Food and Drug AdministrationDockets 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 August 24, 2000

TABLE OF CONTENTS

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80N-0042 Anticaries Drug Products for OTC Human Use *
98N-0359 Program priorities/Center for Food Safety & Applied Nutritin *
00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1471 ANDA Suitability Petition Propofol Injectable Emulsion 2% *
00P-1472 Over-the-counter sodium phosphate bowel preparation products *
00V-1473 Laser Light Show*
80N-0042 Anticaries Drug Products for OTC Human Use

MT 8 HFD-560, HFD-540 & Warner-Lambert Co. Vol#: 318

98N-0359 Program priorities/Center for Food Safety & Applied Nutritin

C 43 International Food Additives Council Vol#: 6

C 44 Enzyme Technical Association Vol#: 6

C 45 Association for Dressing & Sauces (ADS) Vol#: 6

C 46 International Jelly & Preserve Assn Vol#: 6

C 47 Association of Food & Drug Officials Vol#: 6

C 48 Kraft Foods Vol#: 6

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

C 14605 T Augustyn Vol#: 445

C 14606 C Fish Vol#: 445

C 14607 G Gorlitz Vol#: 445

C 14608 S Levine Vol#: 445

C 14609 S Busdieker Vol#: 445

C 14610 L Horstmann Vol#: 445

C 14611 S Fasten Vol#: 445

C 14612 H Hartman Vol#: 445

C 14613 K Greeley Vol#: 445

C 14614 C Frey Vol#: 445

C 14615 P Murphy Vol#: 445

C 14616 M Lesko Vol#: 445

C 14617 Mr & Mrs C Lixey Vol#: 445

C 14618 B Castle & L Miller Vol#: 445

C 14619 C. Patton Vol#: 445

C 14620 J Hulbard & L Phillips Vol#: 445

C 14621 D. Bissonnette Vol#: 445

C 14622 S Drake Vol#: 445

C 14623 C Sweeney Vol#: 445

C 14624 L. Gehman Vol#: 445

C 14625 B Beeman Vol#: 445

C 14626 J Frechette Vol#: 445

C 14627 M Snyder Vol#: 445

C 14628 R Altman Vol#: 445

C 14629 W. Maples, Sr. Vol#: 445

C 14630 Ca Shortall Vol#: 445

C 14631 D Hutchinson Vol#: 445

C 14632 B Matthes Vol#: 445

C 14633 L Fisher Vol#: 445

C 14634 R Regalado Vol#: 445

C 14635 C Castell Vol#: 445

C 14636 A Trombetta Vol#: 445

C 14637 J Moyer Vol#: 445

C 14638 F McGovern Vol#: 445

C 14639 B Shrader Vol#: 445

C 14640 L Delman Vol#: 445

C 14641 J Pooser Vol#: 445

C 14642 Ko Mosher Vol#: 445

C 14643 K Karnos Vol#: 445

C 14644 P Mandolin Vol#: 445

C 14645 M Withrow Vol#: 445

C 14646 J Burks Vol#: 445

EMC 3046 M Jacobson Vol#: 445

EMC 3047 M Preston Vol#: 445

EMC 3048 H Chin Vol#: 445

EMC 3049 A Trattner Vol#: 445

EMC 3050 S Spontak Vol#: 445

EMC 3051 Z E. Vol#: 445

EMC 3052 N Deckha, Ph.D. Vol#:

EMC 3053 J Leong Vol#: 445

EMC 3054 C Thomas Vol#: 445

EMC 3055 S Weigel Vol#: 445

EMC 3056 Janis Forde Vol#: 445

EMC 3057 A Hartman Vol#: 445

EMC 3058 S Hogan Vol#: 445

EMC 3059 L Kauffman Vol#: 445

EMC 3060 H Durrett Vol#: 445

EMC 3061 L Cobb Vol#: 445

EMC 3062 L Shamber Vol#: 445

REF 2 Assembly Task Force on Food, Farm Nutrit Vol#: 445

99N-4955 Amendment of Various Device Regulations

NCR 1 Vol#: 1

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

EMC 6 K Kendells Vol#: 7

EMC 7 R Johnson Vol#: 7

EMC 8 R Tamsin Vol#: 7

EMC 9 E Lebowitz Vol#: 7

EMC 10 T Faulkner Vol#: 7

EMC 11 K Walsh Vol#: 7

EMC 12 R Roth Vol#: 7

EMC 13 K Kolb Vol#: 7

EMC 14 P Allamong Vol#: 7

EMC 15 A LaLiberty Vol#: 7

EMC 16 R Bashaw Vol#: 7

EMC 17 C McDonell Vol#: 7

EMC 18 J Conant Vol#: 7

EMC 19 J Olmstead Vol#: 7

EMC 20 C Corbin Vol#: 7

EMC 21 Deborah Lush Vol#: 7

EMC 22 C Adelman Vol#: 7

EMC 23 E Chamberlin Vol#: 7

EMC 24 D Trooper Vol#: 7

EMC 25 S Turner Vol#: 7

EMC 26 M Reagan Vol#: 7

EMC 27 A Paulson Vol#: 7

EMC 28 E Cuprak Vol#: 7

EMC 29 C Campbell Vol#: 7

EMC 30 H Heyman Vol#: 7

EMC 31 P Rivard Vol#: 7

EMC 32 R Huszagh Vol#: 7

EMC 33 R Kruser Vol#: 7

EMC 34 J Martin Vol#: 7

EMC 35 G Colado Vol#: 7

EMC 36 JUBILY Vol#: 7

00D-0186 M4 Common Technical Document;InterNatl Confern on Harmonisat

GDL 2 Guideline Vol#: 1

NAD 2 Vol#: 1

00N-0914 Importer's Entry Notice; Agency Information Collection Activ

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1 

00N-1256 Over-the-Counter Drug Products;Public Hearing

CH 466 S Pitt, MD et al Vol#: 18

CH 467 S Morrison Vol#: 18

CH 468 D Moynihan Vol#: 18

CH 469 Amer Academy of Pediatrics Vol#: 18

00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop

C 10 G Duwe Vol#: 1

C 11 Laboratory Compliance Consultants Inc Vol#: 1

EXT 1 College of American Pathologists Vol#: 1

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 4848 J Harp Vol#: 195

C 4849 V Bellis Vol#: 195

C 4850 L Nettles Vol#: 195

C 4851 R Braver Vol#: 195

C 4852 M Gallagher Vol#: 195

C 4853 M. Oneil Vol#: 195

C 4854 A Rachman Vol#: 195

C 4855 P. Gerber Vol#: 195

C 4856 C Skomp Vol#: 195

C 4857 C Townsend Vol#: 195

C 4858 J Kern Vol#: 195

C 4859 M McMorris Vol#: 195

C 4860 N Reynolds Vol#: 195

C 4861 M Payne Vol#: 195

C 4862 B Robinson Vol#: 195

C 4863 T Joristani Vol#: 195

C 4864 N Nohlgren Vol#: 195

C 4865 R Shapin Vol#: 195

C 4866 L Rhodes Vol#: 195

C 4867 P McDade Vol#: 195

C 4868 C Dietrich Vol#: 195

C 4869 E Dunn Vol#: 195

C 4870 L Margosian Vol#: 195

C 4871 A Conklin Vol#: 195

C 4872 N Suria Vol#: 195

C 4873 R Rendo Vol#: 195

C 4874 D Narp Vol#: 195

C 4875 P Lee Vol#: 195

C 4876 I Walker Vol#: 195

C 4877 C. Hettell Vol#: 195

C 4878 S. Booguart Vol#: 195

C 4879 A Perlo Vol#: 195

C 4880 A Scott Vol#: 195

C 4881 J Mayers Vol#: 195

C 4882 T Tyler Vol#: 195

C 4883 E. Gutchell Vol#: 195

C 4884 M. Varano Vol#: 195

C 4885 D Fieri Vol#: 195

C 4886 W Pond Vol#: 195

C 4887 A Risler Vol#: 195

C 4888 J Barton Vol#: 195

C 4889 N Bowen Vol#: 195

C 4890 M Fuchs Vol#: 195

C 4891 J Penfield Vol#: 195

C 4892 H. Ruhm Vol#: 195

C 4893 J Allender Vol#: 195

C 4894 E. Price Vol#: 195

C 4895 C Lynne Vol#: 195

C 4896 L Clark Vol#: 195

C 4897 T Brookhart Vol#: 195

C 4898 D Bryant Vol#: 195

C 4899 M Oppenheim Vol#: 195

C 4900 R Oates Vol#: 195

C 4901 E Gaudiani Vol#: 195

C 4902 P McGinnis Vol#: 195

C 4903 D Nace Vol#: 195

C 4904 M Maracle Vol#: 195

C 4905 K Homan Vol#: 195

C 4906 J. Williams Vol#: 195

C 4907 J Alderman Vol#: 195

C 4908 J Gaynor Vol#: 195

C 4909 G Noble Vol#: 195

C 4910 H. Best Vol#: 195

C 4911 J. W. Thomas Vol#: 195

C 4912 B Heiner Vol#: 195

C 4913 C Vidmar Vol#: 195

C 4914 J. Dwyer Vol#: 195

C 4915 G Nisson Vol#: 195

C 4916 T Block Vol#: 195

C 4917 J Fajardo Vol#: 195

C 4918 L Ronchetti Vol#: 195

C 4919 M Levine Vol#: 195

C 4920 H Bauer Vol#: 195

C 4921 M Maidman Vol#: 195

C 4922 B Bear Vol#: 195

C 4923 M. Caron Vol#: 195

C 4924 M. Downes Vol#: 195

C 4925 J. Giddings Vol#: 195

C 4926 A. Carrion Vol#: 195

C 4927 T Rutenberg Vol#: 195

C 4928 A Lantz Vol#: 195

C 4929 R Carr Vol#: 195

C 4930 B Derr Vol#: 195

C 4931 C. Slaski Vol#: 195

C 4932 J Swick Vol#: 195

C 4933 P Deraney Vol#: 195

C 4934 C Ostopoff Vol#: 195

C 4935 L. Weise Vol#: 195

C 4936 J Montgomery Vol#: 195

C 4937 J Banks Vol#: 195

C 4938 J Sullivan Vol#: 195

C 4939 E Gentzsch Vol#: 195

C 4940 F Olson Vol#: 195

C 4941 C Miller Vol#: 195

C 4942 E Karkkainen Vol#: 195

C 4943 N Barshick Vol#: 195

C 4944 L Wilder Vol#: 195

C 4945 F Donahue Vol#: 195

C 4946 W. Hanzalek Vol#: 195

C 4947 Z Lankewich Vol#: 195

C 4948 J Brooke Vol#: 195

C 4949 R Souza Vol#: 195

C 4950 L Mallony Vol#: 195

C 4951 K Roberts Vol#: 195

C 4952 M Goodsell Vol#: 195

C 4953 C Morgan Vol#: 195

C 4954 L Rooney Vol#: 195

C 4955 E Meservey Vol#: 195

C 4956 S Skurpski Vol#: 195

C 4957 B Verbon Vol#: 195

C 4958 D McBride Vol#: 195

C 4959 B. Alexander Vol#: 195

C 4960 E Morton Vol#: 195

EMC 1951 Edward Insinger Vol#: 195

EMC 1952 Valerie Niederhoffer Vol#: 195

EMC 1953 Trish Meyer Vol#: 195

EMC 1954 Betty Smith Vol#: 195

EMC 1955 S Harrison Vol#: 195

EMC 1956 D Hamilton Vol#: 195

EMC 1957 L DeVaney Vol#: 195

EMC 1958 A Jacus Vol#: 195

EMC 1959 J Sjolin Vol#: 195

EMC 1960 M Knijneburg Vol#: 195

EMC 1961 S Floyd Vol#: 195

EMC 1962 S Brauneis Vol#: 195

EMC 1963 Chris Arn Vol#: 195

EMC 1964 B Johnson Vol#: 195

EMC 1965 V Carlsomn Vol#: 195

EMC 1966 J Butler Vol#: 195

EMC 1967 J Weldon Vol#: 195

EMC 1968 Pam Apple Vol#: 195

EMC 1969 P Rennekamp Vol#: 195

EMC 1970 D Edwards Vol#: 195

EMC 1971 Dr. D Cinquemani Vol#: 195

EMC 1972 P Villa Vol#: 195

EMC 1973 C Knijnenburg Vol#: 195

EMC 1974 C Hoag Vol#: 195

EMC 1975 R Paul Vol#: 195

EMC 1976 N Thomas Vol#: 195

EMC 1977 Sheila Baummer Vol#: 195

EMC 1978 M Wines Vol#: 195

EMC 1979 A Carlson Vol#: 195

00P-1471 ANDA Suitability Petition Propofol Injectable Emulsion 2%

ACK 1 HFA-305 Vol#: 1

CP 1 GensiaSicor Pharmaceuticals Vol#: 1

00P-1472 Over-the-counter sodium phosphate bowel preparation products

ACK 1 HFA-305 Vol#: 1

CP 1 Klein Kaplan & Becker/Braintree Lab Inc Vol#: 1

00V-1473 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Steve Skrien Vol#: 1