Dockets Entered on August 14, 2007, 2007

Dockets Management



Dockets Entered On August 14, 2007 - Corrected



Docket #	Title

1995C-0286	Safe Use of Bone Black in Cosmetics

1996N-0417	CGMP in Mfg. Packing or Holding Dietary Supplements

1998D-0077	Treatment of osteoarthritis/drugs, devices and biological pt

1998D-0307	Exports/Imports under FDA export reform/enhancement Act 1996

2004P-0557	ANDA for a generic version of Efudex Cream(fluorouracil) cream

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

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2006P-0445	Determine if Mivacron (mivacurium chloride injection) was withdrawn for safety or efficacy reasons

2006P-0520	Determination for Methotrexate Injection, USP, Preservative Free, Eq. 500 mg base/20 mL, NDA 11-719)

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

2007P-0320	Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers

1995C-0286	Safe Use of Bone Black in Cosmetics

NFR 2	FDA	Vol #:	1

1996N-0417	CGMP in Mfg. Packing or Holding Dietary Supplements

C 271	V. Carrick	Vol #:	54

C 272	C. Currie	Vol #:	54

C 273	B. Burke	Vol #:	54

C 274	R.W. Gross	Vol #:	54

C 275	D. Donaho	Vol #:	54

1998D-0077	Treatment of osteoarthritis/drugs, devices and biological pt

N 1	FDA	Vol #:	1

1998D-0307	Exports/Imports under FDA export reform/enhancement Act 1996

GDL 2	Guidance	Vol #:	2

NAD 2	FDA	Vol #:	2

2004P-0557	ANDA for a generic version of Efudex Cream(fluorouracil) cream

	Document Removed	:

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

C 3742	C. Poinelli	Vol #:	55

C 3743	K. Ruthroff	Vol #:	55

C 3744	Unknown	Vol #:	55



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

C 851	R. Yale	Vol #:	9

C 852	D. Corbett	Vol #:	9

C 853	J. Harris	Vol #:	9

C 854	B. Long	Vol #:	9

C 855	W. Pardue	Vol #:	9

C 856	R. Warren	Vol #:	9

C 857	S. Wilson	Vol #:	9

C 858	B. Miller	Vol #:	9

C 859	J. Colsman	Vol #:	9

C 860	R. Elkins	Vol #:	9

C 861	F. Staton	Vol #:	9

C 862	E. Wilner	Vol #:	9

C 863	W. Potter	Vol #:	9

C 864	D. Dennick	Vol #:	9

C 865	G. Thomas	Vol #:	9

C 866	P Caralno	Vol #:	9

C 867	M. Tallent	Vol #:	9

C 868	L. Curran	Vol #:	9

C 869	S. Hunter	Vol #:	9

C 870	J. Griffith	Vol #:	9

C 871	A. Joachim	Vol #:	9

C 872	R. Wolfe	Vol #:	9

C 873	R. Rice Sr	Vol #:	9

C 874	J. Raftery	Vol #:	9

C 875	A. Arnhold	Vol #:	9

C 876	B. Lynch	Vol #:	9

C 877	no signature	Vol #:	9

C 878	C. Puccio	Vol #:	9

C 879	J Worhoch	Vol #:	9

C 880	J Doran	Vol #:	9

C 881	A. Frischberg	Vol #:	9

C 882	D. Barrow	Vol #:	9

C 883	A. Cote	Vol #:	9

C 884	J. Wey	Vol #:	9

C 885	O. Colquhoun	Vol #:	9



C 886	L. Williams	Vol #:	9

C 887	R. Blake	Vol #:	9

C 888	P. Winters	Vol #:	9

C 889	E. Gumble	Vol #:	9

C 890	V. Hayden	Vol #:	9

C 891	J. Raber	Vol #:	9

C 892	E. Liller	Vol #:	9

C 893	M. Watson	Vol #:	9

C 894	M. Sanders	Vol #:	9

C 895	A. Davis	Vol #:	9

C 896	I. Smith	Vol #:	9

C 897	R. Cummings	Vol #:	9

C 898	C. Luwisch	Vol #:	9

C 899	T. Driggins	Vol #:	9

C 900	R. Hippen Jr	Vol #:	9

C 901	L. Kindermann	Vol #:	10

C 902	E. Gatteman	Vol #:	10

C 903	B. Bernhardt	Vol #:	10

C 904	B. Joyce	Vol #:	10

C 905	J. Shields	Vol #:	10

C 906	S. Wein	Vol #:	10

C 907	T. Johns	Vol #:	10

C 908	H. Gallagher	Vol #:	10

C 909	C. Dunn	Vol #:	10

C 910	H. Cooley	Vol #:	10

C 911	L. Dielkey	Vol #:	10

C 912	B. Lane	Vol #:	10

C 913	W. Kimsey	Vol #:	10

C 914	R. Sullivan	Vol #:	10

C 915	A. Siders	Vol #:	10

C 916	E. Katleman	Vol #:	10

C 917	H. Robinson	Vol #:	10

C 918	P Sulllivan	Vol #:	10

C 919	E. Neatherlin	Vol #:	10

C 920	R. Davis	Vol #:	10

C 921	J. Turner	Vol #:	10

C 922	I. Clough	Vol #:	10



C 923	J. Rhodes	Vol #:	10

C 924	J. Bohanon	Vol #:	10

C 925	F. Skiba	Vol #:	10

C 926	T. Allen	Vol #:	10

C 927	A. Bedell	Vol #:	10

C 928	D. Adams	Vol #:	10

C 929	C. Sissel	Vol #:	10

C 930	S. Harris	Vol #:	10

C 931	M. Hamilton	Vol #:	10

C 932	B. Hifrong	Vol #:	10

C 933	D. Fleming	Vol #:	10

C 934	M. Singleton	Vol #:	10

C 935	B. Surette	Vol #:	10

C 936	D. Wright	Vol #:	10

C 937	L. Mohrman	Vol #:	10

C 938	D. Michaels	Vol #:	10

C 939	W Erwin	Vol #:	10

C 940	P Voigt	Vol #:	10

C 941	L. Shell	Vol #:	10

C 942	M. Schlabed	Vol #:	10

C 943	L. Haugh	Vol #:	10

C 944	P. Gazzeray	Vol #:	10

C 945	A. Sabbe	Vol #:	10

C 946	M. Parkin	Vol #:	10

C 947	E. Phillips	Vol #:	10

C 948	E. Lyles	Vol #:	10

C 949	B. Smith	Vol #:	10

C 950	P. Flynn Jr	Vol #:	10

C 951	Y. Soleymani	Vol #:	10

C 952	J. Player	Vol #:	10

C 953	M. Bogdanowich	Vol #:	10

C 954	G. Moore	Vol #:	10

C 955	F. Gawlak	Vol #:	10

C 956	D. Cunningham	Vol #:	10

C 957	A. Coyle	Vol #:	10

C 958	L. Liston	Vol #:	10

C 959	I Ludington Jr	Vol #:	10



C 960	R/ Beard	Vol #:	10

C 961	M Powe	Vol #:	10

C 962	M. Smith	Vol #:	10

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

N 1	FDA	Vol #:	1

2006P-0445	Determine if Mivacron (mivacurium chloride injection) was withdrawn for safety or efficacy reasons

LET 2	Christine F. Rogers	Vol #:	1

2006P-0520	Determination for Methotrexate Injection, USP, Preservative Free, Eq. 500 mg base/20 mL, NDA 11-719)

LET 2	Elena Cohen	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 220	Jacob R. Lauser	Vol #:	6

C 221	Mary Lou Hulse	Vol #:	6

C 222	Jacob R. Lauser	Vol #:	6

C 223	Tamra Flesch	Vol #:	6

C 224	Unknown	Vol #:	6

C 225	Unknown	Vol #:	6

C 226	Unknown	Vol #:	6

C 227	Iris P. Gonzalez	Vol #:	6

C 228	James M. Guidry	Vol #:	6

C 229	Shirley Skorbiansky	Vol #:	6

C 230	Jennifer K. Crosby	Vol #:	6

C 231	Paul Kolenbrander	Vol #:	6

C 232	Dale W. Logue	Vol #:	6

C 233	Leslie Wiemik	Vol #:	6

C 234	Joan Beer	Vol #:	6

C 235	Unknown	Vol #:	6

C 236	Unknown	Vol #:	6

C 237	Maria A. Sproul	Vol #:	6

C 238	Alison Mueller	Vol #:	6

C 239	Unknown	Vol #:	6

C 240	Ashley West Leonard	Vol #:	6

C 241	Sara Spiegel	Vol #:	6

C 242	Deborah Phillips	Vol #:	6

C 243	Robert A. Shaw	Vol #:	6



C 244	Christina Cionvica	Vol #:	6

C 245	Morton and Marlene Abramson	Vol #:	6

C 246	David Long	Vol #:	6

C 247	Juliet Chu	Vol #:	6

C 248	C.P. Dalpiaz	Vol #:	6

C 249	Sharon Donegan	Vol #:	6

C 250	David E. Finnell	Vol #:	6

C 251	Brian LaFlamme	Vol #:	6

C 252	Eleanor G. Kinnaird	Vol #:	6

C 253	Brian Redmond	Vol #:	6

C 254	Kathleen M. Dickinson	Vol #:	6

C 255	Nancy Gilbert	Vol #:	6

C 256	Thomas W. Lincoln	Vol #:	6

C 257	Jim and Carolla Ault	Vol #:	6

C 258	Cynthia Ellis	Vol #:	6

C 259	Raphael & Mary Siegel	Vol #:	6

C 260	Joy L. Swensen	Vol #:	6

C 261	Unknown	Vol #:	6

C 262	Marie Lutz	Vol #:	6

LET 1	Galfand Berger LLP	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

CCP 2	HiFi DNA Tech, LLC	Vol #:	5

2007P-0320	Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers

ACK 1	FDA/DDM to Sanford Lewis	Vol #:	1

C 1	MedAssets Supply Chain Systems	Vol #:	1

CP 1	Health Care Without Harm	Vol #:	1

Page created on August 17, 2007 ue

FDA/Dockets Management