Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870  [E-mail] 

DOCKETS ENTERED on 03/17/00

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]  [ ITEM CODES ]

 
99P-4613 Revoke the Regulation That Approved Posilac *
00P-1199 Approval of ANDAs for Extended-Release *

93F-0331 Safe use of dioctadecyldisulfide

NWL 1 Vol#: 1

95F-0065 Safe Use of polyamide-ethyleneimine-epichlorohydrin resin

BKG 1 BACKGROUND MATERIAL Vol#: 2

NFR 1 BASF Corp. Vol#: 1

96G-0035 Use of Dextranase enzyme in cane and beet sugar processing

NWL 1 Vol#: 1

96N-0277 Eligibility Criteria for Considering Additional Condition

EC 2 Number Not Used Vol#: 3

EC 3 Number Not Used Vol#: 3

EC 4 Number Not Used Vol#: 3

EC 5 Number Not Used Vol#: 3

EC 6 Number Not Used Vol#: 3

98N-0046 Comprehensive List of Current Guidance Documents at FDA

N 6 Vol#: 1

98N-0222 Dissemination of Information on Unapproved/New Uses

BKG 2 Background Vol#: 4

NFR 2 Vol#: 4

98N-0608 Plasma Protein Fraction (Human)/Immune Globulin (Human)

NFR 2 Vol#: 1

99D-2249 Technical Requirements for VICH

GDL 2 Guidance Vol#: 1

NAD 2 Vol#: 1

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

EC 2001 Number Not Used Vol#: 240

EC 2002 Number Not Used Vol#: 240

EC 2003 Daugherty Systems Vol#: 240

EC 2004 Ms. Helen Kuchta Vol#: 240

EC 2005 Mr. David Walters Vol#: 240

EC 2006 Leading Edge Products & Services Co. Vol#: 240

EC 2007 Cereon Genomics Vol#: 240

EC 2008 Millennium Marketing Vol#: 240

EC 2009 Mr. Rodney Shafer Vol#: 240

EC 2010 Number Not Used Vol#: 240

EC 2011 Miss Elyse Beffa Vol#: 240

EC 2012 Mr. Wesley Shirley Vol#: 240

EC 2013 Number Not Used Vol#: 240

EC 2014 Mr. Joseph Warren Vol#: 240

EC 2015 Number Not Used Vol#: 240

EC 2016 Number Not Used Vol#: 240

EC 2017 Number Not Used Vol#: 240

EC 2018 Number Not Used Vol#: 240

EC 2019 Number Not Used Vol#: 240

EC 2020 Number Not Used Vol#: 240

EC 2021 Number Not Used Vol#: 240

EC 2022 Mr. Daniel Schultz Vol#: 240

EC 2023 Ms. Kim Crowdis Vol#: 240

EC 2024 Professor (emeritus) Vol#: 240

EC 2025 Mr. Paul kaczmarczyk Vol#: 240

EC 2026 Ms. Kim Crowdis Vol#: 240

EC 2027 Ms. Kris Marohn Vol#: 240

EC 2028 Mr. James Copens Vol#: 240

EC 2029 Mr. Hualin Xi Vol#: 240

EC 2030 Dr. Richard Johnson Vol#: 230

EC 2031 Chicago Reader Vol#: 240

EC 2032 Monsanto Vol#: 240

EC 2033 Dr. Nanfei Xu Vol#: 240

EC 2034 Miss Wende Pfahler Vol#: 240

EC 2035 Mr. Riley McIntire Vol#: 240

EC 2036 Miss test test Vol#: 240

EC 2037 LuLu's Market and Delicatessen Vol#: 240

EC 2038 Ms. Laura Garon Vol#: 240

EC 2039 Ms. Anne Tiracchia Vol#: 240

EC 2040 Monsanto Vol#: 240

EC 2041 Monteray Bay Resistance to Genetic Engin Vol#: 240

EC 2042 Ms. Miriam Tassinare Tassinare Vol#: 240

EC 2043 Ms. Robin Oldham Vol#: 240

EC 2044 Mrs. Stacey Harrison Vol#: 240

EC 2045 N/A Vol#: 240

EC 2046 Agracetus Vol#: 240

EC 2047 O.B. People's Food Co-op Vol#: 240

EC 2048 Sustain Vol#: 240

EC 2049 Mrs. Christine Dente Vol#: 240

EC 2050 Mr. Andrew Grigsby Vol#: 240

EC 2051 White Lung Association Vol#: 240

EC 2052 Mr. Steven Goldstein Vol#: 240

EC 2053 Mr. Steve Phillips Vol#: 240

EC 2054 Ms. Paula Patrice Vol#: 240

EC 2055 Ms. Christine McKenna Vol#: 240

EC 2056 Ms. Jane Kimbrough Vol#: 240

EC 2057 Ms. Barbara Best Vol#: 240

EC 2058 Dr. Thomas Beals Vol#: 240

EC 2059 Ms. Nelle Greene Vol#: 240

EC 2060 Mrs. Laura Teksler Vol#: 240

EC 2061 Ms. Joan Rodriguez Vol#: 240

EC 2062 Ms. Jennifer Guthals Vol#: 240

EC 2063 Ms. Annie Hawkins Vol#: 240

EC 2064 Ms. Sharon Michnay Vol#: 240

EC 2065 Ms. Mary Wiley Vol#: 240

EC 2066 Ms. Maggie Wigen Vol#: 240

EC 2067 Mr. Bobbie Flowers Vol#: 240

EC 2068 Ms. Michele Bedjai Vol#: 240

EC 2069 Mr. Howard Pavane Vol#: 240

EC 2070 Ms. Sarita Parikh Vol#: 240

EC 2071 Ms. Sharon Flavell Vol#: 240

EC 2072 Frontier Natural Foods Co-op Vol#: 240

EC 2073 Ms. Kimber Nelsonq Vol#: 240

EC 2074 Ms. Jean Murphy Vol#: 240

EC 2075 Mrs. Lori Budington Vol#: 240

EC 2076 Cereon Genomics Vol#: 240

EC 2077 Mrs. Joann Henderson Vol#: 240

EC 2078 Dr. Paul Swanson Vol#: 240

EC 2079 Ms. Donna Hoaglin Vol#: 240

EC 2080 Ms. Kate Harris Vol#: 240

EC 2081 Oasis Gardens Community Supported Agricu Vol#: 240

EC 2082 None Vol#: 240

EC 2083 Ms. Susan Norris Vol#: 240

EC 2084 Mr. Stuart Blood Vol#: 240

EC 2085 Ms. Nancy Thibeault Vol#: 240

EC 2086 Mr. edgar lawson Vol#: 240

EC 2087 Ms. Nancy Thibeault Vol#: 240

EC 2088 Ms. tenar woodring Vol#: 240

EC 2089 None Vol#: 240

EC 2090 Mr. Douglas Taylor Vol#: 240

EC 2091 N/A Vol#: 240

EC 2092 Mrs. Marta Bancal Vol#: 240

EC 2093 Mr. David Fischhoff Vol#: 240

EC 2094 Ms. Audrey Pitigliano Vol#: 240

EC 2095 Ms. Debra Klaber Vol#: 240

EC 2096 Mr. Fred Strickhouser Vol#: 240

EC 2097 C & J Enterprises Vol#: 240

EC 2098 Mr. Timothy Reich Vol#: 240

EC 2099 The Campaign Vol#: 240

EC 2100 Ms. amy haskins Vol#: 240

EC 2101 Mr. Noah Khoshbin Vol#: 241

EC 2102 Mr. George Kailis Vol#: 241

EC 2103 Ms. Charla Chamberlain Vol#: 241

EC 2104 Mrs. elizabeth wymer Vol#: 241

EC 2105 none Vol#: 241

EC 2106 Ms. Kimberly Easson Vol#: 241

EC 2107 Ms. nancy hawkins Vol#: 241

EC 2108 Ms. Lauren Larkin Vol#: 241

EC 2109 Ms. Lori Tostado Vol#: 241

EC 2110 Mr. James Glover Vol#: 241

EC 2111 mothers for a childs safe future Vol#: 241

EC 2112 Ms. Caroline Miros Vol#: 241

EC 2113 Mr. Greg Snyder Vol#: 241

EC 2114 What's Growing On? Vol#: 241

EC 2115 Virginia Consumer Actionn Vol#: 241

EC 2116 Mr. jonathan grimes Vol#: 241

EC 2117 Mrs. Gretchen Handlos Vol#: 241

EC 2118 Mrs. Gretchen Handlos Vol#: 241

EC 2119 none Vol#: 241

EC 2120 Nordtech Research, Inc. Vol#: 241

EC 2121 Hanrahan and Assoc Vol#: 241

EC 2122 Ms. Annette Robbins Vol#: 241

EC 2123 Dr. Dwight Sims Vol#: 241

EC 2124 Mrs. Dana Nicolaysen Vol#: 241

EC 2125 Mr. Zarlot Darwheg Vol#: 241

EC 2126 Mr. Patrik Schumann Vol#: 241

EC 2127 UC Cooperative Extension Vol#: 241

EC 2128 Dr. Anne-Lise Francois Vol#: 241

EC 2129 just concerned consumer Vol#: 241

EC 2130 Mr. Mark Frerich Vol#: 241

EC 2131 Ms. Gail Dobson Vol#: 241

EC 2132 Mr. Rory Adams Vol#: 241

EC 2133 Ms. Elizabeth Chien-Hale Vol#: 241

EC 2134 Mr. William Costello Vol#: 241

EC 2135 Mr. Kurt Schanaman Vol#: 241

EC 2136 Monsanto Vol#: 241

EC 2137 Ms. Ellen Lockwood Vol#: 241

EC 2138 MONSANTO Vol#: 241

EC 2139 Bright Wings, Inc. Vol#: 241

EC 2140 Mr. Dean Whitlock Vol#: 241

EC 2141 Mr. Paul Sellmyer Vol#: 241

EC 2142 Monsanto Vol#: 241

EC 2143 Ms. Marilynn Gerry Vol#: 241

EC 2144 Mr. Lawrence Young Vol#: 241

EC 2145 Mr. Steven Klump Vol#: 241

EC 2146 Ms. Pearl Wishney Vol#: 241

EC 2147 Monsanto Vol#: 241

EC 2148 Mr. david warner Vol#: 241

EC 2149 Ms. Maria Vugrin Vol#: 241

EC 2150 Mr. Scott Baucum Vol#: 241

EC 2151 Mr. Robert DeWaine Vol#: 241

EC 2152 Mr. Scott Baucum Vol#: 241

EC 2153 Winsor School Vol#: 241

EC 2154 self Vol#: 241

EC 2155 Monsanto Company Vol#: 241

EC 2156 Monsanto/Searle Vol#: 241

EC 2157 Dow AgroSciences Vol#: 241

EC 2158 Mrs. Wendy Poulsen Vol#: 241

EC 2159 Mrs. Wendy Poulsen Vol#: 241

EC 2160 Mr. kevin karr Vol#: 241

EC 2161 Dr. Carol Goland Vol#: 241

EC 2162 Mr. Al Wideman Vol#: 241

EC 2163 Monsanto Vol#: 241

EC 2164 Monsanto Vol#: 241

EC 2165 Searle Vol#: 241

EC 2166 Ms. alan ford Vol#: 241

EC 2167 Searle Vol#: 241

EC 2168 Mr. John Flahive Vol#: 241

EC 2169 Ms. alan ford Vol#: 241

EC 2170 Mrs. Margaret Shelton Vol#: 241

EC 2171 Mrs. Wendy Poulsen Vol#: 241

EC 2172 Monsanto Vol#: 241

EC 2173 Mr. Christopher West Vol#: 241

EC 2174 Ms. Valerie Spence Vol#: 241

EC 2175 Ms. Lynda Fletcher Vol#: 241

EC 2176 Mr. Jean-Pierre Bressieux Vol#: 241

EC 2177 Mrs. Gail Hemedinger Vol#: 241

EC 2178 Private Citizan Vol#: 241

EC 2179 Mrs. Diane Barbeau Vol#: 241

EC 2180 Mrs. Terri Kirby Vol#: 241

EC 2181 Mr. David Woodburn Vol#: 241

EC 2182 Mr. brian avery Vol#: 241

EC 2183 Dr. hans kok Vol#: 241

EC 2184 Ms. Melissa Baker Vol#: 241

EC 2185 none Vol#: 241

EC 2186 none Vol#: 241

EC 2187 Mr. Louis Briscoe Vol#: 241

EC 2188 none Vol#: 241

EC 2189 Monsanto Co. Vol#: 241

EC 2190 none Vol#: 241

EC 2191 Mr. John Arns Vol#: 241

EC 2192 Mr. Joseph Byrne Vol#: 241

EC 2193 Ms. Julia Fischer Vol#: 241

EC 2194 Ms. Janet Lenius Vol#: 241

EC 2195 Mr. Leonard Pike Vol#: 241

EC 2196 Self Vol#: 241

EC 2197 Mrs. Susan Karasek Vol#: 241

EC 2198 Fonta Vol#: 241

EC 2199 Ms. Elizabeth Schneider Vol#: 241

EC 2200 Ms. Julia Fischer Vol#: 241

EC 2201 Ms. Carol Vracarich Vol#: 254

EC 2202 Mr. John Piekarski Vol#: 254

EC 2203 Fonta Vol#: 254

EC 2204 Ms. Nancy Merrick Vol#: 254

EC 2205 Mr. John Piekarski Vol#: 254

EC 2206 Searle Vol#: 254

EC 2207 Ms. Carol Benjamin Vol#: 254

EC 2208 Mrs. Faith Thompson Vol#: 254

EC 2209 Ms. Ruth Boatman Vol#: 254

EC 2210 Mrs. Carol Edel Vol#: 254

EC 2211 Farmer Vol#: 254

EC 2212 Psychologist Vol#: 254

EC 2213 Retired Vol#: 254

EC 2214 SYSTEMS PERTH Vol#: 254

EC 2215 Mrs. Carol Edel Vol#: 254

EC 2216 Ms. Barbara Ruff Vol#: 254

EC 2217 Agracetus-Monsanto Vol#: 254

EC 2218 Mrs. Sharon Tutchings Vol#: 254

99P-4613 Revoke the Regulation That Approved Posilac

EMC 1716 Monika & Robert Kowalewski Vol#: 19

EMC 1717 I S Vol#: 19

EMC 1718 Patricia Michelle Holcomb Vol#: 19

EMC 1719 Angrm Vol#: 19

EMC 1720 Sunstar Publishing Ltd. Vol#: 19

EMC 1721 Amanda Udis-Kessler Vol#: 19

EMC 1722 Jeri Schatz Vol#: 19

EMC 1723 Victor & Gigia Kolouch Vol#: 19

EMC 1724 Janet E. Lincoln Vol#: 19

EMC 1725 Lilia F. Wood Vol#: 19

EMC 1726 Brett James Carroll Vol#: 19

EMC 1727 Gail M. Francis Vol#: 19

EMC 1728 Charles B. Morenus Vol#: 19

EMC 1729 Chelsea Shure Vol#: 19

EMC 1730 Kerrie Saunders, Ph.D. Vol#: 19

EMC 1731 Nan Taska Vol#: 19

EMC 1732 Jennifer Huskey Vol#: 19

EMC 1733 Paul Malcolm Vol#: 19

EMC 1734 Susan Spicer Vol#: 19

EMC 1735 Ken Carta Vol#: 19

EMC 1736 Lotus Kresky Vol#: 19

EMC 1737 Higgins Restaurant & Bar Vol#: 19

EMC 1738 Bo Y Vol#: 19

EMC 1739 Deborah Madison Vol#: 19

EMC 1740 Lenore Morton Vol#: 19

EMC 1741 Daniel Jahn Vol#: 19

EMC 1742 Patrick Rooney Vol#: 19

EMC 1743 Carl Derrington Vol#: 19

EMC 1744 Lenora Boyle Vol#: 19

EMC 1745 John Wade Vol#: 19

EMC 1746 Brian D. Cupp Vol#: 19

EMC 1747 Tim Jennings Vol#: 19

EMC 1748 Bruce Grady Vol#: 19

EMC 1749 Ed Muniak Vol#: 19

EMC 1750 Ellen Coleman Vol#: 19

EMC 1751 Caspar Davis Vol#: 19

EMC 1752 Sonia Cole Vol#: 19

EMC 1753 Timothy Ernst Vol#: 19

EMC 1754 David Cull Vol#: 19

EMC 1755 Marilyn Hopping Vol#: 19

EMC 1756 Roger & Melinda Bedell Vol#: 19

EMC 1757 Ken Robinson Vol#: 19

EMC 1758 George Cull Vol#: 19

EMC 1759 Shelley Fulcher Vol#: 19

EMC 1760 David Goldstein Vol#: 19

EMC 1761 Lisa Perry Vol#: 19

EMC 1762 Paul Jackson Vol#: 19

EMC 1763 Destiny Vol#: 19

EMC 1764 Dana Stone Vol#: 19

EMC 1765 Lomeli John Amn Vol#: 19

EMC 1766 Alix Fano, MA Vol#: 19

EMC 1767 Lorraine Craig Vol#: 19

EMC 1768 David A. Campbell Vol#: 19

EMC 1769 Martha K. Dudley Vol#: 19

EMC 1770 Holly Dressel Vol#: 19

EMC 1771 Dr. Eric Darier Vol#: 19

EMC 1772 EarthSave Canada Vol#: 19

EMC 1773 Derek Stack Vol#: 19

EMC 1774 Derek Stack Vol#: 19

EMC 1775 A. T. Dudani Ph.D. (New Delhi, India) Vol#: 19

EMC 1776 Catriona Sandilands Vol#: 19

EMC 1777 Cathleen Kneen Vol#: 19

EMC 1778 Anna Walters Vol#: 19

EMC 1779 Bina Robinson Vol#: 19

EMC 1780 Rene Coignaud (Quebec Canada) Vol#: 19

EMC 1781 University of Victoria (Canada) Vol#: 19

EMC 1782 Maria Acosta Vol#: 19

EMC 1783 George Hrebar Vol#: 19

EMC 1784 Andrew Taynton (Republic of South Africa Vol#: 19

EMC 1785 Mellanie Colt Vol#: 20

EMC 1786 Glenda Lindsay Vol#: 20

EMC 1787 Diana Moreton Vol#: 20

EMC 1788 Sankar Vol#: 20

EMC 1789 Mark S. Reifslager Vol#: 20

EMC 1790 Jane Cawthorne Vol#: 20

EMC 1791 Francis Rouleau Vol#: 20

EMC 1792 Gilles Marin Vol#: 20

EMC 1793 Karen Seidman Vol#: 20

EMC 1794 Bette Myerson Vol#: 20

EMC 1795 Abra Brynne Vol#: 20

00C-0929 Sodium copper chloropphyllin to color citrus base dry bevera

NFL 1 Kraft Foods, Inc. Vol#: 1

00D-0835 Documentation of Qualitative Pharmaceutical Equivalence

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

00D-0892 Content/Format of NDA/ANDA for certain positron emission

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

00H-0035 Civil Money Penalty;Beaudry Convenience, Inc;dba Beaudry Exp

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

00H-0727 Civil Money Penalty;Gas City Ltd,dba Gas City Family Pantry

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0728 Civil Money Penalty;Gregory W Liles,dba Watkins Grocery and

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0729 Civil Money Penalty;Ronald p Taylor,dba Taylor Corner Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0817 Civil Money Penalty;Alliosn Oil Compnay Inc,dba R&R Country

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0818 Civil Money Penalty;Clark Retail Eneterprises Inc,dba Clark

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0819 Civil Money Penalty;Duhamel Enterprises LLC,dba Village Liqu

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0820 Civil Money Penalty;Billie Henry,dba M&B 501 Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0821 Civil Money Penalty;Home Oil & Gas Company Inc,dba Homeplace

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0822 Civil Money Penalty;Vercie L Newell,dba Dedeaux Road Tobacco

LET 1 HHS/CDER/FDA Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0823 Civil Money Penalty;Glen Ostrander,dba Spud's Pub

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0824 Civil Money Penalty;Romesh Raj,dba 77 Fuel Center

LET 1 Offiice of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0826 Civil Money Penalty;AKL Enterprises of Maryland Inc,dba Ali'

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0827 Civil Money Penalty;Benson Drug Company Inc,dba Benson Drug

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0828 Civil Money Penalty;Juanita Cooley,dba Corner Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0829 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #5752

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0830 Civil Money Penalty;Good to Go Inc,dba White Hen Pantry #350

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0831 Civil Money Penalty;Ginger Howton,dba I-40 Kwik Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0832 Civil Money Penalty;Jewel Food Stores Inc,dba Jewel Food Sto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0833 Civil Money Penalty;Lucky Louie's Inc,dba Lucky Louie's Disc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0834 Civil Money Penalty;Michelle Ma and William Ma,dba Handy's

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0837 Civil Money Penalty;Mohammad T Barber,dba Silver Lane Sunoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0838 Civil Money Penalty;Sofia Mom Sons LLC,dba Krauszer's #629

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0839 Civil Money Penalty;Gerald J Williams

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0840 Civil Money Penalty;Anita Dingus,dba Lake Market & Mercantil

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0841 civil Money Penalty;Roy Holdiness and Reba Holdiness,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00N-0553 Safety/Effectiveness Certain PET Drugs Specific Indications

BKG 1 BACKGROUND Vol#: 2

N 1 Vol#: 1

00N-0598 Dietary Supplement Health Claims

EAPE1 Consumer Healthcare Products Association Vol#: 1

EAPE2 Grocery Manufacturers of America Vol#: 1

EAPE3 ENVIRON International Corporation Vol#: 1

EAPE4 Procter & Gamble Vol#: 1

EAPE5 House Government Reform Subcommittee on Vol#: 1

EAPE6 Bristol-Myers Squibb Vol#: 1

EAPE7 Arent Fox Kintner Plotkin & Kahn, PLLC Vol#: 1

EAPE8 Bayer Corp. Consumer Care Division Vol#: 1

EAPE9 Bristol-Myers Squibb Co. Vol#: 1

EAPE10 Council for Responsible Nutrition Vol#: 1

EAPE11 CTFA Vol#: 1

EAPE12 American Home Products Corporation Vol#: 1

EAPE13 Perrigo Company Vol#: 1

EAPE14 American Academy of Physician Assistants Vol#: 1

EC 1 Number Not Used Vol#: 1

EC 2 Dr. Stacey Zawel Vol#: 1

NM 1 Vol#: 1

00P-1199 Approval of ANDAs for Extended-Release

ACK 1 HFA-305 Vol#: 1

CP 1 Biovail Corporation Vol#: 1