Dockets Entered on September 12, 2005

Dockets Management



Dockets Entered On September 12, 2005 Table of Contents



Docket #	Title

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

1998C-0431	Synthetic Iron Oxide

1999F-4372	National Fisheries Institute and the Louisiana Dep of Agricu

1999P-1340	Declared Eternity eau de Parfum Misbranded

2001P-0345	Listing the color additive yellow #5 for use in food/Drug

2003N-0076	Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

2004H-0322	Civil Money Penalty Re: Ecumed Health Group, Inc.

2004P-0265	Designate an official name for cis-8-methyl-N-vanillyl-6-nonenamide different than zucapsaicin

2004P-0379	Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons

2005D-0174	Guidance on Expiration Dating of Unit-Dose Repackaged Drugs

2005D-0223	Draft Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability

2005D-0288	International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management

2005D-0312	Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability

2005N-0137	Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting

2005N-0218	FDA Vision 2006: A Conversation with the American Public

2005N-0262	Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program

2005N-0279	Food Labeling; Gluten-Free Labeling of Foods; Public Meeting

2005N-0345	Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product

2005P-0104	Determine whether Peptavlon (pentagastrin) was voluntarily withdrawn from sale for reasons other than safety or effectiveness

2005P-0116	To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations

2005P-0323	Immediately remove Adderall and Adderall XR from the market for safety reasons

2005V-0333	Projector for a Laser Light Show

2005V-0365	Laser Light Show

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

RPT 289	Naturaleaf Inc	Vol #:	227

RPT 290	Aminocare Products LP	Vol #:	214

1998C-0431	Synthetic Iron Oxide

EMC 2	Gatewood Organization LLC	Vol #:	1

1999F-4372	National Fisheries Institute and the Louisiana Dep of Agricu

OB 1	G Atwood	Vol #:	8

1999P-1340	Declared Eternity eau de Parfum Misbranded

EMC 609	R C Cordero	Vol #:	24

2001P-0345	Listing the color additive yellow #5 for use in food/Drug



EMC 1280	K Jobalia	Vol #:	6

EMC 1281	P Rose	Vol #:	6

EMC 1282	S Charlton	Vol #:	6

EMC 1283	Sekora's	Vol #:	6

2003N-0076	Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

EMC 1108	J Collum	Vol #:	11

EMC 1109	R Lyles	Vol #:	11

EMC 1110	J Drake	Vol #:	11

2004H-0322	Civil Money Penalty Re: Ecumed Health Group, Inc.

CFF 1	Juan C. Carrai	Vol #:	2

CFF 2	Juan C. Carrai	Vol #:	2

CS 14	HFA-305	Vol #:	2

OR 13	HF-3 to Ecumned Health Group, Amador Reyes, Juan C. Carrai, Richard W. Stone & Erlinda E. Enri	Vol #:	2

2004P-0265	Designate an official name for cis-8-methyl-N-vanillyl-6-nonenamide different than zucapsaicin

PDN 1	HF-22 to Winston Laboratories Inc	Vol #:	2

2004P-0379	Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons

ANS 1	HFD-7 to AAC Consulting Group	Vol #:	1

2005D-0174	Guidance on Expiration Dating of Unit-Dose Repackaged Drugs

C 7	Cardinal Health	Vol #:	1

2005D-0223	Draft Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability

C 1	Bracco Diagnostics Inc	Vol #:	1

2005D-0288	International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management

EC 1	Mr. Stephen Hall	Vol #:	1

EC 2	Teva Pharmaceutical Industries Ltd.	Vol #:	1

2005D-0312	Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability

C 2	B Jennings	Vol #:	1

2005N-0137	Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting

EC 14	Ms. Elizabeth Graham	Vol #:	1

2005N-0218	FDA Vision 2006: A Conversation with the American Public

EC 1	American College of Neuropsychopharmacology	Vol #:	1



2005N-0262	Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program

EC 8	None	Vol #:	1

2005N-0279	Food Labeling; Gluten-Free Labeling of Foods; Public Meeting

C 443	S Khosla	Vol #:	14

C 444	M W Rose	Vol #:	14

C 445	A Garrahan	Vol #:	14

C 446	H Brower	Vol #:	14

C 447	D W & A Snow	Vol #:	14

C 448	A Burns	Vol #:	14

C 449	M J Howard	Vol #:	14

C 450	E Rohrer	Vol #:	14

C 451	C Styma	Vol #:	14

C 452	J. D'Amour	Vol #:	14

C 453	J Gough	Vol #:	14

C 454	F S Rich	Vol #:	14

C 455	M A Barther	Vol #:	14

C 456	P Roos	Vol #:	14

C 457	B C Clapp	Vol #:	14

C 458	R Christ	Vol #:	14

C 459	C Mankowski	Vol #:	14

C 460	H E Streetman	Vol #:	14

EC 543	Ms. Lisa O'Laughlin	Vol #:	15

EC 544	Celiac Support	Vol #:	15

EC 545	Ms. Sandra Truslow	Vol #:	15

EC 546	Mrs. Patricia Dorner	Vol #:	15

EC 547	Ms. Veronica Mulleneaux	Vol #:	15

EC 548	Mrs. Joyce Borgelt	Vol #:	15

EC 549	Mrs. Deborah McManus	Vol #:	15

EC 550	Mrs. Carol Wright	Vol #:	15

EC 551	Mrs. Deana Young	Vol #:	15

EC 552	private citizen	Vol #:	15

EC 553	Mrs. Louella Prutsman	Vol #:	15

EC 554	Ms. Leslie Foy	Vol #:	15

EC 555	Ms. June Bahr	Vol #:	15

EC 556	Mrs. JJ Anderson	Vol #:	15

EC 557	Mrs. Jaimr Emanuelo	Vol #:	15



EC 558	Mr. Laurence Kagan	Vol #:	15

EC 559	Ms. Julie Skeeters	Vol #:	15

EC 560	Ms. Julie Vastine	Vol #:	15

EC 561	Mrs. Bethann Schaffzin	Vol #:	15

EC 562	Mrs. Jean Olson	Vol #:	15

EC 563	Mr. Nathan Kagan	Vol #:	15

EC 564	Ms. Jennifer Holden	Vol #:	15

EC 565	Mrs. Sandra Kagan	Vol #:	15

EC 566	Ms. Amy Smith	Vol #:	15

EC 567	Mr. Mark Delfeld	Vol #:	15

EC 568	Mrs. Susan Delfeld	Vol #:	15

EC 569	Mrs. Nancy Piersma	Vol #:	15

EC 570	Ms. Esther Bowring	Vol #:	15

EC 571	Mrs. Nancy Hover	Vol #:	15

EC 572	Mrs. Theresa Canham	Vol #:	15

EC 573	Ms. Elizabeth Smith	Vol #:	15

EC 574	Ms. Mary Hegdal	Vol #:	15

EC 575	Ms. D C Maslyn	Vol #:	15

EC 576	Mrs. Anne Steele	Vol #:	15

EC 577	Ms. Georgia Barton	Vol #:	15

EC 578	Mrs. Jane Wilson	Vol #:	15

EC 579	Mr. John Boardman	Vol #:	15

EC 580	Ms. Beverly Weager	Vol #:	15

EC 581	Mrs. Katherine Scortino	Vol #:	15

EC 582	Mr. Tom Schrank	Vol #:	15

EC 583	Mr. Allan Smith	Vol #:	15

EC 584	Ms. tammi ford	Vol #:	15

EC 585	Miss. Miriam Bowring	Vol #:	15

EC 586	Miss. Amanda Barnett	Vol #:	15

EC 587	Ms. Donna Conrad	Vol #:	15

EC 588	Mrs. Janelle Kaske	Vol #:	15

EC 589	Mr. Fred Parshley	Vol #:	15

EC 590	Mr. KAREN SMITH	Vol #:	15

EC 591	Mrs. Linda Salinas	Vol #:	15

EC 592	Dr. Rolf Meyersohn	Vol #:	15

EC 593	Mr. Louis Suarez	Vol #:	15

EC 594	Ms. CINDY GOLDMAN	Vol #:	15



EC 595	Mrs. Judy Bertagna	Vol #:	15

EC 596	Mr. Dennis J. Underwood	Vol #:	15

EC 597	Mr. Richard Underwood	Vol #:	15

EC 598	Mr. Michael Tuzzio	Vol #:	15

EC 599	Mr. Michael Tuzzio	Vol #:	15

EC 600	Mrs. Ann Drake	Vol #:	15

EC 601	Mrs. Sandra Stark	Vol #:	15

EC 602	St. Elizabeth Medical Center	Vol #:	15

EC 603	Ms. DEE BAERTSCH	Vol #:	15

EC 604	Miss. Melinda Maxwell	Vol #:	15

EC 605	Ms. Katherine Mitchell	Vol #:	15

EC 606	Ms. Carrol Gury	Vol #:	15

EC 607	Mrs. Kathleen Johnson	Vol #:	15

EC 608	Mr. g edward bloom	Vol #:	15

EC 609	Mrs. Jan Everly	Vol #:	15

EC 610	Mr. Siamak Tajik	Vol #:	15

EC 611	Mr. Jerry Lynch	Vol #:	15

EC 612	Mr. Dennis Bradley	Vol #:	15

EC 613	Mr. Lance Partain	Vol #:	15

EC 614	Mrs. Lisa Marten	Vol #:	15

EC 615	Mr. Beau Caruthers	Vol #:	15

EC 616	Mr. Bruce Radtke	Vol #:	15

EC 617	Mrs. Gayle Francis	Vol #:	15

EC 618	Mrs. rhonda st.charles	Vol #:	15

EC 619	Mrs. Mary Boucher	Vol #:	15

EC 620	Mr. Robert Andrus	Vol #:	15

EC 621	Mrs. April Wysatta	Vol #:	15

EC 622	Mr. william gaskins	Vol #:	15

EC 623 Attachment	Ms. Annamaria Christov	Vol #:	15

EC 624	Mr. Joel Green	Vol #:	15

EC 625	Mrs. Doris Bateman	Vol #:	15

EC 626	Mr. Scott Weiner	Vol #:	15

EC 627	Mrs. Marie Knauss	Vol #:	15

EC 628	Mrs. Patricia Ford	Vol #:	15

EC 629	Miss. Anne Hardin	Vol #:	15

EC 630	Ms. Linda Freeman	Vol #:	15

EC 631	Mrs. Karen Valentine	Vol #:	15



EC 632	Celiac Sprue Association	Vol #:	15

EC 633	Mr. Ronald Germie	Vol #:	15

EC 634	Mrs. Madlyn Kantor	Vol #:	15

EC 635	Mrs. Donna Neumeyer	Vol #:	15

EC 636	Mrs. Andrea Utley	Vol #:	15

EC 637	Mr. Robert Shearer	Vol #:	15

EC 638	Mrs. C Butler	Vol #:	15

EC 639	Mr. Hiero Russell	Vol #:	15

EC 640	Ms. Carol McCue	Vol #:	15

EC 641	Mrs. Margo Hantman	Vol #:	15

EC 642	Ms. Connie Garland	Vol #:	15

EC 643	Mrs. S Thienel	Vol #:	15

EC 644	Ms. Amani Ahrens	Vol #:	15

EC 645	Mrs. Tanya Byington	Vol #:	15

EC 646	Mrs. Donna Scott	Vol #:	15

EC 647	Ms. Arlene Grant	Vol #:	15

EC 648	Ms. Sara Pomerance	Vol #:	15

EC 649	Mrs. Dawn Leighty	Vol #:	15

EC 650	Mrs. Constance Smith	Vol #:	15

EC 651	Dr. Lisa Peppas	Vol #:	15

EC 652	Mr. Matthew Weatherby	Vol #:	15

EC 653	Ms. Lisa Morris	Vol #:	15

EC 654	Ms. Terry Scholten	Vol #:	15

EC 655	Ms. Wanda Rucker	Vol #:	15

EC 656	Mrs. Sharon Yates	Vol #:	15

EC 657	Mrs. Sally Strganac	Vol #:	15

EC 658	Ms. Mary Eade	Vol #:	15

EC 659	Mrs. Sandra Brown	Vol #:	15

EC 660	Mr. Dwight Senne	Vol #:	15

EC 661	Mr. Marc Porter-Zasada	Vol #:	15

EC 662	private citizen	Vol #:	15

EC 663	self	Vol #:	15

EC 664	Mrs. Alma Brown	Vol #:	15

EC 665	Mr. Mark Dorner	Vol #:	15

EC 666	Ms. Kasha Koregaokar	Vol #:	15

EC 667	Miss. Alexandra Dorner	Vol #:	15

EC 668	Miss. Ava Dorner	Vol #:	15



EC 669	Mrs. Carol Taddeo	Vol #:	15

EC 670	Mrs. Carol Pearson	Vol #:	15

EC 671	Mrs. Tammy Johnson	Vol #:	15

EC 672	Mrs. Lisa Isley	Vol #:	15

EC 673	Mrs. Diana Martin	Vol #:	15

EC 674	Ms. Donna Behrens	Vol #:	15

EC 675	Mrs. Tanya Massoglia	Vol #:	15

EC 676	Mrs. Lisa Wilhelm-Stanton	Vol #:	15

EC 677	Ms. MARJORIE RUNG	Vol #:	15

EC 678	Mrs. Pamela VanTimmeren	Vol #:	15

EC 679	Miss. Mary Beth Novak	Vol #:	15

EC 680	Celiac	Vol #:	15

EC 681	Miss. tenbye avenell	Vol #:	15

EC 682	Dr. Christine White	Vol #:	15

EC 683	Ms. Dru Edrington	Vol #:	15

EC 684	Ms. Linda Braffitt	Vol #:	15

EC 685	Miss. Susan Ford	Vol #:	15

EC 686	Mrs. Kandee McKinley	Vol #:	15

EC 687	Mrs. Margarita L Aguilar	Vol #:	15

EC 688	Ms. Kathleen OConnor	Vol #:	15

EC 689	Mrs. Nancy Weaver	Vol #:	15

EC 690	Miss. Olivia Spence	Vol #:	15

EC 691	Mrs. Judy Walsh	Vol #:	15

EC 692	Mrs. H H Yarbrough	Vol #:	15

EC 693	Mrs. Lynn Pearson	Vol #:	15

EC 694	West Michigan Celiac Support Group	Vol #:	15

EC 695	Dr. GEORGE KACHEN	Vol #:	15

EC 696	Mrs. Cathleen Viilo	Vol #:	15

EC 697	Mrs. Sharon Bryan	Vol #:	15

EC 698	ROCK Chairwoman	Vol #:	15

EC 699	fuller life health ministry	Vol #:	15

EC 700	Mr. Christopher Anderson	Vol #:	15

EC 701	Miss. Michelle Roberts	Vol #:	15

EC 702	Dr. Claudia Crawn	Vol #:	15

EC 703	Ms. Pat Doty	Vol #:	15

EC 704	Mrs. Karen deGraaf	Vol #:	15

EC 705	Ms. Joline Richard	Vol #:	15



EC 706	Mrs. Barbara Harris	Vol #:	15

EC 707	Mr. Bill Fickling	Vol #:	15

EC 708	Ms. Lucy Reeves	Vol #:	15

EC 709	Mrs. Carol Wanke	Vol #:	15

EC 710	Miss. Kathryn Harris	Vol #:	15

EC 711	Mr. JUSTIN SLAUGHTER	Vol #:	15

EC 712	individual. i am also an r.n.	Vol #:	15

EC 713	Mrs. Meg Nehil	Vol #:	15

EC 714	Mrs. Julie Watson	Vol #:	15

EC 715	Mrs. Kathryn Janssen	Vol #:	15

EC 716	Mrs. Patricia Cremens	Vol #:	15

EC 717	Mrs. Chantelle Harris	Vol #:	15

EC 718	Ms. Janice Bartell	Vol #:	15

EC 719	Mrs. Cindy Bennett	Vol #:	15

EC 720	Mr. Michael Zimmerman	Vol #:	15

EC 721	Miss. Adrienne Fodor	Vol #:	15

EC 722	individual	Vol #:	15

EC 723	Mrs. Melissa Conroy	Vol #:	15

EC 724	Mr. steven hegstrom	Vol #:	15

EC 725	Mrs. Dena Logan	Vol #:	15

EC 726	Mrs. Catherine Dowling	Vol #:	15

EC 727	Dr. Barbara Coughlin	Vol #:	15

EC 728	Mr. Matt Orem	Vol #:	15

EC 729	Ms. Kathleen Ehlers	Vol #:	15

EC 730	Mrs. Dorothy Nash	Vol #:	15

EC 731	Ms. Robin Weinberger	Vol #:	15

EC 732	Ms. Alyssa Schneider	Vol #:	15

EC 733	Mrs. Sandra Chappell	Vol #:	15

EC 734	Ms. Ellen Morfei	Vol #:	15

EC 735	Mr. Glenn Taubert	Vol #:	15

EC 736	Mrs. Giorgia Normington	Vol #:	15

EC 737	Ms. Ardis Kennedy	Vol #:	15

EC 738	Mrs. jean carmichael	Vol #:	15

EC 739	Mrs. Mary Sadlier	Vol #:	15

EC 740	Mrs. Rachel Lloys	Vol #:	15

EMC 267	San Diego Youth & Community Services	Vol #:	5

EMC 268	B Skrivan	Vol #:	5



EMC 269	R A Woodruff	Vol #:	5

EMC 270	M Jordon	Vol #:	5

2005N-0345	Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product

C 4	M E Thielke	Vol #:	1

2005P-0104	Determine whether Peptavlon (pentagastrin) was voluntarily withdrawn from sale for reasons other than safety or effectiveness

LET 1	HFD-5 to Arnall Golden Gregory LLP	Vol #:	1

2005P-0116	To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations

EMC 3	T Grabowski	Vol #:	2

EMC 4	C Nawrocki	Vol #:	2

EMC 5	A E Fylling	Vol #:	2

2005P-0323	Immediately remove Adderall and Adderall XR from the market for safety reasons

SUP 1	D Lowe	Vol #:	1

2005V-0333	Projector for a Laser Light Show

VRA 1	HFZ-200 to Brilor LLC / Amika Nightclub	Vol #:	1

2005V-0365	Laser Light Show

ACK 1	HFA-305 to Hologic, Inc.	Vol #:	1

VAR 1	Hologic, Inc.	Vol #:	1

Page created on September 27, 2005 RSC

FDA/Dockets Management