Dockets Entered on March 11, 2005

Dockets Management



Dockets Entered On March 11, 2005 Table of Contents



Docket #	Title

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

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

2003N-0528	Revision of the Requirements for Spore-Forming Microorganisms

2004N-0230	Food; Current Good Manufacturing Practice Regulations; Public Meetings

2004Q-0151	Qualified Health Claim (QHC): soy protein and cancer

2005N-0038	Reporting of Adverse Events to Institutional Review Boards; Public Hearing

1995S-0316	75-Day Premarket Notifications for New Dietary Ingredients
RPT 264	Medical Research Institute	Vol #:	193

RPT 265	Artjen Complexus Holdings Corp.	Vol #:	194

RPT 266	Kaneka Corporation	Vol #:	195

RPT 267	Kaneka Corporation	Vol #:	198

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

LET 15575	Enzymatic Therapy	Vol #:	137

LET 15576	Nature's Way Products, Inc.	Vol #:	137

LET 15577	Nature's Way Products, Inc.	Vol #:	137

LET 15578	Nature's Way Products, Inc.	Vol #:	137

LET 15579	Nature's Way Products, Inc.	Vol #:	137

LET 15580	Nature's Way Products, Inc.	Vol #:	137

LET 15581	Nature's Way Products, Inc.	Vol #:	137

LET 15582	Enzymatic Therapy	Vol #:	137

LET 15583	NBTY Inc.	Vol #:	137

LET 15584	NBTY Inc.	Vol #:	137

LET 15585	Lyons Health Products	Vol #:	137

LET 15586	Nature's Way Products, Inc.	Vol #:	137

LET 15587	Nature's Way Products, Inc.	Vol #:	137

LET 15588	Nature's Way Products, Inc.	Vol #:	137

LET 15589	SomaLabs, Inc.	Vol #:	137

LET 15590	Vita Pharmica, Inc.	Vol #:	137

LET 15591	Vita Pharmica, Inc.	Vol #:	137

LET 15592	Enzymatic Therapy	Vol #:	137

LET 15593	Metagenics. Inc.	Vol #:	137

LET 15594	NBTY Inc.	Vol #:	137

LET 15595	NBTY Inc.	Vol #:	137

LET 15596	Advocare International, L.P.	Vol #:	137

LET 15597	NBTY Inc.	Vol #:	137



LET 15598	NBTY Inc.	Vol #:	137

LET 15599	NBTY Inc.	Vol #:	137

LET 15600	NBTY Inc.	Vol #:	137

LET 15601	NBTY Inc.	Vol #:	137

LET 15602	NBTY Inc.	Vol #:	137

LET 15603	NBTY Inc.	Vol #:	137

LET 15604	NBTY Inc.	Vol #:	137

LET 15605	NBTY Inc.	Vol #:	137

LET 15606	Nutronix International	Vol #:	137

2003N-0528	Revision of the Requirements for Spore-Forming Microorganisms

EC 2	My Self	Vol #:	1

2004N-0230	Food; Current Good Manufacturing Practice Regulations; Public Meetings

C 341	S and M McGalddery	Vol #:	8

C 342	R. Baxter	Vol #:	8

C 343	D. Wallace, MD	Vol #:	8

C 344	Dr. L. Cooper	Vol #:	8

C 345	K. Ebeling	Vol #:	8

C 346	Allergy and Asthma Specialist of Bloomfield Hills	Vol #:	8

C 347	J. Carter	Vol #:	8

C 348	D and A Driscoll	Vol #:	8

C 349	S. Dylan	Vol #:	8

C 350	T. Anderson	Vol #:	8

C 351	C. McNutt	Vol #:	8

C 352	D. Walls	Vol #:	8

C 353	T. DeMann	Vol #:	8

C 354	E. Neville	Vol #:	8

C 355	K. Bragg	Vol #:	8

C 356	G. Evans	Vol #:	8

C 357	M. Medlock	Vol #:	8

C 358	T. Kralj	Vol #:	8

C 359	A. Butcher	Vol #:	8

C 360	J. Hoover	Vol #:	8

C 361	F. Crowley	Vol #:	8

C 362	M. Pilewski	Vol #:	8

C 363	K Willard and J Virant	Vol #:	8



C 364	R. O'Leary, MD	Vol #:	8

C 365	S. Rush	Vol #:	8

C 366	S. Leavitt	Vol #:	8

C 367	Mr and Mrs F and R Concilio	Vol #:	8

C 368	A. Rooney	Vol #:	8

C 369	R and C Fisher	Vol #:	8

C 370	J. Rettagliata	Vol #:	8

C 371	N. Curley	Vol #:	8

C 372	L. francoeur, Esq	Vol #:	8

C 373	D. Whitney	Vol #:	8

C 374	L. Burnett	Vol #:	8

C 375	B. Hjorth	Vol #:	8

C 376	D. Lombardo	Vol #:	8

C 377	S. Cheney	Vol #:	8

C 378	K. Munching	Vol #:	8

C 379	J. Merkel	Vol #:	8

C 380	P. Goswami	Vol #:	8

C 381	G and R Powell	Vol #:	8

C 382	Dr. A. Goswami	Vol #:	8

C 383	K and D Berger	Vol #:	8

C 384	N. Metry, MD	Vol #:	8

C 385	T. Medsker	Vol #:	8

C 386	N. Barnes	Vol #:	8

C 387	L. Fengstad	Vol #:	8

C 388	H. Evers	Vol #:	8

C 389	M. Newingham	Vol #:	8

C 390	T. Grenz	Vol #:	8

C 391	E. Carlson	Vol #:	8

C 392	T. Antonino	Vol #:	8

C 393	L. Johnson	Vol #:	8

C 394	D. Newingham	Vol #:	8

C 395	C and P Kent	Vol #:	8

C 396	L and G Voss	Vol #:	8

C 397	A Peyser & B Abbott	Vol #:	8

C 398	C. Bailey	Vol #:	8

C 399	C. Cavanaugh	Vol #:	8

C 400	J. Bazuzi	Vol #:	8



C 401	M. Bjork	Vol #:	9

C 402	A. McSweeney, LPN	Vol #:	9

C 403	C. Ramos	Vol #:	9

C 404	M and A Folkins	Vol #:	9

C 405	K. Merges	Vol #:	9

C 406	E. Baron	Vol #:	9

C 407	M. Duffy	Vol #:	9

C 408	G. Flaskamp	Vol #:	9

C 409	L. McTeigue	Vol #:	9

C 410	D. Bloom	Vol #:	9

C 411	S and C McKay	Vol #:	9

C 412	M. Simmonds	Vol #:	9

C 413	K. McGrury	Vol #:	9

C 414	T. Selz	Vol #:	9

C 415	J and J Dodson	Vol #:	9

C 416	C. Timpte, PhD	Vol #:	9

C 417	N and B Wickert	Vol #:	9

C 418	L. Linthicum	Vol #:	9

C 419	T and T Engleman	Vol #:	9

C 420	T. Cruz	Vol #:	9

C 421	J. McDonald	Vol #:	9

C 422	D. Goelzer	Vol #:	9

C 423	J and C Waters	Vol #:	9

C 424	E. Zuckert	Vol #:	9

C 425	C. Waters	Vol #:	9

C 426	K. Doty, MD	Vol #:	9

C 427	MMP Group	Vol #:	9

C 428	S. Thomas	Vol #:	9

C 429	K. Grace	Vol #:	9

C 430	J . Brown	Vol #:	9

C 431	R. Santos	Vol #:	9

C 432	N. McGinnis	Vol #:	9

C 433	J. Anderson	Vol #:	9

C 434	R and B Vachha	Vol #:	9

C 435	J. Wolfe	Vol #:	9

C 436	J. Riehl	Vol #:	9

C 437	S. Whittington	Vol #:	9



C 438	F. Holland	Vol #:	9

C 439	K Willard & J Virant	Vol #:	9

C 440	K. Gould	Vol #:	9

C 441	J and R Rock	Vol #:	9

C 442	S. Parker	Vol #:	9

C 443	C. Filiato	Vol #:	9

C 444	R. Cool	Vol #:	9

C 445	Alvernon Allergy & Asthma, PC	Vol #:	9

C 446	M. George	Vol #:	9

C 447	D. Towarnicky	Vol #:	9

C 448	C. Keathley	Vol #:	9

C 449	D. Evans	Vol #:	9

C 450	C. Pennacchio	Vol #:	9

C 451	J. Nitchey	Vol #:	9

C 452	M. Kaltwasser	Vol #:	9

C 453	J. Bamberger,MS,RD,CD	Vol #:	9

C 454	R. Goldman	Vol #:	9

C 455	L and N Narry	Vol #:	9

C 456	S. Burns	Vol #:	9

C 457	A. Gunderson	Vol #:	9

C 458	M and B Lopa	Vol #:	9

C 459	D. Harrington	Vol #:	9

C 460	A. Mudd	Vol #:	9

C 461	J and S Thomas	Vol #:	9

C 462	D and P Christie, RN/BS	Vol #:	9

C 463	Dr. E. Shashoua	Vol #:	9

C 464	N. Smith	Vol #:	9

C 465	J and L Connolly	Vol #:	9

C 466	C. Barnes	Vol #:	9

C 467	A. Bonanno	Vol #:	9

C 468	M. Beckman	Vol #:	9

C 469	A. Rider	Vol #:	9

C 470	L. Gold	Vol #:	9

C 471	L. Mattson	Vol #:	9

C 472	D. Holzman	Vol #:	9

C 473	K. Gansemer	Vol #:	9

C 474	J. Warfield	Vol #:	9



C 475	N. Lowerhouse	Vol #:	9

C 476	E. Bonanno	Vol #:	9

C 477	Manhasset Allergy and Asthma Associates, LLP	Vol #:	9

C 478	Manhasset Allergy and Asthma Associates, LLP	Vol #:	9

C 479	Manhasset Allergy and Asthma Associates, LLP	Vol #:	9

C 480	A. Pask	Vol #:	9

C 481	B and L Brookshire	Vol #:	9

C 482	C. Cipolla	Vol #:	9

C 483	K. Wilson	Vol #:	9

C 484	S and D Burch	Vol #:	9

C 485	A. Brown, D.O. and N. Brown, RN, BSN	Vol #:	9

C 486	S and D Campbell	Vol #:	9

C 487	T and Markman	Vol #:	9

C 488	K. Pepper	Vol #:	9

C 489	J. Held	Vol #:	9

C 490	A nad M Stafman	Vol #:	9

C 491	D. Ryan	Vol #:	9

C 492	D. Reisner	Vol #:	9

C 493	H. Shack	Vol #:	9

C 494	P. Jones	Vol #:	9

C 495	T and D Lohmann	Vol #:	9

C 496	J. Liebman	Vol #:	9

C 497	S. Forcello	Vol #:	9

C 498	M. Conlan	Vol #:	9

C 499	J. Price	Vol #:	9

C 500	W. Zielke	Vol #:	9

C 501	D. Rossler	Vol #:	10

C 502	K. Shack	Vol #:	10

C 503	L. Every	Vol #:	10

C 504	M. Laffin	Vol #:	9

C 505	S. Rosenzweig	Vol #:	10

C 506	Dr. M. Migliore	Vol #:	10

C 507	J. Migliore, PhD	Vol #:	10

C 508	Dr. P Jordan, MD	Vol #:	10

C 509	W and R Wessel	Vol #:	10

C 510	K. Colomer	Vol #:	10

C 511	R and D Bownds	Vol #:	10



C 512	T. Foley	Vol #:	10

C 513	P. Reisner	Vol #:	10

C 514	V. Eckhoff	Vol #:	10

C 515	K. Foley	Vol #:	10

C 516	J. Mitchell	Vol #:	10

C 517	M. Johnston	Vol #:	10

C 518	C. Kersey	Vol #:	10

C 519	Arkansas Allergy & asthma Clinic, PA	Vol #:	10

C 520	D. Rosenzweig	Vol #:	10

C 521	P. Megroz	Vol #:	10

C 522	K. Ellis	Vol #:	10

C 523	M. Howard	Vol #:	10

C 524	A. Braley	Vol #:	10

C 525	M. Carr	Vol #:	10

C 526	T. Spicer	Vol #:	10

C 527	G. Lafars	Vol #:	10

C 528	The Food Allergy & Anaphylaxis Network	Vol #:	10

C 529	J. Leonard	Vol #:	10

C 530	V. Garland	Vol #:	10

C 531	J. Eitel	Vol #:	10

C 532	H. Ingalls	Vol #:	10

C 533	M and B Morse	Vol #:	10

C 534	R. Fumi	Vol #:	10

C 535	J. Morgan	Vol #:	10

C 536	H. Cornwell	Vol #:	10

C 537	Mount Sinai School of Medicine	Vol #:	10

C 538	K. Catacutan	Vol #:	10

C 539	Mr and Mrs C Hucek	Vol #:	10

C 540	A. Deldicque	Vol #:	10

C 541	J. Doucette	Vol #:	10

C 542	Sourthern California Permanente Medical group	Vol #:	10

C 543	G, L and J Conway	Vol #:	10

C 544	J. Jin, PharmD	Vol #:	10

C 545	T. Kish	Vol #:	10

C 546	P. Bermann	Vol #:	10

C 547	L. Colasacco	Vol #:	10

C 548	V. Grodsky	Vol #:	10



C 549	P. Bennett	Vol #:	10

C 550	K and R Barnhart	Vol #:	10

C 551	S. hill	Vol #:	10

C 552	V. Hampton	Vol #:	10

C 553	S. Riley	Vol #:	10

C 554	A. Gordon	Vol #:	10

C 555	W. Mileski	Vol #:	10

C 556	S. Pereira	Vol #:	10

C 557	K. Scheer	Vol #:	10

C 558	S. Machtinger, MD	Vol #:	10

C 559	L. Harty	Vol #:	10

C 560	T. Bizokas	Vol #:	10

C 561	H. Yantus	Vol #:	10

C 562	R and A Muradaz	Vol #:	10

C 563	V. Weikers	Vol #:	10

C 564	L. Masserang	Vol #:	10

C 565	D. Kristofferson	Vol #:	10

C 566	C. Quarantillo	Vol #:	10

C 567	C. Burge	Vol #:	10

C 568	P. Martinez	Vol #:	10

C 569	S. Zachos	Vol #:	10

C 570	C. Joiner	Vol #:	10

C 571	W. Green	Vol #:	10

C 572	J. Pace	Vol #:	10

C 573	J. DeMann	Vol #:	10

C 574	D. Ford	Vol #:	10

C 575	K. and M O'Mara	Vol #:	10

C 576	C. Vaughan	Vol #:	10

C 577	R. Rosebrock	Vol #:	10

C 578	E. Hoehn	Vol #:	10

C 579	D. D'Antuono	Vol #:	10

C 580	W. Markle	Vol #:	10

C 581	D and J King	Vol #:	10

C 582	R and J Muradaz	Vol #:	10

C 583	D. Bugg	Vol #:	10

C 584	L. Colasacco	Vol #:	10

C 585	P. Kaier	Vol #:	10



C 586	K. Green	Vol #:	10

C 587	M. Green	Vol #:	10

C 588	D. Green	Vol #:	10

C 589	S. Shaker	Vol #:	10

C 590	C. Mitson	Vol #:	10

C 591	A. Pickrel	Vol #:	10

C 592	L. Cuppett	Vol #:	10

C 593	B Paulson and S Reed	Vol #:	10

C 594	L and C Wundrow	Vol #:	10

C 595	S and J Wundrow	Vol #:	10

C 596	J and E Duellman	Vol #:	10

C 597	E. Fliss	Vol #:	10

C 598	D. Tank	Vol #:	10

C 599	D. Terrien	Vol #:	10

C 600	W and E Muller	Vol #:	10

C 601	D. Muller and S Forbes	Vol #:	11

C 602	K. Morgan	Vol #:	11

C 603	R. Wang,RN,MPH	Vol #:	11

C 604	T. Leibowitz	Vol #:	11

C 605	M and A Muradaz	Vol #:	11

C 606	N. Proteau	Vol #:	11

C 607	G and J Schmeling	Vol #:	11

C 608	M. Megroz	Vol #:	11

C 609	D. Markley	Vol #:	11

C 610	T. Kish	Vol #:	11

C 611	D. Nelson	Vol #:	11

C 612	T. Moore	Vol #:	11

C 613	L. Bischoff	Vol #:	11

C 614	L. Peterson	Vol #:	11

C 615	M. Hornickle	Vol #:	11

C 616	B and N Wickert	Vol #:	11

C 617	D. Kresock	Vol #:	11

C 618	N. Kresock	Vol #:	11

C 619	S and S Brickman	Vol #:	11

C 620	D. Gianfrancesco	Vol #:	11

C 621	M. Reff	Vol #:	11

C 622	J. Farhat	Vol #:	11



C 623	J. Jordan	Vol #:	11

C 624	D. McCook	Vol #:	11

C 625	T. Notarcola	Vol #:	11

C 626	M. Gruebele	Vol #:	11

C 627	M. Villa	Vol #:	11

C 628	G. Spezia	Vol #:	11

C 629	R. Waggoner	Vol #:	11

C 630	D. Rosenzweig	Vol #:	11

C 631	S. Ruple	Vol #:	11

C 632	A. Vannoy	Vol #:	11

C 633	S. Gale	Vol #:	11

C 634	D Weiner and J McLaughlin	Vol #:	11

C 635	S. Curiale	Vol #:	11

C 636	E and A Karlin	Vol #:	11

C 637	L. Collins	Vol #:	11

C 638	M. Migliore	Vol #:	11

C 639	W. Tichenor, MD	Vol #:	11

C 640	T. Alburger	Vol #:	11

C 641	A. Streitz	Vol #:	11

C 642	Form Letter	Vol #:	12

2004Q-0151	Qualified Health Claim (QHC): soy protein and cancer

LET 7	HFS-800 to Solae LLC	Vol #:	5

2005N-0038	Reporting of Adverse Events to Institutional Review Boards; Public Hearing

EC 6	Minneapolis VAMC Institutional Review Board	Vol #:	2

Page created on March 14, 2005 dp

FDA/Dockets Management