Dockets Entered on September 25, 2007

Dockets Management



Dockets Entered On September 25, 2007



Docket #	Title

1992N-0391	Analysis of Adverse Reactions to Monosodium Glutamate (MSG)

1995S-0316	75-Day Premarket Notifications for New Dietary Ingredients

1998P-0031	Protecting America from the consequences of tobacco products

2005H-0271	Civil Money Penalty: TMJ Implants, Inc.

2005N-0374	Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers

2005P-0293	Citizen Petition Regarding the Labeling of Vitamin A by Supplement Companies

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

2007D-0202	Guidance for Industry: Microbiological Considerations for

2007N-0262	Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)

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

2007P-0085	Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity

2007P-0210	Reclassification Petition for Human Papillomavirus (HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection under Section 513(f), 21 CFR 860 Subpart C

2007V-0360	Laser Light Show

1992N-0391	Analysis of Adverse Reactions to Monosodium Glutamate (MSG)

C 247	Carolyn Harris	Vol #:	18

1995S-0316	75-Day Premarket Notifications for New Dietary Ingredients

SUP 17	Chr. Hansen, Inc.	Vol #:	327

1998P-0031	Protecting America from the consequences of tobacco products

C 3	Form Letter Count 39	Vol #:	1

2005H-0271	Civil Money Penalty: TMJ Implants, Inc.

CS 29	FDA/DDM	Vol #:	245

OR 26	FDA/Administrative Law Judge	Vol #:	245

2005N-0374	Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers

C 12	Thomas Burnside	Vol #:	1

2005P-0293	Citizen Petition Regarding the Labeling of Vitamin A by Supplement Companies

C 1	Jean Heister	Vol #:	1

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

C 2783	J Wood	Vol #:	28

C 2784	J Palmer	Vol #:	28

C 2785	M Neal	Vol #:	28

C 2786	E Pecoraro	Vol #:	28

C 2787	A Owens	Vol #:	28



C 2788	P Garey	Vol #:	28

C 2789	D Williams	Vol #:	28

C 2790	B Pritchard	Vol #:	28

C 2791	C Phillips	Vol #:	28

C 2792	R Searles	Vol #:	28

C 2793	N Ventura	Vol #:	28

C 2794	O Jurey	Vol #:	28

C 2795	R Blaine	Vol #:	28

C 2796	W Hultman	Vol #:	28

C 2797	M Peterson	Vol #:	28

C 2798	S Leonard	Vol #:	28

C 2799	S Ehm	Vol #:	28

C 2800	L Wood	Vol #:	28

C 2801	G Hardymon	Vol #:	28

C 2802	M Friedman	Vol #:	28

C 2803	D Davis	Vol #:	28

C 2804	H Leveque	Vol #:	28

C 2805	I Baumgardner	Vol #:	28

C 2806	A Schl oz	Vol #:	28

C 2807	R Arnold	Vol #:	28

C 2808	D Huffman	Vol #:	28

C 2809	A Richter	Vol #:	28

C 2810	H Schallmo	Vol #:	28

C 2811	D Donovan	Vol #:	28

C 2812	R Stern	Vol #:	28

C 2813	P Hensley	Vol #:	28

C 2814	E Wallace	Vol #:	28

C 2815	C Jeffrey	Vol #:	28

C 2816	P Nagel	Vol #:	28

C 2817	S Caldwell	Vol #:	28

C 2818	W Sebastian	Vol #:	28

C 2819	P Georgeson	Vol #:	28

C 2820	I Glover	Vol #:	28

C 2821	G Kohel	Vol #:	28

C 2822	M Nolan	Vol #:	28

C 2823	R Endeward	Vol #:	28

C 2824	D Randall	Vol #:	28



C 2825	R Greve	Vol #:	28

C 2826	G Steven	Vol #:	28

C 2827	R Marohn	Vol #:	28

C 2828	M Frost	Vol #:	28

C 2829	J hacker	Vol #:	28

C 2830	V Sullivan	Vol #:	28

C 2831	B Rubermer	Vol #:	28

C 2832	C Schulte	Vol #:	28

C 2833	C Mock	Vol #:	28

C 2834	J Nehls	Vol #:	28

C 2835	G Ceamak	Vol #:	28

C 2836	J Baumeister	Vol #:	28

C 2837	D Rubright	Vol #:	28

C 2838	P Baade	Vol #:	28

C 2839	L Matthews	Vol #:	28

C 2840	S Denby	Vol #:	28

C 2841	M Anderson	Vol #:	28

C 2842	I Workley	Vol #:	29

C 2843	J Krenik	Vol #:	29

C 2844	L Ross	Vol #:	29

C 2845	J Fisher	Vol #:	29

C 2846	V Barney	Vol #:	29

C 2847	B Collier	Vol #:	29

C 2848	J Murphy	Vol #:	29

C 2849	D Pilolla	Vol #:	29

C 2850	R Whitaker	Vol #:	29

C 2851	M Horton	Vol #:	29

C 2852	I Friedman	Vol #:	29

C 2853	J O'Donnell	Vol #:	29

C 2854	N Wilson	Vol #:	29

C 2855	J Florence	Vol #:	29

C 2856	B Lerch	Vol #:	29

C 2857	R Wegrzyn	Vol #:	29

C 2858	L Stewart	Vol #:	29

C 2859	C Thurn	Vol #:	29

C 2860	M Rivera	Vol #:	29

C 2861	B Gordon	Vol #:	29



C 2862	C Wint	Vol #:	29

C 2863	J McClelland	Vol #:	29

C 2864	W Burton	Vol #:	29

C 2865	M Dudley	Vol #:	29

C 2866	S Cook	Vol #:	29

C 2867	L Aman	Vol #:	29

C 2868	M Bjornson	Vol #:	29

C 2869	A Lysne	Vol #:	29

C 2870	F Layer	Vol #:	29

C 2871	C Weimer	Vol #:	29

C 2872	R Suckley	Vol #:	29

C 2873	B clark	Vol #:	29

C 2874	M Strifler	Vol #:	29

C 2875	L Davis	Vol #:	29

C 2876	G Stortz	Vol #:	29

C 2877	H Preiss	Vol #:	29

C 2878	L Prindiville	Vol #:	29

C 2879	B Schmisseur	Vol #:	29

C 2880	G Perez	Vol #:	29

C 2881	M Stock	Vol #:	29

C 2882	P Leonard	Vol #:	29

C 2883	J Wagner	Vol #:	29

C 2884	B Honea	Vol #:	29

C 2885	M Heaton	Vol #:	29

C 2886	L Hildebrant	Vol #:	29

C 2887	J Rogers Sr	Vol #:	29

C 2888	Allergy & Asthma Care	Vol #:	29

C 2889	D Hein	Vol #:	29

C 2890	A Winch	Vol #:	29

C 2891	B CLiff	Vol #:	29

C 2892	M Russo	Vol #:	29

C 2893	B Morris	Vol #:	29

C 2894	E Weidenmoyer	Vol #:	29

C 2895	D Gardner	Vol #:	29

C 2896	M Kosciuk	Vol #:	29

C 2897	J Underdown	Vol #:	29

C 2898	L Bonini	Vol #:	29



C 2899	R Jahnke	Vol #:	29

C 2900	D Hennessy	Vol #:	29

C 2901	D Smith	Vol #:	29

C 2902	B Upin	Vol #:	29

C 2903	W Boyle	Vol #:	29

C 2904	J Cox	Vol #:	29

C 2905	F Schlup	Vol #:	29

C 2906	G Miller	Vol #:	29

C 2907	M Grimes	Vol #:	29

C 2908	J Bowman Jr	Vol #:	29

C 2909	R Bailey	Vol #:	29

C 2910	L Cornelsen	Vol #:	29

C 2911	N Cummings	Vol #:	29

C 2912	S Hidalgo	Vol #:	29

C 2913	D Wooten	Vol #:	29

C 2914	N Greer	Vol #:	29

C 2915	D Backus	Vol #:	29

C 2916	M Davis	Vol #:	29

C 2917	F Yee	Vol #:	29

C 2918	M Gallup	Vol #:	29

C 2919	G Landes	Vol #:	29

C 2920	P Daves	Vol #:	29

C 2921	J Grigsby	Vol #:	29

C 2922	G McCleary	Vol #:	29

C 2923	I Wray	Vol #:	29

C 2924	H Webb Sr	Vol #:	29

C 2925	C Eagan	Vol #:	29

C 2926	C Myers	Vol #:	29

C 2927	M Walchak	Vol #:	29

C 2928	R Zimmerman	Vol #:	29

C 2929	M Burroughs	Vol #:	29

C 2930	B Ellett	Vol #:	29

C 2931	M Springer	Vol #:	29

C 2932	C Glenn	Vol #:	29

C 2933	H Prock	Vol #:	29

C 2934	M Fox	Vol #:	29

C 2935	D Katzen	Vol #:	29



C 2936		S Storm	Vol #:	29

C 2937		P Barentine	Vol #:	29

C 2938		M Erlewine	Vol #:	29

C 2939		J Adrianenssens	Vol #:	29

C 2940		D Javurek	Vol #:	29

C 2941		M Hocmann	Vol #:	29

C 2942		R Horschmann	Vol #:	29

C 2943		J Coody	Vol #:	29

C 2944		M Lambert	Vol #:	29

C 2945		J Baker	Vol #:	29

C 2946		R Robbins	Vol #:	29

C 2947		A Ostipow	Vol #:	29

C 2948		B Vinson	Vol #:	29

C 2949		S Giles	Vol #:	29

C 2950		E Littlefor	Vol #:	29

C 2951		J Rochester	Vol #:	29

C 2952		E Thorn	Vol #:	29

C 2953		l Jones	Vol #:	29

C 2954		R Kelley	Vol #:	29

C 2955		S Kimmelman	Vol #:	29

C 2956		William A Schaffer	Vol #:	29

C 2957		E Swider	Vol #:	29

C 2958		J Dobbs	Vol #:	29

C 2959		R Melbourne	Vol #:	29

C 2960		P Blankenship	Vol #:	29

C 2961		L Adams	Vol #:	29

C 2962		M Ulrich	Vol #:	29

2007D-0202		Guidance for Industry: Microbiological Considerations for

GDL 1		Guidance	Vol #:	1

NAD 1		FDA	Vol #:	1

2007N-0262		Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)

EREG 1		b. sachau	Vol #:	1

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

C 1		Rita Kamani	Vol #:	1

2007P-0085	Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity



C 314	Shelly Kellogg	Vol #:	6

C 315	Theresa G. Martin	Vol #:	6

C 316	Wilma M. Ahrens	Vol #:	6

C 317	Ellen A. Morgan	Vol #:	6

C 318	Bob Gerber	Vol #:	6

C 319	Lorrie Maurer	Vol #:	6

LET 1	Steven R. Mason	Vol #:	6

2007P-0210	Reclassification Petition for Human Papillomavirus (HPV) DNA Nested Polymerase Chain Reaction (PCR) Detection under Section 513(f), 21 CFR 860 Subpart C

C 1	Mercola.com	Vol #:	1

2007V-0360	Laser Light Show

ACK 1	FDA/ DDM/ to Bel Entertainment LLC	Vol #:	1

VAR 1	Bel Entertainment LLC	Vol #:	1

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FDA/Dockets Management