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H.R. 307 Pandemic and All-Hazards Preparedness Reauthorization Act of 2013
AT THE FIRST SESSION
Begun and held at the City of Washington on Thursday,
the third day of January, two thousand and thirteen
To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
(a) Short Title.—This Act may be cited as the “Pandemic and All-Hazards Preparedness Reauthorization Act of 2013”.
(b) Table Of Contents.—The table of contents of this Act is as follows:
Sec. 1. Short title; table of contents.
TITLE I—STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC HEALTH EMERGENCIES
Sec. 101. National Health Security Strategy.
Sec. 102. Assistant Secretary for Preparedness and Response.
Sec. 103. National Advisory Committee on Children and Disasters.
Sec. 104. Modernization of the National Disaster Medical System.
Sec. 105. Continuing the role of the Department of Veterans Affairs.
TITLE II—OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND RESPONSE
Sec. 201. Temporary reassignment of State and local personnel during a public health emergency.
Sec. 202. Improving State and local public health security.
Sec. 203. Hospital preparedness and medical surge capacity.
Sec. 204. Enhancing situational awareness and biosurveillance.
Sec. 205. Eliminating duplicative Project Bioshield reports.
TITLE III—ENHANCING MEDICAL COUNTERMEASURE REVIEW
Sec. 301. Special protocol assessment.
Sec. 302. Authorization for medical products for use in emergencies.
Sec. 303. Definitions.
Sec. 304. Enhancing medical countermeasure activities.
Sec. 305. Regulatory management plans.
Sec. 306. Report.
Sec. 307. Pediatric medical countermeasures.
TITLE IV—ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND DEVELOPMENT
Sec. 401. BioShield.
Sec. 402. Biomedical Advanced Research and Development Authority.
Sec. 403. Strategic National Stockpile.
Sec. 404. National Biodefense Science Board.
(1) in subsection (a)(1), by striking “2009” and inserting “2014”; and
(A) in paragraph (1)(A), by inserting “, including drills and exercises to ensure medical surge capacity for events without notice” after “exercises”; and
(I) by striking “facilities), and trauma care” and inserting “and ambulatory care facilities and which may include dental health facilities), and trauma care, critical care,”; and
(II) by inserting “(including related availability, accessibility, and coordination)” after “public health emergencies”;
(ii) in subparagraph (A), by inserting “and trauma” after “medical”;
(iii) in subparagraph (B), by striking “Medical evacuation and fatality management” and inserting “Fatality management”;
(iv) by redesignating subparagraphs (C), (D), and (E) as subparagraphs (D), (E), and (F), respectively;
(v) by inserting after subparagraph (B), the following the new subparagraph:
“(C) Coordinated medical triage and evacuation to appropriate medical institutions based on patient medical need, taking into account regionalized systems of care.”;
(vi) in subparagraph (E), as redesignated by clause (iv), by inserting “(which may include such dental health assets)” after “medical assets”; and
(vii) by adding at the end the following:
“(G) Optimizing a coordinated and flexible approach to the medical surge capacity of hospitals, other health care facilities, critical care, trauma care (which may include trauma centers), and emergency medical systems.”;
(i) in subparagraph (A), by inserting “, including the unique needs and considerations of individuals with disabilities,” after “medical needs of at-risk individuals”; and
(ii) in subparagraph (B), by inserting “the” before “purpose of this section”; and
(D) by adding at the end the following:
“(A) Promoting strategic initiatives to advance countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin, chemical, radiological, or nuclear agent or agents, whether naturally occurring, unintentional, or deliberate.
“(B) For purposes of this paragraph, the term ‘countermeasures’ has the same meaning as the terms ‘qualified countermeasures’ under section 319F–1, ‘qualified pandemic and epidemic products’ under section 319F–3, and ‘security countermeasures’ under section 319F–2.
“(8) MEDICAL AND PUBLIC HEALTH COMMUNITY RESILIENCY.—Strengthening the ability of States, local communities, and tribal communities to prepare for, respond to, and be resilient in the event of public health emergencies, whether naturally occurring, unintentional, or deliberate by—
“(A) optimizing alignment and integration of medical and public health preparedness and response planning and capabilities with and into routine daily activities; and
“(B) promoting familiarity with local medical and public health systems.”.
(b) At-Risk Individuals.—Section 2814 of the Public Health Service Act (42 U.S.C. 300hh–16) is amended—
(1) by striking paragraphs (5), (7), and (8);
(2) in paragraph (4), by striking “2811(b)(3)(B)” and inserting “2802(b)(4)(B)”;
(3) by redesignating paragraphs (1) through (4) as paragraphs (2) through (5), respectively;
(4) by inserting before paragraph (2) (as so redesignated), the following:
“(1) monitor emerging issues and concerns as they relate to medical and public health preparedness and response for at-risk individuals in the event of a public health emergency declared by the Secretary under section 319;”;
(5) by amending paragraph (2) (as so redesignated) to read as follows:
“(2) oversee the implementation of the preparedness goals described in section 2802(b) with respect to the public health and medical needs of at-risk individuals in the event of a public health emergency, as described in section 2802(b)(4);”; and
(6) by inserting after paragraph (6), the following:
“(7) disseminate and, as appropriate, update novel and best practices of outreach to and care of at-risk individuals before, during, and following public health emergencies in as timely a manner as is practicable, including from the time a public health threat is identified; and
“(8) ensure that public health and medical information distributed by the Department of Health and Human Services during a public health emergency is delivered in a manner that takes into account the range of communication needs of the intended recipients, including at-risk individuals.”.
(A) in paragraph (3), by inserting “, security countermeasures (as defined in section 319F–2),” after “qualified countermeasures (as defined in section 319F–1)”;
(B) in paragraph (4), by adding at the end the following:
“(D) POLICY COORDINATION AND STRATEGIC DIRECTION.—Provide integrated policy coordination and strategic direction with respect to all matters related to Federal public health and medical preparedness and execution and deployment of the Federal response for public health emergencies and incidents covered by the National Response Plan developed pursuant to section 504(6) of the Homeland Security Act of 2002, or any successor plan, before, during, and following public health emergencies.
“(E) IDENTIFICATION OF INEFFICIENCIES.—Identify and minimize gaps, duplication, and other inefficiencies in medical and public health preparedness and response activities and the actions necessary to overcome these obstacles.
“(F) COORDINATION OF GRANTS AND AGREEMENTS.—Align and coordinate medical and public health grants and cooperative agreements as applicable to preparedness and response activities authorized under this Act, to the extent possible, including program requirements, timelines, and measurable goals, and in consultation with the Secretary of Homeland Security, to—
“(i) optimize and streamline medical and public health preparedness and response capabilities and the ability of local communities to respond to public health emergencies; and
“(ii) gather and disseminate best practices among grant and cooperative agreement recipients, as appropriate.
“(G) DRILL AND OPERATIONAL EXERCISES.—Carry out drills and operational exercises, in consultation with the Department of Homeland Security, the Department of Defense, the Department of Veterans Affairs, and other applicable Federal departments and agencies, as necessary and appropriate, to identify, inform, and address gaps in and policies related to all-hazards medical and public health preparedness and response, including exercises based on—
“(i) identified threats for which countermeasures are available and for which no countermeasures are available; and
“(ii) unknown threats for which no countermeasures are available.
“(H) NATIONAL SECURITY PRIORITY.—On a periodic basis consult with, as applicable and appropriate, the Assistant to the President for National Security Affairs, to provide an update on, and discuss, medical and public health preparedness and response activities pursuant to this Act and the Federal Food, Drug, and Cosmetic Act, including progress on the development, approval, clearance, and licensure of medical countermeasures.”; and
(C) by adding at the end the following:
“(7) COUNTERMEASURES BUDGET PLAN.—Develop, and update on an annual basis, a coordinated 5-year budget plan based on the medical countermeasure priorities described in subsection (d). Each such plan shall—
“(i) basic research and advanced research and development;
“(ii) approval, clearance, licensure, and authorized uses of products; and
“(iii) procurement, stockpiling, maintenance, and replenishment of all products in the Strategic National Stockpile;
“(B) inform prioritization of resources and include measurable outputs and outcomes to allow for the tracking of the progress made toward identified priorities;
“(C) identify medical countermeasure life-cycle costs to inform planning, budgeting, and anticipated needs within the continuum of the medical countermeasure enterprise consistent with section 319F–2; and
“(D) be made available to the appropriate committees of Congress upon request.”;
(2) by striking subsection (c) and inserting the following:
“(1) have lead responsibility within the Department of Health and Human Services for emergency preparedness and response policy coordination and strategic direction;
“(A) the National Disaster Medical System pursuant to section 2812;
“(B) the Hospital Preparedness Cooperative Agreement Program pursuant to section 319C–2;
“(C) the Biomedical Advanced Research and Development Authority pursuant to section 319L;
“(D) the Medical Reserve Corps pursuant to section 2813;
“(E) the Emergency System for Advance Registration of Volunteer Health Professionals pursuant to section 319I; and
“(F) administering grants and related authorities related to trauma care under parts A through C of title XII, such authority to be transferred by the Secretary from the Administrator of the Health Resources and Services Administration to such Assistant Secretary;
“(3) exercise the responsibilities and authorities of the Secretary with respect to the coordination of—
“(A) the Public Health Emergency Preparedness Cooperative Agreement Program pursuant to section 319C–1;
“(B) the Strategic National Stockpile pursuant to section 319F–2; and
“(C) the Cities Readiness Initiative; and
“(4) assume other duties as determined appropriate by the Secretary.”; and
(3) by adding at the end the following:
“(1) IN GENERAL.—Not later than 180 days after the date of enactment of this subsection, and every year thereafter, the Assistant Secretary for Preparedness and Response shall develop and submit to the appropriate committees of Congress a coordinated strategy and accompanying implementation plan for medical countermeasures to address chemical, biological, radiological, and nuclear threats. In developing such a plan, the Assistant Secretary for Preparedness and Response shall consult with the Director of the Biomedical Advanced Research and Development Authority, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of Food and Drugs. Such strategy and plan shall be known as the ‘Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan’.
“(A) describe the chemical, biological, radiological, and nuclear agent or agents that may present a threat to the Nation and the corresponding efforts to develop qualified countermeasures (as defined in section 319F–1), security countermeasures (as defined in section 319F–2), or qualified pandemic or epidemic products (as defined in section 319F–3) for each threat;
“(B) evaluate the progress of all activities with respect to such countermeasures or products, including research, advanced research, development, procurement, stockpiling, deployment, distribution, and utilization;
“(C) identify and prioritize near-, mid-, and long-term needs with respect to such countermeasures or products to address a chemical, biological, radiological, and nuclear threat or threats;
“(D) identify, with respect to each category of threat, a summary of all awards and contracts, including advanced research and development and procurement, that includes—
“(i) the time elapsed from the issuance of the initial solicitation or request for a proposal to the adjudication (such as the award, denial of award, or solicitation termination); and
“(ii) an identification of projected timelines, anticipated funding allocations, benchmarks, and milestones for each medical countermeasure priority under subparagraph (C), including projected needs with regard to replenishment of the Strategic National Stockpile;
“(E) be informed by the recommendations of the National Biodefense Science Board pursuant to section 319M;
“(F) evaluate progress made in meeting timelines, allocations, benchmarks, and milestones identified under subparagraph (D)(ii);
“(G) report on the amount of funds available for procurement in the special reserve fund as defined in section 319F–2(h) and the impact this funding will have on meeting the requirements under section 319F–2;
“(H) incorporate input from Federal, State, local, and tribal stakeholders;
“(I) identify the progress made in meeting the medical countermeasure priorities for at-risk individuals (as defined in 2802(b)(4)(B)), as applicable under subparagraph (C), including with regard to the projected needs for related stockpiling and replenishment of the Strategic National Stockpile, including by addressing the needs of pediatric populations with respect to such countermeasures and products in the Strategic National Stockpile, including—
“(i) a list of such countermeasures and products necessary to address the needs of pediatric populations;
“(ii) a description of measures taken to coordinate with the Office of Pediatric Therapeutics of the Food and Drug Administration to maximize the labeling, dosages, and formulations of such countermeasures and products for pediatric populations;
“(iii) a description of existing gaps in the Strategic National Stockpile and the development of such countermeasures and products to address the needs of pediatric populations; and
“(iv) an evaluation of the progress made in addressing priorities identified pursuant to subparagraph (C);
“(J) identify the use of authority and activities undertaken pursuant to sections 319F–1(b)(1), 319F–1(b)(2), 319F–1(b)(3), 319F–1(c), 319F–1(d), 319F–1(e), 319F–2(c)(7)(C)(iii), 319F–2(c)(7)(C)(iv), and 319F–2(c)(7)(C)(v) of this Act, and subsections (a)(1), (b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act, by summarizing—
“(i) the particular actions that were taken under the authorities specified, including, as applicable, the identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the authority was used;
“(ii) the reasons underlying the decision to use such authorities, including, as applicable, the options that were considered and rejected with respect to the use of such authorities;
“(iii) the number of, nature of, and other information concerning the persons and entities that received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and entities that were considered and rejected for such a grant, cooperative agreement, or contract, except that the report need not disclose the identity of any such person or entity;
“(iv) whether, with respect to each procurement that is approved by the President under section 319F–2(c)(6), a contract was entered into within one year after such approval by the President; and
“(v) with respect to section 319F–1(d), for the one-year period for which the report is submitted, the number of persons who were paid amounts totaling $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less than $100,000; and
“(K) be made publicly available.
“(A) IN GENERAL.—Not later than 1 year after the date of the submission to the Congress of the first Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of Congress a report, concerning such Strategy and Implementation Plan.
“(i) the near-term, mid-term, and long-term medical countermeasure needs and identified priorities of the Federal Government pursuant to paragraph (2)(C);
“(ii) the activities of the Department of Health and Human Services with respect to advanced research and development pursuant to section 319L; and
“(iii) the progress made toward meeting the timelines, allocations, benchmarks, and milestones identified in the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan under this subsection.
“(e) Protection Of National Security.—In carrying out subsections (b)(7) and (d), the Secretary shall ensure that information and items that could compromise national security, contain confidential commercial information, or contain proprietary information are not disclosed.”.
(b) Interagency Coordination Plan.—In the first Public Health Emergency Countermeasures Enterprise Strategy and Implementation Plan submitted under subsection (d) of section 2811 of the Public Health Service Act (42 U.S.C. 300hh–10) (as added by subsection (a)(3)), the Secretary of Health and Human Services, in consultation with the Secretary of Defense, shall include a description of the manner in which the Department of Health and Human Services is coordinating with the Department of Defense regarding countermeasure activities to address chemical, biological, radiological, and nuclear threats. Such report shall include information with respect to—
(1) the research, advanced research, development, procurement, stockpiling, and distribution of countermeasures to meet identified needs; and
(2) the coordination of efforts between the Department of Health and Human Services and the Department of Defense to address countermeasure needs for various segments of the population.
Subtitle B of title XXVIII of the Public Health Service Act (42 U.S.C. 300hh et seq.) is amended by inserting after section 2811 the following:
“(a) Establishment.—The Secretary, in consultation with the Secretary of Homeland Security, shall establish an advisory committee to be known as the ‘National Advisory Committee on Children and Disasters’ (referred to in this section as the ‘Advisory Committee’).
“(1) provide advice and consultation with respect to the activities carried out pursuant to section 2814, as applicable and appropriate;
“(2) evaluate and provide input with respect to the medical and public health needs of children as they relate to preparation for, response to, and recovery from all-hazards emergencies; and
“(3) provide advice and consultation with respect to State emergency preparedness and response activities and children, including related drills and exercises pursuant to the preparedness goals under section 2802(b).
“(c) Additional Duties.—The Advisory Committee may provide advice and recommendations to the Secretary with respect to children and the medical and public health grants and cooperative agreements as applicable to preparedness and response activities authorized under this title and title III.
“(1) IN GENERAL.—The Secretary, in consultation with such other Secretaries as may be appropriate, shall appoint not to exceed 15 members to the Advisory Committee. In appointing such members, the Secretary shall ensure that the total membership of the Advisory Committee is an odd number.
“(2) REQUIRED MEMBERS.—The Secretary, in consultation with such other Secretaries as may be appropriate, may appoint to the Advisory Committee under paragraph (1) such individuals as may be appropriate to perform the duties described in subsections (b) and (c), which may include—
“(A) the Assistant Secretary for Preparedness and Response;
“(B) the Director of the Biomedical Advanced Research and Development Authority;
“(C) the Director of the Centers for Disease Control and Prevention;
“(D) the Commissioner of Food and Drugs;
“(E) the Director of the National Institutes of Health;
“(F) the Assistant Secretary of the Administration for Children and Families;
“(G) the Administrator of the Federal Emergency Management Agency;
“(H) at least two non-Federal health care professionals with expertise in pediatric medical disaster planning, preparedness, response, or recovery;
“(I) at least two representatives from State, local, territorial, or tribal agencies with expertise in pediatric disaster planning, preparedness, response, or recovery; and
“(J) representatives from such Federal agencies (such as the Department of Education and the Department of Homeland Security) as determined necessary to fulfill the duties of the Advisory Committee, as established under subsections (b) and (c).
“(e) Meetings.—The Advisory Committee shall meet not less than biannually.
“(f) Sunset.—The Advisory Committee shall terminate on September 30, 2018.”.
Section 2812 of the Public Health Service Act (42 U.S.C. 300hh–11) is amended—
(1) in subsection (a)(3)—
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