NOTICES

Docket No. 98D-0143 OC98433. Agency Information Collection Activities; Announcement of OMB Approval; Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units From Prior Collections from Donors with Repeatedly Reactive Screening Test for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV.  Page 4112 [FR Doc. 99-1795]  [TXT] [PDF]

Supporting Statement

OC994. Notice of Formation of a Subcommittee to the Food and Drug Administration Science Board.  Pages  4114-4115 [FR Doc. 99-1793] [TXT] [PDF]

Docket No. 98E-0783 OC9918. Determination of Regulatory Review Period for Purposes of Patent Extension; Emadine.  Pages 4116-4117 [FR Doc. 99-1792]  [TXT] [PDF] Written comments by March 29, 1999 and petition by July 26, 1999.

Docket No. 98E-0784 OC9921. Determination of Regulatory Review Period for Purposes of Patent Extension; Viagra.  Page 4115 [FR Doc. 99-1796]   [TXT] [PDF] Written comments by March 29, 1999 and petition by July 26, 1999.

Docket No.  98E-0757 OC9922.  Determination of Regulatory Review Period for Purposes of Patent Extension; Xeloda.  Pages  4115-4116 [FR Doc. 99-1851]  [TXT] [PDF]  Written comments by March 29, 1999and petition by July 26, 1999.

DOCKET 98D-1268 CDER98153. Guidance for Industry on Variations in Drug Products That May Be Included in a Single Abbreviated New Drug Application; Availability.  Pages 4117-4118 [FR Doc. 99-1850]   [TXT] [PDF]  Written comments by April 27, 1999.

Draft Guidance

Draft Guidance