Browse Arkansas Code titles and sections
42 U.S.C. § 247d–5 — Combating antimicrobial resistance
Federal law — U.S. Code and appendices · legal_authorities
**(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 d
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 247d–5
Stored review status: release_metadata_unconfirmed. A text match is a research starting point; applicability is not established.
Original supplied file — preserved unchanged
Download original Markdown file
File SHA-256: 4c67512ed9a8037bba5e7cf029798fa907543585de07a910a80e4b00b8b251c7. The original may include catalog metadata, neighboring provisions, or embedded records outside this collection's scope. Search shows only the selected federal record. Historical editions and unverified snapshots are not a statement of current law.
Authority boundary: historical or unconfirmed source not current law verified.
Record provenance
Stable record: federal_law:legal_authorities:record_usc_99d2e7c2bf06960fb99b2e92
Source file: Laws/federal/codes/united-states-code/title-42/section-247d5-combating-antimicrobial-resistance--b98768bc49.md
Pages: Not recorded – Not recorded
Passage SHA-256: 5912db13208c9055732c8ceb915e247434377de0747803d4cc88b538818ded2c
Source location: Title 42, Chapter 6A, § 247d–5; chapter-6a-public-health-service.md
Stored source content
**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356/h&num=0&edition=prelim);
(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356/h&num=0&edition=prelim).
**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356/h&num=0&edition=prelim), 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356/h&num=0&edition=prelim) 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.
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
Federal law — U.S. Code and appendices · legal_authorities
**(a) In General.—**
(1) **Advisory committees in existence on january 5, 1973.—** — Each advisory committee that is in existence on January 5, 1973, shall terminate not later than the expiration of the 2-year period following that date unless—
(A) in the case of an advisory committee established by the President or an officer of the Federal Government, such advisory committee is renewed by the President or that officer by appropriate action prior to the expiration of such 2-year period; or
(B) in the case of an advisory committee established by an Act of Congress, its duration is otherwise provided for by law.
(2) **Advisory committees established after january 5, 1973.—** — Each advisory committee established after January 5, 1973, shall terminate not later than the expiration of the 2-year period beginning on the date of its establishment unless—
(A) in the case of an advisory committee established by the President or an officer of the Federal Government 11 So in original. Probably should be followed by a comma. such advisory committee is renewed by the President or such officer by appropriate action prior to the end of such period; or
(B) in the case of an advisory committee established by an Act of Congress, its duration is otherwise provided for by law.
**(b) Charters.—**
(1) **Upon renewal.—** — Upon the renewal of an advisory committee, the advisory committee shall file a charter in accordance with [section 1008(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section1008/c&num=0&edition=prelim).
(2) **Upon expiration of successive 2-year periods.—** — An advisory committee established by an Act of Congress shall file a charter in accordance with [section 1008(c) of this title](https://uscode.house.gov/view.x
Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 1013
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.
Source: Supplied U.S. Code snapshot — release unconfirmed · 18 U.S.C. § 1905
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Designation of a drug as a breakthrough therapy**
(1) **In general** — The Secretary shall, at the request of the sponsor of a drug, expedite the development and review of such drug if the drug is intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. (In this section, such a drug is referred to as a “breakthrough therapy”.)
(2) **Request for designation** — The sponsor of a drug may request the Secretary to designate the drug as a breakthrough therapy. A request for the designation may be made concurrently with, or at any time after, the submission of an application for the investigation of the drug under [section 355(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim) or section 351(a)(3) of the Public Health Service Act [[42 U.S.C. 262(a)(3)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a/3&num=0&edition=prelim)].
(3) **Designation**
(A) *In general* — Not later than 60 calendar days after the receipt of a request under paragraph (2), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (1). If the Secretary finds that the drug meets the criteria, the Secretary shall designate the drug as a breakthrough therapy and shall take such actions as are appropriate to expedite the development and review of the application for approval of such drug.
(B) *Actions* — The actions to
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 356
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
In this chapter:
(1) **Administrator.—** — The term “Administrator” means the Administrator of General Services.
(2) **Advisory committee.—**
(A) *In general.—* — The term “advisory committee” means a committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof (hereafter in this paragraph referred to as “committee”) that is established or utilized to obtain advice or recommendations for the President or one or more agencies or officers of the Federal Government and that is—
(i) established by statute or reorganization plan;
(ii) established or utilized by the President; or
(iii) established or utilized by one or more agencies.
(B) *Exclusions.—* — The term “advisory committee” excludes—
(i) a committee that is composed wholly of full-time, or permanent part-time, officers or employees of the Federal Government; and
(ii) a committee that is created by the National Academy of Sciences or the National Academy of Public Administration.
(3) **Agency.—** — The term “agency” has the meaning given the term in [section 551 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section551&num=0&edition=prelim).
(4) **Presidential advisory committee.—** — The term “Presidential advisory committee” means an advisory committee that advises the President.
Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 1001
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
The President of the United States is authorized to designate and empower the head of any department or agency in the executive branch, or any official thereof who is required to be appointed by and with the advice and consent of the Senate, to perform without approval, ratification, or other action by the President (1) any function which is vested in the President by law, or (2) any function which such officer is required or authorized by law to perform only with or subject to the approval, ratification, or other action of the President: Provided, That nothing contained herein shall relieve the President of his responsibility in office for the acts of any such head or other official designated by him to perform such functions. Such designation and authorization shall be in writing, shall be published in the Federal Register, shall be subject to such terms, conditions, and limitations as the President may deem advisable, and shall be revocable at any time by the President in whole or in part.
Source: Supplied U.S. Code snapshot — release unconfirmed · 3 U.S.C. § 301
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Unsafe new animal drugs and animal feed containing such drugs; conditions of safety; exemption of drugs for research; import tolerances**
(1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for purposes of [section 351(a)(5) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section351/a/5&num=0&edition=prelim) and [section 342(a)(2)(C)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a/2/C/ii&num=0&edition=prelim) unless—
(A) there is in effect an approval of an application filed pursuant to subsection (b) with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such approved application;
(B) there is in effect a conditional approval of an application filed pursuant to [section 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim) with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such conditionally approved application;
(C) there is in effect an index listing pursuant to [section 360ccc–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc-1&num=0&edition=prelim) with respect to such use or intended use of such drug in a minor species, and such drug, its labeling, and such use conform to such index listing; or
(D) there is in effect an authorization pursuant to [section 360bbb–3 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb-3&num=0&edition=prelim) with respect to such use or intended use of such drug, and such drug, its labeling, and su
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360b
Stored review status: release_metadata_unconfirmed. Incoming connection: Explicit cross-reference supplied in source Markdown; currentness and applicability require review.