Dockets Entered on July 9, 2007

Dockets Management



Dockets Entered On July 9, 2007



Docket #	Title

2004D-0524	Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information

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

2006D-0480	Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food and Drug Administration

2006N-0357	Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products

2006N-0362	General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device

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

2007C-0245	Nippon Oil Corporation; Filing of Color Additive Petition

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

2007D-0249	Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage

2007N-0121	Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing

2007N-0221	Otsuka Pharmaceutical Co., Ltd.; Withdrawal of Approval of a New Drug Application

2007N-0229	Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations

2007N-0236	Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Applications and Supporting Regulations, and Form FDA 356V

2007N-0240	Agency Information Collection Activities: Proposed collection; Comment Request, Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions Part 60 (21 CFR Part 60) Exte


2007P-0004	Take steps to insure the safety of Americans regarding the misuses of Lasik

2007P-0085	Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity

2007P-0272	ANDA Suitability for Acetaminophen, Caffeine and Dihydrocodeine Tablets, 534.6 mg/45 mg/24 mg

2007P-0273	Request that CDER update the official drug labels for penicillin G potassium and penicillin Gsodium for injection

2007P-0274	Request that CDRH allow 510(k) clearance of devices for antimicrobial susceptibility testing of Streptococcus pneumoniae with pencillin

2007V-0271	Laser Light Show

2004D-0524	Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information

GDL 2	Guidance	Vol #:	1

NAD 2	FDA	Vol #:	1

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

C 531	M. Grivett	Vol #:	13

C 532	M. Robbins Jones	Vol #:	13

C 533	V. A. Hill	Vol #:	13

C 534	G. Williams	Vol #:	13

C 535	S. Blunkosky	Vol #:	13

C 536	J. Carlson	Vol #:	13

C 537	C. Traversa	Vol #:	13

C 538	M. Kakens	Vol #:	13

C 539	G. King	Vol #:	13

C 540	D. Petrakis	Vol #:	13



C 541	S. Schoen	Vol #:	13

C 542	N. Miller	Vol #:	13

C 543	A. Terpos	Vol #:	13

C 544	G. Barrett	Vol #:	13

C 545	J. Freeland	Vol #:	13

C 546	S. Andrews	Vol #:	13

C 547	D. Deane	Vol #:	13

C 548	J. Strait	Vol #:	13

C 549	M. Meyer	Vol #:	13

C 550	Y. Chavez	Vol #:	13

C 551	T. Price	Vol #:	13

C 552	E. Whitcomb	Vol #:	13

C 553	G. Graffius	Vol #:	13

C 554	S. Obrien	Vol #:	13

C 555	M. Bugarin	Vol #:	13

C 556	E. Eden	Vol #:	13

C 557	H. Redman	Vol #:	13

C 558	G. Caraway	Vol #:	13

C 559	R. Schoedler	Vol #:	13

C 560	R. Venable	Vol #:	13

C 561	D.I. Schoewalter	Vol #:	13

C 562	T. Truong	Vol #:	13

C 563	L. Topliffe	Vol #:	13

C 564	A. Tomasello	Vol #:	13

C 565	S. Pascale	Vol #:	13

C 566	J. Powers	Vol #:	13

C 567	F. Schneider	Vol #:	13

C 568	L. Wasso	Vol #:	13

C 569	S. A. Miller	Vol #:	13

C 570	G. Six	Vol #:	13

C 571	A. Sentes	Vol #:	13

C 572	B. Palecek	Vol #:	13

C 573	J. Pettengill	Vol #:	13

C 574	B. Johnson	Vol #:	13

C 575	T. L. Travis	Vol #:	13

C 576	K. Longley	Vol #:	13

C 577	R. Campbell	Vol #:	13



C 578	B. S.	Vol #:	13

C 579	B. Badtke	Vol #:	13

C 580	B. Valentin	Vol #:	13

C 581	V. Coolier	Vol #:	13

C 582	R. Hancock	Vol #:	13

C 583	J. Warcup	Vol #:	13

C 584	C. J.stein	Vol #:	13

C 585	A.j. O'brien	Vol #:	13

C 586	D. Mcgarity	Vol #:	13

C 587	E. Homberger	Vol #:	13

C 588	A. Tumarkin	Vol #:	13

C 589	P. Zeitler	Vol #:	13

C 590	L. Hertog	Vol #:	13

C 591	J. Wolff	Vol #:	13

C 592	V. S. Mencher	Vol #:	13

C 593	M. Godey	Vol #:	13

C 594	B. Rubin	Vol #:	13

C 595	S. Fischetti	Vol #:	13

C 596	J. Fritzke	Vol #:	13

C 597	R. Young	Vol #:	13

C 598	J. Wildman	Vol #:	13

C 599	D. Lavery	Vol #:	13

C 600	T. Purkey	Vol #:	13

C 601	C. Hansen	Vol #:	13

C 602	J. Hansen	Vol #:	13

C 603	C. Mora	Vol #:	13

C 604	J. Hisrich	Vol #:	13

C 605	B. Hemmings Gray	Vol #:	13

C 606	W. Franklin	Vol #:	13

C 607	A. Fox	Vol #:	13

C 608	I. Kane	Vol #:	13

C 609	M. Kinzie	Vol #:	13

C 610	G. And B. Freeman	Vol #:	13

C 611	P. Wright	Vol #:	13

C 612	A. Welch	Vol #:	13

C 613	A. Richards	Vol #:	13

C 614	E. Racoosin	Vol #:	13



C 615	E. Enser	Vol #:	13

C 616	C. Lee	Vol #:	13

C 617	B. Edwards	Vol #:	13

C 618	R. J. Herbison	Vol #:	13

C 619	H. Schott	Vol #:	13

C 620	C. Lauzon	Vol #:	13

C 621	V. Czarnecki	Vol #:	13

C 622	D. Dentino	Vol #:	13

C 623	P. Ziegler	Vol #:	13

C 624	S. Smith	Vol #:	13

C 625	A. Thornhill	Vol #:	13

C 626	M. Crowe	Vol #:	13

C 627	B. Riesterer	Vol #:	13

C 628	T. Daly	Vol #:	13

C 629	S. Hinkle	Vol #:	13

C 630	J. Patrick	Vol #:	13

C 631	L. & C. Terbot	Vol #:	13

C 632	D. Rodgers	Vol #:	13

C 633	L. Donell	Vol #:	13

C 634	D. Corrigan	Vol #:	13

C 635	D. Thomsen Minenga	Vol #:	13

C 636	J. Zaccaro	Vol #:	13

C 637	D. Hanna	Vol #:	13

C 638	G. Bolten	Vol #:	13

C 639	M. Friedman	Vol #:	13

C 640	M. Guertin	Vol #:	13

C 641	A. Mateo	Vol #:	13

C 642	J. Curtis	Vol #:	13

C 643	M. Bracken	Vol #:	13

C 644	M. Jarvis	Vol #:	13

C 645	P. Leonard	Vol #:	13

C 646	A. Meyer	Vol #:	13

C 647	L. Borthwick	Vol #:	13

C 648	C. K. Mcwilliams	Vol #:	13

C 649	L. Behler	Vol #:	13

C 650	C. Singer	Vol #:	13

C 651	W. Jackson	Vol #:	13



C 652	H. Koeing	Vol #:	13

C 653	I. Iverson	Vol #:	13

C 654	Z. Kopp	Vol #:	13

C 655	S. Somarriba-urgarte	Vol #:	13

C 656	J. Range	Vol #:	13

C 657	C. Rittenhouse	Vol #:	13

C 658	J. Sobiranski	Vol #:	13

C 659	J. Langer	Vol #:	13

C 660	T. Halpert	Vol #:	13

C 661	L. Metzler	Vol #:	13

C 662	J. Newell	Vol #:	13

C 663	M. Solo	Vol #:	13

C 664	J. P. Kirby	Vol #:	13

C 665	K. O.	Vol #:	13

C 666	N. J. Cornett	Vol #:	13

C 667	C. Koval	Vol #:	13

C 668	N. Moore	Vol #:	13

C 669	J. Gormley	Vol #:	13

C 670	A. Weber	Vol #:	13

C 671	K. Farrell	Vol #:	13

C 672	S. Jacobson	Vol #:	13

C 673	C. Abrams	Vol #:	13

C 674	E. H. Weis	Vol #:	13

C 675	J. Hasselgren	Vol #:	13

C 676	T. Burner	Vol #:	13

C 677	T. Moyer	Vol #:	13

C 678	J. Hoover	Vol #:	13

C 679	M. Garvey	Vol #:	13

C 680	C. R. Willoughby	Vol #:	13

C 681	D. Kalins	Vol #:	13

C 682	L. W. Wardenski	Vol #:	13

C 683	D. Crawford	Vol #:	13

C 684	D. Bentz	Vol #:	13

C 685	N. Acee	Vol #:	13

C 686	T. Moses	Vol #:	13

C 687	R. O'reilly	Vol #:	13

C 688	V. Kight	Vol #:	13



C 689	E.s. Wells	Vol #:	13

C 690	B.e. Meadows	Vol #:	13

C 691	H. Hoppenstedt	Vol #:	13

C 692	A. Biswell	Vol #:	13

C 693	A. Roth	Vol #:	13

C 694	C. A. Macklin	Vol #:	13

C 695	Y. Asher	Vol #:	13

C 696	S. Wagner	Vol #:	13

C 697	R. Kantrowitz	Vol #:	13

C 698	N. Rose	Vol #:	13

C 699	J. Fox	Vol #:	13

C 700	M. Meinschein	Vol #:	13

C 701	J. Salomon	Vol #:	13

C 702	L. Meltzer	Vol #:	13

C 703	R. Spence	Vol #:	13

C 704	J. Shidler	Vol #:	13

C 705	J. Chandler	Vol #:	13

C 706	H. Mccullough	Vol #:	13

C 707	J. Ainger	Vol #:	13

C 708	J. Helperin	Vol #:	13

C 709	G. Moses	Vol #:	13

C 710	S. L. King	Vol #:	13

C 711	S. Frantz	Vol #:	13

C 712	R. Thomas	Vol #:	13

C 713	D. Pedersen	Vol #:	13

C 714	M. Donohue	Vol #:	13

C 715	E. Dale	Vol #:	13

C 716	L. M. Gramigna	Vol #:	13

C 717	M. Devine	Vol #:	13

C 718	M. Borth	Vol #:	13

C 719	E. Schecter	Vol #:	13

C 720	D. Warner	Vol #:	13

C 721	P. Mcglamery	Vol #:	13

C 722	L. Elms	Vol #:	13

C 723	C. Leeper	Vol #:	13

C 724	D. Delunas	Vol #:	13



2006D-0480	Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food and Drug Administration

EC 1597	Ms. Michelle Viesselman	Vol #:	28

EC 1598	Ms. Mary Merry	Vol #:	28

EC 1599	Ms. Riox Frosher	Vol #:	28

EC 1600	Ms. Megan Shucart	Vol #:	28

EC 1601	Ms. Renee Neuharth	Vol #:	28

EC 1602	Ms. Billie Andrew	Vol #:	28

EC 1603	Mr. Michael Jacobson	Vol #:	28

EC 1604	International School for Colon Hydrotherapy, Inc.	Vol #:	28

EC 1605	Mr. Peter Johnson	Vol #:	28

EC 1606	Mr. Alex Bates	Vol #:	28

EC 1607	Ms. William Jacques	Vol #:	28

EC 1608	Mrs. Renee Duerr	Vol #:	28

EC 1609	Mr. charles cuseo	Vol #:	28

EC 1610	Mrs. Erin Coleman	Vol #:	28

EC 1611	Mrs. Evelyn Davila	Vol #:	28

EC 1612	none	Vol #:	28

EC 1613	Mr. Robert Brink	Vol #:	28

EC 1614	Mr. David Sell, LMT	Vol #:	28

EC 1615	Mrs. Joyce Lopez	Vol #:	28

EC 1616	Mrs. Cathy Lafever, LMT	Vol #:	28

EC 1617	Ms. Nannette Garrett	Vol #:	28

EC 1618	Mr. Mark DiPietro	Vol #:	28

EC 1619	Adept Solutions, Inc.	Vol #:	28

EC 1620	Mr. Jeff Griffin	Vol #:	28

EC 1621	Johnson and wales University	Vol #:	28

EC 1622	Mr. Robert Mitchell	Vol #:	28

EC 1623	Mr. Richard Leigh	Vol #:	28

EC 1624	Mr. Daniel Juffernbruch	Vol #:	28

EC 1625	Mr. robert flowers	Vol #:	28

EC 1626	Last Chance for Animals GHS	Vol #:	28

EC 1627	Brushy Mountain Massage Therapy	Vol #:	28

EC 1628	Dr. Carlos Braghini	Vol #:	28

EC 1629	Mr. Kevin Potter	Vol #:	28

EC 1630	We Are All Green	Vol #:	28

EC 1631	Mrs. Joyce Kroker	Vol #:	28



EC 1632	Mr. William Ash	Vol #:	28

EC 1633	Mr. David Matteson	Vol #:	28

EC 1634	AMTA	Vol #:	28

EC 1635	Mr. Dennis Russell	Vol #:	28

EC 1636	Mr. Neil Levin	Vol #:	28

EC 1637	Mr. Joseph Gates	Vol #:	28

EC 1638	Mrs. Ellen Grimes	Vol #:	28

EC 1639	Mrs. Margaret Kraft	Vol #:	28

EC 1640	Mrs. Catherine Kincaid	Vol #:	28

EC 1641	Mr. JOSEPH RINKUNAS	Vol #:	28

EC 1642	Mrs. Kathy Conner	Vol #:	28

EC 1643	Massage	Vol #:	28

EC 1644	Mr. steve earles	Vol #:	28

EC 1645	Mr. Dennis Drake	Vol #:	28

EC 1646	Mr. Russell McElroy	Vol #:	28

EC 1647	Dr. John Perkins	Vol #:	28

EC 1648	Mrs. Tandi Hartle	Vol #:	28

EC 1649	massage therapist	Vol #:	28

EC 1650	Ms. Valerie Cassity	Vol #:	28

EC 1651	none	Vol #:	28

EC 1652	Private Citizen	Vol #:	28

EC 1653	AMTA	Vol #:	28

EC 1654	Mrs. Ashley Wilson	Vol #:	28

EC 1655	Mrs. Amy DeArmas	Vol #:	28

EC 1656	Mrs. Rebecca Hammond	Vol #:	28

EC 1657	Ms. Antonia Nelson	Vol #:	28

EC 1658	Mrs. K Beckett	Vol #:	28

EC 1659	Mrs. Stephanie Witt	Vol #:	28

EC 1660	Mr. Miguel Franco	Vol #:	28

EC 1661	Concerned Citizen	Vol #:	28

EC 1662	Mrs. Sandra Bradbury	Vol #:	28

EC 1663	na	Vol #:	28

EC 1664	Miss. Harriet Kubek	Vol #:	28

EC 1665	Mrs. Elaine McBee	Vol #:	28

EC 1666	Dr. GEORGE RITTER	Vol #:	28

EC 1667	Right To Choose Healthy Food	Vol #:	28

EC 1668	Mrs. Mary Joan Bayer	Vol #:	28



EC 1669	Mrs. Dian Richold	Vol #:	28

EC 1670	Mr. Benjamin Marantz	Vol #:	28

EC 1671	Ms. Emilie Kosa	Vol #:	28

EC 1672	Ms. megan radmore	Vol #:	28

EC 1673	Mr. Clyde Reis	Vol #:	28

EC 1674	Mr. William Williams	Vol #:	28

EC 1675	Mr. peter juergensen	Vol #:	28

EC 1676	Mr. FRank Locke	Vol #:	28

EC 1677	Mrs. Marie Corey	Vol #:	28

EC 1678	Ms. Lynne Watson	Vol #:	28

EC 1679	Mrs. Vera McLean	Vol #:	28

EC 1680	Little Friends Daycare	Vol #:	28

EC 1681	Miss. Don't F*** With my Health	Vol #:	28

EC 1682	Mr. Todd Wilson	Vol #:	28

EC 1683	Ms. Lisa Whaley	Vol #:	28

EC 1684	Ms. Chyenne Pate	Vol #:	28

EC 1685	Ms. Lana Leveque	Vol #:	28

EC 1686	Mr. david ham	Vol #:	28

EC 1687	Mr. Michael Santell	Vol #:	28

EC 1688	Equine Concepts	Vol #:	28

EC 1689	Mrs. Judy Fretwell-Gottman	Vol #:	28

EC 1690	na	Vol #:	28

EC 1691	Mr. Jeff Dorais	Vol #:	28

EC 1692	Mrs. Kathie Dice	Vol #:	28

EC 1693	Ms. Krista Avalon	Vol #:	28

EC 1694	Miss. Maryanne Petranek	Vol #:	28

EC 1695	Ms. Bonnie Peterson	Vol #:	28

EC 1696	Mr. George Drew	Vol #:	28

EC 1697	Mrs. Linda Matheson	Vol #:	28

EC 1698	Mr. carl erickson	Vol #:	28

EC 1699	Mrs. Jane Voulgaris	Vol #:	28

EC 1700	Mrs. Aimee Hicks	Vol #:	28

EC 1701	Massage Therapy	Vol #:	28

EC 1702	Ms. NL Needham	Vol #:	28

EC 1703	Mr. Matthew Baldwin	Vol #:	28

EC 1704	Mr. robert mantz, jr	Vol #:	28

EC 1705	Ms. Cass von Braun	Vol #:	28



EC 1706	American citizens	Vol #:	28

EC 1707	American Cancer Society	Vol #:	28

EC 1708	Mr. David Christian	Vol #:	28

EC 1709	AMTA	Vol #:	28

EC 1710	Ms. Erin McIntire	Vol #:	28

EC 1711	Colorado School of Traditional Chinese Medicine	Vol #:	28

EC 1712	Mr. Warren Gaul	Vol #:	28

EC 1713	Mrs. LC Evans	Vol #:	28

EC 1714	Ms. Lynne Mohr	Vol #:	28

EC 1715	Mr. jerry hawkins	Vol #:	28

EC 1716	Shiatsu	Vol #:	28

EC 1717	Ms. Rebecca Hennessey	Vol #:	28

EC 1718	Mr. dean voight	Vol #:	28

EC 1719	Ms. Kristin Curth	Vol #:	28

EC 1720	Miss. Dawn-Marie Vasco	Vol #:	28

EC 1721	Ms. Barbara Enteen	Vol #:	28

EC 1722	Mrs. Jan Dickinson	Vol #:	28

EC 1723	Mr. David Swanson	Vol #:	28

EC 1724	Dr. Timothy Starkey	Vol #:	28

EC 1725	Ms. Erika Michael	Vol #:	28

EC 1726	Mr. Christopher Bousquet	Vol #:	28

EC 1727	Miss. Alexandria D'Agostino	Vol #:	28

EC 1728	FOUNDATION FOR WELLNESS PROFESSIONAL	Vol #:	28

EC 1729	Ms. Margaret Garron	Vol #:	28

EC 1730	Mr. Ambrose Avery	Vol #:	28

EC 1731	Mrs. lisa campbell	Vol #:	28

EC 1732	Mrs. Linda Evans	Vol #:	28

EC 1733	Mr. Gene Macdonald	Vol #:	28

EC 1734	Mr. Steve Welch	Vol #:	28

EC 1735	Mrs. Carolyn Gretta	Vol #:	28

EC 1736	Ms. ANGELA VASQUEZ	Vol #:	28

EC 1737	Miss. Heather Howe	Vol #:	28

EC 1738	Mr. David Hancock	Vol #:	28

EC 1739	none	Vol #:	28

EC 1740	Mrs. Cara Cerna	Vol #:	28

EC 1741	American Massage Therapy Association	Vol #:	28

EC 1742	Dr. Phyllis Shaw	Vol #:	28



EC 1743	Mr. Abram Davis	Vol #:	28

EC 1744	Mr. Jamal Khan	Vol #:	28

EC 1745	Mrs. Patricia Gleason	Vol #:	28

EC 1746	Ms. Lois Evenson	Vol #:	28

EC 1747	Mr. Anthony Frederick	Vol #:	28

EC 1748	Mrs. Amy Jones	Vol #:	28

EC 1749	Mrs. Cheryl Kiepke	Vol #:	28

EC 1750	Ms. Suzanne Seay	Vol #:	28

EC 1751	Ms. Kya Eckstrand	Vol #:	28

EC 1752	Miss. Meaghan Doyle	Vol #:	28

EC 1753	Tim Middleton Health	Vol #:	28

EC 1754	Mrs. B McGuire	Vol #:	28

EC 1755	Sisters of Notre Dame of Chardon OH	Vol #:	28

EC 1756	Mrs. Keri Rome	Vol #:	28

EC 1757	Mr. Omar Castillo	Vol #:	28

EC 1758	Ms. Pamela Loy	Vol #:	28

EC 1759	Miss. Ashley Hackel	Vol #:	28

EC 1760	Ms. Cynthia Dalcone-DenBleyker	Vol #:	28

EC 1761	Mr. Justin Nelson	Vol #:	28

EC 1762	Ms. jaci smith	Vol #:	28

EC 1763	Mr. Kirby Morris	Vol #:	28

EC 1764	Mrs. Debra West	Vol #:	28

EC 1765	Ms. Becky Tarrant	Vol #:	28

EC 1766	Mrs. Sally Lavery	Vol #:	28

EC 1767	Mrs. Janine Hatton	Vol #:	28

EC 1768	Ms. patti Schippani	Vol #:	28

EC 1769	Mrs. Heather Reay	Vol #:	28

EC 1770	Ms. Cheryl Barnes-Neff	Vol #:	28

EC 1771	Mr. Hugh Brackett	Vol #:	28

EC 1772	Ms. Arvette Reese	Vol #:	28

EC 1773	FDA	Vol #:	28

EC 1774	Mr. Kirby Foster	Vol #:	28

EC 1775	Mrs. Bill Chisholm	Vol #:	28

EC 1776	Mr. jIM DUBOSE	Vol #:	28

EC 1777	Miss. Laura Pasetto	Vol #:	28

EC 1778	Mrs. Christy Raines	Vol #:	28

EC 1779	Dr. Tanya Taylor	Vol #:	28



EC 1780	Mr. brian tennant	Vol #:	28

EC 1781	Mr. HUBERT PORZNER	Vol #:	28

EC 1782	Ms. Heidi Schlatter	Vol #:	28

EC 1783	Mr. edward hower	Vol #:	28

EC 1784	holistic energy worker	Vol #:	28

EC 1785	Mr. Paul Flor	Vol #:	28

EC 1786	Ms. Chance McDade	Vol #:	28

EC 1787	Mr. gerald verdine	Vol #:	28

EC 1788	Mr. G. Holland	Vol #:	28

EC 1789	Mrs. Michelle Botts	Vol #:	28

EC 1790	Mr. David Forde	Vol #:	28

EC 1791	Ms. Taye Rosser	Vol #:	28

EC 1792	Mr. Kevin Johnson	Vol #:	28

EC 1793	Mrs. leigh ann tatnall	Vol #:	28

EC 1794	Mr. kirk tatnall	Vol #:	28

EC 1795	Mrs. Karen Heikkala	Vol #:	28

EC 1796	Mr. Oscar (Gene) Grimes	Vol #:	28

EC 1797	Mr. Tymothy Smith	Vol #:	28

EC 1798	Mr. David Ellis	Vol #:	28

EC 1799	Ms. Cynthia Dorst	Vol #:	28

EC 1800	Mr. Andrew Robinson	Vol #:	28

EC 1801	Invigorate Chiropractic	Vol #:	28

EC 1802	Mrs. lynn faulconer	Vol #:	28

EC 1803	Ms. Alice McCool	Vol #:	28

EC 1804	Ms. Amanda Lawrence	Vol #:	28

EC 1805	Mr. ron horvat	Vol #:	28

EC 1806	Ms. patricia weller	Vol #:	28

EC 1807	Mrs. Wendy Wolthausen	Vol #:	28

EC 1808	Ms. Kathi Downs	Vol #:	28

EC 1809	none	Vol #:	28

EC 1810	Mr. L. Hardy Mason	Vol #:	28

EC 1811	Ms. Marilyn Traver	Vol #:	28

EC 1812	Mr. Mark Genovese	Vol #:	28

EC 1813	Mr. Seth Reber	Vol #:	28

EC 1814	Mr. thomas deakin	Vol #:	28

EC 1815	Mr. Russell Burnham	Vol #:	28

EC 1816	AMTA	Vol #:	28



EC 1817	home	Vol #:	28

EC 1818	Ms. Lory Rosenberg	Vol #:	28

EC 1819	Dr. Bill Asenjo	Vol #:	28

EC 1820	Ms. Dawn Klinge	Vol #:	28

EC 1821	Ms. Carole Foster	Vol #:	28

EC 1822	Mrs. Sheila Runkle	Vol #:	28

EC 1823	Ms. Susan Smith	Vol #:	28

EC 1824	Ms. Mary Scoles	Vol #:	28

EC 1825	Mr. Gary Parker	Vol #:	28

EC 1826	Consultant	Vol #:	28

EC 1827	citzen of a country where our freedoms are being t	Vol #:	28

EC 1828	APPALACHIAN MASSAGE	Vol #:	28

EC 1829	Ms. Reta Wright	Vol #:	28

EC 1830	Ms. elizabeth armao	Vol #:	28

EC 1831	Mr. Dieter Schleber	Vol #:	28

EC 1832	Miss. Ellie Cassidy	Vol #:	28

EC 1833	Dr. James Gascoyne	Vol #:	28

EC 1834	Pure Gold Publishing	Vol #:	28

EC 1835	Ms. kathleen parrott	Vol #:	28

EC 1836	Mr. Gary Elliott	Vol #:	28

EC 1837	Mrs. colleen dodge	Vol #:	28

EC 1838	Ms. dana toomey	Vol #:	28

EC 1839	Mr. Denwood Chapin	Vol #:	28

EC 1840	Mrs. Enrique Gutierrez	Vol #:	28

EC 1841	Ms. Diana J. Eckholdt	Vol #:	28

EC 1842	Ms. andrea wiener	Vol #:	28

EC 1843	Mrs. Theresa Mazzei	Vol #:	28

EC 1844	NA	Vol #:	28

EC 1845	Ms. Anna Kilbridge	Vol #:	28

EC 1846	Mrs. ANNETTE NEAL	Vol #:	28

EC 1847	Jennifer Massage	Vol #:	28

EC 1848	Mr. Zachery Dacuk	Vol #:	28

EC 1849	Ms. Roberta Murray	Vol #:	28

EC 1850	Mr. Adam Rostad	Vol #:	28

EC 1851	Dr. Michael Bucknell	Vol #:	28

EC 1852	Ms. Nina Gould	Vol #:	28

EC 1853	Mr. Jason Yoder	Vol #:	28



EC 1854	GAIA CENTER	Vol #:	28

EC 1855	Mr. Fred Nelsen	Vol #:	28

EC 1856	Ms. Michelle Hernandez	Vol #:	28

EC 1857	Mrs. Amy Kehrer	Vol #:	28

EC 1858	Ms. Susan Stoltz	Vol #:	28

EC 1859	Mr. Timothy Martin	Vol #:	28

2006N-0357	Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products

NAL 1	FDA	Vol #:	1

SS 1	Supporting Statement	Vol #:	1

2006N-0362	General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device

ACK 1	FDA/DDM to DuVal & Associates	Vol #:	1

CP 1	Ferrosan A/S	Vol #:	1

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

NM 1	FDA	Vol #:	1

2007C-0245	Nippon Oil Corporation; Filing of Color Additive Petition

NFL 1	FDA	Vol #:	1

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

GDL 1	Guidance	Vol #:	1

NAD 1	FDA	Vol #:	1

2007D-0249	Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage

GDL 1	Guidance	Vol #:	2

NAD 1	FDA	Vol #:	2

REF 1	References to Draft Guidance	Vol #:	1

2007N-0121	Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing

EMC 32	Dr. Sharav via Diane Ehrlich	Vol #:	1

2007N-0221	Otsuka Pharmaceutical Co., Ltd.; Withdrawal of Approval of a New Drug Application

NCR 1	FDA	Vol #:	1

2007N-0229	Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations

N 1	FDA	Vol #:	1

2007N-0236	Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Applications and Supporting Regulations, and Form FDA 356V

N 1	FDA	Vol #:	1



2007N-0240	Agency Information Collection Activities: Proposed collection; Comment Request, Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions Part 60 (21 CFR Part 60) Exte



N 1	FDA	Vol #:	1

2007P-0004	Take steps to insure the safety of Americans regarding the misuses of Lasik

EMC 4	LASIKsucks4u	Vol #:	1

2007P-0085	Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity

EC 943	Don't Mess With Our Chocolate	Vol #:	11

EC 944	Ms. Erin Morrissey	Vol #:	11

EC 945	None	Vol #:	11

EC 946	Ms. Cecil Daughton	Vol #:	11

EC 947	Mr. William Medlicott	Vol #:	11

EC 948	Mrs. Laura Sparks	Vol #:	11

EC 949	Ms. joanna miller	Vol #:	11

EC 950	Ms. Anne Madden	Vol #:	11

EC 951	Mrs. Adele Calo	Vol #:	11

EC 952	Dont Mess with Our Chocolate	Vol #:	11

EC 953	Ms. Patricia Campbell	Vol #:	11

EC 954	Don't Mess With Our Chocolate	Vol #:	11

EC 955	Ms. LYNN DEUTSCH	Vol #:	11

EC 956	Ms. Rosa Li	Vol #:	11

EC 957	Mr. Don Ripperger	Vol #:	11

EC 958	Ms. Mary Ann Agre	Vol #:	11

EC 959	Ms. Joan Perez	Vol #:	11

EC 960	Mrs. Celestine Sofilka	Vol #:	11

EC 961	Mr. Keith Stetson	Vol #:	11

EC 962	Don't Mess With Our Chocolate	Vol #:	11

EC 963	Ms. Sarah McNeil	Vol #:	11

EC 964	Ms. Mary Murphy	Vol #:	11

EC 965	Don't Mess With Our Chocolate	Vol #:	11

EC 966	Mrs. Dyahnee Goosby	Vol #:	11

EC 967	Mr. charlie mccloskey	Vol #:	11

EC 968	Mr. Alexander L. Baer	Vol #:	11

EC 969	Ms. Katie Milburn	Vol #:	11

EC 970	Don't mess with my chocolate	Vol #:	11

EC 971	Miss. Sy Fang Pan	Vol #:	11

EC 972	Ms. Jan Donohoe	Vol #:	11



EC 973	Don't Mess With Our Chocolate	Vol #:	11

EC 974	Ms. Sarah Robinson	Vol #:	11

EC 975	Ms. Marki Smylie	Vol #:	11

EC 976	Ms. Sherilyn Saporito	Vol #:	11

EC 977	Ms. Michelle Csonka	Vol #:	11

EC 978	Don't Mess With Our Chocolate	Vol #:	11

EC 979	Mr. Lowell Rapaport	Vol #:	11

EC 980	Mr. Michael Macchioni	Vol #:	11

2007P-0272	ANDA Suitability for Acetaminophen, Caffeine and Dihydrocodeine Tablets, 534.6 mg/45 mg/24 mg

ACK 1	FDA/DDM to Lachman Consultant Services, Inc.	Vol #:	1

CP 1	Lachman Consultant Services, Inc.	Vol #:	1

2007P-0273	Request that CDER update the official drug labels for penicillin G potassium and penicillin Gsodium for injection

ACK 1	FDA/DDM to Clinical and Laboratory Standards Institute	Vol #:	1

CP 1	Clinical and Laboratory Standards Institute	Vol #:	1

2007P-0274	Request that CDRH allow 510(k) clearance of devices for antimicrobial susceptibility testing of Streptococcus pneumoniae with pencillin

ACK 1	FDA/DDM to Clinical and Laboratory Standards Institute	Vol #:	1

CP 1	FDA/DDM to Clinical and Laboratory Standards Institute	Vol #:	1

2007V-0271	Laser Light Show

ACK 1	FDA /DDM to Margaret C. Woodson Planetarium	Vol #:	1

VAR 1	Margaret C. Woodson Planetarium	Vol #:	1

Page created on July 9, 2007 ue

FDA/Dockets Management