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42 U.S.C. § 247d–5Combating antimicrobial resistance

submitted 82 years ago by Pub. L. 106-505 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 1,757 words · no verdicts yet

in plain englishAI-generated · not legal advice

This law creates a federal task force and programs to fight antimicrobial resistance. The Secretary of Health and Human Services must fund research, train health workers, run surveillance networks, and give grants to states and other groups. It also funds a lab network and international cooperation on drug-resistant pathogens.

(a) Task force The Secretary must set up an Antimicrobial Resistance Task Force to advise the Secretary and coordinate federal antimicrobial-resistance programs. Instead of creating a new one, the Secretary may use an existing committee or organization — one that existed as of November 13, 2000 — as the task force, if it meets this section's requirements. The task force must include representatives from the federal agencies the Secretary picks, and must get input from public health groups, manufacturers, veterinary and medical professional societies, and others the Secretary thinks are needed, in order to build and carry out a full plan against antimicrobial resistance. The task force must consider factors the Secretary thinks are relevant, including: what is driving rising resistance; public health needs for detecting and tracking resistance; strategies to detect, prevent, and control resistant pathogens; the need for better data; assessing the risk each pathogen poses to public health; and any other relevant issues. Working with the task force and state and local officials, the Secretary must develop, improve, or expand participation in a surveillance plan to detect and track emerging resistance, and in an information system that lets health departments share resistance data with each other. The task force must meet at least twice a year, or more often if the Secretary decides that is needed. (b) Research and development of new antimicrobial drugs and diagnostics Following the task force's recommendations, the Secretary and the Director of Agricultural Research Services must fund research — directly, or through grants or cooperative agreements — on: new treatments, including vaccines and antimicrobials, against resistant pathogens; new or improved diagnostic tests to detect resistant pathogens; the epidemiology, mechanisms, and biology of resistance; genome sequencing and other DNA or comparative analysis of priority pathogens, chosen by the Director of the National Institutes of Health with the task force, done together with the Department of Defense and the Department of Energy's Joint Genome Institute; and other relevant research areas. (c) Education of medical and public health personnel After consulting the Assistant Secretary for Health, the Surgeon General, the CDC Director, the Health Resources and Services Administration, the Agency for Healthcare Research and Quality, task force members, professional groups, and other officials as needed, the Secretary must: build public-awareness programs about the threat of antimicrobial resistance and proper antibiotic use; build training programs for health care workers on using antibiotics wisely; and build training programs for lab staff on recognizing and identifying resistant pathogens. (d) Grants The Secretary must give competitive grants to eligible groups to build their capacity to detect, track, and fight antimicrobial resistance. Eligible groups are state or local public health agencies, Indian tribes or tribal organizations, and other nonprofit public or private groups. Grant recipients must spend the money on activities matching the task force's factors from subsection (a)(3), which may include training staff to spot resistance patterns quickly and accurately, building information systems to share resistance data fast among health agencies and providers, and creating policies to stop resistance from spreading. (e) Grants for demonstration programs The Secretary must give competitive grants to eligible groups to run demonstration programs that promote smart antimicrobial use or control the spread of resistant pathogens. Eligible groups may include hospitals, clinics, long-term care facilities, professional medical societies, schools that train medical lab staff, and other nonprofit groups. The Secretary must give appropriate technical help to grant recipients. (f) Monitoring at Federal health care facilities The Secretary must encourage the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service to report combined data on antimicrobial drug use, resistance, and stewardship programs at their facilities, and must give technical help to the Secretaries of Defense and Veterans Affairs, as appropriate and on request. (g) Report on antimicrobial resistance in humans and use of antimicrobial drugs Within 1 year of December 13, 2016, and every year after, the Secretary must publish data on: national and regional trends in human antimicrobial resistance, including for drugs approved under section 356(h) of title 21; antimicrobial stewardship efforts, which may include state-level summaries; and coordination between the CDC Director and the Commissioner of Food and Drugs on monitoring that resistance and those approved drugs. (h) Information related to antimicrobial stewardship programs The Secretary must share guidance, education, and other materials to help 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 — build and run evidence-based antimicrobial stewardship programs. (i) Supporting State-based activities to combat antimicrobial resistance The Secretary must keep working with state and local health departments on statewide or regional antimicrobial-resistance programs, which may include identifying resistance patterns, preventing the spread of resistant infections, and promoting antimicrobial stewardship. (j) Antimicrobial resistance and stewardship activities To support stewardship activities, track changes in resistance, and check how well drugs approved under section 356(h) of title 21 are working, the Secretary must give facilities a way to report their stewardship data and outcomes, and must evaluate resistance data using a standard method and drug-use trends by patient group. The Secretary must use existing systems, such as the National Healthcare Safety Network or others the Secretary identifies, to do this work. (k) Network of antibiotic resistance regional laboratories Through the CDC Director, the Secretary must, as appropriate, maintain a network of antibiotic-resistance laboratory sites, within the CDC's existing lab capacity, to: identify and track patterns in resistant pathogens; detect, identify, confirm, and isolate resistant pathogens, including doing this for other labs on request and helping respond to local or regional outbreaks; and support diagnosis of resistant pathogens and testing which treatments a pathogen sample will respond to. The Secretary must spread this capacity fairly across the geographic regions of the United States. These labs may be based at academic centers, state health departments, or other public or private facilities that already do this kind of laboratory or public health surveillance work. (l) International collaboration With other federal agencies, the Secretary must support work on antimicrobial resistance internationally, including by funding research on resistant pathogens — even ones not yet found in the United States — improving related surveillance and lab capacity, and giving technical assistance on controlling resistant infections. To do this, the Secretary may award grants, contracts, or cooperative agreements, including to nongovernmental organizations, to support new and innovative ways to prevent, detect, and reduce antimicrobial-resistant pathogens. (m) Antimicrobial For subsections (f) through (j), "antimicrobial" includes antibacterial and antifungal drugs, and may include other drugs that eliminate or slow the growth of microorganisms, as appropriate. (n) Supplement not supplant Money from this section must add to, and not replace, other federal, state, and local public funding already provided for these activities. (o) Authorization of appropriations Congress authorized $40,000,000 for fiscal year 2001, $25,000,000 for each of fiscal years 2002 and 2003, and whatever amount is necessary for each of fiscal years 2004 through 2006.
the actual law source: uscode.house.gov ↗public domain
(a) Task force
(1) In general

The Secretary shall establish an Antimicrobial Resistance Task Force to provide advice and recommendations to the Secretary and coordinate Federal programs relating to antimicrobial resistance. The Secretary may appoint or select a committee, or other organization in existence as of November 13, 2000, to serve as such a task force, if such committee, or other organization meets the requirements of this section.

(2) Members of task force

The task force described in paragraph (1) shall be composed of representatives from such Federal agencies, and shall seek input from public health constituencies, manufacturers, veterinary and medical professional societies and others, as determined to be necessary by the Secretary, to develop and implement a comprehensive plan to address the public health threat of antimicrobial resistance.

(3) Agenda
(A) In general

The task force described in paragraph (1) shall consider factors the Secretary considers appropriate, including—

(i)

public health factors contributing to increasing antimicrobial resistance;

(ii)

public health needs to detect and monitor antimicrobial resistance;

(iii)

detection, prevention, and control strategies for resistant pathogens;

(iv)

the need for improved information and data collection;

(v)

the assessment of the risk imposed by pathogens presenting a threat to the public health; and

(vi)

any other issues which the Secretary determines are relevant to antimicrobial resistance.

(B) Detection and control

The Secretary, in consultation with the task force described in paragraph (1) and State and local public health officials, shall—

(i)

develop, improve, coordinate or enhance participation in a surveillance plan to detect and monitor emerging antimicrobial resistance; and

(ii)

develop, improve, coordinate or enhance participation in an integrated information system to assimilate, analyze, and exchange antimicrobial resistance data between public health departments.

(4) Meetings

The task force described under paragraph (1) shall convene not less than twice a year, or more frequently as the Secretary determines to be appropriate.

(b) Research and development of new antimicrobial drugs and diagnostics

The Secretary and the Director of Agricultural Research Services, consistent with the recommendations of the task force established under subsection (a), shall directly or through awards of grants or cooperative agreements to public or private entities provide for the conduct of research, investigations, experiments, demonstrations, and studies in the health sciences that are related to—

(1)

the development of new therapeutics, including vaccines and antimicrobials, against resistant pathogens;

(2)

the development or testing of medical diagnostics to detect pathogens resistant to antimicrobials;

(3)

the epidemiology, mechanisms, and pathogenesis of antimicrobial resistance;

(4)

the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens (as determined by the Director of the National Institutes of Health in consultation with the task force established under subsection (a)), in collaboration and coordination with the activities of the Department of Defense and the Joint Genome Institute of the Department of Energy; and

(5)

other relevant research areas.

(c) Education of medical and public health personnel

The Secretary, after consultation with the Assistant Secretary for Health, the Surgeon General, the Director of the Centers for Disease Control and Prevention, the Administrator of the Health Resources and Services Administration, the Director of the Agency for Healthcare Research and Quality, members of the task force described in subsection (a), professional organizations and societies, and such other public health officials as may be necessary, shall—

(1)

develop and implement educational programs to increase the awareness of the general public with respect to the public health threat of antimicrobial resistance and the appropriate use of antibiotics;

(2)

develop and implement educational programs to instruct health care professionals in the prudent use of antibiotics; and

(3)

develop and implement programs to train laboratory personnel in the recognition or identification of resistance in pathogens.

(d) Grants
(1) In general

The Secretary shall award competitive grants to eligible entities to enable such entities to increase the capacity to detect, monitor, and combat antimicrobial resistance.

(2) Eligible entities

Eligible entities for grants under paragraph (1) shall be State or local public health agencies, Indian tribes or tribal organizations, or other public or private nonprofit entities.

(3) Use of funds

An eligible entity receiving a grant under paragraph (1) shall use funds from such grant for activities that are consistent with the factors identified by the task force under subsection (a)(3), which may include activities that—

(A)

provide training to enable such entity to identify patterns of resistance rapidly and accurately;

(B)

develop, improve, coordinate or enhance participation in information systems by which data on resistant infections can be shared rapidly among relevant national, State, and local health agencies and health care providers; and

(C)

develop and implement policies to control the spread of antimicrobial resistance.

(e) Grants for demonstration programs
(1) In general

The Secretary shall award competitive grants to eligible entities to establish demonstration programs to promote judicious use of antimicrobial drugs or control the spread of antimicrobial-resistant pathogens.

(2) Eligible entities

Eligible entities for grants under paragraph (1) may include hospitals, clinics, institutions of long-term care, professional medical societies, schools or programs that train medical laboratory personnel, or other public or private nonprofit entities.

(3) Technical assistance

The Secretary shall provide appropriate technical assistance to eligible entities that receive grants under paragraph (1).

(f) Monitoring at Federal health care facilities

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.

(g) Report on antimicrobial resistance in humans and use of antimicrobial drugs

Not later than 1 year after December 13, 2016, and annually thereafter, the Secretary shall prepare and make publicly available data and information concerning—

(1)

aggregate national and regional trends of antimicrobial resistance in humans to antimicrobial drugs, including such drugs approved under section 356(h) of title 21;

(2)

antimicrobial stewardship, which may include summaries of State efforts to address antimicrobial resistance in humans to antimicrobial drugs and antimicrobial stewardship; and

(3)

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—

(A)

any applicable resistance under paragraph (1); and

(B)

drugs approved under section 356(h) of title 21.

(h) Information related to antimicrobial stewardship programs

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.

(i) Supporting State-based activities to combat antimicrobial resistance

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—

(1)

identifying patterns of bacterial and fungal resistance in humans to antimicrobial drugs;

(2)

preventing the spread of bacterial and fungal infections that are resistant to antimicrobial drugs; and

(3)

promoting antimicrobial stewardship.

(j) Antimicrobial resistance and stewardship activities
(1) In general

For the purposes of supporting stewardship activities, examining changes in antimicrobial resistance, and evaluating the effectiveness of section 356(h) of title 21, the Secretary shall—

(A)

provide a mechanism for facilities to report data related to their antimicrobial stewardship activities (including analyzing the outcomes of such activities); and

(B)

evaluate—

(i)

antimicrobial resistance data using a standardized approach; and

(ii)

trends in the utilization of drugs approved under such section 356(h) of title 21 with respect to patient populations.

(2) Use of systems

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.

(k) Network of antibiotic resistance regional laboratories
(1) In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, as appropriate, maintain a network of antibiotic resistance laboratory sites to ensure the maintenance of appropriate capabilities, within existing laboratory capacity maintained or supported by the Centers for Disease Control and Prevention, to—

(A)

identify and monitor the emergence and changes in the patterns of antimicrobial-resistant pathogens;

(B)

detect, identify, confirm, and isolate such resistant pathogens, including, as appropriate, performing such activities upon the request of another laboratory and providing related technical assistance, and, as applicable, support efforts to respond to local or regional outbreaks of such resistant pathogens; and

(C)

perform activities to support the diagnosis of such resistant pathogens and determine the susceptibility of relevant pathogen samples to applicable treatments.

(2) Geographic distribution

The Secretary shall ensure that such capacity and capabilities are appropriately distributed among the geographical regions of the United States.

(3) Partnerships and nonduplication of current domestic capacity

Activities supported under this subsection may be based in an academic center, a State health department, or other facility operated by a public or private entity that carries out relevant laboratory or public health surveillance activities.

(l) International collaboration
(1) In general

The Secretary, in coordination with heads of other relevant Federal departments and agencies, shall support activities related to addressing antimicrobial resistance internationally, including by—

(A)

supporting basic, translational, epidemiological, and clinical research related to antimicrobial-resistant pathogens, including such pathogens that have not yet been detected in the United States, and improving related public health surveillance systems, and laboratory and other response capacity; and

(B)

providing technical assistance related to antimicrobial resistant infection and control activities.

(2) Awards

In carrying out paragraph (1), the Secretary may award grants, contracts, or cooperative agreements to public and private entities, including nongovernmental organizations, with applicable expertise, for purposes of supporting new and innovative approaches to the prevention, detection, and mitigation of antimicrobial-resistant pathogens.

(m) Antimicrobial

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.

(n) Supplement not supplant

Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section.

(o) Authorization of appropriations

There are authorized to be appropriated to carry out this section, $40,000,000 for fiscal year 2001, $25,000,000 for each of the fiscal years 2002 and 2003, and such sums as may be necessary for each of the fiscal years 2004 through 2006.

Source credit: (July 1, 1944, ch. 373, title III, § 319E, as added Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114 Stat. 2318; amended Pub. L. 107–188, title I, § 109, June 12, 2002, 116 Stat. 610; Pub. L. 114–255, div. A, title III, § 3041(a), Dec. 13, 2016, 130 Stat. 1111; Pub. L. 117–328, div. FF, title II, § 2234, Dec. 29, 2022, 136 Stat. 5754.)

history & why it existsrecord from the source credit
  • 1944Enacted · Pub. L. 106-505 · 114 Stat. 2318
  • 2002Amended · Pub. L. 107-188 · 116 Stat. 610
  • 2016Amended · Pub. L. 114-255 · 130 Stat. 1111
  • 2022Amended · Pub. L. 117-328 · 136 Stat. 5754

A history note hasn’t been published yet. The record shows enactment by Pub. L. 106-505 on 1944-07-01.

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