The Food and Drug Administration (FDA) is issuing regulations to permit FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or
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medical devices that are or will be included in the Strategic National Stockpile (SNS). Under this rule, the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public.

Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft information technology (IT) plan entitled ``Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan.'' This plan is intended to provide regulated industry and other stakeholders with information on FDA's vision and plan for improving

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration