Dockets Entered on June 18, 2007

Dockets Management



Dockets Entered On June 18, 2007



Docket #	Title

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

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

2002N-0275	Bioterrorism Preparedness; Administrative Detention

2002N-0276	Bioterrorism Preparedness; Registration of Food Facilities

2003N-0573	Draft Animal Cloning Risk Assessment

2004N-0184	Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food

2004N-0257	Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle

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

2005P-0146	to establish guidance or regulations providing bioequivalence requirement for oral locally-acting gastrointestinal(GI) drug products prior to approval of any generic versions of such drugs

2006D-0480	Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food D Drug Administration

2006P-0253	ANDA Suitability for Loperamide Hydrochloride

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

2007D-0027	Voluntary Self Inspection of Medicated Feed Manufacturing Facilities

2007D-0083	Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process

2007D-0106	Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection

2007D-0117	Guidance for Industry on Orally Disintegrating Tablets

2007N-0051	Safety of Fresh Produce; Public Hearings

2007N-0121	Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing

2007N-0217	Licensure of Apheresis Blood Products; Public Workshop

2007N-0225	Anthrax Vaccines - Bridging Correlates of Protection in Animals to Immunogenicity in Humans; Public Workshop

2007P-0235	Change the labeling requirements for eggs sold in the United States

2007P-0237	Clear new susceptibility test devices or modification of existing devices using Clinical and Laboratory Standards Institute (CLSI) interpretive breakpoints in those instances regarding susceptibility

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

LET 20214	Next Proteins, Inc.	Vol #:	176

LET 20215	Next Proteins, Inc.	Vol #:	176

LET 20216	Next Proteins, Inc.	Vol #:	176

LET 20217	Integrity Nutraceuticals	Vol #:	176

LET 20218	DHC USA Incorporated	Vol #:	176

LET 20219	Coromega Company, Inc.	Vol #:	176

LET 20220	JOL Management	Vol #:	176

LET 20221	Natural Factors Nutritional Products, Inc.	Vol #:	177

LET 20222	Natural Factors Nutritional Products	Vol #:	177

LET 20223	Bayer Consumer Care Division	Vol #:	177

LET 20224	Bayer Consumer Care Division	Vol #:	177

LET 20225	Kura Natural, Inc.	Vol #:	177



LET 20226	McLind Corporation	Vol #:	177

LET 20227	McLind Corporation	Vol #:	177

LET 20228	McLind Corporation	Vol #:	177

LET 20229	McLind Corporation	Vol #:	177

LET 20230	McLind Corporation	Vol #:	177

LET 20231	McLind Corporation	Vol #:	177

LET 20232	McLind Corporation	Vol #:	177

LET 20233	McLind Corporation	Vol #:	177

LET 20234	McLind Corporation	Vol #:	177

LET 20235	McLind Corporation	Vol #:	177

LET 20236	McLind Corporation	Vol #:	177

LET 20237	McLind Corporation	Vol #:	177

LET 20238	McLind Corporation	Vol #:	177

LET 20239	McLind Corporation	Vol #:	177

LET 20240	McLind Corporation	Vol #:	177

LET 20241	McLind Corporation	Vol #:	177

LET 20242	McLind Corporation	Vol #:	177

LET 20243	McLind Corporation	Vol #:	177

LET 20244	McLind Corporation	Vol #:	177

LET 20245	McLind Corporation	Vol #:	177

LET 20246	McLind Corporation	Vol #:	177

LET 20247	McLind Corporation	Vol #:	177

LET 20248	McLind Corporation	Vol #:	177

LET 20249	McLind Corporation	Vol #:	177

LET 20250	McLind Corporation	Vol #:	177

LET 20251	McLind Corporation	Vol #:	177

LET 20252	McLind Corporation	Vol #:	177

LET 20253	McLind Corporation	Vol #:	177

LET 20254	McLind Corporation	Vol #:	177

LET 20255	McLind Corporation	Vol #:	177

LET 20256	McLind Corporation	Vol #:	177

LET 20257	McLind Corporation	Vol #:	177

LET 20258	McLind Corporation	Vol #:	177

LET 20259	McLind Corporation	Vol #:	177

LET 20260	McLind Corporation	Vol #:	177

LET 20261	McLind Corporation	Vol #:	177

LET 20262	McLind Corporation	Vol #:	177



LET 20263	McLind Corporation	Vol #:	177

LET 20264	McLind Corporation	Vol #:	177

LET 20265	McLind Corporation	Vol #:	177

LET 20266	McLind Corporation	Vol #:	177

LET 20267	Enzymatic Therapy, Inc.	Vol #:	177

LET 20268	Enzymatic Therapy, Inc.	Vol #:	177

LET 20269	Enzymatic Therapy, Inc.	Vol #:	177

LET 20270	Enzymatic Therapy, Inc.	Vol #:	177

LET 20271	Enzymatic Therapy, Inc.	Vol #:	177

LET 20272	Enzymatic Therapy, Inc	Vol #:	177

LET 20273	Enzymatic Therapy, Inc	Vol #:	177

LET 20274	Enzymatic Therapy, Inc	Vol #:	177

LET 20275	Enzymatic Therapy, Inc	Vol #:	177

LET 20276	Enzymatic Therapy, Inc	Vol #:	177

LET 20277	Enzymatic Therapy, Inc	Vol #:	177

LET 20278	Enzymatic Therapy, Inc	Vol #:	177

LET 20279	Source Naturals	Vol #:	177

LET 20280	Source Naturals	Vol #:	177

LET 20281	Source Naturals	Vol #:	177

LET 20282	McLind Corporation	Vol #:	177

LET 20283	McLind Corporation	Vol #:	177

LET 20284	McLind Corporation	Vol #:	177

LET 20285	McLind Corporation	Vol #:	177

LET 20286	Enzymatic Therapy, Inc.	Vol #:	177

LET 20287	Enzymatci Therapy, Inc.	Vol #:	177

LET 20288	Enzymatci Therapy, Inc.	Vol #:	177

LET 20289	Enzymatci Therapy, Inc.	Vol #:	177

LET 20290	Enzymatci Therapy, Inc.	Vol #:	177

LET 20291	Enzymatci Therapy, Inc.	Vol #:	177

LET 20292	DHC USA Incorporated	Vol #:	177

LET 20293	New Chapter, Inc.	Vol #:	177

LET 20294	New Chapter, Inc.	Vol #:	177

LET 20295	New Chapter, Inc.	Vol #:	177

LET 20296	New Chapter, Inc.	Vol #:	177

LET 20297	New Chapter, Inc.	Vol #:	177

LET 20298	New Chapter, Inc.	Vol #:	177

LET 20299	New Chapter, Inc.	Vol #:	177



LET 20300	New Chapter, Inc.	Vol #:	177

LET 20301	New Chapter, Inc.	Vol #:	177

LET 20302	New Chapter, Inc.	Vol #:	177

LET 20303	New Chapter, Inc.	Vol #:	177

LET 20304	New Chapter, Inc.	Vol #:	177

LET 20305	New Chapter, Inc.	Vol #:	177

LET 20306	New Chapter, Inc.	Vol #:	177

LET 20307	ProCaps Laboratories	Vol #:	177

LET 20308	Leiner Health Products	Vol #:	178

LET 20309	Leiner Health Products	Vol #:	178

LET 20310	Leiner Health Products	Vol #:	178

LET 20311	Leiner Health Products	Vol #:	178

LET 20312	Leiner Health Products	Vol #:	178

LET 20313	Leiner Health Products	Vol #:	178

LET 20314	Leiner Health Products	Vol #:	178

LET 20315	Leiner Health Products	Vol #:	178

LET 20316	Leiner Health Products	Vol #:	178

LET 20317	Leiner Health Products	Vol #:	178

LET 20318	Leiner Health Products	Vol #:	178

LET 20319	Leiner Health Products	Vol #:	178

LET 20320	Leiner Health Products	Vol #:	178

LET 20321	Leiner Health Products	Vol #:	178

LET 20322	Leiner Health Products	Vol #:	178

LET 20323	McLind Corporation	Vol #:	178

LET 20324	Enzymatic Therapy, Inc.	Vol #:	178

LET 20325	Source Naturals	Vol #:	178

LET 20326	Source Naturals	Vol #:	178

LET 20327	Source Naturals	Vol #:	178

LET 20328	Source Naturals	Vol #:	178

LET 20329	Wellness International Network, Ltd.	Vol #:	178

LET 20330	Wellness International Network, Ltd.	Vol #:	178

LET 20331	Wellness International Network, Ltd.	Vol #:	178

LET 20332	Wellness International Network, Ltd.	Vol #:	178

LET 20333	Wellness International Network, Ltd.	Vol #:	178

LET 20334	Wellness International Network, Ltd.	Vol #:	178

LET 20335	Wellness International Network, Ltd.	Vol #:	178

LET 20336	Wellness International Network, Ltd.	Vol #:	178



LET 20337	Wellness International Network, Ltd.	Vol #:	178

LET 20338	Wellness International Network, Ltd.	Vol #:	178

LET 20339	Wellness International Network, Ltd.	Vol #:	178

LET 20340	Wellness International Network, Ltd.	Vol #:	178

LET 20341	Wellness International Network, Ltd.	Vol #:	178

LET 20342	Wellness International Network, Ltd.	Vol #:	178

LET 20343	Wellness International Network, Ltd.	Vol #:	178

LET 20344	Wellness International Network, Ltd.	Vol #:	178

LET 20345	Wellness International Network, Ltd.	Vol #:	178

LET 20346	Wellness International Network, Ltd.	Vol #:	178

LET 20347	Wellness International Network, Ltd.	Vol #:	178

LET 20348	Wellness International Network, Ltd.	Vol #:	178

LET 20349	Wellness International Network, Ltd.	Vol #:	178

LET 20350	Wellness International Network, Ltd.	Vol #:	178

LET 20351	Wellness International Network, Ltd.	Vol #:	178

LET 20352	Wellness International Network, Ltd.	Vol #:	178

LET 20353	NBTY Inc.	Vol #:	178

LET 20354	NBTY Inc.	Vol #:	178

LET 20355	NBTY Inc.	Vol #:	178

LET 20356	Enzymatic Therapy, Inc.	Vol #:	178

LET 20357	Enzymatic Therapy, Inc.	Vol #:	178

LET 20358	Enzymatic Therapy, Inc.	Vol #:	178

LET 20359	Enzymatic Therapy, Inc.	Vol #:	178

LET 20360	Enzymatic Therapy, Inc.	Vol #:	178

LET 20361	Enzymatic Therapy, Inc.	Vol #:	178

LET 20362	Enzymatic Therapy, Inc.	Vol #:	178

LET 20363	Enzymatic Therapy, Inc.	Vol #:	178

LET 20364	Enzymatic Therapy, Inc.	Vol #:	178

LET 20365	Enzymatic Therapy, Inc.	Vol #:	178

LET 20366	Enzymatic Therapy, Inc.	Vol #:	178

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

C 1419	R. Rudis	Vol #:	262

2002N-0275	Bioterrorism Preparedness; Administrative Detention

REF 2	OMB Review	Vol #:	14

2002N-0276	Bioterrorism Preparedness; Registration of Food Facilities



REF 5	OMB Review	Vol #:	28

2003N-0573	Draft Animal Cloning Risk Assessment

C 3936	J. Marino	Vol #:	238

C 3937	C. Rogers	Vol #:	238

C 3938	G. Satterfield	Vol #:	238

C 3939	J. Vegan	Vol #:	238

C 3940	S. Miller	Vol #:	238

C 3941	S. Brown`	Vol #:	238

C 3942	N. Harris	Vol #:	238

C 3943	D. Failla	Vol #:	238

C 3944	C. Dodds	Vol #:	238

C 3945	R. Schaef	Vol #:	238

C 3946	W. Jewell	Vol #:	238

C 3947	J. Chemes	Vol #:	238

C 3948	K. Treiber	Vol #:	238

C 3949	S. Lanier	Vol #:	238

C 3950	K. Kent	Vol #:	238

C 3951	G. Lewis	Vol #:	238

C 3952	T. Wirth	Vol #:	238

C 3953	A. Valdez	Vol #:	238

C 3954	L. Dadgar	Vol #:	238

C 3955	C. Wells	Vol #:	238

C 3956	J. St. Cyr	Vol #:	238

C 3957	S. Kepner	Vol #:	238

C 3958	C. Cheng	Vol #:	238

C 3959	K. Kawazoe	Vol #:	238

C 3960	D. Greene	Vol #:	238

C 3961	S. Ansorge	Vol #:	238

C 3962	A. Meyer	Vol #:	238

C 3963	L. Henry	Vol #:	238

C 3964	K. Ventura	Vol #:	238

C 3965	J. Paolucci	Vol #:	238

C 3966	D. Bales	Vol #:	238

C 3967	M. Goscilo	Vol #:	238

C 3968	G. Salatrik	Vol #:	238

C 3969	D.Lynch	Vol #:	238



C 3970	L. D'ovidio	Vol #:	238

C 3971	T. Tweed	Vol #:	238

C 3972	D. Becker	Vol #:	238

C 3973	D. Lamb	Vol #:	238

C 3974	D. Moore	Vol #:	238

C 3975	G. Ollmann	Vol #:	238

C 3976	A. Griffin	Vol #:	238

C 3977	J. Izzo	Vol #:	238

C 3978	J. Shannon	Vol #:	238

C 3979	A. Scotomayor	Vol #:	238

C 3980	M. Thacker	Vol #:	238

C 3981	C. Santigo	Vol #:	238

C 3982	J. Woltz-Nurani	Vol #:	238

C 3983	C. Bloom	Vol #:	238

C 3984	G. Thomas	Vol #:	238

C 3985	J. Harnett	Vol #:	238

C 3986	C. Fischer	Vol #:	238

C 3987	L. Rom	Vol #:	238

C 3988	L. Denny	Vol #:	238

C 3989	P. Berry	Vol #:	238

C 3990	J. Courtemanche	Vol #:	238

C 3991	J. Farrell	Vol #:	238

C 3992	J. Beard	Vol #:	238

C 3993	J. King	Vol #:	238

C 3994	T. Havens	Vol #:	238

C 3995	J. Oliver	Vol #:	238

C 3996	V. Markovich	Vol #:	238

C 3997	B. Sanders	Vol #:	238

C 3998	M. Burke	Vol #:	238

C 3999	H. Gietl	Vol #:	238

C 4000	J. Lavin	Vol #:	238

C 4001	K. Martellaro	Vol #:	238

C 4002	C. Holmquist	Vol #:	238

C 4003	M. Ruhr	Vol #:	238

C 4004	C. Tritt	Vol #:	238

C 4005	M. Thomas and 4 other signatures	Vol #:	238

C 4006	A. Floolis	Vol #:	238



C 4007	M. Cichy	Vol #:	238

C 4008	G. Burrey	Vol #:	238

C 4009	T. Louie	Vol #:	238

C 4010	M. Stillings	Vol #:	238

C 4011	S. Beers	Vol #:	238

C 4012	C, Wright	Vol #:	238

C 4013	P. Fisher	Vol #:	238

2004N-0184	Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food

REF 1	OMB Review	Vol #:	3

2004N-0257	Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle

REF 2	OMB Review	Vol #:	7

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

C 120	L. Grunseth	Vol #:	8

2005P-0146	to establish guidance or regulations providing bioequivalence requirement for oral locally-acting gastrointestinal(GI) drug products prior to approval of any generic versions of such drugs



SUP 3	Salix Pharmaceuticals, Inc.	Vol #:	1

2006D-0480	Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food D Drug Administration

C 1021	J. & S. Baer	Vol #:	22

C 1022	R. Potts	Vol #:	22

C 1023	L. Clifft	Vol #:	22

C 1024	N. Beers	Vol #:	22

C 1025	D. Wilson	Vol #:	22

C 1026	K. Hernandez	Vol #:	22

C 1027	J. Hernandez	Vol #:	22

C 1028	S. Zeiser	Vol #:	22

C 1029	The Rolf Institute	Vol #:	22

C 1030	L. Cootz	Vol #:	22

C 1031	V. Corley	Vol #:	22

C 1032	S. Harbach	Vol #:	22

C 1033	J. Finch	Vol #:	22

C 1034	E. Simmons	Vol #:	22

C 1035	M. Fleming	Vol #:	22

C 1036	T. Casper	Vol #:	22

C 1037	N. Arbuckle	Vol #:	22



C 1038	J. Martin	Vol #:	22

C 1039	C. Rosati	Vol #:	22

C 1040	V. Freels	Vol #:	22

C 1041	Best Eastern Acupuncture & Herbal Clinic	Vol #:	22

C 1042	L. Nishimura	Vol #:	22

C 1043	A. Messer	Vol #:	22

C 1044	R. Schriefer	Vol #:	22

C 1045	J. Powell	Vol #:	22

C 1046	K. Hubbard	Vol #:	22

C 1047	L. Marko	Vol #:	22

C 1048	M. Cunney	Vol #:	22

C 1049	L. Robinson	Vol #:	22

C 1050	N. Huffman	Vol #:	22

C 1051	J. Casper	Vol #:	22

C 1052	M. Shimkin	Vol #:	22

C 1053	E. Andrew	Vol #:	22

C 1054	M. Cavinder	Vol #:	22

C 1055	Georgia Council of Chiropractice, Inc.	Vol #:	22

C 1056	G. Douthit	Vol #:	22

C 1057	P. Pape	Vol #:	22

C 1058	E. Makabe	Vol #:	22

C 1059	M. Wilson and 107 signatures	Vol #:	22

C 1060	P. Meyer	Vol #:	22

C 1061	The Natural Products Association	Vol #:	22

C 1062	Institute of Health Science	Vol #:	22

C 1063	A. Steinhardt	Vol #:	22

C 1064	N. Gonzalez	Vol #:	22

C 1065	M. Cada	Vol #:	22

C 1066	M. & P. Schneider	Vol #:	22

C 1067	B. & A. Cave	Vol #:	22

C 1068	B. Brown	Vol #:	22

C 1069	P. Thomas	Vol #:	22

C 1070	Y. Ma	Vol #:	22

C 1071	M. Jenkins	Vol #:	22

C 1072	W. Rudnick	Vol #:	22

C 1073	K.	Vol #:	22

C 1074	L. Hill	Vol #:	22



C 1075	HeteroGeneity, LLC	Vol #:	22

C 1076	E. Allison	Vol #:	22

C 1077	K. McCormick-Hanson	Vol #:	23

C 1078	C. Allen	Vol #:	23

C 1079	P. Zhong-Fong	Vol #:	23

C 1080	K. Whitcoe	Vol #:	23

C 1081	M. Wilson	Vol #:	23

C 1082	L. & J. McCurdy	Vol #:	22

C 1083	H. Wright	Vol #:	23

C 1084	S. Tegarden	Vol #:	23

C 1085	K. Verhoorn	Vol #:	23

C 1086	D. Owen	Vol #:	23

C 1087	L. Carbo	Vol #:	23

C 1088	B. Buttram	Vol #:	23

C 1089	E. Allison	Vol #:	23

C 1090	T. Davis	Vol #:	23

C 1091	MacCator	Vol #:	23

C 1092	J. Ganley	Vol #:	23

C 1093	W. Spina	Vol #:	23

C 1094	L. Roberts	Vol #:	23

C 1095	G. Griffin	Vol #:	23

C 1096	T. Reckwerdt	Vol #:	23

C 1097	C. Campbell	Vol #:	23

C 1098	Bristol Financial Services	Vol #:	23

C 1099	D. Austin	Vol #:	23

C 1100	C. Whalen	Vol #:	23

C 1101	Jones Family, Brooks Family and others	Vol #:	23

C 1102	L. Erdman	Vol #:	23

C 1103	D. Decker	Vol #:	23

C 1104	L. Hill	Vol #:	23

C 1105	The American Association of Naturopathic Physicians	Vol #:	23

C 1106	S. Calhoun	Vol #:	23

C 1107	R. Buchanan	Vol #:	23

C 1108	G. Whitener	Vol #:	23

C 1109	G. Whitener	Vol #:	23

C 1110	B. Lee	Vol #:	23

C 1111	K. Cavinder	Vol #:	23



C 1112	A. Leuice	Vol #:	23

C 1113	R. Hall	Vol #:	23

C 1114	D. Soyer	Vol #:	23

C 1115	M. Delaney	Vol #:	23

C 1116	Grace Chiropractice & Hands On Therapy	Vol #:	23

C 1117	M. Newburg	Vol #:	23

C 1118	A. Hunt	Vol #:	23

C 1119	Stanislaus Acupuncture & Natural Health Care	Vol #:	23

C 1120	L. Revander	Vol #:	23

C 1121	D. Moreno	Vol #:	23

C 1122	M. Levy	Vol #:	23

C 1123	B. Wolenec	Vol #:	23

C 1124	B. Jagiello	Vol #:	23

C 1125	J. Tackett	Vol #:	23

C 1126	M. Cox	Vol #:	23

C 1127	L. Taavola	Vol #:	23

C 1128	R. Boyd	Vol #:	23

C 1129	C. Mogle	Vol #:	23

C 1130	C. Alvar	Vol #:	23

C 1131	F. Draus	Vol #:	23

C 1132	R. Montserrat	Vol #:	23

C 1133	D. Risinger	Vol #:	23

C 1134	G. Greenlees	Vol #:	23

C 1135	M. Nelson	Vol #:	23

C 1136	I. Ely	Vol #:	23

C 1137	K. Fuller	Vol #:	23

C 1138	M. Braisted	Vol #:	23

C 1139	V. Yawn	Vol #:	23

C 1140	W. Robb	Vol #:	23

C 1141	S. Klenk	Vol #:	23

C 1142	Congress of the United States House of Represenatives	Vol #:	23

C 1143	J. Parke	Vol #:	23

C 1144	I. Holifield	Vol #:	23

C 1145	Sacramento Natural Foods Co-op	Vol #:	23

C 1146	V. Yoder	Vol #:	23

C 1147	L. & C. Brack	Vol #:	23

C 1148	N. & B. Heironimus	Vol #:	23



C 1149	F. & N. Cranmer	Vol #:	23

C 1150	H. Wu	Vol #:	23

C 1151	N. Yumol	Vol #:	23

C 1152	J. Brewer	Vol #:	23

C 1153	I. Middlebrooks-Hightower	Vol #:	24

C 1154	R. Fast	Vol #:	24

C 1155	K. Kurtz	Vol #:	24

C 1156	L. & M. Kapp	Vol #:	24

C 1157	D. Stanley	Vol #:	24

C 1158	J. Lee	Vol #:	24

C 1159	A. Hasley	Vol #:	24

C 1160	F. Simensen	Vol #:	24

C 1161	F. Simensen	Vol #:	24

C 1162	J. Warner	Vol #:	24

C 1163	A. Katz	Vol #:	24

C 1164	A. Lewis	Vol #:	24

C 1165	S. Hanson	Vol #:	24

C 1166	J. Cappelli	Vol #:	24

C 1167	J. Guhl	Vol #:	24

C 1168	K. Beaufeaux	Vol #:	24

C 1169	T. Zirkle	Vol #:	24

C 1170	C. Zirkle	Vol #:	24

C 1171	M. Carver	Vol #:	24

C 1172	Harrison Chiropractice Center, P. C.	Vol #:	24

C 1173	A. Stanczyk	Vol #:	24

C 1174	D. Kurtzman	Vol #:	24

C 1175	M.	Vol #:	24

C 1176	E. Atchley	Vol #:	24

C 1177	S. Achurra	Vol #:	24

C 1178	E. Rausch	Vol #:	24

C 1179	M. Casey	Vol #:	24

C 1180	P. Heffenstein	Vol #:	24

C 1181	M. Gregory	Vol #:	24

C 1182	K. & L. Taylor	Vol #:	24

C 1183	R. Allen, P. Walker & K. Wentworth	Vol #:	24

C 1184	S. & B. Achurra	Vol #:	24

C 1185	R. Rodriguez	Vol #:	24



C 1186	M. Daugherty & W. Miller	Vol #:	24

C 1187	J. Doucette	Vol #:	24

C 1188	S. Burgio	Vol #:	24

C 1189	G. Hamilton	Vol #:	24

C 1190	M. Artege, M. Amenn & A. Nicholas	Vol #:	24

C 1191	G. Adomurine & C. Adamiec	Vol #:	24

C 1192	A. Graber	Vol #:	24

C 1193	S. Airov-Bieling	Vol #:	24

C 1194	E. Liel	Vol #:	24

C 1195	S. Williams	Vol #:	24

C 1196	A. King	Vol #:	24

C 1197	C. Musch	Vol #:	24

C 1198	D. Holley	Vol #:	24

C 1199	J. White	Vol #:	24

C 1200	L. Neilson	Vol #:	24

C 1201	G. Greenlees	Vol #:	24

C 1202	D. Dettor	Vol #:	24

C 1203	C. Bottomley	Vol #:	24

C 1204	M. Jaffe	Vol #:	24

C 1205	D. Miller-Smiley	Vol #:	24

C 1206	H. DeHoff	Vol #:	24

C 1207	No Signature	Vol #:	24

C 1208	T. Sparks	Vol #:	24

C 1209	K. Sparks	Vol #:	24

C 1210	L. Low	Vol #:	24

C 1211	D. Frese	Vol #:	24

C 1212	T. Insulia	Vol #:	24

C 1213	N. Gonzalez	Vol #:	24

C 1214	H. Elliott	Vol #:	24

C 1215	S. Teague	Vol #:	24

C 1216	L. Nicholson	Vol #:	24

C 1217	R. Stover	Vol #:	24

C 1218	F. & A. Adamson	Vol #:	24

C 1219	C. Nosler	Vol #:	24

C 1220	Illegible	Vol #:	24

C 1221	J. Hattori	Vol #:	24

C 1222	C. Grohmann	Vol #:	24



C 1223	No Signature	Vol #:	24

C 1224	J. Dixon	Vol #:	24

C 1225	E. Aktar	Vol #:	24

C 1226	D. Frese	Vol #:	24

C 1227	Y. J. Cao, P. Delvecchio, J. Bordiak et al	Vol #:	24

C 1228	M. Leichter & A. Lowe-Suehter	Vol #:	24

C 1229	L. Buchanan	Vol #:	24

C 1230	J. Olivett	Vol #:	24

C 1231	H. Boals	Vol #:	24

C 1232	C. Saphir	Vol #:	24

C 1233	M. Gross & D. Bernier	Vol #:	25

C 1234	D. Hodges	Vol #:	25

C 1235	R. Rivera	Vol #:	25

C 1236	R. Vedder	Vol #:	25

C 1237	Wellgenity Centers of America	Vol #:	25

C 1238	E. Tischler	Vol #:	25

C 1239	Biomed Comm, Inc.	Vol #:	25

C 1240	D. & D. Seibold	Vol #:	25

C 1241	S. Hanson	Vol #:	25

C 1242	C. Hale	Vol #:	25

C 1243	P. Taylor	Vol #:	25

C 1244	Alpha & Omega Creations	Vol #:	25

C 1245	M. Cracchiolo	Vol #:	25

C 1246	W. Kraeger	Vol #:	25

C 1247	S. Neal	Vol #:	25

C 1248	J. Becher	Vol #:	25

C 1249	C. Agvele	Vol #:	25

C 1250	A. Hughes	Vol #:	25

C 1251	J. Melville	Vol #:	25

C 1252	American Holistic Nurses Association	Vol #:	25

C 1253	D. Hensinger	Vol #:	25

C 1254	M. Bailey	Vol #:	25

C 1255	B. Walker	Vol #:	25

C 1256	C. Dailey	Vol #:	25

C 1257	A. Tobin	Vol #:	25

C 1258	K. Kistler	Vol #:	25

C 1259	N. Gonzalez	Vol #:	25



C 1260	L. Bradak	Vol #:	25

C 1261	G. Gajeski	Vol #:	25

C 1262	S. Bourassa	Vol #:	25

C 1263	B. Rhodes	Vol #:	25

C 1264	A. Clark	Vol #:	25

C 1265	United Natural Products Alliance	Vol #:	25

C 1266	R. Alswager	Vol #:	25

C 1267	R. Ortiz	Vol #:	25

C 1268	D. Boogaard	Vol #:	25

C 1269	Pure Pro Massage Oils, Inc.	Vol #:	25

C 1270	Ojai Herb & Acupuncture Clinic	Vol #:	25

C 1271	R. Tacy	Vol #:	25

C 1272	S. Grubb	Vol #:	25

C 1273	S. Martin	Vol #:	25

C 1274	Z. Wilson	Vol #:	25

C 1275	J. Fabatz	Vol #:	25

C 1276	T. Ziadle	Vol #:	25

C 1277	N. Siron	Vol #:	25

C 1278	Council for Responsible Nutrition	Vol #:	25

C 1279	Citizens for Health	Vol #:	25

C 1280	National Health Freedom Action	Vol #:	25

LET 5	Congress of the United States-House of Represenatives	Vol #:	25

M 1	FDA/Office of Policy & Planning	Vol #:	25

2006P-0253	ANDA Suitability for Loperamide Hydrochloride

LET 1	Kendle Regulatory Affairs	Vol #:	1

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

C 100	K. Kurma	Vol #:	7

2007D-0027	Voluntary Self Inspection of Medicated Feed Manufacturing Facilities

C 1	American Feed Industry Association	Vol #:	1

2007D-0083	Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process



C 2	Cook Group Incorporated	Vol #:	1

2007D-0106	Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection

C 4	Aultman	Vol #:	1



C 5	American Academy of Orthopaedic Surgeons	Vol #:	1

2007D-0117	Guidance for Industry on Orally Disintegrating Tablets

C 10	GlaxoSmithKline	Vol #:	1

2007N-0051	Safety of Fresh Produce; Public Hearings

C 11	Food & Water Watch	Vol #:	2

2007N-0121	Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing

C 1	Aurora Pharmacy	Vol #:	7

2007N-0217	Licensure of Apheresis Blood Products; Public Workshop

NM 1	FDA	Vol #:	1

2007N-0225	Anthrax Vaccines - Bridging Correlates of Protection in Animals to Immunogenicity in Humans; Public Workshop

NM 1	FDA	Vol #:	1

2007P-0235	Change the labeling requirements for eggs sold in the United States

LET 1	Federal Trade Commission	Vol #:	1

2007P-0237	Clear new susceptibility test devices or modification of existing devices using Clinical and Laboratory Standards Institute (CLSI) interpretive breakpoints in those instances regarding susceptibility



ACK 1	FDA/DDM to Clinical and Laboratory Standards Institute	Vol #:	1

CP 1	Clinical and Laboratory Standards Institute	Vol #:	1

Page created on June 19, 2007 ue

FDA/Dockets Management