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DOCKETS ENTERED on September 24, 2001 TABLE OF CONTENTS Hyper links are part of the Docket title - not all dockets/documents are linked NOTE: Documents received by the Dockets Management Branch "MAY" be posted on the Internet. PLEASE DO NOT include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence. |
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78N-036L OTC Laxative * 97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD * 98N-0337 Over the counter human drugs labeling requirements * 99P-1268 ANDA Suitability for Clozapine Tablets, 200mg * 00P-1322 Food Labeling and Allergen Contamination Control * 00P-1628 Insurance Matters Regarding Unemployment & Social Security * 01D-0194 Statistical Aspects Design,Analysis,Interpretation,chronic * 01D-0281 Proposed Globally Harmonized Alternative for PMA Procedures * 01N-0196 Phenylpropanolamine proposal to withdraw approval of NDA * 01P-0230 Domestic Marketing & Importation of Transgenic Fish * |
LET 195 Chester Labs Vol#: 107
97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD
EXT 1 American Assn of Blood Banks (AABB) Vol#: 1
EXT 2 Plasma Protein Therapeutics Assn Vol#: 1
98N-0337 Over the counter human drugs labeling requirements
AMD 2 L. Perrigo Company Vol#: 8
99P-1268 ANDA Suitability for Clozapine Tablets, 200mg
C 1 Phar-Mor, Inc., Store #124 Vol#: 1
99V-1630 Laser Light Show
RPT 1 Visual Ex Vol#: 1
00D-1538 Electronic Records; Electronic Signatures, Validation
GDL 1 Guidance for Industry Vol#: 2
LST 4 General References for Guidance Document Vol#: 2
LST 5 General References for Guidance Document Vol#: 2
MM 14 HFC-240 & NuGenesis Technologies Corp Vol#: 5
MM 15 HFC-240 & Datatrak International Inc Vol#: 5
MM 16 HFC-240 & Prelude Computer Solutions Inc Vol#: 5
MM 17 HFC-240 & Ionics Instruments 09/06/01 Vol#: 5
MM 18 HFC-240 & Scientific Software Inc 8/2/01 Vol#: 5
NAD 1 Vol#: 2
RPT 6 NIST Nat'l Institute of Standards & Tech Vol#: 2
00D-1539 Electronic Records & Signatures, Retention of Electronic Rec
LST 4 General References for Guidance Document Vol#: 2
LST 5 General References for Guidance Document Vol#: 2
MM 14 HFC-240 & NuGenesis Technologies Corp Vol#: 5
MM 15 HFC-240 & Datatrak International Inc Vol#: 5
MM 16 HFC-240 & Prelude Computer Solutions Inc Vol#: 5
MM 17 HFC-240 & Ionics Instruments 09/06/01 Vol#: 5
MM 18 HFC-240 & Scientific Software Inc 8/2/01 Vol#: 5
RPT 6 NIST Nat'l Institute of Standards & Tech Vol#: 2
00D-1540 Electronic Signatures, Electronic Copies of Electronic Recor
LST 4 General References for Guidance Document Vol#: 2
LST 5 General References for Guidance Document Vol#: 2
MM 14 HFC-240 & NuGenesis Technologies Corp Vol#: 5
MM 15 HFC-240 & Datatrak International Inc Vol#: 5
MM 16 HFC-240 & Prelude Computer Solutions Inc Vol#: 5
MM 17 HFC-240 & Ionics Instruments 09/06/01 Vol#: 5
MM 18 HFC-240 & Scientific Software Inc 8/2/01 Vol#: 5
RPT 6 NIST Nat'l Institute of Standards & Tech Vol#: 2
00D-1541 Electronic Signatures: Audit Trails
LST 4 General References for Guidance Document Vol#: 2
LST 5 General References for Guidance Document Vol#: 2
MM 15 HFC-240 & NuGenesis Technologies Corp Vol#: 5
MM 16 HFC-240 & Datatrak International Inc Vol#: 5
MM 17 HFC-240 & Prelude Computer Solutions Inc Vol#: 5
MM 18 HFC-240 & Ionics Instruments 09/06/01 Vol#: 5
MM 19 HFC-240 & Scientific Software Inc 8/2/01 Vol#: 5
RPT 7 NIST Nat'l Institute of Standards & Tech Vol#: 2
00D-1542 Electronic Signatures: Time Stamps
LST 4 General References for Guidance Document Vol#: 2
LST 5 General References for Guidance Document Vol#: 2
MM 14 HFC-240 & NuGenesis Technologies Corp Vol#: 5
MM 15 HFC-240 & Datatrak International Inc Vol#: 5
MM 16 HFC-240 & Prelude Computer Solutions Inc Vol#: 5
MM 17 HFC-240 & Ionics Instruments 09/06/01 Vol#: 5
MM 18 HFC-240 & Scientific Software Inc 8/2/01 Vol#: 5
RPT 6 Datum Trusted Time Stamp Server SA100 Vol#: 2
RPT 7 NIST Nat'l Institute of Standards & Tech Vol#: 2
00D-1543 Electronic Signatures: Glossary of Terms
GDL 1 Guidance for Industry Vol#: 2
LST 4 General References for Guidance Document Vol#: 2
LST 5 General References for Guidance Document Vol#: 2
MM 14 HFC-240 & NuGenesis Technologies Corp Vol#: 5
MM 15 HFC-240 & Datatrak International Inc Vol#: 5
MM 16 HFC-240 & Prelude Computer Solutions Inc Vol#: 5
MM 17 HFC-240 & Ionics Instruments 09/06/01 Vol#: 5
MM 18 HFC-240 & Scientific Software Inc 8/2/01 Vol#: 5
NAD 1 Vol#: 2
RPT 6 NIST Nat'l Institute of Standards & Tech Vol#: 2
00P-1322 Food Labeling and Allergen Contamination Control
C 388 Lois S. Gray Vol#: 25
00P-1628 Insurance Matters Regarding Unemployment & Social Security
PDN 1 HF-11 to Anthron Bethea Vol#: 1
01D-0194 Statistical Aspects Design,Analysis,Interpretation,chronic
C 12 Peter N. Lee Vol#: 1
C 13 A.V. Prabhakar Vol#: 1
C 14 Tsuyoshi Takizawa Vol#: 1
01D-0281 Proposed Globally Harmonized Alternative for PMA Procedures
C 3 Abbott Laboratories Vol#: 1
01E-0029 Patent Extension for Trileptal, No. 4,559,174
N 1 Vol#: 1
01M-0412 P000032; HerOption Uterine Cryoblation Therapy
APP 1 CryoGen, Inc. Vol#: 1
01M-0413 P010016; OrCel (Bilayered Cellular Matrix)
AAV 1 Ortec International, Inc. Vol#: 1
01M-0414 P010023; SOUNDTEC Direct System
AAV 1 SOUNDTEC, Inc. Vol#: 1
01N-0196 Phenylpropanolamine proposal to withdraw approval of NDA
C 4 American Home Products Corporation (AHPC Vol#: 1
01N-0397 Transportation Safety & Potentially Sedating or Impairing
NM 1 Vol#: 1
01P-0230 Domestic Marketing & Importation of Transgenic Fish
C 205 Adorers of the Blood of Christ Vol#: 23