The Federal Register

Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile

Fri, Dec 28 2007 11:00:00 GMT

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 appropriate FDA Center Director may grant an exception or alternative to such labeling requirements if he or she determines that compliance with the requirements could adversely affect the safety, effectiveness, or availability of specified lots, batches, or other units of human drugs, biological products, or medical devices that are or will be included in the SNS, including not only those that are approved, licensed, or cleared for marketing, but also those that are investigational. A grant of an exception or alternative under these regulations will include any safeguards or conditions deemed appropriate by the FDA Center Director to ensure that the la

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

Fri, Dec 28 2007 11:00:00 GMT

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 agency on FDA's regulatory issues.

Date and Time: The meeting will be held by teleconference on February 5, 2008, from 12 noon to approximately 3:15 p.m. Eastern Time.

Location: National Institutes of Health, Building 29B, Conference Room C, 9000 Rockville Pike, Bethesda, MD. This meeting will be held by teleconference. The public is welcome to attend the meeting at the specified location. A speakerphone will be provided at the specified location for public participation in the meeting, on site. Important information about transportation and directions to the NIH campus, parking, and security procedures is available on the Internet at

Draft Prescription Drug User Fee Act IV Information Technology Plan; Availability for Comment

Fri, Dec 28 2007 11:00:00 GMT

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 the automation of business processes and maintaining information systems that support the process for the review of human drug applications to achieve the objectives defined in the PDUFA Performance Goals.