Dockets Entered on January 10, 2007

Dockets Management



Dockets Entered On January 10, 2007



Docket #	Title

1978N-0065	Skin Bleaching Drug Products

2000P-1211	Establish Mandatory Pre-Market Safety Testing for GE Foods

2002E-0100	Patent Application for Dutrasteride

2002P-0122	Request Rulemaking on Functional Foods & Establish Adv. Com.

2002P-0317	Recall Aspartame as a Neurotoxic Drug

2003E-0254	Patent Extension for Inspra (eplerenone), 4,559,332

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

2003N-0573	Draft Animal Cloning Risk Assessment

2004E-0308	Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937

2004P-0464	Vitamin D & Calcium & Reduced Risk of Osteoporosis

2006D-0303	Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements

2006D-0383	Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases

2006D-0515	Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays

2006E-0022	Patent Extension Application for SYMLIN (pramlintide acetate), U.S. Patent No. 5,686,411

2006E-0026	Patent Extension Application for Luveris (recombinant human luteinizing hormone), U.S. Patent No. 5,639,639

2006N-0036	Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur


2006N-0061	Charging for Investigational Drugs

2006N-0517	Medical Devices; Immunology and Microbiology Devices; Classification of Quality Control Material for Cystic Fibrosis Nucleic Acid Assays

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

2006P-0415	Petition Seeking Regulation of Cloned Animals

2006P-0462	Determine whether Prevacid NapraPAC, 15 mg/250 mg (lansoprazole delayed-release, 15 mg capsules and naproxen 250 mg tablets kit) (NDA No. 021507) by Tap Pharm, has been voluntarily withdrawn or withhe


2006P-0498	Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods

2006P-0535	Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products

2007P-0004	Take steps to insure the safey of Americans regarding th misues of Lasik

1978N-0065	Skin Bleaching Drug Products

EC 566	Ms. Simi Bakshi	Vol #:	19

EC 567	CDM Corp	Vol #:	19

EMC 4	T. Dailey	Vol #:	15

2000P-1211	Establish Mandatory Pre-Market Safety Testing for GE Foods

EMC 3420	Number Not Used	Vol #:	297

2002E-0100	Patent Application for Dutrasteride

LET 5	FDA/CDER to the U.S. Patent and Trademark Office	Vol #:	1

2002P-0122	Request Rulemaking on Functional Foods & Establish Adv. Com.



EMC 1	Hyman, Phelps & McNamara, P. C.	Vol #:	2

2002P-0317	Recall Aspartame as a Neurotoxic Drug

EMC 753	Calorie Control Council	Vol #:	10

2003E-0254	Patent Extension for Inspra (eplerenone), 4,559,332

LET 4	FDA/CDER to the U.S. Patent and Trademark Office	Vol #:	1

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

EMC 1421	S. Rush	Vol #:	12

EMC 1422	M. Taylor	Vol #:	12

EMC 1423	J. Lathan	Vol #:	12

EMC 1424	A. F. N. I.	Vol #:	12

EMC 1425	J. Perry	Vol #:	12

2003N-0573	Draft Animal Cloning Risk Assessment

EMC 38	J. Atkins	Vol #:	5

EMC 39	G. Stout	Vol #:	5

EMC 40	M. North	Vol #:	5

EMC 41	J. Williams	Vol #:	5

EMC 42	G. Ambrosio	Vol #:	5

EMC 43	K. Cubala	Vol #:	5

EMC 44	B. Sachau	Vol #:	5

EMC 45	L. Gazzaola	Vol #:	5

EMC 46	L. Jorgenson	Vol #:	5

2004E-0308	Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
LET 5	FDA/CDER to U.S. Patent and Trademark Office	Vol #:	1

2004P-0464	Vitamin D & Calcium & Reduced Risk of Osteoporosis

EC 1	Mr. Robert Zaremba	Vol #:	9

EC 2	Director, Sports Medicine North Osteoporosis Cente	Vol #:	9

EREG 1	B. Sachau	Vol #:	9

2006D-0303	Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements

EC 9	Mr. mike Cook	Vol #:	1

EC 10	Ms. Laura Wuest	Vol #:	10

2006D-0383	Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases



C 490	E. Lernmer	Vol #:	33

C 491	T. Bailey	Vol #:	33

C 492	B. Hansen	Vol #:	33

C 493	P and E Karls	Vol #:	33

C 494	J and N Ball	Vol #:	33

C 495	S and L Martelli	Vol #:	33

C 496	G. Demars	Vol #:	33

C 497	R. Mayer	Vol #:	33

C 498	M. Grist	Vol #:	33

C 499	J and B Griffin	Vol #:	33

C 500	M. Clark	Vol #:	33

C 501	M. Sherry	Vol #:	33

C 502	M. Jordan	Vol #:	33

C 503	A and R Christman	Vol #:	33

C 504	E. Hill	Vol #:	33

C 505	J and M Feldman	Vol #:	33

C 506	M. Kennedy	Vol #:	33

C 507	F. Gunten, OD, FAAO	Vol #:	33

C 508	Illinois Right to Life Committee	Vol #:	33

C 509	C and D Lopez	Vol #:	33

C 510	A. Gaddini	Vol #:	33

C 511	L and R Borelli	Vol #:	33

C 512	D. and M Massa	Vol #:	33

C 513	M. Barth	Vol #:	33

C 514	T. Mayer	Vol #:	33

C 515	M and R Spaeth	Vol #:	33

C 516	J. Wieber	Vol #:	33

C 517	A. Jordan	Vol #:	33

C 518	E. Thomas	Vol #:	33

C 519	K. Hill	Vol #:	33

C 520	J. McSweeney and E. Sinnott	Vol #:	33

C 521	E. Ludwig	Vol #:	33

C 522	N and U Malwitz	Vol #:	33

C 523	J and M Rohde	Vol #:	34

C 524	E. Waldon	Vol #:	34

C 525	M. Brennan	Vol #:	33

C 526	Catholic Medical Association (CMA)	Vol #:	34



C 527	San Francisco Guild of the Catholic Medical Association	Vol #:	34

C 528	R. McClone	Vol #:	34

C 529	S. Costanzo	Vol #:	34

C 530	S. Costanzo	Vol #:	34

C 531	D. Tripi	Vol #:	34

C 532	S. Placek	Vol #:	33

C 533	J and D Giallombardo	Vol #:	34

C 534	D Hjelstrom et al.	Vol #:	34

C 535	P. Kraemer	Vol #:	34

C 536	T. Phelan III	Vol #:	34

C 537	P. McClone	Vol #:	34

C 538	G. Borgeson	Vol #:	34

C 539	M. Zawoysky	Vol #:	34

C 540	D. Jones	Vol #:	34

C 541	M. Cates	Vol #:	34

C 542	E. Romo	Vol #:	34

C 543	B. Sitar	Vol #:	34

C 544	J. McDermott	Vol #:	34

C 545	M. Walter	Vol #:	34

C 546	J. Higgins	Vol #:	34

C 547	T. Guillette	Vol #:	34

C 548	E. Timmerman	Vol #:	34

C 549	C and P Mohler	Vol #:	34

C 550	L. Caslavka	Vol #:	34

C 551	D. Guillotte	Vol #:	34

C 552	J. Cosentino	Vol #:	34

C 553	D and J Feasel	Vol #:	34

C 554	E. Biance	Vol #:	34

C 555	M. Christman	Vol #:	34

C 556	M. Anstoetter	Vol #:	34

C 557	M. Holiday	Vol #:	34

C 558	D. Butten	Vol #:	34

C 559	C. Steyer	Vol #:	34

C 560	J. Munoz	Vol #:	34

C 561	G. Lodzinski	Vol #:	34

C 562	S. Command	Vol #:	34

C 563	Illigible	Vol #:	34



C 564	M. Simon	Vol #:	34

C 565	T. Sheehy	Vol #:	34

C 566	R. Howell	Vol #:	34

C 567	R and M Weiden	Vol #:	34

C 568	J. Moran	Vol #:	34

C 569	J. Ksiojdk	Vol #:	34

C 570	B. Roggay	Vol #:	34

C 571	E. Neubaum	Vol #:	34

C 572	D. Curl	Vol #:	34

C 573	F. Vangeli	Vol #:	34

C 574	M. Zucearo	Vol #:	34

C 575	S. Kendall	Vol #:	34

C 576	M. Falconio	Vol #:	34

C 577	J. Rohr	Vol #:	34

C 578	N. Roberts	Vol #:	34

C 579	V and C Oukrop	Vol #:	34

C 580	J. Daly	Vol #:	34

C 581	E. Dagit	Vol #:	34

C 582	R. Reicher	Vol #:	34

C 583	M. Kunick	Vol #:	34

C 584	S. Barron	Vol #:	34

C 585	E. Sava	Vol #:	34

C 586	J. Locke	Vol #:	34

C 587	B. Drapiewski	Vol #:	34

C 588	M. Biel	Vol #:	34

C 589	P. Hayes	Vol #:	34

C 590	B. Toth	Vol #:	34

C 591	C. Maffey	Vol #:	34

C 592	Illigible	Vol #:	34

C 593	10 signatures	Vol #:	34

C 594	J. Kammer	Vol #:	34

C 595	K. Crouch	Vol #:	34

C 596	D. Bidey	Vol #:	34

C 597	M. McLauchlin	Vol #:	34

C 598	D. Horning	Vol #:	34

C 599	J. Byrne	Vol #:	34

C 600	R. Trudell	Vol #:	34



C 601	F. Dantzman	Vol #:	34

C 602	J and Alexander Sasso	Vol #:	34

C 603	D. Hottman	Vol #:	34

C 604	M. Dunne	Vol #:	34

C 605	P. Moran	Vol #:	34

C 606	V. Daum	Vol #:	34

C 607	A. Reardon	Vol #:	34

C 608	P. Hoffman	Vol #:	34

C 609	A. Nugent	Vol #:	34

C 610	M. LaLonde	Vol #:	34

C 611	J. Sitar	Vol #:	34

C 612	B. Rastenis	Vol #:	34

C 613	A. Langlois	Vol #:	34

C 614	M. Clos	Vol #:	34

C 615	C. Sayegh	Vol #:	34

C 616	Illigible	Vol #:	34

C 617	J. Lynch	Vol #:	34

C 618	J. Thomas	Vol #:	34

C 619	National Catholic Bioethics Center	Vol #:	34

C 620	Wyeth Pharmaceuticals Inc. (Wyeth)	Vol #:	34

C 621	10193 signatures	Vol #:	35

C 622	D. Devillers	Vol #:	36

C 623	J. Factor	Vol #:	36

C 624	D. Pogor	Vol #:	36

C 625	R. Agner	Vol #:	36

C 626	B and C Glaser	Vol #:	36

C 627	L. Cahill, MD	Vol #:	36

C 628	G. Smith, MD and P. Smith, RN	Vol #:	36

C 629	M. Jones	Vol #:	36

C 630	D. Gomolski	Vol #:	36

C 631	A. Guerrero	Vol #:	36

C 632	M. Wiedemer	Vol #:	36

C 633	K. Fastiggi	Vol #:	36

C 634	K. Tuncy	Vol #:	36

C 635	M. Ridge	Vol #:	36

C 636	L. Harris	Vol #:	36

C 637	R. Smith	Vol #:	36



C 638	T. Brosh	Vol #:	36

C 639	J. Stein	Vol #:	36

C 640	D and D Williams	Vol #:	36

C 641	T. Damaren	Vol #:	36

C 642	Illigible	Vol #:	36

C 643	GlaxoSmithKline (GSK)	Vol #:	36

C 644	54 signatures	Vol #:	36

C 645	63 signatures	Vol #:	36

C 646	J. Pindell	Vol #:	36

C 647	F. Wheeler	Vol #:	36

C 648	R and K Meidl	Vol #:	36

C 649	R and J Bauer	Vol #:	36

C 650	J. Edliefson	Vol #:	36

C 651	M. Kimes, RN	Vol #:	36

C 652	C. Brien	Vol #:	36

C 653	P. Laconto	Vol #:	36

C 654	A. Clift	Vol #:	36

C 655	J and M Nicholson	Vol #:	36

C 656	S. Wharam	Vol #:	36

C 657	M. Gigandet	Vol #:	36

C 658	M and L Deters	Vol #:	36

C 659	E and C Klaport	Vol #:	36

C 660	S. Warrick	Vol #:	36

C 661	T. Whalen	Vol #:	36

C 662	L. Webb	Vol #:	36

C 663	A and C Nicolosi	Vol #:	36

C 664	C. Quinn	Vol #:	36

C 665	E. Perona	Vol #:	36

C 666	M. Klein	Vol #:	36

C 667	Illigible	Vol #:	36

C 668	M. Maley	Vol #:	36

C 669	L. Hemmerly	Vol #:	36

C 670	C. Serafin	Vol #:	36

C 671	E. Cummings	Vol #:	36

C 672	A and J McGawley	Vol #:	36

C 673	J and A Meis	Vol #:	36

C 674	I. Pastuszka	Vol #:	36



C 675	M. Ceruzzi	Vol #:	36

C 676	A. Glynn	Vol #:	36

C 677	A and J Feldpausch	Vol #:	36

C 678	Human Life International	Vol #:	36

C 679	P and A Shafer	Vol #:	36

C 680	S. Jennings	Vol #:	36

C 681	R. Erb	Vol #:	36

C 682	E. Race	Vol #:	36

C 683	A. Porter	Vol #:	36

C 684	B. Moran	Vol #:	36

C 685	T. Short, MD	Vol #:	36

C 686	A. Lindberg	Vol #:	36

C 687	A. Schuck	Vol #:	36

C 688	K. Miller	Vol #:	36

C 689	J. Olson	Vol #:	36

C 690	M. Iannitello	Vol #:	36

C 691	R and L Feldpausch	Vol #:	36

C 692	C. Niedos	Vol #:	36

C 693	T. Cornell	Vol #:	36

C 694	S. Costanzo	Vol #:	36

C 695	S. Costanzo	Vol #:	36

C 696	K. Hill	Vol #:	36

C 697	P. McClone	Vol #:	36

C 698	A. Jordan	Vol #:	36

C 699	Church of Saint Patrick	Vol #:	36

C 700	C. Litzelman	Vol #:	36

C 701	C. Cunningham	Vol #:	36

C 702	D and C Lopez	Vol #:	36

C 703	T. Phelan III	Vol #:	36

C 704	E. Thomas	Vol #:	36

C 705	S. Placek	Vol #:	36

C 706	D. Mordini	Vol #:	36

C 707	M. Brennen	Vol #:	36

C 708	D. Jones	Vol #:	36

C 709	San Francisco Guild of the Catholic Medical Association	Vol #:	36

C 710	R. McClone	Vol #:	36

C 711	T. Brennan	Vol #:	36



C 712	T. Huether	Vol #:	36

C 713	P. Essig	Vol #:	36

C 714	L. Curley	Vol #:	36

C 715	A and M Caldieraro	Vol #:	36

C 716	F. Smith, MD	Vol #:	37

C 717	K. Simon	Vol #:	36

C 718	M. Wilson	Vol #:	37

C 719	National Catholic Bioethics Center	Vol #:	36

C 720	A and R Malatt	Vol #:	37

C 721	Illigible	Vol #:	37

C 722	M. Vicente	Vol #:	37

C 723	M. McGuirk	Vol #:	37

C 724	A. Petullo	Vol #:	37

C 725	J. Higgins	Vol #:	37

C 726	R. Sibley	Vol #:	37

C 727	M. Donnelley	Vol #:	37

C 728	W. Rice, PhD	Vol #:	37

C 729	G. Urban	Vol #:	37

C 730	C. Knop	Vol #:	37

C 731	F. Depman	Vol #:	37

C 732	J and P O'Brien	Vol #:	37

C 733	P. Contermarsh	Vol #:	37

C 734	L. Courtney	Vol #:	37

C 735	B. Fink	Vol #:	37

C 736	D. Rosek	Vol #:	37

C 737	A. Dina	Vol #:	37

C 738	G. Nagasava	Vol #:	37

C 739	L and F Schneider	Vol #:	37

C 740	Concerned Women for America	Vol #:	37

C 741	Mr and Mrs D. Hurley	Vol #:	37

C 742	E. Roling et al	Vol #:	37

C 743	D and M Arbogast	Vol #:	37

C 744	D and P Glass	Vol #:	37

C 745	K. Green	Vol #:	37

C 746	E. Berger	Vol #:	37

C 747	V. Kasper	Vol #:	37

C 748	L. Martinez	Vol #:	37



C 749	B. Meier	Vol #:	37

C 750	12 signatures	Vol #:	37

C 751	B and M Kaiser	Vol #:	37

C 752	E. Stone	Vol #:	37

C 753	K. Campbell	Vol #:	37

C 754	R. Romo	Vol #:	37

C 755	M. Cronauer	Vol #:	37

C 756	M. Warren	Vol #:	37

C 757	Illigible	Vol #:	37

C 758	M. Trebon	Vol #:	37

C 759	I Surmel	Vol #:	37

C 760	F. Roloff	Vol #:	37

C 761	J and J Donahoe	Vol #:	37

C 762	G. Slyke	Vol #:	37

C 763	L. Jennings	Vol #:	37

C 764	S. Naseman	Vol #:	37

2006D-0515	Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays

GDL 1	Guidance	Vol #:	1

NAD 1	FDA	Vol #:	1

2006E-0022	Patent Extension Application for SYMLIN (pramlintide acetate), U.S. Patent No. 5,686,411

LET 5	FDA/CDER to U.S. Patent and Trademark Office	Vol #:	1

2006E-0026	Patent Extension Application for Luveris (recombinant human luteinizing hormone), U.S. Patent No. 5,639,639

LET 6	FDA/CDER to U.S. Patent and Trademark Office	Vol #:	1

2006N-0036	Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur


EMC 1	BanTransFats.com	Vol #:	1

EMC 2	J. Maloof	Vol #:	1

EMC 3	J. Pinard	Vol #:	1

EMC 4	C. Sargent	Vol #:	1

EMC 5	R. Maez	Vol #:	1

EMC 6	T. Clayton	Vol #:	1

EMC 7	K. Cole	Vol #:	1

EMC 8	J. Stephens	Vol #:	1

EMC 9	G. McCown	Vol #:	1



EMC 10	J. Cihocki	Vol #:	1

2006N-0061	Charging for Investigational Drugs

EC 2	UnitedHealth Group	Vol #:	1

EC 3	Mrs. Melanie Lounds	Vol #:	1

2006N-0517	Medical Devices; Immunology and Microbiology Devices; Classification of Quality Control Material for Cystic Fibrosis Nucleic Acid Assays

NFR 1	FDA	Vol #:	1

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

EC 473	Ms. Ashley Brotzge	Vol #:	7

2006P-0415	Petition Seeking Regulation of Cloned Animals

EC 731	Mrs. Ginelle Edmondson	Vol #:	4

EC 732	Mr. Gabriel Perkins	Vol #:	4

EC 733	Dr. Philip Hurzeler	Vol #:	4

EC 734	Mr. Gerald Miller	Vol #:	4

EC 735	Mr. R Smith	Vol #:	4

EC 736	DeStefano Architects	Vol #:	4

EC 737	Mr. Kerry Lagueux	Vol #:	4

EC 738	Mr. Duane Bruce	Vol #:	4

EC 739	Ms. Amanda Moser	Vol #:	4

EC 740	Mrs. Brenda Coman	Vol #:	4

EC 741	Miss. Deborah Fenker	Vol #:	4

EC 742	Mr. Walter Botich	Vol #:	4

EC 743	Mr. Gabriel Churray	Vol #:	4

EC 744	Mrs. Elisha Gray	Vol #:	4

EC 745	Mr. Greg Reyna	Vol #:	4

EC 746	Miss. Tracy Hall	Vol #:	4

EC 747	Mrs. Gina Fields	Vol #:	4

EC 748	Ms. Ella Elledge	Vol #:	4

EC 749	ALBRECHT FARM	Vol #:	4

EC 750	Mrs. Tina` Sporn	Vol #:	4

EC 751	No affiliation	Vol #:	4

EC 752	Mrs. Andre Christou	Vol #:	4

EC 753	Mr. Pierre Avignon	Vol #:	4

EC 754	Ms. Marie Begay	Vol #:	4

EC 755	Mrs. jessica cole	Vol #:	4



EC 756	Ms. Lisa Algarin	Vol #:	4

EC 757	Mrs. Tearra Leger	Vol #:	4

EC 758	Mrs. Nicole Saunders	Vol #:	4

EC 759	Mrs. Michele Lee	Vol #:	4

EMC 34	H. Lebed	Vol #:	5

EMC 35	T. Rush	Vol #:	5

2006P-0462	Determine whether Prevacid NapraPAC, 15 mg/250 mg (lansoprazole delayed-release, 15 mg capsules and naproxen 250 mg tablets kit) (NDA No. 021507) by Tap Pharm, has been voluntarily withdrawn or withhe


EC 1	micheleleeclw@yahoo.com	Vol #:	1

2006P-0498	Use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods

EC 3	none	Vol #:	1

2006P-0535	Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products

EC 12	Mrs. stacy carney	Vol #:	3

2007P-0004	Take steps to insure the safey of Americans regarding th misues of Lasik

EMC 2	Dean Kantis	Vol #:	1

EMC 3	Dean Kantis	Vol #:	1

Page created on January 11, 2007 kk

FDA/Dockets Management