Dockets Entered on August 6, 2007

Dockets Management



Dockets Entered On August 6, 2007



Docket #	Title

1975N-0183F	Topical Antimicrobial Drug Products For OTC Human Use - First Aid

1975N-0183H	Health-Care Antiseptic Drug Products for OTC Human Use

1976N-0052N	OTC Nasal Decongestants

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

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

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

2006P-0160	Change Daranide Tablets, 50 mg to a generic version

2006P-0287	Determine Whether Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily withdrawn from sale for safety or efficacy reasons

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

2006P-0399	To determine whether PhosLo (calcium acetate) Tablets, eq 169 mg calcium, and PhosLo (calcuim acetate) Capsules, eq 169 mg calcium, has been withdrawn for safety or efficacy reasons

2006P-0446	ANDA for PHENERGAN Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg

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

2007M-0303	P050024 - CryoCor CryoAblation System

2007N-0179	Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop

2007N-0238	Medical Devices: The Mammography Quality Standards Act of 1992 and Subsequent Mammography Quality Standards Reauthorization Act and Amendments; Inspection Fees

1975N-0183F	Topical Antimicrobial Drug Products For OTC Human Use - First Aid

C 23	G. Drexler	Vol #:	13

1975N-0183H	Health-Care Antiseptic Drug Products for OTC Human Use

C 94	Greg Drexler	Vol #:	204

1976N-0052N	OTC Nasal Decongestants

C 253	Consumer Healthcare Product Association (CHPA)	Vol #:	86

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

LET 20525	Enzmatic	Vol #:	179

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

C 3378	V. Kreitling	Vol #:	39

C 3379	M. Lambert	Vol #:	39

C 3380	G. Wood	Vol #:	39

C 3381	J. Reid	Vol #:	39

C 3382	W. E. Baer	Vol #:	39

C 3383	L. Seno	Vol #:	39

C 3384	P. Bacon	Vol #:	39

C 3385	D. Pinkston	Vol #:	39



C 3386	T. Myers	Vol #:	39

C 3387	C. Tate	Vol #:	39

C 3388	L. Fahrner	Vol #:	39

C 3389	M. Oyola	Vol #:	39

C 3390	T. Damiano	Vol #:	39

C 3391	H. Lutrin	Vol #:	39

C 3392	J. Edie	Vol #:	39

C 3393	N. Allison	Vol #:	39

C 3394	L. Roper	Vol #:	39

C 3395	D. Yutzy	Vol #:	39

C 3396	L. J. Burgos	Vol #:	39

C 3397	L. Lucenta	Vol #:	39

C 3398	J. Gollihur	Vol #:	39

C 3399	B. Fitzpatrick	Vol #:	39

C 3400	C. Ring	Vol #:	39

C 3401	R. Butts	Vol #:	39

C 3402	L. Stone	Vol #:	39

C 3403	R. Stoeckel	Vol #:	39

C 3404	T. Sullivan	Vol #:	39

C 3405	N. Strandt	Vol #:	39

C 3406	T. Bertossi	Vol #:	39

C 3407	S. Floyd	Vol #:	39

C 3408	D. Herrera	Vol #:	39

C 3409	P. Gaffney	Vol #:	39

C 3410	D. Washington	Vol #:	39

C 3411	E. Whitton	Vol #:	39

C 3412	L. Kaplan	Vol #:	39

C 3413	D. Pelletier	Vol #:	39

C 3414	S. Fellman	Vol #:	39

C 3415	A. Moriarty	Vol #:	39

C 3416	V. Landis	Vol #:	39

C 3417	A. Gallardo-perez	Vol #:	39

C 3418	M. I. George	Vol #:	39

C 3419	F. Rinella	Vol #:	39

C 3420	C. Coley	Vol #:	39

C 3421	J. Compere	Vol #:	39

C 3422	J. Ferrante	Vol #:	39



C 3423	J. And M. Stoltenberg	Vol #:	39

C 3424	P. Jeden	Vol #:	39

C 3425	C. Newton	Vol #:	39

C 3426	R. Vanyi	Vol #:	39

C 3427	S. Miller	Vol #:	39

C 3428	J. I. Vincent	Vol #:	39

C 3429	S. Daly	Vol #:	39

C 3430	B. J. Wilcox	Vol #:	39

C 3431	V. Anderson	Vol #:	39

C 3432	M. Bogden	Vol #:	39

C 3433	A. Shampine	Vol #:	39

C 3434	J. Zoss	Vol #:	39

C 3435	M. Herzog	Vol #:	39

C 3436	A. Esner	Vol #:	39

C 3437	B. Bowman	Vol #:	39

C 3438	M. Rodriguez	Vol #:	39

C 3439	S. Bayer	Vol #:	39

C 3440	D. White	Vol #:	39

C 3441	T. Machado	Vol #:	39

C 3442	E. Wood	Vol #:	39

C 3443	M. Finchum	Vol #:	39

C 3444	K. Skrobiza	Vol #:	39

C 3445	G. Muenzler	Vol #:	39

C 3446	K. Owen	Vol #:	39

C 3447	E. Shampine	Vol #:	39

C 3448	V. Blessing	Vol #:	39

C 3449	R. Reichel	Vol #:	39

C 3450	K. Alberti	Vol #:	39

C 3451	A. Saldamando	Vol #:	39

C 3452	C. Price	Vol #:	39

C 3453	M. Benavides	Vol #:	39

C 3454	D. Mckitrick	Vol #:	39

C 3455	H. Cary	Vol #:	39

C 3456	Guy Boggs	Vol #:	39

C 3457	G. Tucker	Vol #:	39

C 3458	S. Goll	Vol #:	39

C 3459	P. Ferrari	Vol #:	39



C 3460	B. Swan	Vol #:	39

C 3461	L. Reyes	Vol #:	39

C 3462	M. Lee	Vol #:	39

C 3463	J. Sieling	Vol #:	39

C 3464	H. Malloy	Vol #:	39

C 3465	J. Guarisco	Vol #:	39

C 3466	C. D. Beardslee	Vol #:	39

C 3467	S. Whalen	Vol #:	39

C 3468	M. Pinckert	Vol #:	39

C 3469	R. A. Main	Vol #:	39

C 3470	B. Fritz	Vol #:	39

C 3471	L. K. Beard	Vol #:	39

C 3472	M. F. Krupa	Vol #:	39

C 3473	I. Mele	Vol #:	39

C 3474	W. Stremic	Vol #:	39

C 3475	S. Omalley	Vol #:	39

C 3476	P. Mcarthur	Vol #:	39

C 3477	M. Alford	Vol #:	39

C 3478	C. Jenkins	Vol #:	39

C 3479	C. Roell	Vol #:	39

C 3480	D. Ream	Vol #:	39

C 3481	B. Schanding	Vol #:	39

C 3482	H. Jackson	Vol #:	39

C 3483	R. Condict	Vol #:	39

C 3484	S. Pullen	Vol #:	39

C 3485	V. Seeley	Vol #:	39

C 3486	M. Rick	Vol #:	39

C 3487	K. J. Townsend	Vol #:	39

C 3488	B. Dirosse	Vol #:	39

C 3489	K. Marohn	Vol #:	39

C 3490	D. Maurer	Vol #:	39

C 3491	J. Orr	Vol #:	39

C 3492	M. Mutch	Vol #:	39

C 3493	J. Andrzejewski	Vol #:	39

C 3494	M. Harrison	Vol #:	39

C 3495	K. Ward	Vol #:	39

C 3496	D. Gatlin	Vol #:	39



C 3497	L. C. Granger	Vol #:	39

C 3498	L. Reuther	Vol #:	39

C 3499	J. O'connor	Vol #:	39

C 3500	M. Cremer	Vol #:	39

C 3501	P. Joshi	Vol #:	39

C 3502	H. Porter	Vol #:	39

C 3503	V. Myers	Vol #:	39

C 3504	J. Czubati	Vol #:	39

C 3505	Rev. T. Brown	Vol #:	39

C 3506	B. Jefferies	Vol #:	39

C 3507	M. Maginel	Vol #:	39

C 3508	M. Lewis	Vol #:	39

C 3509	R. Hosek	Vol #:	39

C 3510	R. A. Roth	Vol #:	39

C 3511	S. L. Johnston	Vol #:	39

C 3512	N. Bettinger	Vol #:	39

C 3513	C. Snively	Vol #:	39

C 3514	R. Stuart	Vol #:	39

C 3515	R. Martinez	Vol #:	39

C 3516	R. Young	Vol #:	39

C 3517	A. Jones	Vol #:	39

C 3518	S. Eames	Vol #:	39

C 3519	D. Waters	Vol #:	39

C 3520	J. Limbach	Vol #:	39

C 3521	D. Mendall	Vol #:	39

C 3522	D. Tickner	Vol #:	40

C 3523	Y. Quimby	Vol #:	40

C 3524	F. Greenlee	Vol #:	40

C 3525	P. Houseweart	Vol #:	40

C 3526	C. Timo	Vol #:	40

C 3527	K. Waxler	Vol #:	40

C 3528	P. Robertson	Vol #:	40

C 3529	K. Mclaren	Vol #:	40

C 3530	J. Bryan	Vol #:	40

C 3531	Bernadette Wesolowski	Vol #:	40

C 3532	T. Jeffries	Vol #:	40

C 3533	B. Norwood	Vol #:	40



C 3534	C. Barrett	Vol #:	40

C 3535	F. Powers	Vol #:	40

C 3536	G. Beals	Vol #:	40

C 3537	L. Brent	Vol #:	40

C 3538	G. Thomas	Vol #:	40

C 3539	P. Corral	Vol #:	40

C 3540	F. Scheffel	Vol #:	40

C 3541	K. Nadasky	Vol #:	40

C 3542	J. Eisenstein	Vol #:	40

C 3543	R. Wright	Vol #:	40

C 3544	D. Marvel	Vol #:	40

C 3545	M. Larson	Vol #:	40

C 3546	P. Kurth	Vol #:	40

C 3547	T. Wampler	Vol #:	40

C 3548	G. Brandt	Vol #:	40

C 3549	J. Lafleur	Vol #:	40

C 3550	B. Wilson	Vol #:	40

C 3551	S. Trumbo	Vol #:	40

C 3552	S. Herbert	Vol #:	40

C 3553	M. Monteleon	Vol #:	40

C 3554	D. Gilliam	Vol #:	40

C 3555	E. Oberweiser	Vol #:	40

C 3556	K. Honeycutt	Vol #:	40

C 3557	H. Pitre	Vol #:	40

C 3558	J. E. Farrell	Vol #:	40

C 3559	A. M. Skinner	Vol #:	40

C 3560	D. Clore	Vol #:	40

C 3561	D. Weinischke	Vol #:	40

C 3562	K. Sturtz	Vol #:	40

C 3563	M. Beaudin	Vol #:	40

C 3564	T. Lauro	Vol #:	40

C 3565	B. Crowley	Vol #:	40

C 3566	C. Morris	Vol #:	40

C 3567	S. Marshall	Vol #:	40

C 3568	G. Walker	Vol #:	40

C 3569	M. Thrantell	Vol #:	40

C 3570	E. Mcnamee	Vol #:	40



C 3571	R. Criner	Vol #:	40

C 3572	M. Mckay	Vol #:	40

C 3573	J. Davis	Vol #:	40

C 3574	M. Potkin	Vol #:	40

C 3575	E. Arena	Vol #:	40

C 3576	J. Matthews	Vol #:	40

C 3577	C. Gates	Vol #:	40

C 3578	C. Behrendt	Vol #:	40

C 3579	A. Drager	Vol #:	40

C 3580	S. Hong	Vol #:	40

C 3581	B. Batcheldor	Vol #:	40

C 3582	B. Deckard	Vol #:	40

C 3583	S. and A. Osborn	Vol #:	40

C 3584	K. Pettit	Vol #:	40

C 3585	W. Schmidt	Vol #:	40

C 3586	R. Gingerich	Vol #:	40

C 3587	G. Vince	Vol #:	40

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

C 105	W. & R. McKinstry	Vol #:	2

C 106	B. Freitag	Vol #:	2

C 107	R. Small	Vol #:	2

C 108	D. Silver	Vol #:	2

C 109	R. Droz	Vol #:	2

C 110	P. Averill	Vol #:	2

C 111	A. Torre	Vol #:	2

C 112	R. Kantrowitz	Vol #:	2

C 113	L. Monzo	Vol #:	2

C 114	A. Papp	Vol #:	2

C 115	A. Fussell	Vol #:	2

C 116	T. Nikolits	Vol #:	2

C 117	D. Frye	Vol #:	2

C 118	B. Schultz	Vol #:	2

C 119	E. Avers	Vol #:	2

C 120	J. Brenner	Vol #:	2

C 121	V. Lazar	Vol #:	2

C 122	S. Chan	Vol #:	2



C 123	K. Ogborn	Vol #:	2

C 124	S. Torimino	Vol #:	2

C 125	K. Kelly	Vol #:	2

C 126	J. Simmons	Vol #:	2

C 127	D. Kominsky	Vol #:	2

C 128	J. Gogan	Vol #:	2

C 129	M. Avila	Vol #:	2

C 130	C. Zajackowski	Vol #:	2

C 131	G. King	Vol #:	2

C 132	S. Dyson	Vol #:	2

C 133	D. Cortese	Vol #:	2

C 134	J.Malone	Vol #:	2

C 135	L. Muller	Vol #:	2

C 136	D. Leister	Vol #:	2

C 137	S. Levy	Vol #:	2

C 138	M. Ayers-Cumbow	Vol #:	2

C 139	D. Wenclewicz	Vol #:	2

C 140	S. Mann	Vol #:	2

C 141	R. Austin	Vol #:	2

C 142	N. Gamlam	Vol #:	2

C 143	B. Shaw	Vol #:	2

C 144	J. Hayes	Vol #:	2

C 145	C.Hudson	Vol #:	2

C 146	K. Hisey	Vol #:	2

C 147	M. Potvin	Vol #:	2

C 148	J. Hogan	Vol #:	2

C 149	B. Friedman	Vol #:	2

C 150	P. George	Vol #:	2

C 151	L. Goo	Vol #:	2

C 152	N. Lloyd	Vol #:	2

C 153	C. Moccia	Vol #:	2

C 154	J. Thomasson	Vol #:	2

C 155	M. Picoult	Vol #:	2

C 156	S. Finocchiaro	Vol #:	2

C 157	F. Stowman	Vol #:	2

C 158	K. Ryzewski	Vol #:	2

C 159	T. Wright	Vol #:	2



C 160	C. Cron	Vol #:	2

C 161	S. Wilson	Vol #:	2

C 162	M. King	Vol #:	2

C 163	E. LaMore	Vol #:	2

C 164	R. Poletti	Vol #:	2

C 165	D. Gussert	Vol #:	2

C 166	William Storms Allergy Clinic	Vol #:	2

C 167	M. Kaliner	Vol #:	2

C 168	H. Hough	Vol #:	3

C 169	W. Lilley	Vol #:	3

C 170	E. Chandler	Vol #:	3

C 171	L. Bozman	Vol #:	3

C 172	w. Holton	Vol #:	3

C 173	M. Balavender	Vol #:	3

C 174	B. Robinson	Vol #:	3

C 175	J. Bogle	Vol #:	3

C 176	K. Groh	Vol #:	3

C 177	L. Yob	Vol #:	3

C 178	J. Henthorn	Vol #:	3

C 179	P. McDougall	Vol #:	3

C 180	R. Hoke	Vol #:	3

C 181	M. Kurkowski	Vol #:	3

C 182	E. Cipriani	Vol #:	3

C 183	D. Causer	Vol #:	3

C 184	S. Chiodo	Vol #:	3

C 185	M. Wintter	Vol #:	3

C 186	N. Dowd	Vol #:	3

C 187	J. Flaherty	Vol #:	3

C 188	J. Kish	Vol #:	3

C 189	R. Latham	Vol #:	3

C 190	C. Silver	Vol #:	3

C 191	V. Focosi	Vol #:	3

C 192	J. Geoffrion	Vol #:	3

C 193	K. Johnston	Vol #:	3

C 194	J. Pinto	Vol #:	3

C 195	C. Parks	Vol #:	3

C 196	W. Hyde	Vol #:	3



C 197	J. Hengesbach	Vol #:	3

C 198	D. Morse	Vol #:	3

C 199	E. Maniaci	Vol #:	3

C 200	A. Cunningham	Vol #:	3

C 201	H. Szcyurek	Vol #:	3

C 202	D. Osman	Vol #:	3

C 203	E. Huber	Vol #:	3

C 204	C. Browning	Vol #:	3

C 205	R. Rosenberg	Vol #:	3

C 206	L. Pang	Vol #:	3

C 207	L. Spychalski	Vol #:	3

C 208	E. Warrick	Vol #:	3

C 209	R. Payton	Vol #:	3

C 210	W. Hunt	Vol #:	3

C 211	H. Morton	Vol #:	3

C 212	T. Vogt	Vol #:	3

C 213	G. McMillan	Vol #:	3

C 214	J. Thacher	Vol #:	3

C 215	I. Collazo	Vol #:	3

2006P-0160	Change Daranide Tablets, 50 mg to a generic version

N 1	FDA	Vol #:	1

2006P-0287	Determine Whether Phoslo (calcium acetate) Tablets, eq 169 mg Calcium, have been voluntarily withdrawn from sale for safety or efficacy reasons

N 1	FDA	Vol #:	1

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

C 126	J. Davenport	Vol #:	7

C 127	A. Arbogast	Vol #:	7

2006P-0399	To determine whether PhosLo (calcium acetate) Tablets, eq 169 mg calcium, and PhosLo (calcuim acetate) Capsules, eq 169 mg calcium, has been withdrawn for safety or efficacy reasons



N 1	FDA	Vol #:	1

2006P-0446	ANDA for PHENERGAN Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg

N 1	FDA	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 5	Advance Medical Technology Association (AdvaMed)	Vol #:	1



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

C 1	J. Slama	Vol #:	1

EXT 1	A. Young	Vol #:	1

2007M-0303	P050024 - CryoCor CryoAblation System

AAV 1	CryoCor, Inc.	Vol #:	1

2007N-0179	Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop

TS 3	HHS/AHRQ	Vol #:	2

TS 4	FDA	Vol #:	2

TS 5	University of Pennsylvania	Vol #:	2

TS 6	FDA	Vol #:	2

TS 7	Fairfield County MM Support Group	Vol #:	2

TS 8	MS Internet Support Forum	Vol #:	2

TS 9	Blue Cross and Blue Shield	Vol #:	2

TS 10	Blue Cross and Blue Shield	Vol #:	2

TS 11	Kaiser Permanente	Vol #:	2

TS 12	Veteran's Administration	Vol #:	2

TS 13	American Academy of Family Physicians	Vol #:	2

TS 14	Celgene Corporation	Vol #:	2

TS 15	Biogen Idec, Inc.	Vol #:	2

TS 16	AHRQ/FDA	Vol #:	2

TS 17	Duke Center for Education and Research on Therapeutics	Vol #:	2

TS 18	University of Pennsylvania	Vol #:	2

TS 19	FDA	Vol #:	2

TS 20	University of Arizona	Vol #:	2

TS 21	HMO Research Network CERT	Vol #:	2

TS 22	FDA	Vol #:	2

TS 23	National Steering Committee CERT	Vol #:	2

TS 24	National Steering Committee CERT	Vol #:	2

TS 25	Outcome Sciences	Vol #:	2

TS 26	National Health Insurance in Taiwan	Vol #:	2

TS 27	Johnson & Johnson	Vol #:	2

TS 28	American Foundation for Material and Child Health	Vol #:	1

2007N-0238	Medical Devices: The Mammography Quality Standards Act of 1992 and Subsequent Mammography Quality Standards Reauthorization Act and Amendments; Inspection Fees

BKG 1	Background Material	Vol #:	1

Page created on August 7, 2007 ue

FDA/Dockets Management