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 February 21, 2002

TABLE OF CONTENTS

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NOTE:  Documents received by the Dockets Management Branch "MAY" be posted on the Internet.

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

 
01D-0037 Pre-Store leukocyle reduction/Blood components for transfusi *
01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm *
01D-0493 Exemptions from the Warning Label Requirement for Juice;Reco *
01D-0510 Industry on Integration of dose-counting Mechanisms into MDI *
01N-0450 Prescription Drug User Fee Act (PDUFA) *
01N-0476 Electronic Interchange Standard for Digital ECG; Public Meet *
01P-0244 Investigate the Use of Polyethylene Glycol in Children *
01P-0283 ANDA for Pentoxifylline Extended-release Tablets, 500 mg. *
01P-0358 ANDA for drug Carbidopa-Levodopa dispersible tablets, 10mg *
01P-0383 Determine whether Imuran tablets were withdrawn for safety r *
01P-0470 Establish Appropriate Approval Standards for Generic Clonidi *
02N-0027 Swine Mycoplasmal Pneumonia Technical Workshop *
02P-0078 ANDA for Baclofen Orally Disintegrating Tablets, 10 mg & 20 *

76N-052N OTC Nasal Decongestants

EMC 126 Marsha Ensor Vol#: 76

77N-0085 Saccharin and Its Salts

CA 39486 Cecil & Nellie Underwood Vol#: 620

CA 39487 T. K. Kobayashi Vol#: 620

CA 39488 Charlotte Patterson Vol#: 620

CA 39489 Denise Hamel & Justin A. Hamel Vol#: 620

CA 39490 Jennifer J. Forry Vol#: 620

CA 39491 Mrs. Elnia Dyson Vol#: 620

CA 39492 Bruce Johnson Vol#: 620

CA 39493 Merle B. Cooley Vol#: 620

CA 39494 Ruth Ann Overbey Vol#: 620

CA 39495 John H. Phillips Vol#: 620

CA 39496 Edith Hillman & Sam Hillman Vol#: 620

CA 39497 Mr. D. E. Gibron Vol#: 620

CA 39498 Marilyn Trautner, M.D. Vol#: 620

CA 39499 Mrs. E. M. Brightbill Vol#: 620

CA 39500 William Lindsay Vol#: 620

CA 39501 Susan Hansen Shippey Vol#: 620

CA 39502 Kyle MacDonald Vol#: 620

CA 39503 Lynne & Lance Forstat Vol#: 620

CA 39504 Andrew M. Morrow, Jr. Vol#: 620

CA 39505 Mrs. M. H. Salsbury Vol#: 620

CA 39506 Gerrie Fish Vol#: 620

CA 39507 Kathleen M. Daily Vol#: 620

CA 39508 Teri Heaton Vol#: 620

CA 39509 Rev. Arnold F. Buja Vol#: 620

CA 39510 Mr. & Mrs. Floyd E. Woods Vol#: 620

CA 39511 Marion King Vol#: 620

CA 39512 Mrs. Roberta Walli Vol#: 620

CA 39513 Arnold Berkens Vol#: 620

CA 39514 Dale Powell Vol#: 620

CA 39515 Dolores Evangelistr Vol#: 620

CA 39516 Mrs. Ray Scavezze Vol#: 620

CA 39517 Sharon Ann Sobon Vol#: 620

CA 39518 Mrs. Judith H. Philipps Vol#: 620

CA 39519 Phil Spring Vol#: 620

CA 39520 Richard Turner Vol#: 620

CA 39521 Rex Murphy, m.D. Vol#: 620

CA 39522 Joseph R. Martin Vol#: 620

CA 39523 Calvin T. Lorenz Vol#: 620

CA 39524 K. E. Sewell Vol#: 620

CA 39525 Lorraine Hogg Vol#: 620

CA 39526 Mrs. S. G. Peterson Vol#: 620

CA 39527 C. L. Mulder Vol#: 620

CA 39528 Father robert J. Kinkel Vol#: 620

CA 39529 Ellsworth Mason Vol#: 620

CA 39530 Laurie Cullen-Dayton Vol#: 620

CA 39531 Mrs. Sandra Callahan Vol#: 620

CA 40647 Mrs. Leonard Gonsorowski Vol#: 631

CA 40648 Marilyn Kercher Vol#: 631

CA 40649 Mr. & Mrs. John Greir Means Jr. Vol#: 631

CA 40650 Marion Van Dyke Vol#: 631

CA 40651 Warren B. Mi Naad Vol#: 631

CA 40652 Jos. McGoiey Vol#: 631

CA 40653 JUNE m. BURNS Vol#: 631

CA 40654 E. W. Schauerte Vol#: 631

CA 40655 Lois BorBury Vol#: 631

CA 40656 No Signature Vol#: 631

CA 40657 Mr. & Mrs. Wayne Gottwaid Vol#: 631

CA 40658 Synott L. McNeel Vol#: 631

CA 40659 Adelaide L. McGarrett Vol#: 631

CA 40660 Ralph Gibbs Vol#: 631

CA 40662 John Himes Vol#: 631

CA 40663 Della Herberger Vol#: 631

CA 40664 Martha M. Tabs Vol#: 631

CA 40665 Beatrice Edlin Vol#: 631

CA 40666 Mrs. Peggy A. Stroner Vol#: 631

CA 40667 Gerald Ziskovsky Vol#: 631

CA 40668 Mr. & Mrs. C. A. Roggensack Vol#: 631

CA 40669 Kay Gladson Vol#: 631

CA 40670 Cecilia Gysple Vol#: 631

CA 40671 Katherine B. Straub Vol#: 631

CA 40672 R. J. Fuog Vol#: 631

CA 40673 Mrs. Charles L. Boyer Vol#: 631

CA 40674 Mis Dale Hanna Vol#: 631

CA 40675 Mrs. Gean L. Bonde Vol#: 631

CA 40676 Dolores L. Tietz Vol#: 631

CA 40677 Mrs. Richard Shaw Vol#: 631

CA 40678 Yranne E. Short Vol#: 631

CA 40679 Joseph A. Lombard Vol#: 631

CA 40680 James P. Kumppmiller Vol#: 631

CA 40681 Bernie dunne Vol#: 631

CA 40682 Betty Lee Vol#: 631

CA 40683 Mrs. L. F. McGraw Jr. Vol#: 631

CA 40684 Linda Bienkoff Vol#: 631

CA 40685 mrs. James W. Umner Vol#: 631

CA 40686 M. S. Barnett Vol#: 631

CA 40687 Barbara & Alfred Fox Vol#: 631

CA 40688 Lee Revsberger Vol#: 631

CA 40689 Cheryl Tibor Vol#: 631

CA 40690 William C. Matthews Vol#: 631

CA 40691 Ruth Graham Vol#: 631

CA 40692 Jack Ritter Vol#: 631

CA 40693 William J. kriey Vol#: 631

CA 40694 Deborah Ole Vol#: 631

CA 40695 Pauline Lieberman Vol#: 631

CA 40696 Mrs. Lois Fisher Vol#: 631

CA 40697 Mark Levis Vol#: 631

CA 40698 Natalie J. Snarr Vol#: 631

CA 40699 Mrs. Robert E. Hamilton Vol#: 631

CA 40700 Luez Greyoo Vol#: 631

CA 40701 Mr. & Mrs. R. C. McMillan Vol#: 631

CA 40702 Bert Sahaffer Vol#: 631

CA 40703 Robert F. Blatteau Vol#: 631

CA 40704 Ruth D. Ayers Vol#: 631

CA 40705 Ronald D. Kluyor Vol#: 631

CA 40706 Kerry Smith Vol#: 631

CA 40707 Katherine Donaldson Vol#: 631

CA 40708 Albert R. MacFarlane Vol#: 631

CA 40709 Mrs. Mary A. Black Vol#: 631

CA 40710 Diane S. Creedon Vol#: 631

CA 40754 John E. Hundt Vol#: 632

CA 40755 Mr. & Mrs. H. J. Kuhlemeier Vol#: 632

CA 40756 Margaret A. Murray Vol#: 632

CA 40757 Miss Abbe Bershatsky Vol#: 632

CA 40758 Mrs. William Shannon Vol#: 632

CA 40759 Mrs. Paul Kunkle Vol#: 632

CA 40760 J. R. Handelsman, M.D. Vol#: 632

CA 40761 Mrs. E. Stevens Vol#: 632

CA 40762 Mrs. L. A. Jeffers Vol#: 632

CA 40763 Ms. Mary Criswell Vol#: 632

CA 40764 Gary Lucas Vol#: 632

CA 40765 Dennis & Irene Batalias Vol#: 632

CA 40766 Philip J. Lynch Vol#: 632

CA 40767 Mrs. John P. Boone Vol#: 632

CA 40768 Bernet Friedman Vol#: 632

CA 40769 Mary D. Sexton Vol#: 632

CA 40770 Robert C. Arnold Vol#: 632

CA 40771 Daniel M. Olsen Vol#: 632

CA 40772 Marie Goodman Vol#: 632

CA 40773 Donna L. Crawford Vol#: 632

CA 40774 Debbie Cameron & Sherry Griffin Vol#: 632

CA 40775 Mrs. A. B. Berkebile Vol#: 632

CA 40776 Patricia A. Breyley Vol#: 632

CA 40777 Charles Sommer Vol#: 632

CA 40778 Debbie Dixon Vol#: 632

CA 40779 Eugene V. Erwin Vol#: 632

CA 40780 A. M. Rosenberg Vol#: 632

CA 40781 E. Thomas Spengler Vol#: 632

CA 40782 Peter D. & Jessie J. Johnson Vol#: 632

CA 40783 Mrs. Fletcher Pratt Vol#: 632

CA 40784 Teresa Brown Vol#: 632

CA 40785 Philip A. Odeen Vol#: 632

CA 40786 Mrs. Clara Davis & Mr. H. Lloyd Davis Vol#: 632

CA 40787 Mrs. Paul A. Allee Vol#: 632

CA 40788 Vera M. young Vol#: 632

CA 40789 Michael H. Farber Vol#: 632

CA 40790 Tracey Watkins Vol#: 632

CA 40791 Janet Vol#: 632

CA 40792 Wallace Burton Vol#: 632

CA 40793 Bobbie F. Wolf Vol#: 632

CA 40794 Mrs. Jerry E. Lundholm Vol#: 632

CA 40795 Stanley Hillier Vol#: 632

CA 40796 Lorraine B. Smith Vol#: 632

CA 40797 Majorie McKeefe Vol#: 632

CA 40798 Madge E. Howell Vol#: 632

CA 40799 George Ellis Vol#: 632

CA 40800 Mrs. Wilma Schuster Vol#: 632

CA 40801 Dr. Merle S. Glick Vol#: 632

CA 40802 Harold H. Fink Vol#: 632

CA 40803 John Teirin Vol#: 632

CA 40804 Mrs. Charles A. Root, Jr. Vol#: 632

CA 40805 Morton Isaacs Vol#: 632

CA 40806 Joy Karlsen Vol#: 632

CA 40807 Grover & Edna Hitah Vol#: 632

CA 40808 Donald D. Thureau & Lani C. Thureau Vol#: 632

CA 40809 Mr. & Mrs. Wm. McKnelly Vol#: 632

CA 40810 Mabel C. & Gertrude M. Schneider Vol#: 633

CA 40811 Thomas F. Mason Vol#: 633

CA 40812 R. Forrest Johnson & Velora W. Johnson Vol#: 633

CA 40813 Gerald W. Mottenson Vol#: 633

CA 40814 Mrs. Helen T. Krivonak Vol#: 633

CA 40815 R. D. Weeks Vol#: 633

CA 40816 Kathryn Waller Vol#: 633

CA 40817 Lynn C. Stahl Vol#: 633

CA 40818 Myra Collier Vol#: 632

CA 40819 Ann Copple Vol#: 633

CA 40820 Gwen Arnold Vol#: 633

CA 40821 Mrs. Fred Krueger Vol#: 633

CA 40822 Charles E. Fox Vol#: 633

CA 40823 Frances Svaer Vol#: 633

CA 40824 Robert Tolley Vol#: 633

CA 40825 Beatrice Ploch Vol#: 633

CA 40826 Mr. & Mrs. Heber Little Vol#: 633

CA 40827 John R. Quillman Vol#: 633

CA 40828 Rose Perkowrtz Vol#: 633

CA 40829 Mrs. G. R. Jenkins Vol#: 633

CA 40830 James W. Campbell Vol#: 633

CA 40831 Joe Kelber Vol#: 633

CA 40832 Newton J. Krabbe Vol#: 633

CA 40833 David Eiseman Vol#: 633

CA 40834 Louise J. Kneer Vol#: 633

CA 40835 Martha Krohn Vol#: 633

CA 40836 Ruth Nercel Vol#: 633

CA 40837 Margaret Bailey Vol#: 633

CA 40838 sordi Lceduig Vol#: 633

CA 40839 Mary M. Hill Vol#: 633

CA 40840 Allen R. Zeedyk Vol#: 633

CA 40841 Mrs. robert Scherder Vol#: 633

CA 40842 Merriel E. Brown Vol#: 633

CA 40843 Meg Gammond Vol#: 633

CA 40844 Mrs. H. C. Otherum Vol#: 633

CA 40845 Roy Rohl Vol#: 633

CA 40846 W. Hayward & Ruth L. Hayward Vol#: 633

CA 40847 lavalle H. Ballard Vol#: 633

CA 40849 Yugune Barnes Vol#: 633

CA 40850 Mrs. Helen Mangino Vol#: 633

CA 40851 Mrs. E. K. Kainin Vol#: 633

CA 40852 Leora Morrill Vol#: 633

CA 40853 Mrs. Jerry Hames Vol#: 633

CA 40854 Shirley Thompson Vol#: 633

CA 40855 Horace G. Jacobs Vol#: 633

CA 40856 Mrs. G. S. Showalter Vol#: 633

CA 40857 Ms. Martha Anne Walton Vol#: 633

CA 40858 Mildred & Lee Becker Vol#: 633

CA 40859 Anne C. Joyce Vol#: 633

CA 40860 Dale & Joey hermann Vol#: 633

CA 40861 Robert I. Williams Vol#: 633

CA 40862 Marparel C. Newton Vol#: 633

CA 40863 Harvey C. Burgess Vol#: 633

CA 40864 Harold E. Cheyney Vol#: 633

CA 40865 Barry T. Whitman Vol#: 633

CA 40866 Mrs. Garry W. Graham Vol#: 633

CA 40867 Winifred Norrice Vol#: 633

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

C 2215 Sameera V. Thurmond Vol#: 65

EMC 517 Rob Baron Vol#: 65

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

EMC 3 Peter Marks Vol#: 2

EMC 4 Rob Lonni Vol#: 2

98N-0044 Effect of dietary supplement on structure/function of body

C 22417 Jay Scher Vol#: 883

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

EMC 472 Carmy Justin Vol#: 32

EMC 473 Prentice J. Bess Sr. Vol#: 32

00D-1543 Electronic Signatures: Glossary of Terms

EMC 3 SEC Associates, Inc. Vol#: 7

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9680 Eligible Vol#: 476

C 9681 Walt Socha Vol#: 476

C 9682 Eligible Vol#: 476

C 9683 Sherry Magee Vol#: 476

EMC 11855 Susan Gerritsen Vol#: 426

EMC 11856 Jay Capela Vol#: 426

EMC 11857 Anna Jacus Vol#: 426

EMC 11858 Stephen Moore Vol#: 426

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

EMC 33 American Medical Assn Vol#: 78

EMC 34 No signature Vol#: 78

00N-1269 Labeling for human prescription drug/Biologic Products

EMC 8 Melissa Moncavage Vol#: 5

00P-1322 Food Labeling and Allergen Contamination Control

EMC 468 No signature Vol#: 20

EMC 469 P. Minakin Vol#: 20

00P-1603 Rescind Any Contraindications For Use of Misoprostol In Preg

EMC 7 Dale P. Reisner, MD Vol#: 1

01D-0037 Pre-Store leukocyle reduction/Blood components for transfusi

C 22 Blood Banks of Mid-Florida Medical Servi Vol#: 2

01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm

C 13 Genzyme Corporation Vol#: 1

C 14 University of Wisconsin Medical School Vol#: 1

C 15 Abbott Laboratories Vol#: 1

C 16 AdvaMed Vol#: 1

C 17 Medtronic, Inc. Vol#: 1

C 18 Daniel F. Hayes, MD Vol#: 1

C 19 Eli Lilly & Company Vol#: 1

C 20 Novartis Pharmaceutical Corporation Vol#: 1

EMC 2 National Cancer Institute Vol#: 1

EMC 3 Dana-Farber Cancer Institute Vol#: 1

EMC 4 Catherine Cowie et al. Vol#: 1

EMC 5 National Cancer Institute Vol#: 1

EMC 6 Thomas R. Fleming, PhD Vol#: 1

01D-0493 Exemptions from the Warning Label Requirement for Juice;Reco

C 3 CSPI Vol#: 1

C 4 National Juice Products Assn Vol#: 1

01D-0510 Industry on Integration of dose-counting Mechanisms into MDI

EMC 1 Boehringer Ingelheim Pharmaceuticals Vol#: 1

01E-0094 Calozal, Patent Extension Application No. 4,412,992

LET 2 HFD-5 to U.S. Patent and Trademark Offic Vol#: 1

01E-0225 Patent Term Extension Application, CANCIDAS No. 5,514,650

LET 2 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

01E-0366 Patent Term Extension Application, PEG-Intron No. 5,951,974

LET 2 HFD-005 to U.S. Patent & Trademark Offi Vol#: 1

01E-0404 Patent Term Extension Application; No. 5,444,106

LET 2 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

01E-0405 Patent Term Extension Application, Evoxac No. 4,855,290

LET 2 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

01E-0420 Patent Term Extension Application for Lotronex No. 5,360,800

LET 2 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

EMC 194 Sherry Adkins Vol#: 2

01N-0450 Prescription Drug User Fee Act (PDUFA)

EMC 1 National Consumers League Vol#: 2

EMC 2 Public Citizen's Health Research Group Vol#: 2

EMC 3 Public Citizen's Health Research Group Vol#: 2

01N-0476 Electronic Interchange Standard for Digital ECG; Public Meet

EMC 2 CDISC Vol#: 1

01P-0190 Fountain Diet Coca-Cola and Bottled Diet Coca-Cola

EMC 1 No signature Vol#: 1

EMC 2 Michael Wilson Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 810 Karen Kalware Vol#: 143

01P-0244 Investigate the Use of Polyethylene Glycol in Children

LET 1 HFD-001 to Jeanie Ward Vol#: 1

01P-0283 ANDA for Pentoxifylline Extended-release Tablets, 500 mg.

LET 1 The Weinberg Group Inc. Vol#: 1

01P-0358 ANDA for drug Carbidopa-Levodopa dispersible tablets, 10mg

LET 1 The Weinberg Group, Inc. Vol#: 1

01P-0383 Determine whether Imuran tablets were withdrawn for safety r

ANS 1 HFD-7 to AAI International an aai Pharm. Vol#: 1

01P-0470 Establish Appropriate Approval Standards for Generic Clonidi

SUP 1 Boehringer Ingelheim Pharm,Inc Vol#: 3

02E-0019 Patent Term Application for Axert No. 5,565,447

LET 2 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

02E-0020 Patent Term Application for Zometa No. 4,939,130

LET 2 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

02E-0022 Patent Term Application for Solage No. 5,194,247

LET 2 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

02E-0023 Patent Term Application for Definity No. 5,527,521

LET 2 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

02E-0024 Patent Term Application for Gleevac No. 5,521,184

LET 2 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

02N-0027 Swine Mycoplasmal Pneumonia Technical Workshop

APE 1 Roy Schultz DVM MS Vol#: 1

APE 2 Intervet, Inc. Vol#: 1

APE 3 Pharmacia Animal Health Vol#: 1

02P-0078 ANDA for Baclofen Orally Disintegrating Tablets, 10 mg & 20

ACK 1 HFA-305 Vol#: 1

CP 1 Kleinfeld, Kaplan & Becker Vol#: 1