Food and Drug Administration Revitalization Act

• Digital transformation and Information technology harmonizing FDA as information agency • Enforcement programs streamlined by contingencies of FDA field activities • Establishment of Office of Criminal Investigations • New drug approval process funding by prescription drug user fee • Progressive domestic and imports investigation programs by FDA • Proposed rule for regulation of tobacco by U.S. FDA • Quality standards for mammography facilities endorsed by Mammography Quality Act • Reduction in application, IND, and NDA review times for healthcare products • Safety information and adverse event reporting program ― MedWatch • Standardization of nutrition facts label as authorized by Nutrition Labeling Act The Title 21 amendment was signed into law on November 28, 1990, by President George H. W. Bush. ==Provisions of the Act==

The Food and Drug Administration Revitalization Act of 1990 was penned with four legislative titles establishing a medium for the rejuvenation of the public health agency. Title I: Administrative and Laboratory Facility Consolidation - 21 U.S.C. § 379b :General Services Administration provided authority to grant contracts for consolidated Food and Drug Administration facilities. The contracts shall be granted for the design, construction, and operation of consolidated Food and Drug Administration facilities. Title II: Recovery and Retention of Fees for FOIA Requests - 21 U.S.C. § 379c :Charge fees shall be applied to recover reasonable costs incurred in processing Freedom of Information requests for records obtained or created under this Act. Title III: Scientific Review Groups - 21 U.S.C. § 394 :Technical and scientific review groups shall be established as needed to perform functions of the Food and Drug Administration. Title IV: Automation of FDA - 21 U.S.C. § 379d :Agency shall automate appropriate activities of the Food and Drug Administration to ensure timely review of regulatory activities under this Act. ==References==

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