Dockets Entered on April 4, 2006


Dockets Management
	Dockets Entered On July 10, 2006 Table of Contents



	Docket #	Title

	1998N-0046	Comprehensive List of Current Guidance Documents at FDA

	2000D-1318	Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment

	2001D-0220	Biological Prod Deviation Reporting for Blood & Plasma Estab

	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

	2004D-0369	Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use

	2005D-0022	International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals

	2005D-0288	International Conference on Harmonisation; Guidance on Q9 Quality Risk Management

	2005D-0356	Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records

	2005D-0385	Guidance for Industry on Using Electronic Means to Distribute Certain Product Information

	2005N-0262	Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program

	2005N-0413	Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments

	2005N-0437	Medical Gas Containers and Closures; Current Good Manufacturing

	2005P-0139	Withdraw approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152

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

	2006D-0172	Guidance for Clinical Investigators, Institutional Review Boards and Sponsors Process for Handling Referrals to FDA Under 21 CFR 50.54 : Additional Safeguards for Children in Clinical Investigations

	2006D-0190	Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Olfactory Test Device; Availability

	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-0107	FDA-Regulated Products Containing Nanotechnology Materials

	2006P-0146	Amend Reg. for Prescription Drug Advertising to Establish Separate Criteria for Practitioner-Directed & Consumer-Directed Advertising and Establish Advisory Committee

	2006P-0151	Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants

	2006P-0158	Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food

	2006P-0209	Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml

	2006P-0242	Approval of any Budesonide Inhalation Suspension Product using Pulmicort Respules

	2006P-0245	Exclusivity Determination for Risperidone

	2006P-0249	Refain from approving all abbreviated applications for generic enrofloxacin that purport to copy Bayer's Baytril 100 Injectable Solution

	2006P-0251	Label change or removal from the market of the psychotropic drug Depakote

	2006V-0216	Laser Light Show

	1996V-0138	Laser Light Show

	VRA 6	FDA/CDRH to Strictly F/X, LLC	Vol #:	1



1998N-0046	Comprehensive List of Current Guidance Documents at FDA

EC 10	Mr. Dave Lowe	Vol #:	2

2000D-1318	Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment

EC 1	Mr. Dave Lowe	Vol #:	2

2001D-0220	Biological Prod Deviation Reporting for Blood & Plasma Estab

EMC 3	Plasma Protein Therapeutics Association (PPTA)	Vol #:	1

EMC 4	Plasma Protein Therapeutics Association (PPTA)	Vol #:	1

EMC 5	Plasma Protein Therapeutics Association (PPTA)	Vol #:	1

2002P-0317	Recall Aspartame as a Neurotoxic Drug

EMC 670	Calorie Control Council	Vol #:	10

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

EMC 1321	E. LaFayette	Vol #:	12

EMC 1322	B. Westlake	Vol #:	12

2004D-0369	Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use

EMC 1567	B. Sachau	Vol #:	22

2005D-0022	International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals

EC 3	Mr. Dave Lowe	Vol #:	1

2005D-0288	International Conference on Harmonisation; Guidance on Q9 Quality Risk Management

EC 5	Mr. Dave Lowe	Vol #:	1

2005D-0356	Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records

EC 4	Mr. Dave Lowe	Vol #:	1

2005D-0385	Guidance for Industry on Using Electronic Means to Distribute Certain Product Information

EC 12	Mr. Dave Lowe	Vol #:	1

2005N-0262	Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program

EC 13	Mr. Dave Lowe	Vol #:	1

EC 14	Mr. Dave Lowe	Vol #:	1

2005N-0413	Assessing Consumer Perceptions of Health Claims; Public Meeting; Request for Comments

EMC 5	E. Bernstein	Vol #:	2

EMC 6	K. Chen	Vol #:	2

2005N-0437	Medical Gas Containers and Closures; Current Good Manufacturing



C 3	American Association for Homecare (AAHomecare)	Vol #:	1

C 4	Valley Home Care	Vol #:	1

C 5	Norco, Inc.	Vol #:	1

C 6	Linde Gas, LLC	Vol #:	1

C 7	Praxair, Inc. (Praxair)	Vol #:	1

EC 7	American Association for Homecare	Vol #:	1

EMC 4	Sky Oxygen	Vol #:	1

2005P-0139	Withdraw approvals of certain herdwide/flockwide uses of critically and highly important antibiotics pursuant to guidance #152

EMC 769	D. Addison	Vol #:	3

EMC 770	P. Loeff	Vol #:	3

EMC 771	L. Taylor	Vol #:	3

EMC 772	M. Bailey	Vol #:	3

EMC 773	J. Witt	Vol #:	3

EMC 774	T, Curry	Vol #:	3

EMC 775	M. Derr	Vol #:	3

EMC 776	M. Salmond	Vol #:	3

EMC 777	J. Harvey	Vol #:	3

EMC 778	K. Strovink	Vol #:	3

EMC 779	A. Montapert	Vol #:	3

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

C 14564	K. Egan	Vol #:	164

C 14565	S. Easley	Vol #:	164

C 14566	D. Cooper	Vol #:	164

C 14567	C. Simpson-Giles	Vol #:	164

C 14568	B. Evans	Vol #:	164

C 14569	C. Ciaccio	Vol #:	164

C 14570	D. Laundy	Vol #:	164

C 14571	S. Kreutzer	Vol #:	164

C 14572	D. Harlow	Vol #:	164

C 14573	M. Freel	Vol #:	164

C 14574	S. Carlton	Vol #:	164

C 14575	H. Fowler	Vol #:	164

C 14576	J. Easton	Vol #:	164

C 14577	N. LaMarco	Vol #:	164

C 14578	K. Moss	Vol #:	164



C 14579	S. Sims	Vol #:	164

C 14580	K. Douglas	Vol #:	164

C 14581	A. Stanton	Vol #:	164

C 14582	L. Thrash	Vol #:	164

C 14583	E. Sinclair	Vol #:	164

C 14584	M. Oerther	Vol #:	164

C 14585	J. Wagner	Vol #:	164

C 14586	E. Venhoff	Vol #:	164

C 14587	J. Douglas	Vol #:	164

C 14588	J. Kenkel	Vol #:	164

C 14589	S. Sieber	Vol #:	164

C 14590	R. Kot	Vol #:	164

C 14591	J. Mrachina	Vol #:	164

C 14592	J. Brockhaus	Vol #:	164

C 14593	L. Duffy	Vol #:	164

C 14594	M. Sheppard	Vol #:	164

C 14595	T. Gibb	Vol #:	164

C 14596	L. Besch	Vol #:	164

C 14597	C. Shields	Vol #:	164

C 14598	L. Chambo	Vol #:	164

C 14599	S. Ward	Vol #:	164

C 14600	M. Blain	Vol #:	164

C 14601	K. Piech	Vol #:	164

C 14602	K. Quintard	Vol #:	164

C 14603	R. Hawthorne	Vol #:	164

C 14604	M. Berry	Vol #:	164

C 14605	L. Tegeder	Vol #:	164

C 14606	R. Schultz	Vol #:	164

C 14607	N. Sims	Vol #:	164

C 14608	A. Langs	Vol #:	164

C 14609	L. Christianson	Vol #:	164

C 14610	D. Cotman	Vol #:	164

C 14611	Corvallis Integral Medicine	Vol #:	164

C 14612	E. Coffey	Vol #:	164

C 14613	A. Veit	Vol #:	164

C 14614	J. O'Doherty	Vol #:	164

C 14615	S. Blum	Vol #:	164



C 14616	H. Kottar	Vol #:	164

C 14617	W. Ronish	Vol #:	164

C 14618	T. King	Vol #:	164

C 14619	N. Valinski	Vol #:	164

C 14620	P. Fransconiak	Vol #:	164

C 14621	N. Frazee	Vol #:	164

C 14622	R. Felden	Vol #:	164

C 14623	B. Zdzianski	Vol #:	164

C 14624	L. Martel	Vol #:	164

C 14625	K. Allen	Vol #:	164

C 14626	M. Ledel	Vol #:	164

C 14627	D. Pitre	Vol #:	164

C 14628	S. Eymard	Vol #:	164

C 14629	L. Reed	Vol #:	164

C 14630	L. LaFont	Vol #:	164

C 14631	T. Scholl	Vol #:	164

C 14632	A. Lloyd	Vol #:	164

C 14633	L. McPherson	Vol #:	164

C 14634	B. Henson	Vol #:	164

C 14635	M. Sempek	Vol #:	164

C 14636	Valley Health Center-Ohio	Vol #:	164

C 14637	S. Clark	Vol #:	164

C 14638	G. Boyle	Vol #:	164

C 14639	L. Strunk	Vol #:	164

C 14640	R. Leon	Vol #:	164

C 14641	A. Lambeth	Vol #:	164

C 14642	Virginia Pharmacists Association	Vol #:	164

C 14643	S. Lee	Vol #:	164

C 14644	G. Henderson	Vol #:	164

C 14645	L. Wittig	Vol #:	164

C 14646	G. Weber	Vol #:	164

C 14647	S. Benedickt	Vol #:	164

C 14648	L. Knobloch	Vol #:	164

C 14649	G. Hollingsworth	Vol #:	164

C 14650	K. Bechen	Vol #:	164

C 14651	S. Norwood	Vol #:	164

C 14652	S. Henningsen	Vol #:	164



C 14653	J. Hemmingsen	Vol #:	164

C 14654	G. Leslie	Vol #:	164

C 14655	T. Doepker	Vol #:	164

C 14656	A. Bibello	Vol #:	164

C 14657	S. Marks	Vol #:	164

C 14658	E. Ashby	Vol #:	164

C 14659	G. Punsha	Vol #:	164

C 14660	D. Fischer	Vol #:	164

C 14661	K. Sanders	Vol #:	164

C 14662	L. Magyari	Vol #:	164

C 14663	V. Reathrer	Vol #:	164

C 14664	D. Magyari	Vol #:	164

C 14665	M. Price	Vol #:	164

C 14666	L. Mead	Vol #:	164

C 14667	M. Carroll	Vol #:	164

C 14668	A. Barnes	Vol #:	164

C 14669	S. Schatzman	Vol #:	164

C 14670	J. Laswell	Vol #:	164

C 14671	L. Thompson	Vol #:	164

C 14672	P. Conrad	Vol #:	164

C 14673	A. Myers	Vol #:	164

C 14674	V. Malone	Vol #:	164

C 14675	K. Heck	Vol #:	164

C 14676	P. Richardson	Vol #:	164

C 14677	C. Jackson	Vol #:	164

C 14678	A. Fewless	Vol #:	164

C 14679	E. Drulias	Vol #:	164

C 14680	R. Tiernan	Vol #:	164

C 14681	S. Chandler	Vol #:	164

C 14682	P. Conklin	Vol #:	164

C 14683	P. Campbell	Vol #:	165

C 14684	M. Nichols	Vol #:	165

C 14685	C. Scott	Vol #:	165

C 14686	B. Ames	Vol #:	165

C 14687	C. Strange	Vol #:	165

C 14688	S. Hughes	Vol #:	165

C 14689	A. Perez	Vol #:	165



C 14690	J. Christianson	Vol #:	165

C 14691	J. Maxson	Vol #:	165

C 14692	A. Economakos	Vol #:	165

C 14693	E. Wayne	Vol #:	165

C 14694	J. Hinojosa	Vol #:	165

C 14695	Congress of the United States-House of Represenatives	Vol #:	165

C 14696	J. Brown	Vol #:	165

C 14697	K. Rizor	Vol #:	165

C 14698	V. Cohen	Vol #:	165

C 14699	L. Beebe	Vol #:	165

C 14700	D. Lowell	Vol #:	165

C 14701	D. Pedrys	Vol #:	165

C 14702	R. Carlson	Vol #:	165

C 14703	J. Lamphere	Vol #:	165

C 14704	E. Steele	Vol #:	165

C 14705	P. Jones	Vol #:	165

C 14706	E. Morin	Vol #:	165

C 14707	V. Topel	Vol #:	165

C 14708	B. Payton	Vol #:	165

C 14709	D. Martin	Vol #:	165

C 14710	L. Orta	Vol #:	165

C 14711	Michigan Pharmacists Association	Vol #:	165

C 14712	J. Blair	Vol #:	165

C 14713	C. Laventhol	Vol #:	165

C 14714	S. Cannon-Vines	Vol #:	165

C 14715	C. Yost	Vol #:	165

C 14716	N. Barnes	Vol #:	165

C 14717	S. Schneider	Vol #:	165

C 14718	L. Hieb	Vol #:	165

C 14719	E. Holden	Vol #:	165

C 14720	C. Hensley	Vol #:	165

C 14721	T. Cruise	Vol #:	165

C 14722	J. Gatton	Vol #:	165

C 14723	M. Bullmer	Vol #:	165

C 14724	J. Shumaler	Vol #:	165

C 14725	G. Scheff	Vol #:	165

C 14726	L. DeSpain-Brown	Vol #:	165



C 14727	S. Cruit	Vol #:	165

C 14728	C. McCleary	Vol #:	165

C 14729	T. Le	Vol #:	165

C 14730	J. Prosser	Vol #:	165

C 14731	M. Tucker	Vol #:	165

C 14732	D. Williams	Vol #:	165

C 14733	D. Cook	Vol #:	165

C 14734	M. Bosinger	Vol #:	165

C 14735	K. Piper	Vol #:	165

C 14736	M. Hammes	Vol #:	165

C 14737	P. Johnson	Vol #:	165

C 14738	L. Anderson	Vol #:	165

C 14739	M. Brewton	Vol #:	165

C 14740	R. Najimy	Vol #:	165

C 14741	T. Loudiana	Vol #:	165

C 14742	D. Polniak	Vol #:	165

C 14743	J. Scammell	Vol #:	165

C 14744	P. Bream	Vol #:	165

C 14745	M. Kurtz	Vol #:	165

C 14746	M. Nelson	Vol #:	165

C 14747	J. Dunn	Vol #:	165

C 14748	D. Ruljancich	Vol #:	165

C 14749	A. Turnbaugh	Vol #:	165

C 14750	E. Roy	Vol #:	165

C 14751	P. Hill	Vol #:	165

C 14752	J. Prefontaine	Vol #:	165

C 14753	L. Long	Vol #:	165

C 14754	J. Dunn	Vol #:	165

C 14755	O. Hershey	Vol #:	165

C 14756	K. Stevens	Vol #:	165

C 14757	J. Todd	Vol #:	165

C 14758	M. Stein	Vol #:	165

C 14759	E. M. C. Capitol Management, Inc.	Vol #:	165

C 14760	M. Hammontree	Vol #:	165

C 14761	S. Slaughter	Vol #:	165

C 14762	M. Campernel	Vol #:	165

C 14763	W. Dunn	Vol #:	165



C 14764	M. Andrews	Vol #:	166

C 14765	L. Arnold	Vol #:	166

C 14766	L. Arnold	Vol #:	166

C 14767	G. Patrick	Vol #:	166

C 14768	L. Tanck	Vol #:	166

C 14769	C. Simmons	Vol #:	166

C 14770	G. Strelser	Vol #:	166

C 14771	A. Nicholas	Vol #:	166

C 14772	J. Davis	Vol #:	166

C 14773	M. Hitchman	Vol #:	166

C 14774	S. Lund	Vol #:	166

C 14775	T. Bondi	Vol #:	166

C 14776	A. Dimmitt	Vol #:	166

C 14777	G. LaRive	Vol #:	166

C 14778	D. Bennett	Vol #:	166

C 14779	J. Gillespie	Vol #:	166

C 14780	D. Peralta	Vol #:	166

C 14781	C. Crosley	Vol #:	166

C 14782	L. Ballowe	Vol #:	166

C 14783	J. Maze	Vol #:	166

C 14784	D. Oberlitner	Vol #:	166

C 14785	P. Tabbutt	Vol #:	166

C 14786	L. Methrin	Vol #:	166

C 14787	L. Reda	Vol #:	166

C 14788	J. Lester	Vol #:	166

C 14789	P. Taliaferro	Vol #:	166

C 14790	G. June	Vol #:	166

C 14791	J. Butte	Vol #:	166

C 14792	T. Powers	Vol #:	166

C 14793	D. Argile	Vol #:	166

C 14794	L. Beckwith	Vol #:	166

C 14795	C. Farmer	Vol #:	166

C 14796	J. Baltrinic	Vol #:	166

C 14797	N. Roch	Vol #:	166

C 14798	M. Casiello	Vol #:	166

C 14799	J. Butzdorff	Vol #:	166

C 14800	A. Lockwood	Vol #:	166



C 14801	C. Tinness	Vol #:	166

C 14802	S. McLeod	Vol #:	166

C 14803	V. Cartolano	Vol #:	166

C 14804	L. Garcia	Vol #:	166

C 14805	B. Russell	Vol #:	166

C 14806	J. Smith	Vol #:	166

C 14807	C. Stone	Vol #:	166

C 14808	D. Shepard	Vol #:	166

C 14809	S. Starnes	Vol #:	166

C 14810	R. McFadden	Vol #:	166

C 14811	L. Udovich	Vol #:	166

C 14812	L. Horn	Vol #:	166

C 14813	C. Johnson	Vol #:	166

C 14814	C. McLeod	Vol #:	166

C 14815	M. Basford	Vol #:	166

C 14816	G. Baker	Vol #:	166

C 14817	V. McMath	Vol #:	166

C 14818	J. Patric	Vol #:	166

C 14819	M. Marcus	Vol #:	166

C 14820	J. Gibson	Vol #:	16

C 14821	L. Wells	Vol #:	166

C 14822	M. Fowler	Vol #:	166

C 14823	T. Preston	Vol #:	166

C 14824	L. Hersh	Vol #:	166

C 14825	D. Burris	Vol #:	166

C 14826	H. Tatebe	Vol #:	166

C 14827	M. Wayne	Vol #:	166

C 14828	E. Jones	Vol #:	166

C 14829	S. Darren	Vol #:	166

C 14830	R. Hammer	Vol #:	166

C 14831	C. Finch	Vol #:	166

C 14832	A. Aal	Vol #:	166

C 14833	C. Williams	Vol #:	166

C 14834	S. Muell	Vol #:	166

C 14835	L. Shefler	Vol #:	166

C 14836	L. Yamamura	Vol #:	166

C 14837	E. Bonser	Vol #:	166



C 14838	P. Wright	Vol #:	166

C 14839	N. Heyser	Vol #:	166

C 14840	M. Yee	Vol #:	166

C 14841	K. Yee	Vol #:	166

C 14842	R. McClain	Vol #:	166

C 14843	P. Wilhelmsen	Vol #:	166

C 14844	L. Zehnder	Vol #:	166

C 14845	R. Murphy	Vol #:	166

C 14846	R. Misicka	Vol #:	166

C 14847	P. Mills	Vol #:	166

C 14848	L. Stewart	Vol #:	166

C 14849	D. Drake	Vol #:	166

C 14850	North Carolina Association of Pharmacists	Vol #:	166

C 14851	B. Jett	Vol #:	166

C 14852	B. Jett	Vol #:	166

C 14853	M. Garrison	Vol #:	166

C 14854	K. Tait	Vol #:	166

C 14855	J. Beisner	Vol #:	166

C 14856	D. Pourzan	Vol #:	166

C 14857	M. Hammelle	Vol #:	166

C 14858	North Carolina Association of Pharmacists	Vol #:	166

C 14859	D. Samuel	Vol #:	166

C 14860	M. Noller	Vol #:	166

C 14861	D. Erickson	Vol #:	166

C 14862	I. Lomba	Vol #:	166

C 14863	C. Ryan	Vol #:	166

C 14864	L. McPherson	Vol #:	166

C 14865	C. Daubner	Vol #:	166

C 14866	N. Scott	Vol #:	166

C 14867	R. Tessman	Vol #:	166

C 14868	E. Frazee	Vol #:	166

C 14869	R. Romaro	Vol #:	166

C 14870	O. Bailey	Vol #:	166

C 14871	S. McIntosh	Vol #:	166

C 14872	M. Nicholson	Vol #:	166

C 14873	A. Porter	Vol #:	166

C 14874	K. Wagley	Vol #:	166



C 14875	A. Porter	Vol #:	166

C 14876	D. Sayers	Vol #:	166

C 14877	M. Perry	Vol #:	166

C 14878	L. Brandt	Vol #:	166

C 14879	D. Powers	Vol #:	166

C 14880	D. Chambers	Vol #:	166

C 14881	L. Shubert	Vol #:	166

C 14882	L. Riley	Vol #:	166

C 14883	R. Bendiksen	Vol #:	166

C 14884	C. Lund	Vol #:	166

C 14885	G. Hain	Vol #:	166

C 14886	J. Tomasell	Vol #:	166

C 14887	F. DiMuccio	Vol #:	166

C 14888	L. Nicholes	Vol #:	166

C 14889	A. Muhleman	Vol #:	166

C 14890	M. Bjornson	Vol #:	166

C 14891	J. Schmidt	Vol #:	166

C 14892	J. Cooper	Vol #:	166

C 14893	M. Fulks	Vol #:	166

C 14894	A. Schuette	Vol #:	166

C 14895	L. Fernandez	Vol #:	166

C 14896	C. Stark	Vol #:	166

C 14897	K. Phillips	Vol #:	166

C 14898	J. Swanson	Vol #:	166

C 14899	R. Lenihan	Vol #:	166

C 14900	N. Walden	Vol #:	166

C 14901	S. Terstegen	Vol #:	166

C 14902	W. Vigars	Vol #:	166

C 14903	K. Back	Vol #:	166

C 14904	J. Thoreson	Vol #:	166

C 14905	R. Macy	Vol #:	166

C 14906	K. Adams	Vol #:	166

C 14907	K. Aiello	Vol #:	166

C 14908	G. Green	Vol #:	167

C 14909	E. Gause	Vol #:	167

C 14910	B. Shandley	Vol #:	167

C 14911	D. Retton	Vol #:	167



C 14912	S. Paskett	Vol #:	167

C 14913	M. Cook	Vol #:	167

C 14914	W. Church	Vol #:	167

C 14915	J. Moosa	Vol #:	167

C 14916	C. Jones	Vol #:	167

C 14917	D. Pearson & S. Shaw	Vol #:	167

C 14918	R. Felden	Vol #:	167

C 14919	G. Johnson	Vol #:	167

C 14920	B. Pomerance	Vol #:	167

C 14921	M. Volk	Vol #:	167

C 14922	T. Jones	Vol #:	167

C 14923	R. Cochran	Vol #:	167

C 14924	D. Smith	Vol #:	167

C 14925	E. Marchiany	Vol #:	167

C 14926	L. Hubbard	Vol #:	167

C 14927	S. Hughins	Vol #:	167

C 14928	J. Leriman-Gabis	Vol #:	167

C 14929	R. Dunn	Vol #:	167

C 14930	L. Grupe	Vol #:	167

C 14931	B. Glenn	Vol #:	167

C 14932	L. Faul	Vol #:	167

C 14933	K. Pettifer	Vol #:	167

C 14934	M. Bukatz	Vol #:	167

C 14935	J. Austin	Vol #:	167

C 14936	L. Sollami	Vol #:	167

C 14937	L. Grace	Vol #:	167

C 14938	R. Currier	Vol #:	167

C 14939	A. Currier	Vol #:	167

C 14940	L. Kunkel	Vol #:	167

C 14941	L. Copeland	Vol #:	167

C 14942	T. Weidner	Vol #:	167

C 14943	B. Cezar	Vol #:	167

C 14944	B. Buchanan	Vol #:	167

C 14945	M. Clise	Vol #:	167

C 14946	V. Dunivin	Vol #:	167

C 14947	J. Placido	Vol #:	167

C 14948	M. Aronson	Vol #:	167



C 14949	D. Barney	Vol #:	167

C 14950	M. Smith	Vol #:	167

C 14951	H. Bennett	Vol #:	167

C 14952	D. Walker	Vol #:	167

C 14953	M. Cowell	Vol #:	167

C 14954	C. Heisler	Vol #:	167

C 14955	B. Siebert	Vol #:	167

C 14956	L. Lareau	Vol #:	167

C 14957	J. Meyer	Vol #:	167

C 14958	M. Thomas	Vol #:	167

C 14959	L. Cook	Vol #:	167

C 14960	J. Burnett	Vol #:	167

C 14961	L. Mims	Vol #:	167

C 14962	T. Berk	Vol #:	167

C 14963	A. Hudson	Vol #:	167

C 14964	J. Morgan	Vol #:	167

C 14965	P. Rapaport	Vol #:	167

C 14966	S. Gilkey	Vol #:	167

C 14967	D. Garcia	Vol #:	167

C 14968	M. Draper	Vol #:	167

C 14969	J. Draper	Vol #:	167

C 14970	L. Kilkelly	Vol #:	167

C 14971	G. Murphy	Vol #:	167

C 14972	N. Laster	Vol #:	167

C 14973	P. Rae	Vol #:	167

C 14974	G. Frost	Vol #:	167

C 14975	J. Teitelbaum	Vol #:	167

C 14976	J. Slosser	Vol #:	167

C 14977	S. Ristesund	Vol #:	167

C 14978	E. Saunders	Vol #:	167

C 14979	C. Klein	Vol #:	167

C 14980	J. DiJoseph	Vol #:	167

C 14981	R. Cockrum	Vol #:	167

C 14982	N. Bush	Vol #:	167

C 14983	L. Artzberger	Vol #:	167

C 14984	P. Walker	Vol #:	167

C 14985	R. Fortner	Vol #:	167



C 14986	C. Petersen	Vol #:	167

C 14987	C. Omoso	Vol #:	167

C 14988	A. Corey	Vol #:	167

C 14989	E. Coleman	Vol #:	167

C 14990	K. Pefry	Vol #:	167

C 14991	L. Hesterlee	Vol #:	167

C 14992	B. VanderSloot	Vol #:	167

C 14993	D. Black	Vol #:	167

C 14994	C. Sparks	Vol #:	167

C 14995	A. Ferrara	Vol #:	167

C 14996	J. Baldwin	Vol #:	167

C 14997	M. Santini	Vol #:	167

C 14998	D. Seuer	Vol #:	167

C 14999	C. Wahkinney	Vol #:	167

C 15000	T. St. Joyha	Vol #:	167

C 15001	S. Rodriquez	Vol #:	167

C 15002	L. DeSpain-Brown	Vol #:	167

C 15003	P. Featherston	Vol #:	167

C 15004	A. Erb	Vol #:	167

C 15005	V. Barber	Vol #:	167

C 15006	J. LaFond	Vol #:	167

C 15007	L. Hodis	Vol #:	167

C 15008	Y. Hosey	Vol #:	167

C 15009	M. Pierce	Vol #:	167

C 15010	D. Yorsett	Vol #:	167

C 15011	D. Yorsett	Vol #:	167

C 15012	D. Yorsett	Vol #:	167

C 15013	H. Hemry	Vol #:	167

C 15014	J. Davis	Vol #:	167

C 15015	R. Whiteton	Vol #:	167

C 15016	Z. Alexis-Stricker	Vol #:	167

C 15017	M. Alt	Vol #:	167

C 15018	F. Biggerstaff	Vol #:	167

C 15019	E. Crook	Vol #:	167

C 15020	V. Greene	Vol #:	167

C 15021	J. Manea	Vol #:	167

C 15022	D. Carter	Vol #:	167



C 15023	J. Fairburn	Vol #:	167

C 15024	H. Bauer	Vol #:	167

C 15025	R. Cruz	Vol #:	167

C 15026	N. Strate	Vol #:	167

C 15027	R. Barca	Vol #:	167

C 15028	D. Payne	Vol #:	167

C 15029	N. William	Vol #:	167

C 15030	A. Kohl	Vol #:	167

C 15031	M. McGoever	Vol #:	167

C 15032	B. Battle	Vol #:	167

C 15033	W. Trudeau	Vol #:	167

C 15034	M. Moniz	Vol #:	167

C 15035	S. Minor-Cardenales	Vol #:	167

C 15036	B. Battle	Vol #:	167

C 15037	J. Hoesterey	Vol #:	167

C 15038	D. Sexton	Vol #:	167

C 15039	D. Sarta	Vol #:	167

EC 33246	Ms. ML Gregory	Vol #:	142

EMC 2985	D. Tuber	Vol #:	157

EMC 2986	D. Tuber	Vol #:	157

EMC 2987	No signature	Vol #:	157

EMC 2988	K. Glover	Vol #:	157

EMC 2989	D. Reynolds	Vol #:	157

EMC 2990	V. Salabor	Vol #:	157

EMC 2991	P. Pennino	Vol #:	157

EMC 2992	J. Pearson	Vol #:	157

EMC 2993	R. Nutter	Vol #:	157

EMC 2994	K. Bennett	Vol #:	157

EMC 2995	L. Kardish	Vol #:	157

EMC 2996	P. Champoux	Vol #:	157

EMC 2997	T. Ganoe	Vol #:	157

EMC 2998	S. Lucas	Vol #:	157

EMC 2999	A. McMillan	Vol #:	157

EMC 3000	C. Russo	Vol #:	157

EMC 3001	A. Cotton	Vol #:	157

EMC 3002	C. Baime	Vol #:	157

EMC 3003	H. Sapiro	Vol #:	157



EMC 3004	R. Arsenault	Vol #:	157

EMC 3005	S. Miskel	Vol #:	157

EMC 3006	S. Miskel	Vol #:	157

EMC 3007	B. Helmkamp	Vol #:	157

EMC 3008	P. Hawkins	Vol #:	157

EMC 3009	D. Revis	Vol #:	157

EMC 3010	J. Joyce	Vol #:	157

EMC 3011	L. Johnson	Vol #:	157

EMC 3012	M. Bowers, RN	Vol #:	157

EMC 3013	B. Thibault	Vol #:	157

EMC 3014	N. Larson	Vol #:	157

EMC 3015	J. Deaett	Vol #:	157

EMC 3016	A. Miller	Vol #:	157

EMC 3017	J. Gleim	Vol #:	157

EMC 3018	L. Scullan	Vol #:	157

EMC 3019	K. Gurman	Vol #:	157

EMC 3020	K. Johnston	Vol #:	157

EMC 3021	G. Lord	Vol #:	157

EMC 3022	C. Conway	Vol #:	157

EMC 3023	H. Lorenz	Vol #:	157

EMC 3024	S. Clinard	Vol #:	157

EMC 3025	B. Rose	Vol #:	157

EMC 3026	D. Norton	Vol #:	157

EMC 3027	P. Burrell	Vol #:	157

EMC 3028	B. Schriver	Vol #:	157

EMC 3029	P. Dhont	Vol #:	157

EMC 3030	D. Andersen	Vol #:	157

EMC 3031	D. Cook	Vol #:	157

EMC 3032	A. Rollins	Vol #:	157

EMC 3033	S. Jackson	Vol #:	157

EMC 3034	J. Cash	Vol #:	157

EMC 3035	No signature	Vol #:	157

2006D-0172	Guidance for Clinical Investigators, Institutional Review Boards and Sponsors Process for Handling Referrals to FDA Under 21 CFR 50.54 : Additional Safeguards for Children in Clinical Investigations


C 1	Stanford University	Vol #:	1

EC 1	Stanford University	Vol #:	1



2006D-0190	Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Olfactory Test Device; Availability

EC 1	Mr. Dave Lowe	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


C 2	A. Wildman	Vol #:	1

2006N-0107	FDA-Regulated Products Containing Nanotechnology Materials

EC 6	Mr. Dave Lowe	Vol #:	1

2006P-0146	Amend Reg. for Prescription Drug Advertising to Establish Separate Criteria for Practitioner-Directed & Consumer-Directed Advertising and Establish Advisory Committee

EC 2	Mrs. Sophia DeMonte	Vol #:	2

2006P-0151	Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants

EC 585	Ms. Jill Woodward	Vol #:	3

EC 586	Ms. cheryl kirkbride	Vol #:	3

EC 587	Mrs. Cheryl Newberry	Vol #:	3

EC 588	Mrs. Rogene Schorer	Vol #:	3

EC 589	Ms. Mary Frances Sears	Vol #:	3

EC 590	Ms. Rebekah Wilce	Vol #:	3

EC 591	Ms. Kimberly Brockway	Vol #:	3

EC 592	Mrs. PAULA MURRELL	Vol #:	3

EC 593	Ms. judy kemecsei	Vol #:	3

EC 594	Mrs. Sheilah Winn	Vol #:	3

EC 595	Mrs. Joyce Erb	Vol #:	3

EC 596	Mrs. Courtney Sulak-Zahid	Vol #:	3

EC 597	Mrs. Patricia Faussett	Vol #:	3

EC 598	Miss. Emma Roy	Vol #:	3

EC 599	Ms. Jana Diederen	Vol #:	3

EC 600	Ms. Jill Cousino	Vol #:	3

EC 601	Ms. Michele Nihipali	Vol #:	3

EC 602	Mr. bruce tucker	Vol #:	3

EC 603	Mrs. Ursula Mosley	Vol #:	3

EC 604	Mrs. Cheryl Taylor	Vol #:	3

EC 605	Our Bodies Ourselves	Vol #:	3

EC 606	Widow	Vol #:	3

EC 607	Miss. lena canepa	Vol #:	3

EC 608	Ms. Pam Weppler	Vol #:	3



EC 609	Ms. Jeanette Howard	Vol #:	3

EC 610	University of Massachusetts, Dept of Family Med.	Vol #:	3

EC 611	Mrs. Brenda Parker	Vol #:	3

EC 612	Ms. Sarah Lombardo	Vol #:	3

EC 613	Mrs. Debra Roundy	Vol #:	3

EMC 1	K. Bowler	Vol #:	5

EMC 2	A. Ehrlich	Vol #:	5

2006P-0158	Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food

EMC 6	E. Arellano	Vol #:	1

2006P-0209	Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml

EC 7	Mr. Dave Lowe	Vol #:	1

EC 8	Mr. Dave Lowe	Vol #:	1

2006P-0242	Approval of any Budesonide Inhalation Suspension Product using Pulmicort Respules

EC 2	Mr. Dave Lowe	Vol #:	2

2006P-0245	Exclusivity Determination for Risperidone

EC 8	Mr. Dave Lowe	Vol #:	1

2006P-0249	Refain from approving all abbreviated applications for generic enrofloxacin that purport to copy Bayer's Baytril 100 Injectable Solution

EC 1	Mr. David Lowe	Vol #:	1

EC 2	Mr. Dave Lowe	Vol #:	1

2006P-0251	Label change or removal from the market of the psychotropic drug Depakote

EC 3	Mr. Dave Lowe	Vol #:	1

2006V-0216	Laser Light Show

VRA 1	FDA/CDRH to UniversalStudios Florida	Vol #:	1

Page created on October 6, 2006 kk

FDA/Dockets Management