TH D CONGRESS SESSION S. ll

1 TAM22118 C9S 117 THCONGRESS 2 DSESSION S. ll To prepare for, and respond to, existing viruses, emerging new threats, and pandemics. IN THE SENATE OF THE UNITED STATES llllllllll llllllllll introduced the following bill; which was read twice and referred to the Committee on llllllllll A BILL To prepare for, and respond to, existing viruses, emerging new threats, and pandemics. Be it enacted by the Senate and House of Representa-1tives of the United States of America in CONGRESS assembled, 2 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3(a) SHORTTITLE. This Act may be cited as the 4 Prepare for and Respond to Existing Viruses, Emerging 5 New Threats, and Pandemics Act or the PREVENT 6 Pandemics Act.

2 7(b) TABLE OFCONTENTS. The table of contents for 8this Act is as follows: 9 Sec. 1. Short title; table of contents. 2 TAM22118 C9S TITLE I STRENGTHENING FEDERAL AND STATE PREPAREDNESS Subtitle A Federal Leadership and Accountability Sec. 101. Comprehensive review of the COVID 19 response. Sec. 102. Appointment and authority of the Director of the Centers for Disease Control and Prevention. Sec. 103. Public health and medical preparedness and response coordination. Sec. 104. Strengthening public health communication. Subtitle B State and Local Readiness Sec. 111. Improving State and local public health security.

3 Sec. 112. Supporting access to mental health and substance use disorder serv-ices during public health emergencies. Sec. 113. Trauma care reauthorization. Sec. 114. Assessment of containment and mitigation of infectious diseases. TITLE II IMPROVING PUBLIC HEALTH PREPAREDNESS AND RESPONSE CAPACITY Subtitle A Addressing Disparities and Improving Public Health Emergency Responses Sec. 201. Addressing social determinants of health and improving health out-comes. Sec. 202. National Academies of Sciences report. Subtitle B Improving Public Health Data Sec. 211. Modernizing biosurveillance capabilities and infectious disease data collection.

4 Sec. 212. Genomic sequencing, analytics, and public health surveillance of pathogens. Sec. 213. Supporting public health data availability and access. Sec. 214. Epidemic forecasting and outbreak analytics. Subtitle C Revitalizing the Public Health Workforce Sec. 221. Improving recruitment and retention of the frontline public health workforce. Sec. 222. Awards to support community health workers and community health. Sec. 223. Improving public health emergency response capacity. Sec. 224. Extension of authorities to support health professional volunteers at community health centers.

5 Subtitle D Improving Public Health Responses Sec. 231. Centers for public health preparedness and response. Sec. 232. Vaccine distribution plans. TITLE III ACCELERATING RESEARCH AND COUNTERMEASURE DISCOVERY Sec. 301. Research and activities related to long-term health effects of SARS CoV 2 infection. Sec. 302. Research centers for pathogens of pandemic concern. Sec. 303. Improving medical countermeasure research coordination. 3 TAM22118 C9S Sec. 304. Accessing specimen samples and diagnostic tests. TITLE IV MODERNIZING AND STRENGTHENING THE SUPPLY CHAIN FOR VITAL MEDICAL PRODUCTS Sec.

6 401. Warm base manufacturing capacity for medical countermeasures. Sec. 402. Supply chain considerations for the Strategic National Stockpile. Sec. 403. Strategic National Stockpile equipment maintenance. Sec. 404. Improving transparency and predictability of processes of the Stra-tegic National Stockpile. Sec. 405. Improving supply chain flexibility for the Strategic National Stock-pile. Sec. 406. Strategic National Stockpile contract duration. Sec. 407. Reimbursement for certain supplies. Sec. 408. Action reporting on stockpile depletion. Sec. 409. Provision of medical countermeasures to Indian programs and facili-ties.

7 Sec. 410. Grants for State strategic stockpiles. TITLE V ENHANCING DEVELOPMENT AND COMBATING SHORTAGES OF MEDICAL PRODUCTS Subtitle A Development and Review Sec. 501. Advancing qualified infectious disease product innovation. Sec. 502. Modernizing clinical trials. Sec. 503. Accelerating countermeasure development and review. Sec. 504. Third party test evaluation during emergencies. Sec. 505. Facilitating the use of real world evidence. Sec. 506. Advanced platform technologies. Sec. 507. Increasing EUA decision transparency. Sec. 508. Improving FDA guidance and communication. Sec. 509.

8 GAO study and report on hiring challenges at FDA. Subtitle B Mitigating Shortages Sec. 511. Ensuring registration of foreign drug and device manufacturers. Sec. 512. Extending expiration dates for certain drugs. Sec. 513. Unannounced foreign facility inspections pilot program. Sec. 514. Combating counterfeit devices. Sec. 515. Strengthening medical device supply chains. Sec. 516. Preventing medical device shortages. Sec. 517. Remote records assessments for medical devices. Sec. 518. Advanced manufacturing technologies designation pilot program. Sec. 519. Technical corrections. 4 TAM22118 C9S TITLE I STRENGTHENING FED-1 ERAL AND STATE PREPARED-2 NESS 3 Subtitle A Federal Leadership 4and Accountability 5 SEC.

9 101. COMPREHENSIVE REVIEW OF THE COVID 19 RE-6 SPONSE. 7(a) ESTABLISHMENT OFTASKFORCE. There is es-8tablished a task force to be known as the National Task 9 Force on the Response of the United States to the 10 COVID 19 Pandemic (referred to in this section as the 11 Task Force ). 12(b) PURPOSES. The purposes of the Task Force are 13to 14(1) examine, assess, and report upon the 15 United States preparedness for, and response to, 16the COVID 19 pandemic, including 17(A) the initial Federal, State, local, and 18territorial responses in the United States; 19(B) the ongoing Federal, State, local, and 20territorial responses in the United States, in-21cluding the activities, policies, and decisions of 22the Trump Administration and the Biden Ad-23ministration.

10 245 TAM22118 C9S (C) the impact of the pandemic on public 1health and health care systems; and 2(D) the initial outbreak in Wuhan, China, 3including efforts to determine the potential 4causes for the emergence of the SARS CoV 2 5virus, and Federal actions to mitigate its spread 6internationally; 7(2) build upon existing or ongoing evaluations 8and avoid unnecessary duplication, by reviewing the 9findings, conclusions, and recommendations of other 10appropriate task forces, committees, commissions, or 11entities established by other public or nonprofit pri-12vate entities related to the United States prepared-13ness for, and response to, the COVID 19 pandemic.