(a) Short title.—This Act may be cited as the “Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018”.

(b) Table of contents.—The table of contents for this Act is as follows:

Sec. 1. Short title; table of contents.

Except as otherwise specified—

(1) amendments made by this division to a section or other provision of law are amendments to such section or other provision of the Public Health Service Act (42 U.S.C. 201 et seq.); and

(2) any reference to “this Act” contained in this division shall be treated as referring only to the provisions of this division.

Section 2802 (42 U.S.C. 300hh–1) is amended—

(1) in subsection (a)—

(A) in paragraph (1)—

(i) by striking “2014” and inserting “2018”; and

(ii) by striking the second sentence and inserting the following: “Such National Health Security Strategy shall describe potential emergency health security threats and identify the process for achieving the preparedness goals described in subsection (b) to be prepared to identify and respond to such threats and shall be consistent with the national preparedness goal (as described in section 504(a)(19) of the Homeland Security Act of 2002), the National Incident Management System (as defined in section 501(7) of such Act), and the National Response Plan developed pursuant to section 504 of such Act, or any successor plan.”;

(B) in paragraph (2), by inserting before the period at the end of the second sentence the following: “, and an analysis of any changes to the evidence-based benchmarks and objective standards under sections 319C–1 and 319C–2”; and

(C) in paragraph (3)—

(i) by striking “2009” and inserting “2022”;

(ii) by inserting “(including gaps in the environmental health and animal health workforces, as applicable), describing the status of such workforce” after “gaps in such workforce”;

(iii) by striking “and identifying strategies” and inserting “identifying strategies”; and

(iv) by inserting before the period at the end “, and identifying current capabilities to meet the requirements of section 2803”; and

(2) in subsection (b)—

(A) in paragraph (2)—

(i) in subparagraph (A), by striking “and investigation” and inserting “investigation, and related information technology activities”;

(ii) in subparagraph (B), by striking “and decontamination” and inserting “decontamination, relevant health care services and supplies, and transportation and disposal of medical waste”; and

(iii) by adding at the end the following:

“(E) Response to environmental hazards.”;

(B) in paragraph (3)—

(i) in the matter preceding subparagraph (A), by striking “including mental health” and inserting “including pharmacies, mental health facilities,”; and

(ii) in subparagraph (F), by inserting “or exposures to agents that could cause a public health emergency” before the period;

(C) in paragraph (5), by inserting “and other applicable compacts” after “Compact”; and

(D) by adding at the end the following:

“(9) ZOONOTIC DISEASE, FOOD, AND AGRICULTURE.—Improving coordination among Federal, State, local, tribal, and territorial entities (including through consultation with the Secretary of Agriculture) to prevent, detect, and respond to outbreaks of plant or animal disease (including zoonotic disease) that could compromise national security resulting from a deliberate attack, a naturally occurring threat, the intentional adulteration of food, or other public health threats, taking into account interactions between animal health, human health, and animals' and humans' shared environment as directly related to public health emergency preparedness and response capabilities, as applicable.

“(10) GLOBAL HEALTH SECURITY.—Assessing current or potential health security threats from abroad to inform domestic public health preparedness and response capabilities.”.

(a) Evaluating measurable evidence-based benchmarks and objective standards.—Section 319C–1 (42 U.S.C. 247d–3a) is amended by inserting after subsection (j) the following:

“(k) Evaluation.—

“(1) IN GENERAL.—Not later than 2 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 and every 2 years thereafter, the Secretary shall conduct an evaluation of the evidence-based benchmarks and objective standards required under subsection (g). Such evaluation shall be submitted to the congressional committees of jurisdiction together with the National Health Security Strategy under section 2802, at such time as such strategy is submitted.

“(2) CONTENT.—The evaluation under this paragraph shall include—

“(A) a review of evidence-based benchmarks and objective standards, and associated metrics and targets;

“(B) a discussion of changes to any evidence-based benchmarks and objective standards, and the effect of such changes on the ability to track whether entities are meeting or making progress toward the goals under this section and, to the extent practicable, the applicable goals of the National Health Security Strategy under section 2802;

“(C) a description of amounts received by eligible entities described in subsection (b) and section 319C–2(b), and amounts received by subrecipients and the effect of such funding on meeting evidence-based benchmarks and objective standards; and

“(D) recommendations, as applicable and appropriate, to improve evidence-based benchmarks and objective standards to more accurately assess the ability of entities receiving awards under this section to better achieve the goals under this section and section 2802.”.

(b) Evaluating the partnership for State and regional hospital preparedness.—Section 319C–2(i)(1) (42 U.S.C. 247–3b(i)(1)) is amended by striking “section 319C–1(g), (i), and (j)” and inserting “section 319C–1(g), (i), (j), and (k)”.

(a) Cooperative agreement applications for improving State and local public health security.—Section 319C–1 (42 U.S.C. 247d–3a) is amended—

(1) in subsection (a), by inserting “, acting through the Director of the Centers for Disease Control and Prevention,” after “the Secretary”; and

(2) in subsection (b)(2)(A)—

(A) in clause (vi), by inserting “, including public health agencies with specific expertise that may be relevant to public health security, such as environmental health agencies,” after “stakeholders”;

(B) by redesignating clauses (vii) through (ix) as clauses (viii) through (x);

(C) by inserting after clause (vi) the following:

“(vii) a description of how, as applicable, such entity may integrate information to account for individuals with behavioral health needs following a public health emergency;”;

(D) in clause (ix), as so redesignated, by striking “; and” and inserting a semicolon; and

(E) by adding at the end the following:

“(xi) a description of how the entity will partner with health care facilities, including hospitals and nursing homes and other long-term care facilities, to promote and improve public health preparedness and response; and

“(xii) a description of how, as appropriate and practicable, the entity will include critical infrastructure partners, such as utility companies within the entity’s jurisdiction, in planning pursuant to this subparagraph to help ensure that critical infrastructure will remain functioning during, or return to function as soon as practicable after, a public health emergency;”.

(b) Exception relating to application of certain requirements.—

(1) IN GENERAL.—Section 319C–1(g) (42 U.S.C. 247d–3a(g)) is amended—

(A) in paragraph (5)—

(i) in the matter preceding subparagraph (A), by striking “Beginning with fiscal year 2009” and inserting “Beginning with fiscal year 2019”; and

(ii) in subparagraph (A)—

(I) by striking “for the immediately preceding fiscal year” and inserting “for either of the 2 immediately preceding fiscal years”; and

(II) by striking “2008” and inserting “2018”; and

(B) in paragraph (6), by amending subparagraph (A) to read as follows:

“(A) IN GENERAL.—The amounts described in this paragraph are the following amounts that are payable to an entity for activities described in this section or section 319C–2:

“(i) For no more than 1 of each of the first 2 fiscal years immediately following a fiscal year in which an entity experienced a failure described in subparagraph (A) or (B) of paragraph (5), an amount equal to 10 percent of the amount the entity was eligible to receive for the respective fiscal year.

“(ii) For no more than 1 of the first 2 fiscal years immediately following the third consecutive fiscal year in which an entity experienced such a failure, in lieu of applying clause (i), an amount equal to 15 percent of the amount the entity was eligible to receive for the respective fiscal year.”.

(2) EFFECTIVE DATE.—The amendments made by paragraph (1) shall apply with respect to cooperative agreements awarded on or after the date of enactment of this Act.

(c) Partnership for State and regional hospital preparedness to improve surge capacity.—Section 319C–2 (42 U.S.C. 247d–3b) is amended—

(1) in subsection (a)—

(A) by inserting “, acting through the Assistant Secretary for Preparedness and Response,” after “The Secretary”; and

(B) by striking “preparedness for public health emergencies” and inserting “preparedness for, and response to, public health emergencies in accordance with subsection (c)”;

(2) in subsection (b)(1)(A)—

(A) by striking “partnership consisting of” and inserting “coalition that includes”;

(B) in clause (ii), by striking “; and” and inserting a semicolon; and

(C) by adding at the end the following:

“(iv) one or more emergency medical service organizations or emergency management organizations; and”;

(3) in subsection (d)—

(A) in paragraph (1)(B), by striking “partnership” each place it appears and inserting “coalition”; and

(B) in paragraph (2)(C), by striking “medical preparedness” and inserting “preparedness and response”;

(4) in subsection (f), by striking “partnership” and inserting “coalition”;

(5) in subsection (g)(2)—

(A) by striking “Partnerships” and inserting “Coalitions”;

(B) by striking “partnerships” and inserting “coalitions”; and

(C) by inserting “and response” after “preparedness”; and

(6) in subsection (i)(1)—

(A) by striking “An entity” and inserting “A coalition”; and

(B) by striking “such partnership” and inserting “such coalition”.

(d) Public health security grants authorization of appropriations.—Section 319C–1(h)(1)(A) (42 U.S.C. 247d–3a(h)(1)(A)) is amended by striking “$641,900,000 for fiscal year 2014” and all that follows through the period at the end and inserting “$685,000,000 for each of fiscal years 2019 through 2023 for awards pursuant to paragraph (3) (subject to the authority of the Secretary to make awards pursuant to paragraphs (4) and (5)).”.

(e) Partnership for State and regional hospital preparedness authorization of appropriations.—Section 319C–2(j) (42 U.S.C. 247d–3b(j)) is amended—

(1) by amending paragraph (1) to read as follows:

“(1) IN GENERAL.—

“(A) AUTHORIZATION OF APPROPRIATIONS.—For purposes of carrying out this section and section 319C–3, in accordance with subparagraph (B), there is authorized to be appropriated $385,000,000 for each of fiscal years 2019 through 2023.

“(B) RESERVATION OF AMOUNTS FOR REGIONAL SYSTEMS.—

“(i) IN GENERAL.—Subject to clause (ii), of the amount appropriated under subparagraph (A) for a fiscal year, the Secretary may reserve up to 5 percent for the purpose of carrying out section 319C–3.

“(ii) RESERVATION CONTINGENT ON CONTINUED APPROPRIATIONS FOR THIS SECTION.—If for fiscal year 2019 or a subsequent fiscal year, the amount appropriated under subparagraph (A) is such that, after application of clause (i), the amount remaining for the purpose of carrying out this section would be less than the amount available for such purpose for the previous fiscal year, the amount that may be reserved under clause (i) shall be reduced such that the amount remaining for the purpose of carrying out this section is not less than the amount available for such purpose for the previous fiscal year.

“(iii) SUNSET.—The authority to reserve amounts under clause (i) shall expire on September 30, 2023.”;

(2) in paragraph (2), by striking “paragraph (1) for a fiscal year” and inserting “paragraph (1)(A) for a fiscal year and not reserved for the purpose described in paragraph (1)(B)(i)”; and

(3) in paragraph (3)(A), by striking “paragraph (1) and not reserved under paragraph (2)” and inserting “paragraph (1)(A) and not reserved under paragraph (1)(B)(i) or (2)”.

(a) In general.—Part B of title III (42 U.S.C. 243 et seq.) is amended by inserting after section 319C–2 the following:

(b) GAO report to Congress.—

(1) REPORT.—Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States (referred to in this subsection as the “Comptroller General”) shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Finance of the Senate and the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives, a report on the extent to which hospitals and health care facilities have implemented the recommended guidelines under section 319C–3(b) of the Public Health Service Act (as added by subsection (a)), including an analysis and evaluation of any challenges hospitals or health care facilities experienced in implementing such guidelines.

(2) CONTENT.—The Comptroller General shall include in the report under paragraph (1)—

(A) data on the preparedness and response capabilities that have been informed by the guidelines under section 319C–3(b) of the Public Health Service Act to improve regional emergency health care preparedness and response capability, including hospital and health care facility capacity and medical surge capabilities to prepare for, and respond to, public health emergencies; and

(B) recommendations to reduce gaps in incentives for regional health partners, including hospitals and health care facilities, to improve capacity and medical surge capabilities to prepare for, and respond to, public health emergencies, consistent with subsection (a), which may include consideration of facilities participating in programs under section 319C–2 of the Public Health Service Act (42 U.S.C. 247d–3b) or in programs under the Centers for Medicare & Medicaid Services (including innovative health care delivery and payment models), and input from private sector financial institutions.

(3) CONSULTATION.—In carrying out paragraphs (1) and (2), the Comptroller General shall consult with the heads of appropriate Federal agencies, including—

(A) the Assistant Secretary for Preparedness and Response;

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

(C) the Administrator of the Centers for Medicare & Medicaid Services;

(D) the Assistant Secretary for Mental Health and Substance Use;

(E) the Assistant Secretary of Labor for Occupational Safety and Health; and

(F) the Secretary of Veterans Affairs.

(c) Annual reports.—Section 319C–2(i)(1) (42 U.S.C. 247d–3b(i)(1)) is amended by inserting after the first sentence the following: “In submitting reports under this paragraph, a coalition shall include information on the progress that the coalition has made toward the implementation of section 319C–3 (or barriers to progress, if any).”.

(d) National health security strategy incorporation of regionalized emergency preparedness and response.—Subparagraph (G) of section 2802(b)(3) (42 U.S.C. 300hh–1(b)(3)) is amended to read as follows:

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

(e) Improving State and local public health security.—

(1) STATE AND LOCAL SECURITY.—Section 319C–1(e) (42 U.S.C. 247d–3a(e)) is amended by striking “, and local emergency plans.” and inserting “, local emergency plans, and any regional health care emergency preparedness and response system established pursuant to the applicable guidelines under section 319C–3.”.

(2) PARTNERSHIPS.—Section 319C–2(d)(1)(A) (42 U.S.C. 247d–3b(d)(1)(A)) is amended—

(A) in clause (i), by striking “; and” and inserting “;”;

(B) by redesignating clause (ii) as clause (iii); and

(C) inserting after clause (i), the following:

“(ii) among one or more facilities in a regional health care emergency system under section 319C–3; and”.

Title XII (42 U.S.C. 300d et seq.) is amended by adding at the end the following new part:

(a) Facilities, capacities, and biosurveillance capabilities.—Section 319D (42 U.S.C. 247d–4) is amended—

(1) in the section heading, by striking “Revitalizing” and inserting “Facilities and capacities of”;

(2) in subsection (a)—

(A) in the subsection heading, by striking “Facilities; capacities” and inserting “In general”;

(B) in paragraph (1), by striking “and improved” and inserting “, improved, and appropriately maintained”;

(C) in paragraph (3), in the matter preceding subparagraph (A), by striking “expand, enhance, and improve” and inserting “expand, improve, enhance, and appropriately maintain”; and

(D) by adding at the end the following:

“(4) STUDY OF RESOURCES FOR FACILITIES AND CAPACITIES.—Not later than June 1, 2022, the Comptroller General of the United States shall conduct a study on Federal spending in fiscal years 2013 through 2018 for activities authorized under this subsection. Such study shall include a review and assessment of obligations and expenditures directly related to each activity under paragraphs (2) and (3), including a specific accounting of, and delineation between, obligations and expenditures incurred for the construction, renovation, equipping, and security upgrades of facilities and associated contracts under this subsection, and the obligations and expenditures incurred to establish and improve the situational awareness and biosurveillance network under subsection (b), and shall identify the agency or agencies incurring such obligations and expenditures.”;

(3) in subsection (b)—

(A) in the subsection heading, by striking “national” and inserting “Establishment of systems of public health”;

(B) in paragraph (1)(B), by inserting “immunization information systems,” after “centers,”; and

(C) in paragraph (2)—

(i) by inserting “develop a plan to, and” after “The Secretary shall”; and

(ii) by inserting “and in a form readily usable for analytical approaches” after “in a secure manner”; and

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

“(3) STANDARDS.—

“(A) IN GENERAL.—Not later than 1 year after the date of the enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, the Secretary, in cooperation with health care providers, State, local, tribal, and territorial public health officials, and relevant Federal agencies (including the Office of the National Coordinator for Health Information Technology and the National Institute of Standards and Technology), shall, as necessary, adopt technical and reporting standards, including standards for interoperability as defined by section 3000, for networks under paragraph (1) and update such standards as necessary. Such standards shall be made available on the internet website of the Department of Health and Human Services, in a manner that does not compromise national security.

“(B) DEFERENCE TO STANDARDS DEVELOPMENT ORGANIZATIONS.—In adopting and implementing standards under this subsection and subsection (c), the Secretary shall give deference to standards published by standards development organizations and voluntary consensus-based standards entities.”;

(4) in subsection (c)—

(A) in paragraph (1)—

(i) by striking “Not later than 2 years after the date of enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, the Secretary” and inserting “The Secretary”;

(ii) by inserting “, and improve as applicable and appropriate,” after “shall establish”;

(iii) by striking “of rapid” and inserting “of, rapid”; and

(iv) by striking “such connectivity” and inserting “such interoperability”;

(B) by amending paragraph (2) to read as follows:

“(2) COORDINATION AND CONSULTATION.—In establishing and improving the network under paragraph (1) the Secretary shall—

“(A) facilitate coordination among agencies within the Department of Health and Human Services that provide, or have the potential to provide, information and data to, and analyses for, the situational awareness and biosurveillance network under paragraph (1), including coordination among relevant agencies related to health care services, the facilitation of health information exchange (including the Office of the National Coordinator for Health Information Technology), and public health emergency preparedness and response; and

“(B) consult with the Secretary of Agriculture, the Secretary of Commerce (and the Director of the National Institute of Standards and Technology), the Secretary of Defense, the Secretary of Homeland Security, the Secretary of Veterans Affairs, and the heads of other Federal agencies, as the Secretary determines appropriate.”;

(C) in paragraph (3)—

(i) by redesignating subparagraphs (A) through (E) as clauses (i) through (v), respectively, and adjusting the margins accordingly;

(ii) in clause (iv), as so redesignated—

(I) by inserting “immunization information systems,” after “poison control,”; and

(II) by striking “and clinical laboratories” and inserting “, clinical laboratories, and public environmental health agencies”;

(iii) by striking “The network” and inserting the following:

“(A) IN GENERAL.—The network”; and

(iv) by adding at the end the following:

“(B) REVIEW.—Not later than 2 years after the date of the enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 and every 6 years thereafter, the Secretary shall conduct a review of the elements described in subparagraph (A). Such review shall include a discussion of the addition of any elements pursuant to clause (v), including elements added to advancing new technologies, and identify any challenges in the incorporation of elements under subparagraph (A). The Secretary shall provide such review to the congressional committees of jurisdiction.”;

(D) in paragraph (5)—

(i) by redesignating subparagraphs (A) through (D) as clauses (i) through (iv), respectively, and adjusting the margins accordingly;

(ii) by striking “In establishing” and inserting the following:

“(A) IN GENERAL.—In establishing”;

(iii) by adding at the end the following:

“(B) PUBLIC MEETING.—

“(i) IN GENERAL.—Not later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, the Secretary shall convene a public meeting for purposes of discussing and providing input on the potential goals, functions, and uses of the network described in paragraph (1) and incorporating the elements described in paragraph (3)(A).

“(ii) EXPERTS.—The public meeting shall include representatives of relevant Federal agencies (including representatives from the Office of the National Coordinator for Health Information Technology and the National Institute of Standards and Technology); State, local, tribal, and territorial public health officials; stakeholders with expertise in biosurveillance and situational awareness; stakeholders with expertise in capabilities relevant to biosurveillance and situational awareness, such as experts in informatics and data analytics (including experts in prediction, modeling, or forecasting); and other representatives as the Secretary determines appropriate.

“(iii) TOPICS.—Such public meeting shall include a discussion of—

“(I) data elements, including minimal or essential data elements, that are voluntarily provided for such network, which may include elements from public health and public and private health care entities, to the extent practicable;

“(II) standards and implementation specifications that may improve the collection, analysis, and interpretation of data during a public health emergency;

“(III) strategies to encourage the access, exchange, and use of information;

“(IV) considerations for State, local, tribal, and territorial capabilities and infrastructure related to data exchange and interoperability;

“(V) privacy and security protections provided at the Federal, State, local, tribal, and territorial levels, and by nongovernmental stakeholders; and

“(VI) opportunities for the incorporation of innovative technologies to improve the network.”; and

(iv) in subparagraph (A), as so designated by clause (ii)—

(I) in clause (i), as so redesignated—

(aa) by striking “as determined” and inserting “as adopted”; and

(bb) by inserting “and the National Institute of Standards and Technology” after “Office of the National Coordinator for Health Information Technology”;

(II) in clause (iii), as so redesignated, by striking “; and” and inserting a semicolon;

(III) in clause (iv), as so redesignated, by striking the period and inserting “; and”; and

(IV) by adding at the end the following:

“(v) pilot test standards and implementation specifications, consistent with the process described in section 3002(b)(3)(C), which State, local, tribal, and territorial public health entities may utilize, on a voluntary basis, as a part of the network.”;

(E) by redesignating paragraph (6) as paragraph (7);

(F) by inserting after paragraph (5) the following:

“(6) STRATEGY AND IMPLEMENTATION PLAN.—

“(A) IN GENERAL.—Not later than 18 months after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, the Secretary shall submit to the congressional committees of jurisdiction a coordinated strategy and an accompanying implementation plan that—

“(i) is informed by the public meeting under paragraph (5)(B);

“(ii) includes a review and assessment of existing capabilities of the network and related infrastructure, including input provided by the public meeting under paragraph (5)(B);

“(iii) identifies and demonstrates the measurable steps the Secretary will carry out to—

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

“(II) modernize and enhance biosurveillance activities, including strategies to include innovative technologies and analytical approaches (including prediction and forecasting for pandemics and all-hazards) from public and private entities;

“(III) improve information sharing, coordination, and communication among disparate biosurveillance systems supported by the Department of Health and Human Services, including the identification of methods to improve accountability, better utilize resources and workforce capabilities, and incorporate innovative technologies within and across agencies; and

“(IV) test and evaluate capabilities of the interoperable network of systems to improve situational awareness and biosurveillance capabilities;

“(iv) includes performance measures and the metrics by which performance measures will be assessed with respect to the measurable steps under clause (iii); and

“(v) establishes dates by which each measurable step under clause (iii) will be implemented.

“(B) ANNUAL BUDGET PLAN.—Not later than 2 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 and on an annual basis thereafter, in accordance with the strategy and implementation plan under this paragraph, the Secretary shall, taking into account recommendations provided by the National Biodefense Science Board, develop a budget plan based on the strategy and implementation plan under this section. Such budget plan shall include—

“(i) a summary of resources previously expended to establish, improve, and utilize the nationwide public health situational awareness and biosurveillance network under paragraph (1);

“(ii) estimates of costs and resources needed to establish and improve the network under paragraph (1) according to the strategy and implementation plan under subparagraph (A);

“(iii) the identification of gaps and inefficiencies in nationwide public health situational awareness and biosurveillance capabilities, resources, and authorities needed to address such gaps; and

“(iv) a strategy to minimize and address such gaps and improve inefficiencies.”;

(G) in paragraph (7), as so redesignated—

(i) in subparagraph (A), by inserting “(taking into account zoonotic disease, including gaps in scientific understanding of the interactions between human, animal, and environmental health)” after “human health”;

(ii) in subparagraph (B)—

(I) by inserting “and gaps in surveillance programs” after “surveillance programs”; and

(II) by striking “; and” and inserting a semicolon;

(iii) in subparagraph (C)—

(I) by inserting “, animal health organizations related to zoonotic disease,” after “health care entities”; and

(II) by striking the period and inserting “; and”; and

(iv) by adding at the end the following:

“(D) provide recommendations to the Secretary on policies and procedures to complete the steps described in this paragraph in a manner that is consistent with section 2802.”; and

(H) by adding at the end the following:

“(8) SITUATIONAL AWARENESS AND BIOSURVEILLANCE AS A NATIONAL SECURITY PRIORITY.—The Secretary, on a periodic basis as applicable and appropriate, shall meet with the Director of National Intelligence to inform the development and capabilities of the nationwide public health situational awareness and biosurveillance network.”;

(5) in subsection (d)—

(A) in paragraph (1)—

(i) by inserting “environmental health agencies,” after “public health agencies,”; and

(ii) by inserting “immunization programs,” after “poison control centers,”; and

(B) in paragraph (2)—

(i) in subparagraph (B), by striking “and” at the end;

(ii) in subparagraph (C), by striking the period and inserting “; and”; and

(iii) by adding after subparagraph (C) the following:

“(D) an implementation plan that may include measurable steps to achieve the purposes described in paragraph (1).”; and

(C) by striking paragraph (5) and inserting the following:

“(5) TECHNICAL ASSISTANCE.—The Secretary may provide technical assistance to States, localities, tribes, and territories or a consortium of States, localities, tribes, and territories receiving an award under this subsection regarding interoperability and the technical standards set forth by the Secretary.”;

(6) by redesignating subsections (f) and (g) as subsections (i) and (j), respectively; and

(7) by inserting after subsection (e) the following:

“(f) Personnel authorities.—

“(1) SPECIALLY QUALIFIED PERSONNEL.—In addition to any other personnel authorities, to carry out subsections (b) and (c), the Secretary may—

“(A) appoint highly qualified individuals to scientific or professional positions at the Centers for Disease Control and Prevention, not to exceed 30 such employees at any time (specific to positions authorized by this subsection), with expertise in capabilities relevant to biosurveillance and situational awareness, such as experts in informatics and data analytics (including experts in prediction, modeling, or forecasting), and other related scientific or technical fields; and

“(B) compensate individuals appointed under subparagraph (A) in the same manner and subject to the same terms and conditions in which individuals appointed under 9903 of title 5, United States Code, are compensated, without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates.

“(2) LIMITATIONS.—The Secretary shall exercise the authority under paragraph (1) in a manner that is consistent with the limitations described in section 319F–1(e)(2).

“(g) Timeline.—The Secretary shall accomplish the purposes under subsections (b) and (c) no later than September 30, 2023, and shall provide a justification to the congressional committees of jurisdiction for any missed or delayed implementation of measurable steps identified under subsection (c)(6)(A)(iii).

“(h) Independent evaluation.—Not later than 3 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, the Comptroller General of the United States shall conduct an independent evaluation and submit to the Secretary and the congressional committees of jurisdiction a report concerning the activities conducted under subsections (b) and (c), and provide recommendations, as applicable and appropriate, on necessary improvements to the biosurveillance and situational awareness network.”.

(b) Authorization of appropriations.—Subsection (i) of section 319D (42 U.S.C. 247d–4), as redesignated by subsection (a)(6), is amended by striking “$138,300,000 for each of fiscal years 2014 through 2018” and inserting “$161,800,000 for each of fiscal years 2019 through 2023”.

(c) Biological threat detection report.—The Secretary of Health and Human Services shall, in coordination with the Secretary of Defense and the Secretary of Homeland Security, not later than 180 days after the date of enactment of this Act, report to the Committee on Energy and Commerce, the Committee on Armed Services, and the Committee on Homeland Security of the House of Representatives and the Committee on Health, Education, Labor, and Pensions, the Committee on Armed Services, and the Committee on Homeland Security and Governmental Affairs of the Senate on the state of Federal biological threat detection efforts, including the following—

(1) an identification of technological, operational, and programmatic successes and failures of domestic detection programs supported by Federal departments and agencies for intentionally-introduced or accidentally-released biological threat agents and naturally occurring infectious diseases;

(2) a description of Federal efforts to facilitate the exchange of information related to the information described in paragraph (1) among Federal departments and agencies that utilize biological threat detection technology;

(3) a description of the capabilities of detection systems in use by Federal departments and agencies including the capability to—

(A) rapidly detect, identify, characterize, and confirm the presence of biological threat agents;

(B) recover live biological agents from collection devices;

(C) determine the geographical distribution of biological agents;

(D) determine the extent of environmental contamination and persistence of biological agents; and

(E) provide advanced molecular diagnostics to State, local, tribal, and territorial public health and other laboratories that support biological threat detection activities;

(4) a description of Federal interagency coordination related to biological threat detection;

(5) a description of efforts by Federal departments and agencies that utilize biological threat detection technology to collaborate with State, local, tribal, and territorial public health laboratories and other users of biological threat detection systems, including collaboration regarding the development of—

(A) biological threat detection requirements or standards;

(B) a standardized integration strategy;

(C) training requirements or guidelines;

(D) guidelines for a coordinated public health response, including preparedness capabilities, and, as applicable, for coordination with public health surveillance systems; and

(E) a coordinated environmental remediation plan, as applicable; and

(6) recommendations related to research, advanced research, development, and procurement for Federal departments and agencies to improve and enhance biological threat detection systems, including recommendations on the transfer of biological threat detection technology among Federal departments and agencies, as necessary and appropriate.

Section 319 (42 U.S.C. 247d) is amended—

(1) in subsection (b)—

(A) in paragraph (1)—

(i) in the first sentence, by inserting “or if the Secretary determines there is the significant potential for a public health emergency, to allow the Secretary to rapidly respond to the immediate needs resulting from such public health emergency or potential public health emergency” before the period; and

(ii) by inserting “The Secretary shall plan for the expedited distribution of funds to appropriate agencies and entities.” after the first sentence;

(B) by redesignating paragraph (2) as paragraph (3);

(C) by inserting after paragraph (1) the following:

“(2) USES.—The Secretary may use amounts in the Fund established under paragraph (1), to—

“(A) facilitate coordination between and among Federal, State, local, tribal, and territorial entities and public and private health care entities that the Secretary determines may be affected by a public health emergency or potential public health emergency referred to in paragraph (1) (including communication of such entities with relevant international entities, as applicable);

“(B) make grants, provide for awards, enter into contracts, and conduct supportive investigations pertaining to a public health emergency or potential public health emergency, including further supporting programs under section 319C–1, 319C–2, or 319C–3;

“(C) facilitate and accelerate, as applicable, advanced research and development of security countermeasures (as defined in section 319F–2), qualified countermeasures (as defined in section 319F–1), or qualified pandemic or epidemic products (as defined in section 319F–3), that are applicable to the public health emergency or potential public health emergency under paragraph (1);

“(D) strengthen biosurveillance capabilities and laboratory capacity to identify, collect, and analyze information regarding such public health emergency or potential public health emergency, including the systems under section 319D;

“(E) support initial emergency operations and assets related to preparation and deployment of intermittent disaster response personnel under section 2812 and the Medical Reserve Corps under section 2813; and

“(F) carry out other activities, as the Secretary determines applicable and appropriate.”; and

(D) by inserting after paragraph (3), as so redesignated, the following:

“(4) REVIEW.—Not later than 2 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, the Secretary, in coordination with the Assistant Secretary for Preparedness and Response, shall conduct a review of the Fund under this section and provide recommendations to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives on policies to improve such Fund for the uses described in paragraph (2).

“(5) GAO REPORT.—Not later than 4 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, the Comptroller General of the United States shall—

“(A) conduct a review of the Fund under this section, including its uses and the resources available in the Fund; and

“(B) submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on such review, including recommendations related to such review, as applicable.”; and

(2) in subsection (c)—

(A) by inserting “rapidly respond to public health emergencies or potential public health emergencies and” after “used to”; and

(B) by striking “section.” and inserting “Act or funds otherwise provided for emergency response.”.

(a) In general.—Section 319I (42 U.S.C. 247d–7b) is amended—

(1) in the section heading, by striking “Health Professions Volunteers” and inserting “Volunteer Health Professional”;

(2) in subsection (a), by adding at the end the following: “Such health care professionals may include members of the National Disaster Medical System, members of the Medical Reserve Corps, and individual health care professionals.”;

(3) in subsection (i) by adding at the end “In order to inform the development of such mechanisms by States, the Secretary shall make available information and material provided by States that have developed mechanisms to waive the application of licensing requirements to applicable health professionals seeking to provide medical services during a public health emergency. Such information shall be made publicly available in a manner that does not compromise national security.”; and

(4) in subsection (k) by striking “2014 through 2018” and inserting “2019 through 2023”.

(b) All-Hazards Public Health Emergency Preparedness and Response Plan.—Section 319C–1(b)(2)(A)(iv) (42 U.S.C. 247d–3a(b)(2)(A)(iv)) is amended to read as follows:

“(iv) a description of the mechanism the entity will implement to utilize the Emergency Management Assistance Compact, or other mutual aid agreement, for medical and public health mutual aid, and, as appropriate, the activities such entity will implement pursuant to section 319I to improve enrollment and coordination of volunteer health care professionals seeking to provide medical services during a public health emergency, which may include—

“(I) providing a public method of communication for purposes of volunteer coordination (such as a phone number);

“(II) providing for optional registration to participate in volunteer services during processes related to State medical licensing, registration, or certification or renewal of such licensing, registration or certification; or

“(III) other mechanisms as the State determines appropriate;”.

(a) In general.—Title II (42 U.S.C. 202 et seq.) is amended by inserting after section 224 the following:

(b) GAO study.—Not later than one year after the date of enactment of this Act, the Comptroller General of the United States shall conduct a review of—

(1) the number of health care providers who register under the Emergency System for Advance Registration of Volunteer Health Professionals under section 319I of the Public Health Service Act (42 U.S.C. 247d–7b) in advance to provide services during a public health emergency;

(2) the number of health care providers who are credentialed to provide services during the period of a public health emergency declaration, including those who are credentialed though programs established in the Emergency System for Advance Registration of Volunteer Health Professionals under such section 319I and those credentialed by authorities within the State in which the emergency occurred;

(3) the average time to verify the credentials of a health care provider during the period of a public health emergency declaration, including the average time pursuant to the Emergency System for Advance Registration of Volunteer Health Professionals under such section 319I and for an individual’s credentials to be verified by an authority within the State; and

(4) the Emergency System for Advance Registration of Volunteer Health Professionals program in States, including whether physician or medical groups, associations, or other relevant provider organizations utilize such program for purposes of volunteering during public health emergencies.

Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report containing recommendations related to maintaining an adequate national blood supply, including—

(1) challenges associated with the continuous recruitment of blood donors (including those newly eligible to donate);

(2) ensuring the adequacy of the blood supply in the case of public health emergencies;

(3) implementation of the transfusion transmission monitoring system; and

(4) other measures to promote safety and innovation, such as the development, use, or implementation of new technologies, processes, and procedures to improve the safety and reliability of the blood supply.

(a) Study.—

(1) IN GENERAL.—Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall enter into an agreement with an appropriate entity to conduct a study regarding the public health preparedness and response capabilities and medical surge capacities of hospitals, long-term care facilities, and other health care facilities to prepare for, and respond to, public health emergencies, including natural disasters.

(2) CONSULTATION.—In conducting the study under paragraph (1), the entity shall consult with Federal, State, local, tribal, and territorial public health officials (as appropriate), and health care providers and facilities with experience in public health preparedness and response activities.

(3) EVALUATION.—The study under paragraph (1) shall include—

(A) an evaluation of the current benchmarks and objective standards, as applicable, related to programs that support hospitals, long-term care facilities, and other health care facilities, and their effect on improving public health preparedness and response capabilities and medical surge capacities, including the Hospital Preparedness Program, the Public Health Emergency Preparedness cooperative agreements, and the Regional Health Care Emergency Preparedness and Response Systems under section 319C–3 of the Public Health Service Act (as added by section 203);

(B) the identification of gaps in preparedness, including with respect to such benchmarks and objective standards, such as those identified during recent public health emergencies, for hospitals, long-term care facilities, and other health care facilities to address future potential public health threats;

(C) an evaluation of coordination efforts between the recipients of Federal funding for programs described in subparagraph (A) and entities with expertise in emergency power systems and other critical infrastructure partners during a public health emergency, to ensure a functioning critical infrastructure, to the greatest extent practicable, during a public health emergency;

(D) an evaluation of coordination efforts between the recipients of Federal funding for programs described in subparagraph (A) and environmental health agencies with expertise in emergency preparedness and response planning for hospitals, long-term care facilities, and other health care facilities; and

(E) an evaluation of current public health preparedness and response capabilities and medical surge capacities related to at-risk individuals during public health emergencies, including an identification of gaps in such preparedness as they relate to such individuals.

(b) Report.—

(1) IN GENERAL.—The agreement under subsection (a) shall require the entity to submit to the Secretary of Health and Human Services and the congressional committees of jurisdiction, not later than 3 years after the date of enactment of this Act, a report on the results of the study conducted pursuant to this section.

(2) CONTENTS.—The report under paragraph (1) shall—

(A) describe the findings and conclusions of the evaluation conducted pursuant to subsection (a); and

(B) provide recommendations for improving public health preparedness and response capability and medical surge capacity for hospitals, long-term care facilities, and other health care facilities, including—

(i) improving the existing benchmarks and objective standards for the Federal grant programs described in subsection (a)(3)(A) or developing new benchmarks and standards for such programs; and

(ii) identifying best practices for improving public health preparedness and response programs and medical surge capacity at hospitals, long-term care facilities, and other health care facilities, including recommendations for the evaluation under subparagraphs (C) and (D) of subsection (a)(3).

(a) National Disaster Medical System.—

(1) STRENGTHENING THE NATIONAL DISASTER MEDICAL SYSTEM.—Clause (ii) of section 2812(a)(3)(A) (42 U.S.C. 300hh–11(a)(3)(A)) is amended to read as follows:

“(ii) be present at locations, and for limited periods of time, specified by the Secretary on the basis that the Secretary has determined that a location is at risk of a public health emergency during the time specified, or there is a significant potential for a public health emergency.”.

(2) REVIEW OF THE NATIONAL DISASTER MEDICAL SYSTEM.—Section 2812(b)(2) (42 U.S.C. 300hh–11(b)(2)) is amended to read as follows:

“(2) JOINT REVIEW AND MEDICAL SURGE CAPACITY STRATEGIC PLAN.—

“(A) REVIEW.—Not later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, the Secretary, in coordination with the Secretary of Homeland Security, the Secretary of Defense, and the Secretary of Veterans Affairs, shall conduct a joint review of the National Disaster Medical System. Such review shall include—

“(i) an evaluation of medical surge capacity, as described in section 2803(a);

“(ii) an assessment of the available workforce of the intermittent disaster response personnel described in subsection (c);

“(iii) the capacity of the workforce described in clause (ii) to respond to all hazards, including capacity to simultaneously respond to multiple public health emergencies and the capacity to respond to a nationwide public health emergency;

“(iv) the effectiveness of efforts to recruit, retain, and train such workforce; and

“(v) gaps that may exist in such workforce and recommendations for addressing such gaps.

“(B) UPDATES.—As part of the National Health Security Strategy under section 2802, the Secretary shall update the findings from the review under subparagraph (A) and provide recommendations to modify the policies of the National Disaster Medical System as necessary.”.

(3) NOTIFICATION OF SHORTAGE.—Section 2812(c) (42 U.S.C. 300hh–11(c)) is amended by adding at the end the following:

“(3) NOTIFICATION.—Not later than 30 days after the date on which the Secretary determines the number of intermittent disaster-response personnel of the National Disaster Medical System is insufficient to address a public health emergency or potential public health emergency, the Secretary shall submit to the congressional committees of jurisdiction a notification detailing—

“(A) the impact such shortage could have on meeting public health needs and emergency medical personnel needs during a public health emergency; and

“(B) any identified measures to address such shortage.

“(4) CERTAIN APPOINTMENTS.—

“(A) IN GENERAL.—If the Secretary determines that the number of intermittent disaster response personnel within the National Disaster Medical System under this section is insufficient to address a public health emergency or potential public health emergency, the Secretary may appoint candidates directly to personnel positions for intermittent disaster response within such system. The Secretary shall provide updates on the number of vacant or unfilled positions within such system to the congressional committees of jurisdiction each quarter for which this authority is in effect.

“(B) SUNSET.—The authority under this paragraph shall expire on September 30, 2021.”.

(4) AUTHORIZATION OF APPROPRIATIONS.—Section 2812(g) (42 U.S.C. 300hh–11(g)) is amended by striking “$52,700,000 for each of fiscal years 2014 through 2018” and inserting “$57,400,000 for each of fiscal years 2019 through 2023”.

(b) Volunteer medical reserve corps.—

(1) IN GENERAL.—Section 2813(a) (42 U.S.C. 42 U.S.C. 300hh–15(a)) is amended by striking the second sentence and inserting “The Secretary may appoint a Director to head the Corps and oversee the activities of the Corps chapters that exist at the State, local, tribal, and territorial levels.”.

(2) AUTHORIZATION OF APPROPRIATIONS.—Section 2813(i) (42 U.S.C. 300hh–15(i)) is amended by striking “2014 through 2018” and inserting “2019 through 2023”.

(c) Strengthening the Epidemic Intelligence Service.—Section 317F (42 U.S.C. Sec. 247b–7) is amended—

(1) in subsection (a)—

(A) in paragraph (1)—

(i) by inserting “or preparedness and response activities, including rapid response to public health emergencies and significant public health threats” after “conduct prevention activities”; and

(ii) by striking “$35,000” and inserting “$50,000”; and

(B) in paragraph (2)(B), by striking “3 years” and inserting “2 years”; and

(2) in subsection (c)—

(A) by striking “For the purpose of carrying out this section” and inserting the following:

“(1) IN GENERAL.—For the purpose of carrying out this section, except as described in paragraph (2)”; and

(B) by adding at the end the following:

“(2) EPIDEMIC INTELLIGENCE SERVICE PROGRAM.—For purposes of carrying out this section with respect to qualified health professionals serving in the Epidemic Intelligence Service, as authorized under section 317G, there are authorized to be appropriated $1,000,000 for each of fiscal years 2019 through 2023.”.

(d) Service benefit for National Disaster Medical System volunteers.—

(1) IN GENERAL.—Section 2812(c) (42 U.S.C. 300hh–11(c)), as amended by subsection (a)(3), is further amended by adding at the end the following:

“(5) SERVICE BENEFIT.—Individuals appointed to serve under this subsection shall be considered eligible for benefits under part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968. The Secretary shall provide notification to any eligible individual of any effect such designation may have on other benefits for which such individual is eligible, including benefits from private entities.”.

(2) PUBLIC SAFETY OFFICER BENEFITS.—Section 1204(9) of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (34 U.S.C. 10284(9)) is amended—

(A) in subparagraph (C)(ii), by striking “or” at the end;

(B) in subparagraph (D), by striking the period and inserting “; or”; and

(C) by inserting after subparagraph (D) the following:

“(E) an individual appointed to the National Disaster Medical System under section 2812 of the Public Health Service Act (42 U.S.C. 300hh–11) who is performing official duties of the Department of Health and Human Services, if those official duties are—

“(i) related to responding to a public health emergency or potential public health emergency, or other activities for which the Secretary of Health and Human Services has activated such National Disaster Medical System; and

“(ii) determined by the Secretary of Health and Human Services to be hazardous.”.

(3) SUNSET.—The amendments made by paragraphs (1) and (2) shall cease to have force or effect on October 1, 2021.

(e) Mission readiness report to Congress.—

(1) REPORT.—Not later than one year after the date of enactment of this section, the Comptroller General of the United States (referred to in this subsection as the “Comptroller General”) shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the medical surge capacity of the United States in the event of a public health emergency, including the capacity and capability of the current health care workforce to prepare for, and respond to the full range of public health emergencies or potential public health emergencies, and recommendations to address any gaps identified in such workforce.

(2) CONTENTS.—The Comptroller General shall include in the report under paragraph (1)—

(A) the number of health care providers who have volunteered to provide health care services during a public health emergency, including members of the National Disaster Medical System, the Disaster Medical Assistant Teams, the Medical Reserve Corps, and other volunteer health care professionals in the verification network pursuant to section 319I of the Public Health Service Act (42 U.S.C. 247d–7b);

(B) the capacity of the workforce described in subparagraph (A) to respond to a public health emergency or potential public health emergency, including the capacity to respond to multiple concurrent public health emergencies and the capacity to respond to a nationwide public health emergency;

(C) the preparedness and response capabilities and mission readiness of the workforce described in subparagraph (A) taking into account areas of health care expertise and considerations for at-risk individuals (as defined in section 2802(b)(4)(B) of the Public Health Service Act (42 U.S.C. 300hh–1(b)(4)(B)));

(D) an assessment of the effectiveness of efforts to recruit, retain, and train such workforce; and

(E) identification of gaps that may exist in such workforce and recommendations for addressing such gaps, the extent to which the Assistant Secretary for Preparedness and Response plans to address such gaps, and any recommendations from the Comptroller General to address such gaps.

(a) Coordination of preparedness.—Section 2811(b)(5) (42 U.S.C. 300hh–10(b)(5)) is amended by adding at the end the following: “Such logistical support shall include working with other relevant Federal, State, local, tribal, and territorial public health officials and private sector entities to identify the critical infrastructure assets, systems, and networks needed for the proper functioning of the health care and public health sectors that need to be maintained through any emergency or disaster, including entities capable of assisting with, responding to, and mitigating the effect of a public health emergency, including a public health emergency determined by the Secretary pursuant to section 319(a) or an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act or the National Emergencies Act, including by establishing methods to exchange critical information and deliver products consumed or used to preserve, protect, or sustain life, health, or safety, and sharing of specialized expertise.”.

(b) Manufacturing Capacity.—Section 2811(d)(2)(C) (42 U.S.C. 300hh–10(d)(2)(C)) is amended by inserting “, and ancillary medical supplies to assist with the utilization of such countermeasures or products,” after “products”.

(c) Evaluation of barriers to rapid delivery of medical countermeasures.—

(1) RAPID DELIVERY STUDY.—The Assistant Secretary for Preparedness and Response may conduct a study on issues that have the potential to adversely affect the handling and rapid delivery of medical countermeasures to individuals during public health emergencies occurring in the United States.

(2) NOTICE TO CONGRESS.—Not later than 9 months after the date of the enactment of this Act, the Assistant Secretary for Preparedness and Response shall notify the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate if the Assistant Secretary for Preparedness and Response does not plan to conduct the study under paragraph (1) and shall provide such committees a summary explanation for such decision.

(3) REPORT TO CONGRESS.—Not later than 1 year after the Assistant Secretary for Preparedness and Response conducts the study under paragraph (1), such Assistant Secretary shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate containing the findings of such study.

(a) At-risk individuals in the National Health Security Strategy.—Section 2802(b)(4)(B) (42 U.S.C. 300hh–1(b)(4)(B)) is amended—

(1) by striking “this section and sections 319C–1, 319F, and 319L,” and inserting “this Act,”; and

(2) by striking “special” and inserting “access or functional”.

(b) Countermeasure considerations.—Section 319L(c)(6) (42 U.S.C. 247d–7e(c)(6)) is amended—

(1) by striking “elderly” and inserting “older adults”; and

(2) by inserting “with relevant characteristics that warrant consideration during the process of researching and developing such countermeasures and products” before the period.

(c) Biosurveillance of emerging public health threats.—Section 2814 is amended—

(1) in paragraph (7), by striking “; and” and inserting a semicolon;

(2) in paragraph (8), by striking the period and inserting “; and”; and

(3) by adding at the end the following:

“(9) facilitate coordination to ensure that, in implementing the situational awareness and biosurveillance network under section 319D, the Secretary considers incorporating data and information from Federal, State, local, tribal, and territorial public health officials and entities relevant to detecting emerging public health threats that may affect at-risk individuals, such as pregnant and postpartum women and infants, including adverse health outcomes of such populations related to such emerging public health threats.”.

Part B of title III (42 U.S.C. 243 et seq.) is amended by inserting after section 319D the following:

(a) Reauthorizing the National Advisory Committee on Children and Disasters.—Section 2811A (42 U.S.C. 300hh–10a) is amended—

(1) in subsection (b)(2), by inserting “, mental and behavioral,” after “medical”;

(2) in subsection (d)—

(A) in paragraph (1), by striking “15” and inserting “25”; and

(B) by striking paragraph (2) and inserting the following:

“(2) REQUIRED NON-FEDERAL MEMBERS.—The Secretary, in consultation with such other heads of Federal agencies as may be appropriate, shall appoint to the Advisory Committee under paragraph (1) at least 13 individuals, including—

“(A) at least 2 non-Federal professionals with expertise in pediatric medical disaster planning, preparedness, response, or recovery;

“(B) at least 2 representatives from State, local, tribal, or territorial agencies with expertise in pediatric disaster planning, preparedness, response, or recovery;

“(C) at least 4 members representing health care professionals, which may include members with expertise in pediatric emergency medicine; pediatric trauma, critical care, or surgery; the treatment of pediatric patients affected by chemical, biological, radiological, or nuclear agents, including emerging infectious diseases; pediatric mental or behavioral health related to children affected by a public health emergency; or pediatric primary care; and

“(D) other members as the Secretary determines appropriate, of whom—

“(i) at least one such member shall represent a children’s hospital;

“(ii) at least one such member shall be an individual with expertise in schools or child care settings;

“(iii) at least one such member shall be an individual with expertise in children and youth with special health care needs; and

“(iv) at least one such member shall be an individual with expertise in the needs of parents or family caregivers, including the parents or caregivers of children with disabilities.”.

“(3) FEDERAL MEMBERS.—The Advisory Committee under paragraph (1) shall include the following Federal members or their designees (who may be non-voting members, as determined by the Secretary):

“(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 Health Resources and Services Administration.

“(H) The Administrator of the Federal Emergency Management Agency.

“(I) The Administrator of the Administration for Community Living.

“(J) The Secretary of Education.

“(K) Representatives from such Federal agencies (such as the Substance Abuse and Mental Health Services Administration and the Department of Homeland Security) as the Secretary determines appropriate to fulfill the duties of the Advisory Committee under subsections (b) and (c).”.

“(4) TERM OF APPOINTMENT.—Each member of the Advisory Committee appointed under paragraph (2) shall serve for a term of 3 years, except that the Secretary may adjust the terms of the Advisory Committee appointees serving on the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, or appointees who are initially appointed after such date of enactment, in order to provide for a staggered term of appointment for all members.

“(5) CONSECUTIVE APPOINTMENTS; MAXIMUM TERMS.—A member appointed under paragraph (2) may serve not more than 3 terms on the Advisory Committee, and not more than 2 of such terms may be served consecutively.”;

(3) in subsection (e), by adding at the end “At least one meeting per year shall be an in-person meeting.”;

(4) by redesignating subsection (f) as subsection (g);

(5) by inserting after subsection (e) the following:

“(f) Coordination.—The Secretary shall coordinate duties and activities authorized under this section in accordance with section 2811D.”; and

(6) in subsection (g), as so redesignated, by striking “2018” and inserting “2023”.

(b) Authorizing the National Advisory Committee on Seniors and Disasters.—Subtitle B of title XXVIII (42 U.S.C. 300hh et seq.) is amended by inserting after section 2811A the following:

(c) National advisory committee on individuals with disabilities and disasters.—Subtitle B of title XXVIII (42 U.S.C. 300hh et seq.), as amended by subsection (b), is further amended by inserting after section 2811B the following:

(d) Advisory committee coordination.—Subtitle B of title XXVIII (42 U.S.C. 300hh et seq.), as amended by subsection (c), is further amended by inserting after section 2811C the following:

Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue final guidance regarding the ability of personnel funded by programs authorized under this Act (including the amendments made by this Act) to participate in drills and operational exercises related to all-hazards medical and public health preparedness and response. Such drills and operational exercises may include activities that incorporate medical surge capacity planning, medical countermeasure distribution and administration, and preparing for and responding to identified threats for that region. Such personnel may include State, local, tribal, and territorial public health department or agency personnel funded under this Act (including the amendments made by this Act). The Secretary shall consult 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 in the development of such guidance. The Secretary shall make the guidance available on the internet website of the Department of Health and Human Services.

Section 2811(b) (42 U.S.C. 300hh–10(b)) is amended—

(1) in the matter preceding paragraph (1) by inserting “utilize experience related to public health emergency preparedness and response, biodefense, medical countermeasures, and other relevant topics to” after “shall”; and

(2) in paragraph (4) by adding at the end the following:

“(I) THREAT AWARENESS.—Coordinate with the Director of the Centers for Disease Control and Prevention, the Director of National Intelligence, the Secretary of Homeland Security, the Assistant to the President for National Security Affairs, the Secretary of Defense, and other relevant Federal officials, such as the Secretary of Agriculture, to maintain a current assessment of national security threats and inform preparedness and response capabilities based on the range of the threats that have the potential to result in a public health emergency.”.

(a) In general.—Title XXVIII is amended by inserting after section 2811 (42 U.S.C. 300hh–10) the following:

(b) Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan.—Section 2811(d) (42 U.S.C. 300hh–10(d)) is amended—

(1) in paragraph (1)—

(A) by striking “Not later than 180 days after the date of enactment of this subsection, and every year thereafter” and inserting “Not later than March 15, 2020, and biennially thereafter”; and

(B) by striking “Director of the Biomedical” and all that follows through “Food and Drugs” and inserting “Public Health Emergency Medical Countermeasures Enterprise established under section 2811–1”; and

(2) in paragraph (2)(J)(v), by striking “one-year period” and inserting “2-year period”.

(a) In general.—Section 319F–2(a) (42 U.S.C. 247d–6b(a)) is amended—

(1) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; and

(2) in paragraph (1)—

(A) by inserting “the Assistant Secretary for Preparedness and Response and” after “collaboration with”;

(B) by inserting “and optimize” after “provide for”;

(C) by inserting “and, as informed by existing recommendations of, or consultations with, the Public Health Emergency Medical Countermeasure Enterprise established under section 2811–1, make necessary additions or modifications to the contents of such stockpile or stockpiles based on the review conducted under paragraph (2)” before the period of the first sentence; and

(D) by striking the second sentence;

(3) by inserting after paragraph (1) the following:

“(2) THREAT-BASED REVIEW.—

“(A) IN GENERAL.—The Secretary shall conduct an annual threat-based review (taking into account at-risk individuals) of the contents of the stockpile under paragraph (1), including non-pharmaceutical supplies, and, in consultation with the Public Health Emergency Medical Countermeasures Enterprise established under section 2811–1, review contents within the stockpile and assess whether such contents are consistent with the recommendations made pursuant to section 2811–1(c)(1)(A). Such review shall be submitted on June 15, 2019, and on March 15 of each year thereafter, to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, in a manner that does not compromise national security.

“(B) ADDITIONS, MODIFICATIONS, AND REPLENISHMENTS.—Each annual threat-based review under subparagraph (A) shall, for each new or modified countermeasure procurement or replenishment, provide—

“(i) information regarding—

“(I) the quantities of the additional or modified countermeasure procured for, or contracted to be procured for, the stockpile;

“(II) planning considerations for appropriate manufacturing capacity and capability to meet the goals of such additions or modifications (without disclosing proprietary information), including consideration of the effect such additions or modifications may have on the availability of such products and ancillary medical supplies in the health care system;

“(III) the presence or lack of a commercial market for the countermeasure at the time of procurement;

“(IV) the emergency health security threat or threats such countermeasure procurement is intended to address, including whether such procurement is consistent with meeting emergency health security needs associated with such threat or threats;

“(V) an assessment of whether the emergency health security threat or threats described in subclause (IV) could be addressed in a manner that better utilizes the resources of the stockpile and permits the greatest possible increase in the level of emergency preparedness to address such threats;

“(VI) whether such countermeasure is replenishing an expiring or expired countermeasure, is a different countermeasure with the same indication that is replacing an expiring or expired countermeasure, or is a new addition to the stockpile;

“(VII) a description of how such additions or modifications align with projected investments under previous countermeasures budget plans under section 2811(b)(7), including expected life-cycle costs, expenditures related to countermeasure procurement to address the threat or threats described in subclause (IV), replenishment dates (including the ability to extend the maximum shelf life of a countermeasure), and the manufacturing capacity required to replenish such countermeasure; and

“(VIII) appropriate protocols and processes for the deployment, distribution, or dispensing of the countermeasure at the State and local level, including plans for relevant capabilities of State and local entities to dispense, distribute, and administer the countermeasure; and

“(ii) an assurance, which need not be provided in advance of procurement, that for each countermeasure procured or replenished under this subsection, the Secretary completed a review addressing each item listed under this subsection in advance of such procurement or replenishment.”;

(4) in paragraph (3), as so redesignated—

(A) in subparagraph (A), by inserting “and the Public Health Emergency Medical Countermeasures Enterprise established under section 2811–1” before the semicolon;

(B) in subparagraph (C), by inserting “, and the availability, deployment, dispensing, and administration of countermeasures” before the semicolon;

(C) by amending subparagraph (E) to read as follows:

“(E) devise plans for effective and timely supply-chain management of the stockpile, in consultation with the Director of the Centers for Disease Control and Prevention, the Assistant Secretary for Preparedness and Response, the Secretary of Transportation, the Secretary of Homeland Security, the Secretary of Veterans Affairs, and the heads of other appropriate Federal agencies; State, local, tribal, and territorial agencies; and the public and private health care infrastructure, as applicable, taking into account the manufacturing capacity and other available sources of products and appropriate alternatives to supplies in the stockpile;”;

(D) in subparagraph (G), by striking “; and” and inserting a semicolon;

(E) in subparagraph (H), by striking the period and inserting a semicolon; and

(F) by adding at the end the following:

“(I) ensure that each countermeasure or product under consideration for procurement pursuant to this subsection receives the same consideration regardless of whether such countermeasure or product receives or had received funding under section 319L, including with respect to whether the countermeasure or product is most appropriate to meet the emergency health security needs of the United States; and

“(J) provide assistance, including technical assistance, to maintain and improve State and local public health preparedness capabilities to distribute and dispense medical countermeasures and products from the stockpile, as appropriate.”; and

(5) by adding at the end the following:

“(5) GAO REPORT.—

“(A) IN GENERAL.—Not later than 3 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, and every 5 years thereafter, the Comptroller General of the United States shall conduct a review of any changes to the contents or management of the stockpile since January 1, 2015. Such review shall include—

“(i) an assessment of the comprehensiveness and completeness of each annual threat-based review under paragraph (2), including whether all newly procured or replenished countermeasures within the stockpile were described in each annual review, and whether, consistent with paragraph (2)(B), the Secretary conducted the necessary internal review in advance of such procurement or replenishment;

“(ii) an assessment of whether the Secretary established health security and science-based justifications, and a description of such justifications for procurement decisions related to health security needs with respect to the identified threat, for additions or modifications to the stockpile based on the information provided in such reviews under paragraph (2)(B), including whether such review was conducted prior to procurement, modification, or replenishment;

“(iii) an assessment of the plans developed by the Secretary for the deployment, distribution, and dispensing of countermeasures procured, modified, or replenished under paragraph (1), including whether such plans were developed prior to procurement, modification, or replenishment;

“(iv) an accounting of countermeasures procured, modified, or replenished under paragraph (1) that received advanced research and development funding from the Biomedical Advanced Research and Development Authority;

“(v) an analysis of how such procurement decisions made progress toward meeting emergency health security needs related to the identified threats for countermeasures added, modified, or replenished under paragraph (1);

“(vi) a description of the resources expended related to the procurement of countermeasures (including additions, modifications, and replenishments) in the stockpile, and how such expenditures relate to the ability of the stockpile to meet emergency health security needs;

“(vii) an assessment of the extent to which additions, modifications, and replenishments reviewed under paragraph (2) align with previous relevant reports or reviews by the Secretary or the Comptroller General;

“(viii) with respect to any change in the Federal organizational management of the stockpile, an assessment and comparison of the processes affected by such change, including planning for potential countermeasure deployment, distribution, or dispensing capabilities and processes related to procurement decisions, use of stockpiled countermeasures, and use of resources for such activities; and

“(ix) an assessment of whether the processes and procedures described by the Secretary pursuant to section 403(b) of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 are sufficient to ensure countermeasures and products under consideration for procurement pursuant to subsection (a) receive the same consideration regardless of whether such countermeasures and products receive or had received funding under section 319L, including with respect to whether such countermeasures and products are most appropriate to meet the emergency health security needs of the United States.

“(B) SUBMISSION.—Not later than 6 months after completing a classified version of the review under subparagraph (A), the Comptroller General shall submit an unclassified version of the review to the congressional committees of jurisdiction.”.

(b) Additional reporting.—In the first threat-based review submitted after the date of enactment of this Act pursuant to paragraph (2) of section 319F–2(a) of the Public Health Service Act (42 U.S.C. 247d–6b(a)), as amended by subsection (a), the Secretary shall include a description of the processes and procedures through which the Director of Strategic National Stockpile and the Director of the Biomedical Advanced Research and Development Authority coordinate with respect to countermeasures and products procured under such section 319F–2(a), including such processes and procedures in place to ensure countermeasures and products under consideration for procurement pursuant to such section 319F–2(a) receive the same consideration regardless of whether such countermeasures or products receive or had received funding under section 319L of the Public Health Service Act (42 U.S.C. 247d–7e), and whether such countermeasures and products are the most appropriate to meet the emergency health security needs of the United States.

(c) Authorization of appropriations, strategic national stockpile.—Section 319F–2(f)(1) (42 U.S.C. 247d–6b(f)(1)) is amended by striking “$533,800,000 for each of fiscal years 2014 through 2018” and inserting “$610,000,000 for each of fiscal years 2019 through 2023, to remain available until expended”.

(a) Strategic initiatives.—Section 319L(c)(4) (247d–7e(c)(4)) is amended by adding at the end the following:

“(F) STRATEGIC INITIATIVES.—The Secretary, acting through the Director of BARDA, may implement strategic initiatives, including by building on existing programs and by awarding contracts, grants, and cooperative agreements, or entering into other transactions, to support innovative candidate products in preclinical and clinical development that address priority, naturally occurring and man-made threats that, as determined by the Secretary, pose a significant level of risk to national security based on the characteristics of a chemical, biological, radiological or nuclear threat, or existing capabilities to respond to such a threat (including medical response and treatment capabilities and manufacturing infrastructure). Such initiatives shall accelerate and support the advanced research, development, and procurement of, countermeasures and products, as applicable, to address areas including—

“(i) chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, for which insufficient approved, licensed, or authorized countermeasures exist, or for which such threat, or the result of an exposure to such threat, may become resistant to countermeasures or existing countermeasures may be rendered ineffective;

“(ii) threats that consistently exist or continually circulate and have a significant potential to become a pandemic, such as pandemic influenza, which may include the advanced research and development, manufacturing, and appropriate stockpiling of qualified pandemic or epidemic products, and products, technologies, or processes to support the advanced research and development of such countermeasures (including multiuse platform technologies for diagnostics, vaccines, and therapeutics; virus seeds; clinical trial lots; novel virus strains; and antigen and adjuvant material); and

“(iii) threats that may result primarily or secondarily from a chemical, biological, radiological, or nuclear agent, or emerging infectious diseases, and which may present increased treatment complications such as the occurrence of resistance to available countermeasures or potential countermeasures, including antimicrobial resistant pathogens.”.

(b) Protection of national security from threats.—Section 2811 (42 U.S.C. 300hh–10) is amended by adding at the end the following:

“(f) Protection of national security from threats.—

“(1) IN GENERAL.—In carrying out subsection (b)(3), the Assistant Secretary for Preparedness and Response shall implement strategic initiatives or activities to address threats, including pandemic influenza and which may include a chemical, biological, radiological, or nuclear agent (including any such agent with a significant potential to become a pandemic), that pose a significant level of risk to public health and national security based on the characteristics of such threat. Such initiatives shall include activities to—

“(A) accelerate and support the advanced research, development, manufacturing capacity, procurement, and stockpiling of countermeasures, including initiatives under section 319L(c)(4)(F);

“(B) support the development and manufacturing of virus seeds, clinical trial lots, and stockpiles of novel virus strains; and

“(C) maintain or improve preparedness activities, including for pandemic influenza.

“(2) AUTHORIZATION OF APPROPRIATIONS.—

“(A) IN GENERAL.—To carry out this subsection, there is authorized to be appropriated $250,000,000 for each of fiscal years 2019 through 2023.

“(B) SUPPLEMENT, NOT SUPPLANT.—Amounts appropriated under this paragraph shall be used to supplement and not supplant funds provided under sections 319L(d) and 319F–2(g).

“(C) DOCUMENTATION REQUIRED.—The Assistant Secretary for Preparedness and Response, in accordance with subsection (b)(7), shall document amounts expended for purposes of carrying out this subsection, including amounts appropriated under the heading ‘Public Health and Social Services Emergency Fund’ under the heading ‘Office of the Secretary’ under title II of division H of the Consolidated Appropriations Act, 2018 (Public Law 115–141) and allocated to carrying out section 319L(c)(4)(F).”.

Section 351A(k) (42 U.S.C. 262a(k)) is amended—

(1) by striking “The Secretary” and inserting the following:

“(1) IN GENERAL.—The Secretary”; and

(2) by adding at the end the following:

“(2) IMPLEMENTATION OF RECOMMENDATIONS OF THE FEDERAL EXPERTS SECURITY ADVISORY PANEL AND THE FAST TRACK ACTION COMMITTEE ON SELECT AGENT REGULATIONS.—

“(A) IN GENERAL.—Not later than 1 year after the date of the enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, the Secretary shall report to the congressional committees of jurisdiction on the implementation of recommendations of the Federal Experts Security Advisory Panel concerning the select agent program.

“(B) CONTINUED UPDATES.—The Secretary shall report to the congressional committees of jurisdiction annually following the submission of the report under subparagraph (A) until the recommendations described in such subparagraph are fully implemented, or a justification is provided for the delay in, or lack of, implementation.”.

Section 2811(b)(7) (42 U.S.C. 300hh–10(b)(7)) is amended—

(1) in the matter preceding subparagraph (A), by striking “March 1” and inserting “March 15”;

(2) in subparagraph (A)—

(A) in clause (ii), by striking “; and” and inserting “;”; and

(B) by striking clause (iii) and inserting the following:

“(iii) procurement, stockpiling, maintenance, and potential replenishment (including manufacturing capabilities) of all products in the Strategic National Stockpile;

“(iv) the availability of technologies that may assist in the advanced research and development of countermeasures and opportunities to use such technologies to accelerate and navigate challenges unique to countermeasure research and development; and

“(v) potential deployment, distribution, and utilization of medical countermeasures; development of clinical guidance and emergency use instructions for the use of medical countermeasures; and, as applicable, potential post-deployment activities related to medical countermeasures;”;

(3) by redesignating subparagraphs (D) and (E) as subparagraphs (E) and (F), respectively; and

(4) by inserting after subparagraph (C), the following:

“(D) identify the full range of anticipated medical countermeasure needs related to research and development, procurement, and stockpiling, including the potential need for indications, dosing, and administration technologies, and other countermeasure needs as applicable and appropriate;”.

(a) Congressional notification of material threat determination.—Section 319F–2(c)(2)(C) (42 U.S.C. 247d–6b(c)(2)(C)) is amended by striking “The Secretary and the Homeland Security Secretary shall promptly notify the appropriate committees of Congress” and inserting “The Secretary and the Secretary of Homeland Security shall send to Congress, on an annual basis, all current material threat determinations and shall promptly notify the Committee on Health, Education, Labor, and Pensions and the Committee on Homeland Security and Governmental Affairs of the Senate and the Committee on Energy and Commerce and the Committee on Homeland Security of the House of Representatives”.

(b) Contracting communication.—Section 319F–2(c)(7)(B)(ii)(III) (42 U.S.C. 247d–6b(c)(7)(B)(ii)(III)) is amended by adding at the end the following: “The Secretary shall notify the vendor within 90 days of a determination by the Secretary to renew, extend, or terminate such contract.”.

Section 565(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4(f)) is amended—

(1) by redesignating paragraphs (3) through (6) as paragraphs (4) through (7), respectively;

(2) by inserting after paragraph (2) the following:

“(3) PUBLICATION.—The Secretary shall make available on the internet website of the Food and Drug Administration information regarding regulatory management plans, including—

“(A) the process by which an applicant may submit a request for a regulatory management plan;

“(B) the timeframe by which the Secretary is required to respond to such request;

“(C) the information required for the submission of such request;

“(D) a description of the types of development milestones and performance targets that could be discussed and included in such plans; and

“(E) contact information for beginning the regulatory management plan process.”;

(3) in paragraph (6), as so redesignated, in the matter preceding subparagraph (A)—

(A) by striking “paragraph (4)(A)” and inserting “paragraph (5)(A)”; and

(B) by striking “paragraph (4)(B)” and inserting “paragraph (5)(B)”; and

(4) in paragraph (7)(A), as so redesignated, by striking “paragraph (3)(A)” and inserting “paragraph (4)(A)”.

(a) BioShield special reserve fund.—Section 319F–2(g)(1) (42 U.S.C. 247d–6b(g)(1)) is amended—

(1) by striking “$2,800,000,000 for the period of fiscal years 2014 through 2018” and inserting “$7,100,000,000 for the period of fiscal years 2019 through 2028, to remain available until expended”; and

(2) by striking the second sentence.

(b) The Biomedical Advanced Research and Development Authority.—Section 319L(d)(2) (42 U.S.C. 247d–7e(d)(2)) is amended by striking “$415,000,000 for each of fiscal years 2014 through 2018” and inserting “$611,700,000 for each of fiscal years 2019 through 2023”.

(a) Advisory council.—The Secretary of Health and Human Services (referred to in this section as the “Secretary”) may continue the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, referred to in this section as the “Advisory Council”.

(b) Duties.—The Advisory Council shall advise and provide information and recommendations to the Secretary regarding programs and policies intended to reduce or combat antibiotic-resistant bacteria that may present a public health threat and improve capabilities to prevent, diagnose, mitigate, or treat such resistance. Such advice, information, and recommendations may be related to improving—

(1) the effectiveness of antibiotics;

(2) research and advanced research on, and the development of, improved and innovative methods for combating or reducing antibiotic resistance, including new treatments, rapid point-of-care diagnostics, alternatives to antibiotics, including alternatives to animal antibiotics, and antimicrobial stewardship activities;

(3) surveillance of antibiotic-resistant bacterial infections, including publicly available and up-to-date information on resistance to antibiotics;

(4) education for health care providers and the public with respect to up-to-date information on antibiotic resistance and ways to reduce or combat such resistance to antibiotics related to humans and animals;

(5) methods to prevent or reduce the transmission of antibiotic-resistant bacterial infections, including stewardship programs; and

(6) coordination with respect to international efforts in order to inform and advance United States capabilities to combat antibiotic resistance.

(c) Meetings and coordination.—

(1) MEETINGS.—The Advisory Council shall meet not less than biannually and, to the extent practicable, in coordination with meetings of the Antimicrobial Resistance Task Force established in section 319E(a) of the Public Health Service Act.

(2) COORDINATION.—The Advisory Council shall, to the greatest extent practicable, coordinate activities carried out by the Council with the Antimicrobial Resistance Task Force established under section 319E(a) of the Public Health Service Act (42 U.S.C. 247d–5(a)).

(d) FACA.—The Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the activities and duties of the Advisory Council.

(e) Extension of Advisory Council.—Not later than October 1, 2022, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a recommendation on whether the Advisory Council should be extended, and in addition, identify whether there are other committees, councils, or task forces that have overlapping or similar duties to that of the Advisory Council, and whether such committees, councils, or task forces should be combined, including with respect to section 319E(a) of the Public Health Service Act (42 U.S.C. 247d–5(a)).

Section 319L(c)(4)(D)(iii) (42 U.S.C. 247d–7e(c)(4)(D)(iii)) is amended by striking “and platform technologies” and inserting “platform technologies, technologies to administer countermeasures, and technologies to improve storage and transportation of countermeasures”.

Section 319L (42 U.S.C. 247d–7e) is amended—

(1) in subsection (a)(3), by striking “, such as” and all that follows through “Code”; and

(2) in subsection (c)(5)(A)—

(A) in clause (i), by striking “under this subsection” and all that follows through “Code” and inserting “(as defined in subsection (a)(3)) under this subsection”; and

(B) in clause (ii)—

(i) by amending subclause (I) to read as follows:

“(I) IN GENERAL.—To the maximum extent practicable, competitive procedures shall be used when entering into transactions to carry out projects under this subsection.”; and

(ii) in subclause (II)—

(I) by striking “$20,000,000” and inserting “$100,000,000”;

(II) by striking “senior procurement executive for the Department (as designated for purpose of section 16(c) of the Office of Federal Procurement Policy Act (41 U.S.C. 414(c)))” and inserting “Assistant Secretary for Financial Resources”; and

(III) by striking “senior procurement executive under” and inserting “Assistant Secretary for Financial Resources under”.

(a) In general.—The purpose of this section (including section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b)) is to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products by facilitating and encouraging submission of data and information to support the development of such products, and through clarifying the authority to cross-reference to data and information previously submitted to the Secretary of Health and Human Services (referred to in this section as the “Secretary”), including data and information submitted to medical countermeasure master files or other master files.

(b) Medical countermeasure master files.—Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 565A the following:

(c) Stakeholder Input.—Not later than 18 months after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Assistant Secretary for Preparedness and Response, shall solicit input from stakeholders, including stakeholders developing security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products, and stakeholders developing technologies to assist in the development of such countermeasures with respect to how the Food and Drug Administration can advance the use of tools and technologies to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products, including through reliance on cross-referenced data and information contained within master files and submissions previously submitted to the Secretary as set forth in section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b).

(d) Guidance.—Not later than 2 years after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall publish draft guidance about how reliance on cross-referenced data and information contained within master files under section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b) or submissions otherwise submitted to the Secretary may be used for specific tools or technologies (including platform technologies) that have the potential to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products. The Secretary, acting through the Commissioner of Food and Drugs, shall publish the final guidance not later than 3 years after the enactment of this Act.

(a) Study.—The Comptroller General of the United States shall conduct a study on the application of the requirements under subsections (c) and (d) of section 565 of the of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4) (referred to in this section as the “animal rule”) as a component of medical countermeasure advanced development under the Biomedical Advanced Research and Development Authority and regulatory review by the Food and Drug Administration. In conducting such study, the Comptroller General shall examine the following:

(1) The extent to which advanced development and review of a medical countermeasure are coordinated between the Biomedical Advanced Research and Development Authority and the Food and Drug Administration, including activities that facilitate appropriate and efficient design of studies to support approval, licensure, and authorization under the animal rule, consistent with the recommendations in the animal rule guidance, issued pursuant to section 565(c) of the Federal Food Drug and Cosmetic Act (21 U.S.C. 360bbb–4(c)) and entitled “Product Development Under the Animal Rule: Guidance for Industry” (issued in October 2015), to resolve discrepancies in the design of adequate and well-controlled efficacy studies conducted in animal models related to the provision of substantial evidence of effectiveness for the product approved, licensed, or authorized under the animal rule.

(2) The consistency of the application of the animal rule among and between review divisions within the Food and Drug Administration.

(3) The flexibility pursuant to the animal rule to address variations in countermeasure development and review processes, including the extent to which qualified animal models are adopted and used within the Food and Drug Administration in regulatory decisionmaking with respect to medical countermeasures.

(4) The extent to which the guidance issued under section 565(c) of the Federal Food Drug and Cosmetic Act (21 U.S.C. 360bbb–4(c)), entitled, “Product Development Under the Animal Rule: Guidance for Industry” (issued in October 2015), has assisted in achieving the purposes described in paragraphs (1), (2), and (3).

(b) Consultations.—In conducting the study under subsection (a), the Comptroller General of the United States shall consult with—

(1) the Federal agencies responsible for advancing, reviewing, and procuring medical countermeasures, including the Office of the Assistant Secretary for Preparedness and Response, the Biomedical Advanced Research and Development Authority, the Food and Drug Administration, and the Department of Defense;

(2) manufacturers involved in the research and development of medical countermeasures to address biological, chemical, radiological, or nuclear threats; and

(3) other biodefense stakeholders, as applicable.

(c) Report.—Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing the results of the study conducted under subsection (a) and recommendations to improve the application and consistency of the requirements under subsections (c) and (d) of section 565 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360bbb–4) to support and expedite the research and development of medical countermeasures, as applicable.

(d) Protection of national security.—The Comptroller General of the United States shall conduct the study and issue the assessment and report under this section in a manner that does not compromise national security.

(a) Meeting.—

(1) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall convene a meeting to discuss the potential role advancements in genomic engineering technologies (including genome editing technologies) may have in advancing national health security. Such meeting shall be held in a manner that does not compromise national security.

(2) ATTENDEES.—The attendees of the meeting under paragraph (1)—

(A) shall include—

(i) representatives from the Office of the Assistant Secretary for Preparedness and Response, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration; and

(ii) representatives from academic, private, and nonprofit entities with expertise in genome engineering technologies, biopharmaceuticals, medicine, or biodefense, and other relevant stakeholders; and

(B) may include—

(i) other representatives from the Department of Health and Human Services, as the Secretary determines appropriate; and

(ii) representatives from the Department of Homeland Security, the Department of Defense, the Department of Agriculture, and other departments, as the Secretary may request for the meeting.

(3) TOPICS.—The meeting under paragraph (1) shall include a discussion of—

(A) the current state of the science of genomic engineering technologies related to national health security, including—

(i) medical countermeasure development, including potential efficiencies in the development pathway and detection technologies; and

(ii) the international and domestic regulation of products utilizing genome editing technologies; and

(B) national security implications, including—

(i) capabilities of the United States to leverage genomic engineering technologies as a part of the medical countermeasure enterprise, including current applicable research, development, and application efforts underway within the Department of Defense;

(ii) the potential for state and non-state actors to utilize genomic engineering technologies as a national health security threat; and

(iii) security measures to monitor and assess the potential threat that may result from utilization of genomic engineering technologies and related technologies for the purpose of compromising national health security.

(b) Report.—Not later than 270 days after the meeting described in subsection (a) is held, the Assistant Secretary for Preparedness and Response shall issue a report to the congressional committees of jurisdiction on the topics discussed at such meeting, and provide recommendations, as applicable, to utilize innovations in genomic engineering (including genome editing) and related technologies as a part of preparedness and response activities to advance national health security. Such report shall be issued in a manner that does not compromise national security.

Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing efforts and activities to coordinate with other countries and international partners during recent public health emergencies with respect to the research and advanced research on, and development of, qualified pandemic or epidemic products (as defined in section 319F–3 of the Public Health Service Act (42 U.S.C. 247d–6d)). Such report may include information regarding relevant work carried out under section 319L(c)(5)(E) of the Public Health Service Act (42 U.S.C. 247d–7e(c)(5)(E)), through public-private partnerships, and through collaborations with other countries to assist with or expedite the research and development of qualified pandemic or epidemic products. Such report shall not include information that may compromise national security.

(a) Reauthorization of mosquito abatement for safety and health program.—Section 317S (42 U.S.C. 247b–21) is amended—

(1) in subsection (a)(1)(B)—

(A) by inserting “including programs to address emerging infectious mosquito-borne diseases,” after “subdivisions for control programs,”; and

(B) by inserting “or improving existing control programs” before the period at the end;

(2) in subsection (b)—

(A) in paragraph (1), by inserting “, including improvement,” after “operation”;

(B) in paragraph (2)—

(i) in subparagraph (A)—

(I) in clause (ii), by striking “or” at the end;

(II) in clause (iii), by striking the semicolon at the end and inserting “, including an emerging infectious mosquito-borne disease that presents a serious public health threat; or”; and

(III) by adding at the end the following:

“(iv) a public health emergency due to the incidence or prevalence of a mosquito-borne disease that presents a serious public health threat;”; and

(ii) by amending subparagraph (D) to read as follows:

“(D) (i) is located in a State that has received a grant under subsection (a); or

“(ii) that demonstrates to the Secretary that the control program is consistent with existing State mosquito control plans or policies, or other applicable State preparedness plans.”;

(C) in paragraph (4)(C), by striking “that extraordinary” and all that follows through the period at the end and inserting the following: “that—

“(i) extraordinary economic conditions in the political subdivision or consortium of political subdivisions involved justify the waiver; or

“(ii) the geographical area covered by a political subdivision or consortium for a grant under paragraph (1) has an extreme mosquito control need due to—

“(I) the size or density of the potentially impacted human population;

“(II) the size or density of a mosquito population that requires heightened control; or

“(III) the severity of the mosquito-borne disease, such that expected serious adverse health outcomes for the human population justify the waiver.”; and

(D) by amending paragraph (6) to read as follows:

“(6) NUMBER OF GRANTS.—A political subdivision or a consortium of political subdivisions may not receive more than one grant under paragraph (1).”; and

(3) in subsection (f)—

(A) in paragraph (1) by striking “for fiscal year 2003, and such sums as may be necessary for each of fiscal years 2004 through 2007” and inserting “for each of fiscal years 2019 through 2023”;

(B) in paragraph (2), by striking “the Public Health Security and Bioterrorism Preparedness and Response Act of 2002” and inserting “this Act and other medical and public health preparedness and response laws”; and

(C) in paragraph (3)—

(i) in the paragraph heading, by striking “2004” and inserting “2019”; and

(ii) by striking “2004,” and inserting “2019,”.

(b) Epidemiology-Laboratory capacity grants.—Section 2821 (42 U.S.C. 300hh–31) is amended—

(1) in subsection (a)(1), by inserting “, including mosquito and other vector-borne diseases,” after “infectious diseases”; and

(2) in subsection (b), by striking “2010 through 2013” and inserting “2019 through 2023”.

(a) Veterans Affairs.—Section 8117(g) of title 38, United States Code, is amended by striking “2014 through 2018” and inserting “2019 through 2023”.

(b) Vaccine tracking and distribution.—Section 319A(e) (42 U.S.C. 247d–1(e)) is amended by striking “2014 through 2018” and inserting “2019 through 2023”.

(c) Temporary reassignment.—Section 319(e)(8) (42 U.S.C. 247d(e)(8)) is amended by striking “2018” and inserting “2023”.

(d) Strategic Innovation Partner.—Section 319L(c)(4)(E)(ix) (42 U.S.C. 247d–7e(c)(4)(E)(ix)) is amended by striking “2022” and inserting “2023”.

(e) Limited antitrust exemption.—

(1) IN GENERAL.—Section 405 of the Pandemic and All-Hazards Preparedness Act (Public Law 109–417; 42 U.S.C. 247d–6a note) is amended—

(A) in subsection (a)(1)(A)—

(i) by striking “Secretary of Health and Human Services (referred to in this subsection as the ‘Secretary’)” and inserting “Secretary”;

(ii) by striking “of the Public Health Service Act (42 U.S.C. 247d–6b)) (as amended by this Act”;

(iii) by striking “of the Public Health Service Act (42 U.S.C. 247d–6a)) (as amended by this Act”; and

(iv) by striking “of the Public Health Service Act (42 U.S.C. 247d–6d)”;

(B) in subsection (b), by striking “12-year” and inserting “17-year”;

(C) by redesignating such section 405 as section 319L–1; and

(D) by transferring such section 319L–1, as redesignated, to the Public Health Service Act (42 U.S.C. 201 et seq.), to appear after section 319L of such Act (42 U.S.C. 247d–7e).

(2) CONFORMING AMENDMENT.—The table of contents in section 1(b) of the Pandemic and All-Hazards Preparedness Act (Public Law 109–417) is amended by striking the item related to section 405.

(f) Inapplicability of certain provisions.—Subsection (e)(1) of section 319L (42 U.S.C. 247d–7e(e)(1)) is amended—

(1) by amending subparagraph (A) to read as follows:

“(A) NON-DISCLOSURE OF INFORMATION.—

“(i) IN GENERAL.—Information described in clause (ii) shall be deemed to be information described in section 552(b)(3) of title 5, United States Code.

“(ii) INFORMATION DESCRIBED.—The information described in this clause is information relevant to programs of the Department of Health and Human Services that could compromise national security and reveal significant and not otherwise publicly known vulnerabilities of existing medical or public health defenses against chemical, biological, radiological, or nuclear threats, and is comprised of—

“(I) specific technical data or scientific information that is created or obtained during the countermeasure and product advanced research and development carried out under subsection (c);

“(II) information pertaining to the location security, personnel, and research materials and methods of high-containment laboratories conducting research with select agents, toxins, or other agents with a material threat determination under section 319F–2(c)(2); or

“(III) security and vulnerability assessments.”;

(2) by redesignating subparagraph (C) as subparagraph (D);

(3) by inserting after subparagraph (B) the following:

“(C) REPORTING.—One year after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, and annually thereafter, the Secretary shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the number of instances in which the Secretary has used the authority under this subsection to withhold information from disclosure, as well as the nature of any request under section 552 of title 5, United States Code that was denied using such authority.”; and

(4) in subparagraph (D), as so redesignated, by striking “12” and inserting “17”.

Subsection (d) of section 319F–2 (42 U.S.C. 247d–6b) is amended to read as follows:

“(d) Disclosures.—No Federal agency may disclose under section 552 of title 5, United States Code any information identifying the location at which materials in the stockpile described in subsection (a) are stored, or other information regarding the contents or deployment capability of the stockpile that could compromise national security.”.

(a) Strategy for public health preparedness and response to cybersecurity threats.—

(1) STRATEGY.—Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall prepare and submit to the relevant committees of Congress a strategy for public health preparedness and response to address cybersecurity threats (as defined in section 102 of Cybersecurity Information Sharing Act of 2015 (6 U.S.C. 1501)) that present a threat to national health security. Such strategy shall include—

(A) identifying the duties, functions, and preparedness goals for which the Secretary is responsible in order to prepare for and respond to such cybersecurity threats, including metrics by which to measure success in meeting preparedness goals;

(B) identifying gaps in public health capabilities to achieve such preparedness goals; and

(C) strategies to address identified gaps and strengthen public health emergency preparedness and response capabilities to address such cybersecurity threats.

(2) PROTECTION OF NATIONAL SECURITY.—The Secretary shall make such strategy available to the Committee on Health, Education, Labor, and Pensions of the Senate, the Committee on Energy and Commerce of the House of Representatives, and other congressional committees of jurisdiction, in a manner that does not compromise national security.

(b) Coordination of preparedness for and response to all-hazards public health emergencies.—Subparagraph (D) of section 2811(b)(4) (42 U.S.C. 300hh–10(b)(4)) is amended to read as follows:

“(D) POLICY COORDINATION AND STRATEGIC DIRECTION.—Provide integrated policy coordination and strategic direction, before, during, and following public health emergencies, 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 described in section 504(a)(6) of the Homeland Security Act of 2002 (6 U.S.C. 314(a)(6)), or any successor plan; and such Federal responses covered by the National Cybersecurity Incident Response Plan developed under section 228(c) of the Homeland Security Act of 2002 (6 U.S.C. 149(c)), including public health emergencies or incidents related to cybersecurity threats that present a threat to national health security.”.

Not later than 14 days after the date of the enactment of this Act, the Secretary of Health and Human Services, in coordination with the Assistant Secretary for Preparedness and Response and the Assistant Secretary for the Administration on Children and Families or other appropriate office, and in collaboration with other departments, as appropriate, shall submit to the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, and other relevant congressional committees—

(1) a formal strategy, including interdepartmental actions and efforts to reunify children with their parents or guardians, in all cases in which such children have been separated from their parents or guardians as a result of the initiative announced on April 6, 2018, and due to prosecution under section 275(a) of the Immigration and Nationality Act (8 U.S.C. 1325(a)), if the parent or guardian chooses such reunification and the child—

(A) was separated from a parent or guardian and placed into a facility funded by the Department of Health and Human Services;

(B) as of the date of the enactment of this Act, remains in the care of the Department of Health and Human Services; and

(C) can be safely reunited with such parent or guardian; and

(2) a report on challenges and deficiencies related to the oversight of, and care for, unaccompanied alien children and appropriately reuniting such children with their parents or guardians, and the actions taken to address any challenges and deficiencies related to unaccompanied alien children in the custody of the Department of Health and Human Services, including deficiencies identified and publicly reported by Congress, the Government Accountability Office, or the Inspectors General of the Department of Health and Human Services or other Federal departments.

(a) Public Health Service Act.—Title III (42 U.S.C. 241 et seq.) is amended—

(1) in paragraphs (1) and (5) of section 319F–1(a) (42 U.S.C. 247d–6a(a)), by striking “section 319F(h)” each place such term appears and inserting “section 319F(e)”; and

(2) in section 319K(a) (42 U.S.C. 247d–7d(a)), by striking “section 319F(h)(4)” and inserting “section 319F(e)(4)”.

(b) Public health security grants.—Section 319C–1(b)(2) (42 U.S.C. 247d–3a(b)(2)) is amended—

(1) in subparagraph (C), by striking “individuals,,” and inserting “individuals,”; and

(2) in subparagraph (F), by striking “make satisfactory annual improvement and describe” and inserting “makes satisfactory annual improvement and describes”.

(c) Emergency use instructions.—Subparagraph (A) of section 564A(e)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3a(e)(2)) is amended by striking “subsection (a)(1)(C)(i)” and inserting “subsection (a)(1)(C)”.

(d) Products held for emergency use.—Section 564B(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3b) is amended—

(1) in subparagraph (B), by inserting a comma after “505”; and

(2) in subparagraph (C), by inserting “or section 564A” before the period at the end.

(e) Transparency.—Section 507(c)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357(c)(3)) is amended—

(1) by striking “Nothing in” and inserting the following:

“(A) IN GENERAL.—Nothing in”;

(2) by inserting “or directing” after “authorizing”;

(3) by striking “disclose any” and inserting “disclose—

“(i) any”;

(4) by striking the period and inserting “; or”; and

(5) by adding at the end the following:

“(ii) in the case of a drug development tool that may be used to support the development of a qualified countermeasure, security countermeasure, or qualified pandemic or epidemic product, as defined in sections 319F–1, 319F–2, and 319F–3, respectively, of the Public Health Service Act, any information that the Secretary determines has a significant potential to affect national security.

“(B) PUBLIC ACKNOWLEDGMENT.—In the case that the Secretary, pursuant to subparagraph (A)(ii), does not make information publicly available, the Secretary shall provide on the internet website of the Food and Drug Administration an acknowledgment of the information that has not been disclosed, pursuant to subparagraph (A)(ii).”.

(a) Short title.—This division may be cited as the “Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018”.

(b) References.—Except as otherwise specified, any reference to “this Act” contained in this division shall be treated as referring only to the provisions of this division.

(a) In general.—Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 505F of such Act (21 U.S.C. 355g) the following:

(b) GAO study.—Not later than 4 years after the date of enactment of this Act, the Comptroller General of the United States shall submit a study to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate addressing the effectiveness and overall impact of exclusivity under section 505G of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), and section 586C of such Act (21 U.S.C. 360fff–3), including the impact of such exclusivity on consumer access. Such study shall include—

(1) an analysis of the impact of exclusivity under such section 505G for nonprescription drug products, including—

(A) the number of nonprescription drug products that were granted exclusivity and the indication for which the nonprescription drug products were determined to be generally recognized as safe and effective;

(B) whether the exclusivity for such drug products was granted for—

(i) a new active ingredient (including any ester or salt of the active ingredient); or

(ii) changes in the conditions of use of a drug, for which new human data studies conducted or sponsored by the requestor were essential;

(C) whether, and to what extent, the exclusivity impacted the requestor’s or sponsor’s decision to develop the drug product;

(D) an analysis of the implementation of the exclusivity provision in such section 505G, including—

(i) the resources used by the Food and Drug Administration;

(ii) the impact of such provision on innovation, as well as research and development in the nonprescription drug market;

(iii) the impact of such provision on competition in the nonprescription drug market;

(iv) the impact of such provision on consumer access to nonprescription drug products;

(v) the impact of such provision on the prices of nonprescription drug products; and

(vi) whether the administrative orders initiated by requestors under such section 505G have been sufficient to encourage the development of nonprescription drug products that would likely not be otherwise developed, or developed in as timely a manner; and

(E) whether the administrative orders initiated by requestors under such section 505G have been sufficient incentive to encourage innovation in the nonprescription drug market; and

(2) an analysis of the impact of exclusivity under such section 586C for sunscreen ingredients, including—

(A) the number of sunscreen ingredients that were granted exclusivity and the specific ingredient that was determined to be generally recognized as safe and effective;

(B) whether, and to what extent, the exclusivity impacted the requestor’s or sponsor’s decision to develop the sunscreen ingredient;

(C) whether, and to what extent, the sunscreen ingredient granted exclusivity had previously been available outside of the United States;

(D) an analysis of the implementation of the exclusivity provision in such section 586C, including—

(i) the resources used by the Food and Drug Administration;

(ii) the impact of such provision on innovation, as well as research and development in the sunscreen market;

(iii) the impact of such provision on competition in the sunscreen market;

(iv) the impact of such provision on consumer access to sunscreen products;

(v) the impact of such provision on the prices of sunscreen products; and

(vi) whether the administrative orders initiated by requestors under such section 505G have been utilized by sunscreen ingredient sponsors and whether such process has been sufficient to encourage the development of sunscreen ingredients that would likely not be otherwise developed, or developed in as timely a manner; and

(E) whether the administrative orders initiated by requestors under such section 586C have been sufficient incentive to encourage innovation in the sunscreen market.

(c) Conforming amendment.—Section 751(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379r(d)(1)) is amended—

(1) in the matter preceding subparagraph (A)—

(A) by striking “final regulation promulgated” and inserting “final order under section 505G”; and

(B) by striking “and not misbranded”; and

(2) in subparagraph (A), by striking “regulation in effect” and inserting “regulation or order in effect”.

Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following:

“(ee) If it is a nonprescription drug that is subject to section 505G, is not the subject of an application approved under section 505, and does not comply with the requirements under section 505G.

“(ff) If it is a drug and it was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required by section 744M.”.

(a) In general.—Nothing in this Act (or the amendments made by this Act) shall apply to any nonprescription drug (as defined in section 505G(q) of the Federal Food, Drug, and Cosmetic Act, as added by section 1001 of this Act) which was excluded by the Food and Drug Administration from the Over-the-Counter Drug Review in accordance with the paragraph numbered 25 on page 9466 of volume 37 of the Federal Register, published on May 11, 1972.

(b) Rule of construction.—Nothing in this section shall be construed to preclude or limit the applicability of any other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

(a) Review of nonprescription sunscreen active ingredients.—

(1) APPLICABILITY OF SECTION 505G FOR PENDING SUBMISSIONS.—

(A) IN GENERAL.—A sponsor of a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that, as of the date of enactment of this Act, is subject to a proposed sunscreen order under section 586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–3) may elect, by means of giving written notification to the Secretary of Health and Human Services within 180 calendar days of the enactment of this Act, to transition into the review of such ingredient or combination of ingredients pursuant to the process set out in section 505G of the Federal Food, Drug, and Cosmetic Act, as added by section 1001 of this Act.

(B) ELECTION EXERCISED.—Upon receipt by the Secretary of Health and Human Services of a timely notification under subparagraph (A)—

(i) the proposed sunscreen order involved is deemed to be a request for an order under subsection (b) of section 505G of the Federal Food, Drug, and Cosmetic Act, as added by section 1001 of this Act; and

(ii) such order is deemed to have been accepted for filing under subsection (b)(6)(A)(i) of such section 505G.

(C) ELECTION NOT EXERCISED.—If a notification under subparagraph (A) is not received by the Secretary of Health and Human Services within 180 calendar days of the date of enactment of this Act, the review of the proposed sunscreen order described in subparagraph (A)—

(i) shall continue under section 586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–3); and

(ii) shall not be eligible for review under section 505G, added by section 1001 of this Act.

(2) DEFINITIONS.—In this subsection, the terms “sponsor”, “nonprescription”, “sunscreen active ingredient”, and “proposed sunscreen order” have the meanings given to those terms in section 586 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff).

(b) Amendments to sunscreen provisions.—

(1) FINAL SUNSCREEN ORDERS.—Paragraph (3) of section 586C(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–3(e)) is amended to read as follows:

“(3) RELATIONSHIP TO ORDERS UNDER SECTION 505G.—A final sunscreen order shall be deemed to be a final order under section 505G.”.

(2) MEETINGS.—Paragraph (7) of section 586C(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–3(b)) is amended—

(A) by striking “A sponsor may request” and inserting the following:

“(A) IN GENERAL.—A sponsor may request”; and

(B) by adding at the end the following:

“(B) CONFIDENTIAL MEETINGS.—A sponsor may request one or more confidential meetings with respect to a proposed sunscreen order, including a letter deemed to be a proposed sunscreen order under paragraph (3), to discuss matters relating to data requirements to support a general recognition of safety and effectiveness involving confidential information and public information related to such proposed sunscreen order, as appropriate. The Secretary shall convene a confidential meeting with such sponsor in a reasonable time period. If a sponsor requests more than one confidential meeting for the same proposed sunscreen order, the Secretary may refuse to grant an additional confidential meeting request if the Secretary determines that such additional confidential meeting is not reasonably necessary for the sponsor to advance its proposed sunscreen order, or if the request for a confidential meeting fails to include sufficient information upon which to base a substantive discussion. The Secretary shall publish a post-meeting summary of each confidential meeting under this subparagraph that does not disclose confidential commercial information or trade secrets. This subparagraph does not authorize the disclosure of confidential commercial information or trade secrets subject to 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.”.

(3) EXCLUSIVITY.—Section 586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–3) is amended by adding at the end the following:

“(f) Exclusivity.—

“(1) IN GENERAL.—A final sunscreen order shall have the effect of authorizing solely the order requestor (or the licensees, assignees, or successors in interest of such requestor with respect to the subject of such request and listed under paragraph (5)) for a period of 18 months, to market a sunscreen ingredient under this section incorporating changes described in paragraph (2) subject to the limitations under paragraph (4), beginning on the date the requestor (or any licensees, assignees, or successors in interest of such requestor with respect to the subject of such request and listed under paragraph (5)) may lawfully market such sunscreen ingredient pursuant to the order.

“(2) CHANGES DESCRIBED.—A change described in this paragraph is a change subject to an order specified in paragraph (1) that permits a sunscreen to contain an active sunscreen ingredient not previously incorporated in a marketed sunscreen listed in paragraph (3).

“(3) MARKETED SUNSCREEN.—The marketed sunscreen ingredients described in this paragraph are sunscreen ingredients—

“(A) marketed in accordance with a final monograph for sunscreen drug products set forth at part 352 of title 21, Code of Federal Regulations (as published at 64 Fed. Reg. 27687); or

“(B) marketed in accordance with a final order issued under this section.

“(4) LIMITATIONS ON EXCLUSIVITY.—Only one 18-month period may be granted per ingredient under paragraph (1).

“(5) LISTING OF LICENSEES, ASSIGNEES, OR SUCCESSORS IN INTEREST.—Requestors shall submit to the Secretary at the time when a drug subject to such request is introduced or delivered for introduction into interstate commerce, a list of licensees, assignees, or successors in interest under paragraph (1).”.

(4) SUNSET PROVISION.—Subchapter I of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff et seq.) is amended by adding at the end the following:

(5) TREATMENT OF FINAL SUNSCREEN ORDER.—The Federal Food, Drug, and Cosmetic Act is amended by striking section 586E of such Act (21 U.S.C. 360fff–5).

(c) Treatment of Authority Regarding Finalization of Sunscreen Monograph.—

(1) IN GENERAL.—

(A) REVISION OF FINAL SUNSCREEN ORDER.—Not later than November 26, 2019, the Secretary of Health and Human Services (referred to in this subsection as the “Secretary”) shall amend and revise the final administrative order concerning nonprescription sunscreen (referred to in this subsection as the “sunscreen order”) for which the content, prior to the date of enactment of this Act, was represented by the final monograph for sunscreen drug products set forth in part 352 of title 21, Code of Federal Regulations (as in effect on May 21, 1999).

(B) ISSUANCE OF REVISED SUNSCREEN ORDER; EFFECTIVE DATE.—A revised sunscreen order described in subparagraph (A) shall be—

(i) issued in accordance with the procedures described in section 505G(c)(2) of the Federal Food, Drug, and Cosmetic Act;

(ii) issued in proposed form not later than May 28, 2019;

(iii) effective not later than November 26, 2020; and

(iv) issued by the Secretary at least 1 year prior to the effective date of the revised order.

(2) REPORTS.—If a revised sunscreen order issued under paragraph (1) does not include provisions related to the effectiveness of various sun protection factor levels, and does not address all dosage forms known to the Secretary to be used in sunscreens marketed in the United States without a new drug application approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), the Secretary shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the rationale for omission of such provisions from such order, and a plan and timeline to compile any information necessary to address such provisions through such order.

(d) Treatment of non-sunscreen time and extent applications.—

(1) IN GENERAL.—Any application described in section 586F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–6) that was submitted to the Secretary pursuant to section 330.14 of title 21, Code of Federal Regulations, as such provisions were in effect immediately prior to the date of enactment date of this Act, shall be extinguished as of such date of enactment, subject to paragraph (2).

(2) ORDER REQUEST.—Nothing in paragraph (1) precludes the submission of an order request under section 505G(b) of the Federal Food, Drug, and Cosmetic Act, as added by section 1001 of this Act, with respect to a drug that was the subject of an application extinguished under paragraph (1).

(a) In general.—Subject to subsection (c), the Secretary of Health and Human Services shall, beginning not later than 1 year after the date of enactment of this Act, annually submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a letter describing the progress of the Food and Drug Administration—

(1) in evaluating the cough and cold monograph described in subsection (b) with respect to children under age 6; and

(2) as appropriate, revising such cough and cold monograph to address such children through the order process under section 505G(b) of the Federal Food, Drug, and Cosmetic Act, as added by section 1001 of this Act.

(b) Cough and cold monograph described.—The cough and cold monograph described in this subsection consists of the conditions under which nonprescription drugs containing antitussive, expectorant, nasal decongestant, or antihistamine active ingredients (or combinations thereof) are generally recognized as safe and effective, as specified in part 341 of title 21, Code of Federal Regulations (as in effect immediately prior to the date of enactment of this Act), and included in an order deemed to be established under section 505G(b) of the Federal Food, Drug, and Cosmetic Act, as added by section 1001 of this Act.

(c) Duration of authority.—The requirement under subsection (a) shall terminate as of the date of a letter submitted by the Secretary of Health and Human Services pursuant to such subsection in which the Secretary indicates that the Food and Drug Administration has completed its evaluation and revised, in a final order, as applicable, the cough and cold monograph as described in subsection (a)(2).

(a) Imports and exports.—Section 801(e)(4)(E)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)(4)(E)(iii)) is amended by striking “subparagraph” each place such term appears and inserting “paragraph”.

(b) FDA Reauthorization Act of 2017.—

(1) IN GENERAL.—Section 905(b)(4) of the FDA Reauthorization Act of 2017 (Public Law115–52) is amended by striking “Section 744H(e)(2)(B)” and inserting “Section 744H(f)(2)(B)”.

(2) EFFECTIVE DATE.—The amendment made by paragraph (1) shall take effect as of the enactment of the FDA Reauthorization Act of 2017 (Public Law 115–52).

(a) Short title.—This title may be cited as the “Over-the-Counter Monograph User Fee Act of 2018”.

(b) Finding.—The Congress finds that the fees authorized by the amendments made in this title will be dedicated to OTC monograph drug activities, as set forth in the goals identified for purposes of part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.

Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et seq.) is amended by inserting after part 9 the following: