Dockets Entered on September 17, 2007

Dockets Management



Dockets Entered On September 17, 2007



Docket #	Title

1978N-0038	Sunscreen Drug Products

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

1999D-2013	Cooperative Manufacturing Arrangements for Licensed

2004D-0002	Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants

2006D-0347	Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays

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

2006P-0487	Health Claim Petition: Isomaltulose and Dental Caries

2007D-0201	Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents

2007D-0223	Guidance for Industry on Use of the Computer Crossmatch

2007D-0233	Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document

2007D-0268	Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology

2007N-0179	Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop

2007N-0186	Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary


2007N-0231	Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-market Approval of Medical Devices

2007N-0277	Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing

2007P-0282	Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%

2007P-0297	Request to reconsider the failure to approve Provenge

1978N-0038	Sunscreen Drug Products

EC 2388	Mr. Ilan Gutherz	Vol #:	161

EC 2389	Ms. Marjorie Carlson	Vol #:	161

EC 2390	Mr. Erik Kreider	Vol #:	161

EC 2391	Ms. Tracie Beasley	Vol #:	161

EC 2392	Ms. Dana Goldstein	Vol #:	161

EC 2393	Miss. Molly Hale	Vol #:	161

EC 2394	Mr. S K	Vol #:	161

EC 2395	Mrs. Kedrann Hill	Vol #:	161

EC 2396	Mrs. Suzanne Maddox	Vol #:	161

EC 2397	Ms. Trish Smith	Vol #:	161

EC 2398	Mrs. mrtha coonley	Vol #:	161

EC 2399	Ms. Anja Schiller	Vol #:	161

EC 2400	Mr. Sid Fincher	Vol #:	161

EC 2401	Mrs. LeeAnn Carrow	Vol #:	161

EC 2402	Mrs. Jackie VanBrocklin	Vol #:	161

EC 2403	Mrs. Elly Hereth	Vol #:	161



EC 2404	Ms. Katie Wehr	Vol #:	161

EC 2405	Mrs. Susan Redding	Vol #:	161

EC 2406	Mr. Michael Cannella	Vol #:	161

EC 2407	Mrs. Lori Robinson	Vol #:	161

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

LET 20740	NOW Foods	Vol #:	181

LET 20741	PHI-TEN USA, INC.	Vol #:	181

LET 20742	PHI-TEN USA, INC.	Vol #:	181

LET 20743	PHI-TEN USA, INC.	Vol #:	181

LET 20744	NOW Foods	Vol #:	181

LET 20745	NOW Foods	Vol #:	181

LET 20746	NOW Foods	Vol #:	181

LET 20747	NOW Foods	Vol #:	181

LET 20748	NOW Foods	Vol #:	181

LET 20749	NOW Foods	Vol #:	181

LET 20750	NOW Foods	Vol #:	181

LET 20751	NOW Foods	Vol #:	181

LET 20752	NOW Foods	Vol #:	181

LET 20753	NOW Foods	Vol #:	181

LET 20754	NOW Foods	Vol #:	181

LET 20755	NOW Foods	Vol #:	181

LET 20756	NOW Foods	Vol #:	181

LET 20757	NOW Foods	Vol #:	181

LET 20758	NOW Foods	Vol #:	181

LET 20759	NOW Foods	Vol #:	181

LET 20760	NOW Foods	Vol #:	181

LET 20761	NOW Foods	Vol #:	181

LET 20762	NOW Foods	Vol #:	181

LET 20763	NOW Foods	Vol #:	181

LET 20764	NOW Foods	Vol #:	181

LET 20765	NOW Foods	Vol #:	181

LET 20766	NOW Foods	Vol #:	181

LET 20767	NOW Foods	Vol #:	181

LET 20768	NOW Foods	Vol #:	181

LET 20769	NOW Foods	Vol #:	181

LET 20770	NOW Foods	Vol #:	181



1999D-2013	Cooperative Manufacturing Arrangements for Licensed

EC 1	Hollister-Stier Laboratories, LLC	Vol #:	1

2004D-0002	Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants

EC 23	Ms. Tammi Raabe	Vol #:	2

2006D-0347	Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays

NEC 2	FDA	Vol #:	3

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

C 2301	P Smith	Vol #:	26

C 2302	S Davis	Vol #:	26

C 2303	S Gribble	Vol #:	26

C 2304	Pediatric Medicine of Wallingford	Vol #:	26

C 2305	S Barnes	Vol #:	26

C 2306	J Filippone	Vol #:	26

C 2307	L Wilkerson	Vol #:	26

C 2308	M Hartlage	Vol #:	26

C 2309	D Stoterau	Vol #:	26

C 2310	R Adolph	Vol #:	26

C 2311	M Murray	Vol #:	26

C 2312	M Clay	Vol #:	26

C 2313	A Baker	Vol #:	26

C 2314	H Tolmas	Vol #:	26

C 2315	B Swaner	Vol #:	26

C 2316	G Rater	Vol #:	26

C 2317	A Marceau	Vol #:	26

C 2318	B Vowels	Vol #:	26

C 2319	K Ciske	Vol #:	26

C 2320	L Jacobs	Vol #:	26

C 2321	J Dorow	Vol #:	26

C 2322	A Cates	Vol #:	26

C 2323	A Hickey	Vol #:	26

C 2324	C Stone	Vol #:	26

C 2325	P Muzerolle	Vol #:	26

C 2326	D Boyle	Vol #:	26

C 2327	G Moore	Vol #:	26

C 2328	J Bandreau	Vol #:	26



C 2329	D Bogue	Vol #:	26

C 2330	J Duncan	Vol #:	26

C 2331	L Hagen	Vol #:	26

C 2332	V Wright	Vol #:	26

C 2333	K Berry	Vol #:	26

C 2334	R Luttrell	Vol #:	26

C 2335	S Carson	Vol #:	26

C 2336	I Peters	Vol #:	26

C 2337	W Fisher	Vol #:	26

C 2338	V Bowles	Vol #:	26

C 2339	J Rocha	Vol #:	26

C 2340	R Thompson	Vol #:	26

C 2341	P Denoma	Vol #:	26

C 2342	D Kilpatrich	Vol #:	26

C 2343	N Burns	Vol #:	26

C 2344	H DeYoung	Vol #:	26

C 2345	R Quick	Vol #:	26

C 2346	B W Stufflebam	Vol #:	26

C 2347	B Ohlau	Vol #:	26

C 2348	B Kinsey	Vol #:	26

C 2349	B Ezell	Vol #:	26

C 2350	J Bragg	Vol #:	26

C 2351	B Beck	Vol #:	26

C 2352	M Clark	Vol #:	26

C 2353	L Nichrent	Vol #:	26

C 2354	C Jones	Vol #:	26

C 2355	O Schlabach	Vol #:	26

C 2356	F W Forster	Vol #:	26

C 2357	H Robert	Vol #:	26

C 2358	G Havens	Vol #:	26

C 2359	E Ludwick	Vol #:	26

C 2360	T McCue	Vol #:	26

C 2361	E Kray	Vol #:	26

C 2362	H Mitchell	Vol #:	26

C 2363	N Mann	Vol #:	26

C 2364	J Kilpatrick	Vol #:	26

C 2365	J Gophart	Vol #:	26



C 2366	J Jerbic	Vol #:	26

C 2367	E Evans	Vol #:	26

C 2368	A Deines	Vol #:	26

C 2369	T Huhn	Vol #:	26

C 2370	J Bushirk	Vol #:	26

C 2371	W Martiny	Vol #:	26

C 2372	G Reeker	Vol #:	26

C 2373	D Hashman	Vol #:	26

C 2374	D Spencer	Vol #:	26

C 2375	F Deibler	Vol #:	26

C 2376	E Little	Vol #:	26

C 2377	C Snyder	Vol #:	26

C 2378	R Jirata	Vol #:	26

C 2379	R Canup	Vol #:	26

C 2380	J Hand	Vol #:	26

C 2381	E Carberry	Vol #:	26

C 2382	R Walker	Vol #:	26

C 2383	M Rowe	Vol #:	26

C 2384	B Smith	Vol #:	26

C 2385	R McKernan	Vol #:	26

C 2386	B Grandin	Vol #:	26

C 2387	B. Phipps	Vol #:	26

C 2388	L Butler	Vol #:	26

C 2389	B Sims	Vol #:	26

C 2390	D Anderson	Vol #:	26

C 2391	E Keith	Vol #:	26

C 2392	D Steiner	Vol #:	26

C 2393	E Yawn	Vol #:	26

C 2394	S Morris	Vol #:	26

C 2395	L Conrad	Vol #:	26

C 2396	A Nelson	Vol #:	26

C 2397	M Halamicek	Vol #:	26

C 2398	D Shaffer	Vol #:	26

C 2399	J McNevin	Vol #:	26

C 2400	M Adams	Vol #:	26

C 2401	D Vlahovic	Vol #:	26

C 2402	R Gates	Vol #:	26



C 2403	W Shea	Vol #:	26

C 2404	H Lighty	Vol #:	26

C 2405	D Sprouse	Vol #:	26

C 2406	R Rogers	Vol #:	26

C 2407	S Barlter	Vol #:	26

C 2408	D Williams	Vol #:	26

C 2409	A Weissman	Vol #:	26

C 2410	D Zemann	Vol #:	26

C 2411	M Moore	Vol #:	26

C 2412	N Berry	Vol #:	26

C 2413	P Kennison	Vol #:	26

C 2414	J Macaluso	Vol #:	26

C 2415	S Frazier	Vol #:	26

C 2416	J Philhower	Vol #:	26

C 2417	P Thomas	Vol #:	26

C 2418	J Claflin	Vol #:	26

C 2419	D Phillips	Vol #:	26

C 2420	S Bloch	Vol #:	26

C 2421	M Shields	Vol #:	26

C 2422	W Vowles	Vol #:	26

2006P-0487	Health Claim Petition: Isomaltulose and Dental Caries

BKG 1	Background	Vol #:	2

NIR 1	FDA	Vol #:	1

2007D-0201	Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents

EC 2	Mr. gregory pinchinat	Vol #:	1

2007D-0223	Guidance for Industry on Use of the Computer Crossmatch

EC 4	AABB	Vol #:	1

EC 5	CMS	Vol #:	1

2007D-0233	Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document

EC 3	Schering-Plough	Vol #:	1

EC 4	Merck Research Laboratories	Vol #:	1

EC 5	Pfizer Inc	Vol #:	1

2007D-0268	Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology



EC 7	Miss. Emma Rohrbach	Vol #:	1

2007N-0179	Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop

TR 1	Transcript of 6/25/07	Vol #:	3

TR 2	Transcript of 6/26/07	Vol #:	4

2007N-0186	Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary



NEC 1	FDA	Vol #:	1

2007N-0231	Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-market Approval of Medical Devices

N 2	FDA	Vol #:	1

2007N-0277	Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing

EC 17	Ms. Kelly Bowling	Vol #:	1

EC 18	University of Wisconsin-Madison	Vol #:	1

EC 19	Salt Institute	Vol #:	1

EC 20	Mr. Chad Larson	Vol #:	1

2007P-0282	Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%

EC 29	Plattsburgh State University	Vol #:	1

EC 30	Ms. Sheila Braun	Vol #:	1

EC 31	Retired	Vol #:	1

EC 32	Mr. Owen Brady	Vol #:	1

EC 33	University of Vermont	Vol #:	1

EC 34	The University of Vermont	Vol #:	1

EC 35	Mr. Dan Harvey	Vol #:	1

EC 36	University of Vermont	Vol #:	1

EC 37	UVM	Vol #:	1

EC 38	home	Vol #:	1

EC 39	Mrs. Linda Corse	Vol #:	1

EC 40	Dr. Josh Bongard	Vol #:	1

EC 41	Mrs. Treya Palmer	Vol #:	1

EC 42	Mr. Willard Sawma	Vol #:	1

EC 43	Mrs. Samantha Balmes	Vol #:	1

EC 44	Vermont Law School	Vol #:	1

EC 45	Mrs. Lydia Fiedler	Vol #:	1

EC 46	Animal Answers	Vol #:	1

EC 47	individual	Vol #:	1



EC 48	Ms. Keri Toksu	Vol #:	1

EC 49	Mt. Aberham Union High School	Vol #:	1

EC 50	University of Vermont	Vol #:	1

EC 51	Ms. Clara Bond	Vol #:	1

EC 52	Mr. Winfield Carlough	Vol #:	1

EC 53	Mr. Travis Gang	Vol #:	1

EC 54	concerned citizen	Vol #:	1

EC 55	Dr. William Stickney	Vol #:	1

EC 56	n/a	Vol #:	1

EC 57	Ms. Barbara Mines	Vol #:	1

EC 58	Mr. Kevin Wrenner	Vol #:	1

EC 59	Mrs. Tamara Smith	Vol #:	1

2007P-0297	Request to reconsider the failure to approve Provenge

EC 99	Mr. Jeffery Rhoads	Vol #:	1

EC 100	Mr. kevin smallwood	Vol #:	1

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FDA/Dockets Management