Department of Health and Human Services November 18, 2008 – Federal Register Recent Federal Regulation Documents

Draft Guidance for Industry on Process Validation: General Principles and Practices; Availability
Document Number: E8-27321
Type: Notice
Date: 2008-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Process Validation: General Principles and Practices.'' FDA is revising its guidance for industry entitled ``Guideline on General Principles of Process Validation,'' which issued in May 1987 (the 1987 guidance). The revised draft guidance promotes a ``lifecycle'' approach to process validation that includes scientifically sound design practices, robust qualification, and process verification. When finalized, this draft guidance will replace the 1987 guidance.
Office of the Director, National Institutes of Health; Amended Notice of Meeting
Document Number: E8-27264
Type: Notice
Date: 2008-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-27263
Type: Notice
Date: 2008-11-18
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Amended Notice of Meeting
Document Number: E8-27262
Type: Notice
Date: 2008-11-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: E8-27261
Type: Notice
Date: 2008-11-18
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: E8-27260
Type: Notice
Date: 2008-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications
Document Number: E8-27258
Type: Notice
Date: 2008-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: E8-27255
Type: Notice
Date: 2008-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile; Technical Amendment
Document Number: E8-27254
Type: Rule
Date: 2008-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the biologics regulations to reincorporate a regulation that was inadvertently removed. This action is being taken to correct the regulations.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-27253
Type: Notice
Date: 2008-11-18
Agency: Department of Health and Human Services, National Institutes of Health