Sec. 205. PUBLIC HEALTH AND HEALTH CARE SYSTEM SITUATIONAL AWARENESS AND BIOSURVEILLANCE CAPABILITIES
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## SEC. 205 PUBLIC HEALTH AND HEALTH CARE SYSTEM SITUATIONAL AWARENESS AND BIOSURVEILLANCE CAPABILITIES ###
(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,”; #####
(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 2019, 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 2019 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 2019, 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 2019, 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 2019 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,”; #####
(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 2019, 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. ####
(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.
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Sec. 205
PUBLIC HEALTH AND HEALTH CARE SYSTEM SITUATIONAL AWARENESS AND BIOSURVEILLANCE CAPABILITIES
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