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DOCKETS ENTERED on 1/14/03

Docket Number - Title

81N-0144 Topically Applied Hormone Drug Products for OTC Human Use *
00N-1571 Enrofloxacin for Poultry: Opportunity for Hearing *
01P-0572 Petition for Regulation of Ariva Tobacco Lozenges *
02D-0324 Bioengineered Plants for Use in Humans and Animals*
02D-0402 Field offices on "Regulatory procedures Manual, Chapter 9 *
02D-0449 Administrative New Animal Drug Appilication Process*
02D-0515 Health Claims labeling conventional foods/dietary supplement*
02N-0486 Prescription Drug Marketing Act of 1987 *
02P-0075 Flavored Candy-like Products Containing Tobacco *
02P-0312 Periostat (doxycycline hyclate) 20 mg Capsules *
02P-0413 Health Claim: Phosphatidylserine and cognitive dysfunction*
02P-0457 Selenium and Anticarcinogenic effects in certain caners*

81N-0144 Topically Applied Hormone Drug Products for OTC Human Use

MM 1 Vol#: 1

83M-0004 St Jude Medical Cardiac Valve

SS 1 Summary of Safety & Effectiveness Vol#: 1

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

RPT 119 Mica Gaia, Inc. Vol#: 84

RPT 120 Wealth Express Industrial Ltd. Vol#: 83

RPT 121 Premiere Towa, Inc. Vol#: 83

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

C 18221 Lauren R. Skaleske Vol#: 506

C 18222 Sheryl Matsik Vol#: 506

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

C 616 Arthur G. Epstien, Ph.D. Vol#: 32

00N-1571 Enrofloxacin for Poultry: Opportunity for Hearing

LET 11 Bayer Corporation Vol#: 353

MO 33 Bayer Corporation Vol#: 353

01N-0565 Proposal to Debar Harry W. Snyder, Jr.; Opportunity for Hear

NFR 1 Vol#: 1

01N-0566 Proposal to Debar Renee Peugeot; Notice of Opportunity for H

NFR 1 Vol#: 1

01P-0572 Petition for Regulation of Ariva Tobacco Lozenges

RC 7 Star Scientific, Inc. Vol#: 2

02D-0324 Bioengineered Plants for Use in Humans and Animals

EC 13 Mr. Shawn James-Leavey Vol#: 9

EC 14 Iowa Farm Bureau Federation Vol#: 9

EC 15 Mr. Doug Long Vol#: 9

EC 16 Washington Biotechnology Action Council Vol#: 9

EC 17 Mr. Arlen Grossman Vol#: 9

EC 18 Human Race Vol#: 9

EC 19 Ms. Jennifer Moix Vol#: 9

EC 20 Mr. Anthony Bandy-Zalatoris Vol#: 9

EC 21 Ms. Catherine Slattery Vol#: 9

EC 22 Ms. Jennifer Maassen Vol#: 9

EC 23 mother of three Vol#: 9

EC 24 Ms. janet drake Vol#: 9

EC 25 citizen Vol#: 9

EC 26 Mr. Michael Farnan Vol#: 9

EC 27 Ms. Virginia Wolter Vol#: 9

EC 28 Dana-Farber Cancer Institute Vol#: 9

EC 29 Ms. Temperance David Vol#: 9

EC 30 Large Scale Biology Vol#: 9

EC 31 VIllage Counseling Vol#: 9

EC 32 Mr. Andrew Leighton Vol#: 9

02D-0402 Field offices on "Regulatory procedures Manual, Chapter 9

EC 1 National Fisheries Institute Vol#: 1

02D-0449 Administrative New Animal Drug Appilication Process

EC 1 Central Institute of Fisheries Education Vol#: 1

02D-0468 Manufacture and Labeling of Raw Meat Foods

EC 7 private citizen (for this purpose) Vol#: 1

02D-0515 Health Claims labeling conventional foods/dietary supplement

C 1 CFA, Consumer Federation of America Vol#: 1

02E-0099 Patent Term Extension Application for XIGRIS No. 4,775,624

APP 1 Eli Lilly and Company Vol#: 1

LET 1 U.S. Patent & Trademark Office Vol#: 1

LET 2 HFD-5 Vol#: 1

02M-0295 Premarket Approval for Paragon CRT, Paragon Quadra RG, and

NAL 1 Vol#: 1

02M-0298 PMA ANCURE Aortoiliac System, P990017/S030

NAL 1 Vol#: 1

02M-0299 PMA TECHNOLAS 217A Excimer Laser System, P990027/S002

NAL 1 Vol#: 1

02M-0310 PMA InFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device

NAL 1 Vol#: 1

02M-0322 PMA Mentor Saline-Filled Testicular Prosthesis, P020003

NAL 1 Vol#: 1

02M-0336 PMA Siemens SONOCUR Basic

NAL 1 Vol#: 1

02M-0348 PMA Cordis PAMAZ Balloon Expandable Stent (Models P104R etc

NAL 1 Vol#: 1

02M-0352 PMA Ventak Prizm 2 VR/DR Models 1860/1861, etc

NAL 1 Vol#: 1

02M-0353 PMA Ventak Prizm 2 VR.DR Models 1860/1861, etc.

NAL 1 Vol#: 1

02M-0361 PMA Neurolink System, H010004

NAL 1 Vol#: 1

02M-0381 PMA InSync ICD Model 7272 Dual Chamber Implantable Cardio De

NAL 1 Vol#: 1

02M-0409 HDE Neuroform Microdelivery Stent System, H02002

NAL 1 Vol#: 1

02M-0412 PMA, GlucoWatch G2 Biographer, P990026/S008

NAL 1 Vol#: 1

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

NM 1 Vol#: 3

02N-0278 Bioterrorism; Prior Notice of Imported Food Shipments

NM 1 Vol#: 3

02N-0486 Prescription Drug Marketing Act of 1987

C 2 Family Care Hlth Ctrs. Pharmacy Departme Vol#: 1

EC 4 Ms. Beverly Maricelli Vol#: 1

EC 5 Mr. Jordan Lund Vol#: 1

02N-0529 Withdrawing approval of NDA Rezulin (troglitazone) tablets

N 1 Vol#: 1

02P-0075 Flavored Candy-like Products Containing Tobacco

RC 6 Star Scientific, Inc. Vol#: 2

02P-0177 Health Claim: D-tagatose and Noncariogenicity

EC 3 Ms. Claudia Shwide-Slavin Vol#: 2

02P-0312 Periostat (doxycycline hyclate) 20 mg Capsules

LET 1 HFD-1 to Collagenex Pharmaceuticals, Inc Vol#: 1

02P-0413 Health Claim: Phosphatidylserine and cognitive dysfunction

LET 4 GCF-1 to Emord & Associates, P.C. Vol#: 6

LET 5 Emord & Associates, P.C. Vol#: 6

02P-0457 Selenium and Anticarcinogenic effects in certain caners

LET 2 GCF-1 to Emord & Associates, P.C. Vol#: 3

LET 3 Emord & Associates, P.C. Vol#: 3