Version	Word Count	Changes From Previous Version	Percent Change
Introduced in House	16,365	n/a	n/a
Engrossed in House	15,907	3	1%
Referred in Senate	16,288	5	0%
Reported in Senate	31,882	118	8%
Engrossed Amendment Senate	16,252	14	55%
Enrolled Bill	15,573	12 Show Changes Hide Changes	1%

Display Version Introduced in House Engrossed in House Referred in Senate Reported in Senate Engrossed Amendment Senate Enrolled Bill

HR 307 EAS

In the Senate of the United States,

February 27, 2013.

Resolved, That the bill from the House of Representatives (H.R.307CommentsClose CommentsPermalink

) entitled ‘An Act t One Hundred Thirteenth Congress CommentsClose CommentsPermalink

CommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

’, do pass with the following

AMENDMENT:

Strike out all after the enacting clause and insert:

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.CommentsClose CommentsPermalink

(a) Short Title- This Act may be cited as the ‘Pandemic and All-Hazards Preparedness Reauthorization Act of 2013’.CommentsClose CommentsPermalink





(b) Table of Contents- The table of contents of this Act is as follows:CommentsClose CommentsPermalink





Sec. 1. Short title; table of contents.CommentsClose CommentsPermalink

TITLE I--STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC HEALTH EMERGENCIES

Sec. 101. National Health Security Strategy.CommentsClose CommentsPermalink





Sec. 102. Assistant Secretary for Preparedness and Response.CommentsClose CommentsPermalink





Sec. 103. National Advisory Committee on Children and Disasters.CommentsClose CommentsPermalink





Sec. 104. Modernization of the National Disaster Medical System.CommentsClose CommentsPermalink





Sec. 105. Continuing the role of the Department of Veterans Affairs.CommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink





Sec. 202. Improving State and local public health security.CommentsClose CommentsPermalink





Sec. 203. Hospital preparedness and medical surge capacity.CommentsClose CommentsPermalink





Sec. 204. Enhancing situational awareness and biosurveillance.CommentsClose CommentsPermalink





Sec. 205. Eliminating duplicative Project Bioshield reports.CommentsClose CommentsPermalink

TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW

Sec. 301. Special protocol assessment.CommentsClose CommentsPermalink





Sec. 302. Authorization for medical products for use in emergencies.CommentsClose CommentsPermalink





Sec. 303. Definitions.CommentsClose CommentsPermalink





Sec. 304. Enhancing medical countermeasure activities.CommentsClose CommentsPermalink





Sec. 305. Regulatory management plans.CommentsClose CommentsPermalink





Sec. 306. Report.CommentsClose CommentsPermalink





Sec. 307. Pediatric medical countermeasures.CommentsClose CommentsPermalink

TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND DEVELOPMENT

Sec. 401. BioShield.CommentsClose CommentsPermalink





Sec. 402. Biomedical Advanced Research and Development Authority.CommentsClose CommentsPermalink





Sec. 403. Strategic National Stockpile.CommentsClose CommentsPermalink





Sec. 404. National Biodefense Science Board.CommentsClose CommentsPermalink

TITLE I--STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC HEALTH EMERGENCIESCommentsClose CommentsPermalink

SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.CommentsClose CommentsPermalink

(a) In General- Section 2802 of the Public Health Service Act (42 U.S.C. 300hh-1) is amended--CommentsClose CommentsPermalink





(1) in subsection (a)(1), by striking ‘2009’ and inserting ‘2014’; andCommentsClose CommentsPermalink





(2) in subsection (b)--CommentsClose CommentsPermalink





(A) in paragraph (1)(A), by inserting ‘, including drills and exercises to ensure medical surge capacity for events without notice’ after ‘exercises’; andCommentsClose CommentsPermalink





(B) in paragraph (3)--CommentsClose CommentsPermalink





(i) in the matter preceding subparagraph (A)--CommentsClose CommentsPermalink





(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,’; andCommentsClose CommentsPermalink





(II) by inserting ‘(including related availability, accessibility, and coordination)’ after ‘public health emergencies’;CommentsClose CommentsPermalink





(ii) in subparagraph (A), by inserting ‘and trauma’ after ‘medical’;CommentsClose CommentsPermalink





(iii) in subparagraph (B), by striking ‘Medical evacuation and fatality management’ and inserting ‘Fatality management’;CommentsClose CommentsPermalink





(iv) by redesignating subparagraphs (C), (D), and (E) as subparagraphs (D), (E), and (F), respectively;CommentsClose CommentsPermalink





(v) by inserting after subparagraph (B), the following the new subparagraph:CommentsClose CommentsPermalink





‘(C) Coordinated medical triage and evacuation to appropriate medical institutions based on patient medical need, taking into account regionalized systems of care.’;CommentsClose CommentsPermalink





(vi) in subparagraph (E), as redesignated by clause (iv), by inserting ‘(which may include such dental health assets)’ after ‘medical assets’; andCommentsClose CommentsPermalink





(vii) by adding at the end the following:CommentsClose CommentsPermalink





‘(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.’;CommentsClose CommentsPermalink





(C) in paragraph (4)--CommentsClose CommentsPermalink





(i) in subparagraph (A), by inserting ‘, including the unique needs and considerations of individuals with disabilities,’ after ‘medical needs of at-risk individuals’; andCommentsClose CommentsPermalink





(ii) in subparagraph (B), by inserting ‘the’ before ‘purpose of this section’; andCommentsClose CommentsPermalink





(D) by adding at the end the following:CommentsClose CommentsPermalink





‘(7) COUNTERMEASURES-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) optimizing alignment and integration of medical and public health preparedness and response planning and capabilities with and into routine daily activities; andCommentsClose CommentsPermalink





‘(B) promoting familiarity with local medical and public health systems.’.CommentsClose CommentsPermalink





(b) At-Risk Individuals- Section 2814 of the Public Health Service Act (42 U.S.C. 300hh-16) is amended--CommentsClose CommentsPermalink





(1) by striking paragraphs (5), (7), and (8);CommentsClose CommentsPermalink





(2) in paragraph (4), by striking ‘2811(b)(3)(B)’ and inserting ‘2802(b)(4)(B)’;CommentsClose CommentsPermalink





(3) by redesignating paragraphs (1) through (4) as paragraphs (2) through (5), respectively;CommentsClose CommentsPermalink





(4) by inserting before paragraph (2) (as so redesignated), the following:CommentsClose CommentsPermalink





‘(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;’;CommentsClose CommentsPermalink





(5) by amending paragraph (2) (as so redesignated) to read as follows:CommentsClose CommentsPermalink





‘(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);’; andCommentsClose CommentsPermalink





(6) by inserting after paragraph (6), the following:CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink

SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.CommentsClose CommentsPermalink

(a) In General- Section 2811 of the Public Health Service Act (42 U.S.C. 300hh-10) is amended--CommentsClose CommentsPermalink





(1) in subsection (b)--CommentsClose CommentsPermalink





(A) in paragraph (3), by inserting ‘, security countermeasures (as defined in section 319F-2),’ after ‘qualified countermeasures (as defined in section 319F-1)’;CommentsClose CommentsPermalink





(B) in paragraph (4), by adding at the end the following:CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) optimize and streamline medical and public health preparedness and response capabilities and the ability of local communities to respond to public health emergencies; andCommentsClose CommentsPermalink





‘(ii) gather and disseminate best practices among grant and cooperative agreement recipients, as appropriate.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) identified threats for which countermeasures are available and for which no countermeasures are available; andCommentsClose CommentsPermalink





‘(ii) unknown threats for which no countermeasures are available.CommentsClose CommentsPermalink





‘(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.’; andCommentsClose CommentsPermalink





(C) by adding at the end the following:CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) include consideration of the entire medical countermeasures enterprise, including--CommentsClose CommentsPermalink





‘(i) basic research and advanced research and development;CommentsClose CommentsPermalink





‘(ii) approval, clearance, licensure, and authorized uses of products; andCommentsClose CommentsPermalink





‘(iii) procurement, stockpiling, maintenance, and replenishment of all products in the Strategic National Stockpile;CommentsClose CommentsPermalink





‘(B) inform prioritization of resources and include measurable outputs and outcomes to allow for the tracking of the progress made toward identified priorities;CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(D) be made available to the appropriate committees of Congress upon request.’;CommentsClose CommentsPermalink





(2) by striking subsection (c) and inserting the following:CommentsClose CommentsPermalink





‘(c) Functions- The Assistant Secretary for Preparedness and Response shall--CommentsClose CommentsPermalink





‘(1) have lead responsibility within the Department of Health and Human Services for emergency preparedness and response policy coordination and strategic direction;CommentsClose CommentsPermalink





‘(2) have authority over and responsibility for--CommentsClose CommentsPermalink





‘(A) the National Disaster Medical System pursuant to section 2812;CommentsClose CommentsPermalink





‘(B) the Hospital Preparedness Cooperative Agreement Program pursuant to section 319C-2;CommentsClose CommentsPermalink





‘(C) the Biomedical Advanced Research and Development Authority pursuant to section 319L;CommentsClose CommentsPermalink





‘(D) the Medical Reserve Corps pursuant to section 2813;CommentsClose CommentsPermalink





‘(E) the Emergency System for Advance Registration of Volunteer Health Professionals pursuant to section 319I; andCommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(3) exercise the responsibilities and authorities of the Secretary with respect to the coordination of--CommentsClose CommentsPermalink





‘(A) the Public Health Emergency Preparedness Cooperative Agreement Program pursuant to section 319C-1;CommentsClose CommentsPermalink





‘(B) the Strategic National Stockpile pursuant to section 319F-2; andCommentsClose CommentsPermalink





‘(C) the Cities Readiness Initiative; andCommentsClose CommentsPermalink





‘(4) assume other duties as determined appropriate by the Secretary.’; andCommentsClose CommentsPermalink





(3) by adding at the end the following:CommentsClose CommentsPermalink





‘(d) Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan-CommentsClose CommentsPermalink





‘(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’.CommentsClose CommentsPermalink





‘(2) REQUIREMENTS- The plan under paragraph (1) shall--CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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); andCommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(E) be informed by the recommendations of the National Biodefense Science Board pursuant to section 319M;CommentsClose CommentsPermalink





‘(F) evaluate progress made in meeting timelines, allocations, benchmarks, and milestones identified under subparagraph (D)(ii);CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(H) incorporate input from Federal, State, local, and tribal stakeholders;CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) a list of such countermeasures and products necessary to address the needs of pediatric populations;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(iv) an evaluation of the progress made in addressing priorities identified pursuant to subparagraph (C);CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(K) be made publicly available.CommentsClose CommentsPermalink





‘(3) GAO REPORT-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) CONTENT- The report described in subparagraph (A) shall review and assess--CommentsClose CommentsPermalink





‘(i) the near-term, mid-term, and long-term medical countermeasure needs and identified priorities of the Federal Government pursuant to paragraph (2)(C);CommentsClose CommentsPermalink





‘(ii) the activities of the Department of Health and Human Services with respect to advanced research and development pursuant to section 319L; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(1) the research, advanced research, development, procurement, stockpiling, and distribution of countermeasures to meet identified needs; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

SEC. 103. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND DISASTERS.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

‘SEC. 2811A. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND DISASTERS.CommentsClose CommentsPermalink

‘(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’).CommentsClose CommentsPermalink





‘(b) Duties- The Advisory Committee shall--CommentsClose CommentsPermalink





‘(1) provide advice and consultation with respect to the activities carried out pursuant to section 2814, as applicable and appropriate;CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(d) Membership-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) the Assistant Secretary for Preparedness and Response;CommentsClose CommentsPermalink





‘(B) the Director of the Biomedical Advanced Research and Development Authority;CommentsClose CommentsPermalink





‘(C) the Director of the Centers for Disease Control and Prevention;CommentsClose CommentsPermalink





‘(D) the Commissioner of Food and Drugs;CommentsClose CommentsPermalink





‘(E) the Director of the National Institutes of Health;CommentsClose CommentsPermalink





‘(F) the Assistant Secretary of the Administration for Children and Families;CommentsClose CommentsPermalink





‘(G) the Administrator of the Federal Emergency Management Agency;CommentsClose CommentsPermalink





‘(H) at least two non-Federal health care professionals with expertise in pediatric medical disaster planning, preparedness, response, or recovery;CommentsClose CommentsPermalink





‘(I) at least two representatives from State, local, territorial, or tribal agencies with expertise in pediatric disaster planning, preparedness, response, or recovery; andCommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(e) Meetings- The Advisory Committee shall meet not less than biannually.CommentsClose CommentsPermalink





‘(f) Sunset- The Advisory Committee shall terminate on September 30, 2018.’.CommentsClose CommentsPermalink

SEC. 104. MODERNIZATION OF THE NATIONAL DISASTER MEDICAL SYSTEM.CommentsClose CommentsPermalink

Section 2812 of the Public Health Service Act (42 U.S.C. 300hh-11) is amended--CommentsClose CommentsPermalink





(1) in subsection (a)(3)--CommentsClose CommentsPermalink





(A) in subparagraph (A), in clause (i) by inserting ‘, including at-risk individuals as applicable’ after ‘victims of a public health emergency’;CommentsClose CommentsPermalink





(B) by redesignating subparagraph (C) as subparagraph (E); andCommentsClose CommentsPermalink





(C) by inserting after subparagraph (B), the following:CommentsClose CommentsPermalink





‘(C) CONSIDERATIONS FOR AT-RISK POPULATIONS- The Secretary shall take steps to ensure that an appropriate specialized and focused range of public health and medical capabilities are represented in the National Disaster Medical System, which take into account the needs of at-risk individuals, in the event of a public health emergency.’.CommentsClose CommentsPermalink





‘(D) ADMINISTRATION- The Secretary may determine and pay claims for reimbursement for services under subparagraph (A) directly or through contracts that provide for payment in advance or by way of reimbursement.’; andCommentsClose CommentsPermalink





(2) in subsection (g), by striking ‘such sums as may be necessary for each of the fiscal years 2007 through 2011’ and inserting ‘$52,700,000 for each of fiscal years 2014 through 2018’.CommentsClose CommentsPermalink

SEC. 105. CONTINUING THE ROLE OF THE DEPARTMENT OF VETERANS AFFAIRS.CommentsClose CommentsPermalink

Section 8117(g) of title 38, United States Code, is amended by striking ‘such sums as may be necessary to carry out this section for each of fiscal years 2007 through 2011’ and inserting ‘$155,300,000 for each of fiscal years 2014 through 2018 to carry out this section’.CommentsClose CommentsPermalink

TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND RESPONSECommentsClose CommentsPermalink

SEC. 201. TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL DURING A PUBLIC HEALTH EMERGENCY.CommentsClose CommentsPermalink

Section 319 of the Public Health Service Act (42 U.S.C. 247d) is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(e) Temporary Reassignment of State and Local Personnel During a Public Health Emergency-CommentsClose CommentsPermalink





‘(1) EMERGENCY REASSIGNMENT OF FEDERALLY FUNDED PERSONNEL- Notwithstanding any other provision of law, and subject to paragraph (2), upon request by the Governor of a State or a tribal organization or such Governor or tribal organization’s designee, the Secretary may authorize the requesting State or Indian tribe to temporarily reassign, for purposes of immediately addressing a public health emergency in the State or Indian tribe, State and local public health department or agency personnel funded in whole or in part through programs authorized under this Act, as appropriate.CommentsClose CommentsPermalink





‘(2) ACTIVATION OF EMERGENCY REASSIGNMENT-CommentsClose CommentsPermalink





‘(A) PUBLIC HEALTH EMERGENCY- The Secretary may authorize a temporary reassignment of personnel under paragraph (1) only during the period of a public health emergency determined pursuant to subsection (a).CommentsClose CommentsPermalink





‘(B) CONTENTS OF REQUEST- To seek authority for a temporary reassignment of personnel under paragraph (1), the Governor of a State or a tribal organization shall submit to the Secretary a request for such reassignment flexibility and shall include in the request each of the following:CommentsClose CommentsPermalink





‘(i) An assurance that the public health emergency in the geographic area of the requesting State or Indian tribe cannot be adequately and appropriately addressed by the public health workforce otherwise available.CommentsClose CommentsPermalink





‘(ii) An assurance that the public health emergency would be addressed more efficiently and effectively through the requested temporary reassignment of State and local personnel described in paragraph (1).CommentsClose CommentsPermalink





‘(iii) An assurance that the requested temporary reassignment of personnel is consistent with any applicable All-Hazards Public Health Emergency Preparedness and Response Plan under section 319C-1.CommentsClose CommentsPermalink





‘(iv) An identification of--CommentsClose CommentsPermalink





‘(I) each Federal program from which personnel would be temporarily reassigned pursuant to the requested authority; andCommentsClose CommentsPermalink





‘(II) the number of personnel who would be so reassigned from each such program.CommentsClose CommentsPermalink





‘(v) Such other information and assurances upon which the Secretary and Governor of a State or tribal organization agree.CommentsClose CommentsPermalink





‘(C) CONSIDERATION- In reviewing a request for temporary reassignment under paragraph (1), the Secretary shall consider the degree to which the program or programs funded in whole or in part by programs authorized under this Act would be adversely affected by the reassignment.CommentsClose CommentsPermalink





‘(D) TERMINATION AND EXTENSION-CommentsClose CommentsPermalink





‘(i) TERMINATION- A State or Indian tribe’s temporary reassignment of personnel under paragraph (1) shall terminate upon the earlier of the following:CommentsClose CommentsPermalink





‘(I) The Secretary’s determination that the public health emergency no longer exists.CommentsClose CommentsPermalink





‘(II) Subject to clause (ii), the expiration of the 30-day period following the date on which the Secretary approved the State or Indian tribe’s request for such reassignment flexibility.CommentsClose CommentsPermalink





‘(ii) EXTENSION OF REASSIGNMENT FLEXIBILITY- The Secretary may extend reassignment flexibility of personnel under paragraph (1) beyond the date otherwise applicable under clause (i)(II) if the public health emergency still exists as of such date, but only if--CommentsClose CommentsPermalink





‘(I) the State or Indian tribe that submitted the initial request for a temporary reassignment of personnel submits a request for an extension of such temporary reassignment; andCommentsClose CommentsPermalink





‘(II) the request for an extension contains the same information and assurances necessary for the approval of an initial request for such temporary reassignment pursuant to subparagraph (B).CommentsClose CommentsPermalink





‘(3) VOLUNTARY NATURE OF TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Unless otherwise provided under the law or regulation of the State or Indian tribe that receives authorization for temporary reassignment of personnel under paragraph (1), personnel eligible for reassignment pursuant to such authorization--CommentsClose CommentsPermalink





‘(i) shall have the opportunity to volunteer for temporary reassignment; andCommentsClose CommentsPermalink





‘(ii) shall not be required to agree to a temporary reassignment.CommentsClose CommentsPermalink





‘(B) PROHIBITION ON CONDITIONING FEDERAL AWARDS- The Secretary may not condition the award of a grant, contract, or cooperative agreement under this Act on the requirement that a State or Indian tribe require that personnel eligible for reassignment pursuant to an authorization under paragraph (1) agree to such reassignment.CommentsClose CommentsPermalink





‘(4) NOTICE TO CONGRESS- The Secretary shall give notice to the Congress in conjunction with the approval under this subsection of--CommentsClose CommentsPermalink





‘(A) any initial request for temporary reassignment of personnel; andCommentsClose CommentsPermalink





‘(B) any request for an extension of such temporary reassignment.CommentsClose CommentsPermalink





‘(5) GUIDANCE- The Secretary shall--CommentsClose CommentsPermalink





‘(A) not later than 6 months after the enactment of this subsection, issue proposed guidance on the temporary reassignment of personnel under this subsection; andCommentsClose CommentsPermalink





‘(B) after providing notice and a 60-day period for public comment, finalize such guidance.CommentsClose CommentsPermalink





‘(6) REPORT TO CONGRESS- Not later than 4 years after the date of enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of the Congress a report, on temporary reassignment under this subsection, including--CommentsClose CommentsPermalink





‘(A) a description of how, and under what circumstances, such temporary reassignment has been used by States and Indian tribes;CommentsClose CommentsPermalink





‘(B) an analysis of how such temporary reassignment has assisted States and Indian tribes in responding to public health emergencies;CommentsClose CommentsPermalink





‘(C) an evaluation of how such temporary reassignment has improved operational efficiencies in responding to public health emergencies;CommentsClose CommentsPermalink





‘(D) an analysis of the extent to which, if any, Federal programs from which personnel have been temporarily reassigned have been adversely affected by the reassignment; andCommentsClose CommentsPermalink





‘(E) recommendations on how medical surge capacity could be improved in responding to public health emergencies and the impact of the reassignment flexibility under this section on such surge capacity.CommentsClose CommentsPermalink





‘(7) DEFINITIONS- In this subsection--CommentsClose CommentsPermalink





‘(A) the terms ‘Indian tribe’ and ‘tribal organization’ have the meanings given such terms in section 4 of the Indian Self-Determination and Education Assistance Act; andCommentsClose CommentsPermalink





‘(B) the term ‘State’ includes, in addition to the entities listed in the definition of such term in section 2, the Freely Associated States.CommentsClose CommentsPermalink





‘(8) SUNSET- This subsection shall terminate on September 30, 2018.’.CommentsClose CommentsPermalink

SEC. 202. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.CommentsClose CommentsPermalink

(a) Cooperative Agreements- Section 319C-1 of the Public Health Service Act (42 U.S.C. 247d-3a) is amended--CommentsClose CommentsPermalink





(1) in subsection (b)(1)(C), by striking ‘consortium of entities described in subparagraph (A)’ and inserting ‘consortium of States’;CommentsClose CommentsPermalink





(2) in subsection (b)(2)--CommentsClose CommentsPermalink





(A) in subparagraph (A)--CommentsClose CommentsPermalink





(i) by striking clauses (i) and (ii) and inserting the following:CommentsClose CommentsPermalink





‘(i) a description of the activities such entity will carry out under the agreement to meet the goals identified under section 2802, including with respect to chemical, biological, radiological, or nuclear threats, whether naturally occurring, unintentional, or deliberate;CommentsClose CommentsPermalink





‘(ii) a description of the activities such entity will carry out with respect to pandemic influenza, as a component of the activities carried out under clause (i), and consistent with the requirements of paragraphs (2) and (5) of subsection (g);’;CommentsClose CommentsPermalink





(ii) in clause (iv), by striking ‘and’ at the end; andCommentsClose CommentsPermalink





(iii) by adding at the end the following:CommentsClose CommentsPermalink





‘(vi) a description of how, as appropriate, the entity may partner with relevant public and private stakeholders in public health emergency preparedness and response;CommentsClose CommentsPermalink





‘(vii) a description of how the entity, as applicable and appropriate, will coordinate with State emergency preparedness and response plans in public health emergency preparedness, including State educational agencies (as defined in section 9101(41) of the Elementary and Secondary Education Act of 1965) and State child care lead agencies (designated under section 658D of the Child Care and Development Block Grant Act of 1990);CommentsClose CommentsPermalink





‘(viii) in the case of entities that operate on the United States-Mexico border or the United States-Canada border, a description of the activities such entity will carry out under the agreement that are specific to the border area including disease detection, identification, investigation, and preparedness and response activities related to emerging diseases and infectious disease outbreaks whether naturally occurring or due to bioterrorism, consistent with the requirements of this section; andCommentsClose CommentsPermalink





‘(ix) a description of any activities that such entity will use to analyze real-time clinical specimens for pathogens of public health or bioterrorism significance, including any utilization of poison control centers;’; andCommentsClose CommentsPermalink





(B) in subparagraph (C), by inserting ‘, including addressing the needs of at-risk individuals,’ after ‘capabilities of such entity’;CommentsClose CommentsPermalink





(3) in subsection (f)--CommentsClose CommentsPermalink





(A) in paragraph (2), by adding ‘and’ at the end;CommentsClose CommentsPermalink





(B) in paragraph (3), by striking ‘; and’ and inserting a period; andCommentsClose CommentsPermalink





(C) by striking paragraph (4);CommentsClose CommentsPermalink





(4) in subsection (g)--CommentsClose CommentsPermalink





(A) in paragraph (1), by striking subparagraph (A) and inserting the following:CommentsClose CommentsPermalink





‘(A) include outcome goals representing operational achievements of the National Preparedness Goals developed under section 2802(b) with respect to all-hazards, including chemical, biological, radiological, or nuclear threats; and’; andCommentsClose CommentsPermalink





(B) in paragraph (2)(A), by adding at the end the following: ‘The Secretary shall periodically update, as necessary and appropriate, such pandemic influenza plan criteria and shall require the integration of such criteria into the benchmarks and standards described in paragraph (1).’;CommentsClose CommentsPermalink





(5) by striking subsection (h);CommentsClose CommentsPermalink





(6) by redesignating subsections (i), (j), and (k) as subsections (h), (i), and (j), respectively;CommentsClose CommentsPermalink





(7) in subsection (h), as so redesignated--CommentsClose CommentsPermalink





(A) in paragraph (1)--CommentsClose CommentsPermalink





(i) in subparagraph (A)--CommentsClose CommentsPermalink





(I) by striking ‘$824,000,000 for fiscal year 2007, of which $35,000,000 shall be used to carry out subsection (h),’ and inserting ‘$641,900,000 for fiscal year 2014’; andCommentsClose CommentsPermalink





(II) by striking ‘such sums as may be necessary for each of fiscal years 2008 through 2011’ and inserting ‘$641,900,000 for each of fiscal years 2015 through 2018’;CommentsClose CommentsPermalink





(ii) by striking subparagraph (B);CommentsClose CommentsPermalink





(iii) by redesignating subparagraphs (C) and (D) as subparagraphs (B) and (C), respectively; andCommentsClose CommentsPermalink





(iv) in subparagraph (C), as so redesignated, by striking ‘subparagraph (C)’ and inserting ‘subparagraph (B)’;CommentsClose CommentsPermalink





(B) in subparagraphs (C) and (D) of paragraph (3), by striking ‘(1)(A)(i)(I)’ each place it appears and inserting ‘(1)(A)’;CommentsClose CommentsPermalink





(C) in paragraph (4)(B), by striking ‘subsection (c)’ and inserting ‘subsection (b)’; andCommentsClose CommentsPermalink





(D) by adding at the end the following:CommentsClose CommentsPermalink





‘(7) AVAILABILITY OF COOPERATIVE AGREEMENT FUNDS-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Amounts provided to an eligible entity under a cooperative agreement under subsection (a) for a fiscal year and remaining unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such funds were provided.CommentsClose CommentsPermalink





‘(B) FUNDS CONTINGENT ON ACHIEVING BENCHMARKS- The continued availability of funds under subparagraph (A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the pandemic influenza plan as described in subsection (g).’; andCommentsClose CommentsPermalink





(8) in subsection (i), as so redesignated--CommentsClose CommentsPermalink





(A) in paragraph (1)(E), by striking ‘subsection (k)’ and inserting ‘subsection (j)’;CommentsClose CommentsPermalink





(B) by striking paragraph (3).CommentsClose CommentsPermalink





(b) Vaccine Tracking and Distribution- Section 319A(e) of the Public Health Service Act (42 U.S.C. 247d-1(e)) is amended by striking ‘such sums for each of fiscal years 2007 through 2011’ and inserting ‘$30,800,000 for each of fiscal years 2014 through 2018’.CommentsClose CommentsPermalink





(c) Technical and Conforming Amendments-CommentsClose CommentsPermalink





(1) Section 319C-1(b)(1)(B) of the Public Health Service Act (42 U.S.C. 247d-3a(b)(1)(B)) is amended by striking ‘subsection (i)(4)’ and inserting ‘subsection (h)(4)’.CommentsClose CommentsPermalink





(2) Section 319C-2 of the Public Health Service Act (42 U.S.C. 247d-3b) is amended--CommentsClose CommentsPermalink





(A) in subsection (i), by striking ‘(j), and (k)’ and inserting ‘(i), and (j)’; andCommentsClose CommentsPermalink





(B) in subsection (j)(3), by striking ‘319C-1(i)’ and inserting ‘319C-1(h)’.CommentsClose CommentsPermalink

SEC. 203. HOSPITAL PREPAREDNESS AND MEDICAL SURGE CAPACITY.CommentsClose CommentsPermalink

(a) All-Hazards Public Health and Medical Response Curricula and Training- Section 319F(a)(5)(B) of the Public Health Service Act (42 U.S.C. 247d-6(a)(5)(B)) is amended by striking ‘public health or medical’ and inserting ‘public health, medical, or dental’.CommentsClose CommentsPermalink





(b) Encouraging Health Professional Volunteers-CommentsClose CommentsPermalink





(1) EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF VOLUNTEER HEALTH PROFESSIONALS- Section 319I(k) of the Public Health Service Act (42 U.S.C. 247d-7b(k)) is amended by striking ‘$2,000,000 for fiscal year 2002, and such sums as may be necessary for each of the fiscal years 2003 through 2011’ and inserting ‘$5,000,000 for each of fiscal years 2014 through 2018’.CommentsClose CommentsPermalink





(2) VOLUNTEERS- Section 2813 of the Public Health Service Act (42 U.S.C. 300hh-15) is amended--CommentsClose CommentsPermalink





(A) in subsection (d)(2), by adding at the end the following: ‘Such training exercises shall, as appropriate and applicable, incorporate the needs of at-risk individuals in the event of a public health emergency.’; andCommentsClose CommentsPermalink





(B) in subsection (i), by striking ‘$22,000,000 for fiscal year 2007, and such sums as may be necessary for each of fiscal years 2008 through 2011’ and inserting ‘$11,200,000 for each of fiscal years 2014 through 2018’.CommentsClose CommentsPermalink





(c) Partnerships for State and Regional Preparedness To Improve Surge Capacity- Section 319C-2 of the Public Health Service Act (42 U.S.C. 247d-3b) is amended--CommentsClose CommentsPermalink





(1) in subsection (a), by inserting ‘, including, as appropriate, capacity and preparedness to address the needs of children and other at-risk individuals’ before the period at the end;CommentsClose CommentsPermalink





(2) in subsection (b)(1)(A)(ii), by striking ‘centers, primary’ and inserting ‘centers, community health centers, primary’;CommentsClose CommentsPermalink





(3) by striking subsection (c) and inserting the following:CommentsClose CommentsPermalink





‘(c) Use of Funds- An award under subsection (a) shall be expended for activities to achieve the preparedness goals described under paragraphs (1), (3), (4), (5), and (6) of section 2802(b) with respect to all-hazards, including chemical, biological, radiological, or nuclear threats.’;CommentsClose CommentsPermalink





(4) by striking subsection (g) and inserting the following:CommentsClose CommentsPermalink





‘(g) Coordination-CommentsClose CommentsPermalink





‘(1) LOCAL RESPONSE CAPABILITIES- An eligible entity shall, to the extent practicable, ensure that activities carried out under an award under subsection (a) are coordinated with activities of relevant local Metropolitan Medical Response Systems, local Medical Reserve Corps, the local Cities Readiness Initiative, and local emergency plans.CommentsClose CommentsPermalink





‘(2) NATIONAL COLLABORATION- Partnerships consisting of one or more eligible entities under this section may, to the extent practicable, collaborate with other partnerships consisting of one or more eligible entities under this section for purposes of national coordination and collaboration with respect to activities to achieve the preparedness goals described under paragraphs (1), (3), (4), (5), and (6) of section 2802(b).’;CommentsClose CommentsPermalink





(5) in subsection (i)--CommentsClose CommentsPermalink





(A) by striking ‘The requirements of’ and inserting the following:CommentsClose CommentsPermalink





‘(1) IN GENERAL- The requirements of’; andCommentsClose CommentsPermalink





(B) by adding at the end the following:CommentsClose CommentsPermalink





‘(2) MEETING GOALS OF NATIONAL HEALTH SECURITY STRATEGY- The Secretary shall implement objective, evidence-based metrics to ensure that entities receiving awards under this section are meeting, to the extent practicable, the applicable goals of the National Health Security Strategy under section 2802.’; andCommentsClose CommentsPermalink





(6) in subsection (j)--CommentsClose CommentsPermalink





(A) by amending paragraph (1) to read as follows:CommentsClose CommentsPermalink





‘(1) IN GENERAL- For purposes of carrying out this section, there is authorized to be appropriated $374,700,000 for each of fiscal years 2014 through 2018.’; andCommentsClose CommentsPermalink





(B) by adding at the end the following:CommentsClose CommentsPermalink





‘(4) AVAILABILITY OF COOPERATIVE AGREEMENT FUNDS-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Amounts provided to an eligible entity under a cooperative agreement under subsection (a) for a fiscal year and remaining unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such funds were provided.CommentsClose CommentsPermalink





‘(B) FUNDS CONTINGENT ON ACHIEVING BENCHMARKS- The continued availability of funds under subparagraph (A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the pandemic influenza plan as required under subsection (i).’.CommentsClose CommentsPermalink

SEC. 204. ENHANCING SITUATIONAL AWARENESS AND BIOSURVEILLANCE.CommentsClose CommentsPermalink

(a) In General- Section 319D of the Public Health Service Act (42 U.S.C. 247d-4) is amended--CommentsClose CommentsPermalink





(1) in subsection (b)--CommentsClose CommentsPermalink





(A) in paragraph (1)(B), by inserting ‘poison control centers,’ after ‘hospitals,’;CommentsClose CommentsPermalink





(B) in paragraph (2), by inserting before the period at the end the following: ‘, allowing for coordination to maximize all-hazards medical and public health preparedness and response and to minimize duplication of effort’; andCommentsClose CommentsPermalink





(C) in paragraph (3), by inserting before the period at the end the following: ‘and update such standards as necessary’;CommentsClose CommentsPermalink





(2) by striking subsection (c);CommentsClose CommentsPermalink





(3) by redesignating subsections (d) through (g) as subsections (c) through (f), respectively;CommentsClose CommentsPermalink





(4) in subsection (c), as so redesignated--CommentsClose CommentsPermalink





(A) in the subsection heading, by striking ‘Public Health Situational Awareness’ and inserting ‘Modernizing Public Health Situational Awareness and Biosurveillance’;CommentsClose CommentsPermalink





(B) in paragraph (1)--CommentsClose CommentsPermalink





(i) by striking ‘Pandemic and All-Hazards Preparedness Act’ and inserting ‘Pandemic and All-Hazards Preparedness Reauthorization Act of 2013’; andCommentsClose CommentsPermalink





(ii) by inserting ‘, novel emerging threats,’ after ‘disease outbreaks’;CommentsClose CommentsPermalink





(C) by striking paragraph (2) and inserting the following:CommentsClose CommentsPermalink





‘(2) STRATEGY AND IMPLEMENTATION PLAN- Not later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, the Secretary shall submit to the appropriate committees of Congress a coordinated strategy and an accompanying implementation plan that identifies and demonstrates the measurable steps the Secretary will carry out to--CommentsClose CommentsPermalink





‘(A) develop, implement, and evaluate the network described in paragraph (1), utilizing the elements described in paragraph (3);CommentsClose CommentsPermalink





‘(B) modernize and enhance biosurveillance activities; andCommentsClose CommentsPermalink





‘(C) improve information sharing, coordination, and communication among disparate biosurveillance systems supported by the Department of Health and Human Services.’;CommentsClose CommentsPermalink





(D) in paragraph (3)(D), by inserting ‘community health centers, health centers’ after ‘poison control,’;CommentsClose CommentsPermalink





(E) in paragraph (5), by striking subparagraph (A) and inserting the following:CommentsClose CommentsPermalink





‘(A) utilize applicable interoperability standards as determined by the Secretary, and in consultation with the Office of the National Coordinator for Health Information Technology, through a joint public and private sector process;’; andCommentsClose CommentsPermalink





(F) by adding at the end the following:CommentsClose CommentsPermalink





‘(6) CONSULTATION WITH THE NATIONAL BIODEFENSE SCIENCE BOARD- In carrying out this section and consistent with section 319M, the National Biodefense Science Board shall provide expert advice and guidance, including recommendations, regarding the measurable steps the Secretary should take to modernize and enhance biosurveillance activities pursuant to the efforts of the Department of Health and Human Services to ensure comprehensive, real-time, all-hazards biosurveillance capabilities. In complying with the preceding sentence, the National Biodefense Science Board shall--CommentsClose CommentsPermalink





‘(A) identify the steps necessary to achieve a national biosurveillance system for human health, with international connectivity, where appropriate, that is predicated on State, regional, and community level capabilities and creates a networked system to allow for two-way information flow between and among Federal, State, and local government public health authorities and clinical health care providers;CommentsClose CommentsPermalink





‘(B) identify any duplicative surveillance programs under the authority of the Secretary, or changes that are necessary to existing programs, in order to enhance and modernize such activities, minimize duplication, strengthen and streamline such activities under the authority of the Secretary, and achieve real-time and appropriate data that relate to disease activity, both human and zoonotic; andCommentsClose CommentsPermalink





‘(C) coordinate with applicable existing advisory committees of the Director of the Centers for Disease Control and Prevention, including such advisory committees consisting of representatives from State, local, and tribal public health authorities and appropriate public and private sector health care entities and academic institutions, in order to provide guidance on public health surveillance activities.’;CommentsClose CommentsPermalink





(5) in subsection (d), as so redesignated--CommentsClose CommentsPermalink





(A) in paragraph (1), by striking ‘subsection (d)’ and inserting ‘subsection (c)’;CommentsClose CommentsPermalink





(B) in paragraph (4)(B), by striking ‘subsection (d)’ and inserting ‘subsection (c)’; andCommentsClose CommentsPermalink





(C) in paragraph (5)--CommentsClose CommentsPermalink





(i) by striking ‘4 years after the date of enactment of the Pandemic and All-Hazards Preparedness Act’ and inserting ‘3 years after the date of enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013’; andCommentsClose CommentsPermalink





(ii) by striking ‘subsection (d)’ and inserting ‘subsection (c)’;CommentsClose CommentsPermalink





(6) in subsection (f), as so redesignated, by striking ‘such sums as may be necessary in each of fiscal years 2007 through 2011’ and inserting ‘$138,300,000 for each of fiscal years 2014 through 2018’; andCommentsClose CommentsPermalink





(7) by adding at the end the following:CommentsClose CommentsPermalink





‘(g) Definition- For purposes of this section the term ‘biosurveillance’ means the process of gathering near real-time biological data that relates to human and zoonotic disease activity and threats to human or animal health, in order to achieve early warning and identification of such health threats, early detection and prompt ongoing tracking of health events, and overall situational awareness of disease activity.’.CommentsClose CommentsPermalink





(b) Technical and Conforming Amendment- Section 319C-1(b)(2)(D) of the Public Health Service Act (42 U.S.C. 247d-3a(b)(2)(D)) is amended by striking ‘section 319D(d)(3)’ and inserting ‘section 319D(c)(3)’.CommentsClose CommentsPermalink

SEC. 205. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD REPORTS.CommentsClose CommentsPermalink

Section 5 of the Project Bioshield Act of 2004 (42 U.S.C. 247d-6c) is repealed.CommentsClose CommentsPermalink

TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEWCommentsClose CommentsPermalink

SEC. 301. SPECIAL PROTOCOL ASSESSMENT.CommentsClose CommentsPermalink

Section 505(b)(5)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is amended by striking ‘size of clinical trials intended’ and all that follows through ‘. The sponsor or applicant’ and inserting the following: ‘size--CommentsClose CommentsPermalink





‘(i)(I) of clinical trials intended to form the primary basis of an effectiveness claim; orCommentsClose CommentsPermalink





‘(II) in the case where human efficacy studies are not ethical or feasible, of animal and any associated clinical trials which, in combination, are intended to form the primary basis of an effectiveness claim; orCommentsClose CommentsPermalink





‘(ii) with respect to an application for approval of a biological product under section 351(k) of the Public Health Service Act, of any necessary clinical study or studies.CommentsClose CommentsPermalink





The sponsor or applicant’.CommentsClose CommentsPermalink

SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.CommentsClose CommentsPermalink

(a) In General- Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3) is amended--CommentsClose CommentsPermalink





(1) in subsection (a)--CommentsClose CommentsPermalink





(A) in paragraph (1), by striking ‘sections 505, 510(k), and 515 of this Act’ and inserting ‘any provision of this Act’;CommentsClose CommentsPermalink





(B) in paragraph (2)(A), by striking ‘under a provision of law referred to in such paragraph’ and inserting ‘under section 505, 510(k), or 515 of this Act or section 351 of the Public Health Service Act’; andCommentsClose CommentsPermalink





(C) in paragraph (3), by striking ‘a provision of law referred to in such paragraph’ and inserting ‘a section of this Act or the Public Health Service Act referred to in paragraph (2)(A)’;CommentsClose CommentsPermalink





(2) in subsection (b)--CommentsClose CommentsPermalink





(A) in the subsection heading, by striking ‘Emergency’ and inserting ‘Emergency or Threat Justifying Emergency Authorized Use’;CommentsClose CommentsPermalink





(B) in paragraph (1)--CommentsClose CommentsPermalink





(i) in the matter preceding subparagraph (A), by striking ‘may declare an emergency’ and inserting ‘may make a declaration that the circumstances exist’;CommentsClose CommentsPermalink





(ii) in subparagraph (A), by striking ‘specified’;CommentsClose CommentsPermalink





(iii) in subparagraph (B)--CommentsClose CommentsPermalink





(I) by striking ‘specified’; andCommentsClose CommentsPermalink





(II) by striking ‘; or’ and inserting a semicolon;CommentsClose CommentsPermalink





(iv) by amending subparagraph (C) to read as follows:CommentsClose CommentsPermalink





‘(C) a determination by the Secretary that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or’; andCommentsClose CommentsPermalink





(v) by adding at the end the following:CommentsClose CommentsPermalink





‘(D) the identification of a material threat pursuant to section 319F-2 of the Public Health Service Act sufficient to affect national security or the health and security of United States citizens living abroad.’;CommentsClose CommentsPermalink





(C) in paragraph (2)--CommentsClose CommentsPermalink





(i) in subparagraph (A), by amending clause (ii) to read as follows:CommentsClose CommentsPermalink





‘(ii) a change in the approval status of the product such that the circumstances described in subsection (a)(2) have ceased to exist.’;CommentsClose CommentsPermalink





(ii) by striking subparagraph (B); andCommentsClose CommentsPermalink





(iii) by redesignating subparagraph (C) as subparagraph (B);CommentsClose CommentsPermalink





(D) in paragraph (4), by striking ‘advance notice of termination, and renewal under this subsection.’ and inserting ‘, and advance notice of termination under this subsection.’; andCommentsClose CommentsPermalink





(E) by adding at the end the following:CommentsClose CommentsPermalink





‘(5) EXPLANATION BY SECRETARY- If an authorization under this section with respect to an unapproved product or an unapproved use of an approved product has been in effect for more than 1 year, the Secretary shall provide in writing to the sponsor of such product an explanation of the scientific, regulatory, or other obstacles to approval, licensure, or clearance of such product or use, including specific actions to be taken by the Secretary and the sponsor to overcome such obstacles.’;CommentsClose CommentsPermalink





(3) in subsection (c)--CommentsClose CommentsPermalink





(A) in the matter preceding paragraph (1)--CommentsClose CommentsPermalink





(i) by inserting ‘the Assistant Secretary for Preparedness and Response,’ after ‘consultation with’;CommentsClose CommentsPermalink





(ii) by striking ‘Health and’ and inserting ‘Health, and’; andCommentsClose CommentsPermalink





(iii) by striking ‘circumstances of the emergency involved’ and inserting ‘applicable circumstances described in subsection (b)(1)’;CommentsClose CommentsPermalink





(B) in paragraph (1), by striking ‘specified’ and inserting ‘referred to’; andCommentsClose CommentsPermalink





(C) in paragraph (2)(B), by inserting ‘, taking into consideration the material threat posed by the agent or agents identified in a declaration under subsection (b)(1)(D), if applicable’ after ‘risks of the product’;CommentsClose CommentsPermalink





(4) in subsection (d)(3), by inserting ‘, to the extent practicable given the circumstances of the emergency,’ after ‘including’;CommentsClose CommentsPermalink





(5) in subsection (e)--CommentsClose CommentsPermalink





(A) in paragraph (1)(A), by striking ‘circumstances of the emergency’ and inserting ‘applicable circumstances described in subsection (b)(1)’;CommentsClose CommentsPermalink





(B) in paragraph (1)(B), by amending clause (iii) to read as follows:CommentsClose CommentsPermalink





‘(iii) Appropriate conditions with respect to collection and analysis of information concerning the safety and effectiveness of the product with respect to the use of such product during the period when the authorization is in effect and a reasonable time following such period.’;CommentsClose CommentsPermalink





(C) in paragraph (2)--CommentsClose CommentsPermalink





(i) in subparagraph (A)--CommentsClose CommentsPermalink





(I) by striking ‘manufacturer of the product’ and inserting ‘person’;CommentsClose CommentsPermalink





(II) by striking ‘circumstances of the emergency’ and inserting ‘applicable circumstances described in subsection (b)(1)’; andCommentsClose CommentsPermalink





(III) by inserting at the end before the period ‘or in paragraph (1)(B)’;CommentsClose CommentsPermalink





(ii) in subparagraph (B)(i), by inserting before the period at the end ‘, except as provided in section 564A with respect to authorized changes to the product expiration date’; andCommentsClose CommentsPermalink





(iii) by amending subparagraph (C) to read as follows:CommentsClose CommentsPermalink





‘(C) In establishing conditions under this paragraph with respect to the distribution and administration of the product for the unapproved use, the Secretary shall not impose conditions that would restrict distribution or administration of the product when distributed or administered for the approved use.’; andCommentsClose CommentsPermalink





(D) by amending paragraph (3) to read as follows:CommentsClose CommentsPermalink





‘(3) GOOD MANUFACTURING PRACTICE; PRESCRIPTION- With respect to the emergency use of a product for which an authorization under this section is issued (whether an unapproved product or an unapproved use of an approved product), the Secretary may waive or limit, to the extent appropriate given the applicable circumstances described in subsection (b)(1)--CommentsClose CommentsPermalink





‘(A) requirements regarding current good manufacturing practice otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this Act, including such requirements established under section 501 or 520(f)(1), and including relevant conditions prescribed with respect to the product by an order under section 520(f)(2);CommentsClose CommentsPermalink





‘(B) requirements established under section 503(b); andCommentsClose CommentsPermalink





‘(C) requirements established under section 520(e).’;CommentsClose CommentsPermalink





(6) in subsection (g)--CommentsClose CommentsPermalink





(A) in the subsection heading, by inserting ‘Review and’ before ‘Revocation’;CommentsClose CommentsPermalink





(B) in paragraph (1), by inserting after the period at the end the following: ‘As part of such review, the Secretary shall regularly review the progress made with respect to the approval, licensure, or clearance of--CommentsClose CommentsPermalink





‘(A) an unapproved product for which an authorization was issued under this section; orCommentsClose CommentsPermalink





‘(B) an unapproved use of an approved product for which an authorization was issued under this section.’; andCommentsClose CommentsPermalink





(C) by amending paragraph (2) to read as follows:CommentsClose CommentsPermalink





‘(2) REVISION AND REVOCATION- The Secretary may revise or revoke an authorization under this section if--CommentsClose CommentsPermalink





‘(A) the circumstances described under subsection (b)(1) no longer exist;CommentsClose CommentsPermalink





‘(B) the criteria under subsection (c) for issuance of such authorization are no longer met; orCommentsClose CommentsPermalink





‘(C) other circumstances make such revision or revocation appropriate to protect the public health or safety.’;CommentsClose CommentsPermalink





(7) in subsection (h)(1), by adding after the period at the end the following: ‘The Secretary shall make any revisions to an authorization under this section available on the Internet Web site of the Food and Drug Administration.’;CommentsClose CommentsPermalink





(8) by adding at the end of subsection (j) the following:CommentsClose CommentsPermalink





‘(4) Nothing in this section shall be construed as authorizing a delay in the review or other consideration by the Secretary of any application or submission pending before the Food and Drug Administration for a product for which an authorization under this section is issued.’; andCommentsClose CommentsPermalink





(9) by adding at the end the following:CommentsClose CommentsPermalink





‘(m) Categorization of Laboratory Tests Associated With Devices Subject to Authorization-CommentsClose CommentsPermalink





‘(1) IN GENERAL- In issuing an authorization under this section with respect to a device, the Secretary may, subject to the provisions of this section, determine that a laboratory examination or procedure associated with such device shall be deemed, for purposes of section 353 of the Public Health Service Act, to be in a particular category of examinations and procedures (including the category described by subsection (d)(3) of such section) if, based on the totality of scientific evidence available to the Secretary--CommentsClose CommentsPermalink





‘(A) such categorization would be beneficial to protecting the public health; andCommentsClose CommentsPermalink





‘(B) the known and potential benefits of such categorization under the circumstances of the authorization outweigh the known and potential risks of the categorization.CommentsClose CommentsPermalink





‘(2) CONDITIONS OF DETERMINATION- The Secretary may establish appropriate conditions on the performance of the examination or procedure pursuant to such determination.CommentsClose CommentsPermalink





‘(3) EFFECTIVE PERIOD- A determination under this subsection shall be effective for purposes of section 353 of the Public Health Service Act notwithstanding any other provision of that section during the effective period of the relevant declaration under subsection (b).’.CommentsClose CommentsPermalink





(b) Emergency Use of Medical Products- Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by inserting after section 564 the following:CommentsClose CommentsPermalink

‘SEC. 564A. EMERGENCY USE OF MEDICAL PRODUCTS.CommentsClose CommentsPermalink

‘(a) Definitions- In this section:CommentsClose CommentsPermalink





‘(1) ELIGIBLE PRODUCT- The term ‘eligible product’ means a product that--CommentsClose CommentsPermalink





‘(A) is approved or cleared under this chapter or licensed under section 351 of the Public Health Service Act;CommentsClose CommentsPermalink





‘(B)(i) is intended for use to prevent, diagnose, or treat a disease or condition involving a biological, chemical, radiological, or nuclear agent or agents; orCommentsClose CommentsPermalink





‘(ii) is intended for use to prevent, diagnose, or treat a serious or life-threatening disease or condition caused by a product described in clause (i); andCommentsClose CommentsPermalink





‘(C) is intended for use during the circumstances under which--CommentsClose CommentsPermalink





‘(i) a determination described in subparagraph (A), (B), or (C) of section 564(b)(1) has been made by the Secretary of Homeland Security, the Secretary of Defense, or the Secretary, respectively; orCommentsClose CommentsPermalink





‘(ii) the identification of a material threat described in subparagraph (D) of section 564(b)(1) has been made pursuant to section 319F-2 of the Public Health Service Act.CommentsClose CommentsPermalink





‘(2) PRODUCT- The term ‘product’ means a drug, device, or biological product.CommentsClose CommentsPermalink





‘(b) Expiration Dating-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The Secretary may extend the expiration date and authorize the introduction or delivery for introduction into interstate commerce of an eligible product after the expiration date provided by the manufacturer if--CommentsClose CommentsPermalink





‘(A) the expiration date extension is intended to support the United States ability to protect--CommentsClose CommentsPermalink





‘(i) the public health; orCommentsClose CommentsPermalink





‘(ii) military preparedness and effectiveness; andCommentsClose CommentsPermalink





‘(B) the expiration date extension is supported by an appropriate scientific evaluation that is conducted or accepted by the Secretary.CommentsClose CommentsPermalink





‘(2) REQUIREMENTS AND CONDITIONS- Any extension of an expiration date under paragraph (1) shall, as part of the extension, identify--CommentsClose CommentsPermalink





‘(A) each specific lot, batch, or other unit of the product for which extended expiration is authorized;CommentsClose CommentsPermalink





‘(B) the duration of the extension; andCommentsClose CommentsPermalink





‘(C) any other requirements or conditions as the Secretary may deem appropriate for the protection of the public health, which may include requirements for, or conditions on, product sampling, storage, packaging or repackaging, transport, labeling, notice to product recipients, recordkeeping, periodic testing or retesting, or product disposition.CommentsClose CommentsPermalink





‘(3) EFFECT- Notwithstanding any other provision of this Act or the Public Health Service Act, an eligible product shall not be considered an unapproved product (as defined in section 564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act because, with respect to such product, the Secretary has, under paragraph (1), extended the expiration date and authorized the introduction or delivery for introduction into interstate commerce of such product after the expiration date provided by the manufacturer.CommentsClose CommentsPermalink





‘(4) EXPIRATION DATE- For purposes of this subsection, the term ‘expiration date’ means the date established through appropriate stability testing required by the regulations issued by the Secretary to ensure that the product meets applicable standards of identity, strength, quality, and purity at the time of use.CommentsClose CommentsPermalink





‘(c) Current Good Manufacturing Practice-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The Secretary may, when the circumstances of a domestic, military, or public health emergency or material threat described in subsection (a)(1)(C) so warrant, authorize, with respect to an eligible product, deviations from current good manufacturing practice requirements otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this Act, including requirements under section 501 or 520(f)(1) or applicable conditions prescribed with respect to the eligible product by an order under section 520(f)(2).CommentsClose CommentsPermalink





‘(2) EFFECT- Notwithstanding any other provision of this Act or the Public Health Service Act, an eligible product shall not be considered an unapproved product (as defined in section 564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act because, with respect to such product, the Secretary has authorized deviations from current good manufacturing practices under paragraph (1).CommentsClose CommentsPermalink





‘(d) Emergency Dispensing- The requirements of sections 503(b) and 520(e) shall not apply to an eligible product, and the product shall not be considered an unapproved product (as defined in section 564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act because it is dispensed without an individual prescription, if--CommentsClose CommentsPermalink





‘(1) the product is dispensed during the circumstances described in subsection (a)(1)(C); andCommentsClose CommentsPermalink





‘(2) such dispensing without an individual prescription occurs--CommentsClose CommentsPermalink





‘(A) as permitted under the law of the State in which the product is dispensed; orCommentsClose CommentsPermalink





‘(B) in accordance with an order issued by the Secretary, for the purposes and duration of the circumstances described in subsection (a)(1)(C).CommentsClose CommentsPermalink





‘(e) Emergency Use Instructions-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The Secretary, acting through an appropriate official within the Department of Health and Human Services, may create and issue emergency use instructions to inform health care providers or individuals to whom an eligible product is to be administered concerning such product’s approved, licensed, or cleared conditions of use.CommentsClose CommentsPermalink





‘(2) EFFECT- Notwithstanding any other provisions of this Act or the Public Health Service Act, a product shall not be considered an unapproved product and shall not be deemed adulterated or misbranded under this Act because of the issuance of emergency use instructions under paragraph (1) with respect to such product or the introduction or delivery for introduction of such product into interstate commerce accompanied by such instructions--CommentsClose CommentsPermalink





‘(A) during an emergency response to an actual emergency that is the basis for a determination described in subsection (a)(1)(C)(i); orCommentsClose CommentsPermalink





‘(B) by a government entity (including a Federal, State, local, or tribal government entity), or a person acting on behalf of such a government entity, in preparation for an emergency response.’.CommentsClose CommentsPermalink





(c) Risk Evaluation and Mitigation Strategies- Section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1), is amended--CommentsClose CommentsPermalink





(1) in subsection (f), by striking paragraph (7); andCommentsClose CommentsPermalink





(2) by adding at the end the following:CommentsClose CommentsPermalink





‘(k) Waiver in Public Health Emergencies- The Secretary may waive any requirement of this section with respect to a qualified countermeasure (as defined in section 319F-1(a)(2) of the Public Health Service Act) to which a requirement under this section has been applied, if the Secretary determines that such waiver is required to mitigate the effects of, or reduce the severity of, the circumstances under which--CommentsClose CommentsPermalink





‘(1) a determination described in subparagraph (A), (B), or (C) of section 564(b)(1) has been made by the Secretary of Homeland Security, the Secretary of Defense, or the Secretary, respectively; orCommentsClose CommentsPermalink





‘(2) the identification of a material threat described in subparagraph (D) of section 564(b)(1) has been made pursuant to section 319F-2 of the Public Health Service Act.’.CommentsClose CommentsPermalink





(d) Products Held for Emergency Use- The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended by inserting after section 564A, as added by subsection (b), the following:CommentsClose CommentsPermalink

‘SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE.CommentsClose CommentsPermalink

‘It is not a violation of any section of this Act or of the Public Health Service Act for a government entity (including a Federal, State, local, or tribal government entity), or a person acting on behalf of such a government entity, to introduce into interstate commerce a product (as defined in section 564(a)(4)) intended for emergency use, if that product--CommentsClose CommentsPermalink





‘(1) is intended to be held and not used; andCommentsClose CommentsPermalink





‘(2) is held and not used, unless and until that product--CommentsClose CommentsPermalink





‘(A) is approved, cleared, or licensed under section 505, 510(k), or 515 of this Act or section 351 of the Public Health Service Act;CommentsClose CommentsPermalink





‘(B) is authorized for investigational use under section 505 or 520 of this Act or section 351 of the Public Health Service Act; orCommentsClose CommentsPermalink





‘(C) is authorized for use under section 564.’.CommentsClose CommentsPermalink

SEC. 303. DEFINITIONS.CommentsClose CommentsPermalink

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-4) is amended by striking ‘The Secretary, in consultation’ and inserting the following:CommentsClose CommentsPermalink





‘(a) Definitions- In this section--CommentsClose CommentsPermalink





‘(1) the term ‘countermeasure’ means a qualified countermeasure, a security countermeasure, and a qualified pandemic or epidemic product;CommentsClose CommentsPermalink





‘(2) the term ‘qualified countermeasure’ has the meaning given such term in section 319F-1 of the Public Health Service Act;CommentsClose CommentsPermalink





‘(3) the term ‘security countermeasure’ has the meaning given such term in section 319F-2 of such Act; andCommentsClose CommentsPermalink





‘(4) the term ‘qualified pandemic or epidemic product’ means a product that meets the definition given such term in section 319F-3 of the Public Health Service Act and--CommentsClose CommentsPermalink





‘(A) that has been identified by the Department of Health and Human Services or the Department of Defense as receiving funding directly related to addressing chemical, biological, radiological, or nuclear threats, including pandemic influenza; orCommentsClose CommentsPermalink





‘(B) is included under this paragraph pursuant to a determination by the Secretary.CommentsClose CommentsPermalink





‘(b) General Duties- The Secretary, in consultation’.CommentsClose CommentsPermalink

SEC. 304. ENHANCING MEDICAL COUNTERMEASURE ACTIVITIES.CommentsClose CommentsPermalink

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-4), as amended by section 303, is further amended--CommentsClose CommentsPermalink





(1) in the section heading, by striking ‘technical assistance’ and inserting ‘countermeasure development, review, and technical assistance’;CommentsClose CommentsPermalink





(2) in subsection (b), by striking the subsection enumerator and all that follows through ‘shall establish’ and inserting the following:CommentsClose CommentsPermalink





‘(b) General Duties- In order to accelerate the development, stockpiling, approval, licensure, and clearance of qualified countermeasures, security countermeasures, and qualified pandemic or epidemic products, the Secretary, in consultation with the Assistant Secretary for Preparedness and Response, shall--CommentsClose CommentsPermalink





‘(1) ensure the appropriate involvement of Food and Drug Administration personnel in interagency activities related to countermeasure advanced research and development, consistent with sections 319F, 319F-1, 319F-2, 319F-3, 319L, and 2811 of the Public Health Service Act;CommentsClose CommentsPermalink





‘(2) ensure the appropriate involvement and consultation of Food and Drug Administration personnel in any flexible manufacturing activities carried out under section 319L of the Public Health Service Act, including with respect to meeting regulatory requirements set forth in this Act;CommentsClose CommentsPermalink





‘(3) promote countermeasure expertise within the Food and Drug Administration by--CommentsClose CommentsPermalink





‘(A) ensuring that Food and Drug Administration personnel involved in reviewing countermeasures for approval, licensure, or clearance are informed by the Assistant Secretary for Preparedness and Response on the material threat assessment conducted under section 319F-2 of the Public Health Service Act for the agent or agents for which the countermeasure under review is intended;CommentsClose CommentsPermalink





‘(B) training Food and Drug Administration personnel regarding review of countermeasures for approval, licensure, or clearance;CommentsClose CommentsPermalink





‘(C) holding public meetings at least twice annually to encourage the exchange of scientific ideas; andCommentsClose CommentsPermalink





‘(D) establishing protocols to ensure that countermeasure reviewers have sufficient training or experience with countermeasures;CommentsClose CommentsPermalink





‘(4) maintain teams, composed of Food and Drug Administration personnel with expertise on countermeasures, including specific countermeasures, populations with special clinical needs (including children and pregnant women that may use countermeasures, as applicable and appropriate), classes or groups of countermeasures, or other countermeasure-related technologies and capabilities, that shall--CommentsClose CommentsPermalink





‘(A) consult with countermeasure experts, including countermeasure sponsors and applicants, to identify and help resolve scientific issues related to the approval, licensure, or clearance of countermeasures, through workshops or public meetings; andCommentsClose CommentsPermalink





‘(B) improve and advance the science relating to the development of new tools, standards, and approaches to assessing and evaluating countermeasures--CommentsClose CommentsPermalink





‘(i) in order to inform the process for countermeasure approval, clearance, and licensure; andCommentsClose CommentsPermalink





‘(ii) with respect to the development of countermeasures for populations with special clinical needs, including children and pregnant women, in order to meet the needs of such populations, as necessary and appropriate; andCommentsClose CommentsPermalink





‘(5) establish’; andCommentsClose CommentsPermalink





(3) by adding at the end the following:CommentsClose CommentsPermalink





‘(c) Final Guidance on Development of Animal Models-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Not later than 1 year after the date of the enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, the Secretary shall provide final guidance to industry regarding the development of animal models to support approval, clearance, or licensure of countermeasures referred to in subsection (a) when human efficacy studies are not ethical or feasible.CommentsClose CommentsPermalink





‘(2) AUTHORITY TO EXTEND DEADLINE- The Secretary may extend the deadline for providing final guidance under paragraph (1) by not more than 6 months upon submission by the Secretary of a report on the status of such guidance to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.CommentsClose CommentsPermalink





‘(d) Development and Animal Modeling Procedures-CommentsClose CommentsPermalink





‘(1) AVAILABILITY OF ANIMAL MODEL MEETINGS- To facilitate the timely development of animal models and support the development, stockpiling, licensure, approval, and clearance of countermeasures, the Secretary shall, not later than 180 days after the enactment of this subsection, establish a procedure by which a sponsor or applicant that is developing a countermeasure for which human efficacy studies are not ethical or practicable, and that has an approved investigational new drug application or investigational device exemption, may request and receive--CommentsClose CommentsPermalink





‘(A) a meeting to discuss proposed animal model development activities; andCommentsClose CommentsPermalink





‘(B) a meeting prior to initiating pivotal animal studies.CommentsClose CommentsPermalink





‘(2) PEDIATRIC MODELS- To facilitate the development and selection of animal models that could translate to pediatric studies, any meeting conducted under paragraph (1) shall include discussion of animal models for pediatric populations, as appropriate.CommentsClose CommentsPermalink





‘(e) Review and Approval of Countermeasures-CommentsClose CommentsPermalink





‘(1) MATERIAL THREAT- When evaluating an application or submission for approval, licensure, or clearance of a countermeasure, the Secretary shall take into account the material threat posed by the chemical, biological, radiological, or nuclear agent or agents identified under section 319F-2 of the Public Health Service Act for which the countermeasure under review is intended.CommentsClose CommentsPermalink





‘(2) REVIEW EXPERTISE- When practicable and appropriate, teams of Food and Drug Administration personnel reviewing applications or submissions described under paragraph (1) shall include a reviewer with sufficient training or experience with countermeasures pursuant to the protocols established under subsection (b)(3)(D).’.CommentsClose CommentsPermalink

SEC. 305. REGULATORY MANAGEMENT PLANS.CommentsClose CommentsPermalink

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-4), as amended by section 304, is further amended by adding at the end the following:CommentsClose CommentsPermalink





‘(f) Regulatory Management Plan-CommentsClose CommentsPermalink





‘(1) DEFINITION- In this subsection, the term ‘eligible countermeasure’ means--CommentsClose CommentsPermalink





‘(A) a security countermeasure with respect to which the Secretary has entered into a procurement contract under section 319F-2(c) of the Public Health Service Act; orCommentsClose CommentsPermalink





‘(B) a countermeasure with respect to which the Biomedical Advanced Research and Development Authority has provided funding under section 319L of the Public Health Service Act for advanced research and development.CommentsClose CommentsPermalink





‘(2) REGULATORY MANAGEMENT PLAN PROCESS- The Secretary, in consultation with the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority, shall establish a formal process for obtaining scientific feedback and interactions regarding the development and regulatory review of eligible countermeasures by facilitating the development of written regulatory management plans in accordance with this subsection.CommentsClose CommentsPermalink





‘(3) SUBMISSION OF REQUEST AND PROPOSED PLAN BY SPONSOR OR APPLICANT-CommentsClose CommentsPermalink





‘(A) IN GENERAL- A sponsor or applicant of an eligible countermeasure may initiate the process described under paragraph (2) upon submission of a written request to the Secretary. Such request shall include a proposed regulatory management plan.CommentsClose CommentsPermalink





‘(B) TIMING OF SUBMISSION- A sponsor or applicant may submit a written request under subparagraph (A) after the eligible countermeasure has an investigational new drug or investigational device exemption in effect.CommentsClose CommentsPermalink





‘(C) RESPONSE BY SECRETARY- The Secretary shall direct the Food and Drug Administration, upon submission of a written request by a sponsor or applicant under subparagraph (A), to work with the sponsor or applicant to agree on a regulatory management plan within a reasonable time not to exceed 90 days. If the Secretary determines that no plan can be agreed upon, the Secretary shall provide to the sponsor or applicant, in writing, the scientific or regulatory rationale why such agreement cannot be reached.CommentsClose CommentsPermalink





‘(4) PLAN- The content of a regulatory management plan agreed to by the Secretary and a sponsor or applicant shall include--CommentsClose CommentsPermalink





‘(A) an agreement between the Secretary and the sponsor or applicant regarding developmental milestones that will trigger responses by the Secretary as described in subparagraph (B);CommentsClose CommentsPermalink





‘(B) performance targets and goals for timely and appropriate responses by the Secretary to the triggers described under subparagraph (A), including meetings between the Secretary and the sponsor or applicant, written feedback, decisions by the Secretary, and other activities carried out as part of the development and review process; andCommentsClose CommentsPermalink





‘(C) an agreement on how the plan shall be modified, if needed.CommentsClose CommentsPermalink





‘(5) MILESTONES AND PERFORMANCE TARGETS- The developmental milestones described in paragraph (4)(A) and the performance targets and goals described in paragraph (4)(B) shall include--CommentsClose CommentsPermalink





‘(A) feedback from the Secretary regarding the data required to support the approval, clearance, or licensure of the eligible countermeasure involved;CommentsClose CommentsPermalink





‘(B) feedback from the Secretary regarding the data necessary to inform any authorization under section 564;CommentsClose CommentsPermalink





‘(C) feedback from the Secretary regarding the data necessary to support the positioning and delivery of the eligible countermeasure, including to the Strategic National Stockpile;CommentsClose CommentsPermalink





‘(D) feedback from the Secretary regarding the data necessary to support the submission of protocols for review under section 505(b)(5)(B);CommentsClose CommentsPermalink





‘(E) feedback from the Secretary regarding any gaps in scientific knowledge that will need resolution prior to approval, licensure, or clearance of the eligible countermeasure and plans for conducting the necessary scientific research;CommentsClose CommentsPermalink





‘(F) identification of the population for which the countermeasure sponsor or applicant seeks approval, licensure, or clearance and the population for which desired labeling would not be appropriate, if known; andCommentsClose CommentsPermalink





‘(G) as necessary and appropriate, and to the extent practicable, a plan for demonstrating safety and effectiveness in pediatric populations, and for developing pediatric dosing, formulation, and administration with respect to the eligible countermeasure, provided that such plan would not delay authorization under section 564, approval, licensure, or clearance for adults.CommentsClose CommentsPermalink





‘(6) PRIORITIZATION-CommentsClose CommentsPermalink





‘(A) PLANS FOR SECURITY COUNTERMEASURES- The Secretary shall establish regulatory management plans for all security countermeasures for which a request is submitted under paragraph (3)(A).CommentsClose CommentsPermalink





‘(B) PLANS FOR OTHER ELIGIBLE COUNTERMEASURES- The Secretary shall determine whether resources are available to establish regulatory management plans for eligible countermeasures that are not security countermeasures. If resources are available to establish regulatory management plans for eligible countermeasures that are not security countermeasures, and if resources are not available to establish regulatory management plans for all eligible countermeasures for which requests have been submitted, the Director of the Biomedical Advanced Research and Development Authority, in consultation with the Commissioner, shall prioritize which eligible countermeasures may receive regulatory management plans.’.CommentsClose CommentsPermalink

SEC. 306. REPORT.CommentsClose CommentsPermalink

Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-4), as amended by section 305, is further amended by adding at the end the following:CommentsClose CommentsPermalink





‘(g) Annual Report- Not later than 180 days after the date of enactment of this subsection, and annually thereafter, the Secretary shall make publicly available on the Web site of the Food and Drug Administration a report that details the countermeasure development and review activities of the Food and Drug Administration, including--CommentsClose CommentsPermalink





‘(1) with respect to the development of new tools, standards, and approaches to assess and evaluate countermeasures--CommentsClose CommentsPermalink





‘(A) the identification of the priorities of the Food and Drug Administration and the progress made on such priorities; andCommentsClose CommentsPermalink





‘(B) the identification of scientific gaps that impede the development, approval, licensure, or clearance of countermeasures for populations with special clinical needs, including children and pregnant women, and the progress made on resolving these challenges;CommentsClose CommentsPermalink





‘(2) with respect to countermeasures for which a regulatory management plan has been agreed upon under subsection (f), the extent to which the performance targets and goals set forth in subsection (f)(4)(B) and the regulatory management plan have been met, including, for each such countermeasure--CommentsClose CommentsPermalink





‘(A) whether the regulatory management plan was completed within the required timeframe, and the length of time taken to complete such plan;CommentsClose CommentsPermalink





‘(B) whether the Secretary adhered to the timely and appropriate response times set forth in such plan; andCommentsClose CommentsPermalink





‘(C) explanations for any failure to meet such performance targets and goals;CommentsClose CommentsPermalink





‘(3) the number of regulatory teams established pursuant to subsection (b)(4), the number of products, classes of products, or technologies assigned to each such team, and the number of, type of, and any progress made as a result of consultations carried out under subsection (b)(4)(A);CommentsClose CommentsPermalink





‘(4) an estimate of resources obligated to countermeasure development and regulatory assessment, including--CommentsClose CommentsPermalink





‘(A) Center-specific objectives and accomplishments; andCommentsClose CommentsPermalink





‘(B) the number of full-time equivalent employees of the Food and Drug Administration who directly support the review of countermeasures;CommentsClose CommentsPermalink





‘(5) the number of countermeasure applications and submissions submitted, the number of countermeasures approved, licensed, or cleared, the status of remaining submitted applications and submissions, and the number of each type of authorization issued pursuant to section 564;CommentsClose CommentsPermalink





‘(6) the number of written requests for a regulatory management plan submitted under subsection (f)(3)(A), the number of regulatory management plans developed, and the number of such plans developed for security countermeasures; andCommentsClose CommentsPermalink





‘(7) the number, type, and frequency of meetings between the Food and Drug Administration and--CommentsClose CommentsPermalink





‘(A) sponsors of a countermeasure as defined in subsection (a); orCommentsClose CommentsPermalink





‘(B) another agency engaged in development or management of portfolios for such countermeasures, including the Centers for Disease Control and Prevention, the Biomedical Advanced Research and Development Authority, the National Institutes of Health, and the appropriate agencies of the Department of Defense.’.CommentsClose CommentsPermalink

SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES.CommentsClose CommentsPermalink

(a) Pediatric Studies of Drugs- Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended--CommentsClose CommentsPermalink





(1) in subsection (d), by adding at the end the following:CommentsClose CommentsPermalink





‘(5) CONSULTATION- With respect to a drug that is a qualified countermeasure (as defined in section 319F-1 of the Public Health Service Act), a security countermeasure (as defined in section 319F-2 of the Public Health Service Act), or a qualified pandemic or epidemic product (as defined in section 319F-3 of the Public Health Service Act), the Secretary shall solicit input from the Assistant Secretary for Preparedness and Response regarding the need for and, from the Director of the Biomedical Advanced Research and Development Authority regarding the conduct of, pediatric studies under this section.’; andCommentsClose CommentsPermalink





(2) in subsection (n)(1), by adding at the end the following:CommentsClose CommentsPermalink





‘(C) For a drug that is a qualified countermeasure (as defined in section 319F-1 of the Public Health Service Act), a security countermeasure (as defined in section 319F-2 of the Public Health Service Act), or a qualified pandemic or epidemic product (as defined in section 319F-3 of such Act), in addition to any action with respect to such drug under subparagraph (A) or (B), the Secretary shall notify the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority of all pediatric studies in the written request issued by the Commissioner of Food and Drugs.’.CommentsClose CommentsPermalink





(b) Addition to Priority List Considerations- Section 409I of the Public Health Service Act (42 U.S.C. 284m) is amended--CommentsClose CommentsPermalink





(1) by striking subsection (a)(2) and inserting the following:CommentsClose CommentsPermalink





‘(2) CONSIDERATION OF AVAILABLE INFORMATION- In developing and prioritizing the list under paragraph (1), the Secretary--CommentsClose CommentsPermalink





‘(A) shall consider--CommentsClose CommentsPermalink





‘(i) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials;CommentsClose CommentsPermalink





‘(ii) particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, may be beneficial in pediatric populations; andCommentsClose CommentsPermalink





‘(iii) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators; andCommentsClose CommentsPermalink





‘(B) may consider the availability of qualified countermeasures (as defined in section 319F-1), security countermeasures (as defined in section 319F-2), and qualified pandemic or epidemic products (as defined in section 319F-3) to address the needs of pediatric populations, in consultation with the Assistant Secretary for Preparedness and Response, consistent with the purposes of this section.’; andCommentsClose CommentsPermalink





(2) in subsection (b), by striking ‘subsection (a)’ and inserting ‘paragraphs (1) and (2)(A) of subsection (a)’.CommentsClose CommentsPermalink





(c) Advice and Recommendations of the Pediatric Advisory Committee Regarding Countermeasures for Pediatric Populations- Subsection (b)(2) of section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended--CommentsClose CommentsPermalink





(1) in subparagraph (C), by striking the period and inserting ‘; and’; andCommentsClose CommentsPermalink





(2) by adding at the end the following:CommentsClose CommentsPermalink





‘(D) the development of countermeasures (as defined in section 565(a) of the Federal Food, Drug, and Cosmetic Act) for pediatric populations.’.CommentsClose CommentsPermalink

TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND DEVELOPMENTCommentsClose CommentsPermalink

SEC. 401. BIOSHIELD.CommentsClose CommentsPermalink

(a) Procurement of Countermeasures- Section 319F-2(c) of the Public Health Service Act (42 U.S.C. 247d-6b(c)) is amended--CommentsClose CommentsPermalink





(1) in paragraph (1)(B)(i)(III)(bb), by striking ‘eight years’ and inserting ‘10 years’;CommentsClose CommentsPermalink





(2) in paragraph (2)(C), by striking ‘the designated congressional committees (as defined in paragraph (10))’ and inserting ‘the appropriate committees of Congress’;CommentsClose CommentsPermalink





(3) in paragraph (5)(B)(ii), by striking ‘eight years’ and inserting ‘10 years’;CommentsClose CommentsPermalink





(4) in subparagraph (C) of paragraph (6)--CommentsClose CommentsPermalink





(A) in the subparagraph heading, by striking ‘DESIGNATED CONGRESSIONAL COMMITTEES’ and inserting ‘APPROPRIATE CONGRESSIONAL COMMITTEES’; andCommentsClose CommentsPermalink





(B) by striking ‘the designated congressional committees’ and inserting ‘the appropriate congressional committees’; andCommentsClose CommentsPermalink





(5) in paragraph (7)(C)--CommentsClose CommentsPermalink





(A) in clause (i)(I), by inserting ‘including advanced research and development,’ after ‘as may reasonably be required,’;CommentsClose CommentsPermalink





(B) in clause (ii)--CommentsClose CommentsPermalink





(i) in subclause (III), by striking ‘eight years’ and inserting ‘10 years’; andCommentsClose CommentsPermalink





(ii) by striking subclause (IX) and inserting the following:CommentsClose CommentsPermalink





‘(IX) CONTRACT TERMS- The Secretary, in any contract for procurement under this section--CommentsClose CommentsPermalink

‘(aa) may specify--CommentsClose CommentsPermalink

‘(AA) the dosing and administration requirements for the countermeasure to be developed and procured;CommentsClose CommentsPermalink

‘(BB) the amount of funding that will be dedicated by the Secretary for advanced research, development, and procurement of the countermeasure; andCommentsClose CommentsPermalink

‘(CC) the specifications the countermeasure must meet to qualify for procurement under a contract under this section; andCommentsClose CommentsPermalink

‘(bb) shall provide a clear statement of defined Government purpose limited to uses related to a security countermeasure, as defined in paragraph (1)(B).’; andCommentsClose CommentsPermalink

(C) by adding at the end the following:CommentsClose CommentsPermalink





‘(viii) FLEXIBILITY- In carrying out this section, the Secretary may, consistent with the applicable provisions of this section, enter into contracts and other agreements that are in the best interest of the Government in meeting identified security countermeasure needs, including with respect to reimbursement of the cost of advanced research and development as a reasonable, allowable, and allocable direct cost of the contract involved.’.CommentsClose CommentsPermalink





(b) Reauthorization of the Special Reserve Fund- Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) is amended--CommentsClose CommentsPermalink





(1) in subsection (c)--CommentsClose CommentsPermalink





(A) by striking ‘special reserve fund under paragraph (10)’ each place it appears and inserting ‘special reserve fund as defined in subsection (h)’; andCommentsClose CommentsPermalink





(B) by striking paragraphs (9) and (10); andCommentsClose CommentsPermalink





(2) by adding at the end the following:CommentsClose CommentsPermalink





‘(g) Special Reserve Fund-CommentsClose CommentsPermalink





‘(1) AUTHORIZATION OF APPROPRIATIONS- In addition to amounts appropriated to the special reserve fund prior to the date of the enactment of this subsection, there is authorized to be appropriated, for the procurement of security countermeasures under subsection (c) and for carrying out section 319L (relating to the Biomedical Advanced Research and Development Authority), $2,800,000,000 for the period of fiscal years 2014 through 2018. Amounts appropriated pursuant to the preceding sentence are authorized to remain available until September 30, 2019.CommentsClose CommentsPermalink





‘(2) USE OF SPECIAL RESERVE FUND FOR ADVANCED RESEARCH AND DEVELOPMENT- The Secretary may utilize not more than 50 percent of the amounts authorized to be appropriated under paragraph (1) to carry out section 319L (related to the Biomedical Advanced Research and Development Authority). Amounts authorized to be appropriated under this subsection to carry out section 319L are in addition to amounts otherwise authorized to be appropriated to carry out such section.CommentsClose CommentsPermalink





‘(3) RESTRICTIONS ON USE OF FUNDS- Amounts in the special reserve fund shall not be used to pay costs other than payments made by the Secretary to a vendor for advanced development (under section 319L) or for procurement of a security countermeasure under subsection (c)(7).CommentsClose CommentsPermalink





‘(4) REPORT- Not later than 30 days after any date on which the Secretary determines that the amount of funds in the special reserve fund available for procurement is less than $1,500,000,000, the Secretary shall submit to the appropriate committees of Congress a report detailing the amount of such funds available for procurement and the impact such reduction in funding will have--CommentsClose CommentsPermalink





‘(A) in meeting the security countermeasure needs identified under this section; andCommentsClose CommentsPermalink





‘(B) on the annual Public Health Emergency Medical Countermeasures Enterprise and Strategy Implementation Plan (pursuant to section 2811(d)).CommentsClose CommentsPermalink





‘(h) Definitions- In this section:CommentsClose CommentsPermalink





‘(1) The term ‘advanced research and development’ has the meaning given such term in section 319L(a).CommentsClose CommentsPermalink





‘(2) The term ‘special reserve fund’ means the ‘Biodefense Countermeasures’ appropriations account, any appropriation made available pursuant to section 521(a) of the Homeland Security Act of 2002, and any appropriation made available pursuant to subsection (g)(1).’.CommentsClose CommentsPermalink

SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.CommentsClose CommentsPermalink

(a) Duties- Section 319L(c)(4) of the Public Health Service Act (42 U.S.C. 247d-7e(c)(4)) is amended--CommentsClose CommentsPermalink





(1) in subparagraph (B)(iii), by inserting ‘(which may include advanced research and development for purposes of fulfilling requirements under the Federal Food, Drug, and Cosmetic Act or section 351 of this Act)’ after ‘development’; andCommentsClose CommentsPermalink





(2) in subparagraph (D)(iii), by striking ‘and vaccine manufacturing technologies’ and inserting ‘vaccine-manufacturing technologies, dose-sparing technologies, efficacy-increasing technologies, and platform technologies’.CommentsClose CommentsPermalink





(b) Transaction Authorities- Section 319L(c)(5) of the Public Health Service Act (42 U.S.C. 247d-7e(c)(5)) is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(G) GOVERNMENT PURPOSE- In awarding contracts, grants, and cooperative agreements under this section, the Secretary shall provide a clear statement of defined Government purpose related to activities included in subsection (a)(6)(B) for a qualified countermeasure or qualified pandemic or epidemic product.’.CommentsClose CommentsPermalink





(c) Fund- Paragraph (2) of section 319L(d) of the Public Health Service Act (42 U.S.C. 247d-7e(d)(2)) is amended to read as follows:CommentsClose CommentsPermalink





‘(2) FUNDING- To carry out the purposes of this section, there is authorized to be appropriated to the Fund $415,000,000 for each of fiscal years 2014 through 2018, such amounts to remain available until expended.’.CommentsClose CommentsPermalink





(d) Continued Inapplicability of Certain Provisions- Section 319L(e)(1)(C) of the Public Health Service Act (42 U.S.C. 247d-7e(e)(1)(C)) is amended by striking ‘7 years’ and inserting ‘12 years’.CommentsClose CommentsPermalink





(e) Extension of Limited Antitrust Exemption-CommentsClose CommentsPermalink





(1) IN GENERAL- Section 405(b) of the Pandemic and All-Hazards Preparedness Act (42 U.S.C. 247d-6a note) is amended by striking ‘6-year’ and inserting ‘12-year’.CommentsClose CommentsPermalink





(2) EFFECTIVE DATE- This subsection shall take effect as if enacted on December 17, 2012.CommentsClose CommentsPermalink





(f) Independent Evaluation- Section 319L of the Public Health Service Act (42 U.S.C. 247d-7e) is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(f) Independent Evaluation-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Not later than 180 days after the date of enactment of this subsection, the Comptroller General of the United States shall conduct an independent evaluation of the activities carried out to facilitate flexible manufacturing capacity pursuant to this section.CommentsClose CommentsPermalink





‘(2) REPORT- Not later than 1 year after the date of enactment of this subsection, the Comptroller General of the United States shall submit to the appropriate committees of Congress a report concerning the results of the evaluation conducted under paragraph (1). Such report shall review and assess--CommentsClose CommentsPermalink





‘(A) the extent to which flexible manufacturing capacity under this section is dedicated to chemical, biological, radiological, and nuclear threats;CommentsClose CommentsPermalink





‘(B) the activities supported by flexible manufacturing initiatives; andCommentsClose CommentsPermalink





‘(C) the ability of flexible manufacturing activities carried out under this section to--CommentsClose CommentsPermalink





‘(i) secure and leverage leading technical expertise with respect to countermeasure advanced research, development, and manufacturing processes; andCommentsClose CommentsPermalink





‘(ii) meet the surge manufacturing capacity needs presented by novel and emerging threats, including chemical, biological, radiological, and nuclear agents.’.CommentsClose CommentsPermalink





(g) Definitions-CommentsClose CommentsPermalink





(1) QUALIFIED COUNTERMEASURE- Section 319F-1(a)(2)(A) of the Public Health Service Act (42 U.S.C. 247d-6a(a)(2)(A)) is amended--CommentsClose CommentsPermalink





(A) in the matter preceding clause (i), by striking ‘to--’ and inserting ‘--’;CommentsClose CommentsPermalink





(B) in clause (i)--CommentsClose CommentsPermalink





(i) by striking ‘diagnose’ and inserting ‘to diagnose’; andCommentsClose CommentsPermalink





(ii) by striking ‘; or’ and inserting a semicolon;CommentsClose CommentsPermalink





(C) in clause (ii)--CommentsClose CommentsPermalink





(i) by striking ‘diagnose’ and inserting ‘to diagnose’; andCommentsClose CommentsPermalink





(ii) by striking the period at the end and inserting ‘; or’; andCommentsClose CommentsPermalink





(D) by adding at the end the following:CommentsClose CommentsPermalink





‘(iii) is a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii).’.CommentsClose CommentsPermalink





(2) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT- Section 319F-3(i)(7)(A) of the Public Health Service Act (42 U.S.C. 247d-6d(i)(7)(A)) is amended--CommentsClose CommentsPermalink





(A) in clause (i)(II), by striking ‘; or’ and inserting ‘;’;CommentsClose CommentsPermalink





(B) in clause (ii), by striking ‘; and’ and inserting ‘; or’; andCommentsClose CommentsPermalink





(C) by adding at the end the following:CommentsClose CommentsPermalink





‘(iii) a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii); and’.CommentsClose CommentsPermalink





(3) TECHNICAL AMENDMENTS- Section 319F-3(i) of the Public Health Service Act (42 U.S.C. 247d-6d(i)) is amended--CommentsClose CommentsPermalink





(A) in paragraph (1)(C), by inserting ‘, 564A, or 564B’ after ‘564’; andCommentsClose CommentsPermalink





(B) in paragraph (7)(B)(iii), by inserting ‘, 564A, or 564B’ after ‘564’.CommentsClose CommentsPermalink

SEC. 403. STRATEGIC NATIONAL STOCKPILE.CommentsClose CommentsPermalink

Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) is amended--CommentsClose CommentsPermalink





(1) in subsection (a)--CommentsClose CommentsPermalink





(A) in paragraph (1)--CommentsClose CommentsPermalink





(i) by inserting ‘consistent with section 2811’ before ‘by the Secretary to be appropriate’; andCommentsClose CommentsPermalink





(ii) by inserting before the period at the end of the second sentence the following: ‘and shall submit such review annually to the appropriate congressional committees of jurisdiction to the extent that disclosure of such information does not compromise national security’; andCommentsClose CommentsPermalink





(B) in paragraph (2)(D), by inserting before the semicolon at the end the following: ‘and that the potential depletion of countermeasures currently in the stockpile is identified and appropriately addressed, including through necessary replenishment’; andCommentsClose CommentsPermalink





(2) in subsection (f)(1), by striking ‘$640,000,000 for fiscal year 2002, and such sums as may be necessary for each of fiscal years 2003 through 2006. Such authorization is in addition to amounts in the special reserve fund referred to in subsection (c)(10)(A).’ and inserting ‘$533,800,000 for each of fiscal years 2014 through 2018. Such authorization is in addition to amounts in the special reserve fund referred to in subsection (h).’.CommentsClose CommentsPermalink

SEC. 404. NATIONAL BIODEFENSE SCIENCE BOARD.CommentsClose CommentsPermalink

Section 319M(a) of the Public Health Service Act (42 U.S.C. 247d-f(a)) is amended--CommentsClose CommentsPermalink





(1) in paragraph (2)--CommentsClose CommentsPermalink





(A) in subparagraph (D)--CommentsClose CommentsPermalink





(i) in clause (i), by striking ‘and’ at the end;CommentsClose CommentsPermalink





(ii) in clause (ii), by striking the period and inserting a semicolon; andCommentsClose CommentsPermalink





(iii) by adding at the end the following:CommentsClose CommentsPermalink





‘(iii) one such member shall be an individual with pediatric subject matter expertise; andCommentsClose CommentsPermalink





‘(iv) one such member shall be a State, tribal, territorial, or local public health official.’; andCommentsClose CommentsPermalink





(B) by adding at the end the following flush sentence:CommentsClose CommentsPermalink





‘Nothing in this paragraph shall preclude a member of the Board from satisfying two or more of the requirements described in subparagraph (D).’; andCommentsClose CommentsPermalink





(2) in paragraph (5)--CommentsClose CommentsPermalink





(A) in subparagraph (B), by striking ‘and’ at the end;CommentsClose CommentsPermalink





(B) in subparagraph (C), by striking the period and inserting ‘; and’; andCommentsClose CommentsPermalink





(C) by adding at the end the following:CommentsClose CommentsPermalink





‘(D) provide any recommendation, finding, or report provided to the Secretary under this paragraph to the appropriate committees of Congress.’.CommentsClose CommentsPermalink

Attest:

Secretary.

113th CONGRESS

1st Session

H.R. 307

AMENDMENT

Speaker of the House of Representatives. CommentsClose CommentsPermalink