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 December 5, 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. |
|
77N-0085 Saccharin and Its Salts
CA 22049 Number Not Used Vol#: 445
CA 22319 Mr. & Mrs. J. R. Sholund Vol#: 448
CA 22357 Jack D. Sidler Vol#: 449
CA 22439 C. Tuttle Vol#: 450
94S-0120 510K Substantially Equivalent List
LST 107 List of October 2001 Vol#: 25
97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)
LET 554 HFS-810 to Earthwise Nutritionals Inc Vol#: 16
LET 555 HFS-810 to Jamieson Laboratories Vol#: 16
LET 556 HFS-810 to Pharmavite Corporation Vol#: 16
LET 557 HFS-810 to Rexall-Sundown Inc Vol#: 16
LET 558 HFS-810 to OvImmune Inc Vol#: 16
LET 559 HFS-810 to Enzymatic Therapy Inc Vol#: 16
00D-1538 Electronic Records; Electronic Signatures, Validation
LST 6 General References for Guidance Document Vol#: 5
00D-1539 Electronic Records & Signatures, Retention of Electronic Rec
LST 6 General References for Guidance Document Vol#: 5
00D-1540 Electronic Signatures, Electronic Copies of Electronic Recor
LST 6 General References for Guidance Document Vol#: 5
00D-1541 Electronic Signatures: Audit Trails
C 1 PhRMA Vol#: 5
LST 6 General References for Guidance Document Vol#: 5
RPT 8 Datum EBA (Datum Trusted Time Stamp Serv Vol#: 5
00D-1542 Electronic Signatures: Time Stamps
LST 6 General References for Guidance Document Vol#: 5
00D-1543 Electronic Signatures: Glossary of Terms
LST 6 General References for Guidance Document Vol#: 5
01M-0507 P990012; Elecsys HBsAg Immunassay, Elecsys HBsAg Confirmator
CR 1 HFZ-402 Vol#: 1
01M-0534 P010032; Genesis Neurostimulation (IPG) System
AAV 1 Advanced Neuromodulation System, Inc. Vol#: 1
01M-0535 P930027/S004; Immulite PSA, Third Generation PSA, 2000, etc
AAV 1 Diagnostic Products Corporation Vol#: 1
01M-0536 P010021; Vitros Immunodiagnostic Products Anti-HCV etc.
AAV 1 Ortho-Clinical Diagnostics, Inc. Vol#: 1
01M-0537 P010007; Immulite AFP and Immulit 2000 AFP
AAV 1 Diagnostic Products Corporation Vol#: 1
01N-0370 Progress on implementing for the common technical document
C 1 AstraZeneca Pharmaceuticals LP Vol#: 1
01P-0230 Domestic Marketing & Importation of Transgenic Fish
C 567 Jennifer Washburn Vol#: 82
C 568 Rosemary Galiani Vol#: 82
C 569 Julie Merritt Daisy Vol#: 82
C 570 Betty Erhart Vol#: 82
C 571 J. Vignone Vol#: 82
C 572 illegible Vol#: 82
C 573 Miriam MacGillis Vol#: 82
C 574 Mark Helms Vol#: 82
C 575 James T. Martin Vol#: 82
C 576 David Zimmerman Vol#: 82
C 577 Anna Watson Vol#: 82
C 578 Peter Richards Vol#: 82
C 579 Natalie Winblade Vol#: 82
C 580 Vivian Casper Vol#: 82
C 581 Marilyn Vranka Vol#: 82
C 582 Mrs. Kathleen E. Moss Vol#: 82
C 583 Jeff & Mary Clement-Hill Vol#: 82
C 584 Gordy Ohliger Vol#: 82
C 585 Noel Forrest Vol#: 82