Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019

II Calendar No. 10 116TH CONGRESS 1ST SESSION H. R. 269 IN THE SENATE OF THE UNITED STATES JANUARY 9, 2019 Received; read the first time JANUARY 10, 2019 Read the second time and placed on the calendar 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, to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘Pandemic and All-Hazards Preparedness and Advancing 5 Innovation Act of 2019’’. 6 VerDate Sep 11 2014 22:22 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H269.PCS H269 kjohnson on DSK79L0C42 with BILLS 2 HR 269 PCS (b) TABLE OF CONTENTS.—The table of contents for 1 this Act is as follows: 2 Sec. 1. Short title; table of contents. DIVISION A—PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND ADVANCING INNOVATION Sec. 100. References in division. 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 emergency 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 children. 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 significant threats. 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. VerDate Sep 11 2014 22:22 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6211 E:\BILLS\H269.PCS H269 kjohnson on DSK79L0C42 with BILLS 3 HR 269 PCS 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 potential 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. DIVISION B—OVER-THE-COUNTER MONOGRAPH SAFETY, INNOVATION, AND REFORM Sec. 1000. Short title; references in division. TITLE I—OTC DRUG REVIEW Sec. 1001. Regulation of certain nonprescription drugs that are marketed with- out an approved drug application. Sec. 1002. Misbranding. Sec. 1003. Drugs excluded from the over-the-counter drug review. Sec. 1004. Treatment of Sunscreen Innovation Act. Sec. 1005. Annual update to Congress on appropriate pediatric indication for certain OTC cough and cold drugs. Sec. 1006. Technical corrections. TITLE II—USER FEES Sec. 2001. Short title; finding. Sec. 2002. Fees relating to over-the-counter drugs. VerDate Sep 11 2014 22:22 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6211 E:\BILLS\H269.PCS H269 kjohnson on DSK79L0C42 with BILLS 4 HR 269 PCS DIVISION A—PANDEMIC AND 1 ALL-HAZARDS PREPARED- 2 NESS AND ADVANCING INNO- 3 VATION 4 SEC. 100. REFERENCES IN DIVISION. 5 Except as otherwise specified— 6 (1) amendments made by this division to a sec- 7 tion or other provision of law are amendments to 8 such section or other provision of the Public Health 9 Service Act (42 U.S.C. 201 et seq.); and 10 (2) any reference to ‘‘this Act’’ contained in 11 this division shall be treated as referring only to the 12 provisions of this division. 13 TITLE I—STRENGTHENING THE 14 NATIONAL HEALTH SECURITY 15 STRATEGY 16 SEC. 101. NATIONAL HEALTH SECURITY STRATEGY. 17 Section 2802 (42 U.S.C. 300hh–1) is amended— 18 (1) in subsection (a)— 19 (A) in paragraph (1)— 20 (i) by striking ‘‘2014’’ and inserting 21 ‘‘2018’’; and 22 (ii) by striking the second sentence 23 and inserting the following: ‘‘Such Na- 24 tional Health Security Strategy shall de- 25 VerDate Sep 11 2014 22:22 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H269.PCS H269 kjohnson on DSK79L0C42 with BILLS 5 HR 269 PCS scribe potential emergency health security 1 threats and identify the process for achiev- 2 ing the preparedness goals described in 3 subsection (b) to be prepared to identify 4 and respond to such threats and shall be 5 consistent with the national preparedness 6 goal (as described in section 504(a)(19) of 7 the Homeland Security Act of 2002), the 8 National Incident Management System (as 9 defined in section 501(7) of such Act), and 10 the National Response Plan developed pur- 11 suant to section 504 of such Act, or any 12 successor plan.’’; 13 (B) in paragraph (2), by inserting before 14 the period at the end of the second sentence the 15 following: ‘‘, and an analysis of any changes to 16 the evidence-based benchmarks and objective 17 standards under sections 319C–1 and 319C–2’’; 18 and 19 (C) in paragraph (3)— 20 (i) by striking ‘‘2009’’ and inserting 21 ‘‘2022’’; 22 (ii) by inserting ‘‘(including gaps in 23 the environmental health and animal 24 health workforces, as applicable), describ- 25 VerDate Sep 11 2014 22:22 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H269.PCS H269 kjohnson on DSK79L0C42 with BILLS 6 HR 269 PCS ing the status of such workforce’’ after 1 ‘‘gaps in such workforce’’; 2 (iii) by striking ‘‘and identifying strat- 3 egies’’ and inserting ‘‘identifying strate- 4 gies’’; and 5 (iv) by inserting before the period at 6 the end ‘‘, and identifying current capabili- 7 ties to meet the requirements of section 8 2803’’; and 9 (2) in subsection (b)— 10 (A) in paragraph (2)— 11 (i) in subparagraph (A), by striking 12 ‘‘and investigation’’ and inserting ‘‘inves- 13 tigation, and related information tech- 14 nology activities’’; 15 (ii) in subparagraph (B), by striking 16 ‘‘and decontamination’’ and inserting ‘‘de- 17 contamination, relevant health care serv- 18 ices and supplies, and transportation and 19 disposal of medical waste’’; and 20 (iii) by adding at the end the fol- 21 lowing: 22 ‘‘(E) Response to environmental hazards.’’; 23 (B) in paragraph (3)— 24 VerDate Sep 11 2014 22:22 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H269.PCS H269 kjohnson on DSK79L0C42 with BILLS 7 HR 269 PCS (i) in the matter preceding subpara- 1 graph (A), by striking ‘‘including mental 2 health’’ and inserting ‘‘including phar- 3 macies, mental health facilities,’’; and 4 (ii) in subparagraph (F), by inserting 5 ‘‘or exposures to agents that could cause a 6 public health emergency’’ before the pe- 7 riod; 8 (C) in paragraph (5), by inserting ‘‘and 9 other applicable compacts’’ after ‘‘Compact’’; 10 and 11 (D) by adding at the end the following: 12 ‘‘(9) ZOONOTIC DISEASE, FOOD, AND AGRI- 13 CULTURE.—Improving coordination among Federal, 14 State, local, Tribal, and territorial entities (including 15 through consultation with the Secretary of Agri- 16 culture) to prevent, detect, and respond to outbreaks 17 of plant or animal disease (including zoonotic dis- 18 ease) that could compromise national security result- 19 ing from a deliberate attack, a naturally occurring 20 threat, the intentional adulteration of food, or other 21 public health threats, taking into account inter- 22 actions between animal health, human health, and 23 animals’ and humans’ shared environment as di- 24 VerDate Sep 11 2014 22:22 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H269.PCS H269 kjohnson on DSK79L0C42 with BILLS 8 HR 269 PCS rectly related to public health emergency prepared- 1 ness and response capabilities, as applicable. 2 ‘‘(10) GLOBAL HEALTH SECURITY.—Assessing 3 current or potential health security threats from 4 abroad to inform domestic public health prepared- 5 ness and response capabilities.’’. 6 TITLE II—IMPROVING 7 PREPAREDNESS AND RESPONSE 8 SEC. 201. IMPROVING BENCHMARKS AND STANDARDS FOR 9 PREPAREDNESS AND RESPONSE. 10 (a) EVALUATING MEASURABLE EVIDENCE-BASED 11 BENCHMARKS AND OBJECTIVE STANDARDS.—Section 12 319C–1 (42 U.S.C. 247d–3a) is amended by inserting 13 after subsection (j) the following: 14 ‘‘(k) EVALUATION.— 15 ‘‘(1) IN GENERAL.—Not later than 2 years 16 after the date of enactment of the Pandemic and 17 All-Hazards Preparedness and Advancing Innovation 18 Act of 2019 and every 2 years thereafter, the Sec- 19 retary shall conduct an evaluation of the evidence- 20 based benchmarks and objective standards required 21 under subsection (g). Such evaluation shall be sub- 22 mitted to the congressional committees of jurisdic- 23 tion together with the National Health Security 24 VerDate Sep 11 2014 22:22 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H269.PCS H269 kjohnson on DSK79L0C42 with BILLS 9 HR 269 PCS Strategy under section 2802, at such time as such 1 strategy is submitted. 2 ‘‘(2) CONTENT.—The evaluation under this 3 paragraph shall include— 4 ‘‘(A) a review of evidence-based bench- 5 marks and objective standards, and associated 6 metrics and targets; 7 ‘‘(B) a discussion of changes to any evi- 8 dence-based benchmarks and objective stand- 9 ards, and the effect of such changes on the abil- 10 ity to track whether entities are meeting or 11 making progress toward the goals under this 12 section and, to the extent practicable, the appli- 13 cable goals of the National Health Security 14 Strategy under section 2802; 15 ‘‘(C) a description of amounts received by 16 eligible entities described in subsection (b) and 17 section 319C–2(b), and amounts received by 18 subrecipients and the effect of such funding on 19 meeting evidence-based benchmarks and objec- 20 tive standards; and 21 ‘‘(D) recommendations, as applicable and 22 appropriate, to improve evidence-based bench- 23 marks and objective standards to more accu- 24 rately assess the ability of entities receiving 25 VerDate Sep 11 2014 22:22 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H269.PCS H269 kjohnson on DSK79L0C42 with BILLS 10 HR 269 PCS awards under this section to better achieve the 1 goals under this section and section 2802.’’. 2 (b) EVALUATING THE PARTNERSHIP FOR STATE AND 3 REGIONAL HOSPITAL PREPAREDNESS.—Section 319C– 4 2(i)(1) (42 U.S.C. 247–3b(i)(1)) is amended by striking 5 ‘‘section 319C–1(g), (i), and (j)’’ and inserting ‘‘section 6 319C–1(g), (i), (j), and (k)’’. 7 SEC. 202. AMENDMENTS TO PREPAREDNESS AND RE- 8 SPONSE PROGRAMS. 9 (a) COOPERATIVE AGREEMENT APPLICATIONS FOR 10 IMPROVING STATE AND LOCAL PUBLIC HEALTH SECU- 11 RITY.—Section 319C–1 (42 U.S.C. 247d–3a) is amend- 12 ed— 13 (1) in subsection (a), by inserting ‘‘, acting 14 through the Director of the Centers for Disease 15 Control and Prevention,’’ after ‘‘the Secretary’’; and 16 (2) in subsection (b)(2)(A)— 17 (A) in clause (vi), by inserting ‘‘, including 18 public health agencies with specific expertise 19 that may be relevant to public health security, 20 such as environmental health agencies,’’ after 21 ‘‘stakeholders’’; 22 (B) by redesignating clauses (vii) through 23 (ix) as clauses (viii) through (x); 24 VerDate Sep 11 2014 22:22 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H269.PCS H269 kjohnson on DSK79L0C42 with BILLS 11 HR 269 PCS (C) by inserting after clause (vi) the fol- 1 lowing: 2 ‘‘(vii) a description of how, as applica- 3 ble, such entity may integrate information 4 to account for individuals with behavioral 5 health needs following a public health 6 emergency;’’; 7 (D) in clause (ix), as so redesignated, by 8 striking ‘‘; and’’ and inserting a semicolon; and 9 (E) by adding at the end the following: 10 ‘‘(xi) a description of how the entity 11 will partner with health care facilities, in- 12 cluding hospitals and nursing homes and 13 other long-term care facilities, to promote 14 and improve public health preparedness 15 and response; and 16 ‘‘(xii) a description of how, as appro- 17 priate and practicable, the entity will in- 18 clude critical infrastructure partners, such 19 as utility companies within the entity’s ju- 20 risdiction, in planning pursuant to this 21 subparagraph to help ensure that critical 22 infrastructure will remain functioning dur- 23 ing, or return to function as soon as prac- 24 ticable after, a public health emergency;’’. 25 VerDate Sep 11 2014 22:22 Jan 10, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H269.PCS H269 kjohnson on DSK79L0C42 with BILLS 12 HR 269 PCS (b) EXCEPTION RELATING TO APPLICATION OF CER- 1 TAIN REQUIREMENTS.— 2 (1) IN GENERAL.—Section 319C–1(g) (42 3 U.S.C. 247d–3a(g)) is a [Text truncated for display. Full text available on Congress.gov.]