133 STAT. 905 PUBLIC LAW 116–22—JUNE 24, 2019 Public Law 116–22 116th Congress An Act To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE; TABLE OF CONTENTS. (a) SHORT TITLE.—This Act may be cited as the ‘‘Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019’’. (b) TABLE OF CONTENTS.—The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. References in Act. TITLE I—STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY Sec. 101. National Health Security Strategy. TITLE II—IMPROVING PREPAREDNESS AND RESPONSE Sec. 201. Improving benchmarks and standards for preparedness and response. Sec. 202. Amendments to preparedness and response programs. Sec. 203. Regional health care emergency preparedness and response systems. Sec. 204. Military and civilian partnership for trauma readiness. Sec. 205. Public health and health care system situational awareness and bio- surveillance capabilities. Sec. 206. Strengthening and supporting the public health emergency rapid re- sponse fund. Sec. 207. Improving all-hazards preparedness and response by public health emer- gency volunteers. Sec. 208. Clarifying State liability law for volunteer health care professionals. Sec. 209. Report on adequate national blood supply. Sec. 210. Report on the public health preparedness and response capabilities and capacities of hospitals, long-term care facilities, and other health care facilities. TITLE III—REACHING ALL COMMUNITIES Sec. 301. Strengthening and assessing the emergency response workforce. Sec. 302. Health system infrastructure to improve preparedness and response. Sec. 303. Considerations for at-risk individuals. Sec. 304. Improving emergency preparedness and response considerations for chil- dren. Sec. 305. National advisory committees on disasters. Sec. 306. Guidance for participation in exercises and drills. TITLE IV—PRIORITIZING A THREAT-BASED APPROACH Sec. 401. Assistant Secretary for Preparedness and Response. Sec. 402. Public Health Emergency Medical Countermeasures Enterprise. Sec. 403. Strategic National Stockpile. Sec. 404. Preparing for pandemic influenza, antimicrobial resistance, and other sig- nificant threats. Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019. 42 USC 201 note. June 24, 2019 [S. 1379] VerDate Sep 11 2014 11:04 Oct 31, 2019 Jkt 089139 PO 00022 Frm 00001 Fmt 6580 Sfmt 6582 E:\PUBLAW\PUBL022.116 PUBL022 dkrause on DSKBC28HB2PROD with PUBLAWS 133 STAT. 906 PUBLIC LAW 116–22—JUNE 24, 2019 Sec. 405. Reporting on the Federal Select Agent Program. TITLE V—INCREASING COMMUNICATION IN MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND DEVELOPMENT Sec. 501. Medical countermeasure budget plan. Sec. 502. Material threat and medical countermeasure notifications. Sec. 503. Availability of regulatory management plans. Sec. 504. The Biomedical Advanced Research and Development Authority and the BioShield Special Reserve Fund. Sec. 505. Additional strategies for combating antibiotic resistance. TITLE VI—ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES Sec. 601. Administration of countermeasures. Sec. 602. Updating definitions of other transactions. Sec. 603. Medical countermeasure master files. Sec. 604. Animal rule report. Sec. 605. Review of the benefits of genomic engineering technologies and their po- tential role in national security. Sec. 606. Report on vaccines development. Sec. 607. Strengthening mosquito abatement for safety and health. TITLE VII—MISCELLANEOUS PROVISIONS Sec. 701. Reauthorizations and extensions. Sec. 702. Location of materials in the stockpile. Sec. 703. Cybersecurity. Sec. 704. Strategy and report. Sec. 705. Technical amendments. SEC. 2. REFERENCES IN ACT. Except as otherwise specified, amendments made by this Act 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.). TITLE I—STRENGTHENING THE NA- TIONAL HEALTH SECURITY STRAT- EGY SEC. 101. NATIONAL HEALTH SECURITY STRATEGY. 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 Manage- ment System (as defined in section 501(7) of such Act), and the National Response Plan developed pursu- ant 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 bench- marks and objective standards under sections 319C–1 and 319C–2’’; and VerDate Sep 11 2014 11:04 Oct 31, 2019 Jkt 089139 PO 00022 Frm 00002 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL022.116 PUBL022 dkrause on DSKBC28HB2PROD with PUBLAWS 133 STAT. 907 PUBLIC LAW 116–22—JUNE 24, 2019 (C) in paragraph (3)— (i) by striking ‘‘2009’’ and inserting ‘‘2022’’; (ii) by inserting ‘‘(including gaps in the environ- mental 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 investiga- tion’’ and inserting ‘‘investigation, and related informa- tion technology activities’’; (ii) in subparagraph (B), by striking ‘‘and decon- tamination’’ 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 Sec- retary of Agriculture) to prevent, detect, and respond to out- breaks of plant or animal disease (including zoonotic disease) that could compromise national security resulting from a delib- erate 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.’’. TITLE II—IMPROVING PREPAREDNESS AND RESPONSE SEC. 201. IMPROVING BENCHMARKS AND STANDARDS FOR PREPARED- NESS AND RESPONSE. (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: Assessment. Coordination. Consultation. VerDate Sep 11 2014 11:04 Oct 31, 2019 Jkt 089139 PO 00022 Frm 00003 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL022.116 PUBL022 dkrause on DSKBC28HB2PROD with PUBLAWS 133 STAT. 908 PUBLIC LAW 116–22—JUNE 24, 2019 ‘‘(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 2019 and every 2 years there- after, the Secretary shall conduct an evaluation of the evidence- based benchmarks and objective standards required under sub- section (g). Such evaluation shall be submitted to the congres- sional 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 objec- tive 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 enti- ties 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 objec- tive standards; and ‘‘(D) recommendations, as applicable and appropriate, to improve evidence-based benchmarks and objective stand- ards 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)’’. SEC. 202. AMENDMENTS TO PREPAREDNESS AND RESPONSE PRO- GRAMS. (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 agen- cies,’’ 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 individ- uals with behavioral health needs following a public health emergency;’’; (D) in clause (ix), as so redesignated, by striking ‘‘; and’’ and inserting a semicolon; and Recommenda- tions. Review. Deadlines. VerDate Sep 11 2014 11:04 Oct 31, 2019 Jkt 089139 PO 00022 Frm 00004 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL022.116 PUBL022 dkrause on DSKBC28HB2PROD with PUBLAWS 133 STAT. 909 PUBLIC LAW 116–22—JUNE 24, 2019 (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 prac- ticable, 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 REQUIRE- MENTS.— (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 imme- diately 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 para- graph 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 one 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 one 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 Sec- retary for Preparedness and Response,’’ after ‘‘The Sec- retary’’; and (B) by striking ‘‘preparedness for public health emer- gencies’’ and inserting ‘‘preparedness for, and response to, 42 USC 247d–3a note. Time periods. VerDate Sep 11 2014 11:04 Oct 31, 2019 Jkt 089139 PO 00022 Frm 00005 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL022.116 PUBL022 dkrause on DSKBC28HB2PROD with PUBLAWS 133 STAT. 910 PUBLIC LAW 116–22—JUNE 24, 2019 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 organiza- tions or emergency management organizations; and’’; (3) in subsection (d)— (A) in paragraph (1)(B), by striking ‘ [Text truncated for display. Full text available on Congress.gov.]