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 Us]

DOCKETS ENTERED on November 21, 2000

TABLE OF CONTENTS

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

NOTE:  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.

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

 
92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992 *
93N-0372 Medical Devices; Hearing Aid Requirements *
95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99F-2673 Irradiation in the Production, Processing & Handling of Food *
00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d *

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

CH 3 Pharmaceutical Distributers Association Vol#: 6

CH 4 Pharmaceutical Distributers Association Vol#: 6

CH 5 Premier Purchasing Partners, LP Vol#: 6

CH 6 Novartis Pharmaceuticals Corporation Vol#: 6

CH 7 Inter Academy of Compounding Pharmacists Vol#: 6

CH 8 Mary M. Gooley HemoCenter Vol#: 6

TS 6 Inter Academy of Compounding Pharmacists Vol#: 6

TS 7 Food Marketing Institute Vol#: 6

93N-0372 Medical Devices; Hearing Aid Requirements

C 4862 Amy Svoboda Vol#: 107

C 4863 Bill Hagenaboucher Vol#: 107

C 4864 Cheryl Pilgrim Vol#: 107

C 4865 Margaret L. King Vol#: 107

C 4866 Shirley Kuish Vol#: 107

C 4867 Patricia Costello Vol#: 107

C 4868 Sound Advice Hearing Aid Centers Vol#: 107

C 4869 Sound Advice Hearing Aid Centers Vol#: 107

C 4870 Miracle Ear Vol#: 107

C 4871 American Academy of Otolaryngologist Vol#: 107

C 4872 Kimberly Hogan Vol#: 107

C 4873 Precision Hearing Instruments, Inc. Vol#: 107

C 4874 Precision Hearing Instruments, Inc. Vol#: 107

C 4875 American Academy of Otolaryngologist Vol#: 107

C 4876 American Academy of Otolaryngologist Vol#: 107

C 4877 Hearing Instrument Sciences Vol#: 107

C 4878 Professional Hearing Health Care Vol#: 107

C 4879 Precision Hearing Instruments, Inc. Vol#: 107

C 4880 Hearing Instrument Sciences Vol#: 107

C 4881 Hearing Instrument Sciences Vol#: 107

C 4882 Better Hearing, Inc. Vol#: 107

C 4883 Miracle Ear Centers of Hemet Vol#: 107

C 4884 Miracle Ear Center, Sears Chapel Hill Vol#: 107

C 4885 Miracle Ear Hearing Aid Centers Vol#: 107

C 4886 Miracle Ear Vol#: 107

C 4887 Miracle Ear Vol#: 107

C 4888 Beltone Hearing Aid Centers Vol#: 107

C 4889 Beltone Hearing Aid Centers Vol#: 107

C 4890 Variety Hearing Instruments Vol#: 107

C 4891 Modesto Hearing Aid Center Vol#: 107

C 4892 Ear Labs Hearing Aid Center Vol#: 107

C 4893 American Academy of Otolaryngologist Vol#: 107

C 4894 Gillett Hearing Aid Center Vol#: 107

C 4895 Daniel Morgan Vol#: 107

C 4896 Sherry Morgan Vol#: 107

C 4897 Beltone Hearing Aid Center Vol#: 107

C 4898 Precision Hearing Instruments, Inc. Vol#: 107

C 4899 Jay K. Nicklas Vol#: 107

C 4900 Sound Choice Hearing Aid Centers, Inc. Vol#: 107

C 4901 Westwood Hearing Aid Center Vol#: 107

C 4902 Atlantic Hearing Aid Center Vol#: 107

C 4903 Master Hearing Aid Center Vol#: 107

C 4904 Ross Hearing Aids Vol#: 107

C 4905 Mary Valiere Vol#: 107

C 4906 Modeato Hearing Aid Center Vol#: 107

C 4907 Precision Hearing Instruments, Inc. Vol#: 107

C 4908 Precision Hearing Instruments, Inc. Vol#: 107

C 4909 Hearing Technologies, Inc. Vol#: 107

C 4910 Miracle Ear Vol#: 107

C 4911 Miracle Ear Centers of Hemet Vol#: 107

C 4912 Hearing Aid Associates Vol#: 107

C 4913 Precision Hearing Instruments, Inc. Vol#: 107

C 4914 Capital Hearing Aid Care Service Vol#: 107

C 4915 Del Mar Hearing Associates & Services Vol#: 107

C 4916 Sears Hearing Aid Centers Vol#: 107

C 4917 Beltone Hearing Aid Sevices Vol#: 107

C 4918 Hearing HU Unlimitied, LLC Vol#: 107

C 4919 Miracle Ear Vol#: 107

C 4920 Cherlyn Kovinlov Vol#: 107

C 4921 Carolyn Salsoura Vol#: 107

C 4922 Karen J. Holmes Vol#: 107

C 4923 Janet Jewell Vol#: 107

C 4924 Jane Fromm Vol#: 107

C 4925 Robert Ingargiola Vol#: 107

C 4926 M. Janssens Vol#: 107

C 4927 John Grygiel Vol#: 107

C 4928 Julie Grygiel Vol#: 107

C 4929 Bryant/Concho Valley Hearing Services Vol#: 113

C 4930 Hearing Aid Services Vol#: 113

C 4931 Love's Hearing Aid Center Vol#: 113

C 4932 Robert O. Stensland & Associates Vol#: 113

C 4933 Hearing Health Care of LA Vol#: 113

C 4934 Hearing Aid Associates of Baltimore Vol#: 113

C 4935 El Cajon Hearing Aid Center Vol#: 113

C 4936 Professional Hearing Health Care Vol#: 113

C 4937 Brown Hearing Aid Centers Vol#: 113

C 4938 Brown Hearing Aid Centers Vol#: 113

C 4939 Allied Hearing Centers Vol#: 113

C 4940 Chenault House of Hearing, Inc. Vol#: 113

C 4941 Affordable Hearing Aid Center Vol#: 113

C 4942 Beltone Hearing Aid Center Vol#: 113

C 4943 Brown Hearing Aid Centers Vol#: 113

C 4944 Sandia Hearing Aids Vol#: 113

C 4945 Sandia Hearing Aids Vol#: 113

C 4946 Sound Advice Hearing Aid Centers Vol#: 113

C 4947 Houston Hearing Aid Center Vol#: 113

C 4948 Beltone Hearing Center Vol#: 113

C 4949 Beltone Hearing Center Vol#: 113

C 4950 Sayer Hearing Aid Center Vol#: 113

C 4951 Precision Hearing Aid Center Vol#: 113

C 4952 Precision Hearing Aid Center Vol#: 113

C 4953 Prescription Design Hearing Vol#: 113

C 4954 Precision Hearing Instruments, Inc. Vol#: 113

C 4955 Beltone Hearing Aid Center Vol#: 113

C 4956 Hearing Health Center Vol#: 113

C 4957 Miracle Ear, Sears Hearing Center Vol#: 113

C 4958 Beltone Hearing Aid Center Vol#: 113

C 4959 Hearing Health Center Vol#: 113

C 4960 Beltone of Morristown Vol#: 113

C 4961 Bryan K. Stinson Vol#: 113

C 4962 Elizabeth Hearing Aid Center Vol#: 113

C 4963 Allied Hearing Centers Vol#: 113

C 4964 Professional Hearing Centers Vol#: 113

C 4965 Professional Hearing Centers Vol#: 113

C 4966 Professional Hearing Centers Vol#: 113

C 4967 Desert Hearing Care Vol#: 113

C 4968 Beltone Hearing Aid Center Vol#: 113

C 4969 Beltone Hearing Aid Center Vol#: 113

C 4970 Beltone Hearing Aid Center Vol#: 113

C 4971 Nancy Sutherland Vol#: 113

C 4972 Miracle Ear Center Vol#: 113

C 4973 Fishman's Acousticon Hearing Aid Service Vol#: 113

C 4974 Miracle Ear Centers of Hemet Vol#: 113

C 4975 Miracle Ear Centers of Hemet Vol#: 113

C 4976 Miracle Ear Centers of Hemet Vol#: 113

C 4977 Miracle Ear Centers of Hemet Vol#: 113

C 4978 Grace A Brewen Vol#: 113

C 4979 John R. Brewen, Jr. Vol#: 113

C 4980 Jewel Jones Mickey Vol#: 113

C 4981 Laura H. Gilliam Vol#: 113

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

RPT 83 Nutratech Inc Vol#: 58

SUP 7 McNeil Consumer Healthcare Inc Vol#: 41

98P-0151 Introduction Of Downed Cattle Into The Food Supply

EMC 410 S. Leatherberry Vol#: 84

EMC 411 Athena Buchanan Vol#: 84

EMC 412 Whinny 3 Vol#: 84

EMC 413 Donna Mason Vol#: 84

EMC 414 Donna Jackson Vol#: 84

EMC 415 Trevor Newton Vol#: 84

EMC 416 Vic4PSU Vol#: 84

EMC 417 J. M. Rattet Vol#: 84

EMC 418 Pat Franzese Vol#: 84

EMC 419 Marisa Herrea Vol#: 84

EMC 420 Marjorie A. Morone Vol#: 84

EMC 421 Greg Corning Vol#: 84

EMC 422 Barbara Widstrand Vol#: 84

EMC 423 W. E. Roberts Vol#: 84

EMC 424 Andrea Kraus, Mike Lorrig Vol#: 84

99F-2673 Irradiation in the Production, Processing & Handling of Food

C 2 Public Citizen Vol#: 1

EMC 31 Maura McCormick Vol#: 1

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

C 16278 Amina Grister Vol#: 477

C 16279 Phyllis B. Smith Vol#: 477

C 16280 David Doren + 6 signatures Vol#: 477

C 16281 Mary Boyle Vol#: 477

C 16282 Fatma Obaid Vol#: 477

C 16283 Becky Gillmor Vol#: 477

C 16284 Vanessa Beggs Vol#: 477

C 16285 David M. Schmidt Vol#: 477

C 16286 Ms. Barbara Mannle Vol#: 477

C 16287 James B. Ferris Vol#: 477

C 16288 Robert J. Wilson Vol#: 477

C 16289 Ms. Barbara Briemer Vol#: 477

C 16290 Charles McFadden Vol#: 477

C 16291 Pamela Owens Vol#: 477

C 16292 Barbara J. Wilson Vol#: 477

C 16293 George A. Dudek Vol#: 477

C 16294 Izaak Walton League of Indiana Vol#: 477

C 16295 Linda Evans Vol#: 477

C 16296 Vito DeSario Vol#: 477

C 16297 Jackie Sparks Vol#: 477

C 16298 Mr & Mrs Vernon Stolte Vol#: 477

C 16299 Lorene M. Nordstrom Vol#: 477

C 16300 Mary Ann Johnston Vol#: 477

C 16301 Candace Beard Vol#: 477

C 16302 Martha K. Burk Vol#: 477

C 16303 Glynna Barron Vol#: 477

C 16304 Shirley A. Bigley Vol#: 477

C 16305 Bobbie Ward Vol#: 477

C 16306 Howard L. Burkhardt Vol#: 477

C 16307 Dana Gliniecki Vol#: 477

C 16308 Mary K. Collins Vol#: 477

C 16309 Vincent J. Perricelli Vol#: 477

C 16310 Marjory M. Jones Vol#: 477

C 16311 Laura K. Rudder Vol#: 477

C 16312 Bernadette Sheats Vol#: 477

C 16313 Deborah Curlee Vol#: 477

C 16314 Patricia A. Lysko Vol#: 477

C 16315 John David Ragan Vol#: 477

C 16316 Cecil E. & Wilda A. Brown Vol#: 477

EMC 3298 Jen Madaffer Vol#: 477

EMC 3299 Susan Klemons Vol#: 477

EMC 3300 Christine Luksza-Paravicini Vol#: 477

EMC 3301 Scott A. McLemore Vol#: 477

EMC 3302 Roger Eggena Vol#: 477

EMC 3303 Brennon Staley Vol#: 477

00H-1242 Civil Money Penalty;Laser Vision Centers Inc. et al

CS 5 HFA-305 Vol#: 2

OR 5 HF-3 Vol#: 2

00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d

C 1 McNeil Consumer Healthcare Vol#: 5

C 2 Cognis Corporation Vol#: 4

00P-1276 Health Claim: Plant stanol esters and heart disease

C 3 McNeil Consumer Healthcare Vol#: 12

C 4 Cognis Corporation Vol#: 11