #:	4

EC 782	Miss. Joanne Hart	Vol #:	4

EC 783	Ms. Joyce Hunter	Vol #:	4

EC 784	None	Vol #:	4

EC 785	Ms. Kimberly Tapio	Vol #:	4

EC 786	Mrs. Collette Jarrett	Vol #:	4

EC 787	Miss. Sheri Elmont	Vol #:	4

EC 788	Mrs. Vicki Olejarczyk	Vol #:	4

EC 789	Ms. Gwendolyn Boozy	Vol #:	4

EC 790	Ms. Kathy Smith	Vol #:	4

EC 791	Miss. Nikki Sherritt	Vol #:	4

EC 792	Mr. John Reinier	Vol #:	4

EC 793	Mrs. Arlene Burnett	Vol #:	4

EC 794	Mr. Brian Knowles	Vol #:	4

EC 795	Ms. Gloria Feldscher	Vol #:	4

EC 796	Mr. Jonathan Damron	Vol #:	4

EC 797	GetHealthyAgain.com	Vol #:	4

EC 798	Mr. jason glackin	Vol #:	4

EC 799	Miss. T Devi	Vol #:	4

EC 800	Mrs. Colleen Haubert	Vol #:	4

EC 801	Mrs. Cheryl White	Vol #:	4

EC 802	Ms. Nancy Manley	Vol #:	4

EC 803	Ms. Elena Bridgman	Vol #:	4

EC 804	Ms. Elizabeth Basescu	Vol #:	4

EC 805	Dr. Patricia Martens Balke	Vol #:	4

EC 806	Dr. Brent Gadberry	Vol #:	4

EC 807	none	Vol #:	4

EC 808	Mrs. Ruth Hershey	Vol #:	4

EC 809	Ms. Linda Sebek-Schlueter	Vol #:	4



EC 810	Mrs. Lsa Kirchner	Vol #:	4

EC 811	Ms. Candace Reed	Vol #:	4

EC 812	Mr. Bennie Gardner	Vol #:	4

EC 813	Ms. Karan Smith	Vol #:	4

EC 814	Ms. Sherie Bohannon	Vol #:	4

EC 815	Miss. Laura Guziak	Vol #:	4

EC 816	Mrs. Trescia Dunn	Vol #:	4

EC 817	Mrs. monica gabler	Vol #:	4

EC 818	Mr. john gabler	Vol #:	4

EC 819	Mr. Matt Richard	Vol #:	4

EC 820	Mrs. Michele Klaus	Vol #:	4

EC 821	Mr. Randy Hunt	Vol #:	4

EC 822	Mrs. Margaret Gallagher	Vol #:	4

2006P-0535	Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products

EC 13	Mrs. Cindy Bodine	Vol #:	3

EC 14	Ms. Sue Ann Wales	Vol #:	3

EC 15	Mr. Brian Adams	Vol #:	3

EC 16	Ms. Twila Nelson	Vol #:	3

EC 17	None	Vol #:	3

EC 18	Miss. Alison Bush	Vol #:	3

EC 19	Miss. Sheri Elmont	Vol #:	3

EC 20	Mrs. Arlene Burnett	Vol #:	3

EC 21	Mrs. Cheryl White	Vol #:	3

EC 22	Mrs. Myrna Overstreet	Vol #:	3

EC 23	Dr. Robert Fortier-Bensen	Vol #:	3

2007N-0005	Prescription Drug User Fee Act (PDUFA): Public Meeting

NM 1	FDA	Vol #:	1

Page created on January 12, 2007 kk

FDA/Dockets Management