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OGC-98-14 1 (1997-11-26)

handle is hein.gao/gaobablsf0001 and id is 1 raw text is: GAO United States General Accounting Office Washington, D.C. 20548 Office of the General Counsel B-278642 November 26, 1997 The Honorable James M. Jeffords Chairman The Honorable Edward M. Kennedy Ranking Minority Member Committee on Labor and Human Resources United States Senate The Honorable Thomas J. Bliley, Jr. Chairman The Honorable John D. Dingell Ranking Minority Member Committee on Commerce House of Representatives Subject: Department of Health and Human Services, Food and Drug Administration: Quality Mammography Standards Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on a major rule promulgated by the Department of Health and Human Services, Food and Drug Administration (FDA), entitled Quality Mammography Standards (RIN: 0910-AA24). We received the rule on November 14, 1997. It was published in the Federal Register as a final rule on October 28, 1997. 62 Fed. Reg. 55852. The final rule amends FDA regulations governing mammography including the requirements for accreditation bodies; procedures for facility certification; and quality standards for mammography personnel, equipment, and practices, including quality assurance. The final rule replaces existing interim rules and will, according to the FDA, provide increased assurance of adequate and consistent evaluation of mammography facilities on a nationwide level and compliance of the facilities with quality standards. Enclosed is our assessment of the FDA's compliance with the procedural steps required by section 801(a)(1)(B)(i) through (iv) of title 5 with respect to the rule. Our review indicates that the FDA complied with the applicable requirements. GAO/OGC-98-14

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