Table of Contents

NFR 1 Vol#: 1

90P-0201 Optimum size & Style of print to be used to label OTC Drugs

LET 3 Consumer Healthcare Products Association Vol#: 7

92N-454A Labeling of Drug Products for Over-the-Counter Human Use

LET 1 Consumer Healthcare Products Association Vol#: 14

95N-0259 Over the Counter Drug Labeling; Public Hearing

LET 4 Consumer Healthcare Products Association Vol#: 12

96N-0417 CGMP in Packing or Holding Dietary Supplements

TR 2 Transcript of September 28, 1999 meeting Vol#: 5

96N-0420 OTC Human Drugs; Proposed Labeling Requirements

LET 8 Consumer Healthcare Products Association Vol#: 24

96P-0215 Withdrawal Norplant's approval for sale in the United States

C 216 Center for NaProEthics Vol#: 5

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

Linked comments below duplicate those for 97P-0197 and 98N-1230, also below

C 753 Lee Edwards Vol#: 27

C 754 Hanna Park & 8 signatures Vol#: 27

C 755 Gary A Spina Vol#: 27

C 756 Jan Kren Vol#: 27

C 757 Michael Caldwell Vol#: 27

C 758 Betty McDonald Vol#: 27

C 759 Jannelle Jones Vol#: 27

C 760 Diana Bocco Vol#: 27

C 761 Pat Miller Vol#: 27

C 762 Honorable Richard W Pombo/11 signatures Vol#: 27

C 763 Honorable Collin C Peterson/11 signature Vol#: 27

C 764 Honorable Gary A Condit/11 signatures Vol#: 27

C 765 Honorable Asa Hutchinson/11 signatures Vol#: 27

C 766 Honorable Charles T Candy/11 signatures Vol#: 27

C 767 Honorable John M McHugh & 11 signatures Vol#: 27

C 768 Honorable Nathan Deal & 11 signatures Vol#: 27

C 769 Honorable Johnny Isakson & 11 signatures Vol#: 27

C 770 Honorable Thomas M Reynolds/11 signature Vol#: 27

C 771 Honorable Stephen E Buyer & 11 signature Vol#: 27

C 772 Honorable Virgil H Goode Jr&11 signature Vol#: 27

C 773 Honorable Geroge R Nethercutt Jr &11etal Vol#: 27

C 774 Elizabeth de Giacomo Vol#: 27

C 775 Dorothy Link Vol#: 27

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

C 12 Internat'l Authority for the Source Plas Vol#: 1

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

C 9603 Ronnie Howard Vol#: 197

97N-0074 President's National Food Safety Initiative

C 137 Ms Jannelle C Jones & 79 signatures Vol#: 11

C 138 Betty Albertine Vol#: 11

C 139 Madonna Niles Vol#: 11

C 140 NACCHO Vol#: 11

C 141 Colorado Department of PHS Vol#: 11

C 142 Elinore B Gordon Vol#: 11

C 143 Julie R Van Horn Vol#: 11

C 144 Kevin M Crupi Vol#: 11

C 145 Joanne Douglas Vol#: 11

EC 2 Crystal S Marshall Vol#: 11

97P-0197 Require that warning labels about risks of salmonella enteri

C 754 Lee Edwards Vol#: 29

C 755 Hanna Park & 8 signatures Vol#: 29

C 756 Gary A Spina Vol#: 29

C 757 Jan Kren Vol#: 29

C 758 Michael Caldwell Vol#: 29

C 759 Betty McDonald Vol#: 29

C 760 Jannelle Jones Vol#: 29

C 761 Diana Bocco Vol#: 29

C 762 Pat Miller Vol#: 29

C 763 Honorable Richard W Pombo/11 signatures Vol#: 29

C 764 Honorable Collin C Peterson/11 signature Vol#: 29

C 765 Honorable Gary A Condit/11 signatures Vol#: 29

C 766 Honorable Asa Hutchinson/11 signatures Vol#: 29

C 767 Honorable Charles T Candy/11 signatures Vol#: 29

C 768 Honorable John M McHugh & 11 signatures Vol#: 29

C 769 Honorable Nathan Deal & 11 signatures Vol#: 29

C 770 Honorable Johnny Isakson & 11 signatures Vol#: 29

C 771 Honorable Thomas M Reynolds/11 signature Vol#: 29

C 772 Honorable Stephen E Buyer & 11 signature Vol#: 29

C 773 Honorable Virgil H Goode Jr&11 signature Vol#: 29

C 774 Honorable Geroge R Nethercutt Jr &11etal Vol#: 29

C 775 Elizabeth de Giacomo Vol#: 29

C 776 Dorothy Link Vol#: 29

98C-0158 D&C VIOLET NO.2 COLOR ABSORBABLE MENISCAL TASKS POLY(L-LACTC

NCD 1 Vol#: 1

98D-0388 Dermatological Drug Product NDA's and ANDA's

C 16 Dermik Laboratories Inc Vol#: 1

98D-0969 Effects of antimicrobial new animal drugs/use in food-produc

C 3 AHI, Animal Health Institute Vol#: 1

C 4 National Pork Producers Council Vol#: 2

TR 1 Transcript of October 4, 1999 meeting Vol#: 2

98N-0313 Surgeons's and Patient Examination Gloves Reclassification

NEC 1 Vol#: 5

98N-0607 General Requirements for Blood,Blood Components and Derivati

C 4 Henry Ford Hospital Vol#: 2

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

C 753 Lee Edwards Vol#: 30

C 754 Hanna Park &8 signatures Vol#: 30

C 755 Gary A Spina Vol#: 30

C 756 Jan Kren Vol#: 30

C 757 Michael Caldwell Vol#: 30

C 758 Betty McDonald Vol#: 30

C 759 Jannelle Jones Vol#: 30

C 760 Diana Bocco Vol#: 30

C 761 Pat Miller Vol#: 30

C 762 Honorable Richard W Pombo/11 signatures Vol#: 30

C 763 Honorable Collin C Peterson/11 signature Vol#: 30

C 764 Honorable Gary A Condit/11 signatures Vol#: 30

C 765 Honorable Asa Hutchinson/11 signatures Vol#: 30

C 766 Honorable Charles T Candy/11 signatures Vol#: 30

C 767 Honorable John M McHugh & 11 signatures Vol#: 30

C 768 Honorable Nathan Deal & 11 signatures Vol#: 30

C 769 Honorable Johnny Isakson & 11 signatures Vol#: 30

C 770 Honorable Thomas M Reynolds/11 signature Vol#: 30

C 771 Honorable Stephen E Buyer & 11 signature Vol#: 30

C 772 Honorable Virgil H Goode Jr&11 signature Vol#: 30

C 773 Honorable George R Nethercutt Jr & 11 et Vol#: 30

C 774 Elizabeth de Giacomo Vol#: 30

C 775 Dorothy Link Vol#: 30

98P-0150 Fast track approval of new drugs to treat preterm labor

PAV 1 HFD-1 Vol#: 1

98P-0218 Reevaluate letter regarding subcutaneous use of Terbutaline

PDN 1 HFD-1 Vol#: 1

98P-0683 Soy Protein Containing Products

NFR 1 Vol#: 21

99D-2096 Interpreting Sameness of Monoclonal Antibody Products

C 3 Coulter Pharmaceutical Vol#: 1

C 4 SmithKline Beecham Pharmaceuticals Vol#: 1

99D-2335 Guidance for Medical Gloves A workshop Manual

NEC 1 Vol#: 1

99D-2635 Draft Guidance Industry on ANDA's Blend Uniformity Analysis

C 4 Searle Vol#: 1

C 5 Parke Davis Pharmaceutical Research Vol#: 1

C 6 Sovereign Pharmaceuticals Inc Vol#: 1

C 7 SmithKline Beecham Pharmaceuticals Vol#: 1

99D-4396 Financial Disclosure By Clinical Investigators

GDL 1 Guidance Vol#: 1

NAD 1 Vol#: 1

99D-4488 Reducing microbial food safety hazards for sprouted seeds

BKG 1 Background material Vol#: 1

GDL 1 Guideline Vol#: 1

99D-4489 Sampling & microbial testing of spent irrigation water

BKG 1 Background material Vol#: 1

GDL 1 Guideline Vol#: 1

99F-0345 Components of Coatings on Cellophane

NFR 1 Vol#: 1

99N-2549 Cosmetic Product Voluntary Reporting Program

N 2 Vol#: 1

99N-2607 Hearing aid devices/professional & patient package labeling

C 1 Hearing Industries Association Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1768 CSPI Vol#: 163

99P-1149 Label of Mintezol be Amended

LET 1 HFD-1 Vol#: 1

99P-1516 To Ban Reprocessed Single Use Devices

ACK 2 HFA-305 Vol#: 1

PDN 1 HFZ-1 Vol#: 1

PRC 1 Medical Device Manufacturers Association Vol#: 1

99P-1653 ANDA for Pamidronate Disodium Injection

WDL 1 Mitchell G. Clark Vol#: 1

99P-2339 Make ANDA 74-984 Immediately Effective, Diltizazem HCl

PDN 1 HFD-1 Vol#: 1

99P-4618 Review and Approve ANDA Suitability Petitions

ACK 1 HFA-305 Vol#: 1

CP 1 NAPM Vol#: 1

99P-4648 ANDA Carbinozamine Maleate Elixir (4 mg per 5 cc)

ACK 1 HFA-305 Vol#: 1

99P-4649 Propoxyphene Napsylate/Acetaminophen Tablets/Capusles 50mg

ACK 1 HFA-305 Vol#: 1

99V-0184 Variance Laser Light Show Projector Model #LP1

ACK 2 HFA-305 Vol#: 1

AMD 1 John's Laser Productions Vol#: 1

99V-4028 Laser Light Show Ar/kr LP1-1001, Ar - LP2 1002

M 1 moved to 99V-0184 Vol#: 1
 

99V-4065 Variance Application for Range Finder

CR 1 FLIR Systems Boston Vol#: 1

99V-4322 Laser Light Show in Big Bang Theater, Am Museum of Nat Hist

VRA 1 HFZ-300 Vol#: 1

99V-4323 Laser Light Show in Space Theater

VRA 1 HFZ-300 Vol#: 1