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 September 14, 2000

TABLE OF CONTENTS

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97D-0268 Container Closure Systems Used for Packaging of Human Drugs *
98P-0880 Borealis Iceberg Water Deviating From Identity Standard *
99D-4809 Applications Covered by Section 505(b)(2) *
00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers *
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal *
00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop *
00P-1199 Approval of ANDAs for Extended-Release *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *

94N-0371 Rami Eisharaiha; Proposal to Debar

NPH 1 Vol#: 1

97D-0268 Container Closure Systems Used for Packaging of Human Drugs

C 33 Schwarz Pharma, Inc. Vol#: 4

98P-0880 Borealis Iceberg Water Deviating From Identity Standard

ANS 1 HFS-800 to Iceberg Industries Corporatio Vol#: 1

99D-4809 Applications Covered by Section 505(b)(2)

C 9 Pharmacia Corp. Vol#: 1
 
99H-1032 Civil Money Penalties;Bert Malone,d/b/a Lazy Lee's One Stop

RBRF1 Lazy Lee's One Stop Inc. Vol#: 2
 
99P-2630 Establish a Daily Value for "added sugars"

EMC 290 Form letter count 721 Vol#: 13

00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers

C 6 APhA, American Pharmaceutical Assn. Vol#: 1

C 7 American College of Obstetricians & Gyne Vol#: 1
 
00D-1400 Reproductive Toxicity Studies preventive vaccines Disease

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1
 
00F-1487 Safe Use of Sodium Chlorite Solutions

EA 1 Environmental Assessment Vol#: 2

NFL 1 Vol#: 1
 
00F-1488 Acidified Sodium Chlorite Solution as Antimicrobial Agent

EA 1 Environmental Assessment Vol#: 2

NFL 1 Vol#: 1
 
00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

RPT 3 Office of Women's Health Vol#: 65
 
00N-1226 Investigational Device Exemptions, Reports and Records

NAL 1 Vol#: 1

SS 1 Supporting Statement Vol#: 1
 
00N-1256 Over-the-Counter Drug Products;Public Hearing

CH 648 C. Bonner Vol#: 24

CH 649 S Wharam Vol#: 24

CH 650 S Balmer Vol#: 24

CH 651 A Reif Vol#: 24

CH 652 M Balonoff Vol#: 24

CH 653 S. Ruth Vol#: 24

EC 534 C Steenburn Vol#: 14
 
00N-1311 Export of Medical Devices Foreign Letters of Approval

N 2 Vol#: 1
 
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal

EC 52 Miss Nicole Cerchio Vol#: 11

EC 53 Mrs. Cheryl Kucsera Vol#: 11

EC 54 Ms. Anna Fitzgerald Vol#: 11

EC 55 Ms. Hollis Martin Vol#: 11

EC 56 Mr. Denis Wichar Vol#: 11

EC 57 Mr. Paul Moss Vol#: 11

EC 58 Ms. Sharon Clifford Vol#: 11

EMC 102 Form Letter count 35 Vol#: 12

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

C 18 American Assn. of Bioanalysts Vol#: 1

C 19 Medtox Labs, Inc. Vol#: 1

00P-1199 Approval of ANDAs for Extended-Release

LET 1 HFD-1 to Biovail Corporation Vol#: 1

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

C 5804 M Fargias Vol#: 244

C 5805 S Hensley Vol#: 244

C 5806 K Gubrud Vol#: 244

C 5807 J. Buisson Vol#: 244

C 5808 K. Oser Vol#: 244

C 5809 I. P. Mele Vol#: 244

C 5810 R Mele Vol#: 244

C 5811 R Mele Vol#: 244

C 5812 A Sorensen Vol#: 244

C 5813 P Rudy Vol#: 244

C 5814 J Lyman Vol#: 244

C 5815 C. Fordyce Vol#: 244

C 5816 L Rainbows Vol#: 244

C 5817 J Matray Vol#: 244

C 5818 N Blair Vol#: 244

C 5819 G Grey Vol#: 244

C 5820 S. Rhoads Vol#: 244

C 5821 R Tamaran Vol#: 244

C 5822 K Bramlet Vol#: 244

C 5823 M Towne Vol#: 244

C 5824 S Prata Vol#: 244

C 5825 B Spiers Vol#: 244

C 5826 G Aaron Vol#: 244

C 5827 D Counts Vol#: 244

C 5828 C Wyrosgh Vol#: 244

C 5829 D Collins Vol#: 244

C 5830 B Reid Vol#: 244

C 5831 S Sanders Vol#: 244

C 5832 K. Cuniskey Vol#: 244

C 5833 R Reeves Vol#: 244

C 5834 L Rhodes Vol#: 244

C 5835 D Bedell Vol#: 244

C 5836 N Bouchard Vol#: 244

C 5837 A McBride Vol#: 244

C 5838 T Carson Vol#: 244

C 5839 J Honeycutt Vol#: 244

C 5840 H Torres Vol#: 244

C 5841 J Winebrenner Vol#: 244

C 5842 G Henderson Vol#: 244

C 5843 C. Mitchell Vol#: 244

C 5844 T Doherty Vol#: 244

C 5845 A Hercek Vol#: 244

C 5846 M. Cave Vol#: 244

C 5847 B. Gilbert Vol#: 244

C 5848 H. Robinson Vol#: 244

C 5849 P Harding-Clark Vol#: 244

C 5850 J Kirschenbaum Vol#: 244

C 5851 N Whiting Vol#: 244

C 5852 P Joyce Vol#: 244

C 5853 E Joyce Vol#: 244

C 5854 P. Troutman Vol#: 244

C 5855 E Bartholomew Vol#: 244

C 5856 R White Vol#: 244

C 5857 B. Sorensen Vol#: 244

C 5858 D. Busby Vol#: 244

C 5859 J BeCoates Vol#: 244

C 5860 M Burns Vol#: 244

C 5861 J De La Cruz Vol#: 244

C 5862 M. Torres Vol#: 244

C 5863 D Napolitan Vol#: 244

C 5864 M Unger Vol#: 244

C 5865 C. Walters Vol#: 244

C 5866 P. Vaughn Vol#: 244

C 5867 T Ward Vol#: 244

C 5868 S Williams Vol#: 244

C 5869 P Incao Vol#: 244

C 5870 B Battaib Vol#: 244

C 5871 B Arnesen Vol#: 244

C 5872 J Brown Vol#: 244

C 5873 E Dawson Vol#: 244

C 5874 C Bosworth Vol#: 244

C 5875 B Milligen Vol#: 244

C 5876 K Strong Vol#: 244

C 5877 G Constantine Vol#: 244

C 5878 O Dahl Vol#: 244

C 5879 A Kesten Vol#: 244

C 5880 K Wigen Vol#: 244

C 5881 D Moen Vol#: 244

C 5882 W Eaton Vol#: 244

C 5883 J Eisenberg Vol#: 244

C 5884 D Pickett Vol#: 244

C 5885 A Salzer Vol#: 244

C 5886 J Biasi Vol#: 244

C 5887 S Paukert Vol#: 244

C 5888 W Fabian Vol#: 244

C 5889 P Kasal Vol#: 244

C 5890 C Ramsey Vol#: 244

C 5891 M Martini Vol#: 244

C 5892 H. Fishler Vol#: 244

C 5893 V Herberger Vol#: 244

C 5894 S Schefter Vol#: 244

C 5895 T Phillips Vol#: 244

C 5896 M Mora Vol#: 244

C 5897 J Kesal Vol#: 244

C 5898 E Martsen Vol#: 244

C 5899 No signature Vol#: 244

C 5900 C Taylor Vol#: 244

C 5901 M Taylor Vol#: 244

C 5902 R Furlong Vol#: 245

C 5903 B Bonsignore Vol#: 245

C 5904 S Bhakti Vol#: 245

C 5905 C Sanders Vol#: 245

C 5906 M Leonard Vol#: 245

C 5907 J Howard Vol#: 245

C 5908 R Golden Vol#: 245

C 5909 L Hebbar Vol#: 245

C 5910 M Weaver Vol#: 245

C 5911 L Quigley Vol#: 245

C 5912 M. Gesche Vol#: 245

C 5913 The Floyd Law Firm, P.C. Vol#: 245

C 5914 N Michell Vol#: 245

C 5915 R Roppa Vol#: 245

C 5916 K Larsen Vol#: 245

C 5917 M. Pravda Vol#: 245

C 5918 H Tapley Vol#: 245

C 5919 J. Andrus Vol#: 245

C 5920 M Harrington Vol#: 245

EMC 2306 J Albrecht, Ph.D Vol#: 245

EMC 2307 R. Trimper III Vol#: 245

EMC 2308 L Needels Vol#: 245

EMC 2309 S Anderson Vol#: 245

EMC 2310 G Blair Vol#: 245

EMC 2311 S Lebrun Vol#: 245

EMC 2312 A Lee Vol#: 245

EMC 2313 L Barp Vol#: 245

EMC 2314 D. Hewitt Vol#: 245

EMC 2315 S Allitt Vol#: 245

EMC 2316 H Freeland Vol#: 245

EMC 2317 H Stevens Vol#: 245

EMC 2318 J Lane Vol#: 245

EMC 2319 K Love Vol#: 245

EMC 2320 H Burman Vol#: 245

EMC 2321 E Gomez Vol#: 245

EMC 2322 L Matthews Vol#: 245

EMC 2323 A McGehee Vol#: 245

EMC 2324 C. Koester Vol#: 245

EMC 2325 J Hubbard Vol#: 245

EMC 2326 R Mazzarella Vol#: 245

EMC 2327 N Kessel Vol#: 245

EMC 2328 G GeRue Vol#: 245

EMC 2329 E. West Vol#: 245

EMC 2330 S. Colonese Vol#: 245

EMC 2331 M. Kendall Vol#: 245

EMC 2332 B. Sutton Vol#: 245

EMC 2333 J Murphy Vol#: 245

EMC 2334 S Bellinger Vol#: 245

EMC 2335 A Guskin Vol#: 245

EMC 2336 P Unbertino Vol#: 245

EMC 2337 C. Garner Vol#: 245

EMC 2338 L Mullins Vol#: 245

EMC 2339 K Forbes Vol#: 245

EMC 2340 J Ault Vol#: 245

EMC 2341 S Linscott Vol#: 245

EMC 2342 E Riley Vol#: 245

EMC 2343 K Toan Vol#: 245

EMC 2344 S Gaines Vol#: 245

EMC 2345 D Johnson-Weinberger Vol#: 245

EMC 2346 J Huang Vol#: 245

EMC 2347 C Salmon Vol#: 245

EMC 2348 J Bottoms Vol#: 245

EMC 2349 E Frew Vol#: 245

EMC 2350 M Hedrick Vol#: 245

EMC 2351 M Wilk Vol#: 245

EMC 2352 G Summer Vol#: 245

EMC 2353 L McDonald Vol#: 245

EMC 2354 K Frost Vol#: 245

EMC 2355 E Cooperrider Vol#: 245

EMC 2356 G Salas Vol#: 245

EMC 2357 M Hauck Vol#: 245

EMC 2358 D Campbell Vol#: 245

EMC 2359 L Weichman Vol#: 245

EMC 2360 M. Erdmann Vol#: 245

EMC 2361 R Saling Vol#: 245

EMC 2362 B Rich Vol#: 245

EMC 2363 J Prestridge Vol#: 245

EMC 2364 K. Davis Vol#: 245

EMC 2365 B Postema Vol#: 245

EMC 2366 G Jorgensen Vol#: 245

EMC 2367 T Goodson Vol#: 245

EMC 2368 E Markson Vol#: 245

EMC 2369 Pastor S Smith Vol#: 245

EMC 2370 O Koelman Vol#: 245

EMC 2371 L Howlett Vol#: 245

EMC 2372 L Brown Vol#: 245

EMC 2373 T Youngblood Vol#: 245

EMC 2374 R Delabarre Vol#: 245

EMC 2375 A Schuetze Vol#: 245

EMC 2376 V Ebell Vol#: 245

EMC 2377 D Zukerman Vol#: 245

EMC 2378 M Herrera Vol#: 245

EMC 2379 E Taylor Vol#: 245

EMC 2380 S Bonecher Vol#: 245

EMC 2381 A Ryan Vol#: 245

EMC 2382 T Laszlo Vol#: 245

EMC 2383 J Bintz Vol#: 245

EMC 2384 L Koslouski Vol#: 245

EMC 2385 J Lareau Vol#: 245

EMC 2386 D Vigil Vol#: 245

EMC 2387 D Mapel Vol#: 245

EMC 2388 D Solomon, C.P.A Vol#: 245

EMC 2389 G Sasaki Vol#: 245

EMC 2390 L Dewing Vol#: 245

EMC 2391 N. Murphy Vol#: 245

EMC 2392 C Jette, Ph.D Vol#: 245

EMC 2393 R Pearce Vol#: 245

EMC 2394 L Styles Vol#: 245

EMC 2395 H Robertson Vol#: 245

EMC 2396 D Banks Vol#: 245

EMC 2397 K Eggerling Vol#: 245

EMC 2398 J Rackley Vol#: 245

EMC 2399 M Johnson Vol#: 245

EMC 2400 A Hirsch Vol#: 245

EMC 2401 S. V. Greene Vol#: 245

EMC 2402 V Jackowski Vol#: 245

EMC 2403 D Bray Vol#: 245

EMC 2404 J Hogan Vol#: 245

EMC 2405 S Gardner Vol#: 245

EMC 2406 S Beard Vol#: 245

EMC 2407 B Elkin Vol#: 245

EMC 2408 T Chance Vol#: 245

EMC 2409 M Suwanski Vol#: 245

EMC 2410 D Pritchard Vol#: 245

EMC 2411 N Milani Vol#: 245

EMC 2412 M Raczko Vol#: 245

EMC 2413 G Davis Vol#: 245

EMC 2414 L Politte Vol#: 245

EMC 2415 L Hazlett Vol#: 245

EMC 2416 D Hamdan Vol#: 245

EMC 2417 A Schelin Vol#: 245

EMC 2418 L Miller Vol#: 245

EMC 2419 J Hall Vol#: 245

EMC 2420 P Boson Vol#: 245

EMC 2421 B Bradley Vol#: 245
 

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

NIR 1 Vol#: 4
 
00P-1276 Health Claim: Plant stanol esters and heart disease

NIR 1 Vol#: 4