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Code · STATUTE-COMPILATIONS · Food and Drug Administration Safety and Innovation Act · Sec. 1125

Sec. 1125. INFORMATION TECHNOLOGY

428 words·~2 min read·/statute-compilations/comps-9932/sec-1125

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## SEC. 1125 INFORMATION TECHNOLOGY **[**[21 U.S.C. 393 note](/us/usc/t21/s393)**]** ###
(a)HHS Report Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall— ####
(1)report to Congress on— #####
(A)the milestones and a completion date for developing and implementing a comprehensive information technology strategic plan to align the information technology systems modernization projects with the strategic goals of the Food and Drug Administration, including results-oriented goals, strategies, milestones, performance measures; #####
(B)efforts to finalize and approve a comprehensive inventory of the information technology systems of the Food and Drug Administration that includes information describing each system, such as costs, system function or purpose, and status information, and incorporate use of the system portfolio into the information investment management process of the Food and Drug Administration; #####
(C)the ways in which the Food and Drug Administration uses the plan described in subparagraph
(A)to guide and coordinate the modernization projects and activities of the Food and Drug Administration, including the interdependencies among projects and activities; and #####
(D)the extent to which the Food and Drug Administration has fulfilled or is implementing recommendations of the Government Accountability Office with respect to the Food and Drug Administration and information technology; and ####
(2)develop— #####
(A)a documented enterprise architecture program management plan that includes the tasks, activities, and timeframes associated with developing and using the architecture and addresses how the enterprise architecture program management will be performed in coordination with other management disciplines, such as organizational strategic planning, capital planning and investment control, and performance management; and #####
(B)a skills inventory, needs assessment, gap analysis, and initiatives to address skills gaps as part of a strategic approach to information technology human capital planning. ###
(b)GAO Report Not later than January 1, 2016, the Comptroller General of the United States shall issue a report regarding the strategic plan described in subsection (a)(1)(A) and related actions carried out by the Food and Drug Administration. Such report shall assess the progress the Food and Drug Administration has made on— ####
(1)the development and implementation of a comprehensive information technology strategic plan, including the results-oriented goals, strategies, milestones, and performance measures identified in subsection (a)(1)(A); ####
(2)the effectiveness of the comprehensive information technology strategic plan described in subsection (a)(1)(A), including the results-oriented goals and performance measures; and ####
(3)the extent to which the Food and Drug Administration has fulfilled recommendations of the Government Accountability Office with respect to such agency and information technology.
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Sec. 1125
INFORMATION TECHNOLOGY
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