H.R. 307 — what changed

“(C) Coordinated medical triage and evacuation to appropriate medical institutions based on patient medical need, taking into account regionalized systems of care.”

changed “(G) Optimizing a coordinated and flexible approach to the medical surge capacity of hospitals, other health care facilities, critical care, and trauma care (which may include trauma centers) centers), and emergency medical systems.”

“(7) Countermeasures

“(A) Promoting strategic initiatives to advance countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin, chemical, radiological, or nuclear agent or agents, whether naturally occurring, unintentional, or deliberate.

“(B) For purposes of this paragraph, the term countermeasures has the same meaning as the terms qualified countermeasures under section 319F–1, “qualified pandemic and epidemic products” under section 319F–3, and “security countermeasures” under section 319F–2.

“(8) Medical and public health community resiliency—Strengthening the ability of States, local communities, and tribal communities to prepare for, respond to, and be resilient in the event of public health emergencies, whether naturally occurring, unintentional, or deliberate by—

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

“(B) promoting familiarity with local medical and public health systems.”

“(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;”

“(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);”

“(7) disseminate and, as appropriate, update novel and best practices of outreach to and care of at-risk individuals before, during, and following public health emergencies in as timely a manner as is practicable, including from the time a public health threat is identified; and

“(8) ensure that public health and medical information distributed by the Department of Health and Human Services during a public health emergency is delivered in a manner that takes into account the range of communication needs of the intended recipients, including at-risk individuals.”

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:

“2811A. National Advisory Committee on Children and Disasters

“(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”).

“(b) Duties—The Advisory Committee shall—

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

“(2) evaluate and provide input with respect to the medical and public health needs of children as they relate to preparation for, response to, and recovery from all-hazards emergencies; and

“(3) provide advice and consultation with respect to State emergency preparedness and response activities and children, including related drills and exercises pursuant to the preparedness goals under section 2802(b).

“(c) Additional duties—The Advisory Committee may provide advice and recommendations to the Secretary with respect to children and the medical and public health grants and cooperative agreements as applicable to preparedness and response activities authorized under this title and title III.

“(d) Membership

“(1) In general—The Secretary, in consultation with such other Secretaries as may be appropriate, shall appoint not to exceed 15 members to the Advisory Committee. In appointing such members, the Secretary shall ensure that the total membership of the Advisory Committee is an odd number.

“(2) Required members—The Secretary, in consultation with such other Secretaries as may be appropriate, may appoint to the Advisory Committee under paragraph (1) such individuals as may be appropriate to perform the duties described in subsections (b) and (c), which may include—

“(A) the Assistant Secretary for Preparedness and Response;

“(B) the Director of the Biomedical Advanced Research and Development Authority;

“(C) the Director of the Centers for Disease Control and Prevention;

“(D) the Commissioner of Food and Drugs;

“(E) the Director of the National Institutes of Health;

“(F) the Assistant Secretary of the Administration for Children and Families;

“(G) the Administrator of the Federal Emergency Management Agency;

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

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

“(J) representatives from such Federal agencies (such as the Department of Education and the Department of Homeland Security) as determined necessary to fulfill the duties of the Advisory Committee, as established under subsections (b) and (c).

“(e) Meetings—The Advisory Committee shall meet not less than biannually.

changed “(f) Sunset—The Advisory Committee shall terminate on the date that is 5 years after the date of enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013.”September 30, 2018.”

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

“(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.”

“(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.”

changed 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 2013 2014 through 2017 2018 to carry out this section”.

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

changed “(e) Temporary redeployment reassignment of federally funded state and local personnel during a public health emergency

changed “(1) Emergency redeployment 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 the chief of a tribe tribal organization or such Governor or chief’s tribal organization’s designee, the Secretary may authorize the requesting State or Indian tribe to temporarily redeploy, reassign, for purposes of immediately addressing a public health emergency in the State or Indian tribe, non-Federal State and local public health department or agency personnel funded in whole or in part through, as appropriate, through programs authorized under this Act.Act, as appropriate.

changed “(2) Activation of emergency redeploymentreassignment

changed “(A) Public health emergency—The Secretary may authorize a temporary redeployment reassignment of personnel under paragraph (1) only during the period of a public health emergency determined pursuant to subsection (a).

changed “(B) Contents of request—To seek authority for a temporary redeployment reassignment of personnel under paragraph (1), the Governor of a State or the chief of a tribe tribal organization shall submit to the Secretary a request for such authority reassignment flexibility and shall include in the request each of the following:

changed “(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.

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

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

“(iv) An identification of—

changed “(I) each Federal program from which personnel would be temporarily redeployed reassigned pursuant to the requested authority; and

changed “(II) the number of personnel who would be so redeployed reassigned from each such program.

changed “(v) Such other information and assurances as upon which the Secretary may require.and Governor of a State or tribal organization agree.

changed “(C) Consideration—In reviewing a request for temporary redeployment reassignment under paragraph (1) of personnel funded through a Federal program, (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 redeployment.reassignment.

“(D) Termination and extension

changed “(i) Termination—A State or Indian tribe’s authority for a temporary redeployment reassignment of personnel under paragraph (1) shall terminate upon the earlier of the following:

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

changed “(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 authority.reassignment flexibility.

changed “(ii) Extension authority—The of reassignment flexibility—The Secretary may extend the authority to authorize a temporary redeployment 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—

changed “(I) the State or Indian tribe that submitted the initial request for authority for a temporary redeployment reassignment of personnel submits a request for an extension of such authority; temporary reassignment; and

changed “(II) the request for an extension contains the same type of information and assurances necessary for the approval of an initial request for such authority.temporary reassignment pursuant to subparagraph (B).

changed “(3) Notice to personnel of possibility of redeployment—The Secretary shall ensure that, if a State or tribe receives Federal funds for personnel who are subject to the Secretary’s redeployment authority under this subsection, the State or tribe gives notice to such personnel Voluntary nature of the possibility temporary reassignment of redeployment—state and local personnel

changed “(A) at In general—Unless otherwise provided under the time law or regulation of hiring; orthe State or Indian tribe that receives authorization for temporary reassignment of personnel under paragraph (1), personnel eligible for reassignment pursuant to such authorization—

changed “(B) in the case of personnel hired before the date of “(i) shall have the enactment of this subsection, as soon as practicable.opportunity to volunteer for temporary reassignment; and

changed “(4) Notice to Congress—The Secretary “(ii) shall give notice not be required to the Congress in conjunction with the approval under this subsection of—agree to a temporary reassignment.

changed “(A) any initial request for authority for a temporary redeployment “(B) Prohibition on conditioning Federal awards—The Secretary may not condition the award of personnel; anda 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.

changed “(B) any request for an extension of such authority.“(4) Notice to congress—The Secretary shall give notice to the Congress in conjunction with the approval under this subsection of—

added “(A) any initial request for temporary reassignment of personnel; and

added “(B) any request for an extension of such temporary reassignment.

“(5) Guidance—The Secretary shall—

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

removed “(A) not later than 6 months after the enactment of this subsection, issue proposed guidance on the temporary redeployment of personnel under this subsection; and

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

removed “(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 the Secretary’s authority under this subsection, including—

removed “(A) a description of how, and under what circumstances, such authority has been used by States and tribes;

changed “(B) an analysis “(6) Report to congress—Not later than 4 years after the date of how such authority has assisted 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 tribes in responding submit to public health emergencies;the appropriate committees of the Congress a report, on temporary reassignment under this subsection, including—

changed “(C) an evaluation “(A) a description of how how, and under what circumstances, such authority temporary reassignment has improved operational efficiencies in responding to public health emergencies;been used by States and Indian tribes;

changed “(D) “(B) an analysis of the extent to which, if any, Federal programs from which personnel have been temporarily redeployed pursuant to how such authority have been adversely affected by the redeployment; andtemporary reassignment has assisted States and Indian tribes in responding to public health emergencies;

changed “(E) recommendations on “(C) an evaluation of how such authority could be temporary reassignment has improved to further assist operational efficiencies in responding to public health emergencies.emergencies;

changed “(7) Definition—In this subsection, “(D) an analysis of the term State includes, in addition extent to the entities listed in the definition of such term in section 2, which, if any, Federal programs from which personnel have been temporarily reassigned have been adversely affected by the Freely Associated States.reassignment; and

changed “(8) Sunset—The authority under this subsection shall terminate “(E) recommendations on the date that is 5 years after how medical surge capacity could be improved in responding to public health emergencies and the date of enactment impact of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013.”reassignment flexibility under this section on such surge capacity.

added “(7) Definitions—In this subsection—

added “(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; and

added “(B) the term State includes, in addition to the entities listed in the definition of such term in section 2, the Freely Associated States.

added “(8) Sunset—This subsection shall terminate on September 30, 2018.”

“(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;

“(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);”

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

“(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);

“(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; and

“(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;”

“(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”

“(7) Availability of cooperative agreement funds

“(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.

“(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).”

“(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.”

“(g) Coordination

“(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.

“(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).”

“(1) In general—The requirements of”

“(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.”

changed “(1) In general—For purposes of carrying out this section, there is authorized to be appropriated $374,700,000 for each of fiscal years 2013 2014 through 2017.”2018.”

“(4) Availability of cooperative agreement funds

“(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.

“(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).”

removed Section 319D of the Public Health Service Act (42 U.S.C. 247d–4) is amended—

“(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—

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

“(B) modernize and enhance biosurveillance activities; and

“(C) improve information sharing, coordination, and communication among disparate biosurveillance systems supported by the Department of Health and Human Services.”

“(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;”

“(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—

“(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;

“(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; and

“(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.”

added “(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.”

removed “(h) 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.”

“(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.”

changed “(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 2013 2014 through 2017, 2018, such amounts to remain available until expended.”

“(f) Independent evaluation

“(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.

“(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—

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

“(B) the activities supported by flexible manufacturing initiatives; and

“(C) the ability of flexible manufacturing activities carried out under this section to—

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

“(ii) meet the surge manufacturing capacity needs presented by novel and emerging threats, including chemical, biological, radiological, and nuclear agents.”

“(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).”

“(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”

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