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Code · BILL · 114th Congress · H.R. 34 (Enrolled) — To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. · Sec. 3041

Sec. 3041. Antimicrobial resistance monitoring

530 words·~2 min read·/bill/114/hr/34/enr/section-3041·

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Section 319E of the Public Health Service Act ( 42 U.S.C. 247d–5 ) is amended— by redesignating subsections
(f)and
(g)as subsections
(l)and (m), respectively; and by inserting after subsection (e), the following: The Secretary shall encourage reporting on aggregate antimicrobial drug use and antimicrobial resistance to antimicrobial drugs and the implementation of antimicrobial stewardship programs by health care facilities of the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service and shall provide technical assistance to the Secretary of Defense and the Secretary of Veterans Affairs, as appropriate and upon request. Not later than 1 year after the date of enactment of the 21st Century Cures Act , and annually thereafter, the Secretary shall prepare and make publicly available data and information concerning— aggregate national and regional trends of antimicrobial resistance in humans to antimicrobial drugs, including such drugs approved under section 506(h) of the Federal Food, Drug, and Cosmetic Act; antimicrobial stewardship, which may include summaries of State efforts to address antimicrobial resistance in humans to antimicrobial drugs and antimicrobial stewardship; and coordination between the Director of the Centers for Disease Control and Prevention and the Commissioner of Food and Drugs with respect to the monitoring of— any applicable resistance under paragraph (1); and drugs approved under section 506(h) of the Federal Food, Drug, and Cosmetic Act. The Secretary shall, as appropriate, disseminate guidance, educational materials, or other appropriate materials related to the development and implementation of evidence-based antimicrobial stewardship programs or practices at health care facilities, such as nursing homes and other long-term care facilities, ambulatory surgical centers, dialysis centers, outpatient clinics, and hospitals, including community and rural hospitals. The Secretary shall continue to work with State and local public health departments on statewide or regional programs related to antimicrobial resistance. Such efforts may include activities to related to— identifying patterns of bacterial and fungal resistance in humans to antimicrobial drugs; preventing the spread of bacterial and fungal infections that are resistant to antimicrobial drugs; and promoting antimicrobial stewardship. For the purposes of supporting stewardship activities, examining changes in antimicrobial resistance, and evaluating the effectiveness of section 506(h) of the Federal Food, Drug, and Cosmetic Act, the Secretary shall— provide a mechanism for facilities to report data related to their antimicrobial stewardship activities (including analyzing the outcomes of such activities); and evaluate— antimicrobial resistance data using a standardized approach; and trends in the utilization of drugs approved under such section 506(h) with respect to patient populations. The Secretary shall use available systems, including the National Healthcare Safety Network or other systems identified by the Secretary, to fulfill the requirements or conduct activities under this section. For purposes of subsections
(f)through (j), the term antimicrobial includes any antibacterial or antifungal drugs, and may include drugs that eliminate or inhibit the growth of other microorganisms, as appropriate. . The Secretary shall make the data collected pursuant to this subsection public. Nothing in this subsection shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.
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  • 42 USC 247d–5
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Sec. 3041
Antimicrobial resistance monitoring
Cite42 USC 247d–5
Cites 1Cited by 0 across 0 sources
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