Table of Contents

N 2 Vol#: 20

91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement

N 2 Vol#: 40

91N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements

N 2 Vol#: 29

91N-100H Health Claims & Label Statements; Folate & Neural Tube Defec

N 2 Vol#: 11
 
 

92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 6275 Mary Bridget Vol#: 160
 
 

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 997 Mrs. Carol W. Lloyd Vol#: 25

C 998 Bernard D. Leete Vol#: 25

C 999 Deborah A. Rowe Vol#: 25

C 1000 Barbara Fusco Vol#: 25

C 1001 Mark H. Wagner Vol#: 25

C 1002 Kevin R. Rhodes Vol#: 25

C 1003 Trina Fentriss Vol#: 25

C 1004 Mrs. William North Vol#: 25

C 1005 William E. Terrell Vol#: 25

EMC 1 Joan Ehrlich Vol#: 25

REF 1 OMB for review Vol#: 30
 
 

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients

LET 2 HFS-456 to Winsor Health Products Ltd Vol#: 26

97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD

GDL 3 GUIDANCE Vol#: 1

NAD 3 Vol#: 1

97N-0074 President's National Food Safety Initiative

C 196 Form letters count 7 Vol#: 14

C 197 Form letters count 5 Vol#: 15

C 198 Form letters count 5 Vol#: 16

C 199 Form letters count 5 Vol#: 17

C 200 Form letters count 4 Vol#: 18

97N-0511 Procedures the safe and sanitary processing/importing juice

NEC 2 Vol#: 13

REF 2 REFERENCE Vol#: 13

REF 3 REFERENCE Vol#: 13

REF 4 REFERENCE Vol#: 13
 
 

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 4230 Weider Nutrition International Inc Vol#: 29

LET 4231 Weider Nutrition International Inc Vol#: 29

LET 4232 Weider Nutrition International Inc Vol#: 29

LET 4233 Weider Nutrition International Inc Vol#: 29

LET 4234 Weider Nutrition International Inc Vol#: 29

LET 4235 Weider Nutrition International Inc Vol#: 29

LET 4236 Weider Nutrition International Inc Vol#: 29

LET 4237 Weider Nutrition International Inc Vol#: 29

LET 4238 Weider Nutrition International Inc Vol#: 29

LET 4239 Weider Nutrition International Inc Vol#: 29

LET 4240 Weider Nutrition International Inc Vol#: 29

LET 4241 Traditional Medicinals Inc Vol#: 29

LET 4242 Traditional Medicinals Inc Vol#: 29

LET 4243 Rexall Showcase International Vol#: 29

LET 4244 Rexall Showcase International Vol#: 29

LET 4245 Rexall Showcase International Vol#: 29

LET 4246 Warner Lambert Company Vol#: 29

LET 4247 Warner Lambert Company Vol#: 29

LET 4248 Maharishi Ayur-Ved products Int., Inc Vol#: 29

LET 4249 Maharishi Ayur-Ved products Int., Inc Vol#: 29

LET 4250 Maharishi Ayur-Ved products Int., Inc Vol#: 29
 
 

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 317 HFS-456 to Performance Labs Inc Vol#: 8

LET 318 HFS-456 to Market America Inc Vol#: 8

98F-0825 3,9-bis[2,4-bis(1-methyl-1-phenlethyl)phenoxy]-2,4,8,10

NFR 1 Vol#: 1

98N-0617 Treatment of Narcotic Dependence

C 36 NC Dept of Hlth & Human Services Vol#: 8

C 37 CA Health & Human Services, Dept of Alco Vol#: 8

C 38 American Osteopathic Association Vol#: 8

C 39 Discovery House Vol#: 8

C 40 New Horizon Treatment Services Inc Vol#: 10

C 41 Ocean Medical Services Inc Vol#: 10

C 42 CO Dept of Human Services Vol#: 10

C 43 Univ of CO Health Sciences Center Vol#: 10

C 44 Springfield Medical Clinic Vol#: 10

C 45 New Orleans Medical Clinic Vol#: 10

C 46 Columbia Medical Clinic Vol#: 10

C 47 Knoxville Medical Clinic Vol#: 10

C 48 American Society of Addiction Medicine Vol#: 10

C 49 Boehringer Ingelheim Roxanne Laboratorie Vol#: 10

C 50 Kansas City Medical Clinic Vol#: 10

C 51 Center for Addictive Problems Vol#: 10

EMC 10 Suzanne Gandolfi-Lapham Vol#: 8

EMC 11 Terri Martinez Vol#: 8
 
 

98N-1038 Irradiation in the production, processing, &handling of food

C 4783 Mary Bridget Dunn Vol#: 138

C 4784 Keith C. Vol#: 138

C 4785 Butte Environmental Council Vol#: 138

C 4786 Jade Pier Vol#: 138

C 4787 Sandra Smith Vol#: 138

C 4788 Helen Golosman Vol#: 138
 
 

98N-1265 Distribution of Compounded Drug Products

C 6144 Carolyn T. McGuigan Vol#: 171

C 6145 Lynue Alexander Vol#: 171

C 6146 A. Jirovetz Vol#: 171

99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA

GDL 2 GUIDANCE Vol#: 3

NAD 2 Vol#: 3
 
 

99D-4488 Reducing microbial food safety hazards for sprouted seeds

THESE LINKED COMMENTS DUPLICATE THOSE FOR 99D-4489, ALSO BELOW

C 4 Douglas Drew Vol#: 2

C 5 Lisa Lappe Vol#: 2

C 6 Jonathan Sprouts Inc Vol#: 2

C 7 Ryan J Magana Vol#: 2

C 8 Maggie Schley Vol#: 2

C 9 Thomas J Salach MD Vol#: 2

C 10 Diane Edinger Vol#: 2

C 11 Sunrise Farms Inc Vol#: 2

C 12 Brenda Hartman Vol#: 2

C 13 Karen J Wick Vol#: 2

C 14 Zannah Crowe Vol#: 2

C 15 Miriam Grunes Vol#: 2

C 16 Form letter count 26 Vol#: 3

99D-4489 Sampling & microbial testing of spent irrigation water

C 4 Douglas Drew Vol#: 2

C 5 Lisa Lappe Vol#: 2

C 6 Jonathan Sprouts Inc Vol#: 2

C 7 Ryan J Magana Vol#: 2

C 8 Maggie Schley Vol#: 2

C 9 Thomas J Salach MD Vol#: 2

C 10 Diane Edinger Vol#: 2

C 11 Sunrise Farms Inc Vol#: 2

C 12 Brenda Hartman Vol#: 2

C 13 Karen J Wick Vol#: 2

C 14 Zannah Crowe Vol#: 2

C 15 Miriam Grunes Vol#: 2

C 16 Form letter count 26 Vol#: 3

99D-4959 ''Disclosure of Materials Provided to Advisory Committees

GDL 1 GUIDANCE Vol#: 1

NAD 1 Center for Drug Evaluation and Resarch Vol#: 1

99D-5013 Labeling of Over-the-Counter Human Drug Products/column form

GDL 1 Guideline Vol#: 1

NAD 1 HFD-560 Vol#: 1

99H-2982 Civil Money Penalty;Ewing Oil Co inc,dba Williamsport Shell

ANS 2 Ewing Oil Co Inc, dba Williamsport Shell Vol#: 1

99H-4188 Civil Money Penalty;Harold Hawkins,dba Hawkins Market

ANS 1 Hawkins Market Vol#: 1

99H-4858 Civil Money Penalty;Cloverland Farms Dairy, Incorporated,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4859 Civil Money Penalty;Cloverland Farms Dairy Incorporated,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4860 Civil Money Penalty;Mitchell Toland,dba O'Donnell Citgo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4861 Civil Money Penalty;Adel Bejjani,dba Southeast Shell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4862 Civil Money Penalty;The Rozier Mercantile Company,dba Rozier

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4863 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart Superce

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4864 Civil Money Penalty;Ronnie Townsend,dba Campus Corner Minit

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4865 Civil Money Penalty;American Drug Stores Inc,dba Sav-On Drug

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4866 Civil Money Penalty;Phillippine Grocery & Gift Shop Inc

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4867 Civil Money Penalty;Bruce Morgan,dba Morgan Perfect Circle

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4868 Civil Money Penalty;Jim Martin Oil Co Inc,dba Homer Stop N g

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4869 Civil Money Penalty;Dicus Cash Super Market Inc,dba Dicus Su

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99N-1852 Status reports/postmarketing studies-human drugs&biological

NPR 1 Vol#: 1
 
 

99P-2630 Establish a Daily Value for "added sugars"

C 103 Lisa Theroux Vol#: 6

C 104 Paula J. Kotzum Vol#: 6

C 105 Charles & Kathy DiSanto Vol#: 6
 
 

99P-5158 Aendment to Definition of ''Milk'' In 21 C.F.R. Part 133.3

CP 1 American Dairy Products Institute Vol#: 1
 
 

99V-5159 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Science City At Union Station Vol#: 1
 
 

99V-5160

ACK 1 HFA-305 Vol#: 1

VAR 1 ARK of MIAMI Inc. Vol#: 1