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 August 5, 1999 Table of Contents (Hyper links are part of the Docket title - not all dockets/documents are linked) (Documents received by the Dockets Management Branch "MAY" be posted on the internet. Please do not include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence. ) |
92N-0139 Statement Policy: Foods Derived from New Plant Varieties * 98N-1265 Distribution of Compounded Drug Products * 99D-0557 Use of Nonhuman Primate Xenografts in Humans * 99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock * 99P-1340 Declared Eternity eau de Parfum Misbranded * |
91F-0328 Slimicides
NWL 1 Yoshitomi Fine Chemicals Vol#: 1
92N-0139 Statement Policy: Foods Derived from New Plant Varieties
C 5721 Christine Caton-McGill Vol#: 134
C 5722 Cynthia A Frye Vol#: 134
C 5723 Eric R Morales Vol#: 134
C 5724 Lee A Swensson Vol#: 134
C 5726 Florence Humphrey Vol#: 134
C 5727 Christina Boskovic Vol#: 134
C 5728 Robert & Peggy Ward Vol#: 134
C 5729 Suzanne Williams Vol#: 134
C 5731 Mytye Glomboslee Vol#: 134
C 5732 Tracy Cardillo Vol#: 134
C 5734 Charles & Dianne Walthers Vol#: 134
C 5735 Mary H Miller Vol#: 134
C 5736 Anne S Watson Vol#: 134
C 5737 Linda Jean Shepherd PhD Vol#: 134
C 5738 Heather E Neisworth Vol#: 134
C 5740 Laurie Mentos Vol#: 134
C 5742 Sister Carole Rozzi Vol#: 134
C 5743 William Kintner Vol#: 134
C 5744 Pamela McNeely Vol#: 134
C 5746 Linda Ruggeroli Vol#: 134
C 5747 Donald Ruggeroli Vol#: 134
C 5748 Joyce A McDonald Vol#: 134
C 5749 Richard W Bachtold Vol#: 134
C 5750 Debbie Skikos Vol#: 134
C 5751 Brenda Swingley Vol#: 134
C 5753 Charlotte Hartman Vol#: 134
C 5754 Leta M Shattuck Vol#: 134
C 5756 Peter L Gebhardt Vol#: 134
C 5757 Mary M Hassett Vol#: 134
C 5758 Evelyn H Singer Vol#: 134
C 5760 Rocco Salvadore Vol#: 134
97P-0350 Reclassify Home Uterine Activity Monitors from III to II
N 1 Vol#: 1
N 2 Vol#: 5
98N-0044 Effect of dietary supplement on structure/function of body
ANS 1 HFS-450 to Emord & Associates Inc Vol#: 876
C 22356 Botanical Enterprises Inc Vol#: 871
C 22357 American Medical Association Vol#: 871
C 22358 American College of Obstetricians & Gyne Vol#: 871
C 22359 Seton Hall University Vol#: 871
C 22360 American Urological Association Inc Vol#: 871
C 22361 American Herbal Products Association Vol#: 871
C 22362 American Cancer Society Vol#: 871
C 22363 Beverly Birchard Vol#: 871
C 22364 Loette Bailey Vol#: 874
C 22365 Dr A L Russell Vol#: 874
C 22366 Ernest M Duckworth Jr PE Vol#: 874
C 22367 Harris Schiller Vol#: 874
C 22368 Velta & Robert Boldra Vol#: 874
C 22369 Research-based Dietary Ingredient Assn Vol#: 874
C 22370 Jag Group Inc, Meditrend Inc etc Vol#: 874
C 22371 Georgetown University Graduate School Vol#: 874
C 22372 Keller and Heckman Vol#: 874
C 22373 Electronic Retailing Association Vol#: 874
C 22374 MGA Development Corp Vol#: 874
C 22375 American Academy of Pediatrics Vol#: 874
C 22376 Nutraceutical Corporation Vol#: 874
C 22377 Citizens for Health Vol#: 874
C 22378 American Heart Association Vol#: 874
C 22379 Consumer Healthcare Products Association Vol#: 875
C 22380 Grocery Manufacturers of America Vol#: 875
C 22381 Roche Vitamins Inc Vol#: 875
C 22382 Wellness International Network Ltd Vol#: 875
C 22383 National Food Processors Association Vol#: 875
C 22384 Metagenics Inc Vol#: 876
EC 5 Jane E. Maurer Vol#: 871
EC 6 Michael L Kanas Vol#: 871
EC 7 William E Ross Vol#: 871
EC 8 Tom and Cara Patterson Vol#: 871
EC 9 Samantha Trepanier Vol#: 871
EC 10 Laura J. Fochtmann, MD Vol#: 874
EC 11 Diedra Smith Vol#: 874
EC 12 Fred A. Baughman Jr., MD Vol#: 874
NCR 1 HF-22 Vol#: 871
TS 1 American Herbal Products Association Vol#: 871
TS 2 Nuhealth Corp. Vol#: 874
98N-0046 Comprehensive List of Current Guidance Documents at FDA
N 5 HF-26 Vol#: 1
98N-0313 Sugeons's and Patient Examination Gloves Reclassification
BKG 1 Vol#: 2
NPR 1 Vol#: 1
REF 1 Vol#: 1
98N-1265 Distribution of Compounded Drug Products
C 4869 Yvonne C. Gabel Vol#: 152
C 4870 Jean Brown Pillor Vol#: 152
C 4871 Jean H. Snyder Vol#: 152
C 4872 Luis Kalahowski Vol#: 152
C 4873 Sherwood Barton Bromley Vol#: 152
C 4874 Diane L. Fahy Vol#: 152
C 4876 Munya Tovares Vol#: 152
C 4879 E. Lee May Jr. Vol#: 152
C 4881 Harriet F. Elkington Vol#: 152
C 4883 Terri A. McNerney Vol#: 152
C 4884 Violet H. Grosch Vol#: 152
C 4886 Justina Theokas Vol#: 152
C 4887 Melissa M. Trail Vol#: 152
C 4888 Diane D. Piotrowski Vol#: 152
C 4889 Carole Mehling Vol#: 152
C 4890 Bonnie S. Wubben Vol#: 152
C 4891 Belinda Hanburg Vol#: 152
C 4892 Noreen A. Knorr Vol#: 152
C 4893 Frederick B. Franco Vol#: 152
C 4894 Carol Migiaccio Vol#: 152
C 4895 Joyce W. Finlay Vol#: 152
C 4896 Charles N. Read Vol#: 152
C 4898 Patricia Woodhead Vol#: 152
C 4899 Deloris Pogulti Vol#: 152
C 4900 Kathryn M. Foley Vol#: 152
C 4902 Irene Jelacic Vol#: 152
C 4904 Alice M. Chafetz Vol#: 152
C 4905 Bessie Kastanis Vol#: 152
C 4907 Louise F. Sarala Vol#: 152
C 4909 Helen Perlmutter Vol#: 152
C 4911 Gail Steinmetz Vol#: 152
C 4912 Barbara D. Wick Vol#: 152
C 4913 Thalia Poulos Vol#: 152
C 4914 Sharon M. Martin Vol#: 152
C 4915 Merrily C. Jones Vol#: 152
C 4916 Hope A. Meador Vol#: 152
C 4917 Barbara Malkin Vol#: 152
C 4919 Patricia P. Host Vol#: 152
C 4920 Dayle J. Keller Vol#: 152
C 4921 Ellis Barnfont Vol#: 152
C 4922 Jennifer Hall Lapointe Vol#: 152
C 4923 Mary Ellen Berard Vol#: 152
C 4924 Diane Zimmerman Vol#: 152
C 4928 Tara L. McKibben Vol#: 152
C 4929 Toyo Tanya Kakane Vol#: 152
C 4930 Romayne Trudo Vol#: 152
C 4931 Karla Jonschwiak Vol#: 152
C 4932 Paula O'Connor Vol#: 152
C 4935 Bonnie S. Carpenter Vol#: 152
C 4936 Jaime G. Walton Vol#: 152
C 4937 M. A. & A. W. Kamstra Vol#: 152
C 4938 Carol Herbert Vol#: 152
C 4941 Mary L. Villaire Vol#: 152
C 4942 Elaine L. Latham Vol#: 152
C 4944 Carolyn Maloy Vol#: 152
C 4945 Roxanne D. Jacob Vol#: 152
C 4946 Margaret Wuensch Vol#: 152
C 4948 Deborah Quilter Vol#: 152
C 4949 Marilyn Peterson Vol#: 152
C 4950 Antonette E. Tobin Vol#: 152
C 4951 Charna Reichel Vol#: 152
C 4953 Mary A. Donato Vol#: 152
C 4955 Cheryl Simpson Vol#: 152
C 4957 Gina Terrazas Vol#: 152
C 4958 S. Lewann Sotnak Vol#: 152
C 4961 Marylyn Anderson Vol#: 152
C 4962 Beverly G. Small Vol#: 152
C 4963 Eleanor Tobin Vol#: 152
C 4964 Christine M. Baermann Vol#: 152
C 4965 Donna Czubernat Vol#: 152
C 4967 Rachel Astrachan Vol#: 152
C 4968 Rose M. Heiner Vol#: 152
C 4969 Lisa Leiderman Vol#: 153
C 4970 Darlene Wakeman Vol#: 153
C 4972 Kathy A. Kauffman Vol#: 153
C 4973 Geraldine Campbell Vol#: 153
C 4975 Audrey Hanlon Vol#: 153
C 4979 Karen G. Lyke Vol#: 153
C 4980 Sybil Lancour Vol#: 153
C 4981 Shirley T. Powell Vol#: 153
C 4982 Elizabeth T Johnson Vol#: 153
C 4983 Lorraine S. Chopek Vol#: 153
C 4985 Freda St John Vol#: 153
C 4986 Andre Jirovetz Vol#: 153
C 4990 Antonette R. Richards Vol#: 153
C 4991 Georgia L. Hopefi Vol#: 153
C 4992 Katherine Lipski Vol#: 153
C 4993 Heather S. Lett Vol#: 153
C 4994 Augustina Perez Vol#: 153
C 4995 Heather Morgan Vol#: 153
C 4996 Kathy Max Steen Vol#: 153
C 4998 Patricia B. Newton Vol#: 153
C 4999 Allaire D. Williams Vol#: 153
C 5000 Elizabeth B. Jamieson Vol#: 153
C 5001 Jean Kornfeld Vol#: 153
C 5002 Sandra A. Beach Vol#: 153
C 5003 Maureen Shirlon Vol#: 153
C 5004 Jerri L. Fontiere Vol#: 153
C 5005 Virginia Beetham Vol#: 153
C 5006 Sharon L. Crooke Vol#: 153
C 5008 Melodie Pleasant Vol#: 153
C 5010 Bonnie Youngdahl Vol#: 153
C 5011 Lori M Steiner Vol#: 153
C 5012 Pamela Hunter Vol#: 153
C 5013 Sandy Hirenberg Vol#: 153
C 5015 Mary Allen Hicks Vol#: 153
C 5016 Sandra Willis Vol#: 153
C 5018 Grace Huenemann Vol#: 153
C 5019 Jacqueline Pettersen Vol#: 153
C 5020 Olive C. James Vol#: 153
C 5021 Dorothy Skinner Vol#: 153
C 5022 Sandra L. Gore Vol#: 153
C 5024 Juran J. Chapin Vol#: 153
C 5026 Donella Johnson Vol#: 153
C 5028 Virginia B. McCleod Vol#: 153
C 5029 Myriam Laverde Vol#: 153
C 5030 Kathleen Murphy Vol#: 153
C 5032 Geraldine Farkas Vol#: 153
C 5033 Gretchen Lucia Vol#: 153
C 5035 Cynthia Marie Lander Vol#: 153
C 5037 Mary K. Henry Vol#: 153
C 5039 Catherine Hobren Vol#: 153
C 5040 Grace M. Collins Vol#: 153
C 5041 Janice Davidson Vol#: 153
C 5044 Jackie Kleinman Vol#: 153
C 5046 Marie Tollstrip Vol#: 153
C 5048 Linda Knowles Vol#: 153
C 5049 Shirley A. Leisses Vol#: 153
C 5052 Revonda Hallman Vol#: 153
C 5053 Marian Castrell Vol#: 153
C 5055 Anna T. Polins Vol#: 153
C 5056 Gretchen Oelhaf Vol#: 153
C 5057 Mavis G. Major Vol#: 153
C 5058 Beverly J. Alston Vol#: 153
C 5060 Frances Fraser Vol#: 153
C 5061 Mary T. Damiano Vol#: 153
C 5064 Victoria Chick Vol#: 153
C 5065 Bonnie Lockamy Vol#: 153
C 5066 Suzanne Engelskirchen Vol#: 153
C 5067 Joan W. Green Vol#: 153
C 5068 Diane Spindler Vol#: 153
98P-0683 Soy Protein Containing Products
N 1 HFS-165 Vol#: 19
99D-0017 Validation of analytical procedures:Methodology
GDL 1 Vol#: 1
NAD 1 HFV-12 Vol#: 1
99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA
NM 1 Vol#: 1
99D-0557 Use of Nonhuman Primate Xenografts in Humans
C 260 John & Margaret Lelko Vol#: 12
C 261 Florence De Lutio Vol#: 12
C 262 The Boyd Family Vol#: 12
C 263 Robert W & Nancy S Breslin Vol#: 12
C 267 Carol Muckleroy Vol#: 12
C 268 Subhadra Gunawardana Vol#: 16
C 270 Mr & Mrs F Schneider Vol#: 16
C 271 Jennifer Johnson Vol#: 16
C 274 Barbara Clinkingberad Vol#: 16
C 277 Ava Barcelona & 26 signatures Vol#: 16
C 279 Patricia Warsaw Vol#: 16
99D-1458 Enforcement Policy for FDA Personnel/Electronic Records& Sig
NCR 1 Vol#: 1
99D-1817 Home Uterine Activity Monitors Guidance
GDL 1 Vol#: 1
NAD 1 Vol#: 1
99D-2171 Accountable analysis for clinical studies/Ophthalmic devices
GDL 1 Vol#: 1
NAD 1 Vol#: 1
99D-2214 Antimicrobial Food Additives
GDL 1 Background Material Vol#: 1
NAD 1 Vol#: 1
99D-2335 Guidance for Medical Gloves A workshop Manual
GDL 1 Vol#: 1
NAD 1 Vol#: 1
99H-0337 Civil Money Penalties;Sunoco Inc,d/b/a Sunoco Coop #7074 Gas
ANS 1 Sunoco, Inc. Vol#: 1
99H-0363 Civil Money Penalty; Sunoco Inc d/b/a A Plus Mini Mart
ANS 1 Sunoco, Inc. Vol#: 1
99H-0395 Civil Money Penalty; Cel-Cris Corp. d/b/a/ Packer Sales
ANS 1 Parker Sales Vol#: 1
99H-0734 Civil Money Penalties;Bill Bueler,d/b/a H S B Tobacconist
LET 2 Office of Tobacco Programs Vol#: 1
99H-0930 Civil Money Penalties;L & J's Country Store Inc,d/b/a L & J
LET 2 Office of Tobacco Programs Vol#: 1
99H-1032 Civil Money Penalties;Bert Malone,d/b/a Lazy Lee's One Stop
ANS 2 Lazy Lee's One Stop Vol#: 1
99H-1641 Civil Money Penalty; Mims Oil Company Inc dba Shell Go #525
ANS 1 Mims Enterprises Vol#: 1
LET 2 Office of Tobacco Programs Vol#: 1
99H-1700 Civil Money Penalties;Fast Fare Inc,d/b/a Fast Fare Convenie
LET 2 Office of Tobacco Programs Vol#: 1
99H-1773 Civil Money Penalty;Pine Island Farmers Elevator Co dba Pine
LET 2 Office of Tobacco Programs Vol#: 1
WDL 1 GCF-1 Vol#: 1
99H-1816 Civil Money Penalty;Jim Wagner,dba Wagner's One Stop
ANS 1 Wagner's One Stop Vol#: 1
99H-1892 Civil Money Penalty;Crown Central Petroleum Co,dba Crown
LET 2 Office of Tobacco Programs Vol#: 1
99H-1937 Civil Money Penalty;Mims Oil Co Inc,dba Shell Go #514
ANS 1 Mims Enterprises Vol#: 1
LET 2 Office of Tobacco Programs Vol#: 1
99H-1950 Civil Money Penalty;Kari Inc,dba Duck In
LET 2 Office of Tobacco Programs Vol#: 1
99H-1974 Civil Money Penalty;Rocky Mountain Pharmacy of Estes Park
EXT 1 Rocky Mountain Pharmacy Vol#: 1
99H-2001 Civil Money Penalty;Bessie Owens Bell,dba Miss Bessie's
ANS 1 Bessie Owens Bell Vol#: 1
99H-2035 Civil Money Penalty;James Fisher,dba Economart
ANS 1 Economart Vol#: 1
99H-2061 Civil Money Penalty;Daniel L Loxtercamp,dba Super America
ANS 1 Super America #4871 Vol#: 1
99H-2066 Civil Money Penalty;Kenneth Evans,dba Hill Top Stop
ANS 1 Hilltop Stop Vol#: 1
99H-2101 Civil Money Penalty;Paradise Petroleum Inc,dba Alli Petroleu
ANS 1 Alii Petroleum Vol#: 1
99H-2157 Civil Money Penalty;Emergency Fuel Station Inc,dba Emergency
ANS 2 Emergency Fuel Station Inc Vol#: 1
99H-2182 Civil Money Penalty;Mikey's One Stop Inc,dba Mike's One Stop
ANS 1 Mikey's One Stop, Inc. Vol#: 1
99H-2227 Civil Money Penalty;Eranosian Ent Inc,dba Grantville Package
ANS 1 Grantville Package Store Vol#: 1
99H-2292 Civil Money Penalty;Friendly Express Inc,dba Friendly Expres
LET 2 Office of Tobacco Programs Vol#: 1
99H-2293
LET 2 Office of Tobacco Programs Vol#: 1
99H-2498 Civil Money Penalty;50's Cafe Inc,dba Cafe & Bar
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2499 Civil Money Penalty;Baber Management Inc,dba Total Food Shop
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2500 Civil Money Penalty;Bob McGlothlin,dba Westside Grocery
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2501 Civil Money Penalty;BP Amoco P L C,dba ACA Amoco
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2502 Civil Money Penalty;Corn Palace Inc,dba Corn Palace
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2503 Civil Money Penalty;Fairlawn Oil Service Inc,dba Woodlawn Mo
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2504 Civil Money Penalty;Houlihan's Restaurants Inc,dba Houlihan'
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2505 Civil Money Penalty;Howard Swanger & Barbara Swanger,dba Log
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2506 Civil Money Penalty;James Wood & Joan Wood,dba Fox Quick Sto
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2507 Civil Money Penalty;Kathy Nelson,dba Bonne Terre C-Mart
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2508 Civil Money Penalty;Larry Bellamy,dba Iron Gates Service
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2509 Civil Money Penalty;Lion Petroleum Inc,dba Citgo
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2510 Civil Money Penalty;Maynard's Food Center of Westbrook Inc
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2511 Civil Money Penalty;Mildred Straight,dba Magnolia Inn
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2512 Civil Money Penalty;Robert Jackson,dba Green Park Texaco
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2513 Civil Money Penalty;Shayona Inc,dba Pat's
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2514 Civil Money Penalty;Steven Johnson,dba Papa Joe's
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2515 Civil Money Penalty;Sobhy Yousef,dba Cathedral City Shell
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2516 Civil Money Penalty;Taneycomo Market & Campground Inc,dba
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2517 Civil Money Penalty;Tom Jones,dba Jone's Food Center
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2518 Civil Money Penalty;Cheng Kwong Seafood Market Inc,dba Cheng
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2519 Civil Money Penalty;Pacific Sun Corp,dba Pacific Super Marke
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2520 Civil Money Penalty;Endicott Pharmacy Inc,dba Endicott Pharm
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-2521 Civil Money Penalty;J P Selby,dba Selby Grocery
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99N-0193 Supplements and Other Changes to an Approved Application
NM 1 Vol#: 1
99N-1174 Development of Strategy for Dietary Supplements
C 36 Elinor Reed Vol#: 1
C 37 Elaine Simms Vol#: 1
C 38 Helen M Allen Vol#: 1
99N-2098 Computer-controlled Potentially High Risk Medical Devices
NAD 1 Vol#: 1
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock
C 1370 Christine Caton-McGill Vol#: 21
99P-1340 Declared Eternity eau de Parfum Misbranded
C 225 Beverly Ver Dohne Vol#: 5
C 231 Marta Sonnenblick Vol#: 5
C 232 Sue Ellen Pector Vol#: 5
C 233 Jacquelyn Y Christian Vol#: 5
C 235 Jeanne Apple Bedwell Vol#: 5
EC 7 Mark Cree Jackson, MSE, MBA Vol#: 5
99S-2669 Determination of Factor Contents in Tylosin by high Performa
REF 1 Eli Lilly and Company Vol#: 1