Dockets Entered on August 22, 2007

Dockets Management



Dockets Entered On August 22, 2007



Docket #	Title

2005D-0490	Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)

2005N-0446	Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients

2006F-0225	Safe Use of glycerol ester of tall oil rosin to adjust the density of citrus oils used in preparations of beverages(FAP 6A4765); to amend the food additive regulations in 21 CFR 172.735

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

2006O-0231	Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredient

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

2007D-0125	Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims

2007N-0267	Medical Devices; General and Plastic Surgery Devices; Classification of Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology

2007N-0321	Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct

2007V-0314	Laser Light Show

2005D-0490	Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)

ANS 1	FDA/CFSAN	Vol #:	1

LET 1	Originz, LLC	Vol #:	1

2005N-0446	Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients

SUP 1	Ciba Specialty Chemicals Corporation	Vol #:	4

SUP 2	Ciba Specialty Chemicals Corporation	Vol #:	10

2006F-0225	Safe Use of glycerol ester of tall oil rosin to adjust the density of citrus oils used in preparations of beverages(FAP 6A4765); to amend the food additive regulations in 21 CFR 172.735

NFR 1	FDA	Vol #:	1

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

C 1361	H. Lucht	Vol #:	15

C 1362	R. Briggs	Vol #:	15

C 1363	A. White	Vol #:	15

C 1364	M. Steele	Vol #:	15

C 1365	H Miller	Vol #:	15

C 1366	E Kelly	Vol #:	15

C 1367	E Sopa	Vol #:	15

C 1368	C Jerome	Vol #:	15

C 1369	D Scherff	Vol #:	15

C 1370	Y Davis	Vol #:	15

C 1371	B Himsel	Vol #:	15

C 1372	J Goetz	Vol #:	15

C 1373	C Rawlins	Vol #:	15

C 1374	R Brown	Vol #:	15



C 1375	G Kohler	Vol #:	15

C 1376	A Vantyle	Vol #:	15

C 1377	M Jump	Vol #:	15

C 1378	M Swan	Vol #:	15

C 1379	J Bostic	Vol #:	15

C 1380	L Charles	Vol #:	15

C 1381	P Jewell	Vol #:	15

C 1382	C Lassaro	Vol #:	15

C 1383	E Sheets	Vol #:	15

C 1384	J Holmberg	Vol #:	15

C 1385	M Morra	Vol #:	15

C 1386	H Graetz	Vol #:	15

C 1387	I Belzar	Vol #:	15

C 1388	L Showalter	Vol #:	15

C 1389	W Smith	Vol #:	15

C 1390	L Rodgers	Vol #:	15

C 1391	K. Lloyd	Vol #:	15

C 1392	D. Powers	Vol #:	15

C 1393	R. Jenney	Vol #:	15

C 1394	M Davisson	Vol #:	15

C 1395	E Ridley	Vol #:	15

C 1396	P Rothman	Vol #:	15

C 1397	A Cook	Vol #:	15

C 1398	J Kelly	Vol #:	15

C 1399	P Henson	Vol #:	15

C 1400	M Borer	Vol #:	15

C 1401	D Garrett	Vol #:	15

C 1402	C Lobdell	Vol #:	15

C 1403	R Cogburn	Vol #:	15

C 1404	T Ciezki	Vol #:	15

C 1405	C Munt	Vol #:	15

C 1406	L Burns	Vol #:	15

C 1407	R Sellars	Vol #:	15

C 1408	R Simpson Sr	Vol #:	15

C 1409	J Eurich	Vol #:	15

C 1410	L Bruha	Vol #:	15

C 1411	J Smith	Vol #:	15



C 1412	R Triebdd	Vol #:	15

C 1413	C Kitchen	Vol #:	15

C 1414	L Richford	Vol #:	15

C 1415	H Lefkofsky	Vol #:	15

C 1416	G Byars	Vol #:	15

C 1417	J Bailey	Vol #:	15

C 1418	E Rothrock	Vol #:	15

C 1419	S Papplardo	Vol #:	15

C 1420	R Richeson Sr	Vol #:	15

C 1421	R Durivage	Vol #:	15

C 1422	M Farmer	Vol #:	15

C 1423	M Johanneson	Vol #:	15

C 1424	B Evans	Vol #:	15

C 1425	J Wright	Vol #:	15

C 1426	M Holt	Vol #:	15

C 1427	L Smith	Vol #:	15

C 1428	P Yaccarino	Vol #:	15

C 1429	C Wakefield	Vol #:	15

C 1430	P Shelbourne	Vol #:	15

C 1431	E Harmon	Vol #:	15

C 1432	C Allen	Vol #:	15

C 1433	S Ello	Vol #:	15

C 1434	B Reif	Vol #:	15

C 1435	R Osweiler	Vol #:	15

C 1436	F Gossfeld	Vol #:	15

C 1437	J Hughes	Vol #:	15

C 1438	D Peters	Vol #:	15

C 1439	C Boehm	Vol #:	15

C 1440	L Jahsman	Vol #:	15

C 1441	R Abb	Vol #:	17

C 1442	A Mayonado	Vol #:	17

C 1443	J Sytsma	Vol #:	17

C 1444	M Militzer	Vol #:	17

C 1445	J Keal	Vol #:	17

C 1446	C Bolo	Vol #:	17

C 1447	F Perosko	Vol #:	17

C 1448	R. Torstenson	Vol #:	17



C 1449	P Jordan	Vol #:	17

C 1450	J Wininger	Vol #:	17

C 1451	E Ritzer	Vol #:	17

C 1452	S Lane	Vol #:	17

C 1453	D Bublitz	Vol #:	17

C 1454	R Main	Vol #:	17

C 1455	D Laman	Vol #:	17

C 1456	M Laudati	Vol #:	17

C 1457	M Campagnolo	Vol #:	17

C 1458	L Goodin	Vol #:	17

C 1459	L Thompson	Vol #:	17

C 1460	B Edwards	Vol #:	17

C 1461	B Smoke	Vol #:	17

C 1462	T Walsh	Vol #:	17

C 1463	W Denny	Vol #:	17

C 1464	D Walker	Vol #:	17

C 1465	P Arbuckle	Vol #:	17

C 1466	R Hewlett	Vol #:	17

C 1467	E Wenger	Vol #:	17

C 1468	J London	Vol #:	17

C 1469	M Bates	Vol #:	17

C 1470	B Lobur	Vol #:	17

C 1471	D Moors	Vol #:	17

C 1472	T Gattie	Vol #:	17

C 1473	C Megginson	Vol #:	17

C 1474	H Bowling	Vol #:	17

C 1475	D Taylor	Vol #:	17

C 1476	C. Everette	Vol #:	17

C 1477	P Raghuprasad	Vol #:	17

2006O-0231	Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredient

M 1	FDA/CDER/ONPD	Vol #:	2

M 2	3V, Inc.	Vol #:	5

MT 1	Memo of Tele/conv. Between Robert L. Hoegle and Michael Koenig	Vol #:	2

SUP 1	3V, Inc.	Vol #:	2

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



C 136	Robin Gruenfeld	Vol #:	7

C 137	Jeff Dorsen	Vol #:	7

C 138	Laurie Mills	Vol #:	7

2007D-0125	Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims

EMC 56	Lynnette Andureal	Vol #:	1

EMC 57	Jan Fowler	Vol #:	1

EMC 58	Jeff Batter	Vol #:	1

EMC 59	BJ Novack	Vol #:	1

EMC 60	Martha Cobb	Vol #:	1

EMC 61	Mary Mason	Vol #:	1

EMC 62	Bonnie Chiara	Vol #:	1

EMC 63	Norma Raymond	Vol #:	1

EMC 64	Catherine Syrett	Vol #:	1

EMC 65	Joanna Conrad-Pacelli	Vol #:	1

EMC 66	Alfred Mateczun	Vol #:	1

EMC 67	Beverly Cox	Vol #:	1

EMC 68	Brian Haring	Vol #:	1

EMC 69	Carrie Lynch	Vol #:	1

EMC 70	Joseph Clews	Vol #:	1

EMC 71	Lin Crider	Vol #:	1

EMC 72	Terrye Seckinger	Vol #:	1

EMC 73	Joseph Lucier	Vol #:	1

EMC 74	Sharrhan Williamson	Vol #:	1

EMC 75	Jennifer Youngberg	Vol #:	1

EMC 76	Lisa Land	Vol #:	1

EMC 77	Dorothy Blum	Vol #:	1

EMC 78	Margaret Weston	Vol #:	1

EMC 79	Raven Cox	Vol #:	1

EMC 80	Elliott Haines III	Vol #:	1

EMC 81	Airean Andureal	Vol #:	1

EMC 82	Tiffanie Lorensen	Vol #:	1

EMC 83	Hope Campbell	Vol #:	1

EMC 84	Wendy Levy	Vol #:	1

EMC 85	Jessica Lupien	Vol #:	1

EMC 86	Robert Kovacs	Vol #:	1

EMC 87	Kathleen Osta	Vol #:	1



EMC 88	Mirto Capeder	Vol #:	1

EMC 89	Sandra Lee	Vol #:	1

EMC 90	Lyle Brown	Vol #:	1

EMC 91	Louisa Dyer	Vol #:	1

EMC 92	Rini Twait	Vol #:	1

EMC 93	Kathleen Gresham	Vol #:	1

EMC 94	Blaise Gauba	Vol #:	1

EMC 95	Brad Burke	Vol #:	1

EMC 96	Dolores Darst	Vol #:	1

EMC 97	Karen Ragan-George	Vol #:	1

EMC 98	Jo Sanders	Vol #:	1

EMC 99	Paula Yates	Vol #:	1

EMC 100	Regina Kozak	Vol #:	1

EMC 101	Marilyn Morgan	Vol #:	1

EMC 102	Darrin Oakes	Vol #:	1

EMC 103	Dana Sherrell	Vol #:	1

EMC 104	Suzanne Jenkins	Vol #:	1

EMC 105	James Love	Vol #:	1

EMC 106	Erica Jordan	Vol #:	1

EMC 107	Brian Runyan	Vol #:	1

EMC 108	Jean Loggins	Vol #:	1

EMC 109	Roland Campos	Vol #:	1

EMC 110	Holli Diel	Vol #:	1

EMC 111	Eleanore Dunn	Vol #:	1

EMC 112	Tim Gettig	Vol #:	1

EMC 113	Robert Marshall	Vol #:	1

EMC 114	Karil Daniels	Vol #:	1

EMC 115	Suzanne Wasilik	Vol #:	1

2007N-0267	Medical Devices; General and Plastic Surgery Devices; Classification of Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology

BKG 1	Tepha, Inc	Vol #:	1

2007N-0321	Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct



N 1	FDA	Vol #:	1

2007V-0314	Laser Light Show

VRA 1	Lynne L. Rice	Vol #:	1

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FDA/Dockets Management