I 

116TH CONGRESS 

2D SESSION H. R. 14 

To increase the Federal commitment to defeating the virus that causes 

COVID–19 and prepare for future pandemics, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 30, 2020 

Mr. HUDSON (for himself, Mr. MCCARTHY, Mr. WALDEN, Mr. BRADY, and 

Ms. GRANGER) introduced the following bill; which was referred to the 

Committee on Energy and Commerce, and in addition to the Committees 

on Homeland Security, Transportation and Infrastructure, the Judiciary, 

Ways and Means, the Budget, and Science, Space, and Technology, for 

a period to be subsequently determined by the Speaker, in each case for 

consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To increase the Federal commitment to defeating the virus 

that causes COVID–19 and prepare for future 

pandemics, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Commitment to Defeat 

5 the Virus and Keep America Healthy Act’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 The table of contents for this Act is as follows: 


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Sec. 1. Short title. 

Sec. 2. Table of contents. 

TITLE I—PANDEMIC PREPAREDNESS AND RESPONSE 

Subtitle A—Clarifying the Role of the Department of Health and Human 

Services During Public Health Emergencies 

Sec. 1001. Lead agency for Federal public health and medical response to public health emergencies. 

Sec. 1002. Deployment by the Secretary of Health and Human Services of National Strategic Stockpile. 

Sec. 1003. Authority and responsibilities of the Federal Emergency Management Agency regarding the Strategic National Stockpile. 

Subtitle B—Reagan-Udall Foundation and Foundation for the National 

Institutes of Health 

Sec. 1011. Reagan-Udall Foundation and Foundation for the National Institutes of Health. 

Subtitle C—Protections for Good Samaritan Health Professionals 

Sec. 1021. Limitation on liability for volunteer health care professionals. 

Sec. 1022. Sense of the Congress. 

Subtitle D—Medical Sheltering 

Sec. 1031. Reducing the spread of COVID–19 through payments to States to 

lease hotels to temporarily house eligible individuals. 

Subtitle E—CDC Campaign on COVID–19 Awareness 

Sec. 1041. COVID–19 public awareness campaign. 

Subtitle F—Protecting Children From COVID–19 

Sec. 1051. Study on children’s role in transmitting SARS–CoV–2. 

Subtitle G—Ensuring Understanding of COVID–19 

Sec. 1061. Study on the impact of COVID–19. 

Subtitle H—Safeguarding Therapeutics 

Sec. 1071. Authority to destroy counterfeit devices. 

Sec. 1072. Determination of budgetary effects. 

Subtitle I—Advisory Committee on Immunization Practices 

Sec. 1081. Expedited meeting of ACIP for COVID–19 vaccines. 

Subtitle J—Improvements to Transparency of the Pricing of Diagnostic 

Testing for COVID–19 

Sec. 1091. Improvements to transparency of the pricing of diagnostic testing 

for COVID–19. 

TITLE II—DOMESTIC MANUFACTURING AND SUPPLY CHAIN 


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Subtitle A—Sustained On-Shore Manufacturing Capacity for Public Health 

Emergencies 

Sec. 2001. Sustained on-shore manufacturing capacity for public health emergencies. 

Subtitle B—Manufacturing API, Drugs, and Excipients in America 

Sec. 2011. Report to Congress on barriers to domestic manufacturing of medical products and supplies. 

Sec. 2012. Enhancing intra-agency coordination and public health assessment 

with regard to compliance activities. 

Sec. 2013. Encouraging international harmonization. 

Sec. 2014. Mutual recognition agreements for inspections and review activities. 

Sec. 2015. Enhancing transparency of drug facility inspection timelines. 

Sec. 2016. Advanced manufacturing technologies program. 

Subtitle C—Improving the American Drug Supply Chain 

Sec. 2021. Study and reporting on domestic and foreign production. 

Subtitle D—Essential Medicines Strategic Stockpile 

Sec. 2031. Pilot program on ensuring medication supply stability. 

Subtitle E—National Centers of Excellence in Continuous Pharmaceutical 

Manufacturing 

Sec. 2041. National Centers of Excellence in Continuous Pharmaceutical Manufacturing. 

TITLE III—STRATEGIC NATIONAL STOCKPILE IMPROVEMENTS 

Subtitle A—Stockpiling for America’s Future Endeavors 

Sec. 3001. Strategic National Stockpile. 

Subtitle B—Stockpile Inventory Modernization 

Sec. 3011. Reimbursable transfers. 

Subtitle C—Equipment Maintenance 

Sec. 3021. Equipment maintenance. 

Subtitle D—Medical Supplies for Pandemics 

Sec. 3031. Supply chain flexibility manufacturing pilot. 

Subtitle E—State Stockpile Readiness 

Sec. 3041. Grants for State strategic stockpiles. 

Subtitle F—Process Improvements and Reports 

Sec. 3051. GAO study on the feasibility and benefits of user fee agreements. 

Sec. 3052. Action reporting. 

Sec. 3053. Improved, transparent processes. 

Subtitle G—Strategic National Stockpile Funding 


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Sec. 3061. Authorization of appropriations. 

TITLE IV—PUBLIC HEALTH INFRASTRUCTURE IMPROVEMENTS 

Subtitle A—Public Health Infrastructure Modernization 

Sec. 4001. Public health data system transformation. 

Subtitle B—Modernizing Infectious Disease Data Collection 

Sec. 4011. Modernizing infectious disease data collection. 

Subtitle C—Diagnostic Testing for Public Health Labs 

Sec. 4021. Grants for public health laboratories to acquire high-throughput diagnostic equipment. 

Subtitle D—Rapid Testing for Communities 

Sec. 4031. Grants for same-day point-of-care clinical laboratory diagnostic testing in communities. 

Subtitle E—Public Health Workforce Loan Repayment 

Sec. 4041. Public Health Workforce Loan Repayment Program. 

Subtitle F—Vaccine Awareness and Disease Prevention 

Sec. 4051. Improving awareness of disease prevention. 

Subtitle G—Protecting the Health of America’s Older Adults During COVID– 

19 & Beyond 

Sec. 4061. National COVID–19 Resource Center for Older Adults. 

Sec. 4062. Healthy Aging Program. 

Sec. 4063. Authorization of appropriations. 

Subtitle H—Expanding Capacity for Health Outcomes 

Sec. 4071. Expanding capacity for health outcomes. 

Subtitle I—Community Readiness 

Sec. 4081. Grants for research on, or establishing, wastewater surveillance and 

other early warning systems. 

TITLE V—ADDRESSING COVID–19 HEALTH DISPARITIES 

Subtitle A—Tribal Health Data Improvement 

Sec. 5001. Collection and availability of health data with respect to Indian 

Tribes. 

Sec. 5002. Improving health statistics reporting with respect to Indian Tribes. 

Subtitle B—Tribal Medical Supplies Stockpile Access 

Sec. 5011. Provision of items to Indian programs and facilities. 

Subtitle C—Native American Suicide Prevention 

Sec. 5021. Native American suicide prevention. 


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Subtitle D—Pursuing Equity in Mental Health 

PART 1—HEALTH EQUITY AND ACCOUNTABILITY

Sec. 5031. Integrated Health Care Demonstration Program. 

Sec. 5032. Addressing racial and ethnic minority mental health disparities research gaps. 

Sec. 5033. Health professions competencies to address racial and ethnic minority mental health disparities. 

Sec. 5034. Racial and ethnic minority behavioral and mental health outreach 

and education strategy. 

Sec. 5035. Additional funds for National Institutes of Health. 

Sec. 5036. Additional funds for National Institute on Minority Health and 

Health Disparities. 

PART 2—OTHER PROVISIONS

Sec. 5037. Reauthorization of Minority Fellowship Program. 

Sec. 5038. Study on the Effects of Smartphone and Social Media Use on Adolescents. 

Sec. 5039. Technical correction. 

Subtitle E—Maternal Health Quality Improvement 

Sec. 5041. Innovation for maternal health. 

Sec. 5042. Training for health care providers. 

Sec. 5043. Study on training to reduce and prevent discrimination. 

Sec. 5044. Perinatal quality collaboratives. 

Sec. 5045. Integrated services for pregnant and postpartum women. 

Sec. 5046. Improving rural maternal and obstetric care data. 

Sec. 5047. Rural obstetric network grants. 

Sec. 5048. Telehealth network and telehealth resource centers grant programs. 

Sec. 5049. Rural maternal and obstetric care training demonstration. 

TITLE VI—ADDRESSING THE IMPACTS OF COVID–19 ON MENTAL 

HEALTH 

Subtitle A—Creating Resources To Improve Situations of Inherent Severity 

Sec. 6001. Set-aside for evidence-based crisis care services. 

Subtitle B—Emergency Mental Health and Substance Use Training and 

Technical Assistance Center 

Sec. 6011. Emergency mental health and substance use training and technical 

assistance center. 

Subtitle C—Suicide Prevention Grants 

Sec. 6021. Syndromic surveillance of self-harm behaviors program. 

Sec. 6022. Grants to provide self-harm and suicide prevention services. 

Subtitle D—Effective Suicide Screening in the Emergency Department 

Sec. 6031. Program to improve the care provided to patients in the emergency 

department who are at risk of suicide. 

Subtitle E—Suicide Prevention Lifeline Improvement 


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Sec. 6041. Suicide Prevention Lifeline. 

Sec. 6042. Pilot program on innovative technologies. 

Sec. 6043. HHS study and report. 

Sec. 6044. GAO study and report. 

Sec. 6045. Definition. 

Subtitle F—Campaign To Prevent Suicide 

Sec. 6051. National Suicide Prevention Lifeline. 

Sec. 6052. National suicide prevention media campaign. 

Subtitle G—Helping Emergency Responders Overcome 

Sec. 6061. Data system to capture national public safety officer suicide incidence. 

Sec. 6062. Peer-support behavioral health and wellness programs within fire departments and emergency medical service agencies. 

Sec. 6063. Health care provider behavioral health and wellness programs. 

Sec. 6064. Development of resources for educating mental health professionals 

about treating fire fighters and emergency medical services 

personnel. 

Sec. 6065. Best practices and other resources for addressing posttraumatic 

stress disorder in public safety officers. 

Subtitle H—Behavioral Health Intervention Guidelines 

Sec. 6071. Best practices for behavioral intervention teams. 

Subtitle I—Suicide Training and Awareness Nationally Delivered for 

Universal Prevention 

Sec. 6081. Student suicide awareness and prevention training. 

Sec. 6082. Effective date. 

TITLE VII—ADDRESSING THE IMPACTS OF COVID–19 ON 

SUBSTANCE USE DISORDERS 

Subtitle A—Easy Medication Access and Treatment for Opioid Addiction 

Sec. 7001. Dispensation of narcotic drugs for the purpose of relieving acute 

withdrawal symptoms from opioid use disorder. 

Subtitle B—Access to Remote Behavioral Health Treatment 

Sec. 7011. Registration of qualified community mental health centers. 

Subtitle C—PDMP Pilot Program 

Sec. 7021. Pilot program for integrating substance use disorder and behavioral 

health treatment locator tool into State prescription drug monitoring programs. 

Subtitle D—Family Support Services for Addiction 

Sec. 7031. Family support services for individuals struggling with substance 

use disorder. 

Subtitle E—Block, Report, And Suspend Suspicious Shipments 


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Sec. 7041. Clarification of process for registrants to exercise due diligence upon 

discovering a suspicious order. 

Subtitle F—Debarment Enforcement of Bad Actor Registrants 

Sec. 7051. Debarment of certain registrants. 

Subtitle G—Ensuring Compliance Against Opioid Diversion 

Sec. 7061. Modification, transfer, and termination of registration to manufacture, distribute, or dispense controlled substances. 

Subtitle H—Opioid Prescription Verification 

Sec. 7071. Materials for training pharmacists on certain circumstances under 

which a pharmacist may decline to fill a prescription. 

Sec. 7072. Incentivizing States to facilitate responsible, informed dispensing of 

controlled substances. 

Subtitle I—Suspicious Order Identification 

Sec. 7081. Strengthening ARCOS. 

Sec. 7082. Suspicious Orders Task Force. 

Subtitle J—Stop the Importation and Manufacturing of Synthetic Analogues 

Sec. 7091. Establishment of schedule A. 

Sec. 7092. Temporary and permanent scheduling of schedule A substances. 

Sec. 7093. Penalties. 

Sec. 7094. False labeling of schedule A controlled substances. 

Sec. 7095. Registration requirements for importers and exporters of schedule A 

substances. 

Sec. 7096. Additional conforming amendments. 

Sec. 7097. Sentencing review. 

Sec. 7098. Rules of construction. 

Sec. 7099. Clarification of certain registration requirements related to research. 

Sec. 7100. Review of research registration process. 

TITLE VIII—TAX INCENTIVES TO IMPROVE HEALTH CARE 

Sec. 8001. Domestic medical and drug manufacturing credit. 

Sec. 8002. Qualifying advanced medical manufacturing equipment credit. 

Sec. 8003. New medical research expenditure component of credit for increasing research activities. 

Sec. 8004. Refundable portion of research credit for small businesses engaging 

in specified medical research. 

Sec. 8005. Exception from passive loss rules for investments in specified medical research small business pass-thru entities. 

Sec. 8006. Temporary carryover for health and dependent care flexible spending arrangements. 

Sec. 8007. Increase in exclusion for employer-provided dependent care assistance. 

Sec. 8008. Temporary increase in contribution limits for health savings accounts. 

Sec. 8009. Temporary allowance of payments for employment-related expenses 

under health savings accounts. 

Sec. 8010. Treatment of direct primary care service arrangements. 


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Sec. 8011. Allow both spouses to make catch-up contributions to the same HSA 

account. 

Sec. 8012. Repeal of ceiling on deductible and out-of-pocket expenses under a 

high deductible health plan. 

Sec. 8013. On-site employee clinics. 

Sec. 8014. Adjustment of medical expense deduction. 

Sec. 8015. Healthy workplace tax credit. 

TITLE IX—MEDICARE PROVISIONS 

Subtitle A—Telehealth 

Sec. 9001. Removing certain geographic and originating site restrictions on the 

furnishing of telehealth services under the Medicare program. 

Sec. 9002. Making permanent FQHC and RHC telehealth payments. 

Sec. 9003. Expanding the list of practitioners eligible to furnish telehealth services. 

Sec. 9004. Allowing for the provision of telehealth services via audio-only telecommunications systems. 

Sec. 9005. Making permanent the safe harbor for absence of deductible for telehealth. 

Sec. 9006. Removing requirement for face-to-face visits between home dialysis 

patients and physicians. 

Sec. 9007. Report on telehealth payment integrity. 

Sec. 9008. Increasing funding for review of telehealth claims. 

Sec. 9009. Telehealth resources. 

Subtitle B—Protecting Access to Innovation During COVID–19 

Sec. 9011. Authorizing the extension of pass-through status under the Medicare 

program for certain drugs and devices impacted by COVID–19. 

Subtitle C—Reducing Unnecessary Senior Hospitalizations 

Sec. 9021. SNF-based provision of preventive acute care and hospitalization reduction program. 

TITLE X—APPROPRIATIONS 

Sec. 10001. Appropriations. 

Subtitle A—Health Programs 

Subtitle B—General Provisions–This Title 


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1 TITLE I—PANDEMIC 

2 PREPAREDNESS AND RESPONSE 

3 Subtitle A—Clarifying the Role of 

4 the Department of Health and 

5 Human Services During Public 

6 Health Emergencies 

7 SEC. 1001. LEAD AGENCY FOR FEDERAL PUBLIC HEALTH 

8 AND MEDICAL RESPONSE TO PUBLIC 

9 HEALTH EMERGENCIES. 

10 Section 2801 of the Public Health Service Act (42 

11 U.S.C. 300hh) is amended— 

12 (1) in subsection (a), by inserting after ‘‘shall 

13 lead all Federal public health and medical response 

14 to public health emergencies and incidents’’ the fol15 lowing: ‘‘(including emergencies and disasters de16 clared by the President pursuant to the National 

17 Emergencies Act or the Robert T. Stafford Disaster 

18 Relief and Emergency Assistance Act)’’; and 

19 (2) in subsection (b), by inserting after ‘‘shall 

20 assume operational control of emergency public 

21 health and medical response assets, as necessary, in 

22 the event of a public health emergency’’ the fol23 lowing: ‘‘or in the event of an emergency or disaster 

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1 gencies Act or the Robert T. Stafford Disaster Re2 lief and Emergency Assistance Act’’. 

3 SEC. 1002. DEPLOYMENT BY THE SECRETARY OF HEALTH 

4 AND HUMAN SERVICES OF NATIONAL STRA5 TEGIC STOCKPILE. 

6 Section 319F–2(a)(3)(F) of the Public Health Serv7 ice Act (42 U.S.C. 247d–6b(a)(3)(F)) is amended by 

8 striking ‘‘as required by’’ and inserting ‘‘in consultation 

9 with’’. 

10 SEC. 1003. AUTHORITY AND RESPONSIBILITIES OF THE 

11 FEDERAL EMERGENCY MANAGEMENT AGEN12 CY REGARDING THE STRATEGIC NATIONAL 

13 STOCKPILE. 

14 The Homeland Security Act of 2002 is amended— 

15 (1) in subparagraph (A) of section 503(b)(2) (6 

16 U.S.C. 313(b)(2)), by inserting ‘‘, in coordination 

17 with relevant Federal agencies,’’ after ‘‘lead’’; and 

18 (2) in subparagraph (D) of section 504(a)(3) (6 

19 U.S.C. 314(a)(3)), by striking ‘‘requiring’’ and in20 serting ‘‘, at the direction of the Secretary of Health 

21 and Human Services, assisting in’’. 


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1 Subtitle B—Reagan-Udall Founda2 tion and Foundation for the Na3 tional Institutes of Health 

4 SEC. 1011. REAGAN-UDALL FOUNDATION AND FOUNDATION 

5 FOR THE NATIONAL INSTITUTES OF HEALTH. 

6 (a) REAGAN-UDALL FOUNDATION FOR THE FOOD

7 AND DRUG ADMINISTRATION.—Section 770(n) of the 

8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

9 379dd(n)) is amended by striking ‘‘$500,000 and not 

10 more than $1,250,000’’ and inserting ‘‘$1,250,000 and 

11 not more than $5,000,000’’. 

12 (b) FOUNDATION FOR THE NATIONAL INSTITUTES

13 OF HEALTH.—Section 499(l) of the Public Health Service 

14 Act (42 U.S.C. 290b(l)) is amended by striking ‘‘$500,000 

15 and not more than $1,250,000’’ and inserting 

16 ‘‘$1,250,000 and not more than $5,000,000’’. 

17 Subtitle C—Protections for Good 

18 Samaritan Health Professionals 

19 SEC. 1021. LIMITATION ON LIABILITY FOR VOLUNTEER 

20 HEALTH CARE PROFESSIONALS. 

21 (a) IN GENERAL.—Title II of the Public Health Serv22 ice Act (42 U.S.C. 202 et seq.) is amended by inserting 

23 after section 224 the following: 


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1 ‘‘SEC. 224A. LIMITATION ON LIABILITY FOR VOLUNTEER 

2 HEALTH CARE PROFESSIONALS. 

3 ‘‘(a) LIMITATION ON LIABILITY.—Except as provided 

4 in subsection (b), a health care professional shall not be 

5 liable under Federal or State law for any harm caused 

6 by an act or omission of the professional in the provision 

7 of health care services if— 

8 ‘‘(1) the professional is serving, for purposes of 

9 responding to a disaster, as a volunteer; and 

10 ‘‘(2) the act or omission occurs— 

11 ‘‘(A) during the period of the disaster, as 

12 determined under the laws listed in subsection 

13 (d)(1); 

14 ‘‘(B) in the State or States for which the 

15 disaster is declared; 

16 ‘‘(C) in the health care professional’s ca17 pacity as a volunteer; 

18 ‘‘(D) in the course of providing services 

19 that are within the scope of the license, reg20 istration, or certification of the volunteer, as de21 fined by the State of licensure, registration, or 

22 certification; and 

23 ‘‘(E) in a good faith belief that the indi24 vidual being treated is in need of health care 

25 services. 


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1 ‘‘(b) EXCEPTIONS.—Subsection (a) does not apply 

2 if— 

3 ‘‘(1) the harm was caused by an act or omission 

4 constituting willful or criminal misconduct, gross 

5 negligence, reckless misconduct, or a conscious fla6 grant indifference to the rights or safety of the indi7 vidual harmed by the health care professional; or 

8 ‘‘(2) the health care professional rendered the 

9 health care services under the influence (as deter10 mined pursuant to applicable State law) of alcohol 

11 or an intoxicating drug. 

12 ‘‘(c) PREEMPTION.— 

13 ‘‘(1) IN GENERAL.—This section preempts the 

14 laws of a State or any political subdivision of a State 

15 to the extent that such laws are inconsistent with 

16 this section, unless such laws provide greater protec17 tion from liability. 

18 ‘‘(2) VOLUNTEER PROTECTION ACT.—Protec19 tions afforded by this section are in addition to those 

20 provided by the Volunteer Protection Act of 1997. 

21 ‘‘(d) DEFINITIONS.—In this section: 

22 ‘‘(1) The term ‘disaster’ means— 

23 ‘‘(A) a national emergency declared by the 

24 President under the National Emergencies Act; 


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1 ‘‘(B) an emergency or major disaster de2 clared by the President under the Robert T. 

3 Stafford Disaster Relief and Emergency Assist4 ance Act; or 

5 ‘‘(C) a public health emergency that is de6 termined by the Secretary under section 319 of 

7 this Act with respect to one or more States 

8 specified in such determination— 

9 ‘‘(i) during only the initial period cov10 ered by such determination; and 

11 ‘‘(ii) excluding any period covered by 

12 a renewal of such determination. 

13 ‘‘(2) The term ‘harm’ includes physical, non14 physical, economic, and noneconomic losses. 

15 ‘‘(3) The term ‘health care professional’ means 

16 an individual who is licensed, registered, or certified 

17 under Federal or State law to provide health care 

18 services. 

19 ‘‘(4) The term ‘health care services’ means any 

20 services provided by a health care professional, or by 

21 any individual working under the supervision of a 

22 health care professional, that relate to— 

23 ‘‘(A) the diagnosis, prevention, or treat24 ment of any human disease or impairment; or 


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1 ‘‘(B) the assessment or care of the health 

2 of a human being. 

3 ‘‘(5) The term ‘State’ includes each of the sev4 eral States, the District of Columbia, the Common5 wealth of Puerto Rico, the Virgin Islands, Guam, 

6 American Samoa, the Northern Mariana Islands, 

7 and any other territory or possession of the United 

8 States. 

9 ‘‘(6)(A) The term ‘volunteer’ means a health 

10 care professional who, with respect to the health 

11 care services rendered, does not receive— 

12 ‘‘(i) compensation; or 

13 ‘‘(ii) any other thing of value in lieu of 

14 compensation, in excess of $500 per year. 

15 ‘‘(B) For purposes of subparagraph (A), the 

16 term ‘compensation’— 

17 ‘‘(i) includes payment under any insurance 

18 policy or health plan, or under any Federal or 

19 State health benefits program; and 

20 ‘‘(ii) excludes— 

21 ‘‘(I) reasonable reimbursement or al22 lowance for expenses actually incurred; 

23 ‘‘(II) receipt of paid leave; and 

24 ‘‘(III) receipt of items to be used ex25 clusively for rendering the health services 


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1 in the health care professional’s capacity 

2 as a volunteer described in subsection 

3 (a)(1).’’. 

4 (b) EFFECTIVE DATE.— 

5 (1) IN GENERAL.—Section 224A of the Public 

6 Health Service Act, as added by subsection (a), shall 

7 take effect 90 days after the date of the enactment 

8 of this Act. 

9 (2) APPLICATION.—Section 224A of the Public 

10 Health Service Act, as added by subsection (a), ap11 plies to a claim for harm only if the act or omission 

12 that caused such harm occurred on or after the ef13 fective date described in paragraph (1). 

14 SEC. 1022. SENSE OF THE CONGRESS. 

15 It is the sense of Congress that— 

16 (1) health care professionals should be encour17 aged to register with the Emergency System for Ad18 vance Registration of Volunteer Health Professionals 

19 (ESAR–VHP), and States should employ online reg20 istration with the promptest processing possible of 

21 such registrations to foster the rapid deployment 

22 and utilization of volunteer health care professionals 

23 following a disaster; 

24 (2) Federal and State agencies and licensing 

25 boards should cooperate to facilitate the timely 


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1 movement of properly licensed volunteer health care 

2 professionals to areas affected by a disaster; and 

3 (3) the appropriate licensing entities should 

4 verify the licenses of volunteer health care profes5 sionals serving disaster victims as soon as is reason6 ably practical following a disaster. 

7 Subtitle D—Medical Sheltering 

8 SEC. 1031. REDUCING THE SPREAD OF COVID–19 THROUGH 

9 PAYMENTS TO STATES TO LEASE HOTELS TO 

10 TEMPORARILY HOUSE ELIGIBLE INDIVID11 UALS. 

12 (a) IN GENERAL.—The Secretary of Health and 

13 Human Services may make payments to States to lease 

14 hotels to temporarily house, on a voluntary basis, eligible 

15 individuals. 

16 (b) FORMULA.—The Secretary shall allocate the 

17 amount appropriated to carry out this section pursuant 

18 to a formula developed by the Secretary that— 

19 (1) distributes the amount among the States 

20 that— 

21 (A) submit applications in accordance with 

22 subsection (c); and 

23 (B) are determined by the Secretary to 

24 need such payments; and 

25 (2) takes into consideration— 


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1 (A) the number of active cases of individ2 uals infected with COVID–19 in the applying 

3 State relative to the overall population of the 

4 State; and 

5 (B) the average income of individuals in 

6 the applying State relative to the average in7 come of individuals in the United States. 

8 (c) APPLICATIONS.— 

9 (1) IN GENERAL.—To seek a payment under 

10 this section, a State shall submit an application to 

11 the Secretary at such time, in such manner, and 

12 containing such information and assurances as the 

13 Secretary may require. 

14 (2) PROCESS.—The Secretary shall— 

15 (A) not later than 15 days after the date 

16 of enactment of this Act, publish the process 

17 for States to apply for payments under this sec18 tion; and 

19 (B) not later than 15 days after the sub20 mission of an application in accordance with 

21 such process, approve or disapprove the applica22 tion. 

23 (3) CONTENTS.—The Secretary shall require 

24 the application of a State under this section to in25 clude— 


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1 (A) a plan for leasing hotels as described 

2 in subsection (a); 

3 (B) health guidelines which the State will 

4 require to be implemented to protect the staff 

5 of the hotels; 

6 (C) the rates to be paid to lease the hotels; 

7 (D) a plan to ensure that the hotels each 

8 have— 

9 (i) workplace safety standards for 

10 their staff; 

11 (ii) proper personal protective equip12 ment and sanitation supplies; 

13 (iii) a cleaning protocol for rooms and 

14 facilities; and 

15 (iv) at least one qualified health care 

16 professional onsite or on call to monitor 

17 the health of individuals being housed at 

18 the hotels; 

19 (E) a plan to feed and provide other nec20 essary materials to individuals described in sub21 section (a) at the hotels, including medications 

22 and hygiene products, without letting such indi23 viduals leave their rooms or accept visitors; 


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1 (F) a plan to assist the hotels in removing 

2 individuals who attempt to continue their stay 

3 after the allotted time; 

4 (G) a plan for hospital networks, local 

5 health departments, and the hotels to coordi6 nate on the exchange and protection of patient 

7 information in accordance with other applicable 

8 law; 

9 (H) a plan to effectively communicate the 

10 State’s program funded through this section to 

11 racial and ethnic minority groups and low-in12 come communities; and 

13 (I) each funding assurance listed in sub14 section (e). 

15 (d) NO RESPONSIBILITY FOR DIET OR ADMINISTRA16 TION OF MEDICINE.—Notwithstanding subsection 

17 (c)(3)(E), a contract between a State and a hotel pursuant 

18 to this section shall not make the hotel responsible for the 

19 diet of, or the administration of medications to, individuals 

20 described in subsection (a). 

21 (e) FUNDING ASSURANCES.—As a condition on re22 ceipt of a payment of this section, a State shall give such 

23 assurances as the Secretary may require that— 

24 (1) each contract between the State and a hotel 

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1 untary basis, and no hotel will be required by the 

2 State to participate in the program under this sec3 tion; 

4 (2) individuals described in subsection (a) will 

5 not be charged for their lodging at a hotel pursuant 

6 to this section, except that such individuals may be 

7 required to reimburse the costs of receiving food and 

8 beverages; 

9 (3) individuals described in subsection (a) will 

10 retain the option of self-isolating at home (including 

11 the option of checking out early and returning to 

12 their homes) rather than being required to stay at 

13 a hotel funded pursuant to this section; 

14 (4) before an individual is allowed to stay at a 

15 hotel pursuant to this section, the individual will be 

16 required to present, in such form and manner as 

17 may be required by the local department of health, 

18 documentation from a physician that the individual 

19 meets the criteria described in subsection (a); 

20 (5) any non-transient homeless population re21 siding at a hotel will not be displaced for purposes 

22 of entering into or carrying out a contract between 

23 the State and the hotel under this section; and 


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1 (6) the State will pay (from funds provided to 

2 the State under this section or from other State 

3 funds)— 

4 (A) at least 40 percent of the costs of the 

5 personal protective equipment and sanitation 

6 supplies needed by individuals staying at a hotel 

7 pursuant to this section and the staff of such 

8 hotel; and 

9 (B) all of the costs of having one or more 

10 qualified health care professionals described in 

11 subsection (c)(3)(D)(iii) for the provision of 

12 monitoring described in such subsection (wheth13 er by being onsite or on call). 

14 (f) REVIEW.—At the conclusion of the program under 

15 this section, the Inspector General of the Department of 

16 Health and Human Services shall— 

17 (1) review the program and activities of each 

18 State funded pursuant to this section; and 

19 (2) submit a report on the results of the review 

20 to— 

21 (A) the Committee on Energy and Com22 merce and the Committee on Ways and Means 

23 of the House of Representatives; and 


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1 (B) the Committee on Finance and the 

2 Committee on Health, Education, Labor, and 

3 Pensions of the Senate. 

4 (g) LIABILITY PROTECTION.— 

5 (1) IN GENERAL.—Except as provided under 

6 paragraph (2), a hotel or member of the staff shall 

7 not be liable under Federal or State law for— 

8 (A) any harm caused by an act or omission 

9 in the provision of hotel services pursuant to 

10 this section; or 

11 (B) failing to keep an individual who is 

12 staying at a hotel pursuant to this section iso13 lated from people other than the staff of the 

14 hotel and any qualified health care professional 

15 described in subsection (c)(3)(D)(iii). 

16 (2) EXCEPTION.—Paragraph (1) does not apply 

17 in the case that the harm was caused by an act or 

18 omission constituting willful or criminal misconduct, 

19 gross negligence, reckless misconduct, or a conscious 

20 flagrant indifference to the rights or safety of the in21 dividual harmed. 

22 (h) DEFINITIONS.—In this section: 

23 (1) The term ‘‘eligible individual’’ means an in24 dividual who is unable to self-isolate at home, does 


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1 not require inpatient or outpatient health care treat2 ment, and— 

3 (A) has a laboratory-confirmed case of 

4 COVID–19; 

5 (B) has a presumptive positive case of 

6 COVID–19; or 

7 (C) is a person under investigation who is 

8 displaying symptoms of COVID–19. 

9 (2) The terms ‘‘Indian tribe’’ and ‘‘tribal orga10 nization’’ have the meanings given to those terms in 

11 section 4 of the Indian Self-Determination and Edu12 cation Assistance Act (25 U.S.C. 5304). 

13 (3) The term ‘‘Secretary’’ means the Secretary 

14 of Health and Human Services. 

15 (4) The term ‘‘State’’ includes each of 50 

16 States, the District of Columbia, each Indian Tribe 

17 and tribal organization, Guam, American Samoa, the 

18 United States Virgin Islands, the Commonwealth of 

19 Puerto Rico, and the Commonwealth of the North20 ern Mariana Islands. 

21 (i) FUNDING.—To carry out this section, there is au22 thorized to be appropriated $1,000,000,000, to remain 

23 available through the earlier of— 

24 (1) the end of calendar year 2021; or 


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1 (2) the end of the emergency period (as defined 

2 in section 1135(g)(1)(B) of the Social Security Act 

3 (42 U.S.C. 1320b–5(g)(1)(B))). 

4 Subtitle E—CDC Campaign on 

5 COVID–19 Awareness 

6 SEC. 1041. COVID–19 PUBLIC AWARENESS CAMPAIGN. 

7 The Secretary of Health and Human Services, acting 

8 through the Director of the Centers for Disease Control 

9 and Prevention and in coordination with other offices and 

10 agencies, as appropriate, shall award competitive grants 

11 or contracts to one or more public or private entities to 

12 carry out a national campaign that is multilingual and cul13 turally competent and based on available scientific evi14 dence to increase awareness and knowledge of COVID– 

15 19, including reducing stigma associated with COVID–19 

16 and improving information on the availability of diagnostic 

17 testing and other related services at community health 

18 centers. 

19 Subtitle F—Protecting Children 

20 From COVID–19 

21 SEC. 1051. STUDY ON CHILDREN’S ROLE IN TRANSMITTING 

22 SARS–COV–2. 

23 (a) STUDY.— 

24 (1) IN GENERAL.—The Secretary of Health and 

25 Human Services (in this section referred to as the 


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1 ‘‘Secretary’’), in coordination with the heads of 

2 agencies of the Department of Health and Human 

3 Services and experts from outside of the Depart4 ment, as appropriate, shall complete a study on chil5 dren’s role in transmitting SARS–CoV–2. 

6 (2) ISSUES TO BE STUDIED.—The study under 

7 paragraph (1) shall address— 

8 (A) the transmissibility of COVID–19 from 

9 child to child, child to adult, and adult to child; 

10 (B) the vulnerability of children, especially 

11 those with underlying health conditions, to se12 vere illness as such vulnerability relates to 

13 COVID–19; 

14 (C) the vulnerability of adults, especially 

15 those with underlying health conditions, who 

16 send their children back to school; and 

17 (D) the vulnerability of adults, especially 

18 those with underlying health conditions, who 

19 interact with children who may be asymp20 tomatic but infectious. 

21 (3) CONSIDERATIONS.—In carrying out the 

22 study under paragraph (1), the Secretary shall— 

23 (A) take into consideration the best avail24 able science, including as provided by the Na25 tional Academy of Sciences; and 


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1 (B) ensure that such study includes con2 sideration of children who are members of ra3 cial or ethnic minority groups. 

4 (b) REPORTING.—The Secretary shall submit a re5 port to the Congress on children’s role in transmitting 

6 SARS–CoV–2. The report shall include the results of the 

7 study under subsection (a). 

8 (c) DISSEMINATION OF BEST PRACTICES.—The Sec9 retary shall disseminate to stakeholders best practices for 

10 protecting children and adults in educational settings. The 

11 first best practices disseminated pursuant to the preceding 

12 sentence shall include any best practices for protecting 

13 children and adults in educational settings identified 

14 through the study under subsection (a). 

15 (d) DEFINITION.—In this section, the term ‘‘emer16 gency period’’ has the meaning given to such term in sec17 tion 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 

18 1320b–5(g)(1)(B)). 

19 Subtitle G—Ensuring 

20 Understanding of COVID–19 

21 SEC. 1061. STUDY ON THE IMPACT OF COVID–19. 

22 Part A of title IV of the Public Health Service Act 

23 (42 U.S.C. 281 et seq.) is amended by adding at the end 

24 the following: 


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1 ‘‘SEC. 404O. STUDY ON THE IMPACT OF COVID–19. 

2 ‘‘(a) IN GENERAL.—The Secretary shall conduct a 

3 longitudinal study, over not less than 10 years, on the full 

4 impact of COVID–19 on infected individuals, including 

5 both short-term and long-term health impacts. 

6 ‘‘(b) TIMING.—The Secretary shall begin enrolling 

7 patients in the study under this section not later than 6 

8 months after the date of enactment of this section. 

9 ‘‘(c) REQUIREMENTS.—The study under this section 

10 shall— 

11 ‘‘(1) be nationwide; 

12 ‘‘(2) include diversity of enrollees to account for 

13 gender, age, race, ethnicity, geography, 

14 comorbidities, and underrepresented populations, in15 cluding pregnant and lactating women; 

16 ‘‘(3) study individuals who were infected with 

17 COVID–19 who experienced mild symptoms, such 

18 individuals who experienced moderate symptoms, 

19 and such individuals who experienced severe symp20 toms; 

21 ‘‘(4) monitor the health outcomes and symp22 toms of individuals who were infected with COVID– 

23 19, or had prenatal exposure to COVID–19, includ24 ing lung capacity and function, and immune re25 sponse, taking into account any pharmaceutical 

26 interventions such individuals may have received; 


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1 ‘‘(5) monitor the mental health outcomes of in2 dividuals infected with COVID–19, taking into ac3 count any interventions that affected mental health; 

4 and 

5 ‘‘(6) monitor individuals enrolled in the study 

6 not less frequently that twice per year after the first 

7 year of the individual’s infection with COVID–19. 

8 ‘‘(d) PUBLIC-PRIVATE RESEARCH NETWORK.—For 

9 purposes of carrying out the study under this section, the 

10 Director of NIH may develop a network of public-private 

11 research partners, provided that all research, including the 

12 research carried out through any such partner, is available 

13 publicly. 

14 ‘‘(e) SUMMARIES OF FINDINGS.—The Director of 

15 NIH shall make public a summary of findings under this 

16 section not less frequently than once every 3 months for 

17 the first 2 years of the study, and not less frequently than 

18 every 6 months thereafter. Such summaries may include 

19 information about how the findings of the study under this 

20 section compare with findings from research conducted 

21 abroad. 

22 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

23 are authorized to be appropriated such sums as may be 

24 necessary to carry out this section.’’. 


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1 Subtitle H—Safeguarding 

2 Therapeutics 

3 SEC. 1071. AUTHORITY TO DESTROY COUNTERFEIT DE4 VICES. 

5 (a) IN GENERAL.—Section 801(a) of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is 

7 amended— 

8 (1) in the fourth sentence, by inserting ‘‘or 

9 counterfeit device’’ after ‘‘counterfeit drug’’; and 

10 (2) by striking ‘‘The Secretary of the Treasury 

11 shall cause the destruction of’’ and all that follows 

12 through ‘‘liable for costs pursuant to subsection 

13 (c).’’ and inserting the following: ‘‘The Secretary of 

14 the Treasury shall cause the destruction of any such 

15 article refused admission unless such article is ex16 ported, under regulations prescribed by the Sec17 retary of the Treasury, within 90 days of the date 

18 of notice of such refusal or within such additional 

19 time as may be permitted pursuant to such regula20 tions, except that the Secretary of Health and 

21 Human Services may destroy, without the oppor22 tunity for export, any drug or device refused admis23 sion under this section, if such drug or device is val24 ued at an amount that is $2,500 or less (or such 

25 higher amount as the Secretary of the Treasury may 


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1 set by regulation pursuant to section 498(a)(1) of 

2 the Tariff Act of 1930 (19 U.S.C. 1498(a)(1))) and 

3 was not brought into compliance as described under 

4 subsection (b). The Secretary of Health and Human 

5 Services shall issue regulations providing for notice 

6 and an opportunity to appear before the Secretary 

7 of Health and Human Services and introduce testi8 mony, as described in the first sentence of this sub9 section, on destruction of a drug or device under the 

10 seventh sentence of this subsection. The regulations 

11 shall provide that prior to destruction, appropriate 

12 due process is available to the owner or consignee 

13 seeking to challenge the decision to destroy the drug 

14 or device. Where the Secretary of Health and 

15 Human Services provides notice and an opportunity 

16 to appear and introduce testimony on the destruc17 tion of a drug or device, the Secretary of Health and 

18 Human Services shall store and, as applicable, dis19 pose of the drug or device after the issuance of the 

20 notice, except that the owner and consignee shall re21 main liable for costs pursuant to subsection (c).’’. 

22 (b) DEFINITION.—Section 201(h) of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) is 

24 amended— 


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1 (1) by redesignating subparagraphs (1), (2), 

2 and (3) as clauses (A), (B), and (C), respectively; 

3 and 

4 (2) after making such redesignations— 

5 (A) by striking ‘‘(h) The term’’ and insert6 ing ‘‘(h)(1) The term’’; and 

7 (B) by adding at the end the following: 

8 ‘‘(2) The term ‘counterfeit device’ means a device 

9 which, or the container, packaging, or labeling of which, 

10 without authorization, bears a trademark, trade name, or 

11 other identifying mark, imprint, or symbol, or any likeness 

12 thereof, or is manufactured using a design, of a device 

13 manufacturer, packer, or distributor other than the person 

14 or persons who in fact manufactured, packed, or distrib15 uted such device and which thereby falsely purports or is 

16 represented to be the product of, or to have been packed 

17 or distributed by, such other device manufacturer, packer, 

18 or distributor. 

19 ‘‘(3) For purposes of subparagraph (2)— 

20 ‘‘(A) the term ‘manufactured’ refers to any of 

21 the following activities: manufacture, preparation, 

22 propagation, compounding, assembly, or processing; 

23 and 


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1 ‘‘(B) the term ‘manufacturer’ means a person 

2 who is engaged in any of the activities listed in 

3 clause (A).’’. 

4 SEC. 1072. DETERMINATION OF BUDGETARY EFFECTS. 

5 The budgetary effects of this subtitle, for the purpose 

6 of complying with the Statutory Pay-As-You-Go Act of 

7 2010, shall be determined by reference to the latest state8 ment titled ‘‘Budgetary Effects of PAYGO Legislation’’ 

9 for this subtitle, submitted for printing in the Congres10 sional Record by the Chairman of the House Budget Com11 mittee, provided that such statement has been submitted 

12 prior to the vote on passage. 

13 Subtitle I—Advisory Committee on 

14 Immunization Practices 

15 SEC. 1081. EXPEDITED MEETING OF ACIP FOR COVID–19 

16 VACCINES. 

17 (a) IN GENERAL.—Notwithstanding section 3091 of 

18 the 21st Century Cures Act (21 U.S.C. 360bbb–4 note), 

19 the Advisory Committee on Immunization Practices shall 

20 meet and issue a recommendation with respect to a vac21 cine that is intended to prevent or treat COVID–19 not 

22 later than 15 business days after the date on which such 

23 vaccine is licensed under section 351 of the Public Health 

24 Service Act (42 U.S.C. 262) or authorized under section 


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1 564 of the Federal Food, Drug, and Cosmetic Act (21 

2 U.S.C. 360bbb–3). 

3 (b) DEFINITION.—In this section, the term ‘‘Advisory 

4 Committee on Immunization Practices’’ means the Advi5 sory Committee on Immunization Practices established by 

6 the Secretary of Health and Human Services pursuant to 

7 section 222 of the Public Health Service Act (42 U.S.C. 

8 217a), acting through the Director of the Centers for Dis9 ease Control and Prevention. 

10 Subtitle J—Improvements to 

11 Transparency of the Pricing of 

12 Diagnostic Testing for COVID– 

13 19 

14 SEC. 1091. IMPROVEMENTS TO TRANSPARENCY OF THE 

15 PRICING OF DIAGNOSTIC TESTING FOR 

16 COVID–19. 

17 (a) IN GENERAL.—Section 3202 of the CARES Act 

18 (Public Law 116–136) is amended— 

19 (1) in subsection (b)— 

20 (A) in the heading, by inserting ‘‘AND RE21 LATED ITEMS AND SERVICES’’ after ‘‘DIAG22 NOSTIC TESTING FOR COVID–19’’; 

23 (B) in paragraph (1)— 

24 (i) by striking ‘‘a diagnostic test for 

25 COVID–19’’ and inserting ‘‘a test, item, or 


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1 service described in section 6001(a) of divi2 sion F of the Families First Coronavirus 

3 Response Act (Public Law 116–127)’’; and 

4 (ii) by striking ‘‘such test’’ and insert5 ing ‘‘such test, item, or service’’; and 

6 (C) in paragraph (2), by striking ‘‘a diag7 nostic test for COVID–19’’ and inserting ‘‘a 

8 test, item, or service described in section 

9 6001(a) of division F of the Families First 

10 Coronavirus Response Act (Public Law 116– 

11 127)’’; and 

12 (2) by adding at the end the following new sub13 sections: 

14 ‘‘(c) IMPROVEMENTS TO TRANSPARENCY POLICY.— 

15 ‘‘(1) IN GENERAL.—Not later than 30 days 

16 after the date of the enactment of this subsection, 

17 the Secretary of Health and Human Services shall 

18 survey providers subject to the requirement under 

19 subsection (b) regarding the cash prices referred to 

20 in such subsection. 

21 ‘‘(2) REPRESENTATIVE SAMPLE.—In carrying 

22 out paragraph (1), the Secretary shall survey a sam23 ple of providers that is representative of the diver24 sity of sizes, geographic locations, and care settings 

25 (such as hospitals, laboratories, and independent 


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1 freestanding emergency departments) in which diag2 nostic testing for COVID–19 is performed. 

3 ‘‘(3) CONSUMER COMPLAINTS.—The Secretary 

4 shall ensure that consumers have a method to sub5 mit complaints to the Department of Health and 

6 Human Services that identify providers that— 

7 ‘‘(A) may be in violation of subsection (b); 

8 and 

9 ‘‘(B) have not made public a cash price in 

10 accordance with such subsection. 

11 ‘‘(d) PUBLIC REPORT.—Not later than 60 days after 

12 the date of the enactment of this subsection, the Secretary 

13 of Health and Human Services shall publish on the inter14 net website of the Department of Health and Human 

15 Services a report on cash prices for items and services 

16 published under subsection (b)(1) during the period begin17 ning on the date of the enactment of this Act and ending 

18 on the date of the enactment of this subsection, which 

19 shall include— 

20 ‘‘(1) the percentage of providers that comply 

21 with the requirement under such subsection; 

22 ‘‘(2) the average cash price for each such item 

23 and service published under such subsection; and 


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1 ‘‘(3) any providers identified pursuant to para2 graph (2) or (3) of subsection (c) and found to be 

3 in violation of such requirement.’’. 

4 TITLE II—DOMESTIC MANUFAC5 TURING AND SUPPLY CHAIN 

6 Subtitle A—Sustained On-Shore 

7 Manufacturing Capacity for 

8 Public Health Emergencies 

9 SEC. 2001. SUSTAINED ON-SHORE MANUFACTURING CAPAC10 ITY FOR PUBLIC HEALTH EMERGENCIES. 

11 (a) IN GENERAL.—Section 319L of the Public 

12 Health Service Act (42 U.S.C. 247d–7e) is amended— 

13 (1) in subsection (a)(6)(B)— 

14 (A) by redesignating clauses (iv) and (v) as 

15 clauses (v) and (vi), respectively; 

16 (B) by inserting after clause (iii), the fol17 lowing: 

18 ‘‘(iv) activities to support domestic 

19 manufacturing surge capacity of products 

20 or platform technologies, including manu21 facturing capacity and capabilities to uti22 lize platform technologies to provide for 

23 flexible manufacturing initiatives;’’; and 

24 (C) in clause (vi) (as so redesignated), by 

25 inserting ‘‘manufacture,’’ after ‘‘improvement,’’; 


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1 (2) in subsection (b)— 

2 (A) in the first sentence of paragraph (1), 

3 by inserting ‘‘support for domestic manufac4 turing surge capacity,’’ after ‘‘initiatives for in5 novation,’’; and 

6 (B) in paragraph (2)— 

7 (i) in subparagraph (B), by striking 

8 ‘‘and’’ at the end; 

9 (ii) by redesignating subparagraph 

10 (C) as subparagraph (D); and 

11 (iii) by inserting after subparagraph 

12 (B), the following: 

13 ‘‘(C) activities to support manufacturing 

14 surge capacities and capabilities to increase the 

15 availability of existing medical countermeasures 

16 and utilize existing novel platforms to manufac17 ture new medical countermeasures to meet 

18 manufacturing demands to address threats that 

19 pose a significant level of risk to national secu20 rity; and’’; 

21 (3) in subsection (c)— 

22 (A) in paragraph (2)— 

23 (i) in subparagraph (C), by striking 

24 ‘‘and’’ at the end; 


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1 (ii) in subparagraph (D), by striking 

2 the period and inserting ‘‘; and’’; and 

3 (iii) by adding at the end the fol4 lowing: 

5 ‘‘(E) promoting domestic manufacturing 

6 surge capacity and capabilities for counter7 measure advanced research and development, 

8 including facilitating contracts to support flexi9 ble or surge manufacturing.’’; 

10 (B) in paragraph (4)— 

11 (i) in subparagraph (B)— 

12 (I) in clause (iii), by striking 

13 ‘‘and’’ at the end; 

14 (II) in clause (iv), by striking the 

15 period and inserting ‘‘; and’’; and 

16 (III) by adding at the end the 

17 following: 

18 ‘‘(v) support and maintain domestic 

19 manufacturing surge capacity and capabili20 ties, including through contracts to sup21 port flexible or surge manufacturing, to en22 sure that additional production of counter23 measures is available in the event that the 

24 Secretary determines there is such a need 

25 for additional production.’’; 


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1 (ii) in subparagraph (D)— 

2 (I) in clause (ii), by striking 

3 ‘‘and’’ at the end; 

4 (II) by redesignating clause (iii) 

5 as clause (iv); and 

6 (III) by inserting after clause (ii) 

7 the following: 

8 ‘‘(iii) research to advance manufac9 turing capacities and capabilities for med10 ical countermeasures and platform tech11 nologies that may be utilized for medical 

12 countermeasures; and’’; and 

13 (iii) in subparagraph (E), by striking 

14 clause (ix); and 

15 (C) in paragraph (7)(C)(i), by striking ‘‘up 

16 to 100 highly qualified individuals, or up to 50 

17 percent of the total number of employees, 

18 whichever is less,’’ and inserting ‘‘75 percent of 

19 the total number of employees’’; 

20 (4) in subsection (e)(1)— 

21 (A) by redesignating subparagraphs (B) 

22 through (D) as subparagraphs (C) through (E), 

23 respectively; and 

24 (B) by inserting after subparagraph (A), 

25 the following: 


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1 ‘‘(B) TEMPORARY FLEXIBILITY.—During a 

2 public health emergency under section 319, the 

3 Secretary shall be provided with an additional 

4 60 business days to comply with information re5 quests for the disclosure of information under 

6 section 552 of title 5, United States Code, re7 lated to the activities under this section (unless 

8 such activities are otherwise exempt under sub9 paragraph (A)).’’; and 

10 (5) in subsection (f)— 

11 (A) in paragraph (1), by striking ‘‘Not 

12 later than 180 days after the date of enactment 

13 of this subsection’’ and inserting ‘‘Not later 

14 than 180 days after the date of enactment of 

15 the Commitment to Defeat the Virus and Keep 

16 America Healthy Act’’; and 

17 (B) in paragraph (2), by striking ‘‘Not 

18 later than 1 year after the date of enactment of 

19 this subsection’’ and inserting ‘‘Not later than 

20 1 year after the date of enactment of the Com21 mitment to Defeat the Virus and Keep America 

22 Healthy Act’’. 

23 (b) MEDICAL COUNTERMEASURE INNOVATION PART24 NER.—The restrictions under section 202 of division A of 

25 the Further Consolidated Appropriations Act, 2020 (PubVerDate Sep 11 2014 19:08 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00041 Fmt 6652 Sfmt 6201 E:\BILLS\H14.IH H14

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1 lic Law 116–94), or any other provision of law imposing 

2 a restriction on salaries of individuals related to a previous 

3 appropriation to the Department of Health and Human 

4 Services, shall not apply with respect to salaries paid pur5 suant to an agreement under the medical countermeasure 

6 innovation partner program under section 319L(c)(4)(E) 

7 of the Public Health Service Act (42 U.S.C. 247d– 

8 7e(c)(4)(E)). 

9 Subtitle B—Manufacturing API, 

10 Drugs, and Excipients in America 

11 SEC. 2011. REPORT TO CONGRESS ON BARRIERS TO DO12 MESTIC MANUFACTURING OF MEDICAL 

13 PRODUCTS AND SUPPLIES. 

14 (a) REPORT.—Not later than January 1, 2021, the 

15 Secretary of Health and Human Services (referred to in 

16 this section as the ‘‘Secretary’’) shall submit to the Com17 mittee on Energy and Commerce of the House of Rep18 resentatives and the Committee on Health, Education, 

19 Labor, and Pensions of the Senate a report on barriers 

20 to domestic manufacturing of active pharmaceutical ingre21 dients, drugs, and devices that are manufactured outside 

22 of the United States. 

23 (b) CONTENTS.—Such report shall— 

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1 maceutical ingredients, drugs, and devices that are 

2 currently manufactured outside of the United 

3 States, including any Federal, State, local, or Tribal 

4 laws and regulations that hinder domestic manufac5 turing opportunities; and 

6 (2) recommend specific strategies to overcome 

7 the challenges identified under paragraph (1), in8 cluding strategies— 

9 (A) to develop effective incentives for do10 mestic manufacturing; and 

11 (B) to make changes to laws or regulations 

12 that hinder domestic manufacturing opportuni13 ties. 

14 (c) CONSULTATION.—In carrying out the report 

15 under subsection (a), the Secretary shall consult with— 

16 (1) the Food and Drug Administration, the 

17 Centers for Medicare & Medicaid Services, the De18 partment of Defense, the Department of Commerce, 

19 the Department of State, the Department of Vet20 erans Affairs, the Department of Justice, and any 

21 other Federal agencies as appropriate; and 

22 (2) relevant stakeholders, including drug, de23 vice, and active pharmaceutical ingredient manufac24 turers, and other entities, as appropriate. 


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1 (d) DEFINITION.—In this section, the term ‘‘active 

2 pharmaceutical ingredient’’ has the meaning given to such 

3 term in section 207.1 of title 21, Code of Federal Regula4 tions (and any successor regulations). 

5 (e) PUBLICATION.—The Secretary shall make the re6 port under subsection (a) available on the public website 

7 of the Department of Health and Human Services. 

8 SEC. 2012. ENHANCING INTRA-AGENCY COORDINATION 

9 AND PUBLIC HEALTH ASSESSMENT WITH RE10 GARD TO COMPLIANCE ACTIVITIES. 

11 (a) BENEFIT/RISK FRAMEWORK.— 

12 (1) IN GENERAL.—Paragraph (2) of section 

13 704(b) of the Federal Food, Drug, and Cosmetic Act 

14 (21 U.S.C. 374(b)) is amended by adding at the end 

15 the following: ‘‘The Secretary shall ensure timely 

16 and effective coordination among such offices re17 garding the reviews of such report and the align18 ment of any feedback regarding such report, and 

19 any corrective or preventive actions in response to 

20 such report, after consideration of the benefits and 

21 risks to the public health, patient safety, the drug 

22 supply and drug supply chain, and timely patient ac23 cess to drugs.’’. 

24 (2) ANNUAL REPORTING.—Subsection (b) of 

25 section 704 of the Federal Food, Drug, and CosVerDate Sep 11 2014 19:08 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00044 Fmt 6652 Sfmt 6201 E:\BILLS\H14.IH H14

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1 metic Act (21 U.S.C. 374) is amended by adding at 

2 the end the following new paragraph: 

3 ‘‘(3) On an annual basis, the Secretary shall prepare 

4 a report on the utilization of the framework described in 

5 paragraph (2) and post such report on the public website 

6 of the Food and Drug Administration.’’. 

7 (3) APPLICABILITY.—The amendments made 

8 by paragraphs (1) and (2) shall take effect on the 

9 effective date described in section 3112 of the 

10 CARES Act (Public Law 116–136), after executing 

11 the amendments made by such section 3112, and 

12 shall apply beginning on the date that is 1 year after 

13 the date of enactment of this Act. 

14 (b) PUBLIC MEETING.—The Secretary of Health and 

15 Human Services shall publish in the Federal Register a 

16 notice of a public meeting to be held no later than six 

17 months after the date of enactment of this Act to discuss 

18 and obtain input and recommendations from public stake19 holders, including patient advocates, consumers, regulated 

20 industry, and health care providers, regarding the con21 tents of a benefit/risk framework described in section 

22 704(b)(2) of the Federal Food, Drug, and Cosmetic Act, 

23 as amended by subsection (a), that supports a safe, stable, 

24 redundant drug supply chain. 


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1 (c) GUIDANCE.—The Secretary of Health and 

2 Human Services shall— 

3 (1) not later than one year after the date on 

4 which the public meeting described in subsection (b) 

5 is held, issue draft guidance regarding the goals and 

6 implementation of a benefit/risk framework de7 scribed in subsection (b); and 

8 (2) not later than two years after such date of 

9 enactment, issue final guidance with respect to the 

10 implementation of such a framework. 

11 SEC. 2013. ENCOURAGING INTERNATIONAL HARMONI12 ZATION. 

13 (a) GAO STUDY.—Not later than one year after the 

14 date of enactment of this Act, the Comptroller General 

15 of the United States shall issue a report evaluating— 

16 (1) the consistency with which the International 

17 Conference on Harmonisation (in this section re18 ferred to as ‘‘ICH’’) guidelines on good manufac19 turing practices, including ICH Guidelines Q8–11, 

20 are being implemented by drug regulatory authori21 ties across countries and international regions; 

22 (2) whether domestic active pharmaceutical in23 gredient manufacturers (including any such contract 

24 manufacturers) are provided sufficient opportunity 


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1 to participate with regulatory authorities in the de2 velopment of guidelines prior to implementation; 

3 (3) whether divergence from ICH guidelines or 

4 differing regulatory standards or requirements by 

5 drug regulatory authorities across countries and 

6 international regions creates— 

7 (A) inefficiencies in drug manufacturing; 

8 (B) incompatible requirements that can 

9 contribute to or exacerbate drug shortages; and 

10 (C) the most common areas of divergence 

11 between ICH guidelines and regulatory stand12 ards and requirements by drug regulatory au13 thorities across countries and international re14 gions that, if rectified, may reduce the ineffi15 ciencies and incompatibilities identified pursu16 ant to subparagraphs (A) and (B). 

17 (b) INTERNATIONAL TRAINING PROGRAM.—Not later 

18 than two years after the date of enactment of this Act, 

19 informed by the needs identified in the report issued pur20 suant to subsection (a), the Secretary of Health and 

21 Human Services, in conjunction with drug regulatory au22 thorities across countries and international regions and 

23 the ICH, shall develop and implement a training program 

24 for drug regulatory authorities across countries and inter25 national regions to promote consistent application of and 


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1 reduce divergence from ICH guidelines on good manufac2 turing practices. 

3 SEC. 2014. MUTUAL RECOGNITION AGREEMENTS FOR IN4 SPECTIONS AND REVIEW ACTIVITIES. 

5 (a) MUTUAL RECOGNITION OF INSPECTIONS.—Pur6 suant to section 809 of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 384e), the Secretary of Health and 

8 Human Services (in this section referred to as the ‘‘Sec9 retary’’) shall establish or expand initiatives for mutual 

10 sharing of review and inspection findings between drug 

11 regulatory authorities across countries and international 

12 regions, such as through the Pharmaceutical Cooperation 

13 Inspection Scheme, the Mutual Recognition Agreement 

14 with the European Union, and the Australia-Canada15 Singapore-Switzerland Consortium, to— 

16 (1) reduce the potential for duplicative regu17 latory evaluation of medical products regulated by 

18 the Food and Drug Administration; and 

19 (2) more constructively allocate appropriations 

20 to the Food and Drug Administration, including 

21 those attributable to user fees, to harmonized regu22 latory processes. 

23 (b) ADDITIONAL COUNTRIES, REGIONS, AND EVAL24 UATION.—In carrying out subsection (a), the Secretary 

25 may expand the initiatives to include— 


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1 (1) additional countries and geographic regions 

2 with established and competent regulatory frame3 works; and 

4 (2) additional types of regulatory evaluation, in5 cluding with respect to— 

6 (A) good manufacturing practice inspec7 tions; and 

8 (B) approval of changes to the manufac9 turing of drugs for which an approval or licen10 sure is in effect under section 505 of the Fed11 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

12 355) or section 351 of the Public Health Serv13 ice Act (42 U.S.C. 262). 

14 (c) IMPLEMENTATION FRAMEWORK.— 

15 (1) PUBLICATION.—Not later than one year 

16 after the date of enactment of this Act, the Sec17 retary shall publish an implementation framework 

18 for the agreements to share review and inspection 

19 findings under subsection (a) on the public website 

20 of the Food and Drug Administration. 

21 (2) CONTENTS.—The implementation frame22 work under this subsection shall— 

23 (A) include the timeline for establishing or 

24 expanding initiatives described in subsection 

25 (a); 


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1 (B) describe additional types of regulatory 

2 processes that will become subject to such ini3 tiatives; 

4 (C) specify the countries and geographic 

5 regions where such initiatives will be established 

6 or expanded; and 

7 (D) identify additional opportunities and 

8 challenges for expanding mutual recognition 

9 agreements in drug and biologic regulation. 

10 (d) ANNUAL REPORTING.— 

11 (1) IN GENERAL.—Not later than the end of 

12 calendar year 2020 and annually thereafter, the Sec13 retary shall publish a report on the public website of 

14 the Food and Drug Administration on the utilization 

15 of agreements described in subsection (c)(1) in the 

16 previous fiscal year. 

17 (2) CONTENTS.—The report under paragraph 

18 (1) shall include each of the following: 

19 (A) The total number of establishments 

20 that are registered under section 510(i) of the 

21 Federal Food, Drug, and Cosmetic Act (21 

22 U.S.C. 360) and located outside of the United 

23 States, and of these establishments, the number 

24 in each region of interest. 


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1 (B) The total number of inspections con2 ducted at establishments described in subpara3 graph (A). 

4 (C) Of the inspections described in sub5 paragraph (B), the total number of inspections 

6 in each of region of interest. 

7 (D) Of the inspections in each region of in8 terest reported pursuant to subparagraph (C), 

9 the number of inspections in each FDA inspec10 tion category. 

11 (E) Of the number of inspections reported 

12 under each of subparagraphs (B), (C), and 

13 (D)— 

14 (i) the number of inspections which 

15 have been conducted pursuant to an agree16 ment described in subsection (c)(1); and 

17 (ii) the number of inspections which 

18 have been conducted by employees or other 

19 agents of the Food and Drug Administra20 tion. 

21 (3) DEFINITIONS.—In this subsection: 

22 (A) The term ‘‘region of interest’’ refers to 

23 China, India, the European Union, and any 

24 other geographic region as determined appro25 priate by the Secretary. 


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1 (B) The term ‘‘FDA inspection category’’ 

2 means refers to the following inspection cat3 egories: 

4 (i) Inspections to support an approval 

5 of a drug under section 505 of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 

7 355) or section 351 of the Public Health 

8 Service Act (42 U.S.C. 262). 

9 (ii) Good manufacturing practice in10 spections. 

11 (iii) For-cause inspections. 

12 SEC. 2015. ENHANCING TRANSPARENCY OF DRUG FACILITY 

13 INSPECTION TIMELINES. 

14 Section 902 of the FDA Reauthorization Act of 2017 

15 (21 U.S.C. 355 note) is amended to read as follows: 

16 ‘‘SEC. 902. ANNUAL REPORT ON INSPECTIONS. 

17 ‘‘Not later than March 1 of each year, the Secretary 

18 of Health and Human Services shall post on the public 

19 website of the Food and Drug Administration information 

20 related to inspections of facilities necessary for approval 

21 of a drug under subsection (c) or (j) of section 505 of 

22 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

23 355), approval of a device under section 515 of such Act 

24 (21 U.S.C. 360e), or clearance of a device under section 

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1 ducted during the previous calendar year. Such informa2 tion shall include the following: 

3 ‘‘(1) The median time following a request from 

4 staff of the Food and Drug Administration review5 ing an application or report to the beginning of the 

6 inspection, and the median time from the beginning 

7 of an inspection to the issuance of a report pursuant 

8 to section 704(b) of the Federal Food, Drug, and 

9 Cosmetic Act (21 U.S.C. 374(b)), including— 

10 ‘‘(A) the median time for drugs described 

11 in 505(j)(11)(A)(i) of the Federal Food, Drug, 

12 and Cosmetic Act (21 U.S.C. 355(j)(11)(A)(i)); 

13 ‘‘(B) the median time for drugs described 

14 in section 506C(a) of such Act (21 U.S.C. 

15 356c(a)) only; and 

16 ‘‘(C) the median time for drugs on the 

17 drug shortage list in effect under section 506E 

18 of such Act (21 U.S.C. 356f). 

19 ‘‘(2) The median time from the issuance of a 

20 report pursuant to such section 704(b) to the send21 ing of a warning letter, issuance of an import alert, 

22 or holding of a regulatory meeting for inspections 

23 for which the Secretary concluded that regulatory or 

24 enforcement action was indicated, including the meVerDate Sep 11 2014 19:08 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00053 Fmt 6652 Sfmt 6201 E:\BILLS\H14.IH H14

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1 dian time for each category of drugs listed in sub2 paragraphs (A) through (C) of paragraph (1). 

3 ‘‘(3) The median time from the sending of a 

4 warning letter, issuance of an import alert, or hold5 ing of a regulatory meeting to resolution of the regu6 latory or enforcement action indicated for inspec7 tions for which the Secretary concluded that such 

8 action was indicated. 

9 ‘‘(4) The number of times that a facility was 

10 issued a report pursuant to such section 704(b) and 

11 approval of an application was delayed due to the 

12 issuance of a withhold recommendation, including 

13 the number of such times for each category of drugs 

14 listed in subparagraphs (A) through (C) of para15 graph (1).’’. 

16 SEC. 2016. ADVANCED MANUFACTURING TECHNOLOGIES 

17 PROGRAM. 

18 Subchapter A of chapter V of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend20 ed by adding at the end the following: 

21 ‘‘SEC. 524B. ADVANCED MANUFACTURING TECHNOLOGIES 

22 PROGRAM. 

23 ‘‘(a) IN GENERAL.—Not later than 1 year after the 

24 date of enactment of the Commitment to Defeat the Virus 

25 and Keep America Healthy Act, the Secretary shall conVerDate Sep 11 2014 19:08 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00054 Fmt 6652 Sfmt 6201 E:\BILLS\H14.IH H14

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1 tinue in effect the program to evaluate new drug manufac2 turing technologies that are included in an application, or 

3 supplement to an application, for a drug under subsection 

4 (b) or (j) of section 505 of this Act or for a biological 

5 product submitted under subsection (a) or (k) of section 

6 351 of the Public Health Service Act. 

7 ‘‘(b) DESIGNATION.—The Secretary shall designate a 

8 method of manufacturing a drug as an advanced manufac9 turing technology under this section if the drug manufac10 turer demonstrates that such technology is likely to— 

11 ‘‘(1) prevent or resolve a drug shortage; 

12 ‘‘(2) maintain an adequate supply of critical 

13 medications for national emergencies; or 

14 ‘‘(3) promote the adoption of innovative ap15 proaches to drug product design and manufacturing. 

16 ‘‘(c) CONSULTATION.—If the Secretary designates a 

17 method of manufacturing as an advanced manufacturing 

18 technology under this section, the Secretary shall take ac19 tions to expedite the development and implementation of 

20 such method of manufacture for purposes of approval of 

21 the application under subsection (c) or (j) of section 505 

22 of this Act or subsection (a) or (k) of section 351 of the 

23 Public Health Service Act, which may include, as appro24 priate— 


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1 ‘‘(1) holding meetings between the sponsor of 

2 the application and appropriate Food and Drug Ad3 ministration staff throughout the development of the 

4 technology; 

5 ‘‘(2) providing timely advice to, and interactive 

6 communication with, the sponsor regarding the de7 velopment of the technology; and 

8 ‘‘(3) involving senior managers and experienced 

9 staff of the Food and Drug Administration, as ap10 propriate, in a collaborative, cross-disciplinary review 

11 of the method of manufacturing. 

12 ‘‘(d) EVALUATION OF AN ADVANCED MANUFAC13 TURING TECHNOLOGY.— 

14 ‘‘(1) PACKAGE.—A sponsor who receives des15 ignation of an advanced manufacturing technology 

16 under this section shall provide the Secretary with a 

17 package of scientific evidence supporting the imple18 mentation of the advanced manufacturing technology 

19 in a particular context-of-use. 

20 ‘‘(2) EVALUATION.—Within 90 days of receiv21 ing the package, the Secretary shall determine 

22 whether a designated advanced manufacturing tech23 nology is validated for the proposed context of use 

24 based on the scientific merit the supporting evidence 

25 provided by the sponsor. 


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1 ‘‘(3) EFFECT OF APPROVAL.—Upon approval, 

2 the same sponsor may rely upon the advanced man3 ufacturing technology for use across multiple manu4 facturing product lines within the same context-of5 use without having to re-submit data to the Sec6 retary validating the underlying technology. 

7 ‘‘(e) IMPLEMENTATION AND REPORTING.— 

8 ‘‘(1) PUBLIC MEETING.—The Secretary shall 

9 publish in the Federal Register a notice of a public 

10 meeting to be held no later than 1 year after the 

11 date of enactment of the Commitment to Defeat the 

12 Virus and Keep America Healthy Act to discuss and 

13 obtain input and recommendations from stake14 holders regarding the goals and scope of, and a suit15 able framework and procedures and requirements 

16 for, the program under this section. 

17 ‘‘(2) PROGRAM GUIDANCE.—The Secretary 

18 shall— 

19 ‘‘(A) not later than 1 year after the date 

20 of enactment of the Commitment to Defeat the 

21 Virus and Keep America Healthy Act, issue 

22 draft guidance regarding the goals and imple23 mentation of the program under this section; 

24 and 


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1 ‘‘(B) not later than 2 years after the date 

2 of enactment of the Commitment to Defeat the 

3 Virus and Keep America Healthy Act, issue 

4 final guidance with respect to the implementa5 tion of such program. 

6 ‘‘(3) REPORT.—The Secretary shall make avail7 able on the public website of the Food and Drug Ad8 ministration an annual report on the progress of the 

9 program under this section.’’. 

10 Subtitle C—Improving the 

11 American Drug Supply Chain 

12 SEC. 2021. STUDY AND REPORTING ON DOMESTIC AND FOR13 EIGN PRODUCTION. 

14 (a) IN GENERAL.—The Secretary of Health and 

15 Human Services shall enter into an agreement with the 

16 National Academies of Sciences, Engineering, and Medi17 cine (referred to in this section as the ‘‘National Acad18 emies’’) under which, not later than 24 months after the 

19 date of enactment of this Act, the National Academies 

20 will— 

21 (1) study the current and historical production 

22 of drugs and key ingredients thereof (including ac23 tive pharmaceutical ingredients) in the United 

24 States and in foreign countries; 


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1 (2) formulate recommendations for promoting 

2 increased production of drugs and key ingredients 

3 thereof (including active pharmaceutical ingredients) 

4 in the United States; and 

5 (3) in a manner that does not compromise na6 tional security or disclose trade secrets or other con7 fidential commercial information that is subject to 

8 section 552(b)(4) of title 5, United States Code, or 

9 section 1905 of title 18, United States Code, submit 

10 a report to the Congress on— 

11 (A) the findings and conclusions of the 

12 study under paragraph (1); and 

13 (B) the recommendations under paragraph 

14 (2). 

15 (b) STUDY TOPICS.—The study pursuant to sub16 section (a)(1) shall include— 

17 (1) evaluation of— 

18 (A) the extent to which production of 

19 drugs for use in the United States and key in20 gredients thereof (including active pharma21 ceutical ingredients) takes place in the United 

22 States; and 

23 (B) the extent to which such production 

24 takes place in foreign countries; 


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1 (2) identification of the foreign countries in 

2 which such production takes place; 

3 (3) evaluation of historical changes in the coun4 tries in which such production takes place; 

5 (4) determination of the reasons why such pro6 duction takes place in foreign countries, including 

7 why such production takes place in particular for8 eign countries, including consideration of— 

9 (A) the reasons for historical migration of 

10 such production to foreign countries, or from 

11 foreign countries to other foreign countries or 

12 the United States; 

13 (B) economic factors, including economic 

14 impediments to domestic production and incen15 tives for foreign production; and 

16 (C) regulatory, intellectual property, inter17 national trade, and other legal and policy fac18 tors; and 

19 (5) evaluation of the benefits of redundancies in 

20 the supply chain of drugs in the United States in 

21 the event of a public health emergency. 

22 (c) RECOMMENDATIONS.—The agreement under sub23 section (a) shall— 

24 (1) provide for inclusion in the recommenda25 tions under subsection (a)(2) of measures (which 


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1 may include statutory, regulatory, and other policy 

2 changes) that should be taken— 

3 (A) to encourage the domestic production 

4 of drugs for use in the United States and key 

5 ingredients thereof (including active pharma6 ceutical ingredients); or 

7 (B) to otherwise reduce the risks to the 

8 availability of drugs in the United States in the 

9 event of a public health emergency; and 

10 (2) require consideration, in developing such 

11 recommendations, of— 

12 (A) factors affecting the production of 

13 drugs, including— 

14 (i) access to skilled labor; 

15 (ii) the cost of raw materials, the cost 

16 of energy, and related costs; 

17 (iii) taxes and other incentives; and 

18 (iv) the effects of regulations; and 

19 (B) the costs and consequences of imple20 menting, or failing to implement, each such rec21 ommendation. 

22 (d) INPUT.—The agreement under subsection (a) 

23 shall require— 

24 (1) consideration of input from the Department 

25 of Health and Human Services, the Department of 


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1 Commerce, and, as appropriate, other Federal agen2 cies; and 

3 (2) consultation with relevant stakeholders, 

4 which— 

5 (A) may include conducting public meet6 ings and other forms of engagement, as appro7 priate; 

8 (B) shall include consultation with experts 

9 in— 

10 (i) the manufacturing of drugs; 

11 (ii) pharmaceutical industry business 

12 and economics; 

13 (iii) drug purchasing, pricing, and re14 imbursement; 

15 (iv) regulatory and intellectual prop16 erty issues affecting drug manufacturing; 

17 (v) economics; 

18 (vi) international trade policy; and 

19 (vii) emergency planning; and 

20 (C) may include consultation with other 

21 entities with experience in drug manufacturing 

22 and pricing, as appropriate. 

23 (e) DEFINITIONS.—In this section, the term ‘‘drug’’ 

24 has the meaning given such term in section 201 of the 

25 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). 


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1 Subtitle D—Essential Medicines 

2 Strategic Stockpile 

3 SEC. 2031. PILOT PROGRAM ON ENSURING MEDICATION 

4 SUPPLY STABILITY. 

5 Part D of title III of the Public Health Service Act 

6 (42 U.S.C. 254b et seq.) is amended by adding at the end 

7 the following new subpart: 

8 ‘‘Subpart XIII—Ensuring Medication Supply Stability 

9 ‘‘SEC. 340J. ENSURING MEDICATION SUPPLY STABILITY. 

10 ‘‘(a) AWARD OF CONTRACTS.—Beginning not later 

11 than January 1, 2021, the Secretary shall award contracts 

12 to eligible entities to each implement and test the effective13 ness of acquiring, maintaining, managing, and distrib14 uting a stockpile that— 

15 ‘‘(1) consists of generic drugs at risk of short16 age; and 

17 ‘‘(2) is of sufficient quantity to ensure that cus18 tomers in the United States of the respective eligible 

19 entity have access to such drugs for at least 6 

20 months (as specified by the Secretary based on the 

21 historic demand for those drugs). 

22 ‘‘(b) SELECTION OF DRUGS.— 

23 ‘‘(1) IN GENERAL.—The Secretary shall— 

24 ‘‘(A) select not more than 50 types of 

25 drugs that may be included by eligible entities 


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1 in a stockpile pursuant to a contract under this 

2 section; 

3 ‘‘(B) maintain an up-to-date list of such 

4 drugs; and 

5 ‘‘(C) make such list publicly available. 

6 ‘‘(2) CHOICE OF ELIGIBLE ENTITIES.—A con7 tract awarded to an eligible entity under this section 

8 need not require the stockpile of the eligible entity 

9 to include all 50 types of drugs listed pursuant to 

10 paragraph (1). 

11 ‘‘(c) SUFFICIENT QUANTITY.—For each generic drug 

12 in a stockpile maintained pursuant to subsection (a), the 

13 Secretary shall specify the quantity of such drug that is 

14 sufficient for purposes of such subsection to ensure that 

15 consumers in the United States of the respective eligible 

16 entity have access to such drug for at least 6 months. 

17 ‘‘(d) DURATION; LIQUIDATION OF INVENTORY.— 

18 ‘‘(1) DURATION.—A contract awarded under 

19 this section shall be for a term of no more than 3 

20 years. 

21 ‘‘(2) LIQUIDATION OF INVENTORY.—A drug 

22 held in a stockpile pursuant to a contract under this 

23 section may be liquidated by the eligible entity at the 

24 end of the period of the contract. 

25 ‘‘(e) STOCKPILE REQUIREMENTS.— 


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1 ‘‘(1) ENSURING AVAILABILITY OF UNEXPIRED

2 PRODUCTS.—Each eligible entity with a contract 

3 under this section for a stockpile of generic drugs at 

4 risk of shortage shall— 

5 ‘‘(A) ensure that each drug maintained in 

6 the stockpile has an expiration date at least 1 

7 year beyond the current date; and 

8 ‘‘(B) to comply with subparagraph (A)— 

9 ‘‘(i) sell drugs in the stockpile through 

10 normal commercial channels and replace 

11 those drugs; or 

12 ‘‘(ii) if there is no commercial market 

13 for a drug in the stockpile, dispose of the 

14 drug, report such disposal to the Secretary, 

15 and replace the drug. 

16 ‘‘(2) MANAGEMENT OF STOCKPILE.— 

17 ‘‘(A) IN GENERAL.—Each eligible entity 

18 with a contract under this section for a stock19 pile of generic drugs at risk of shortage shall— 

20 ‘‘(i) acquire not later than 6 months 

21 following the date the contract is awarded, 

22 and maintain thereafter, a 6-month supply 

23 of each type of drug the eligible entity has 

24 contracted to stockpile, which 6-month 

25 supply shall be in addition to the average 


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1 levels of inventory held by such eligible en2 tity over the previous year for such drug; 

3 and 

4 ‘‘(ii) if it is not possible to comply 

5 with clause (i), notify the Secretary, citing 

6 the reason why it is not possible and the 

7 expected time of acquisition of the drug. 

8 ‘‘(B) INVENTORY MANAGEMENT.—Each el9 igible entity with a contract under this section 

10 for a stockpile of generic drugs at risk of short11 age shall manage inventory to ensure that 

12 drugs in the stockpile are efficiently cycled to 

13 the commercial market and— 

14 ‘‘(i) may stockpile inventory at the eli15 gible entity’s distribution center with speci16 fied inventory amounts virtually reserved 

17 for the Federal Government with constant 

18 cycling to reduce product expiration; or 

19 ‘‘(ii) may store stockpiled inventory 

20 separately in a different location and re21 place drugs in the stockpile inventory with 

22 the same drug with newer dating. 

23 ‘‘(C) INSUFFICIENT FUNDS.—If amounts 

24 available to an eligible entity through contracts 

25 under this section are not sufficient to acquire 


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1 or maintain a 6-month supply of any drug in 

2 the stockpile of the eligible entity funded under 

3 this section, the eligible entity— 

4 ‘‘(i) may acquire and maintain less 

5 than a 6-month supply, but in no case less 

6 than a 3-month supply; and 

7 ‘‘(ii) shall submit a report to the Sec8 retary identifying— 

9 ‘‘(I) each such drug; and 

10 ‘‘(II) the reasons why such 

11 amounts are not sufficient to acquire 

12 or maintain a 6-month supply. 

13 ‘‘(D) ANNUAL AUDITS.—Not more than 

14 annually, the Secretary may request a physical 

15 audit count of the inventories of all eligible enti16 ties with a contract under this section to vali17 date that each such entity is maintaining the 

18 appropriate amount of stockpiled inventory. 

19 ‘‘(3) PERIODIC PRODUCT REVIEW.— 

20 ‘‘(A) USE OF PROCEEDS.—An eligible enti21 ty with a contract under this section for a 

22 stockpile of generic drugs at risk of shortage 

23 shall use the proceeds of the sale of any drugs 

24 in the stockpile to purchase drugs for the stock25 pile in accordance with this section. 


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1 ‘‘(B) MARKET INFLATION OR DEFLA2 TION.—In the case of market inflation or defla3 tion affecting the price of a drug in the stock4 pile of an eligible entity maintained pursuant to 

5 a contract under this section, the contract shall 

6 ensure that the Federal Government does not 

7 profit or suffer loss on items of such drug as 

8 a result of such inflation or deflation. 

9 ‘‘(4) REPORTING.—Each eligible entity with a 

10 contract under this section shall submit reports at 

11 such time and in such manner as the Secretary may 

12 require regarding— 

13 ‘‘(A) current inventory levels of stockpiled 

14 drugs at a drug level; 

15 ‘‘(B) indicators of current inventory levels 

16 of stockpiled drugs relative to acceptable mini17 mums; and 

18 ‘‘(C) such other matters as the Secretary 

19 determines appropriate. 

20 ‘‘(f) CONTRACT TERMS.— 

21 ‘‘(1) PAYMENT OF MONTHLY FEES FOR MAN22 AGEMENT.—Subject to paragraph (2), the Secretary 

23 shall pay to each eligible entity with a contract 

24 under this section for a stockpile of generic drugs at 


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1 risk of shortage appropriate monthly fees for the 

2 management of the stockpile. 

3 ‘‘(2) PAYMENT CONDITIONED ON STOCKPILE

4 ADEQUACY.— 

5 ‘‘(A) IN GENERAL.—Except as provided in 

6 subparagraph (B), each contract with an eligi7 ble entity under this section shall provide that 

8 no payment under the contract may be made 

9 until the entity demonstrates to the Secretary 

10 that the entity has stockpiled such portion of 

11 the total quantity of drugs to be stockpiled 

12 under the contract as the Secretary determines 

13 to be acceptable for payment. 

14 ‘‘(B) EXCEPTIONS FOR ADVANCE PAY15 MENTS.— 

16 ‘‘(i) IN GENERAL.—A contract under 

17 this section may provide that, if the Sec18 retary determines (in the Secretary’s dis19 cretion) that an advance payment, partial 

20 payment for significant milestones, or pay21 ment to increase capacity is necessary to 

22 ensure success of the terms of the con23 tract, the Secretary shall pay, in advance 

24 of delivery, an amount not to exceed 10 

25 percent of the total contract amount to be 


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1 paid to the eligible entity by the Secretary 

2 pursuant to the contract over the full pe3 riod of the contract. 

4 ‘‘(ii) COST OF CAPITAL.—A contract 

5 under this section may provide for pay6 ments to compensate the contracting eligi7 ble entity for additional capital require8 ments related to the additional inventory 

9 to be maintained. 

10 ‘‘(iii) TIMING.—The Secretary shall, 

11 to the extent practicable, make any deter12 mination under clause (i) to make an ad13 vance payment at the same time as the 

14 issuance of a solicitation. 

15 ‘‘(iv) REPAYMENT.—If the Secretary 

16 makes an advance payment pursuant to 

17 clause (i), the Secretary shall require the 

18 eligible entity receiving such advance pay19 ment to repay it if there is a failure to per20 form by the eligible entity. 

21 ‘‘(3) TERMINATION.— 

22 ‘‘(A) IN GENERAL.—Subject to subpara23 graph (B), nothing in this section shall be con24 strued as affecting the rights of eligible entities 

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1 cluding the Federal Acquisition Regulation) re2 lating to the termination of contracts for the 

3 convenience of the Government. 

4 ‘‘(B) LIQUIDATION OF STOCKPILE.—If a 

5 contract under this section is terminated, the 

6 eligible entity with the contract shall liquidate 

7 the drugs comprising the stockpile funded 

8 through the contract and return to the Govern9 ment any amounts owed in relation to such 

10 drugs, but shall collect the management fees as11 sociated with such liquidation. 

12 ‘‘(g) CONGRESSIONAL OVERSIGHT.— 

13 ‘‘(1) INDEPENDENT EVALUATION AND RE14 PORT.—Not later than 1 year after the date of en15 actment of this section and annually thereafter, the 

16 Comptroller General of the United States shall con17 duct an independent evaluation, and submit to the 

18 appropriate congressional committees a report, con19 cerning the program under this section. 

20 ‘‘(2) CONTENTS OF REPORT.—The report under 

21 paragraph (1) shall review, assess, and provide rec22 ommendations, as appropriate, on the following: 

23 ‘‘(A) Details on likely costs and resultant 

24 savings as compared to a stockpiling method 


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1 that does not incorporate perpetual inventory 

2 cycling. 

3 ‘‘(B) Identification of drawdowns from the 

4 stockpile, as evidence of market shortage avoid5 ance. 

6 ‘‘(C) The allocation of drugs included in 

7 the stockpiles funded pursuant to this section to 

8 the customers of the eligible entities with con9 tracts under this section. 

10 ‘‘(D) The degree to which eligible entities 

11 with contracts under this section fulfilled their 

12 obligations under such contracts. 

13 ‘‘(h) DEFINITIONS.—In this section: 

14 ‘‘(1) The term ‘eligible entity’ means an entity 

15 that meets each of the following criteria: 

16 ‘‘(A) The entity is licensed or registered in 

17 accordance with applicable Federal and State 

18 law and in good standing with respect to such 

19 licensure or registration. 

20 ‘‘(B) The entity agrees— 

21 ‘‘(i) to purchase all drugs to be main22 tained in its stockpile funded under this 

23 section directly from the manufacturers of 

24 the drugs or the exclusive distributors of 

25 such manufacturers; or 


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1 ‘‘(ii) in the case of an entity that is a 

2 co-op or chain pharmacy warehouse— 

3 ‘‘(I) to purchase drugs to be 

4 maintained in its stockpile funded 

5 under this section from an authorized 

6 distributor; and 

7 ‘‘(II) distribute those drugs only 

8 to its member pharmacies. 

9 ‘‘(C) The entity holds a verified authorized 

10 wholesale distributor certification issued by the 

11 National Association of Boards of Pharmacy. 

12 ‘‘(D) The entity sells more than 90 percent 

13 of its drugs to dispensers. 

14 ‘‘(E) The entity agrees to distribute inven15 tory from its stockpile funded under this section 

16 only to dispensers that are customers of the en17 tity. 

18 ‘‘(2) The term ‘generic drug at risk of shortage’ 

19 means a drug (as defined in section 201 of the Fed20 eral Food, Drug, and Cosmetic Act) that— 

21 ‘‘(A) is approved pursuant to section 

22 505(j) of such Act; 

23 ‘‘(B) is included in the World Health Or24 ganization’s most recent Model List of Essen25 tial Medicines; 


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1 ‘‘(C) is included, at any point during the 

2 preceding 36 months, on the drug shortage list 

3 in effect under section 506E of the Federal 

4 Food, Drug, and Cosmetic Act; and 

5 ‘‘(D) is manufactured by 3 or fewer per6 sons that are registered under section 510 of 

7 the Federal Food, Drug, and Cosmetic Act for 

8 purposes of such manufacture. 

9 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—To 

10 carry out this section, there is authorized to be appro11 priated $120,000,000 for fiscal years 2021 through 2023, 

12 to remain available until expended.’’. 

13 Subtitle E—National Centers of Ex14 cellence in Continuous Pharma15 ceutical Manufacturing 

16 SEC. 2041. NATIONAL CENTERS OF EXCELLENCE IN CON17 TINUOUS PHARMACEUTICAL MANUFAC18 TURING. 

19 (a) IN GENERAL.—Section 3016 of the 21st Century 

20 Cures Act (21 U.S.C. 399h) is amended to read as follows: 


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1 ‘‘SEC. 3016. NATIONAL CENTERS OF EXCELLENCE IN CON2 TINUOUS PHARMACEUTICAL MANUFAC3 TURING. 

4 ‘‘(a) IN GENERAL.—The Secretary of Health and 

5 Human Services, acting through the Commissioner of 

6 Food and Drugs— 

7 ‘‘(1) shall solicit and, beginning not later than 

8 one year after the date of enactment of the Commit9 ment to Defeat the Virus and Keep America Healthy 

10 Act, receive requests from institutions of higher edu11 cation to be designated as a National Center of Ex12 cellence in Continuous Pharmaceutical Manufac13 turing (in this section referred to as a ‘National 

14 Center of Excellence’) to support the advancement 

15 and development of continuous manufacturing; and 

16 ‘‘(2) shall so designate any institution of higher 

17 education that— 

18 ‘‘(A) requests such designation; and 

19 ‘‘(B) meets the criteria specified in sub20 section (c). 

21 ‘‘(b) REQUEST FOR DESIGNATION.—A request for 

22 designation under subsection (a) shall be made to the Sec23 retary at such time, in such manner, and containing such 

24 information as the Secretary may require. Any such re25 quest shall include a description of how the institution of 


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1 higher education meets or plans to meet each of the cri2 teria specified in subsection (c). 

3 ‘‘(c) CRITERIA FOR DESIGNATION DESCRIBED.—The 

4 criteria specified in this subsection with respect to an in5 stitution of higher education are that the institution has, 

6 as of the date of the submission of a request under sub7 section (a) by such institution— 

8 ‘‘(1) physical and technical capacity for re9 search and development of continuous manufac10 turing; 

11 ‘‘(2) manufacturing knowledge-sharing net12 works with other institutions of higher education, 

13 large and small pharmaceutical manufacturers, ge14 neric and nonprescription manufacturers, contract 

15 manufacturers, and other entities; 

16 ‘‘(3) proven capacity to design and demonstrate 

17 new, highly effective technology for use in contin18 uous manufacturing; 

19 ‘‘(4) a track record for creating and transfer20 ring knowledge with respect to continuous manufac21 turing; 

22 ‘‘(5) the potential to train a future workforce 

23 for research on and implementation of advanced 

24 manufacturing and continuous manufacturing; and 


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1 ‘‘(6) experience in participating in and leading 

2 a continuous manufacturing technology partnership 

3 with other institutions of higher education, large and 

4 small pharmaceutical manufacturers, generic and 

5 nonprescription manufacturers, contract manufac6 turers, and other entities— 

7 ‘‘(A) to support companies with continuous 

8 manufacturing in the United States; 

9 ‘‘(B) to support Federal agencies with 

10 technical assistance, which may include regu11 latory and quality metric guidance as applica12 ble, for advanced manufacturing and continuous 

13 manufacturing; 

14 ‘‘(C) with respect to continuous manufac15 turing, to organize and conduct research and 

16 development activities needed to create new and 

17 more effective technology, capture and dissemi18 nate expertise, create intellectual property, and 

19 maintain technological leadership; 

20 ‘‘(D) to develop best practices for design21 ing continuous manufacturing; and 

22 ‘‘(E) to assess and respond to the work23 force needs for continuous manufacturing, in24 cluding the development of training programs if 

25 needed. 


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1 ‘‘(d) TERMINATION OF DESIGNATION.—The Sec2 retary may terminate the designation of any National Cen3 ter of Excellence designated under this section if the Sec4 retary determines such National Center of Excellence no 

5 longer meets the criteria specified in subsection (c). Not 

6 later than 60 days before the effective date of such a ter7 mination, the Secretary shall provide written notice to the 

8 National Center of Excellence, including the rationale for 

9 such termination. 

10 ‘‘(e) CONDITIONS FOR DESIGNATION.—As a condi11 tion of designation as a National Center of Excellence 

12 under this section, the Secretary shall require that an in13 stitution of higher education enter into an agreement with 

14 the Secretary under which the institution agrees— 

15 ‘‘(1) to collaborate directly with the Food and 

16 Drug Administration to publish the reports required 

17 by subsection (g); 

18 ‘‘(2) to share data with the Food and Drug Ad19 ministration regarding best practices and research 

20 generated through the funding under subsection (f); 

21 ‘‘(3) to develop, along with industry partners 

22 (which may include large and small biopharma23 ceutical manufacturers, generic and nonprescription 

24 manufacturers, and contract manufacturers) and an25 other institution or institutions designated under 


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1 this section, if any, a roadmap for developing a con2 tinuous manufacturing workforce; 

3 ‘‘(4) to develop, along with industry partners 

4 and other institutions designated under this section, 

5 a roadmap for strengthening existing, and devel6 oping new, relationships with other institutions; and 

7 ‘‘(5) to provide an annual report to the Food 

8 and Drug Administration regarding the institution’s 

9 activities under this section, including a description 

10 of how the institution continues to meet and make 

11 progress on the criteria listed in subsection (c). 

12 ‘‘(f) FUNDING.— 

13 ‘‘(1) IN GENERAL.—The Secretary shall award 

14 funding, through grants, contracts, or cooperative 

15 agreements, to the National Centers of Excellence 

16 designated under this section for the purpose of 

17 studying and recommending improvements to contin18 uous manufacturing, including such improvements 

19 as may enable the Centers— 

20 ‘‘(A) to continue to meet the conditions 

21 specified in subsection (e); and 

22 ‘‘(B) to expand capacity for research on, 

23 and development of, continuing manufacturing. 

24 ‘‘(2) CONSISTENCY WITH FDA MISSION.—As a 

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1 section, a National Center of Excellence shall agree 

2 to consider any input from the Secretary regarding 

3 the use of funding that would— 

4 ‘‘(A) help to further the advancement of 

5 continuous manufacturing through the National 

6 Center of Excellence; and 

7 ‘‘(B) be relevant to the mission of the 

8 Food and Drug Administration. 

9 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

10 There is authorized to be appropriated to carry out 

11 this subsection $80,000,000 for the period of fiscal 

12 years 2021 through 2025. 

13 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in 

14 this section shall be construed as precluding a Na15 tional Center for Excellence designated under this 

16 section from receiving funds under any other provi17 sion of this Act or any other Federal law. 

18 ‘‘(g) ANNUAL REVIEW AND REPORTS.— 

19 ‘‘(1) ANNUAL REPORT.—Beginning not later 

20 than one year after the date on which the first des21 ignation is made under subsection (a), and annually 

22 thereafter, the Secretary shall— 

23 ‘‘(A) submit to Congress a report describ24 ing the activities, partnerships and collabora25 tions, Federal policy recommendations, previous 


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1 and continuing funding, and findings of, and 

2 any other applicable information from, the Na3 tional Centers of Excellence designated under 

4 this section; and 

5 ‘‘(B) make such report available to the 

6 public in an easily accessible electronic format 

7 on the website of the Food and Drug Adminis8 tration. 

9 ‘‘(2) REVIEW OF NATIONAL CENTERS OF EX10 CELLENCE AND POTENTIAL DESIGNEES.—The Sec11 retary shall periodically review the National Centers 

12 of Excellence designated under this section to ensure 

13 that such National Centers of Excellence continue to 

14 meet the criteria for designation under this section. 

15 ‘‘(3) REPORT ON LONG-TERM VISION OF FDA

16 ROLE.—Not later than 2 years after the date on 

17 which the first designation is made under subsection 

18 (a), the Secretary, in consultation with the National 

19 Centers of Excellence designated under this section, 

20 shall submit a report to the Congress on the long21 term vision of the Department of Health and 

22 Human Services on the role of the Food and Drug 

23 Administration in supporting continuous manufac24 turing, including— 


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1 ‘‘(A) a national framework of principles re2 lated to the implementation and regulation of 

3 continuous manufacturing; 

4 ‘‘(B) a plan for the development of Federal 

5 regulations and guidance for how advanced 

6 manufacturing and continuous manufacturing 

7 can be incorporated into the development of 

8 pharmaceuticals and regulatory responsibilities 

9 of the Food and Drug Administration; and 

10 ‘‘(C) appropriate feedback solicited from 

11 the public, which may include other institutions, 

12 large and small biopharmaceutical manufactur13 ers, generic and nonprescription manufacturers, 

14 and contract manufacturers. 

15 ‘‘(h) DEFINITIONS.—In this section: 

16 ‘‘(1) ADVANCED MANUFACTURING.—The term 

17 ‘advanced manufacturing’ means an approach for 

18 the manufacturing of pharmaceuticals that incor19 porates novel technology, or uses an established 

20 technique or technology in a new or innovative way 

21 (such as continuous manufacturing where the input 

22 materials are continuously transformed within the 

23 process by two or more unit operations) that en24 hances drug quality or improves the manufacturing 

25 process. 


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1 ‘‘(2) CONTINUOUS MANUFACTURING.—The 

2 term ‘continuous manufacturing’— 

3 ‘‘(A) means a process where the input ma4 terials are continuously fed into and trans5 formed within the process, and the processed 

6 output materials are continuously removed from 

7 the system; and 

8 ‘‘(B) consists of an integrated process that 

9 consists of a series of two or more unit oper10 ations. 

11 ‘‘(3) INSTITUTION OF HIGHER EDUCATION.— 

12 The term ‘institution of higher education’ has the 

13 meaning given such term in section 101(a) of the 

14 Higher Education Act of 1965 (20 U.S.C. 1001(a)). 

15 ‘‘(4) SECRETARY.—The term ‘Secretary’ means 

16 the Secretary of Health and Human Services, acting 

17 through the Commissioner of Food and Drugs.’’. 

18 (b) TRANSITION RULE.—Section 3016 of the 21st 

19 Century Cures Act (21 U.S.C. 399h), as in effect on the 

20 day before the date of the enactment of this section, shall 

21 apply with respect to grants awarded under such section 

22 before such date of enactment. 


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1 TITLE III—STRATEGIC NA2 TIONAL STOCKPILE IM3 PROVEMENTS 

4 Subtitle A—Stockpiling for 

5 America’s Future Endeavors 

6 SEC. 3001. STRATEGIC NATIONAL STOCKPILE. 

7 Section 319F–2(a) of the Public Health Service Act 

8 (42 U.S.C. 247d–6b(a)) is amended by adding at the end 

9 the following: 

10 ‘‘(6) ACCEPTANCE OF GIFTS.— 

11 ‘‘(A) IN GENERAL.—The Secretary may, 

12 without further appropriation and without fiscal 

13 year limitation, accept, use, and dispose of 

14 gifts, bequests, or devises of money, services, or 

15 property, both real and personal, for the pur16 pose of carrying out this subsection. Any such 

17 gift, bequest, or devise of money and proceeds 

18 from sales of other property received as a gift, 

19 bequest, or devise shall be deposited in the 

20 Treasury and shall be available for obligation 

21 and expenditure upon order of the Secretary. 

22 ‘‘(B) LIMITATIONS.— 

23 ‘‘(i) COMPROMISING INTEGRITY.—The 

24 Secretary may not accept a gift, bequest, 

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1 retary determines that the use of the prop2 erty or services would compromise the in3 tegrity or appearance of integrity of— 

4 ‘‘(I) a program of the Depart5 ment of Health and Human Services; 

6 or 

7 ‘‘(II) an individual involved in a 

8 program of the Department. 

9 ‘‘(ii) UNAPPROVED PRODUCTS.—The 

10 Secretary may accept a drug or device (as 

11 those terms are defined in section 201 of 

12 the Federal Food, Drug, and Cosmetic 

13 Act) as part of a gift, bequest, or devise 

14 under this paragraph only if such drug or 

15 device is— 

16 ‘‘(I) a drug that is approved 

17 under section 505 of such Act, that 

18 meets the requirements for marketing 

19 under section 505G of such Act, or 

20 that is licensed under section 351 of 

21 this Act; 

22 ‘‘(II) a device that is approved 

23 under section 515 of the Federal 

24 Food, Drug, and Cosmetic Act, that is 

25 classified under section 513(f)(2) of 


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1 such Act, that is licensed under sec2 tion 351 of this Act, that is cleared 

3 under section 510(k) of the Federal 

4 Food, Drug, and Cosmetic Act, or for 

5 which a report is not required under 

6 such section 510(k); 

7 ‘‘(III) authorized for emergency 

8 use in accordance with section 564 or 

9 564A of the Federal Food, Drug, and 

10 Cosmetic Act or prepositioned for use 

11 in accordance with section 564B of 

12 such Act; 

13 ‘‘(IV) authorized for investiga14 tional use under section 505, 512, or 

15 520 of the Federal Food, Drug, and 

16 Cosmetic Act or section 351 of this 

17 Act; 

18 ‘‘(V) determined by the Commis19 sioner of Food and Drugs to be ap20 propriate for use, without approval, li21 censure, authorization, or clearance, 

22 to respond to a shortage or potential 

23 shortage situation; or 

24 ‘‘(VI) a respiratory protective de25 vice approved and determined to be a 


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1 priority, as described in section 319F– 

2 3(i)(1)(D) of this Act. 

3 ‘‘(C) REPORT.— 

4 ‘‘(i) IN GENERAL.—The Secretary 

5 shall submit to the Committee on Energy 

6 and Commerce of the House of Represent7 atives and the Committee on Health, Edu8 cation, Labor, and Pensions of the Senate 

9 an annual report disclosing— 

10 ‘‘(I) any gift, bequest, or devise 

11 that was accepted under this para12 graph during the year covered by the 

13 report; 

14 ‘‘(II) how the gifts, bequests, and 

15 devises contribute to the mission of 

16 the stockpile; and 

17 ‘‘(III) the amount of Federal sav18 ings that were generated from the ac19 ceptance of the gifts, bequests, and 

20 devises. 

21 ‘‘(ii) PUBLICATION.—Each report re22 quired under clause (i) shall be made pub23 licly available.’’. 


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1 Subtitle B—Stockpile Inventory 

2 Modernization 

3 SEC. 3011. REIMBURSABLE TRANSFERS. 

4 Section 319F–2(a) of the Public Health Service Act 

5 (42 U.S.C. 247d–6b(a)), as amended by section 3001, is 

6 further amended by adding at the end the following: 

7 ‘‘(7) TRANSFERS AND REIMBURSEMENTS.— 

8 ‘‘(A) IN GENERAL.—Without regard to 

9 chapter 5 of title 40, United States Code, the 

10 Secretary may transfer to any Federal depart11 ment or agency, on a reimbursable basis, any 

12 drugs, vaccines and other biological products, 

13 medical devices, and other supplies in the stock14 pile if— 

15 ‘‘(i) the transferred supplies are less 

16 than one year from expiry; 

17 ‘‘(ii) the stockpile is able to replenish 

18 the supplies, as appropriate; and 

19 ‘‘(iii) the Secretary decides the trans20 fer is in the best interest of the United 

21 States Government. 

22 ‘‘(B) USE OF REIMBURSEMENT.—Reim23 bursement derived from the transfer of supplies 

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1 vance in appropriations Acts, be used by the 

2 Secretary to carry out this section. Funds made 

3 available pursuant to the preceding sentence are 

4 in addition to any other funds that may be 

5 made available for such purpose. 

6 ‘‘(C) RULE OF CONSTRUCTION.—This 

7 paragraph shall not be construed to preclude 

8 transfers of products in the stockpile under 

9 other authorities. 

10 ‘‘(D) REPORT.—Not later than September 

11 30, 2022, the Secretary shall submit to the 

12 Committee on Energy and Commerce of the 

13 House of Representatives and the Committee 

14 on Health, Education, Labor, and Pensions of 

15 the Senate a report on each transfer made 

16 under this paragraph and the amount received 

17 by the Secretary in exchange for that transfer. 

18 ‘‘(E) SUNSET.—The authority to make 

19 transfers under this paragraph shall cease to be 

20 effective on September 30, 2023.’’. 

21 Subtitle C—Equipment 

22 Maintenance 

23 SEC. 3021. EQUIPMENT MAINTENANCE. 

24 Section 319F–2 of the Public Health Service Act (42 

25 U.S.C. 247d–6b) is amended— 


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1 (1) in subsection (a)(3)— 

2 (A) in subparagraph (I), by striking ‘‘; 

3 and’’ and inserting a semicolon; 

4 (B) in subparagraph (J), by striking the 

5 period at the end and inserting a semicolon; 

6 and 

7 (C) by inserting the following new subpara8 graph at the end: 

9 ‘‘(K) ensure contents of the stockpile re10 main in good working order and, as appro11 priate, conduct maintenance services on con12 tents of the stockpile; and’’; and 

13 (2) in subsection (c)(7)(B), by adding at the 

14 end the following new clause: 

15 ‘‘(ix) EQUIPMENT MAINTENANCE

16 SERVICE.—In carrying out this section, the 

17 Secretary may enter into contracts for the 

18 procurement of equipment maintenance 

19 services.’’. 

20 Subtitle D—Medical Supplies for 

21 Pandemics 

22 SEC. 3031. SUPPLY CHAIN FLEXIBILITY MANUFACTURING 

23 PILOT. 

24 (a) IN GENERAL.—Section 319F–2(a)(3) of the Pub25 lic Health Service Act (42 U.S.C. 247d–6b(a)(3)), as 


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1 amended by section 3012, is further amended by adding 

2 at the end the following new subparagraph: 

3 ‘‘(L) enhance medical supply chain elas4 ticity and establish and maintain domestic re5 serves of critical medical supplies (including 

6 personal protective equipment, ancillary medical 

7 supplies, and other applicable supplies required 

8 for the administration of drugs, vaccines and 

9 other biological products, and other medical de10 vices (including diagnostic tests)) by— 

11 ‘‘(i) increasing emergency stock of 

12 critical medical supplies; 

13 ‘‘(ii) geographically diversifying do14 mestic production of such medical supplies, 

15 as appropriate; 

16 ‘‘(iii) entering into cooperative agree17 ments or partnerships with respect to man18 ufacturing lines, facilities, and equipment 

19 for the domestic production of such med20 ical supplies; and 

21 ‘‘(iv) managing, either directly or 

22 through cooperative agreements with man23 ufacturers and distributors, domestic re24 serves established under this subparagraph 


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1 by refreshing and replenishing stock of 

2 such medical supplies.’’. 

3 (b) REPORTING; SUNSET.—Section 319F–2(a) of the 

4 Public Health Service Act (42 U.S.C. 247d–6b(a)), as 

5 amended by section 3011, is further amended by adding 

6 at the end the following: 

7 ‘‘(8) REPORTING.—Not later than September 

8 30, 2022, the Secretary shall submit to the Com9 mittee on Energy and Commerce of the House of 

10 Representatives and the Committee on Health, Edu11 cation, Labor, and Pensions of the Senate a report 

12 on the details of each cooperative agreement or part13 nership entered into under paragraph (3)(L), includ14 ing the amount expended by the Secretary on each 

15 such cooperative agreement or partnership. 

16 ‘‘(9) SUNSET.—The authority to enter into co17 operative agreements or partnerships pursuant to 

18 paragraph (3)(L) shall cease to be effective on Sep19 tember 30, 2023.’’. 

20 (c) FUNDING.—Section 319F–2(f) of the Public 

21 Health Service Act (42 U.S.C. 247d–6b(f)) is amended by 

22 adding at the end the following: 

23 ‘‘(3) SUPPLY CHAIN ELASTICITY.— 

24 ‘‘(A) IN GENERAL.—For the purpose of 

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1 thorized to be appropriated $500,000,000 for 

2 each of fiscal years 2021 through 2023, to re3 main available until expended. 

4 ‘‘(B) RELATION TO OTHER AMOUNTS.— 

5 The amount authorized to be appropriated by 

6 subparagraph (A) for the purpose of carrying 

7 out subsection (a)(3)(L) is in addition to any 

8 other amounts available for such purpose.’’. 

9 Subtitle E—State Stockpile 

10 Readiness 

11 SEC. 3041. GRANTS FOR STATE STRATEGIC STOCKPILES. 

12 Title III of the Public Health Service Act is amended 

13 by inserting after section 319F–4 of such Act (42 U.S.C. 

14 247d–6e) the following new section: 

15 ‘‘SEC. 319F–5. GRANTS FOR STATE STRATEGIC STOCKPILES. 

16 ‘‘(a) IN GENERAL.—The Secretary may establish a 

17 pilot program consisting of awarding grants to States to 

18 expand or maintain a strategic stockpile of commercially 

19 available drugs, devices, personal protective equipment, 

20 and other products deemed by the State to be essential 

21 in the event of a public health emergency. 

22 ‘‘(b) ALLOWABLE USE OF FUNDS.— 

23 ‘‘(1) USES.—A State receiving a grant under 

24 this section may use the grant funds to— 


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1 ‘‘(A) acquire commercially available prod2 ucts listed pursuant to paragraph (2) for inclu3 sion in the State’s strategic stockpile; 

4 ‘‘(B) store, maintain, and distribute prod5 ucts in such stockpile; and 

6 ‘‘(C) conduct planning in connection with 

7 such activities. 

8 ‘‘(2) LIST.—The Secretary shall develop and 

9 publish a list of the products that are eligible, as de10 scribed in subsection (a), for inclusion in a State’s 

11 strategic stockpile using funds received under this 

12 section. 

13 ‘‘(3) CONSULTATION.—In developing the list 

14 under paragraph (2) and otherwise determining the 

15 allowable uses of grant funds under this section, the 

16 Secretary shall consult with States and relevant 

17 stakeholders, including public health organizations. 

18 ‘‘(c) FUNDING REQUIREMENT.—The Secretary may 

19 not obligate or expend any funds to award grants or fund 

20 any previously awarded grants under this section for a fis21 cal year unless the total amount made available to carry 

22 out section 319F–2 for such fiscal year is equal to or 

23 greater than the total amount of funds made available to 

24 carry out section 319F–2 for fiscal year 2020. 

25 ‘‘(d) MATCHING FUNDS.— 


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1 ‘‘(1) IN GENERAL.—With respect to the costs of 

2 expanding and maintaining a strategic stockpile 

3 through a grant under this section, as a condition on 

4 receipt of the grant, a State shall make available (di5 rectly) non-Federal contributions in cash toward 

6 such costs in an amount that is equal to not less 

7 than the amount of Federal funds provided through 

8 the grant. 

9 ‘‘(2) WAIVER.—The Secretary may waive the 

10 requirement of paragraph (1) with respect to a State 

11 for the first two years of the State receiving a grant 

12 under this section if the Secretary determines that 

13 such waiver is needed for the State to establish a 

14 strategic stockpile described in subsection (a). 

15 ‘‘(e) TECHNICAL ASSISTANCE.—The Secretary shall 

16 provide technical assistance to States in establishing, ex17 panding, and maintaining a stockpile described in sub18 section (a). 

19 ‘‘(f) DEFINITION.—In this section, the term ‘drug’ 

20 has the meaning given to that term in section 201 of the 

21 Federal Food, Drug, and Cosmetic Act. 

22 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To 

23 carry out this section, there is authorized to be appro24 priated $3,500,000,000 for each of fiscal years 2021 

25 through 2023, to remain available until expended. 


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1 ‘‘(h) SUNSET.—The authority vested by this section 

2 terminates at the end of fiscal year 2023.’’. 

3 Subtitle F—Process Improvements 

4 and Reports 

5 SEC. 3051. GAO STUDY ON THE FEASIBILITY AND BENEFITS 

6 OF USER FEE AGREEMENTS. 

7 (a) IN GENERAL.—The Comptroller General of the 

8 United States shall conduct a study to investigate the fea9 sibility of establishing user fees to offset certain Federal 

10 costs attributable to the procurement of single-source ma11 terials for the Strategic National Stockpile under section 

12 319F–2 of the Public Health Service Act (42 U.S.C. 

13 247d–6b) and distributions of such materials from the 

14 Stockpile. In conducting this study, the Comptroller Gen15 eral shall consider, to the extent information is available— 

16 (1) whether entities receiving such distributions 

17 generate profits from those distributions; 

18 (2) any Federal costs attributable to such dis19 tributions; 

20 (3) whether such user fees would provide the 

21 Secretary with funding to potentially offset procure22 ment costs of such materials for the Strategic Na23 tional Stockpile; and 

24 (4) any other issues the Comptroller General 

25 identifies as relevant. 


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1 (b) REPORT.—Not later than February 1, 2023, the 

2 Comptroller General of the United States shall submit to 

3 the Congress a report on the findings and conclusions of 

4 the study under subsection (a). 

5 SEC. 3052. ACTION REPORTING. 

6 (a) IN GENERAL.—The Secretary of Health and 

7 Human Services or the Assistant Secretary for Prepared8 ness and Response, in consultation with the Administrator 

9 of the Federal Emergency Management Agency, shall— 

10 (1) not later than 30 days after the date of en11 actment of this Act, issue a report to the Committee 

12 on Energy and Commerce of the House of Rep13 resentatives and the Committee on Health, Edu14 cation, Labor, and Pensions of the Senate regarding 

15 all State, local, Tribal, and territorial requests for 

16 supplies from the Strategic National Stockpile re17 lated to COVID–19; and 

18 (2) not less than every 30 days thereafter 

19 through the end of the emergency period (as such 

20 term is defined in section 1135(g)(1)(B) of the So21 cial Security Act (42 U.S.C. 1320b–5(g)(1)(B))), 

22 submit to such committees an updated version of 

23 such report. 

24 (b) REPORTING PERIOD.— 


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1 (1) INITIAL REPORT.—The initial report under 

2 subsection (a) shall address all requests described in 

3 such subsection made during the period— 

4 (A) beginning on January 31, 2020; and 

5 (B) ending on the date that is 30 days be6 fore the date of submission of the report. 

7 (2) UPDATES.—Each update to the report 

8 under subsection (a) shall address all requests de9 scribed in such subsection made during the period— 

10 (A) beginning at the end of the previous 

11 reporting period under this section; and 

12 (B) ending on the date that is 30 days be13 fore the date of submission of the updated re14 port. 

15 (c) CONTENTS OF REPORT.—The report under sub16 section (a) (and updates thereto) shall include— 

17 (1) the details of each request described in such 

18 subsection, including— 

19 (A) the specific medical countermeasures, 

20 devices, personal protective equipment, and 

21 other materials requested; and 

22 (B) the amount of such materials re23 quested; and 

24 (2) the outcomes of each request described in 

25 subsection (a), including— 


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1 (A) whether the request was wholly ful2 filled, partially fulfilled, or denied; 

3 (B) if the request was wholly or partially 

4 fulfilled, the fulfillment amount; and 

5 (C) if the request was partially fulfilled or 

6 denied, a rationale for such outcome. 

7 SEC. 3053. IMPROVED, TRANSPARENT PROCESSES. 

8 (a) IN GENERAL.—Not later than January 1, 2021, 

9 the Secretary of Health and Human Services shall develop 

10 and implement improved, transparent processes for the 

11 use and distribution of drugs, vaccines and other biological 

12 products, medical devices, and other supplies (including 

13 personal protective equipment, ancillary medical supplies, 

14 and other applicable supplies required for the administra15 tion of drugs, vaccines and other biological products, med16 ical devices, and diagnostic tests) in the Strategic National 

17 Stockpile under section 319F–2 of the Public Health Serv18 ice Act (42 U.S.C. 247d–6b) (in this section referred to 

19 as the ‘‘Stockpile’’). 

20 (b) PROCESSES.—The processes developed under 

21 subsection (a) shall include— 

22 (1) the form and manner in which States, local23 ities, Tribes, and territories are required to submit 

24 requests for supplies from the Stockpile; 


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1 (2) the criteria used by the Secretary of Health 

2 and Human Services in responding to such requests, 

3 including the reasons for fulfilling or denying such 

4 requests; 

5 (3) what circumstances result in prioritization 

6 of distribution of supplies from the Stockpile to 

7 States, localities, Tribes, or territories; 

8 (4) clear plans for future, urgent communica9 tion between the Secretary and States, localities, 

10 Tribes, and territories regarding the outcome of 

11 such requests; and 

12 (5) any differences in the processes developed 

13 under subsection (a) for geographically related emer14 gencies, such as weather events, and national emer15 gencies, such as pandemics. 

16 (c) CLASSIFICATION.—The processes developed under 

17 subsection (a) shall be unclassified to the greatest extent 

18 possible consistent with national security. The Secretary 

19 of Health and Human Services may classify portions of 

20 such processes as necessary to protect national security. 

21 (d) REPORT TO CONGRESS.—Not later than January 

22 1, 2021, the Secretary of Health and Human Services 

23 shall— 

24 (1) submit a report to the Committee on En25 ergy and Commerce of the House of Representatives 


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1 and the Committee on Health, Education, Labor, 

2 and Pensions of the Senate regarding the improved, 

3 transparent processes developed under this section; 

4 (2) include in such report recommendations for 

5 opportunities for communication (by telebriefing, 

6 phone calls, or in-person meetings) between the Sec7 retary and States, localities, Tribes, and territories 

8 regarding such improved, transparent processes; and 

9 (3) submit such report in unclassified form to 

10 the greatest extent possible, except that the Sec11 retary may include a classified appendix if necessary 

12 to protect national security. 

13 Subtitle G—Strategic National 

14 Stockpile Funding 

15 SEC. 3061. AUTHORIZATION OF APPROPRIATIONS. 

16 Section 319F–2(f)(1) of the Public Health Service 

17 Act (42 U.S.C. 247d–6b(f)(1)) is amended by striking 

18 ‘‘$610,000,000 for each of fiscal years 2019 through 

19 2023’’ and inserting ‘‘$705,000,000 for each of fiscal 

20 years 2021 through 2023’’. 


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1 TITLE IV—PUBLIC HEALTH IN2 FRASTRUCTURE IMPROVE3 MENTS 

4 Subtitle A—Public Health 

5 Infrastructure Modernization 

6 SEC. 4001. PUBLIC HEALTH DATA SYSTEM TRANS7 FORMATION. 

8 Subtitle C of title XXVIII of the Public Health Serv9 ice Act (42 U.S.C. 300hh–31 et seq.) is amended by add10 ing at the end the following: 

11 ‘‘SEC. 2822. PUBLIC HEALTH DATA SYSTEM TRANS12 FORMATION. 

13 ‘‘(a) EXPANDING CDC AND PUBLIC HEALTH DE14 PARTMENT CAPABILITIES.— 

15 ‘‘(1) IN GENERAL.—The Secretary, acting 

16 through the Director of the Centers for Disease 

17 Control and Prevention, shall— 

18 ‘‘(A) conduct activities to expand, enhance, 

19 and improve public health data systems used by 

20 the Centers for Disease Control and Prevention, 

21 related to the interoperability and improvement 

22 of such systems (including with respect to pre23 paredness for, prevention and detection of, and 

24 response to public health emergencies); and 


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1 ‘‘(B) award grants or cooperative agree2 ments to State, local, Tribal, or territorial pub3 lic health departments for the expansion and 

4 modernization of public health data systems, to 

5 assist public health departments in— 

6 ‘‘(i) assessing current data infrastruc7 ture capabilities and gaps to improve con8 sistency in data collection, storage, and 

9 analysis, and as appropriate to improve 

10 dissemination of public health-related in11 formation; 

12 ‘‘(ii) improving secure public health 

13 data collection, transmission, exchange, 

14 maintenance, and analysis; 

15 ‘‘(iii) improving the secure exchange 

16 of data between the Centers for Disease 

17 Control and Prevention, State, local, Trib18 al, and territorial public health depart19 ments, public health organizations, and 

20 health care providers, including— 

21 ‘‘(I) between public health offi22 cials in multiple jurisdictions within a 

23 State; and 

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1 viders pursuant to State law, includ2 ing through the use of health informa3 tion technology; 

4 ‘‘(iv) enhancing the interoperability of 

5 public health data systems (including sys6 tems created or accessed by public health 

7 departments) with health information tech8 nology, including with health information 

9 technology certified under section 

10 3001(c)(5); 

11 ‘‘(v) supporting and training public 

12 health data systems, data science, and 

13 informatics personnel; 

14 ‘‘(vi) supporting earlier disease and 

15 health condition detection, such as through 

16 near real-time data monitoring, to support 

17 rapid public health responses; 

18 ‘‘(vii) supporting activities within the 

19 applicable jurisdiction related to the expan20 sion and modernization of electronic case 

21 reporting; and 

22 ‘‘(viii) developing and disseminating 

23 information related to the use and impor24 tance of public health data. 


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1 ‘‘(2) DATA STANDARDS.—In carrying out para2 graph (1), the Secretary, acting through the Direc3 tor of the Centers for Disease Control and Preven4 tion, shall, as appropriate and in coordination with 

5 the Office of the National Coordinator for Health 

6 Information Technology, designate data and tech7 nology standards (including standards for interoper8 ability) for public health data systems, with def9 erence given to standards published by consensus10 based standards development organizations with 

11 public input and voluntary consensus-based stand12 ards bodies. 

13 ‘‘(3) PUBLIC-PRIVATE PARTNERSHIPS.—The 

14 Secretary may develop and utilize public-private 

15 partnerships for technical assistance, training, and 

16 related implementation support for State, local, 

17 Tribal, and territorial public health departments, 

18 and the Centers for Disease Control and Prevention, 

19 on the expansion and modernization of electronic 

20 case reporting and public health data systems, as 

21 applicable. 

22 ‘‘(b) REQUIREMENTS.— 

23 ‘‘(1) HEALTH INFORMATION TECHNOLOGY

24 STANDARDS.—The Secretary may not award a grant 

25 or cooperative agreement under subsection (a)(1)(B) 


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1 unless the applicant uses or agrees to use standards 

2 endorsed by the National Coordinator for Health In3 formation Technology pursuant to section 

4 3001(c)(1) or adopted by the Secretary under sec5 tion 3004. 

6 ‘‘(2) WAIVER.—The Secretary may waive the 

7 requirement under paragraph (1) with respect to an 

8 applicant if the Secretary determines that the activi9 ties under subsection (a)(1)(B) cannot otherwise be 

10 carried out within the applicable jurisdiction. 

11 ‘‘(3) APPLICATION.—A State, local, Tribal, or 

12 territorial health department applying for a grant or 

13 cooperative agreement under this section shall sub14 mit an application to the Secretary at such time and 

15 in such manner as the Secretary may require. Such 

16 application shall include information describing— 

17 ‘‘(A) the activities that will be supported 

18 by the grant or cooperative agreement; and 

19 ‘‘(B) how the modernization of the public 

20 health data systems involved will support or im21 pact the public health infrastructure of the 

22 health department, including a description of 

23 remaining gaps, if any, and the actions needed 

24 to address such gaps. 


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1 ‘‘(c) STRATEGY AND IMPLEMENTATION PLAN.—Not 

2 later than 180 days after the date of enactment of this 

3 section, the Secretary, acting through the Director of the 

4 Centers for Disease Control and Prevention, shall submit 

5 to the Committee on Health, Education, Labor, and Pen6 sions of the Senate and the Committee on Energy and 

7 Commerce of the House of Representatives a coordinated 

8 strategy and an accompanying implementation plan that 

9 identifies and describes the measures the Secretary will 

10 utilize to— 

11 ‘‘(1) update and improve public health data sys12 tems used by the Centers for Disease Control and 

13 Prevention; and 

14 ‘‘(2) carry out the activities described in this 

15 section to support the improvement of State, local, 

16 Tribal, and territorial public health data systems. 

17 ‘‘(d) CONSULTATION.—In carrying out this section, 

18 the Secretary, acting through the Director of the Centers 

19 for Disease Control and Prevention, shall consult with 

20 State, local, Tribal, and territorial public health depart21 ments, professional medical and public health associations, 

22 associations representing hospitals or other health care en23 tities, health information technology experts, and other ap24 propriate public or private entities. 


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1 ‘‘(e) REPORT TO CONGRESS.—Not later than 1 year 

2 after the date of enactment of this section, the Secretary 

3 shall submit a report to the Committee on Health, Edu4 cation, Labor, and Pensions of the Senate and the Com5 mittee on Energy and Commerce of the House of Rep6 resentatives that includes— 

7 ‘‘(1) a description of any barriers to— 

8 ‘‘(A) public health authorities imple9 menting interoperable public health data sys10 tems and electronic case reporting; 

11 ‘‘(B) the exchange of information pursuant 

12 to electronic case reporting; or 

13 ‘‘(C) reporting by health care providers 

14 using such public health data systems, as ap15 propriate, and pursuant to State law; 

16 ‘‘(2) an assessment of the potential public 

17 health impact of implementing electronic case re18 porting and interoperable public health data sys19 tems; and 

20 ‘‘(3) a description of the activities carried out 

21 pursuant to this section. 

22 ‘‘(f) ELECTRONIC CASE REPORTING.—In this sec23 tion, the term ‘electronic case reporting’ means the auto24 mated identification, generation, and bilateral exchange of 

25 reports of health events among electronic health record or 


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1 health information technology systems and public health 

2 authorities. 

3 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To 

4 carry out this section, there is authorized to be appro5 priated $100,000,000 for each of fiscal years 2021 

6 through 2025.’’. 

7 Subtitle B—Modernizing Infectious 

8 Disease Data Collection 

9 SEC. 4011. MODERNIZING INFECTIOUS DISEASE DATA COL10 LECTION. 

11 (a) IMPROVING INFECTIOUS DISEASE DATA COLLEC12 TION.—Section 319D of the Public Health Service Act (42 

13 U.S.C. 247d–4) is amended— 

14 (1) in subsection (c)— 

15 (A) in paragraph (3)(A)(iv), by inserting 

16 ‘‘(such as commercial, academic, and other hos17 pital laboratories)’’ after ‘‘clinical laboratories’’; 

18 (B) in paragraph (5)— 

19 (i) in subparagraph (A)— 

20 (I) in the matter preceding clause 

21 (i), by striking ‘‘and operating’’ and 

22 inserting ‘‘, operating, and updating’’; 

23 (II) in clause (iv), by striking 

24 ‘‘and’’ at the end; 


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1 (III) in clause (v), by striking the 

2 period and inserting ‘‘; and’’; and 

3 (IV) by adding at the end the fol4 lowing: 

5 ‘‘(vi) integrate and update applicable 

6 existing Centers for Disease Control and 

7 Prevention data systems and networks in 

8 collaboration with State, local, tribal, and 

9 territorial public health officials, including 

10 public health surveillance and disease de11 tection systems.’’; and 

12 (ii) in subparagraph (B)— 

13 (I) in clause (i), by inserting 

14 ‘‘and 60 days after the date of enact15 ment of the Commitment to Defeat 

16 the Virus and Keep America Healthy 

17 Act’’ after ‘‘Innovation Act of 2019’’; 

18 (II) in clause (ii), by inserting 

19 ‘‘epidemiologists, clinical microbiolo20 gists, pathologists and laboratory ex21 perts, experts in health information 

22 technology, privacy, and data secu23 rity’’ after ‘‘forecasting);’’; and 

24 (III) in clause (iii)— 


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1 (aa) in subclause (V), by 

2 striking ‘‘and’’ at the end; 

3 (bb) in subclause (VI), by 

4 striking the period; and 

5 (cc) by adding at the end 

6 the following: 

7 ‘‘(VII) strategies to integrate lab8 oratory and epidemiology systems and 

9 capabilities to conduct rapid and accu10 rate laboratory tests; 

11 ‘‘(VIII) strategies to improve the 

12 collection and reporting of appro13 priate, aggregated, deidentified demo14 graphic data to inform responses to 

15 public health emergencies, including 

16 identification of at-risk populations 

17 and to address health disparities; and 

18 ‘‘(IX) strategies to improve the 

19 electronic exchange of health informa20 tion between State and local health 

21 departments and health care providers 

22 and facilities to improve public health 

23 surveillance.’’; and 

24 (C) in paragraph (6)— 

25 (i) in subparagraph (A)— 


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1 (I) in clause (iii)— 

2 (aa) in subclause (III), by 

3 striking ‘‘and’’ at the end; 

4 (bb) in subclause (IV), by 

5 inserting ‘‘, including the ability 

6 to conduct and report on rapid 

7 and accurate laboratory testing 

8 during a public health emer9 gency’’ before the semicolon; and 

10 (cc) by adding at the end 

11 the following: 

12 ‘‘(V) improve coordination and 

13 collaboration, as appropriate, with 

14 other Federal departments; and 

15 ‘‘(VI) implement applicable les16 sons learned from recent public health 

17 emergencies to address gaps in situa18 tional awareness and biosurveillance 

19 capabilities, including an evaluation of 

20 ways to improve the collection and re21 porting of aggregated, deidentified de22 mographic data to inform public 

23 health preparedness and response’’; 

24 (II) in clause (iv), by striking 

25 ‘‘and’’ at the end; 


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1 (III) in clause (v), by striking the 

2 period and inserting ‘‘including a de3 scription of how such steps will fur4 ther the goal of improving awareness 

5 of and timely responses to emerging 

6 infectious disease threats; and’’; and 

7 (IV) by adding at the end the fol8 lowing: 

9 ‘‘(vi) identifies and demonstrates 

10 measurable steps the Secretary will take to 

11 further develop and integrate infectious 

12 disease detection, including expanding ca13 pabilities to conduct rapid and accurate di14 agnostic laboratory testing during a public 

15 health emergency, and improve coordina16 tion and collaboration with State, local, 

17 Tribal, and territorial public health offi18 cials, clinical laboratories (including com19 mercial, hospital and academic labora20 tories), and other entities with expertise in 

21 public health surveillance.’’; and 

22 (ii) by redesignating subparagraph 

23 (B) as subparagraph (C); and 

24 (iii) by inserting after subparagraph 

25 (A), the following: 


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1 ‘‘(B) REPORTS.— 

2 ‘‘(i) IN GENERAL.—Not later than 1 

3 month after date of enactment of the Com4 mitment to Defeat the Virus and Keep 

5 America Healthy Act, and as provided for 

6 in clause (ii), the Secretary shall submit to 

7 the Committee on Health, Education, 

8 Labor, and Pensions of the Senate and the 

9 Committee on Energy and Commerce of 

10 the House of Representatives, a report on 

11 the status of the Department of Health 

12 and Human Services’ biosurveillance mod13 ernization and assessment progress with 

14 respect to emerging infectious disease 

15 threats. 

16 ‘‘(ii) ADDITIONAL REPORTS.—During 

17 the 2-year period beginning on the date of 

18 enactment of the Commitment to Defeat 

19 the Virus and Keep America Healthy Act, 

20 the Secretary shall provide additional re21 ports under clause (i) every 90 days after 

22 the submission of the initial report under 

23 such clause. The Secretary shall provide 

24 such reports annually thereafter. The Sec25 retary may provide such additional reports 


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1 less frequently, but not less frequently 

2 than every 180 days, during an ongoing 

3 public health emergency or another signifi4 cant infectious disease outbreak.’’; 

5 (2) in subsection (d)— 

6 (A) in paragraph (2)(C), by inserting ‘‘, in7 cluding any public-private partnerships entered 

8 into to improve such capacity’’ before the semi9 colon; and 

10 (B) in paragraph (3)— 

11 (i) in subparagraph (B), by striking 

12 ‘‘and’’ at the end; 

13 (ii) in subparagraph (C), by striking 

14 the period and inserting ‘‘; and’’; and 

15 (iii) by adding at the end the fol16 lowing: 

17 ‘‘(D) may establish, enhance, or maintain 

18 a system or network for the collection of data 

19 to provide for early detection of infectious dis20 ease outbreaks, near real-time access to rel21 evant electronic data and integration of elec22 tronic data and information from public health 

23 and other appropriate sources, such as labora24 tories, hospitals, and epidemiology systems, to 

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1 curate diagnostic laboratory tests to provide for 

2 disease detection.’’; 

3 (3) in subsection (f)(1)(A), by inserting ‘‘pa4 thologists, clinical microbiologists, laboratory profes5 sionals, epidemiologists,’’ after ‘‘forecasting),’’; and 

6 (4) in subsection (h), by adding at the end the 

7 following: ‘‘Such evaluation shall include identifica8 tion of any gaps in biosurveillance and situational 

9 awareness capabilities identified related to recent 

10 public health emergencies, any immediate steps 

11 taken to address such gaps, and any long-term plans 

12 to address such gaps, including steps related to ac13 tivities authorized under this section.’’. 

14 (b) NATIONAL HEALTH SECURITY STRATEGY.—Sec15 tion 2802(b)(2) of the Public Health Service Act (42 

16 U.S.C. 300hh–1(b)(2)) is amended— 

17 (1) in subparagraph (A), by inserting ‘‘such as 

18 by integrating laboratory and epidemiology systems 

19 and capability to conduct rapid and accurate labora20 tory tests,’’ after ‘‘detection, identification,’’; and 

21 (2) in subparagraph (B), by inserting ‘‘labora22 tory testing,’’ after ‘‘services and supplies,’’. 

23 (c) EPIDEMIOLOGY-LABORATORY CAPACITY

24 GRANTS.—Section 2821(a) of the Public Health Service 

25 Act (42 U.S.C. 300hh–31(a)) is amended— 


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1 (1) in paragraph (3), by striking ‘‘and’’; 

2 (2) in paragraph (4), by striking the period and 

3 inserting ‘‘; and’’; and 

4 (3) by adding at the end the following: 

5 ‘‘(5) supporting activities of State and local 

6 public health departments related to biosurveillance 

7 and disease detection, which may include activities 

8 related to section 319D, as appropriate.’’. 

9 Subtitle C—Diagnostic Testing for 

10 Public Health Labs 

11 SEC. 4021. GRANTS FOR PUBLIC HEALTH LABORATORIES 

12 TO ACQUIRE HIGH-THROUGHPUT DIAG13 NOSTIC EQUIPMENT. 

14 Section 2821 of the Public Health Service Act (42 

15 U.S.C. 300hh–31) is amended— 

16 (1) by redesignating subsection (b) as sub17 section (c); 

18 (2) by inserting after subsection (a) the fol19 lowing new subsection: 

20 ‘‘(b) GRANTS FOR PUBLIC HEALTH LABORATORIES

21 TO ACQUIRE HIGH-THROUGHPUT DIAGNOSTIC EQUIP22 MENT.— 

23 ‘‘(1) GRANTS.—The Secretary shall award 

24 grants to eligible entities to assist such entities in 

25 purchasing high-throughput diagnostic equipment 


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1 and related supplies and in hiring and training staff 

2 to use such equipment. 

3 ‘‘(2) ELIGIBILITY.—To be eligible for a grant 

4 under paragraph (1), an entity shall— 

5 ‘‘(A) be— 

6 ‘‘(i) a State, local, or Tribal public 

7 health laboratory; 

8 ‘‘(ii) a laboratory within a public 

9 health laboratory network coordinated or 

10 managed by the Centers for Disease Con11 trol and Prevention; 

12 ‘‘(iii) a laboratory not described in 

13 clause (i) or (ii) that the Secretary deter14 mines (at the Secretary’s discretion) pro15 vides population-based testing for the pre16 vention and control of infectious, commu17 nicable, genetic, or chronic diseases; or 

18 ‘‘(iv) a consortium of 2 or more enti19 ties described in any of clauses (i) through 

20 (iii); and 

21 ‘‘(B) submit to the Secretary an applica22 tion at such time, in such manner, and con23 taining such information as the Secretary may 

24 reasonably require. 


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1 ‘‘(3) USE OF FUNDS.—Amounts received 

2 through a grant under this subsection shall be 

3 used— 

4 ‘‘(A) to purchase high-throughput diag5 nostic equipment and such materials as are nec6 essary to administer, store, and process applica7 ble tests, including diagnostic and serological 

8 tests; and 

9 ‘‘(B) to hire and train staff to use such 

10 equipment. 

11 ‘‘(4) AMOUNT OF GRANT.—The amount of a 

12 grant under paragraph (1) may not exceed 

13 $2,000,000, except in the case of eligible entity de14 scribed in paragraph (2)(A)(iv). 

15 ‘‘(5) HIGH-THROUGHPUT DIAGNOSTIC EQUIP16 MENT DEFINED.—In this subsection, the term ‘high17 throughput diagnostic equipment’ means legally 

18 marketed equipment and supplies capable of per19 forming multichannel analysis for use in clinical lab20 oratory diagnostic testing.’’; and 

21 (3) in subsection (c), as so redesignated— 

22 (A) by redesignating paragraphs (1), (2), 

23 and (3) as subparagraphs (A), (B), and (C), re24 spectively, and moving the margin of each such 

25 redesignated subparagraph 2 ems to the right; 


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1 (B) by striking ‘‘There are authorized to 

2 be appropriated to carry out this section’’ and 

3 inserting the following: 

4 ‘‘(1) IN GENERAL.—There are authorized to be 

5 appropriated to carry out subsection (a)’’; and 

6 (C) by adding at the end the following new 

7 paragraph: 

8 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

9 ‘‘(A) IN GENERAL.—For the purpose of 

10 carrying out subsection (b), there is authorized 

11 to be appropriated $250,000,000 for fiscal year 

12 2021, to remain available until expended. 

13 ‘‘(B) ADMINISTRATIVE EXPENSES.—Of the 

14 amount made available to carry out subsection 

15 (b) for any fiscal year, the Secretary may not 

16 use more than 5 percent of such amount for the 

17 expenses of administering subsection (b).’’. 

18 Subtitle D—Rapid Testing for 

19 Communities 

20 SEC. 4031. GRANTS FOR SAME-DAY POINT-OF-CARE CLIN21 ICAL LABORATORY DIAGNOSTIC TESTING IN 

22 COMMUNITIES. 

23 Section 2821 of the Public Health Service Act (42 

24 U.S.C. 300hh–31) is amended— 


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1 (1) by redesignating subsection (c), as redesig2 nated by section 4021, as subsection (d); 

3 (2) by inserting after subsection (b), as added 

4 by section 4021, the following new subsection: 

5 ‘‘(c) GRANTS FOR SAME-DAY POINT-OF-CARE CLIN6 ICAL LABORATORY DIAGNOSTIC TESTING IN COMMU7 NITIES.— 

8 ‘‘(1) GRANTS.—The Secretary shall award 

9 grants to eligible entities to assist such entities in 

10 acquiring legally marketed equipment and supplies 

11 capable of performing same-day clinical laboratory 

12 diagnostic testing in a point-of-care setting. 

13 ‘‘(2) ELIGIBILITY.—To be eligible for a grant 

14 under paragraph (1), an entity shall— 

15 ‘‘(A) be— 

16 ‘‘(i) a hospital; 

17 ‘‘(ii) a primary care facility; 

18 ‘‘(iii) a clinic; 

19 ‘‘(iv) a physician; or 

20 ‘‘(v) another type of health care pro21 vider as the Secretary may define; and 

22 ‘‘(B) submit to the Secretary an applica23 tion at such time, in such manner, and con24 taining such information as the Secretary may 

25 reasonably require. 


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1 ‘‘(3) USE OF FUNDS.—Amounts received 

2 through a grant under this subsection shall be used 

3 to purchase legally marketed rapid diagnostic equip4 ment and such materials as are necessary to admin5 ister, store, and process same-day clinical laboratory 

6 diagnostic testing in a point-of-care setting, includ7 ing diagnostic and serological tests. 

8 ‘‘(4) AMOUNT OF GRANT.—The amount of a 

9 grant under paragraph (1) may not exceed $20,000. 

10 ‘‘(5) PRIORITY IN MAKING AWARDS.—In award11 ing grants under paragraph (1), the Secretary shall 

12 give priority to eligible entities providing services 

13 to— 

14 ‘‘(A) medically underserved populations (as 

15 defined in section 330(b)(3)) in rural areas; and 

16 ‘‘(B) all other areas.’’; and 

17 (3) by adding at the end of subsection (d), as 

18 redesignated, the following new paragraph: 

19 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

20 ‘‘(A) IN GENERAL.—For the purpose of 

21 carrying out subsection (c), there is authorized 

22 to be appropriated $500,000,000 for fiscal year 

23 2021, to remain available until expended. 

24 ‘‘(B) ADMINISTRATIVE EXPENSES.—Of the 

25 amount made available to carry out subsection 


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1 (c) for any fiscal year, the Secretary may not 

2 use more than 5 percent of such amount for the 

3 expenses of administering this section.’’. 

4 Subtitle E—Public Health 

5 Workforce Loan Repayment 

6 SEC. 4041. PUBLIC HEALTH WORKFORCE LOAN REPAY7 MENT PROGRAM. 

8 Part D of title III of the Public Health Service Act 

9 (42 U.S.C. 254b et seq.), as amended by section 2031, 

10 is further amended by adding at the end the following new 

11 subpart: 

12 ‘‘Subpart XIV—Public Health Workforce 

13 ‘‘SEC. 340K. LOAN REPAYMENT PROGRAM. 

14 ‘‘(a) ESTABLISHMENT.—The Secretary of Health 

15 and Human Services shall establish a program to be 

16 known as the Public Health Workforce Loan Repayment 

17 Program (referred to in this section as the ‘Program’) to 

18 assure an adequate supply of and encourage recruitment 

19 of public health professionals to eliminate critical public 

20 health workforce shortages in local, State, and Tribal pub21 lic health agencies. 

22 ‘‘(b) ELIGIBILITY.—To be eligible to participate in 

23 the Program, an individual shall— 

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1 cational institution in a State or territory in the 

2 final year of a course of study or program leading 

3 to a public health or health professions degree or 

4 certificate and have accepted employment with a 

5 local, State, or Tribal public health agency, or a re6 lated training fellowship, as recognized by the Sec7 retary, to commence upon graduation; or 

8 ‘‘(B)(i) have graduated, during the preceding 

9 10-year period, from an accredited educational insti10 tution in a State or territory and received a public 

11 health or health professions degree or certificate; 

12 and 

13 ‘‘(ii) be employed by, or have accepted employ14 ment with, a local, State, or Tribal public health 

15 agency or a related training fellowship, as recognized 

16 by the Secretary; 

17 ‘‘(2) be a United States citizen; 

18 ‘‘(3)(A) submit an application to the Secretary 

19 to participate in the Program; and 

20 ‘‘(B) execute a written contract as required in 

21 subsection (c); and 

22 ‘‘(4) not have received, for the same service, a 

23 reduction of loan obligations under section 428J, 

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1 cation Act of 1965 (20 U.S.C. 1078–10, 1078–11, 

2 1078–12, 1087e(m), and 1087j). 

3 ‘‘(c) CONTRACT.—The written contract referred to in 

4 subsection (b)(3)(B) between the Secretary and an indi5 vidual shall contain— 

6 ‘‘(1) an agreement on the part of the Secretary 

7 that the Secretary will repay, on behalf of the indi8 vidual, loans incurred by the individual in the pur9 suit of the relevant degree or certificate in accord10 ance with the terms of the contract; 

11 ‘‘(2) an agreement on the part of the individual 

12 that the individual will serve in the full-time employ13 ment of a local, State, or Tribal public health agency 

14 or a related fellowship program in a position related 

15 to the course of study or program for which the con16 tract was awarded for a period of time equal to the 

17 greater of— 

18 ‘‘(A) 3 years; or 

19 ‘‘(B) such longer period of time as deter20 mined appropriate by the Secretary and the in21 dividual; 

22 ‘‘(3) an agreement, as appropriate, on the part 

23 of the individual to relocate to a priority service area 

24 (as determined by the Secretary) in exchange for an 


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1 additional loan repayment incentive amount to be 

2 determined by the Secretary; 

3 ‘‘(4) a provision that any financial obligation of 

4 the United States arising out of a contract entered 

5 into under this section and any obligation of the in6 dividual that is conditioned thereon, is contingent on 

7 funds being appropriated for loan repayments under 

8 this section; 

9 ‘‘(5) a statement of the damages to which the 

10 United States is entitled, under this section for the 

11 individual’s breach of the contract; and 

12 ‘‘(6) such other statements of the rights and li13 abilities of the Secretary and of the individual as the 

14 Secretary determines appropriate, not inconsistent 

15 with this section. 

16 ‘‘(d) PAYMENTS.— 

17 ‘‘(1) IN GENERAL.—A loan repayment provided 

18 for an individual under a written contract referred 

19 to in subsection (b)(3)(B) shall consist of payment, 

20 in accordance with paragraph (2), on behalf of the 

21 individual of the principal, interest, and related ex22 penses on government and commercial loans received 

23 by the individual regarding the undergraduate or 

24 graduate education of the individual (or both), which 


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1 loans were made for tuition expenses incurred by the 

2 individual. 

3 ‘‘(2) PAYMENTS FOR YEARS SERVED.—For 

4 each year of service that an individual contracts to 

5 serve pursuant to subsection (c)(2), the Secretary 

6 may pay not more than $35,000 on behalf of the in7 dividual for loans described in paragraph (1). With 

8 respect to participants under the Program whose 

9 total eligible loans are less than $105,000, the Secretary shall pay an amount that does not exceed 1 10 ⁄3

11 of the eligible loan balance for each year of such 

12 service of such individual. 

13 ‘‘(3) TAX LIABILITY.—For the purpose of pro14 viding reimbursements for tax liability resulting 

15 from payments under paragraph (2) on behalf of an 

16 individual, the Secretary shall, in addition to such 

17 payments, make payments to the individual in an 

18 amount not to exceed 39 percent of the total amount 

19 of loan repayments made for the taxable year in20 volved. 

21 ‘‘(e) POSTPONING OBLIGATED SERVICE.—With re22 spect to an individual receiving a degree or certificate from 

23 a health professions or other related school, the date of 

24 the initiation of the period of obligated service may be 

25 postponed as approved by the Secretary. 


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1 ‘‘(f) BREACH OF CONTRACT.—An individual who fails 

2 to comply with the contract entered into under subsection 

3 (c) shall be subject to the same financial penalties as pro4 vided for under section 338E of the Public Health Service 

5 Act (42 U.S.C. 254o) for breaches of loan repayment con6 tracts under section 338B of such Act (42 U.S.C. section 

7 254l–1). 

8 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

9 is authorized to be appropriated to carry out this section— 

10 ‘‘(1) $100,000,000 for fiscal year 2021; and 

11 ‘‘(2) $75,000,000 for each of fiscal years 2022 

12 through 2026.’’. 

13 Subtitle F—Vaccine Awareness and 

14 Disease Prevention 

15 SEC. 4051. IMPROVING AWARENESS OF DISEASE PREVEN16 TION. 

17 (a) IN GENERAL.—The Public Health Service Act is 

18 amended by striking section 313 of such Act (42 U.S.C. 

19 245) and inserting the following: 

20 ‘‘SEC. 313. PUBLIC AWARENESS CAMPAIGN ON THE IMPOR21 TANCE OF VACCINATIONS. 

22 ‘‘(a) IN GENERAL.—The Secretary, acting through 

23 the Director of the Centers for Disease Control and Pre24 vention and in coordination with other offices and agen25 cies, as appropriate, shall award competitive grants or 


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1 contracts to one or more public or private entities to carry 

2 out a national, evidence-based campaign to increase 

3 awareness and knowledge of the safety and effectiveness 

4 of vaccines for the prevention and control of diseases, com5 bat misinformation about vaccines, and disseminate sci6 entific and evidence-based vaccine-related information, 

7 with the goal of increasing rates of vaccination across all 

8 ages, as applicable, particularly in communities with low 

9 rates of vaccination, to reduce and eliminate vaccine-pre10 ventable diseases. 

11 ‘‘(b) CONSULTATION.—In carrying out the campaign 

12 under this section, the Secretary shall consult with appro13 priate public health and medical experts, including the Na14 tional Academy of Medicine and medical and public health 

15 associations and nonprofit organizations, in the develop16 ment, implementation, and evaluation of the evidence17 based public awareness campaign. 

18 ‘‘(c) REQUIREMENTS.—The campaign under this sec19 tion shall— 

20 ‘‘(1) be a nationwide, evidence-based media and 

21 public engagement initiative; 

22 ‘‘(2) include the development of resources for 

23 communities with low rates of vaccination, including 

24 culturally and linguistically appropriate resources, as 

25 applicable; 


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1 ‘‘(3) include the dissemination of vaccine infor2 mation and communication resources to public 

3 health departments, health care providers, and 

4 health care facilities, including such providers and 

5 facilities that provide prenatal and pediatric care; 

6 ‘‘(4) be complementary to, and coordinated 

7 with, any other Federal, State, local, or Tribal ef8 forts, as appropriate; and 

9 ‘‘(5) assess the effectiveness of communication 

10 strategies to increase rates of vaccination. 

11 ‘‘(d) ADDITIONAL ACTIVITIES.—The campaign under 

12 this section may— 

13 ‘‘(1) include the use of television, radio, the 

14 internet, and other media and telecommunications 

15 technologies; 

16 ‘‘(2) include the use of in-person activities; 

17 ‘‘(3) be focused to address specific needs of 

18 communities and populations with low rates of vac19 cination; and 

20 ‘‘(4) include the dissemination of scientific and 

21 evidence-based vaccine-related information, such 

22 as— 

23 ‘‘(A) advancements in evidence-based re24 search related to diseases that may be pre25 vented by vaccines and vaccine development; 


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1 ‘‘(B) information on vaccinations for indi2 viduals and communities, including individuals 

3 for whom vaccines are not recommended by the 

4 Advisory Committee for Immunization Prac5 tices, and the effects of low vaccination rates 

6 within a community on such individuals; 

7 ‘‘(C) information on diseases that may be 

8 prevented by vaccines; and 

9 ‘‘(D) information on vaccine safety and the 

10 systems in place to monitor vaccine safety. 

11 ‘‘(e) EVALUATION.—The Secretary shall— 

12 ‘‘(1) establish benchmarks and metrics to quan13 titatively measure and evaluate the awareness cam14 paign under this section; 

15 ‘‘(2) conduct qualitative assessments regarding 

16 the awareness campaign under this section; and 

17 ‘‘(3) prepare and submit to the Committee on 

18 Health, Education, Labor, and Pensions of the Sen19 ate and Committee on Energy and Commerce of the 

20 House of Representatives an evaluation of the 

21 awareness campaign under this section. 

22 ‘‘(f) SUPPLEMENT NOT SUPPLANT.—Funds appro23 priated under this section shall be used to supplement and 

24 not supplant other Federal, State, and local public funds 

25 provided for activities described in this section. 


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1 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

2 are authorized to be appropriated to carry out this section 

3 and subsections (k) and (n) of section 317 $10,000,000 

4 for each of fiscal years 2021 through 2025.’’. 

5 (b) GRANTS TO ADDRESS VACCINE-PREVENTABLE

6 DISEASES.—Section 317 of the Public Health Service Act 

7 (42 U.S.C. 247b) is amended— 

8 (1) in subsection (k)(1)— 

9 (A) in subparagraph (C), by striking ‘‘; 

10 and’’ and inserting a semicolon; 

11 (B) in subparagraph (D), by striking the 

12 period and inserting a semicolon; and 

13 (C) by adding at the end the following: 

14 ‘‘(E) planning, implementation, and eval15 uation of activities to address vaccine-prevent16 able diseases, including activities to— 

17 ‘‘(i) identify communities at high risk 

18 of outbreaks related to vaccine-preventable 

19 diseases, including through improved data 

20 collection and analysis; 

21 ‘‘(ii) pilot innovative approaches to 

22 improve vaccination rates in communities 

23 and among populations with low rates of 

24 vaccination; 


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1 ‘‘(iii) reduce barriers to accessing vac2 cines and evidence-based information about 

3 the health effects of vaccines; 

4 ‘‘(iv) partner with community organi5 zations and health care providers to de6 velop and deliver evidence-based interven7 tions, including culturally and linguistically 

8 appropriate interventions, to increase vac9 cination rates; 

10 ‘‘(v) improve delivery of evidence11 based, vaccine-related information to par12 ents and others; and 

13 ‘‘(vi) improve the ability of State, 

14 local, Tribal, and territorial public health 

15 departments to engage communities at 

16 high risk for outbreaks related to vaccine17 preventable diseases, in coordination, as 

18 appropriate, with local educational agen19 cies, as defined in section 8101 of the Ele20 mentary and Secondary Education Act of 

21 1965; and 

22 ‘‘(F) research related to strategies for im23 proving awareness of scientific and evidence24 based, vaccine-related information, including for 

25 communities with low rates of vaccination, in 


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1 order to understand barriers to vaccination, im2 prove vaccination rates, and assess the public 

3 health outcomes of such strategies.’’; and 

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

5 ‘‘(n) VACCINATION DATA.—The Secretary, acting 

6 through the Director of the Centers for Disease Control 

7 and Prevention, shall expand and enhance, and, as appro8 priate, establish and improve, programs and conduct ac9 tivities to collect, monitor, and analyze vaccination cov10 erage data to assess levels of protection from vaccine-pre11 ventable diseases, including by assessing factors contrib12 uting to underutilization of vaccines and variations of such 

13 factors, and identifying communities at high risk of out14 breaks associated with vaccine-preventable diseases.’’. 

15 (c) SUPPLEMENTAL GRANT FUNDS.—Section 

16 330(d)(1) of the Public Health Service Act (42 U.S.C. 

17 254b) is amended— 

18 (1) in subparagraph (F), by striking ‘‘and’’ at 

19 the end; 

20 (2) in subparagraph (G), by striking the period 

21 and inserting ‘‘; and’’; and 

22 (3) by adding at the end the following: 

23 ‘‘(H) improving access to recommended 

24 immunizations.’’. 


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1 (d) UPDATE OF 2015 NVAC REPORT.—The National 

2 Vaccine Advisory Committee established under section 

3 2105 of the Public Health Service Act (42 U.S.C. 300aa– 

4 5) shall, as appropriate, update the report entitled, ‘‘As5 sessing the State of Vaccine Confidence in the United 

6 States: Recommendations from the National Vaccine Advi7 sory Committee’’, approved by the National Vaccine Advi8 sory Committee on June 10, 2015, with respect to factors 

9 affecting childhood vaccination. 

10 Subtitle G—Protecting the Health 

11 of America’s Older Adults Dur12 ing COVID–19 & Beyond 

13 SEC. 4061. NATIONAL COVID–19 RESOURCE CENTER FOR 

14 OLDER ADULTS. 

15 (a) IN GENERAL.—The Secretary of Health and 

16 Human Services (in this subtitle referred to as the ‘‘Sec17 retary’’) shall establish within the Office of the Assistant 

18 Secretary for Health a National COVID–19 Resource 

19 Center for Older Adults (in this section referred to as the 

20 ‘‘Center’’) to identify, curate, and disseminate, promising 

21 and proven practices and tools for the care of older adults 

22 in their homes, community-based care settings, hospitals, 

23 and nursing and acute care facilities. 

24 (b) INVOLVEMENT BY FEDERAL DEPARTMENTS AND

25 ALL LEVELS OF GOVERNMENT.—The Center shall— 


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1 (1) be advised by a team of senior officials 

2 from— 

3 (A) agencies across the Department of 

4 Health and Human Services, including the Ad5 ministration for Community Living (including 

6 the Administration on Aging), the Centers for 

7 Disease Control and Prevention, the Centers for 

8 Medicare & Medicaid Services, the Health Re9 sources and Services Administration, the Indian 

10 Health Service, and the Office of Minority 

11 Health in the Office of the Secretary; and 

12 (B) other Federal departments, including 

13 the Department of Housing and Urban Devel14 opment and the Department of Veterans Af15 fairs; and 

16 (2) collaborate with State and local govern17 ments, Indian tribes and Tribal organizations, and 

18 nonprofit organizations. 

19 (c) ACTIVITIES.—The Center shall perform the fol20 lowing activities: 

21 (1) Develop a set of best practices for older 

22 adult health and well-being during and beyond the 

23 period of the COVID–19 pandemic, including such 

24 best practices with respect to the following focus 

25 areas: 


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1 (A) Providing specialized services to over2 come the risks associated with social isolation, 

3 such as additional resources for home-delivered 

4 meals and other nutrition programs to provide 

5 not only food but also face-to-face interactions. 

6 (B) Streamlining and improving access to 

7 screening, testing, and health care services and 

8 resources, and prioritizing venues older adults 

9 can reach. 

10 (C) Expanding the use of telemedicine, in11 cluding the provision of technology to execute 

12 televisits that safely and comprehensively ad13 dress older adults’ health care needs. 

14 (D) Supporting family caregivers, includ15 ing those with additional responsibilities for 

16 homebound individuals. 

17 (E) Reducing disparities among under18 served populations. 

19 (F) Developing cross-sector collaborative 

20 efforts. 

21 (2) Create and disseminate tools, technical as22 sistance, training, and funding to State, local, Trib23 al, and territorial governments to adopt best prac24 tices developed under subparagraphs (E) and (F) of 

25 paragraph (1). 


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1 (3) Establish mechanisms for providing training 

2 and technical assistance to State, local, Tribal, and 

3 territorial governments to ensure that complemen4 tary cross-sector activities are replicated at the 

5 State, local, Tribal, and territorial levels. 

6 (4) Facilitate the development of learning net7 works of practitioners at the hospital, nursing facil8 ity, and community levels to disseminate the best 

9 practices developed under paragraph (1) and ensure 

10 implementation of such best practices to reduce mor11 bidity and mortality of older adults affected by 

12 COVID–19. 

13 (5) Identify and disseminate approaches that 

14 strengthen public health and health care system ca15 pacity to serve older Americans with regard to 

16 health issues during and beyond the COVID–19 

17 pandemic. 

18 SEC. 4062. HEALTHY AGING PROGRAM. 

19 (a) IN GENERAL.—The Secretary, acting through the 

20 Director of the Centers for Disease Control and Preven21 tion, shall establish a Healthy Aging Program for the pur22 pose of promoting the health and well-being of older adults 

23 by— 


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1 (1) improving the coordination of public health 

2 interventions that promote the health and well-being 

3 of older adults; 

4 (2) disseminating and implementing evidence5 based best practices and programs with respect to 

6 promoting the health and well-being of older adults; 

7 and 

8 (3) coordinating multisectoral efforts to pro9 mote the health and well-being of older adults across 

10 governmental and nongovernmental health and re11 lated agencies. 

12 (b) ACTIVITIES.—For the purpose described in sub13 section (a), the Secretary shall design the Healthy Aging 

14 Program to carry out the following activities: 

15 (1) Regularly assess the health-related needs of 

16 older adults and promote policies addressing those 

17 needs through evidence-based public health interven18 tions to promote overall health and well-being among 

19 older adults and reduce health care costs. 

20 (2) Identify disparities in health among vulner21 able populations of older adults. 

22 (3) Identify gaps in existing public health pro23 grams and policies that focus on older adults. 

24 (4) Promote public health partnerships with 

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1 duplication of efforts and increase efficiency by 

2 working collaboratively across sectors. 

3 (5) Work with multisectoral agencies to improve 

4 emergency preparedness plans and activities for vul5 nerable older adult populations. 

6 (6) Coordinate efforts to promote the health of 

7 older adults with the Administration for Community 

8 Living, other Federal departments and agencies, and 

9 nonprofit organizations. 

10 (7) Identify resources and evidence-based pro11 grams available to local and State health depart12 ments, including resources and programs that could 

13 be coordinated across sectors, to address the health 

14 and well-being of older adults. 

15 (c) GRANTS TO HEALTH DEPARTMENTS.—The Sec16 retary, acting through the Director of the Centers for Dis17 ease Control and Prevention, shall award grants or cooper18 ative agreements to eligible health departments to carry 

19 out any of the following activities: 

20 (1) Improving availability of data on the older 

21 adult population, including through data-sharing 

22 with elder affairs agencies. 

23 (2) Linking the health care sector with the 

24 community services sector (including aging services 


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1 and supports) to coordinate and promote commu2 nity-based prevention services. 

3 (3) Ensuring that State and local emergency 

4 preparedness plans and activities address the special 

5 needs of older adults, particularly the most vulner6 able populations. 

7 (4) Training State and local public health per8 sonnel to implement or adapt evidence-based and in9 novative health promotion and disease prevention 

10 programs and policies. 

11 (5) Improving community conditions and ad12 dressing social determinants to promote health and 

13 well-being and foster independence among older 

14 adults, such as efforts to advance age-friendly com15 munities and dementia-friendly communities. 

16 (d) TECHNICAL ASSISTANCE.—The Secretary shall 

17 (directly or through grants, cooperative agreements, or 

18 contracts) provide technical assistance to eligible health 

19 departments in carrying out activities described in sub20 section (c). 

21 (e) EVALUATIONS.—The Secretary shall (directly or 

22 through grants, cooperative agreements, or contracts) pro23 vide for the evaluation of activities carried out under sub24 sections (a), (b), and (c) in order to determine the extent 

25 to which such activities have been effective in carrying out 


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1 the purpose described in subsection (a), including the ef2 fects of such activities on addressing health disparities. 

3 (f) DEFINITION.—In this section, the term ‘‘eligible 

4 health department’’ means a health department of a State, 

5 the District of Columbia, the Commonwealth of Puerto 

6 Rico, the United States Virgin Islands, Guam, American 

7 Samoa, the Commonwealth of the Northern Mariana Is8 lands, a Tribe (as defined in section 4 of the Indian Self9 Determination and Education Assistance Act (25 U.S.C. 

10 5304)), or a large city (as defined by the Director of the 

11 Centers for Disease Control and Prevention for purposes 

12 of this section). 

13 SEC. 4063. AUTHORIZATION OF APPROPRIATIONS. 

14 There is authorized to be appropriated— 

15 (1) $10,000,000 for the period of fiscal years 

16 2021 through 2025 to carry out section 4061, to re17 main available until September 30, 2025; and 

18 (2) $20,000,000 for each of fiscal years 2021 

19 through 2025 to carry out section 4062, including 

20 for grants under section 4062(c), to remain available 

21 until September 30, 2025. 


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1 Subtitle H—Expanding Capacity 

2 for Health Outcomes 

3 SEC. 4071. EXPANDING CAPACITY FOR HEALTH OUTCOMES. 

4 Title III of the Public Health Service Act is amended 

5 by inserting after section 330M (42 U.S.C. 254c–19) the 

6 following: 

7 ‘‘SEC. 330N. EXPANDING CAPACITY FOR HEALTH OUT8 COMES. 

9 ‘‘(a) DEFINITIONS.—In this section: 

10 ‘‘(1) ELIGIBLE ENTITY.—The term ‘eligible en11 tity’— 

12 ‘‘(A) means an entity that provides, or 

13 supports the provision of, health care services— 

14 ‘‘(i) in rural areas, frontier areas, 

15 health professional shortage areas, or 

16 medically underserved areas; or 

17 ‘‘(ii) to medically underserved popu18 lations or Native Americans, including In19 dian Tribes, Tribal organizations, or urban 

20 Indian organizations; and 

21 ‘‘(B) may include entities leading, or capa22 ble of leading, a technology-enabled collabo23 rative learning and capacity building model or 

24 engaging in technology-enabled collaborative 

25 training of participants in such model. 


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1 ‘‘(2) HEALTH PROFESSIONAL SHORTAGE

2 AREA.—The term ‘health professional shortage area’ 

3 means a health professional shortage area des4 ignated under section 332. 

5 ‘‘(3) INDIAN TRIBE.—The terms ‘Indian Tribe’ 

6 and ‘Tribal organization’ have the meanings given 

7 the terms ‘Indian tribe’ and ‘tribal organization’ in 

8 section 4 of the Indian Self-Determination and Edu9 cation Assistance Act. 

10 ‘‘(4) MEDICALLY UNDERSERVED POPU11 LATION.—The term ‘medically underserved popu12 lation’ has the meaning given the term in section 

13 330(b)(3). 

14 ‘‘(5) NATIVE AMERICANS.—The term ‘Native 

15 Americans’ has the meaning given such term in sec16 tion 736 and includes Indian Tribes and Tribal or17 ganizations. 

18 ‘‘(6) TECHNOLOGY-ENABLED COLLABORATIVE

19 LEARNING AND CAPACITY BUILDING MODEL.—The 

20 term ‘technology-enabled collaborative learning and 

21 capacity building model’ means a distance health 

22 education model that connects health care profes23 sionals, and particularly specialists, with multiple 

24 other health care professionals through simultaneous 

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1 cilitating case-based learning, disseminating best 

2 practices, and evaluating outcomes. 

3 ‘‘(7) URBAN INDIAN ORGANIZATION.—The 

4 ‘urban Indian organization’ has the meaning given 

5 the term ‘Urban Indian organization’ in section 4 of 

6 the Indian Health Care Improvement Act. 

7 ‘‘(b) PROGRAM ESTABLISHED.—The Secretary shall, 

8 as appropriate, award grants to evaluate, develop, and, as 

9 appropriate, expand the use of technology-enabled collabo10 rative learning and capacity building models, to improve 

11 retention of health care providers and increase access to 

12 health care services, such as those to address chronic dis13 eases and conditions, infectious diseases, mental health, 

14 substance use disorders, prenatal and maternal health, pe15 diatric care, pain management, palliative care, and other 

16 specialty care in rural areas, frontier areas, health profes17 sional shortage areas, or medically underserved areas and 

18 for medically underserved populations or Native Ameri19 cans, including Indian Tribes and Tribal organizations. 

20 ‘‘(c) USE OF FUNDS.— 

21 ‘‘(1) IN GENERAL.—Grants awarded under sub22 section (b) shall be used for— 

23 ‘‘(A) the development and acquisition of 

24 instructional programming, and the training of 

25 health care providers and other professionals 


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1 that provide or assist in the provision of serv2 ices through models described in subsection (b), 

3 such as training on best practices for data col4 lection and leading or participating in such 

5 technology-enabled activities consistent with 

6 technology-enabled collaborative learning and 

7 capacity building models; 

8 ‘‘(B) information collection and evaluation 

9 activities to study the impact of such models on 

10 patient outcomes and health care providers, and 

11 to identify best practices for the expansion and 

12 use of such models; or 

13 ‘‘(C) other activities consistent with achiev14 ing the objectives of the grants awarded under 

15 this section, as determined by the Secretary. 

16 ‘‘(2) OTHER USES.—In addition to any of the 

17 uses under paragraph (1), grants awarded under 

18 subsection (b) may be used for— 

19 ‘‘(A) equipment to support the use and ex20 pansion of technology-enabled collaborative 

21 learning and capacity building models, including 

22 for hardware and software that enables distance 

23 learning, health care provider support, and the 

24 secure exchange of electronic health informa25 tion; or 


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1 ‘‘(B) support for health care providers and 

2 other professionals that provide or assist in the 

3 provision of services through such models. 

4 ‘‘(d) LENGTH OF GRANTS.—Grants awarded under 

5 subsection (b) shall be for a period of up to 5 years. 

6 ‘‘(e) GRANT REQUIREMENTS.—The Secretary may 

7 require entities awarded a grant under this section to col8 lect information on the effect of the use of technology9 enabled collaborative learning and capacity building mod10 els, such as on health outcomes, access to health care serv11 ices, quality of care, and provider retention in areas and 

12 populations described in subsection (b). The Secretary 

13 may award a grant or contract to assist in the coordina14 tion of such models, including to assess outcomes associ15 ated with the use of such models in grants awarded under 

16 subsection (b), including for the purpose described in sub17 section (c)(1)(B). 

18 ‘‘(f) APPLICATION.—An eligible entity that seeks to 

19 receive a grant under subsection (b) shall submit to the 

20 Secretary an application, at such time, in such manner, 

21 and containing such information as the Secretary may re22 quire. Such application shall include plans to assess the 

23 effect of technology-enabled collaborative learning and ca24 pacity building models on patient outcomes and health 

25 care providers. 


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1 ‘‘(g) ACCESS TO BROADBAND.—In administering 

2 grants under this section, the Secretary may coordinate 

3 with other agencies to ensure that funding opportunities 

4 are available to support access to reliable, high-speed 

5 internet for grantees. 

6 ‘‘(h) TECHNICAL ASSISTANCE.—The Secretary shall 

7 provide (either directly through the Department of Health 

8 and Human Services or by contract) technical assistance 

9 to eligible entities, including recipients of grants under 

10 subsection (b), on the development, use, and evaluation 

11 of technology-enabled collaborative learning and capacity 

12 building models in order to expand access to health care 

13 services provided by such entities, including for medically 

14 underserved areas and to medically underserved popu15 lations or Native Americans, including Indian Tribes and 

16 Tribal organizations. 

17 ‘‘(i) RESEARCH AND EVALUATION.—The Secretary, 

18 in consultation with stakeholders with appropriate exper19 tise in such models, shall develop a strategic plan to re20 search and evaluate the evidence for such models. The 

21 Secretary shall use such plan to inform the activities car22 ried out under this section. 

23 ‘‘(j) REPORT BY SECRETARY.—Not later than 4 

24 years after the date of enactment of this section, the Sec25 retary shall prepare and submit to the Committee on 


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1 Health, Education, Labor, and Pensions of the Senate and 

2 the Committee on Energy and Commerce of the House 

3 of Representatives, and post on the internet website of the 

4 Department of Health and Human Services, a report in5 cluding, at minimum— 

6 ‘‘(1) a description of any new and continuing 

7 grants awarded to entities under subsection (b) and 

8 the specific purpose and amounts of such grants; 

9 ‘‘(2) an overview of— 

10 ‘‘(A) the evaluations conducted under sub11 section (b); 

12 ‘‘(B) technical assistance provided under 

13 subsection (h); and 

14 ‘‘(C) activities conducted by entities award15 ed grants under subsection (b); and 

16 ‘‘(3) a description of any significant findings or 

17 developments related to patient outcomes or health 

18 care providers and best practices for eligible entities 

19 expanding, using, or evaluating technology-enabled 

20 collaborative learning and capacity building models, 

21 including through the activities described in sub22 section (h). 

23 ‘‘(k) AUTHORIZATION OF APPROPRIATIONS.—There 

24 is authorized to be appropriated to carry out this section, 

25 $20,000,000 for each of fiscal years 2021 through 2025.’’. 


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1 Subtitle I—Community Readiness 

2 SEC. 4081. GRANTS FOR RESEARCH ON, OR ESTABLISHING, 

3 WASTEWATER SURVEILLANCE AND OTHER 

4 EARLY WARNING SYSTEMS. 

5 Subtitle C of title XXVIII of the Public Health Serv6 ice Act (42 U.S.C. 300hh–31 et seq.) is amended by add7 ing at the end the following: 

8 ‘‘SEC. 2823. GRANTS FOR RESEARCH ON, OR ESTABLISHING, 

9 WASTEWATER SURVEILLANCE AND OTHER 

10 EARLY WARNING SYSTEMS. 

11 ‘‘(a) IN GENERAL.—The Secretary, in consultation 

12 with the Administrator of the Environmental Protection 

13 Agency, may award grants to eligible entities to conduct 

14 research on, or to establish, a wastewater surveillance or 

15 other early warning system through— 

16 ‘‘(1) wastewater testing; 

17 ‘‘(2) temperature tracking to monitor axillary 

18 body temperature; and 

19 ‘‘(3) other methods deemed permissible by the 

20 Secretary and Administrator. 

21 ‘‘(b) PERMISSIBLE USES OF FUNDS.—A grant recipi22 ent under this section may use grant funds to support the 

23 activities described in subsection (a), including by— 


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1 ‘‘(1) paying for data-centric services that can 

2 detect infectious diseases before positive cases or 

3 hospitalizations; 

4 ‘‘(2) entering into contracts with private compa5 nies to implement early warning detection methods; 

6 or 

7 ‘‘(3) funding research to study early warning 

8 detection methods. 

9 ‘‘(c) PRIORITY.—In selecting grant recipients under 

10 this section, the Secretary shall give priority to eligible en11 tities proposing to conduct research on, or to establish, 

12 wastewater surveillance or other early warning system in 

13 one or more areas that— 

14 ‘‘(1) are (or include one or more areas that are) 

15 a hot spot; or 

16 ‘‘(2) a higher percentage of vulnerable popu17 lations than the national average. 

18 ‘‘(d) FEDERAL PRIVACY REQUIREMENTS.—Nothing 

19 in this section shall be construed to supersede any Federal 

20 privacy or confidentiality requirement, including the regu21 lations promulgated under section 264(c) of the Health 

22 Insurance Portability and Accountability Act of 1996 and 

23 section 543 of this Act. 

24 ‘‘(e) DEFINITIONS.—In this section: 


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1 ‘‘(1) The term ‘Administrator’ means the Ad2 ministrator of the Environmental Protection Agency. 

3 ‘‘(2) The term ‘eligible entity’ means— 

4 ‘‘(A) a State government; 

5 ‘‘(B) a local government; 

6 ‘‘(C) a Tribal government; 

7 ‘‘(D) an entity that conducts health re8 search; and 

9 ‘‘(E) an academic institution. 

10 ‘‘(3) The term ‘emergency period’ has the 

11 meaning given to that term in section 1135(g)(1)(B) 

12 of the Social Security Act. 

13 ‘‘(4) The term ‘hot spot’ means a geographic 

14 area where the rate of infection with a particular 

15 pathogen exceeds the national average. 

16 ‘‘(5) The term ‘local government’ means a 

17 county, municipality, town, township, village, parish, 

18 borough, or other unit of general local government. 

19 ‘‘(6) The term ‘Secretary’ means the Secretary 

20 of Health and Human Services. 

21 ‘‘(7) The term ‘State’ means each of the several 

22 States, the District of Columbia, the Commonwealth 

23 of Puerto Rico, American Samoa, Guam, the Com24 monwealth of the Northern Mariana Islands, the 


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1 Virgin Islands, and the Trust Territory of the Pa2 cific Islands. 

3 ‘‘(8) The term ‘vulnerable population’ means 

4 people at increased risk of severe illness. 

5 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To 

6 carry out this section, there are authorized to be appro7 priated $18,000,000 for each of fiscal years 2021 through 

8 2025.’’. 

9 TITLE V—ADDRESSING COVID–19 

10 HEALTH DISPARITIES 

11 Subtitle A—Tribal Health Data 

12 Improvement 

13 SEC. 5001. COLLECTION AND AVAILABILITY OF HEALTH 

14 DATA WITH RESPECT TO INDIAN TRIBES. 

15 (a) DATA COLLECTION.—Section 3101(a)(1) of the 

16 Public Health Service Act (42 U.S.C. 300kk(a)(1)) is 

17 amended— 

18 (1) by striking ‘‘, by not later than 2 years 

19 after the date of enactment of this title,’’; and 

20 (2) in subparagraph (B), by inserting ‘‘Tribal,’’ 

21 after ‘‘State,’’. 

22 (b) DATA REPORTING AND DISSEMINATION.—Sec23 tion 3101(c) of the Public Health Service Act (42 U.S.C. 

24 300kk(c)) is amended— 


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1 (1) by amending subparagraph (F) of para2 graph (1) to read as follows: 

3 ‘‘(F) the Indian Health Service, Indian 

4 Tribes, Tribal organizations, and epidemiology 

5 centers authorized under the Indian Health 

6 Care Improvement Act;’’; and 

7 (2) in paragraph (3), by inserting ‘‘Indian 

8 Tribes, Tribal organizations, and epidemiology cen9 ters,’’ after ‘‘Federal agencies,’’. 

10 (c) PROTECTION AND SHARING OF DATA.—Section 

11 3101(e) of the Public Health Service Act (42 U.S.C. 

12 300kk(e)) is amended by adding at the end the following 

13 new paragraphs: 

14 ‘‘(3) DATA SHARING STRATEGY.—With respect 

15 to data access for Tribal epidemiology centers and 

16 Tribes, the Secretary shall create a data sharing 

17 strategy that takes into consideration recommenda18 tions by the Secretary’s Tribal Advisory Committee 

19 for— 

20 ‘‘(A) ensuring that Tribal epidemiology 

21 centers and Indian Tribes have access to the 

22 data sources necessary to accomplish their pub23 lic health responsibilities; and 

24 ‘‘(B) protecting the privacy and security of 

25 such data. 


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1 ‘‘(4) TRIBAL PUBLIC HEALTH AUTHORITY.— 

2 ‘‘(A) AVAILABILITY.—Beginning not later 

3 than 180 days after the date of the enactment 

4 of the Commitment to Defeat the Virus and 

5 Keep America Healthy Act, the Secretary shall 

6 make available to the entities listed in subpara7 graph (B) all data that is collected pursuant to 

8 this title with respect to health care and public 

9 health surveillance programs and activities, in10 cluding such programs and activities that are 

11 federally supported or conducted, so long as— 

12 ‘‘(i) such entities request the data 

13 pursuant to statute; and 

14 ‘‘(ii) the data is requested for use— 

15 ‘‘(I) consistent with Federal law 

16 and obligations; and 

17 ‘‘(II) to satisfy a particular pur18 pose or carry out a specific function 

19 consistent with the purpose for which 

20 the data was collected. 

21 ‘‘(B) ENTITIES.—The entities listed in this 

22 subparagraph are— 

23 ‘‘(i) the Indian Health Service; 

24 ‘‘(ii) Indian Tribes and Tribal organi25 zations; and 


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1 ‘‘(iii) epidemiology centers.’’. 

2 (d) TECHNICAL UPDATES.—Section 3101 of the 

3 Public Health Service Act (42 U.S.C. 300kk) is amend4 ed— 

5 (1) by striking subsections (g) and (h); and 

6 (2) by redesignating subsection (i) as subsection 

7 (h). 

8 (e) DEFINITIONS.—After executing the amendments 

9 made by subsection (d), section 3101 of the Public Health 

10 Service Act (42 U.S.C. 300kk) is amended by inserting 

11 after subsection (f) the following new subsection: 

12 ‘‘(g) DEFINITIONS.—In this section: 

13 ‘‘(1) The term ‘epidemiology center’ means an 

14 epidemiology center established under section 214 of 

15 the Indian Health Care Improvement Act, including 

16 such Tribal epidemiology centers serving Indian 

17 Tribes regionally and any Tribal epidemiology center 

18 serving Urban Indian organizations nationally. 

19 ‘‘(2) The term ‘Indian Tribe’ has the meaning 

20 given to the term ‘Indian tribe’ in section 4 of the 

21 Indian Self-Determination and Education Assistance 

22 Act. 

23 ‘‘(3) The term ‘Tribal organization’ has the 

24 meaning given to the term ‘tribal organization’ in 


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1 section 4 of the of the Indian Self-Determination 

2 and Education Assistance Act. 

3 ‘‘(4) The term ‘Urban Indian organization’ has 

4 the meaning given to that term in section 4 of the 

5 Indian Health Care Improvement Act.’’. 

6 (f) TECHNICAL CORRECTION.—Section 3101(b) of 

7 the Public Health Service Act (42 U.S.C. 300kk(b)) is 

8 amended by striking ‘‘DATA ANALYSIS.—’’ and all that 

9 follows through ‘‘For each federally’’ and inserting ‘‘DATA

10 ANALYSIS.—For each federally’’. 

11 SEC. 5002. IMPROVING HEALTH STATISTICS REPORTING 

12 WITH RESPECT TO INDIAN TRIBES. 

13 (a) TECHNICAL AID TO STATES AND LOCALITIES.— 

14 Section 306(d) of the Public Health Service Act (42 

15 U.S.C. 242k(d)) is amended by inserting ‘‘, Indian Tribes, 

16 Tribal organizations, and epidemiology centers’’ after ‘‘ju17 risdictions’’. 

18 (b) COOPERATIVE HEALTH STATISTICS SYSTEM.— 

19 Section 306(e)(3) of the Public Health Service Act (42 

20 U.S.C. 242k(e)(3)) is amended by inserting ‘‘, Indian 

21 Tribes, Tribal organizations, and epidemiology centers’’ 

22 after ‘‘health agencies’’. 

23 (c) FEDERAL-STATE-TRIBAL COOPERATION.—Sec24 tion 306(f) of the Public Health Service Act (42 U.S.C. 

25 242k(f)) is amended— 


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1 (1) by inserting ‘‘the Indian Health Service,’’ 

2 before ‘‘the Departments of Commerce’’; 

3 (2) by inserting a comma after ‘‘the Depart4 ments of Commerce and Labor’’; 

5 (3) by inserting ‘‘, Indian Tribes, Tribal organi6 zations, and epidemiology centers’’ after ‘‘State and 

7 local health departments and agencies’’; and 

8 (4) by striking ‘‘he shall’’ and inserting ‘‘the 

9 Secretary shall’’. 

10 (d) REGISTRATION AREA RECORDS.—Section 

11 306(h)(1) of the Public Health Service Act (42 U.S.C. 

12 242k(h)(1)) is amended— 

13 (1) by striking ‘‘in his discretion’’ and inserting 

14 ‘‘in the discretion of the Secretary’’; and 

15 (2) by striking ‘‘Hispanics, Asian Americans, 

16 and Pacific Islanders’’ and inserting ‘‘American In17 dians and Alaska Natives, Hispanics, Asian Ameri18 cans, and Native Hawaiian and other Pacific Island19 ers’’. 

20 (e) NATIONAL COMMITTEE ON VITAL AND HEALTH

21 STATISTICS.—Section 306(k) of the Public Health Service 

22 Act (42 U.S.C. 242k(k)) is amended— 

23 (1) in paragraph (3), by striking ‘‘, not later 

24 than 60 days after the date of the enactment of the 


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1 Health Insurance Portability and Accountability Act 

2 of 1996,’’ each place it appears; and 

3 (2) in paragraph (7), by striking ‘‘Not later 

4 than 1 year after the date of the enactment of the 

5 Health Insurance Portability and Accountability Act 

6 of 1996, and annually thereafter, the Committee 

7 shall’’ and inserting ‘‘The Committee shall, on an bi8 ennial basis,’’. 

9 (f) GRANTS FOR ASSEMBLY AND ANALYSIS OF DATA

10 ON ETHNIC AND RACIAL POPULATIONS.—Section 

11 306(m)(4) of the Public Health Service Act (42 U.S.C. 

12 242k(m)(4)) is amended— 

13 (1) in subparagraph (A)— 

14 (A) by striking ‘‘Subject to subparagraph 

15 (B), the’’ and inserting ‘‘The’’; and 

16 (B) by striking ‘‘and major Hispanic sub17 population groups and American Indians’’ and 

18 inserting ‘‘, major Hispanic subgroups, and 

19 American Indians and Alaska Natives’’; and 

20 (2) by amending subparagraph (B) to read as 

21 follows: 

22 ‘‘(B) In carrying out subparagraph (A), with respect 

23 to American Indians and Alaska Natives, the Secretary 

24 shall— 


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1 ‘‘(i) consult with Indian Tribes, Tribal organi2 zations, the Tribal Technical Advisory Group of the 

3 Centers for Medicare & Medicaid Services main4 tained under section 5006(e) of the American Recov5 ery and Reinvestment Act of 2009, and the Tribal 

6 Advisory Committee established by the Centers for 

7 Disease Control and Prevention, in coordination with 

8 epidemiology centers, to develop guidelines for State 

9 and local health agencies to improve the quality and 

10 accuracy of data with respect to the birth and death 

11 records of American Indians and Alaska Natives; 

12 ‘‘(ii) confer with Urban Indian organizations to 

13 develop guidelines for State and local health agencies 

14 to improve the quality and accuracy of data with re15 spect to the birth and death records of American In16 dians and Alaska Natives; 

17 ‘‘(iii) enter into cooperative agreements with In18 dian Tribes, Tribal organizations, Urban Indian or19 ganizations, and epidemiology centers to address 

20 misclassification and undersampling of American In21 dians and Alaska Natives with respect to— 

22 ‘‘(I) birth and death records; and 

23 ‘‘(II) health care and public health surveil24 lance systems, including, but not limited to, 

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1 eases, unintentional injuries, environmental 

2 health, child and adolescent health, maternal 

3 health and mortality, foodborne and waterborne 

4 illness, reproductive health, and any other 

5 notifiable disease or condition; 

6 ‘‘(iv) encourage States to enter into data shar7 ing agreements with Indian Tribes, Tribal organiza8 tions, and epidemiology centers to improve the qual9 ity and accuracy of public health data; and 

10 ‘‘(v) not later than 180 days after the date of 

11 enactment of the Commitment to Defeat the Virus 

12 and Keep America Healthy Act, and biennially 

13 thereafter, issue a report on the following: 

14 ‘‘(I) Which States have data sharing agree15 ments with Indian Tribes, Tribal organizations, 

16 Urban Indian organizations, and Tribal epide17 miology centers to improve the quality and ac18 curacy of health data. 

19 ‘‘(II) What the Centers for Disease Control 

20 and Prevention is doing to encourage States to 

21 enter into data sharing agreements with Indian 

22 Tribes, Tribal organizations, Urban Indian or23 ganizations, and Tribal epidemiology centers to 

24 improve the quality and accuracy of health 

25 data. 


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1 ‘‘(III) Best practices and guidance for 

2 States, Indian Tribes, Tribal organizations, 

3 Urban Indian organizations, and Tribal epide4 miology centers that wish to enter into data 

5 sharing agreements. 

6 ‘‘(IV) Best practices and guidance for 

7 local, State, Tribal, and Federal uniform stand8 ards for the collection of data on race and eth9 nicity.’’. 

10 (g) DEFINITIONS.—Section 306 of the Public Health 

11 Service Act (42 U.S.C. 242k) is amended— 

12 (1) by redesignating subsection (n) as sub13 section (o); and 

14 (2) by inserting after subsection (m) the fol15 lowing: 

16 ‘‘(n) In this section: 

17 ‘‘(1) The term ‘epidemiology center’ means an 

18 epidemiology center established under section 214 of 

19 the Indian Health Care Improvement Act, including 

20 such Tribal epidemiology centers serving Indian 

21 Tribes regionally and any Tribal epidemiology center 

22 serving Urban Indian organizations nationally. 

23 ‘‘(2) The term ‘Indian Tribe’ has the meaning 

24 given to the term ‘Indian tribe’ in section 4 of the 


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1 Indian Self-Determination and Education Assistance 

2 Act. 

3 ‘‘(3) The term ‘Tribal organization’ has the 

4 meaning given to the term ‘tribal organization’ in 

5 section 4 of the Indian Self-Determination and Edu6 cation Assistance Act. 

7 ‘‘(4) The term ‘Urban Indian organization’ has 

8 the meaning given to that term in section 4 of the 

9 Indian Health Care Improvement Act.’’. 

10 (h) AUTHORIZATION OF APPROPRIATIONS.—Section 

11 306(o) of the Public Health Service Act, as redesignated 

12 by subsection (g), is amended to read as follows: 

13 ‘‘(o)(1) To carry out this section, there is authorized 

14 to be appropriated $185,000,000 for each of the fiscal 

15 years 2021 through 2025. 

16 ‘‘(2) Of the amount authorized to be appropriated to 

17 carry out this section for a fiscal year, the Secretary shall 

18 not use more than 10 percent for the combined costs of— 

19 ‘‘(A) administration of this section; and 

20 ‘‘(B) carrying out subsection (m)(2).’’. 


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1 Subtitle B—Tribal Medical 

2 Supplies Stockpile Access 

3 SEC. 5011. PROVISION OF ITEMS TO INDIAN PROGRAMS 

4 AND FACILITIES. 

5 (a) STRATEGIC NATIONAL STOCKPILE.—Section 

6 319F–2(a)(3)(G) of the Public Health Service Act (42 

7 U.S.C. 247d–6b(a)(3)(G)) is amended by inserting ‘‘, and, 

8 in the case that the Secretary deploys the stockpile under 

9 this subparagraph, ensure that appropriate drugs, vac10 cines and other biological products, medical devices, and 

11 other supplies are deployed by the Secretary directly to 

12 health programs or facilities operated by the Indian 

13 Health Service, an Indian tribe, a tribal organization (as 

14 those terms are defined in section 4 of the Indian Self15 Determination and Education Assistance Act (25 U.S.C. 

16 5304)), or an inter-tribal consortium (as defined in section 

17 501 of the Indian Self-Determination and Education As18 sistance Act (25 U.S.C. 5381)) or through an urban In19 dian organization (as defined in section 4 of the Indian 

20 Health Care Improvement Act), while avoiding duplicative 

21 distributions to such programs or facilities’’ before the 

22 semicolon. 

23 (b) DISTRIBUTION OF QUALIFIED PANDEMIC OR EPI24 DEMIC PRODUCTS TO IHS FACILITIES.—Title III of the 

25 Public Health Service Act (42 U.S.C. 241 et seq.), as 


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1 amended by section 3015, is further amended by inserting 

2 after section 319F–5 the following: 

3 ‘‘SEC. 319F–6. DISTRIBUTION OF QUALIFIED PANDEMIC OR 

4 EPIDEMIC PRODUCTS TO INDIAN PROGRAMS 

5 AND FACILITIES. 

6 ‘‘In the case that the Secretary distributes qualified 

7 pandemic or epidemic products (as defined in section 

8 319F–3(i)(7)) to States or other entities, the Secretary 

9 shall ensure that, as appropriate, such products are dis10 tributed directly to health programs or facilities operated 

11 by the Indian Health Service, an Indian tribe, a tribal or12 ganization (as those terms are defined in section 4 of the 

13 Indian Self-Determination and Education Assistance Act 

14 (25 U.S.C. 5304)), or an inter-tribal consortium (as de15 fined in section 501 of the Indian Self-Determination and 

16 Education Assistance Act (25 U.S.C. 5381)) or through 

17 an urban Indian organization (as defined in section 4 of 

18 the Indian Health Care Improvement Act), while avoiding 

19 duplicative distributions to such programs or facilities.’’. 

20 Subtitle C—Native American 

21 Suicide Prevention 

22 SEC. 5021. NATIVE AMERICAN SUICIDE PREVENTION. 

23 Section 520E(b) of the Public Health Service Act (42 

24 U.S.C. 290bb–36(b)) is amended by inserting after para25 graph (3) the following: 


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1 ‘‘(4) CONSULTATION.—A State applying for a 

2 grant or cooperative agreement under this section 

3 shall, in the development and implementation of a 

4 statewide early intervention strategy, consult or con5 fer with entities described in paragraph (1)(C) in 

6 such State.’’. 

7 Subtitle D—Pursuing Equity in 

8 Mental Health 

9 PART 1—HEALTH EQUITY AND ACCOUNTABILITY 

10 SEC. 5031. INTEGRATED HEALTH CARE DEMONSTRATION 

11 PROGRAM. 

12 Part D of title V of the Public Health Service Act 

13 (42 U.S.C. 290dd et seq.) is amended by adding at the 

14 end the following: 

15 ‘‘SEC. 554. INTERPROFESSIONAL HEALTH CARE TEAMS FOR 

16 PROVISION OF BEHAVIORAL HEALTH CARE 

17 IN PRIMARY CARE SETTINGS. 

18 ‘‘(a) GRANTS.—The Secretary shall award grants to 

19 eligible entities for the purpose of establishing interprofes20 sional health care teams that provide behavioral health 

21 care. 

22 ‘‘(b) ELIGIBLE ENTITIES.—To be eligible to receive 

23 a grant under this section, an entity shall be a federally 

24 qualified health center (as defined in section 1861(aa) of 

25 the Social Security Act), rural health clinic, or behavioral 


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1 health program, serving a high proportion of individuals 

2 from racial and ethnic minority groups (as defined in sec3 tion 1707(g)). 

4 ‘‘(c) SCIENTIFICALLY BASED.—Integrated health 

5 care funded through this section shall be scientifically 

6 based, taking into consideration the results of the most 

7 recent peer-reviewed research available. 

8 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—To 

9 carry out this section, there is authorized to be appro10 priated $20,000,000 for each of the first 5 fiscal years 

11 following the date of enactment of the Commitment to De12 feat the Virus and Keep America Healthy Act.’’. 

13 SEC. 5032. ADDRESSING RACIAL AND ETHNIC MINORITY 

14 MENTAL HEALTH DISPARITIES RESEARCH 

15 GAPS. 

16 Not later than 6 months after the date of the enact17 ment of this Act, the Director of the National Institutes 

18 of Health shall enter into an arrangement with the Na19 tional Academies of Sciences, Engineering, and Medicine 

20 (or, if the National Academies of Sciences, Engineering, 

21 and Medicine decline to enter into such an arrangement, 

22 the Patient-Centered Outcomes Research Institute, the 

23 Agency for Healthcare Research and Quality, or another 

24 appropriate entity)— 


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1 (1) to conduct a study with respect to mental 

2 health disparities in racial and ethnic minority 

3 groups (as defined in section 1707(g) of the Public 

4 Health Service Act (42 U.S.C. 300u–6(g))); and 

5 (2) to submit to the Congress a report on the 

6 results of such study, including— 

7 (A) a compilation of information on the dy8 namics of mental disorders in such racial and 

9 ethnic minority groups; and 

10 (B) a compilation of information on the 

11 impact of exposure to community violence, ad12 verse childhood experiences, structural racism, 

13 and other psychological traumas on mental dis14 orders in such racial and minority groups. 

15 SEC. 5033. HEALTH PROFESSIONS COMPETENCIES TO AD16 DRESS RACIAL AND ETHNIC MINORITY MEN17 TAL HEALTH DISPARITIES. 

18 (a) IN GENERAL.—The Secretary of Health and 

19 Human Services shall award grants to qualified national 

20 organizations for the purposes of— 

21 (1) developing, and disseminating to health pro22 fessional educational programs best practices or core 

23 competencies addressing mental health disparities 

24 among racial and ethnic minority groups for use in 

25 the training of students in the professions of social 


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1 work, psychology, psychiatry, marriage and family 

2 therapy, mental health counseling, and substance 

3 misuse counseling; and 

4 (2) certifying community health workers and 

5 peer wellness specialists with respect to such best 

6 practices and core competencies and integrating and 

7 expanding the use of such workers and specialists 

8 into health care to address mental health disparities 

9 among racial and ethnic minority groups. 

10 (b) BEST PRACTICES; CORE COMPETENCIES.—Orga11 nizations receiving funds under subsection (a) may use the 

12 funds to engage in the following activities related to the 

13 development and dissemination of best practices or core 

14 competencies described in subsection (a)(1): 

15 (1) Formation of committees or working groups 

16 comprised of experts from accredited health profes17 sions schools to identify best practices and core com18 petencies relating to mental health disparities among 

19 racial and ethnic minority groups. 

20 (2) Planning of workshops in national fora to 

21 allow for public input into the educational needs as22 sociated with mental health disparities among racial 

23 and ethnic minority groups. 

24 (3) Dissemination and promotion of the use of 

25 best practices or core competencies in undergraduate 


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1 and graduate health professions training programs 

2 nationwide. 

3 (4) Establishing external stakeholder advisory 

4 boards to provide meaningful input into policy and 

5 program development and best practices to reduce 

6 mental health disparities among racial and ethnic 

7 minority groups. 

8 (c) DEFINITIONS.—In this section: 

9 (1) QUALIFIED NATIONAL ORGANIZATION.—The 

10 term ‘‘qualified national organization’’ means a na11 tional organization that focuses on the education of 

12 students in one or more of the professions of social 

13 work, psychology, psychiatry, marriage and family 

14 therapy, mental health counseling, and substance 

15 misuse counseling. 

16 (2) RACIAL AND ETHNIC MINORITY GROUP.— 

17 The term ‘‘racial and ethnic minority group’’ has the 

18 meaning given to such term in section 1707(g) of 

19 the Public Health Service Act (42 U.S.C. 300u– 

20 6(g)). 

21 SEC. 5034. RACIAL AND ETHNIC MINORITY BEHAVIORAL 

22 AND MENTAL HEALTH OUTREACH AND EDU23 CATION STRATEGY. 

24 Part D of title V of the Public Health Service Act 

25 (42 U.S.C. 290dd et seq.), as amended by section 5031, 


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1 is further amended by adding at the end the following new 

2 section: 

3 ‘‘SEC. 555. BEHAVIORAL AND MENTAL HEALTH OUTREACH 

4 AND EDUCATION STRATEGY. 

5 ‘‘(a) IN GENERAL.—The Secretary shall, in consulta6 tion with advocacy and behavioral and mental health orga7 nizations serving racial and ethnic minority groups, de8 velop and implement an outreach and education strategy 

9 to promote behavioral and mental health and reduce stig10 ma associated with mental health conditions and sub11 stance abuse among racial and ethnic minority groups. 

12 Such strategy shall— 

13 ‘‘(1) be designed to— 

14 ‘‘(A) meet the diverse cultural and lan15 guage needs of the various racial and ethnic mi16 nority groups; and 

17 ‘‘(B) be developmentally and age-appro18 priate; 

19 ‘‘(2) increase awareness of symptoms of mental 

20 illnesses common among such groups, taking into 

21 account differences within at-risk subgroups; 

22 ‘‘(3) provide information on evidence-based, cul23 turally and linguistically appropriate and adapted 

24 interventions and treatments; 


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1 ‘‘(4) ensure full participation of, and engage, 

2 both consumers and community members in the de3 velopment and implementation of materials; and 

4 ‘‘(5) seek to broaden the perspective among 

5 both individuals in these groups and stakeholders 

6 serving these groups to use a comprehensive public 

7 health approach to promoting behavioral health that 

8 addresses a holistic view of health by focusing on the 

9 intersection between behavioral and physical health. 

10 ‘‘(b) REPORTS.—Beginning not later than 1 year 

11 after the date of the enactment of this section and annu12 ally thereafter, the Secretary shall submit to Congress, 

13 and make publicly available, a report on the extent to 

14 which the strategy developed and implemented under sub15 section (a) increased behavioral and mental health out16 comes associated with mental health conditions and sub17 stance abuse among racial and ethnic minority groups. 

18 ‘‘(c) DEFINITION.—In this section, the term ‘racial 

19 and ethnic minority group’ has the meaning given to that 

20 term in section 1707(g). 

21 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

22 is authorized to be appropriated to carry out this section 

23 $10,000,000 for each of fiscal years 2021 through 2025.’’. 


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1 SEC. 5035. ADDITIONAL FUNDS FOR NATIONAL INSTITUTES 

2 OF HEALTH. 

3 (a) IN GENERAL.—In addition to amounts otherwise 

4 authorized to be appropriated to the National Institutes 

5 of Health, there is authorized to be appropriated to such 

6 Institutes $100,000,000 for each of fiscal years 2021 

7 through 2025 to build relations with communities and con8 duct or support clinical research, including clinical re9 search on racial or ethnic disparities in physical and men10 tal health. 

11 (b) DEFINITION.—In this section, the term ‘‘clinical 

12 research’’ has the meaning given to such term in section 

13 409 of the Public Health Service Act (42 U.S.C. 284d). 

14 SEC. 5036. ADDITIONAL FUNDS FOR NATIONAL INSTITUTE 

15 ON MINORITY HEALTH AND HEALTH DISPARI16 TIES. 

17 In addition to amounts otherwise authorized to be ap18 propriated to the National Institute on Minority Health 

19 and Health Disparities, there is authorized to be appro20 priated to such Institute $650,000,000 for each of fiscal 

21 years 2021 through 2025. 

22 PART 2—OTHER PROVISIONS 

23 SEC. 5037. REAUTHORIZATION OF MINORITY FELLOWSHIP 

24 PROGRAM. 

25 Section 597(c) of the Public Health Service Act (42 

26 U.S.C. 297ll(c)) is amended by striking ‘‘$12,669,000 for 


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1 each of fiscal years 2018 through 2022’’ and inserting 

2 ‘‘$25,000,000 for each of fiscal years 2021 through 

3 2025’’. 

4 SEC. 5038. STUDY ON THE EFFECTS OF SMARTPHONE AND 

5 SOCIAL MEDIA USE ON ADOLESCENTS. 

6 (a) IN GENERAL.—Not later than 1 year after the 

7 date of enactment of this Act, the Secretary of Health and 

8 Human Services shall conduct or support research on— 

9 (1) smartphone and social media use by adoles10 cents; and 

11 (2) the effects of such use on— 

12 (A) emotional, behavioral, and physical 

13 health and development; and 

14 (B) disparities in minority and under15 served populations. 

16 (b) REPORT.—Not later than 5 years after the date 

17 of the enactment of this Act, the Secretary shall submit 

18 to the Congress, and make publicly available, a report on 

19 the findings of research described in this section. 

20 SEC. 5039. TECHNICAL CORRECTION. 

21 Title V of the Public Health Service Act (42 U.S.C. 

22 290aa et seq.) is amended— 

23 (1) by redesignating the second section 550 of 

24 such Act (42 U.S.C. 290ee–10) (relating to Sobriety 


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1 Treatment And Recovery Teams) as section 553; 

2 and 

3 (2) by moving such section 553, as so redesig4 nated, so as to appear after section 552 of such Act 

5 (42 U.S.C. 290ee–7). 

6 Subtitle E—Maternal Health 

7 Quality Improvement 

8 SEC. 5041. INNOVATION FOR MATERNAL HEALTH. 

9 Part D of title III of the Public Health Service Act 

10 (42 U.S.C. 254b et seq.), as amended by section 4071, 

11 is further amended— 

12 (1) in the section designation of section 330M 

13 of such Act (42 U.S.C. 254c–19) by inserting a pe14 riod after ‘‘330M’’; and 

15 (2) by inserting after section 330N of such Act, 

16 as inserted by section 4071, the following: 

17 ‘‘SEC. 330O. INNOVATION FOR MATERNAL HEALTH. 

18 ‘‘(a) IN GENERAL.—The Secretary, in consultation 

19 with experts representing a variety of clinical specialties, 

20 State, Tribal, or local public health officials, researchers, 

21 epidemiologists, statisticians, and community organiza22 tions, shall establish or continue a program to award com23 petitive grants to eligible entities for the purposes of— 

24 ‘‘(1) identifying, developing, or disseminating 

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1 ity and outcomes, eliminate preventable maternal 

2 mortality and severe maternal morbidity, and im3 prove infant health outcomes, which may include— 

4 ‘‘(A) information on evidence-based prac5 tices to improve the quality and safety of ma6 ternal health care in hospitals and other health 

7 care settings of a State or health care system, 

8 including by addressing topics commonly associ9 ated with health complications or risks related 

10 to prenatal care, labor care, birthing, and 

11 postpartum care; 

12 ‘‘(B) best practices for improving maternal 

13 health care based on data findings and reviews 

14 conducted by a State maternal mortality review 

15 committee that address topics of relevance to 

16 common complications or health risks related to 

17 prenatal care, labor care, birthing, and 

18 postpartum care; and 

19 ‘‘(C) information on addressing deter20 minants of health that impact maternal health 

21 outcomes for women before, during, and after 

22 pregnancy; 

23 ‘‘(2) collaborating with State maternal mor24 tality review committees to identify issues for the de25 velopment and implementation of evidence-based 


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1 practices to improve maternal health outcomes and 

2 reduce preventable maternal mortality and severe 

3 maternal morbidity; 

4 ‘‘(3) providing technical assistance and sup5 porting the implementation of best practices identi6 fied pursuant to paragraph (1) to entities providing 

7 health care services to pregnant and postpartum 

8 women; and 

9 ‘‘(4) identifying, developing, and evaluating new 

10 models of care that improve maternal and infant 

11 health outcomes, which may include the integration 

12 of community-based services and clinical care. 

13 ‘‘(b) ELIGIBLE ENTITIES.—To be eligible for a grant 

14 under subsection (a), an entity shall— 

15 ‘‘(1) submit to the Secretary an application at 

16 such time, in such manner, and containing such in17 formation as the Secretary may require; and 

18 ‘‘(2) demonstrate in such application that the 

19 entity is capable of carrying out data-driven mater20 nal safety and quality improvement initiatives in the 

21 areas of obstetrics and gynecology or maternal 

22 health. 

23 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—To 

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1 priated $5,000,000 for each of fiscal years 2021 through 

2 2025.’’. 

3 SEC. 5042. TRAINING FOR HEALTH CARE PROVIDERS. 

4 Title VII of the Public Health Service Act is amended 

5 by striking section 763 (42 U.S.C. 294p) and inserting 

6 the following: 

7 ‘‘SEC. 763. TRAINING FOR HEALTH CARE PROVIDERS. 

8 ‘‘(a) GRANT PROGRAM.—The Secretary shall estab9 lish a program to award grants to accredited schools of 

10 allopathic medicine, osteopathic medicine, and nursing, 

11 and other health professional training programs for the 

12 training of health care professionals to reduce and prevent 

13 discrimination (including training related to implicit and 

14 explicit biases) in the provision of health care services re15 lated to prenatal care, labor care, birthing, and 

16 postpartum care. 

17 ‘‘(b) ELIGIBILITY.—To be eligible for a grant under 

18 subsection (a), an entity described in such subsection shall 

19 submit to the Secretary an application at such time, in 

20 such manner, and containing such information as the Sec21 retary may require. 

22 ‘‘(c) REPORTING REQUIREMENT.—Each entity 

23 awarded a grant under this section shall periodically sub24 mit to the Secretary a report on the status of activities 


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1 conducted using the grant, including a description of the 

2 impact of such training on patient outcomes, as applicable. 

3 ‘‘(d) BEST PRACTICES.—The Secretary may identify 

4 and disseminate best practices for the training of health 

5 care professionals to reduce and prevent discrimination 

6 (including training related to implicit and explicit biases) 

7 in the provision of health care services related to prenatal 

8 care, labor care, birthing, and postpartum care. 

9 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—To 

10 carry out this section, there are authorized to be appro11 priated $5,000,000 for each of fiscal years 2021 through 

12 2025.’’. 

13 SEC. 5043. STUDY ON TRAINING TO REDUCE AND PREVENT 

14 DISCRIMINATION. 

15 Not later than 2 years after date of enactment of this 

16 Act, the Secretary of Health and Human Services shall, 

17 through a contract with an independent research organiza18 tion, conduct a study and make recommendations for ac19 credited schools of allopathic medicine, osteopathic medi20 cine, and nursing, and other health professional training 

21 programs, on best practices related to training to reduce 

22 and prevent discrimination, including training related to 

23 implicit and explicit biases, in the provision of health care 

24 services related to prenatal care, labor care, birthing, and 

25 postpartum care. 


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1 SEC. 5044. PERINATAL QUALITY COLLABORATIVES. 

2 Section 317K(a)(2) of the Public Health Service Act 

3 (42 U.S.C. 247b–12(a)(2)) is amended by adding at the 

4 end the following: 

5 ‘‘(E)(i) The Secretary, acting through the 

6 Director of the Centers for Disease Control and 

7 Prevention and in coordination with other of8 fices and agencies, as appropriate, shall estab9 lish or continue a competitive grant program 

10 for the establishment or support of perinatal 

11 quality collaboratives to improve perinatal care 

12 and perinatal health outcomes for pregnant and 

13 postpartum women and their infants. A State, 

14 Indian Tribe, or Tribal organization may use 

15 funds received through such grant to— 

16 ‘‘(I) support the use of evidence-based 

17 or evidence-informed practices to improve 

18 outcomes for maternal and infant health; 

19 ‘‘(II) work with clinical teams; ex20 perts; State, local, and, as appropriate, 

21 Tribal public health officials; and stake22 holders, including patients and families, to 

23 identify, develop, or disseminate best prac24 tices to improve perinatal care and out25 comes; and 


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1 ‘‘(III) employ strategies that provide 

2 opportunities for health care professionals 

3 and clinical teams to collaborate across 

4 health care settings and disciplines, includ5 ing primary care and mental health, as ap6 propriate, to improve maternal and infant 

7 health outcomes, which may include the 

8 use of data to provide timely feedback 

9 across hospital and clinical teams to in10 form responses, and to provide support 

11 and training to hospital and clinical teams 

12 for quality improvement, as appropriate. 

13 ‘‘(ii) To be eligible for a grant under 

14 clause (i), an entity shall submit to the Sec15 retary an application in such form and manner 

16 and containing such information as the Sec17 retary may require.’’. 

18 SEC. 5045. INTEGRATED SERVICES FOR PREGNANT AND 

19 POSTPARTUM WOMEN. 

20 (a) GRANTS.—Title III of the Public Health Service 

21 Act is amended by inserting after section 330O of such 

22 Act, as added by section 5041, the following: 


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1 ‘‘SEC. 330P. INTEGRATED SERVICES FOR PREGNANT AND 

2 POSTPARTUM WOMEN. 

3 ‘‘(a) IN GENERAL.—The Secretary may award grants 

4 to States, Indian Tribes, and Tribal organizations for the 

5 purpose of establishing or operating evidence-based or in6 novative, evidence-informed programs to deliver integrated 

7 health care services to pregnant and postpartum women 

8 to optimize the health of women and their infants, includ9 ing to reduce adverse maternal health outcomes, preg10 nancy-related deaths, and related health disparities (in11 cluding such disparities associated with racial and ethnic 

12 minority populations), and, as appropriate, by addressing 

13 issues researched under subsection (b)(2) of section 317K. 

14 ‘‘(b) INTEGRATED SERVICES FOR PREGNANT AND

15 POSTPARTUM WOMEN.— 

16 ‘‘(1) ELIGIBILITY.—To be eligible to receive a 

17 grant under subsection (a), a State, Indian Tribe, or 

18 Tribal organization shall work with relevant stake19 holders that coordinate care (including coordinating 

20 resources and referrals for health care and social 

21 services) to develop and carry out the program, in22 cluding— 

23 ‘‘(A) State, Tribal, and local agencies re24 sponsible for Medicaid, public health, social 

25 services, mental health, and substance use dis26 order treatment and services; 


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1 ‘‘(B) health care providers who serve preg2 nant and postpartum women; and 

3 ‘‘(C) community-based health organiza4 tions and health workers, including providers of 

5 home visiting services and individuals rep6 resenting communities with disproportionately 

7 high rates of maternal mortality and severe ma8 ternal morbidity, and including individuals rep9 resenting racial and ethnic minority popu10 lations. 

11 ‘‘(2) TERMS.— 

12 ‘‘(A) PERIOD.—A grant awarded under 

13 subsection (a) shall be made for a period of 5 

14 years. Any supplemental award made to a 

15 grantee under subsection (a) may be made for 

16 a period of less than 5 years. 

17 ‘‘(B) PREFERENCE.—In awarding grants 

18 under subsection (a), the Secretary shall— 

19 ‘‘(i) give preference to States, Indian 

20 Tribes, and Tribal organizations that have 

21 the highest rates of maternal mortality and 

22 severe maternal morbidity relative to other 

23 such States, Indian Tribes, or Tribal orga24 nizations, respectively; and 


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1 ‘‘(ii) shall consider health disparities 

2 related to maternal mortality and severe 

3 maternal morbidity, including such dispari4 ties associated with racial and ethnic mi5 nority populations. 

6 ‘‘(C) PRIORITY.—In awarding grants 

7 under subsection (a), the Secretary shall give 

8 priority to applications from up to 15 entities 

9 described in subparagraph (B)(i). 

10 ‘‘(D) EVALUATION.—The Secretary shall 

11 require grantees to evaluate the outcomes of the 

12 programs supported under the grant. 

13 ‘‘(c) DEFINITIONS.—In this section, the terms ‘In14 dian Tribe’ and ‘Tribal organization’ have the meanings 

15 given the terms ‘Indian tribe’ and ‘tribal organization’, re16 spectively, in section 4 of the Indian Self-Determination 

17 and Education Assistance Act. 

18 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

19 are authorized to be appropriated to carry out this section 

20 $10,000,000 for each of fiscal years 2021 through 2025.’’. 

21 (b) REPORT ON GRANT OUTCOMES AND DISSEMINA22 TION OF BEST PRACTICES.— 

23 (1) REPORT.—Not later than February 1, 

24 2026, the Secretary of Health and Human Services 

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1 cation, Labor, and Pensions of the Senate and the 

2 Committee on Energy and Commerce of the House 

3 of Representatives a report that describes— 

4 (A) the outcomes of the activities sup5 ported by the grants awarded under the amend6 ment made by this section on maternal and 

7 child health; 

8 (B) best practices and models of care used 

9 by recipients of grants under such amendment; 

10 and 

11 (C) obstacles identified by recipients of 

12 grants under such amendment, and strategies 

13 used by such recipients to deliver care, improve 

14 maternal and child health, and reduce health 

15 disparities. 

16 (2) DISSEMINATION OF BEST PRACTICES.—Not 

17 later than August 1, 2026, the Secretary of Health 

18 and Human Services shall disseminate information 

19 on best practices and models of care used by recipi20 ents of grants under the amendment made by this 

21 section (including best practices and models of care 

22 relating to the reduction of health disparities, includ23 ing such disparities associated with racial and ethnic 

24 minority populations, in rates of maternal mortality 

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1 holders, which may include health providers, medical 

2 schools, nursing schools, relevant State, Tribal, and 

3 local agencies, and the general public. 

4 SEC. 5046. IMPROVING RURAL MATERNAL AND OBSTETRIC 

5 CARE DATA. 

6 (a) MATERNAL MORTALITY AND MORBIDITY ACTIVI7 TIES.—Section 301(e) of the Public Health Service Act 

8 (42 U.S.C. 241(e)) is amended by inserting ‘‘, preventable 

9 maternal mortality and severe maternal morbidity,’’ after 

10 ‘‘delivery’’. 

11 (b) OFFICE OF WOMEN’S HEALTH.—Section 

12 310A(b)(1) of the Public Health Service Act (42 U.S.C. 

13 242s(b)(1)) is amended by striking ‘‘and sociocultural con14 texts,’’ and inserting ‘‘sociocultural (including among 

15 American Indians, Native Hawaiians, and Alaska Na16 tives), and geographical contexts’’. 

17 (c) SAFE MOTHERHOOD.—Section 317K of the Pub18 lic Health Service Act (42 U.S.C. 247b–12) is amended— 

19 (1) in subsection (a)(2)(A), by inserting ‘‘, in20 cluding improving collection of data on race, eth21 nicity, and other demographic information’’ before 

22 the period; and 

23 (2) in subsection (b)(2)— 

24 (A) in subparagraph (L), by striking 

25 ‘‘and’’ at the end; 


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1 (B) by redesignating subparagraph (M) as 

2 subparagraph (N); and 

3 (C) by inserting after subparagraph (L) 

4 the following: 

5 ‘‘(M) an examination of the relationship 

6 between maternal health and obstetric services 

7 in rural areas and outcomes in delivery and 

8 postpartum care; and’’. 

9 (d) OFFICE OF RESEARCH ON WOMEN’S HEALTH.— 

10 Section 486 of the Public Health Service Act (42 U.S.C. 

11 287d) is amended— 

12 (1) in subsection (b), by amending paragraph 

13 (3) to read as follows: 

14 ‘‘(3) carry out paragraphs (1) and (2) with re15 spect to— 

16 ‘‘(A) the aging process in women, with pri17 ority given to menopause; and 

18 ‘‘(B) pregnancy, with priority given to 

19 deaths related to preventable maternal mor20 tality and severe maternal morbidity;’’; and 

21 (2) in subsection (d)(4)(A)(iv), by inserting ‘‘, 

22 including preventable maternal morbidity and severe 

23 maternal morbidity’’ before the semicolon. 


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1 SEC. 5047. RURAL OBSTETRIC NETWORK GRANTS. 

2 The Public Health Service Act is amended by insert3 ing after section 330A–1 (42 U.S.C. 254c–1a) the fol4 lowing: 

5 ‘‘SEC. 330A–2. RURAL OBSTETRIC NETWORK GRANTS. 

6 ‘‘(a) PROGRAM ESTABLISHED.—The Secretary shall 

7 award grants or cooperative agreements to eligible entities 

8 to establish collaborative improvement and innovation net9 works (referred to in this section as ‘rural obstetric net10 works’) to improve maternal and infant health outcomes 

11 and reduce preventable maternal mortality and severe ma12 ternal morbidity by improving maternity care and access 

13 to care in rural areas, frontier areas, maternity care health 

14 professional target areas, or jurisdictions of Indian Tribes 

15 and Tribal organizations. 

16 ‘‘(b) USE OF FUNDS.—Grants or cooperative agree17 ments awarded pursuant to this section shall be used for 

18 the establishment or continuation of collaborative improve19 ment and innovation networks to improve maternal health 

20 in rural areas by improving infant health and maternal 

21 outcomes and reducing preventable maternal mortality 

22 and severe maternal morbidity. Rural obstetric networks 

23 established in accordance with this section may— 

24 ‘‘(1) develop a network to improve coordination 

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1 section (a) with accessing and utilizing maternal and 

2 obstetric care, including health care services related 

3 to prenatal care, labor care, birthing, and 

4 postpartum care to improve outcomes in birth and 

5 maternal mortality and morbidity; 

6 ‘‘(2) identify and implement evidence-based and 

7 sustainable delivery models for maternal and obstet8 ric care (including health care services related to 

9 prenatal care, labor care, birthing, and postpartum 

10 care for women in the areas described in subsection 

11 (a)), including home visiting programs and culturally 

12 appropriate care models that reduce health dispari13 ties; 

14 ‘‘(3) develop a model for maternal health care 

15 collaboration between health care settings to improve 

16 access to care in areas described in subsection (a), 

17 which may include the use of telehealth; 

18 ‘‘(4) provide training for professionals in health 

19 care settings that do not have specialty maternity 

20 care; 

21 ‘‘(5) collaborate with academic institutions that 

22 can provide regional expertise and help identify bar23 riers to providing maternal health care, including 

24 strategies for addressing such barriers; and 


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1 ‘‘(6) assess and address disparities in infant 

2 and maternal health outcomes, including among ra3 cial and ethnic minority populations and underserved 

4 populations in areas described in subsection (a). 

5 ‘‘(c) DEFINITIONS.—In this section: 

6 ‘‘(1) ELIGIBLE ENTITIES.—The term ‘eligible 

7 entities’ means entities providing maternal health 

8 care services in rural areas, frontier areas, or medi9 cally underserved areas, or to medically underserved 

10 populations or Indian Tribes or Tribal organizations. 

11 ‘‘(2) FRONTIER AREA.—The term ‘frontier 

12 area’ means a frontier county, as defined in section 

13 1886(d)(3)(E)(iii)(III) of the Social Security Act. 

14 ‘‘(3) INDIAN TRIBES; TRIBAL ORGANIZATION.— 

15 The terms ‘Indian Tribe’ and ‘Tribal organization’ 

16 have the meanings given the terms ‘Indian tribe’ and 

17 ‘tribal organization’, respectively, in section 4 of the 

18 Indian Self-Determination and Education Assistance 

19 Act. 

20 ‘‘(4) MATERNITY CARE HEALTH PROFESSIONAL

21 TARGET AREA.—The term ‘maternity care health 

22 professional target area’ has the meaning described 

23 in section 332(k)(2). 


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1 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

2 are authorized to be appropriated to carry out this section 

3 $3,000,000 for each of fiscal years 2021 through 2025.’’. 

4 SEC. 5048. TELEHEALTH NETWORK AND TELEHEALTH RE5 SOURCE CENTERS GRANT PROGRAMS. 

6 Section 330I of the Public Health Service Act (42 

7 U.S.C. 254c–14) is amended— 

8 (1) in subsection (f)(3), by adding at the end 

9 the following: 

10 ‘‘(M) Providers of maternal care, including 

11 prenatal, labor care, birthing, and postpartum 

12 care services and entities operating obstetric 

13 care units.’’; and 

14 (2) in subsection (h)(1)(B), by inserting ‘‘labor 

15 care, birthing care, postpartum care,’’ before ‘‘or 

16 prenatal’’. 

17 SEC. 5049. RURAL MATERNAL AND OBSTETRIC CARE 

18 TRAINING DEMONSTRATION. 

19 Subpart 1 of part E of title VII of the Public Health 

20 Service Act (42 U.S.C. 294n et seq.) is amended by adding 

21 at the end the following: 

22 ‘‘SEC. 764. RURAL MATERNAL AND OBSTETRIC CARE TRAIN23 ING DEMONSTRATION. 

24 ‘‘(a) IN GENERAL.—The Secretary shall award 

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1 pathic medicine, and nursing, and other appropriate 

2 health professional training programs, to establish a train3 ing demonstration program to support— 

4 ‘‘(1) training for physicians, medical residents, 

5 fellows, nurse practitioners, physician assistants, 

6 nurses, certified nurse midwives, relevant home vis7 iting workforce professionals and paraprofessionals, 

8 or other professionals who meet relevant State train9 ing and licensing requirements, as applicable, to pro10 vide maternal health care services in rural commu11 nity-based settings; and 

12 ‘‘(2) developing recommendations for such 

13 training programs. 

14 ‘‘(b) APPLICATION.—To be eligible to receive a grant 

15 under subsection (a), an entity shall submit to the Sec16 retary an application at such time, in such manner, and 

17 containing such information as the Secretary may require. 

18 ‘‘(c) ACTIVITIES.— 

19 ‘‘(1) TRAINING FOR HEALTH CARE PROFES20 SIONALS.—A recipient of a grant under subsection 

21 (a)— 

22 ‘‘(A) shall use the grant funds to plan, de23 velop, and operate a training program to pro24 vide maternal health care in rural areas; and 


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1 ‘‘(B) may use the grant funds to provide 

2 additional support for the administration of the 

3 program or to meet the costs of projects to es4 tablish, maintain, or improve faculty develop5 ment, or departments, divisions, or other units 

6 necessary to implement such training. 

7 ‘‘(2) TRAINING PROGRAM REQUIREMENTS.— 

8 The recipient of a grant under subsection (a) shall 

9 ensure that training programs carried out under the 

10 grant are evidence-based and address improving ma11 ternal health care in rural areas, and such programs 

12 may include training on topics such as— 

13 ‘‘(A) maternal mental health, including 

14 perinatal depression and anxiety; 

15 ‘‘(B) substance use disorders; 

16 ‘‘(C) social determinants of health that af17 fect individuals living in rural areas; and 

18 ‘‘(D) implicit and explicit bias. 

19 ‘‘(d) EVALUATION AND REPORT.— 

20 ‘‘(1) EVALUATION.— 

21 ‘‘(A) IN GENERAL.—The Secretary shall 

22 evaluate the outcomes of the demonstration 

23 program under this section. 

24 ‘‘(B) DATA SUBMISSION.—Recipients of a 

25 grant under subsection (a) shall submit to the 


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1 Secretary performance metrics and other re2 lated data in order to evaluate the program for 

3 the report described in paragraph (2). 

4 ‘‘(2) REPORT TO CONGRESS.—Not later than 

5 January 1, 2025, the Secretary shall submit to the 

6 Committee on Health, Education, Labor, and Pen7 sions of the Senate and the Committee on Energy 

8 and Commerce of the House of Representatives a re9 port that includes— 

10 ‘‘(A) an analysis of the effects of the dem11 onstration program under this section on the 

12 quality, quantity, and distribution of maternal 

13 health care services, including health care serv14 ices related to prenatal care, labor care, birth15 ing, and postpartum care, and the demo16 graphics of the recipients of those services; 

17 ‘‘(B) an analysis of maternal and infant 

18 health outcomes (including quality of care, mor19 bidity, and mortality) before and after imple20 mentation of the program in the communities 

21 served by entities participating in the dem22 onstration program; and 

23 ‘‘(C) recommendations on whether the 

24 demonstration program should be continued. 


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1 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

2 are authorized to be appropriated to carry out this section 

3 $5,000,000 for each of fiscal years 2021 through 2025.’’. 

4 TITLE VI—ADDRESSING THE IM5 PACTS OF COVID–19 ON MEN6 TAL HEALTH 

7 Subtitle A—Creating Resources To 

8 Improve Situations of Inherent 

9 Severity 

10 SEC. 6001. SET-ASIDE FOR EVIDENCE-BASED CRISIS CARE 

11 SERVICES. 

12 Section 1920 of the Public Health Service Act (42 

13 U.S.C. 300x–9) is amended— 

14 (1) in subsection (a), by striking 

15 ‘‘$532,571,000 for each of fiscal years 2018 through 

16 2022’’ and inserting ‘‘$532,571,000 for each of fis17 cal years 2018 through 2020, and $758,000,000 for 

18 each of fiscal years 2021 through 2022’’; and 

19 (2) by adding at the end the following: 

20 ‘‘(d) CRISIS CARE.— 

21 ‘‘(1) IN GENERAL.—Except as provided in para22 graph (3), a State shall expend at least 5 percent of 

23 the amount the State receives pursuant to section 

24 1911 for each fiscal year to support evidenced-based 

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1 viduals with serious mental disorders, and children 

2 with serious mental and emotional disturbances. 

3 ‘‘(2) CORE ELEMENTS.—At the discretion of 

4 the single State agency responsible for the adminis5 tration of the program of the State under a grant 

6 under section 1911, funds expended pursuant to 

7 paragraph (1) may be used to fund some or all of 

8 the core crisis care service components, delivered ac9 cording to evidence-based principles, including the 

10 following: 

11 ‘‘(A) Crisis call centers. 

12 ‘‘(B) 24/7 mobile crisis services. 

13 ‘‘(C) Crisis stabilization programs offering 

14 acute care or subacute care in a hospital or ap15 propriately licensed facility, as determined by 

16 the Substance Abuse and Mental Health Serv17 ices Administration, with referrals to inpatient 

18 or outpatient care. 

19 ‘‘(3) STATE FLEXIBILITY.—In lieu of expending 

20 5 percent of the amount the State receives pursuant 

21 to section 1911 for a fiscal year to support evidence22 based programs as required by paragraph (1), a 

23 State may elect to expend not less than 10 percent 

24 of such amount to support such programs by the 

25 end of two consecutive fiscal years.’’. 


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1 Subtitle B—Emergency Mental 

2 Health and Substance Use 

3 Training and Technical Assist4 ance Center 

5 SEC. 6011. EMERGENCY MENTAL HEALTH AND SUBSTANCE 

6 USE TRAINING AND TECHNICAL ASSISTANCE 

7 CENTER. 

8 Subpart 3 of part B of title V of the Public Health 

9 Service Act (42 U.S.C. 290bb–31 et seq.) is amended by 

10 inserting after section 520A (42 U.S.C. 290bb–32) the fol11 lowing: 

12 ‘‘SEC. 520B. EMERGENCY MENTAL HEALTH AND SUB13 STANCE USE TRAINING AND TECHNICAL AS14 SISTANCE CENTER. 

15 ‘‘(a) ESTABLISHMENT.—The Secretary, acting 

16 through the Assistant Secretary, shall establish or operate 

17 a center to be known as the Emergency Mental Health 

18 and Substance Use Training and Technical Assistance 

19 Center (referred to in this section as the ‘Center’) to pro20 vide technical assistance and support— 

21 ‘‘(1) to public or nonprofit entities seeking to 

22 establish or expand access to mental health and sub23 stance use prevention, treatment, and recovery sup24 port services, and increase awareness of such serv25 ices; and 


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1 ‘‘(2) to public health professionals, health care 

2 professionals and support staff, essential workers (as 

3 defined by a State, Tribe, locality, or territory), and 

4 members of the public to address the trauma, stress, 

5 and mental health needs associated with an emer6 gency period. 

7 ‘‘(b) ASSISTANCE AND SUPPORT.—The assistance 

8 and support provided under subsection (a) shall include 

9 assistance and support with respect to— 

10 ‘‘(1) training on identifying signs of trauma, 

11 stress, and mental health needs; 

12 ‘‘(2) providing accessible resources to assist in13 dividuals and families experiencing trauma, stress, 

14 or other mental health needs during and after an 

15 emergency period; 

16 ‘‘(3) providing resources for substance use dis17 order prevention, treatment, and recovery designed 

18 to assist individuals and families during and after an 

19 emergency period; 

20 ‘‘(4) the provision of language access services, 

21 including translation services, interpretation, or 

22 other such services for individuals with limited 

23 English speaking proficiency or individuals with dis24 abilities; and 


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1 ‘‘(5) evaluation and improvement, as necessary, 

2 of the effectiveness of such services provided by pub3 lic or nonprofit entities. 

4 ‘‘(c) BEST PRACTICES.—The Center shall periodi5 cally issue best practices for use by organizations seeking 

6 to provide mental health services or substance use disorder 

7 prevention, treatment, or recovery services, including best 

8 practices for the following special populations: 

9 ‘‘(1) Incarcerated individuals. 

10 ‘‘(2) Children. 

11 ‘‘(3) Pregnant women. 

12 ‘‘(4) Underserved populations. 

13 ‘‘(5) Communities of color. 

14 ‘‘(6) Health care providers and essential work15 ers. 

16 ‘‘(d) EMERGENCY PERIOD.—In this section, the term 

17 ‘emergency period’ has the meaning given such term in 

18 section 1135(g)(1)(A) of the Social Security Act. 

19 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

20 is authorized to be appropriated to carry out this section 

21 $20,000,000 for each of fiscal years 2021 and 2022.’’. 


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1 Subtitle C—Suicide Prevention 

2 Grants 

3 SEC. 6021. SYNDROMIC SURVEILLANCE OF SELF-HARM BE4 HAVIORS PROGRAM. 

5 Title III of the Public Health Service Act is amended 

6 by inserting after section 317U of such Act (42 U.S.C. 

7 247b–23) the following: 

8 ‘‘SEC. 317V. SYNDROMIC SURVEILLANCE OF SELF-HARM BE9 HAVIORS PROGRAM. 

10 ‘‘(a) IN GENERAL.—The Secretary shall award 

11 grants to State, local, Tribal, and territorial public health 

12 departments for the expansion of surveillance of self-harm. 

13 ‘‘(b) DATA SHARING BY GRANTEES.—As a condition 

14 of receipt of such grant under subsection (a), each grantee 

15 shall agree to share with the Centers for Disease Control 

16 and Prevention in real time, to the extent feasible and as 

17 specified in the grant agreement, data on suicides and self18 harm for purposes of— 

19 ‘‘(1) tracking and monitoring self-harm to in20 form response activities to suicide clusters; 

21 ‘‘(2) informing prevention programming for 

22 identified at-risk populations; and 

23 ‘‘(3) conducting or supporting research. 

24 ‘‘(c) DISAGGREGATION OF DATA.—The Secretary 

25 shall provide for the data collected through surveillance 


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1 of self-harm under subsection (b) to be disaggregated by 

2 the following categories: 

3 ‘‘(1) Nonfatal self-harm data of any intent. 

4 ‘‘(2) Data on suicidal ideation. 

5 ‘‘(3) Data on self-harm where there is no evi6 dence, whether implicit or explicit, of suicidal intent. 

7 ‘‘(4) Data on self-harm where there is evidence, 

8 whether implicit or explicit, of suicidal intent. 

9 ‘‘(5) Data on self-harm where suicidal intent is 

10 unclear based on the available evidence. 

11 ‘‘(d) PRIORITY.—In making awards under subsection 

12 (a), the Secretary shall give priority to eligible entities that 

13 are— 

14 ‘‘(1) located in a State with an age-adjusted 

15 rate of nonfatal suicidal behavior that is above the 

16 national rate of nonfatal suicidal behavior, as deter17 mined by the Director of the Centers for Disease 

18 Control and Prevention; 

19 ‘‘(2) serving an Indian Tribe (as defined in sec20 tion 4 of the Indian Self-Determination and Edu21 cation Assistance Act) with an age-adjusted rate of 

22 nonfatal suicidal behavior that is above the national 

23 rate of nonfatal suicidal behavior, as determined 

24 through appropriate mechanisms determined by the 

25 Secretary in consultation with Indian Tribes; or 


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1 ‘‘(3) located in a State with a high rate of cov2 erage of statewide (or Tribal) emergency department 

3 visits, as determined by the Director of the Centers 

4 for Disease Control and Prevention. 

5 ‘‘(e) GEOGRAPHIC DISTRIBUTION.—In making 

6 grants under this section, the Secretary shall make an ef7 fort to ensure geographic distribution, taking into account 

8 the unique needs of rural communities, including— 

9 ‘‘(1) communities with an incidence of individ10 uals with serious mental illness, demonstrated suici11 dal ideation or behavior, or suicide rates that are 

12 above the national average, as determined by the As13 sistant Secretary for Mental Health and Substance 

14 Use; 

15 ‘‘(2) communities with a shortage of prevention 

16 and treatment services, as determined by the Assist17 ant Secretary for Mental Health and Substance Use 

18 and the Administrator of the Health Resources and 

19 Services Administration; and 

20 ‘‘(3) other appropriate community-level factors 

21 and social determinants of health such as income, 

22 employment, and education. 

23 ‘‘(f) PERIOD OF PARTICIPATION.—To be selected as 

24 a grant recipient under this section, a State, local, Tribal, 

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1 ticipate in the program for a period of not less than 4 

2 years. 

3 ‘‘(g) TECHNICAL ASSISTANCE.—The Secretary shall 

4 provide technical assistance and training to grantees for 

5 collecting and sharing the data under subsection (b). 

6 ‘‘(h) DATA SHARING BY HHS.—Subject to sub7 section (b), the Secretary shall, with respect to data on 

8 self-harm that is collected pursuant to this section, share 

9 and integrate such data through— 

10 ‘‘(1) the National Syndromic Surveillance Pro11 gram’s Early Notification of Community Epidemics 

12 (ESSENCE) platform (or any successor platform); 

13 ‘‘(2) the National Violent Death Reporting Sys14 tem, as appropriate; or 

15 ‘‘(3) another appropriate surveillance program, 

16 including such a program that collects data on sui17 cides and self-harm among special populations, such 

18 as members of the military and veterans. 

19 ‘‘(i) RULE OF CONSTRUCTION REGARDING APPLICA20 BILITY OF PRIVACY PROTECTIONS.—Nothing in this sec21 tion shall be construed to limit or alter the application 

22 of Federal or State law relating to the privacy of informa23 tion to data or information that is collected or created 

24 under this section. 

25 ‘‘(j) REPORT.— 


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1 ‘‘(1) SUBMISSION.—Not later than 3 years 

2 after the date of enactment of this Act, the Sec3 retary shall evaluate the suicide and self-harm 

4 syndromic surveillance systems at the Federal, 

5 State, and local levels and submit a report to Con6 gress on the data collected under subsections (b) and 

7 (c) in a manner that prevents the disclosure of indi8 vidually identifiable information, at a minimum, con9 sistent with all applicable privacy laws and regula10 tions. 

11 ‘‘(2) CONTENTS.—In addition to the data col12 lected under subsections (b) and (c), the report 

13 under paragraph (1) shall include— 

14 ‘‘(A) challenges and gaps in data collection 

15 and reporting; 

16 ‘‘(B) recommendations to address such 

17 gaps and challenges; and 

18 ‘‘(C) a description of any public health re19 sponses initiated at the Federal, State, or local 

20 level in response to the data collected. 

21 ‘‘(k) AUTHORIZATION OF APPROPRIATIONS.—To 

22 carry out this section, there are authorized to be appro23 priated $20,000,000 for each of fiscal years 2021 through 

24 2025.’’. 


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1 SEC. 6022. GRANTS TO PROVIDE SELF-HARM AND SUICIDE 

2 PREVENTION SERVICES. 

3 Part B of title V of the Public Health Service Act 

4 (42 U.S.C. 290aa et seq.) is amended by adding at the 

5 end the following: 

6 ‘‘SEC. 520N. GRANTS TO PROVIDE SELF-HARM AND SUICIDE 

7 PREVENTION SERVICES. 

8 ‘‘(a) IN GENERAL.—The Secretary of Health and 

9 Human Services shall award grants to hospital emergency 

10 departments to provide self-harm and suicide prevention 

11 services. 

12 ‘‘(b) ACTIVITIES SUPPORTED.— 

13 ‘‘(1) IN GENERAL.—A hospital emergency de14 partment awarded a grant under subsection (a) shall 

15 use amounts under the grant to implement a pro16 gram or protocol to better prevent suicide attempts 

17 among hospital patients after discharge, which may 

18 include— 

19 ‘‘(A) screening patients for self-harm and 

20 suicide in accordance with the standards of 

21 practice described in subsection (e)(1) and 

22 standards of care established by appropriate 

23 medical and advocacy organizations; 

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1 ance with the results of the screenings de2 scribed in subparagraph (A); and 

3 ‘‘(C) referring patients, as appropriate, to 

4 a health care facility or provider for purposes of 

5 receiving long-term self-harm and suicide pre6 vention services, and providing any additional 

7 follow up services and care identified as appro8 priate as a result of the screenings and short9 term self-harm and suicide prevention services 

10 described in subparagraphs (A) and (B). 

11 ‘‘(2) USE OF FUNDS TO HIRE AND TRAIN

12 STAFF.—Amounts awarded under subsection (a) 

13 may be used to hire clinical social workers, mental 

14 and behavioral health care professionals, and sup15 port staff as appropriate, and to train existing staff 

16 and newly hired staff to carry out the activities de17 scribed in paragraph (1). 

18 ‘‘(c) GRANT TERMS.—A grant awarded under sub19 section (a)— 

20 ‘‘(1) shall be for a period of 3 years; and 

21 ‘‘(2) may be renewed subject to the require22 ments of this section. 

23 ‘‘(d) APPLICATIONS.—A hospital emergency depart24 ment seeking a grant under subsection (a) shall submit 

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1 ner, and accompanied by such information as the Sec2 retary may require. 

3 ‘‘(e) STANDARDS OF PRACTICE.— 

4 ‘‘(1) IN GENERAL.—Not later than 180 days 

5 after the date of the enactment of this section, the 

6 Secretary shall develop standards of practice for 

7 screening patients for self-harm and suicide for pur8 poses of carrying out subsection (b)(1)(C). 

9 ‘‘(2) CONSULTATION.—The Secretary shall de10 velop the standards of practice described in para11 graph (1) in consultation with individuals and enti12 ties with expertise in self-harm and suicide preven13 tion, including public, private, and non-profit enti14 ties. 

15 ‘‘(f) REPORTING.— 

16 ‘‘(1) REPORTS TO THE SECRETARY.— 

17 ‘‘(A) IN GENERAL.—A hospital emergency 

18 department awarded a grant under subsection 

19 (a) shall, at least quarterly for the duration of 

20 the grant, submit to the Secretary a report 

21 evaluating the activities supported by the grant. 

22 ‘‘(B) MATTERS TO BE INCLUDED.—The 

23 report required under subparagraph (A) shall 

24 include— 


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1 ‘‘(i) the number of patients receiv2 ing— 

3 ‘‘(I) screenings carried out at the 

4 hospital emergency department; 

5 ‘‘(II) short-term self-harm and 

6 suicide prevention services at the hos7 pital emergency department; and 

8 ‘‘(III) referrals to health care fa9 cilities for the purposes of receiving 

10 long-term self-harm and suicide pre11 vention; 

12 ‘‘(ii) information on the adherence of 

13 the hospital emergency department to the 

14 standards of practice described in sub15 section (f)(1); and 

16 ‘‘(iii) other information as the Sec17 retary determines appropriate to evaluate 

18 the use of grant funds. 

19 ‘‘(2) REPORTS TO CONGRESS.—Not later than 

20 2 years after the date of the enactment of the Com21 mitment to Defeat the Virus and Keep America 

22 Healthy Act, and biennially thereafter, the Secretary 

23 shall submit to the Committee on Health, Edu24 cation, Labor, and Pensions of the Senate and the 

25 Committee on Energy and Commerce of the House 


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1 of Representatives a report on the grant program 

2 under this section, including— 

3 ‘‘(A) a summary of reports received by the 

4 Secretary under paragraph (1); and 

5 ‘‘(B) an evaluation of the program by the 

6 Secretary. 

7 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To 

8 carry out this section, there are authorized to be appro9 priated $30,000,000 for each of fiscal years 2021 through 

10 2025.’’. 

11 Subtitle D—Effective Suicide 

12 Screening in the Emergency De13 partment 

14 SEC. 6031. PROGRAM TO IMPROVE THE CARE PROVIDED TO 

15 PATIENTS IN THE EMERGENCY DEPARTMENT 

16 WHO ARE AT RISK OF SUICIDE. 

17 Part P of title III of the Public Health Service Act 

18 (42 U.S.C. 280g et seq.) is amended by adding at the end 

19 the following new section: 

20 ‘‘SEC. 399V–7. PROGRAM TO IMPROVE THE CARE PROVIDED 

21 TO PATIENTS IN THE EMERGENCY DEPART22 MENT WHO ARE AT RISK OF SUICIDE. 

23 ‘‘(a) IN GENERAL.—The Secretary shall establish a 

24 program (in this section referred to as the ‘Program’) to 

25 improve the identification, assessment, and treatment of 


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1 patients in emergency departments who are at risk for sui2 cide, including by— 

3 ‘‘(1) developing policies and procedures for 

4 identifying and assessing individuals who are at risk 

5 of suicide; and 

6 ‘‘(2) enhancing the coordination of care for 

7 such individuals after discharge. 

8 ‘‘(b) GRANT ESTABLISHMENT AND PARTICIPA9 TION.— 

10 ‘‘(1) IN GENERAL.—In carrying out the Pro11 gram, the Secretary shall award grants on a com12 petitive basis to not more than 40 eligible health 

13 care sites described in paragraph (2). 

14 ‘‘(2) ELIGIBILITY.—To be eligible for a grant 

15 under this section, a health care site shall— 

16 ‘‘(A) submit an application to the Sec17 retary at such time, in such manner, and con18 taining such information as the Secretary may 

19 specify; 

20 ‘‘(B) be a hospital (as defined in section 

21 1861(e) of the Social Security Act); 

22 ‘‘(C) have an emergency department; and 

23 ‘‘(D) deploy onsite health care or social 

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1 grate patients who are at risk of suicide with 

2 treatment and mental health support services. 

3 ‘‘(3) PREFERENCE.—In awarding grants under 

4 this section, the Secretary may give preference to eli5 gible health care sites described in paragraph (2) 

6 that meet at least one of the following criteria: 

7 ‘‘(A) The eligible health care site is a crit8 ical access hospital (as defined in section 

9 1861(mm)(1) of the Social Security Act). 

10 ‘‘(B) The eligible health care site is a sole 

11 community hospital (as defined in section 

12 1886(d)(5)(D)(iii) of the Social Security Act). 

13 ‘‘(C) The eligible health care site is oper14 ated by the Indian Health Service, by an Indian 

15 tribe or tribal organization (as such terms are 

16 defined in section 4 of the Indian Self-Deter17 mination and Education Assistance Act), or by 

18 an urban Indian organization (as defined in 

19 section 4 of the Indian Health Care Improve20 ment Act). 

21 ‘‘(D) The eligible health care site is located 

22 in a geographic area with a suicide rate that is 

23 higher than the national rate, as determined by 

24 the Secretary based on the most recent data 


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1 from the Centers for Disease Control and Pre2 vention. 

3 ‘‘(c) PERIOD OF GRANT.—A grant awarded to an eli4 gible health care site under this section shall be for a pe5 riod of at least 2 years. 

6 ‘‘(d) GRANT USES.— 

7 ‘‘(1) REQUIRED USES.—A grant awarded under 

8 this section to an eligible health care site shall be 

9 used for the following purposes: 

10 ‘‘(A) To train emergency department 

11 health care professionals to identify, assess, and 

12 treat patients who are at risk of suicide. 

13 ‘‘(B) To establish and implement policies 

14 and procedures for emergency departments to 

15 improve the identification, assessment and 

16 treatment of individuals who are at risk of sui17 cide. 

18 ‘‘(C) To establish and implement policies 

19 and procedures with respect to care coordina20 tion, integrated care models, or referral to evi21 dence-based treatment to be used upon the dis22 charge from the emergency department of pa23 tients who are at risk of suicide. 

24 ‘‘(2) ADDITIONAL PERMISSIBLE USES.—In ad25 dition to the required uses listed in paragraph (1), 


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1 a grant awarded under this section to an eligible 

2 health care site may be used for any of the following 

3 purposes: 

4 ‘‘(A) To hire emergency department psy5 chiatrists, psychologists, nurse practitioners, 

6 counselors, therapists, or other licensed health 

7 care and behavioral health professionals special8 izing in the treatment of individuals at risk of 

9 suicide. 

10 ‘‘(B) To develop and implement best prac11 tices for the follow-up care and long-term treat12 ment of individuals who are at risk of suicide. 

13 ‘‘(C) To increase the availability of and ac14 cess to evidence-based treatment for individuals 

15 who are at risk of suicide, including through 

16 telehealth services and strategies to reduce the 

17 boarding of these patients in emergency depart18 ments. 

19 ‘‘(D) To offer consultation with and refer20 ral to other supportive services that provide evi21 dence-based treatment and recovery for individ22 uals who are at risk of suicide. 

23 ‘‘(e) REPORTING REQUIREMENTS.— 

24 ‘‘(1) REPORTS BY GRANTEES.—Each eligible 

25 health care site receiving a grant under this section 


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1 shall submit to the Secretary an annual report for 

2 each year for which the grant is received on the 

3 progress of the program funded through the grant. 

4 Each such report shall include information on— 

5 ‘‘(A) the number of individuals screened in 

6 the site’s emergency department for being at 

7 risk of suicide; 

8 ‘‘(B) the number of individuals identified 

9 in the site’s emergency department as being— 

10 ‘‘(i) survivors of an attempted suicide; 

11 or 

12 ‘‘(ii) are at risk of suicide; 

13 ‘‘(C) the number of individuals who are 

14 identified in the site’s emergency department as 

15 being at risk of suicide by a health care or be16 havioral health professional hired pursuant to 

17 subsection (d)(2)(A); 

18 ‘‘(D) the number of individuals referred by 

19 the site’s emergency department to other treat20 ment facilities, the types of such other facilities, 

21 and the number of such individuals admitted to 

22 such other facilities pursuant to such referrals; 

23 ‘‘(E) the effectiveness of programs and ac24 tivities funded through the grant in preventing 

25 suicides and suicide attempts; and 


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1 ‘‘(F) any other relevant additional data re2 garding the programs and activities funded 

3 through the grant. 

4 ‘‘(2) REPORT BY SECRETARY.—Not later than 

5 one year after the end of fiscal year 2025, the Sec6 retary shall submit to Congress a report that in7 cludes— 

8 ‘‘(A) findings on the Program; 

9 ‘‘(B) overall patient outcomes achieved 

10 through the Program; 

11 ‘‘(C) an evaluation of the effectiveness of 

12 having a trained health care or behavioral 

13 health professional onsite to identify, assess, 

14 and treat patients who are at risk of suicide; 

15 and 

16 ‘‘(D) a compilation of policies, procedures, 

17 and best practices established, developed, or im18 plemented by grantees under this section. 

19 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

20 is authorized to be appropriated to carry out this section 

21 $20,000,000 for the period of fiscal years 2021 through 

22 2025.’’. 


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1 Subtitle E—Suicide Prevention 

2 Lifeline Improvement 

3 SEC. 6041. SUICIDE PREVENTION LIFELINE. 

4 (a) PLAN.—Section 520E–3 of the Public Health 

5 Service Act (42 U.S.C. 290bb–36c) is amended— 

6 (1) by redesignating subsection (c) as sub7 section (e); and 

8 (2) by inserting after subsection (b) the fol9 lowing: 

10 ‘‘(c) PLAN.— 

11 ‘‘(1) IN GENERAL.—For purposes of maintain12 ing the suicide prevention hotline under subsection 

13 (b)(2), the Secretary shall develop and implement a 

14 plan to ensure the provision of high-quality service. 

15 ‘‘(2) CONTENTS.—The plan required by para16 graph (1) shall include the following: 

17 ‘‘(A) Quality assurance provisions, includ18 ing— 

19 ‘‘(i) clearly defined and measurable 

20 performance indicators and objectives to 

21 improve the responsiveness and perform22 ance of the hotline, including at backup 

23 call centers; and 


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1 ‘‘(ii) quantifiable timeframes to track 

2 the progress of the hotline in meeting such 

3 performance indicators and objectives. 

4 ‘‘(B) Standards that crisis centers and 

5 backup centers must meet— 

6 ‘‘(i) to participate in the network 

7 under subsection (b)(1); and 

8 ‘‘(ii) to ensure that each telephone 

9 call, online chat message, and other com10 munication received by the hotline, includ11 ing at backup call centers, is answered in 

12 a timely manner by a person, consistent 

13 with the guidance established by the Amer14 ican Association of Suicidology or other 

15 guidance determined by the Secretary to be 

16 appropriate. 

17 ‘‘(C) Guidelines for crisis centers and 

18 backup centers to implement evidence-based 

19 practices including with respect to followup and 

20 referral to other health and social services re21 sources. 

22 ‘‘(D) Guidelines to ensure that resources 

23 are available and distributed to individuals 

24 using the hotline who are not personally in a 

25 time of crisis but know of someone who is. 


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1 ‘‘(E) Guidelines to carry out periodic test2 ing of the hotline, including at crisis centers 

3 and backup centers, during each fiscal year to 

4 identify and correct any problems in a timely 

5 manner. 

6 ‘‘(F) Guidelines to operate in consultation 

7 with the State department of health, local gov8 ernments, Indian tribes, and tribal organiza9 tions. 

10 ‘‘(3) INITIAL PLAN; UPDATES.—The Secretary 

11 shall— 

12 ‘‘(A) not later than 6 months after the 

13 date of enactment of the Commitment to Defeat 

14 the Virus and Keep America Healthy Act, com15 plete development of the initial version of the 

16 plan required by paragraph (1), begin imple17 mentation of such plan, and make such plan 

18 publicly available; and 

19 ‘‘(B) periodically thereafter, update such 

20 plan and make the updated plan publicly avail21 able.’’. 

22 (b) TRANSMISSION OF DATA TO CDC.—Section 

23 520E–3 of the Public Health Service Act (42 U.S.C. 

24 290bb–36c) is amended by inserting after subsection (c) 


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1 of such section, as added by subsection (a) of this section, 

2 the following: 

3 ‘‘(d) TRANSMISSION OF DATA TO CDC.—The Sec4 retary shall formalize and strengthen agreements between 

5 the National Suicide Prevention Lifeline program and the 

6 Centers for Disease Control and Prevention to transmit 

7 any necessary epidemiological data from the program to 

8 the Centers, including local call center data, to assist the 

9 Centers in suicide prevention efforts.’’. 

10 (c) AUTHORIZATION OF APPROPRIATIONS.—Sub11 section (e) of section 520E–3 of the Public Health Service 

12 Act (42 U.S.C. 290bb–36c) is amended to read as follows: 

13 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.— 

14 ‘‘(1) IN GENERAL.—To carry out this section, 

15 there are authorized to be appropriated $50,000,000 

16 for each of fiscal years 2021 through 2023. 

17 ‘‘(2) ALLOCATION.—Of the amount authorized 

18 to be appropriated by paragraph (1) for each of fis19 cal years 2021 through 2023, at least 80 percent 

20 shall be made available to crisis centers.’’. 

21 SEC. 6042. PILOT PROGRAM ON INNOVATIVE TECH22 NOLOGIES. 

23 (a) PILOT PROGRAM.— 

24 (1) IN GENERAL.—The Secretary of Health and 

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1 retary for Mental Health and Substance Use, shall 

2 carry out a pilot program to research, analyze, and 

3 employ various technologies and platforms of com4 munication (including social media platforms, 

5 texting platforms, and email platforms) for suicide 

6 prevention in addition to the telephone and online 

7 chat service provided by the Suicide Prevention Life8 line. 

9 (2) AUTHORIZATION OF APPROPRIATIONS.—To 

10 carry out paragraph (1), there is authorized to be 

11 appropriated $5,000,000 for the period of fiscal 

12 years 2021 and 2022. 

13 (b) REPORT.—Not later than 24 months after the 

14 date on which the pilot program under subsection (a) com15 mences, the Secretary of Health and Human Services, act16 ing through the Assistant Secretary for Mental Health 

17 and Substance Use, shall submit to the Congress a report 

18 on the pilot program. With respect to each platform of 

19 communication employed pursuant to the pilot program, 

20 the report shall include— 

21 (1) a full description of the program; 

22 (2) the number of individuals served by the pro23 gram; 

24 (3) the average wait time for each individual to 

25 receive a response; 


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1 (4) the cost of the program, including the cost 

2 per individual served; and 

3 (5) any other information the Secretary deter4 mines appropriate. 

5 SEC. 6043. HHS STUDY AND REPORT. 

6 Not later than 24 months after the Secretary of 

7 Health and Human Services begins implementation of the 

8 plan required by section 520E–3(c) of the Public Health 

9 Service Act, as added by section 6041(a)(2) of this sub10 title, the Secretary shall— 

11 (1) complete a study on— 

12 (A) the implementation of such plan, in13 cluding the progress towards meeting the objec14 tives identified pursuant to paragraph (2)(A)(i) 

15 of such section 520E–3(c) by the timeframes 

16 identified pursuant to paragraph (2)(A)(ii) of 

17 such section 520E–3(c); and 

18 (B) in consultation with the Director of 

19 the Centers for Disease Control and Prevention, 

20 options to expand data gathering from calls to 

21 the Suicide Prevention Lifeline in order to bet22 ter track aspects of usage such as repeat calls, 

23 consistent with applicable Federal and State 

24 privacy laws; and 


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1 (2) submit a report to the Congress on the re2 sults of such study, including recommendations on 

3 whether additional legislation or appropriations are 

4 needed. 

5 SEC. 6044. GAO STUDY AND REPORT. 

6 (a) IN GENERAL.—Not later than 24 months after 

7 the Secretary of Health and Human Services begins imple8 mentation of the plan required by section 520E–3(c) of 

9 the Public Health Service Act, as added by section 

10 6041(a)(2) of this subtitle, the Comptroller General of the 

11 United States shall— 

12 (1) complete a study on the Suicide Prevention 

13 Lifeline; and 

14 (2) submit a report to the Congress on the re15 sults of such study. 

16 (b) ISSUES TO BE STUDIED.—The study required by 

17 subsection (a) shall address— 

18 (1) the feasibility of geolocating callers to direct 

19 calls to the nearest crisis center; 

20 (2) operation shortcomings of the Suicide Pre21 vention Lifeline; 

22 (3) geographic coverage of each crisis call cen23 ter; 

24 (4) the call answer rate of each crisis call cen25 ter; 


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1 (5) the call wait time of each crisis call center; 

2 (6) the hours of operation of each crisis call 

3 center; 

4 (7) funding avenues of each crisis call center; 

5 (8) the implementation of the plan under sec6 tion 520E–3(c) of the Public Health Service Act, as 

7 added by section 6041(a) of this subtitle, including 

8 the progress towards meeting the objectives identi9 fied pursuant to paragraph (2)(A)(i) of such section 

10 520E–3(c) by the timeframes identified pursuant to 

11 paragraph (2)(A)(ii) of such section 520E–3(c); and 

12 (9) service to individuals requesting a foreign 

13 language speaker, including— 

14 (A) the number of calls or chats the Life15 line receives from individuals speaking a foreign 

16 language; 

17 (B) the capacity of the Lifeline to handle 

18 these calls or chats; and 

19 (C) the number of crisis centers with the 

20 capacity to serve foreign language speakers, in 

21 house. 

22 (c) RECOMMENDATIONS.—The report required by 

23 subsection (a) shall include recommendations for improv24 ing the Suicide Prevention Lifeline, including rec25 ommendations for legislative and administrative actions. 


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1 SEC. 6045. DEFINITION. 

2 In this subtitle, the term ‘‘Suicide Prevention Life3 line’’ means the suicide prevention hotline maintained pur4 suant to section 520E–3 of the Public Health Service Act 

5 (42 U.S.C. 290bb–36c). 

6 Subtitle F—Campaign To Prevent 

7 Suicide 

8 SEC. 6051. NATIONAL SUICIDE PREVENTION LIFELINE. 

9 Section 520E–3(b)(2) of the Public Health Service 

10 Act (42 U.S.C. 290bb–36c(b)(2)) is amended by inserting 

11 after ‘‘suicide prevention hotline’’ the following: ‘‘, which, 

12 beginning not later than one year after the date of the 

13 enactment of the Commitment to Defeat the Virus and 

14 Keep America Healthy Act, shall be a 3-digit nationwide 

15 toll-free telephone number,’’. 

16 SEC. 6052. NATIONAL SUICIDE PREVENTION MEDIA CAM17 PAIGN. 

18 (a) NATIONAL SUICIDE PREVENTION MEDIA CAM19 PAIGN.— 

20 (1) IN GENERAL.—Not later than the date that 

21 is three years after the date of the enactment of this 

22 Act, the Secretary of Health and Human Services 

23 (referred to in this section as the ‘‘Secretary’’), in 

24 coordination with the Assistant Secretary for Mental 

25 Health and Substance Use (referred to in this sec26 tion as the ‘‘Assistant Secretary’’) and the Director 


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1 of the Centers for Disease Control and Prevention 

2 (referred to in this section as the ‘‘Director’’), shall 

3 conduct a national suicide prevention media cam4 paign (referred to in this section as the ‘‘national 

5 media campaign’’), in accordance with the require6 ments of this section, for purposes of— 

7 (A) preventing suicide in the United 

8 States; 

9 (B) educating families, friends, and com10 munities on how to address suicide and suicidal 

11 thoughts, including when to encourage individ12 uals with suicidal risk to seek help; and 

13 (C) increasing awareness of suicide preven14 tion resources of the Centers for Disease Con15 trol and Prevention and the Substance Abuse 

16 and Mental Health Services Administration (in17 cluding the suicide prevention hotline main18 tained under section 520E–3 of the Public 

19 Health Service Act (42 U.S.C. 290bb–36c)), 

20 any suicide prevention mobile application of the 

21 Centers for Disease Control and Prevention or 

22 the Substance Abuse Mental Health Services 

23 Administration, and other support resources de24 termined appropriate by the Secretary. 


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1 (2) ADDITIONAL CONSULTATION.—In addition 

2 to coordinating with the Assistant Secretary and the 

3 Director under this section, the Secretary shall con4 sult with, as appropriate, State, local, Tribal, and 

5 territorial health departments, primary health care 

6 providers, hospitals with emergency departments, 

7 mental and behavioral health services providers, cri8 sis response services providers, first responders, sui9 cide prevention and mental health professionals, pa10 tient advocacy groups, survivors of suicide attempts, 

11 and representatives of television and social media 

12 platforms in planning the national media campaign 

13 to be conducted under paragraph (1). 

14 (b) TARGET AUDIENCES.— 

15 (1) TAILORING ADVERTISEMENTS AND OTHER

16 COMMUNICATIONS.—In conducting the national 

17 media campaign under subsection (a)(1), the Sec18 retary may tailor culturally competent advertise19 ments and other communications of the campaign 

20 across all available media for a target audience 

21 (such as a particular geographic location or demo22 graphic) across the lifespan. 

23 (2) TARGETING CERTAIN LOCAL AREAS.—The 

24 Secretary shall, to the maximum extent practicable, 

25 use amounts made available under subsection (f) for 


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1 media that targets individuals in local areas with 

2 higher suicide rates. 

3 (c) USE OF FUNDS.— 

4 (1) REQUIRED USES.— 

5 (A) IN GENERAL.—The Secretary shall, to 

6 the extent reasonably feasible with the funds 

7 made available under subsection (f), carry out 

8 the following, with respect to the national media 

9 campaign: 

10 (i) The purchase of advertising time 

11 and space, including the strategic planning 

12 for, and accounting of, any such purchase. 

13 (ii) Creative services and talent costs. 

14 (iii) Advertising production costs. 

15 (iv) Testing and evaluation of adver16 tising. 

17 (v) Evaluation of the effectiveness of 

18 the national media campaign. 

19 (vi) Operational and management ex20 penses. 

21 (vii) The creation of an educational 

22 toolkit for television and social media plat23 forms to use in discussing suicide and rais24 ing awareness about how to prevent sui25 cide. 


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1 (B) SPECIFIC REQUIREMENTS.— 

2 (i) TESTING AND EVALUATION OF AD3 VERTISING.—In testing and evaluating ad4 vertising under subparagraph (A)(iv), the 

5 Secretary shall test all advertisements 

6 after use in the national media campaign 

7 to evaluate the extent to which such adver8 tisements have been effective in carrying 

9 out the purposes of the national media 

10 campaign. 

11 (ii) EVALUATION OF EFFECTIVENESS

12 OF NATIONAL MEDIA CAMPAIGN.—In eval13 uating the effectiveness of the national 

14 media campaign under subparagraph 

15 (A)(v), the Secretary shall take into ac16 count— 

17 (I) the number of unique calls 

18 that are made to the suicide preven19 tion hotline maintained under section 

20 520E–3 of the Public Health Service 

21 Act (42 U.S.C. 290bb–36c) and as22 sess whether there are any State and 

23 regional variations with respect to the 

24 capacity to answer such calls; 


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1 (II) the number of unique en2 counters with suicide prevention and 

3 support resources of the Centers for 

4 Disease Control and Prevention and 

5 the Substance Abuse and Mental 

6 Health Services Administration and 

7 assess engagement with such suicide 

8 prevention and support resources; 

9 (III) whether the national media 

10 campaign has contributed to increased 

11 awareness that suicidal individuals 

12 should be engaged, rather than ig13 nored; and 

14 (IV) such other measures of eval15 uation as the Secretary determines 

16 are appropriate. 

17 (2) OPTIONAL USES.—The Secretary may use 

18 amounts made available under subsection (f) for the 

19 following, with respect to the national media cam20 paign: 

21 (A) Partnerships with professional and 

22 civic groups, community-based organizations, 

23 including faith-based organizations, and Gov24 ernment or Tribal organizations that the Sec25 retary determines have experience in suicide 


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1 prevention, including the Substance Abuse and 

2 Mental Health Services Administration and the 

3 Centers for Disease Control and Prevention. 

4 (B) Entertainment industry outreach, 

5 interactive outreach, media projects and activi6 ties, public information, news media outreach, 

7 outreach through television programs, and cor8 porate sponsorship and participation. 

9 (d) PROHIBITIONS.—None of the amounts made 

10 available under subsection (f) may be obligated or ex11 pended for any of the following: 

12 (1) To supplant current suicide prevention cam13 paigns. 

14 (2) For partisan political purposes, or to ex15 press advocacy in support of or to defeat any clearly 

16 identified candidate, clearly identified ballot initia17 tive, or clearly identified legislative or regulatory 

18 proposal. 

19 (e) REPORT TO CONGRESS.—Not later than 18 

20 months after implementation of the national media cam21 paign has begun, the Secretary, in coordination with the 

22 Assistant Secretary and the Director, shall, with respect 

23 to the first year of the national media campaign, submit 

24 to Congress a report that describes— 


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1 (1) the strategy of the national media campaign 

2 and whether specific objectives of such campaign 

3 were accomplished, including whether such campaign 

4 impacted the number of calls made to lifeline crisis 

5 centers and the capacity of such centers to manage 

6 such calls; 

7 (2) steps taken to ensure that the national 

8 media campaign operates in an effective and effi9 cient manner consistent with the overall strategy 

10 and focus of the national media campaign; 

11 (3) plans to purchase advertising time and 

12 space; 

13 (4) policies and practices implemented to ensure 

14 that Federal funds are used responsibly to purchase 

15 advertising time and space and eliminate the poten16 tial for waste, fraud, and abuse; and 

17 (5) all contracts entered into with a corpora18 tion, a partnership, or an individual working on be19 half of the national media campaign. 

20 (f) AUTHORIZATION OF APPROPRIATIONS.—For pur21 poses of carrying out this section, there is authorized to 

22 be appropriated $10,000,000 for each of fiscal years 2021 

23 through 2025. 


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1 Subtitle G—Helping Emergency 

2 Responders Overcome 

3 SEC. 6061. DATA SYSTEM TO CAPTURE NATIONAL PUBLIC 

4 SAFETY OFFICER SUICIDE INCIDENCE. 

5 The Public Health Service Act is amended by insert6 ing before section 318 of such Act (42 U.S.C. 247c) the 

7 following: 

8 ‘‘SEC. 317W. DATA SYSTEM TO CAPTURE NATIONAL PUBLIC 

9 SAFETY OFFICER SUICIDE INCIDENCE. 

10 ‘‘(a) IN GENERAL.—The Secretary, in coordination 

11 with the Director of the Centers for Disease Control and 

12 Prevention and other agencies as the Secretary determines 

13 appropriate, shall— 

14 ‘‘(1) develop and maintain a data system, to be 

15 known as the Public Safety Officer Suicide Report16 ing System, for the purposes of— 

17 ‘‘(A) collecting data on the suicide inci18 dence among public safety officers; and 

19 ‘‘(B) facilitating the study of successful 

20 interventions to reduce suicide among public 

21 safety officers; and 

22 ‘‘(2) integrate such system into the National 

23 Violent Death Reporting System, so long as the Sec24 retary determines such integration to be consistent 

25 with the purposes described in paragraph (1). 


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1 ‘‘(b) DATA COLLECTION.—In collecting data for the 

2 Public Safety Officer Suicide Reporting System, the Sec3 retary shall, at a minimum, collect the following informa4 tion: 

5 ‘‘(1) The total number of suicides in the United 

6 States among all public safety officers in a given cal7 endar year. 

8 ‘‘(2) Suicide rates for public safety officers in 

9 a given calendar year, disaggregated by— 

10 ‘‘(A) age and gender of the public safety 

11 officer; 

12 ‘‘(B) State; 

13 ‘‘(C) occupation; including both the indi14 vidual’s role in their public safety agency and 

15 their primary occupation in the case of volun16 teer public safety officers; 

17 ‘‘(D) where available, the status of the 

18 public safety officer as volunteer, paid-on-call, 

19 or career; and 

20 ‘‘(E) status of the public safety officer as 

21 active or retired. 

22 ‘‘(c) CONSULTATION DURING DEVELOPMENT.—In 

23 developing the Public Safety Officer Suicide Reporting 

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1 ing suicide incidence in a safe, sensitive, anonymous, and 

2 effective manner. Such non-Federal experts shall include, 

3 as appropriate, the following: 

4 ‘‘(1) Public health experts with experience in 

5 developing and maintaining suicide registries. 

6 ‘‘(2) Organizations that track suicide among 

7 public safety officers. 

8 ‘‘(3) Mental health experts with experience in 

9 studying suicide and other profession-related trau10 matic stress. 

11 ‘‘(4) Clinicians with experience in diagnosing 

12 and treating mental health issues. 

13 ‘‘(5) Active and retired volunteer, paid-on-call, 

14 and career public safety officers. 

15 ‘‘(6) Relevant national police, and fire and 

16 emergency medical services, organizations. 

17 ‘‘(d) DATA PRIVACY AND SECURITY.—In developing 

18 and maintaining the Public Safety Officer Suicide Report19 ing System, the Secretary shall ensure that all applicable 

20 Federal privacy and security protections are followed to 

21 ensure that— 

22 ‘‘(1) the confidentiality and anonymity of sui23 cide victims and their families are protected, includ24 ing so as to ensure that data cannot be used to deny 

25 benefits; and 


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1 ‘‘(2) data is sufficiently secure to prevent unau2 thorized access. 

3 ‘‘(e) REPORTING.— 

4 ‘‘(1) ANNUAL REPORT.—Not later than 2 years 

5 after the date of enactment of the Commitment to 

6 Defeat the Virus and Keep America Healthy Act, 

7 and biannually thereafter, the Secretary shall submit 

8 a report to the Congress on the suicide incidence 

9 among public safety officers. Each such report 

10 shall— 

11 ‘‘(A) include the number and rate of such 

12 suicide incidence, disaggregated by age, gender, 

13 and State of employment; 

14 ‘‘(B) identify characteristics and contrib15 uting circumstances for suicide among public 

16 safety officers; 

17 ‘‘(C) disaggregate rates of suicide by— 

18 ‘‘(i) occupation; 

19 ‘‘(ii) status as volunteer, paid-on-call, 

20 or career; and 

21 ‘‘(iii) status as active or retired; 

22 ‘‘(D) include recommendations for further 

23 study regarding the suicide incidence among 

24 public safety officers; 


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1 ‘‘(E) specify in detail, if found, any obsta2 cles in collecting suicide rates for volunteers 

3 and include recommended improvements to 

4 overcome such obstacles; 

5 ‘‘(F) identify options for interventions to 

6 reduce suicide among public safety officers; and 

7 ‘‘(G) describe procedures to ensure the 

8 confidentiality and anonymity of suicide victims 

9 and their families, as described in subsection 

10 (d)(1). 

11 ‘‘(2) PUBLIC AVAILABILITY.—Upon the submis12 sion of each report to the Congress under paragraph 

13 (1), the Secretary shall make the full report publicly 

14 available on the website of the Centers for Disease 

15 Control and Prevention. 

16 ‘‘(f) DEFINITION.—In this section, the term ‘public 

17 safety officer’ means— 

18 ‘‘(1) a public safety officer as defined in section 

19 1204 of the Omnibus Crime Control and Safe 

20 Streets Act of 1968; or 

21 ‘‘(2) a public safety telecommunicator as de22 scribed in detailed occupation 43–5031 in the Stand23 ard Occupational Classification Manual of the Office 

24 of Management and Budget (2018). 


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1 ‘‘(g) PROHIBITED USE OF INFORMATION.—Notwith2 standing any other provision of law, if an individual is 

3 identified as deceased based on information contained in 

4 the Public Safety Officer Suicide Reporting System, such 

5 information may not be used to deny or rescind life insur6 ance payments or other benefits to a survivor of the de7 ceased individual.’’. 

8 SEC. 6062. PEER-SUPPORT BEHAVIORAL HEALTH AND 

9 WELLNESS PROGRAMS WITHIN FIRE DEPART10 MENTS AND EMERGENCY MEDICAL SERVICE 

11 AGENCIES. 

12 (a) IN GENERAL.—Part B of title III of the Public 

13 Health Service Act (42 U.S.C. 243 et seq.) is amended 

14 by adding at the end the following: 

15 ‘‘SEC. 320B. PEER-SUPPORT BEHAVIORAL HEALTH AND 

16 WELLNESS PROGRAMS WITHIN FIRE DEPART17 MENTS AND EMERGENCY MEDICAL SERVICE 

18 AGENCIES. 

19 ‘‘(a) IN GENERAL.—The Secretary shall award 

20 grants to eligible entities for the purpose of establishing 

21 or enhancing peer-support behavioral health and wellness 

22 programs within fire departments and emergency medical 

23 services agencies. 


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1 ‘‘(b) PROGRAM DESCRIPTION.—A peer-support be2 havioral health and wellness program funded under this 

3 section shall— 

4 ‘‘(1) use career and volunteer members of fire 

5 departments or emergency medical services agencies 

6 to serve as peer counselors; 

7 ‘‘(2) provide training to members of career, vol8 unteer, and combination fire departments or emer9 gency medical service agencies to serve as such peer 

10 counselors; 

11 ‘‘(3) purchase materials to be used exclusively 

12 to provide such training; and 

13 ‘‘(4) disseminate such information and mate14 rials as are necessary to conduct the program. 

15 ‘‘(c) DEFINITION.—In this section: 

16 ‘‘(1) The term ‘eligible entity’ means a non17 profit organization with expertise and experience 

18 with respect to the health and life safety of members 

19 of fire and emergency medical services agencies. 

20 ‘‘(2) The term ‘member’— 

21 ‘‘(A) with respect to an emergency medical 

22 services agency, means an employee, regardless 

23 of rank or whether the employee receives com24 pensation (as defined in section 1204(7) of the 


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1 Omnibus Crime Control and Safe Streets Act of 

2 1968); and 

3 ‘‘(B) with respect to a fire department, 

4 means any employee, regardless of rank or 

5 whether the employee receives compensation, of 

6 a Federal, State, Tribal, or local fire depart7 ment who is responsible for responding to calls 

8 for emergency service.’’. 

9 (b) TECHNICAL CORRECTION.—Effective as if in10 cluded in the enactment of the Children’s Health Act of 

11 2000 (Public Law 106–310), the amendment instruction 

12 in section 1603 of such Act is amended by striking ‘‘Part 

13 B of the Public Health Service Act’’ and inserting ‘‘Part 

14 B of title III of the Public Health Service Act’’. 

15 SEC. 6063. HEALTH CARE PROVIDER BEHAVIORAL HEALTH 

16 AND WELLNESS PROGRAMS. 

17 Part B of title III of the Public Health Service Act 

18 (42 U.S.C. 243 et seq.), as amended by section 6062, is 

19 further amended by adding at the end the following: 

20 ‘‘SEC. 320C. HEALTH CARE PROVIDER BEHAVIORAL 

21 HEALTH AND WELLNESS PROGRAMS. 

22 ‘‘(a) IN GENERAL.—The Secretary shall award 

23 grants to eligible entities for the purpose of establishing 

24 or enhancing behavioral health and wellness programs for 

25 health care providers. 


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1 ‘‘(b) PROGRAM DESCRIPTION.—A behavioral health 

2 and wellness program funded under this section shall— 

3 ‘‘(1) provide confidential support services for 

4 health care providers to help handle stressful or 

5 traumatic patient-related events, including coun6 seling services and wellness seminars; 

7 ‘‘(2) provide training to health care providers to 

8 serve as peer counselors to other health care pro9 viders; 

10 ‘‘(3) purchase materials to be used exclusively 

11 to provide such training; and 

12 ‘‘(4) disseminate such information and mate13 rials as are necessary to conduct such training and 

14 provide such peer counseling. 

15 ‘‘(c) DEFINITIONS.—In this section, the term ‘eligible 

16 entity’ means a hospital, including a critical access hos17 pital (as defined in section 1861(mm)(1) of the Social Se18 curity Act) or a disproportionate share hospital (as defined 

19 under section 1923(a)(1)(A) of such Act), a federally 

20 qualified health center (as defined in section 

21 1905(1)(2)(B) of such Act), or any other health care facil22 ity.’’. 


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1 SEC. 6064. DEVELOPMENT OF RESOURCES FOR EDUCATING 

2 MENTAL HEALTH PROFESSIONALS ABOUT 

3 TREATING FIRE FIGHTERS AND EMERGENCY 

4 MEDICAL SERVICES PERSONNEL. 

5 (a) IN GENERAL.—The Administrator of the United 

6 States Fire Administration, in consultation with the Sec7 retary of Health and Human Services, shall develop and 

8 make publicly available resources that may be used by the 

9 Federal Government and other entities to educate mental 

10 health professionals about— 

11 (1) the culture of Federal, State, Tribal, and 

12 local career, volunteer, and combination fire depart13 ments and emergency medical services agencies; 

14 (2) the different stressors experienced by fire15 fighters and emergency medical services personnel, 

16 supervisory firefighters and emergency medical serv17 ices personnel, and chief officers of fire departments 

18 and emergency medical services agencies; 

19 (3) challenges encountered by retired fire20 fighters and emergency medical services personnel; 

21 and 

22 (4) evidence-based therapies for mental health 

23 issues common to firefighters and emergency med24 ical services personnel within such departments and 

25 agencies. 


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1 (b) CONSULTATION.—In developing resources under 

2 subsection (a), the Administrator of the United States 

3 Fire Administration and the Secretary of Health and 

4 Human Services shall consult with national fire and emer5 gency medical services organizations. 

6 (c) DEFINITIONS.—In this section: 

7 (1) The term ‘‘firefighter’’ means any employee, 

8 regardless of rank or whether the employee receives 

9 compensation, of a Federal, State, Tribal, or local 

10 fire department who is responsible for responding to 

11 calls for emergency service. 

12 (2) The term ‘‘emergency medical services per13 sonnel’’ means any employee, regardless of rank or 

14 whether the employee receives compensation, as de15 fined in section 1204(7) of the Omnibus Crime Con16 trol and Safe Streets Act of 1968 (34 U.S.C. 

17 10284(7)). 

18 (3) The term ‘‘chief officer’’ means any indi19 vidual who is responsible for the overall operation of 

20 a fire department or an emergency medical services 

21 agency, irrespective of whether such individual also 

22 serves as a firefighter or emergency medical services 

23 personnel. 


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1 SEC. 6065. BEST PRACTICES AND OTHER RESOURCES FOR 

2 ADDRESSING POSTTRAUMATIC STRESS DIS3 ORDER IN PUBLIC SAFETY OFFICERS. 

4 (a) DEVELOPMENT; UPDATES.—The Secretary of 

5 Health and Human Services shall— 

6 (1) develop and assemble evidence-based best 

7 practices and other resources to identify, prevent, 

8 and treat posttraumatic stress disorder and co-oc9 curring disorders in public safety officers; and 

10 (2) reassess and update, as the Secretary deter11 mines necessary, such best practices and resources, 

12 including based upon the options for interventions to 

13 reduce suicide among public safety officers identified 

14 in the annual reports required by section 

15 317W(e)(1)(F) of the Public Health Service Act, as 

16 added by section 6061 of this subtitle. 

17 (b) CONSULTATION.—In developing, assembling, and 

18 updating the best practices and resources under sub19 section (a), the Secretary of Health and Human Services 

20 shall consult with, at a minimum, the following: 

21 (1) Public health experts. 

22 (2) Mental health experts with experience in 

23 studying suicide and other profession-related trau24 matic stress. 

25 (3) Clinicians with experience in diagnosing and 

26 treating mental health issues. 


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1 (4) Relevant national police, fire, and emer2 gency medical services organizations. 

3 (c) AVAILABILITY.—The Secretary of Health and 

4 Human Services shall make the best practices and re5 sources under subsection (a) available to Federal, State, 

6 and local fire, law enforcement, and emergency medical 

7 services agencies. 

8 (d) FEDERAL TRAINING AND DEVELOPMENT PRO9 GRAMS.—The Secretary of Health and Human Services 

10 shall work with Federal departments and agencies, includ11 ing the United States Fire Administration, to incorporate 

12 education and training on the best practices and resources 

13 under subsection (a) into Federal training and develop14 ment programs for public safety officers. 

15 (e) DEFINITION.—In this section, the term ‘‘public 

16 safety officer’’ means— 

17 (1) a public safety officer as defined in section 

18 1204 of the Omnibus Crime Control and Safe 

19 Streets Act of 1968 (34 U.S.C. 10284); or 

20 (2) a public safety telecommunicator as de21 scribed in detailed occupation 43–5031 in the Stand22 ard Occupational Classification Manual of the Office 

23 of Management and Budget (2018). 


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1 Subtitle H—Behavioral Health 

2 Intervention Guidelines 

3 SEC. 6071. BEST PRACTICES FOR BEHAVIORAL INTERVEN4 TION TEAMS. 

5 The Public Health Service Act is amended by insert6 ing after section 520G of such Act (42 U.S.C. 290bb–38) 

7 the following new section: 

8 ‘‘SEC. 520H. BEST PRACTICES FOR BEHAVIORAL INTERVEN9 TION TEAMS. 

10 ‘‘(a) IN GENERAL.—The Secretary, acting through 

11 the Assistant Secretary, shall develop and periodically up12 date— 

13 ‘‘(1) best practices to assist elementary schools, 

14 secondary schools, and institutions of higher edu15 cation in establishing and using behavioral interven16 tion teams; and 

17 ‘‘(2) a list of evidence-based threat assessment 

18 training providers to assist personnel in elementary 

19 schools, secondary schools, and institutions of higher 

20 education in implementing such best practices, in21 cluding with respect to training behavioral interven22 tion teams. 

23 ‘‘(b) ELEMENTS.—The best practices under sub24 section (a)(1) shall include guidance on the following: 


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1 ‘‘(1) How behavioral intervention teams can op2 erate effectively from an evidence-based, objective 

3 perspective while protecting the constitutional and 

4 civil rights of individuals, including any individual of 

5 concern. 

6 ‘‘(2) The use of behavioral intervention teams 

7 to identify individuals of concern, implement inter8 ventions, and manage risk through the framework of 

9 the school’s or institution’s rules or code of conduct, 

10 as applicable. 

11 ‘‘(3) How behavioral intervention teams can, 

12 when assessing an individual of concern— 

13 ‘‘(A) seek training on evidence-based, 

14 threat-assessment rubrics; 

15 ‘‘(B) ensure that such teams— 

16 ‘‘(i) have adequately trained, diverse 

17 stakeholders with varied expertise; and 

18 ‘‘(ii) use cross validation by a wide19 range of individual perspectives on the 

20 team; and 

21 ‘‘(C) use violence risk assessment. 

22 ‘‘(4) How behavioral intervention teams can 

23 avoid— 

24 ‘‘(A) attempting to predict future behavior 

25 by the concept of pre-crime; 


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1 ‘‘(B) inappropriately using a mental health 

2 assessment; 

3 ‘‘(C) inappropriately limiting or restricting 

4 law enforcement’s jurisdiction over criminal 

5 matters; 

6 ‘‘(D) attempting to substitute the behav7 ioral intervention process in place of a criminal 

8 process, or impede a criminal process, when an 

9 individual of concern’s behavior has potential 

10 criminal implications; 

11 ‘‘(E) endangering an individual’s privacy 

12 by failing to ensure that all applicable Federal 

13 and State privacy laws are fully complied with; 

14 or 

15 ‘‘(F) creating school-to-prison pipelines. 

16 ‘‘(c) CONSULTATION.—In carrying out subsection 

17 (a)(1), the Secretary shall consult with— 

18 ‘‘(1) the Secretary of Education; 

19 ‘‘(2) the Director of the National Threat As20 sessment Center of the Department of Homeland 

21 Security; 

22 ‘‘(3) the Attorney General of the United States; 

23 and 

24 ‘‘(4) as appropriate, relevant stakeholders in25 cluding— 


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1 ‘‘(A) teachers and other educators, prin2 cipals, school administrators, school board 

3 members, school psychologists, mental health 

4 professionals, and parents of elementary school 

5 and secondary school students; 

6 ‘‘(B) local law enforcement agencies and 

7 campus law enforcement administrators; 

8 ‘‘(C) mental health mobile crisis providers; 

9 ‘‘(D) child and adolescent psychiatrists; 

10 and 

11 ‘‘(E) other education and mental health 

12 professionals. 

13 ‘‘(d) PUBLICATION.—Not later than 2 years after the 

14 date of enactment of this section, the Secretary shall pub15 lish the best practices under subsection (a)(1) and the list 

16 under subsection (a)(2) on a publicly accessible website 

17 of the Department of Health and Human Services. 

18 ‘‘(e) TECHNICAL ASSISTANCE.—The Secretary shall 

19 provide technical assistance to institutions of higher edu20 cation, elementary schools, and secondary schools to assist 

21 such institutions and schools in implementing the best 

22 practices under subsection (a). 

23 ‘‘(f) DEFINITIONS.—In this section: 

24 ‘‘(1) The term ‘behavioral intervention team’ 

25 means a team of qualified individuals who— 


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1 ‘‘(A) are responsible for identifying and as2 sessing individuals of concern; and 

3 ‘‘(B) develop and facilitate implementation 

4 of evidence-based interventions to mitigate the 

5 threat of harm to self or others posed by indi6 viduals of concern and address the mental and 

7 behavioral health needs of individuals of con8 cern to reduce such threat. 

9 ‘‘(2) The terms ‘elementary school’, ‘parent’, 

10 and ‘secondary school’ have the meanings given to 

11 such terms in section 8101 of the Elementary and 

12 Secondary Education Act of 1965 (20 U.S.C. 7801). 

13 ‘‘(3) The term ‘individual of concern’ means an 

14 individual whose behavior indicates a potential 

15 threat to self or others. 

16 ‘‘(4) The term ‘institution of higher education’ 

17 has the meaning given to such term in section 102 

18 of the Higher Education Act of 1965 (20 U.S.C. 

19 1002). 

20 ‘‘(5) The term ‘mental health assessment’ 

21 means an evaluation, primarily focused on diagnosis, 

22 determining the need for involuntary commitment, 

23 medication management, and on-going treatment 

24 recommendations. 


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1 ‘‘(6) The term ‘pre-crime’ means law-enforce2 ment efforts and strategies to deter crime by pre3 dicting when and where criminal activity will occur. 

4 ‘‘(7) The term ‘violence risk assessment’ refers 

5 to a broad determination of the potential risk of vio6 lence based on evidence-based literature.’’. 

7 Subtitle I—Suicide Training and 

8 Awareness Nationally Delivered 

9 for Universal Prevention 

10 SEC. 6081. STUDENT SUICIDE AWARENESS AND PREVEN11 TION TRAINING. 

12 (a) IN GENERAL.—Title V of the Public Health Serv13 ice Act is amended by inserting after section 520A of such 

14 Act (42 U.S.C. 290bb–32) the following: 

15 ‘‘SEC. 520B. STUDENT SUICIDE AWARENESS AND PREVEN16 TION TRAINING POLICIES. 

17 ‘‘(a) IN GENERAL.—As a condition on receipt of 

18 funds under section 520A, each State educational agency, 

19 local educational agency, and Tribal educational agency 

20 that receives such funds, directly or through a State or 

21 Indian Tribe, for activities to be performed within sec22 ondary schools, including the Project AWARE State Edu23 cation Agency Grant Program, shall— 


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1 ‘‘(1) establish and implement a school-based 

2 student suicide awareness and prevention training 

3 policy; 

4 ‘‘(2) consult with stakeholders (including prin5 cipals, teachers, parents, local Tribal officials, and 

6 other school leaders) in the development of the pol7 icy under subsection (a)(1); and 

8 ‘‘(3) collect and report information in accord9 ance with subsection (c). 

10 ‘‘(b) SCHOOL-BASED STUDENT SUICIDE AWARENESS

11 AND PREVENTION TRAINING POLICY.—A school-based 

12 student suicide awareness and prevention training policy 

13 implemented pursuant to subsection (a)— 

14 ‘‘(1) shall be evidence-based; 

15 ‘‘(2) shall be culturally and linguistically appro16 priate; 

17 ‘‘(3) shall provide evidence-based training to 

18 students in grades 6 through 12, in coordination 

19 with school-based mental health service providers as 

20 defined in section 4102(6) of the Elementary and 

21 Secondary Education Act of 1965, if applicable, re22 garding— 

23 ‘‘(A) suicide education and awareness, in24 cluding warning signs of self-harm or suicidal 

25 ideation; 


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1 ‘‘(B) methods that students can use to 

2 seek help for themselves and others; and 

3 ‘‘(C) student resources for suicide aware4 ness and prevention; 

5 ‘‘(4) shall provide for retraining of such stu6 dents every school year; 

7 ‘‘(5) may last for such period as the State edu8 cational agency, local educational agency, or Tribal 

9 educational agency involved determines to be appro10 priate; 

11 ‘‘(6) may be implemented through any delivery 

12 method, including in-person trainings, digital 

13 trainings, or train-the-trainer models; and 

14 ‘‘(7) may include discussion of comorbidities or 

15 risk factors for suicidal ideation or self-harm, includ16 ing substance misuse, sexual or physical abuse, men17 tal illness, or other evidence-based comorbidities and 

18 risk factors. 

19 ‘‘(c) COLLECTION OF INFORMATION AND REPORT20 ING.—Each State educational agency, local educational 

21 agency, and Tribal educational agency that receives funds 

22 under section 520A shall, with respect to each school 

23 served by the agency, collect and report to the Secretary 

24 the following information: 


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1 ‘‘(1) The number of student trainings con2 ducted. 

3 ‘‘(2) The number of students trained, 

4 disaggregated by age and grade level. 

5 ‘‘(3) The number of help-seeking reports made 

6 by students after implementation of such policy. 

7 ‘‘(d) EVIDENCE-BASED PROGRAM LISTING.—The 

8 Secretary of Health and Human Services shall coordinate 

9 with the Secretary of Education to make publicly available 

10 the policies established by State educational agencies, local 

11 educational agencies, and Tribal educational agencies pur12 suant to this section and the training that is available to 

13 students and teams pursuant to such policies, including 

14 identification of whether such training is available to 

15 trainees at no cost. 

16 ‘‘(e) IMPLEMENTATION TIMELINE.—A State edu17 cational agency, local educational agency, or Tribal edu18 cational agency shall establish and begin implementation 

19 of the policies required by subsection (a)(1) not later than 

20 the beginning of the third fiscal year following the date 

21 of enactment of this section for which the agency receives 

22 funds under section 520A. 

23 ‘‘(f) DEFINITIONS.—In this section and section 

24 520B–1: 


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1 ‘‘(1) The term ‘evidence-based’ has the meaning 

2 given to such term in section 8101 of the Elemen3 tary and Secondary Education Act of 1965. 

4 ‘‘(2) The term ‘local educational agency’ has 

5 the meaning given to such term in section 8101 of 

6 the Elementary and Secondary Education Act of 

7 1965. 

8 ‘‘(3) The term ‘State educational agency’ has 

9 the meaning given to such term in section 8101 of 

10 the Elementary and Secondary Education Act of 

11 1965. 

12 ‘‘(4) The term ‘Tribal educational agency’ has 

13 the meaning given to the term ‘tribal educational 

14 agency’ in section 6132 of the Elementary and Sec15 ondary Education Act of 1965. 

16 ‘‘SEC. 520B–1. BEST PRACTICES FOR STUDENT SUICIDE 

17 AWARENESS AND PREVENTION TRAINING. 

18 ‘‘The Secretary of Health and Human Services, in 

19 consultation with the Secretary of Education and the Bu20 reau of Indian Education, shall— 

21 ‘‘(1) publish best practices for school-based stu22 dent suicide awareness and prevention training, pur23 suant to section 520B, that are based on— 

24 ‘‘(A) evidence-based practices; and 


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1 ‘‘(B) input from relevant Federal agencies, 

2 national organizations, Indian Tribes and Trib3 al organizations, and related stakeholders; 

4 ‘‘(2) publish guidance, based on the best prac5 tices under paragraph (1), to provide State edu6 cational agencies, local educational agencies, and 

7 Tribal educational agencies with information on stu8 dent suicide awareness and prevention best prac9 tices; 

10 ‘‘(3) disseminate such best practices to State 

11 educational agencies, local educational agencies, and 

12 Tribal educational agencies; and 

13 ‘‘(4) provide technical assistance to State edu14 cational agencies, local educational agencies, and 

15 Tribal educational agencies.’’. 

16 SEC. 6082. EFFECTIVE DATE. 

17 The amendments made by this subtitle shall only 

18 apply with respect to applications for assistance under sec19 tion 520A of the Public Health Service Act (42 U.S.C. 

20 290bb–32) that are submitted after the date of enactment 

21 of this Act. 


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1 TITLE VII—ADDRESSING THE IM2 PACTS OF COVID–19 ON SUB3 STANCE USE DISORDERS 

4 Subtitle A—Easy Medication Ac5 cess and Treatment for Opioid 

6 Addiction 

7 SEC. 7001. DISPENSATION OF NARCOTIC DRUGS FOR THE 

8 PURPOSE OF RELIEVING ACUTE WITH9 DRAWAL SYMPTOMS FROM OPIOID USE DIS10 ORDER. 

11 Not later than 180 days after the date of enactment 

12 of this Act, the Attorney General shall revise section 

13 1306.07(b) of title 21, Code of Federal Regulations, so 

14 that practitioners, in accordance with applicable State, 

15 Federal, or local laws relating to controlled substances, are 

16 allowed to dispense not more than a three-day supply of 

17 narcotic drugs to one person or for one person’s use at 

18 one time for the purpose of initiating maintenance treat19 ment or detoxification treatment (or both). 

20 Subtitle B—Access to Remote 

21 Behavioral Health Treatment 

22 SEC. 7011. REGISTRATION OF QUALIFIED COMMUNITY 

23 MENTAL HEALTH CENTERS. 

24 (a) DEFINITIONS.—Section 102 of the Controlled 

25 Substances Act (21 U.S.C. 802) is amended— 


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1 (1) by striking paragraph (54)(A)(i) and insert2 ing the following: 

3 ‘‘(i) while the patient is being treated by, 

4 and physically located in— 

5 ‘‘(I) a hospital or clinic registered 

6 under section 303(f); or 

7 ‘‘(II) a qualified community mental 

8 health center registered under section 

9 303(l); and’’; 

10 (2) by redesignating paragraph (58) as para11 graph (59); 

12 (3) by redesignating the second paragraph (57) 

13 (as added by section 401(a) of the First Step Act 

14 of 2018 (Public Law 115–391)) as paragraph (58); 

15 and 

16 (4) by adding at the end the following: 

17 ‘‘(60) The term ‘qualified community mental health 

18 center’ means a facility that— 

19 ‘‘(A)(i) meets the criteria specified in section 

20 1913(c) of the Public Health Service Act to be con21 sidered a community mental health center; or 

22 ‘‘(ii) meets the criteria specified pursuant to 

23 section 223 of the Protecting Access to Medicare Act 

24 of 2014 to be considered a certified community be25 havioral health clinic; and 


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1 ‘‘(B) is licensed, operated, authorized, certified, 

2 or otherwise recognized by a State government.’’. 

3 (b) REGISTRATION.—Section 303 of the Controlled 

4 Substances Act (21 U.S.C. 823) is amended by adding at 

5 the end the following: 

6 ‘‘(l) QUALIFIED COMMUNITY MENTAL HEALTH CEN7 TERS.— 

8 ‘‘(1) REGISTRATION.—The Attorney General 

9 shall register qualified community mental health 

10 centers to administer controlled substances through 

11 the practice of telemedicine. 

12 ‘‘(2) DENIAL OF APPLICATIONS.—The Attorney 

13 General may deny an application for registration 

14 under paragraph (1) if the Attorney General deter15 mines that the registration would be inconsistent 

16 with the public interest after considering— 

17 ‘‘(A) any recommendation by the licensing 

18 board or professional disciplinary authority of 

19 the State in which the applicant is located; 

20 ‘‘(B) the experience of the applicant in 

21 treating patients; 

22 ‘‘(C) any conviction of an employee of the 

23 applicant under Federal or State law relating to 

24 treatment of patients; 


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1 ‘‘(D) the compliance of the applicant with 

2 applicable Federal, State, or local laws relating 

3 to treatment of patients; and 

4 ‘‘(E) any other conduct by the applicant 

5 that may threaten the public’s health and safe6 ty.’’. 

7 (c) REPORT TO CONGRESS.—Not later than 60 days 

8 after the date of enactment of this Act, the Attorney Gen9 eral of the United States shall submit to the Congress a 

10 plan for implementation of the amendments made by sub11 sections (a) and (b). 

12 (d) DELAYED APPLICABILITY.—The amendments 

13 made by subsections (a) and (b) apply beginning on the 

14 date that is 120 days after the date of enactment of this 

15 Act. 

16 Subtitle C—PDMP Pilot Program 

17 SEC. 7021. PILOT PROGRAM FOR INTEGRATING SUBSTANCE 

18 USE DISORDER AND BEHAVIORAL HEALTH 

19 TREATMENT LOCATOR TOOL INTO STATE 

20 PRESCRIPTION DRUG MONITORING PRO21 GRAMS. 

22 (a) IN GENERAL.—The Secretary of Health and 

23 Human Services, in consultation with the Assistant Sec24 retary for Mental Health and Substance Use, shall estab25 lish and implement a pilot program in which the Secretary 


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1 awards grants to, or enters into cooperative agreements 

2 with, not more than 5 eligible States to test the feasibility 

3 and outcomes of integrating a substance use disorder and 

4 behavioral health treatment locator tool into the State’s 

5 prescription drug monitoring program. 

6 (b) GRANT ESTABLISHMENT AND PARTICIPATION.— 

7 (1) IN GENERAL.—In carrying out the pilot 

8 program under this section, the Secretary shall, on 

9 a competitive basis, award grants to, or enter into 

10 cooperative agreements with, not more than 5 eligi11 ble States. 

12 (2) ELIGIBILITY.—To be eligible for a grant 

13 under this section, a State shall demonstrate to the 

14 Secretary’s satisfaction that the State is making 

15 progress in integrating the State’s PDMP with elec16 tronic health records and health information tech17 nology infrastructure. 

18 (3) PREFERENCE.—In awarding grants under 

19 this section, the Secretary shall give preference to el20 igible States described in paragraph (2) whose rates 

21 of death due to drug overdose per population of 

22 100,000 are in the top quartile according to the 

23 most recent data of the Centers for Disease Control 

24 and Prevention. 


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1 (c) PERIOD OF GRANT.—A grant awarded to an eligi2 ble entity under this section shall be for a period of 2 

3 years. 

4 (d) GRANT USES.— 

5 (1) REQUIRED USES.—A grant awarded under 

6 this section to an eligible State shall be used for 

7 both of the following purposes: 

8 (A) To integrate a substance use disorder 

9 and behavioral health treatment locator tool 

10 into the PDMP. 

11 (B) To develop and disseminate guidance 

12 for health care providers on how to consult and 

13 share information obtained through the sub14 stance use disorder and behavioral health treat15 ment locator tool when a patient’s PDMP infor16 mation indicates possible misuse of a controlled 

17 substance. 

18 (2) ADDITIONAL PERMISSIBLE USES.—A grant 

19 awarded under this section to an eligible State may 

20 be used for any of the following additional purposes: 

21 (A) To integrate a substance use disorder 

22 and behavioral health treatment locator tool 

23 into the PDMP that incorporates direct referral 

24 capabilities that enable the health care pro25 vider— 


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1 (i) to refer a patient to treatment or 

2 for an assessment; and 

3 (ii) consistent with the protection of 

4 information by Federal and State privacy 

5 laws and security rules, receive feedback 

6 about the patient’s engagement with such 

7 treatment or assessment. 

8 (B) To integrate a substance use disorder 

9 and behavioral health treatment locator tool 

10 into the PDMP that provides information re11 garding the current capacity of inpatient or 

12 outpatient treatment resources of a health care 

13 provider. 

14 (e) REPORTING REQUIREMENTS.— 

15 (1) REPORTS BY STATES.—Each eligible State 

16 that participates in the pilot program under this sec17 tion shall submit to the Secretary an annual report 

18 for each year of the pilot program that includes in19 formation on— 

20 (A) the number of health care providers 

21 and health facilities with access to the sub22 stance use disorder and behavioral health treat23 ment locator tool; 


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1 (B) the number of individuals referred to 

2 treatment with the assistance of the locator 

3 tool; 

4 (C) aggregate, de-identified patient data 

5 related to the type of treatment located by the 

6 locator tool, how often patients followed 

7 through on seeking such treatment, and the av8 erage duration of such treatment, to the extent 

9 collected by the State; 

10 (D) feedback from providers with access to 

11 the locator tool on usability and any impact on 

12 outcomes; 

13 (E) recommendations to improve the 

14 usability and efficacy of a substance use dis15 order and behavioral health treatment locator 

16 tool within the PDMP; and 

17 (F) additional information and reporting 

18 metrics as determined by the Secretary. 

19 (2) REPORT BY SECRETARY.—Not less than 

20 180 days after the conclusion of the pilot program 

21 under this section, the Secretary shall submit to the 

22 Congress a report on the findings of the program, 

23 including— 

24 (A) outcomes reported by the participating 

25 States; 


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1 (B) findings on the suitability of including 

2 a substance use disorder and behavioral health 

3 treatment locator tool within State PDMPs; 

4 and 

5 (C) recommendations on best practices for 

6 integrating a substance use disorder and behav7 ioral health treatment locator tool within State 

8 PDMPs. 

9 (f) DEFINITIONS.—In this section: 

10 (1) The term ‘‘prescription drug monitoring 

11 program’’ or ‘‘PDMP’’ has the meaning given to the 

12 term ‘‘PDMP’’ in section 399O of the Public Health 

13 Service Act (42 U.S.C. 280g–3). 

14 (2) The term ‘‘Secretary’’ means the Secretary 

15 of Health and Human Services. 

16 (g) AUTHORIZATION OF APPROPRIATIONS.—To carry 

17 out this section, there are authorized to be appropriated 

18 $2,500,000 for each of fiscal years 2021 and 2022. 


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1 Subtitle D—Family Support 

2 Services for Addiction 

3 SEC. 7031. FAMILY SUPPORT SERVICES FOR INDIVIDUALS 

4 STRUGGLING WITH SUBSTANCE USE DIS5 ORDER. 

6 Part D of title V of the Public Health Service Act 

7 (42 U.S.C. 290dd et seq.) is amended by adding at the 

8 end the following: 

9 ‘‘SEC. 553. FAMILY SUPPORT SERVICES FOR INDIVIDUALS 

10 STRUGGLING WITH SUBSTANCE USE DIS11 ORDER. 

12 ‘‘(a) DEFINITIONS.—In this section— 

13 ‘‘(1) the term ‘family community organization’ 

14 means an independent nonprofit organization that— 

15 ‘‘(A) mobilizes resources within and out16 side of the community of families with individ17 uals living with addiction, to provide a support 

18 network, education, and evidence-informed tools 

19 for families and loved ones of individuals strug20 gling with substance use disorders; and 

21 ‘‘(B) is governed by experts in the field of 

22 addiction, which may include— 

23 ‘‘(i) experts in evidence-informed 

24 interventions for family members; 


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1 ‘‘(ii) experts in the impact of addic2 tion on family systems; 

3 ‘‘(iii) families who have experience 

4 with substance use disorders and addiction; 

5 and 

6 ‘‘(iv) other experts in the field of ad7 diction; and 

8 ‘‘(2) the term ‘family support services’ means 

9 resources or programs that support families that in10 clude an individual with substance use disorder. 

11 ‘‘(b) GRANTS AUTHORIZED.—The Secretary shall 

12 award grants to family community organizations to enable 

13 such organizations to develop, expand, and enhance evi14 dence-informed family support services. 

15 ‘‘(c) FEDERAL SHARE.—The Federal share of the 

16 costs of a program funded by a grant under this section 

17 may not exceed 85 percent. 

18 ‘‘(d) USE OF FUNDS.—Grants awarded under sub19 section (b)— 

20 ‘‘(1) shall be used to develop, expand, and en21 hance community and statewide evidence-informed 

22 family support services; and 

23 ‘‘(2) may be used to— 

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1 sistance between family community organiza2 tions and peer support networks, and with 

3 other family support services, focused on en4 hancing knowledge of evidence-informed inter5 ventions for family members and loved ones of 

6 individuals living with substance use disorders 

7 and reducing harm by educating service pro8 viders on current evidence regarding addiction 

9 and the family, including— 

10 ‘‘(i) behavioral health providers, in11 cluding such providers focused specifically 

12 on family and couples therapy in the con13 text of addiction; 

14 ‘‘(ii) primary care providers; 

15 ‘‘(iii) providers of foster care services 

16 or support services for grandparents, 

17 guardians, and other extended family im18 pacted by addiction; and 

19 ‘‘(iv) other family support services 

20 that connect to community resources for 

21 individuals with substance use disorders, 

22 including non-clinical community services; 

23 ‘‘(B) reduce stigma associated with the 

24 family of individuals with substance use dis25 orders by improving knowledge about addiction 


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1 and its treatment, providing compassionate sup2 port, and dispelling myths that perpetuate such 

3 stigma; 

4 ‘‘(C) conduct outreach on issues relating to 

5 substance use disorders and family support, 

6 which may include education, training, and re7 sources with respect to— 

8 ‘‘(i) building a resilience- and 

9 strengths-based approach to prevention of, 

10 and living with, addiction in the family; 

11 ‘‘(ii) identifying the signs of substance 

12 use disorder; 

13 ‘‘(iii) adopting an approach that mini14 mizes harm to all family members; and 

15 ‘‘(iv) families of individuals with a 

16 substance use disorder, including with re17 spect to— 

18 ‘‘(I) navigating the treatment 

19 and recovery systems; 

20 ‘‘(II) paying for addiction treat21 ment; 

22 ‘‘(III) education about substance 

23 use disorder; and 

24 ‘‘(IV) avoiding predatory treat25 ment programs; and 


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1 ‘‘(D) connect families to evidence-informed 

2 peer support programs. 

3 ‘‘(e) DATA REPORTING AND PROGRAM OVER4 SIGHT.—With respect to a grant awarded under sub5 section (a), not later than 90 days after the end of the 

6 first year of the grant period, and annually thereafter for 

7 the duration of the grant period, the entity shall submit 

8 data, as appropriate and to the extent practicable, to the 

9 Secretary regarding— 

10 ‘‘(1) the programs and activities funded by the 

11 grant; 

12 ‘‘(2) health outcomes of the population of indi13 viduals with a substance use disorder who received 

14 services through programs supported by the grant, 

15 as evaluated by an independent program evaluator 

16 through the use of outcomes measures, as deter17 mined by the Secretary; and 

18 ‘‘(3) any other information that the secretary 

19 may require for the purpose of ensuring that the 

20 grant recipient is complying with all the require21 ments of the grant. 

22 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

23 is authorized to be appropriated to carry out this section 

24 $5,000,000 for each of fiscal years 2021 through 2025.’’. 


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1 Subtitle E—Block, Report, And 

2 Suspend Suspicious Shipments 

3 SEC. 7041. CLARIFICATION OF PROCESS FOR REGISTRANTS 

4 TO EXERCISE DUE DILIGENCE UPON DISCOV5 ERING A SUSPICIOUS ORDER. 

6 (a) IN GENERAL.—Paragraph (3) of section 312(a) 

7 of the Controlled Substances Act (21 U.S.C. 832(a)) is 

8 amended to read as follows: 

9 ‘‘(3) upon discovering a suspicious order or se10 ries of orders— 

11 ‘‘(A) exercise due diligence; 

12 ‘‘(B) establish and maintain (for not less 

13 than a period to be determined by the Adminis14 trator of the Drug Enforcement Administra15 tion) a record of the due diligence that was per16 formed; 

17 ‘‘(C) decline to fill the order or series of 

18 orders if the due diligence fails to resolve all of 

19 the indicators that gave rise to the suspicion 

20 that filling the order or series of orders would 

21 cause a violation of this title by the registrant 

22 or the prospective purchaser; and 

23 ‘‘(D) notify the Administrator of the Drug 

24 Enforcement Administration and the Special 

25 Agent in Charge of the Division Office of the 


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1 Drug Enforcement Administration for the area 

2 in which the registrant is located or conducts 

3 business of— 

4 ‘‘(i) each suspicious order or series of 

5 orders discovered by the registrant; and 

6 ‘‘(ii) the indicators giving rise to the 

7 suspicion that filling the order or series of 

8 orders would cause a violation of this title 

9 by the registrant or the prospective pur10 chaser.’’. 

11 (b) APPLICABILITY.—Section 312(a)(3) of the Con12 trolled Substances Act, as amended by subsection (a), 

13 shall apply beginning on the day that is 6 months after 

14 the date of enactment of this Act. Until such day, section 

15 312(a)(3) of the Controlled Substances Act shall apply as 

16 such section 312(a)(3) was in effect on the day before the 

17 date of enactment of this Act. 

18 (c) REGULATIONS.—The Attorney General shall, 

19 issue regulations specifying, for purposes of paragraph (3) 

20 of section 312(a) of the Controlled Substances Act, as 

21 added by subsection (a), the indicators that give rise to 

22 a suspicion that filling an order or series of orders would 

23 cause a violation of title III of the Controlled Substances 

24 Act (21 U.S.C. 801 et seq.) by a registrant or a prospec25 tive purchaser. 


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1 Subtitle F—Debarment Enforce2 ment of Bad Actor Registrants 

3 SEC. 7051. DEBARMENT OF CERTAIN REGISTRANTS. 

4 Section 304 of the Controlled Substances Act (21 

5 U.S.C. 824) is amended by adding at the end the fol6 lowing: 

7 ‘‘(h) The Attorney General may issue an order to pro8 hibit, conditionally or unconditionally, and permanently or 

9 for such period as the Attorney General may determine, 

10 any person from being registered under this title to manu11 facture, distribute, or dispense a controlled substance or 

12 a list I chemical, if the Attorney General finds that— 

13 ‘‘(1) such person meets or has met any of the 

14 conditions for suspension or revocation of registra15 tion under subsection (a); and 

16 ‘‘(2) such person has a history of prior suspen17 sions or revocations of registration.’’. 


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1 Subtitle G—Ensuring Compliance 

2 Against Opioid Diversion 

3 SEC. 7061. MODIFICATION, TRANSFER, AND TERMINATION 

4 OF REGISTRATION TO MANUFACTURE, DIS5 TRIBUTE, OR DISPENSE CONTROLLED SUB6 STANCES. 

7 Subsection (a) of section 302 of the Controlled Sub8 stances Act (21 U.S.C. 822) is amended by adding at the 

9 end the following new paragraph: 

10 ‘‘(3)(A) Except as provided in subparagraph (C), the 

11 registration of any registrant under this title to manufac12 ture, distribute, or dispense controlled substances or list 

13 I chemicals terminates if and when such registrant— 

14 ‘‘(i) dies; 

15 ‘‘(ii) ceases legal existence; 

16 ‘‘(iii) discontinues business or professional prac17 tice; or 

18 ‘‘(iv) surrenders such registration. 

19 ‘‘(B) In the case of such a registrant who ceases legal 

20 existence or discontinues business or professional practice, 

21 such registrant shall promptly notify the Attorney General 

22 in writing of such fact. 

23 ‘‘(C) No registration under this title to manufacture, 

24 distribute, or dispense controlled substances or list I 

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1 signed or otherwise transferred except upon such condi2 tions as the Attorney General may specify and then only 

3 pursuant to written consent. A registrant to whom a reg4 istration is assigned or transferred pursuant to the pre5 ceding sentence may not manufacture, distribute, or dis6 pense controlled substances or list I chemicals pursuant 

7 to such registration until the Attorney General receives 

8 such written consent. 

9 ‘‘(D) In the case of a registrant under this title to 

10 manufacture, distribute, or dispense controlled substances 

11 or list I chemicals desiring to discontinue business or pro12 fessional practice altogether or with respect to controlled 

13 substances and list I chemicals (without assigning or 

14 transferring such business or professional practice to an15 other entity), such registrant shall return to the Attorney 

16 General for cancellation— 

17 ‘‘(i) the registrant’s certificate of registration; 

18 ‘‘(ii) any unexecuted order forms in the reg19 istrant’s possession; and 

20 ‘‘(iii) any other documentation that the Attor21 ney General may require.’’. 


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1 Subtitle H—Opioid Prescription 

2 Verification 

3 SEC. 7071. MATERIALS FOR TRAINING PHARMACISTS ON 

4 CERTAIN CIRCUMSTANCES UNDER WHICH A 

5 PHARMACIST MAY DECLINE TO FILL A PRE6 SCRIPTION. 

7 (a) UPDATES TO MATERIALS.—Section 3212(a) of 

8 the SUPPORT for Patients and Communities Act (Public 

9 Law 115–271) is amended by striking ‘‘Not later than 1 

10 year after the date of enactment of this Act, the Secretary 

11 of Health and Human Services, in consultation with the 

12 Administrator of the Drug Enforcement Administration, 

13 Commissioner of Food and Drugs, Director of the Centers 

14 for Disease Control and Prevention, and Assistant Sec15 retary for Mental Health and Substance Use, shall develop 

16 and disseminate’’ and inserting ‘‘The Secretary of Health 

17 and Human Services, in consultation with the Adminis18 trator of the Drug Enforcement Administration, Commis19 sioner of Food and Drugs, Director of the Centers for Dis20 ease Control and Prevention, and Assistant Secretary for 

21 Mental Health and Substance Use, shall develop and dis22 seminate not later than 1 year after the date of enactment 

23 of this Act, and update periodically thereafter’’. 


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1 (b) MATERIALS INCLUDED.—Section 3212(b) of the 

2 SUPPORT for Patients and Communities Act (Public 

3 Law 115–271) is amended— 

4 (1) by redesignating paragraphs (1) and (2) as 

5 paragraphs (2) and (3), respectively; and 

6 (2) by inserting before paragraph (2), as so re7 designated, the following new paragraph: 

8 ‘‘(1) pharmacists on how to verify the identity 

9 of individuals picking up prescriptions;’’. 

10 (c) MATERIALS FOR TRAINING ON VERIFICATION OF

11 IDENTITY.—Section 3212 of the SUPPORT for Patients 

12 and Communities Act (Public Law 115–271) is amended 

13 by adding at the end the following new subsection: 

14 ‘‘(d) MATERIALS FOR TRAINING ON VERIFICATION

15 OF IDENTITY OF INDIVIDUALS PICKING UP PRESCRIBED

16 MEDICATIONS.—Not later than 6 months after the date 

17 of enactment of this subsection, the Secretary of Health 

18 and Human Services, after seeking stakeholder input in 

19 accordance with subsection (c), shall— 

20 ‘‘(1) update the materials developed under sub21 section (a) to include information for pharmacists on 

22 how to verify the identity of individuals picking up 

23 prescribed medications; and 

24 ‘‘(2) disseminate, as appropriate, the updated 

25 materials.’’. 


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1 SEC. 7072. INCENTIVIZING STATES TO FACILITATE RESPON2 SIBLE, INFORMED DISPENSING OF CON3 TROLLED SUBSTANCES. 

4 (a) IN GENERAL.—Section 392A of the Public 

5 Health Service Act (42 U.S.C. 280b–1) is amended— 

6 (1) by redesignating subsections (c) and (d) as 

7 subsections (d) and (e), respectively; and 

8 (2) by inserting after subsection (b) the fol9 lowing new subsection: 

10 ‘‘(c) PREFERENCE.—In determining the amounts of 

11 grants awarded to States under subsections (a) and (b), 

12 the Director of the Centers for Disease Control and Pre13 vention may give preference to States in accordance with 

14 such criteria as the Director may specify and may choose 

15 to give preference to States that— 

16 ‘‘(1) maintain a prescription drug monitoring 

17 program; 

18 ‘‘(2) require dispensers of controlled substances 

19 in schedule II, III, or IV to verify the identity of the 

20 person who picks up a prescribed medication by re21 quiring such person to present a photo identification 

22 card that is valid as determined by the respective 

23 State; and 

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1 tive State’s prescription drug monitoring program, 

2 including— 

3 ‘‘(A) the National Drug Code or, in the 

4 case of compounded medications, compound 

5 identifier; 

6 ‘‘(B) the quantity dispensed; 

7 ‘‘(C) the name of the patient; 

8 ‘‘(D) the name of the ultimate user; 

9 ‘‘(E) the name of the person who picks up 

10 the controlled substance, if different from the 

11 patient and ultimate user; and 

12 ‘‘(F) the date filled.’’. 

13 (b) DEFINITIONS.—Subsection (d) of section 392A of 

14 the Public Health Service Act (42 U.S.C. 280b–1), as re15 designated by subsection (a)(1), is amended to read as fol16 lows: 

17 ‘‘(d) DEFINITIONS.—In this section: 

18 ‘‘(1) CONTROLLED SUBSTANCE.—The term 

19 ‘controlled substance’ has the meaning given that 

20 term in section 102 of the Controlled Substances. 

21 ‘‘(2) DISPENSER.—The term ‘dispenser’ means 

22 a physician, pharmacist, or other person that dis23 penses a controlled substance to an ultimate user. 

24 ‘‘(3) INDIAN TRIBE.—The term ‘Indian tribe’ 

25 has the meaning given that term in section 4 of the 


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1 Indian Self-Determination and Education Assistance 

2 Act. 

3 ‘‘(4) STATE.—The term ‘State’ means each of 

4 the 50 States, the District of Columbia, and any 

5 commonwealth or territory of the United States. 

6 ‘‘(5) ULTIMATE USER.—The term ‘ultimate 

7 user’ means a person who has obtained from a dis8 penser, and who possesses, a controlled substance 

9 for the person’s own use, for the use of a member 

10 of the person’s household, or for the use of an ani11 mal.’’. 

12 Subtitle I—Suspicious Order 

13 Identification 

14 SEC. 7081. STRENGTHENING ARCOS. 

15 Section 307(d) of the Controlled Substances Act (21 

16 U.S.C. 827(d)) is amended to read as follows: 

17 ‘‘(1)(A) Every registrant under section 303 shall and 

18 in such form as the Attorney General may require, make 

19 reports in electronic format to the Attorney General of 

20 every sale, delivery, or other disposal (other than by dis21 pensing by a practitioner) by the registrant of any con22 trolled substance, identifying by the registration number 

23 assigned under this title the person or establishment (un24 less exempt from registration under section 302(d)) to 

25 whom such sale, delivery, or other disposal was made. 


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1 ‘‘(B) Every registrant shall make each report re2 quired under subparagraph (A)— 

3 ‘‘(i) not later than 30 days after the sale, deliv4 ery, or other disposal; or 

5 ‘‘(ii) after the date on which the real-time re6 porting system is established under section 

7 7082(e)(3) of the Commitment to Defeat the Virus 

8 and Keep America Healthy Act is implemented, in 

9 real time.’’. 

10 SEC. 7082. SUSPICIOUS ORDERS TASK FORCE. 

11 (a) DEFINITIONS.—In this section: 

12 (1) ADMINISTRATOR.—The term ‘‘Adminis13 trator’’ means the Administrator of the Drug En14 forcement Administration. 

15 (2) CONTROLLED SUBSTANCE; DISTRIBUTOR; 

16 MANUFACTURER.—The terms ‘‘controlled sub17 stance’’, ‘‘distributor’’, and ‘‘manufacturer’’ have the 

18 meanings given those terms in section 102 of the 

19 Controlled Substances Act (21 U.S.C. 802). 

20 (3) REAL TIME.—The term ‘‘real time’’ means 

21 with as little delay as technically and economically 

22 feasible, as determined by the Attorney General fol23 lowing the program designed under subsection 

24 (e)(1), but not to exceed 24 hours. 

25 (4) REGISTRANT.—The term ‘‘registrant’’— 


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1 (A) means a person registered under sec2 tion 303 of the Controlled Substances Act (21 

3 U.S.C. 823); and 

4 (B) does not include practitioner. 

5 (b) ESTABLISHMENT.—The Attorney General, in 

6 consultation with the Director of the Office of National 

7 Drug Control Policy and the Secretary of Health and 

8 Human Services, shall establish a Suspicious Order Moni9 toring Task Force (referred to in this section as the ‘‘Task 

10 Force’’). 

11 (c) COMPOSITION.— 

12 (1) IN GENERAL.—The Task Force shall be 

13 composed of appropriate personnel from— 

14 (A) the Department of Justice; 

15 (B) the Drug Enforcement Administration; 

16 (C) the Office of National Drug Control 

17 Policy; 

18 (D) the National Institute of Standards 

19 and Technology; and 

20 (E) other appropriate Federal, State, and 

21 local law enforcement and regulatory agencies 

22 with experience in investigating and prosecuting 

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1 sultation with the Secretary of Health and 

2 Human Services. 

3 (2) CONSULTANTS.—The Task Force shall con4 sult with— 

5 (A) industry members, including— 

6 (i) data analytic professionals; 

7 (ii) community pharmacies that dis8 pense controlled substances; 

9 (iii) chain pharmacies that dispense 

10 controlled substances; 

11 (iv) distributors of controlled sub12 stances; 

13 (v) manufacturers of controlled sub14 stances; 

15 (vi) State and local public health offi16 cials; and 

17 (vii) other relevant industry profes18 sionals; and 

19 (B) relevant industry regulators and enti20 ties that utilize real-time reporting of trans21 actions, orders, or other activities with the goal 

22 of identifying suspicious activity, such as appro23 priate personnel from the Financial Crimes En24 forcement Network and money transfer indus25 try professionals. 


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1 (d) MEETINGS.— 

2 (1) IN GENERAL.—The Task Force shall meet 

3 not less frequently than 4 times per year and at 

4 such other times as may be determined necessary by 

5 the Task Force. 

6 (2) INITIAL MEETING.—Not later than 60 days 

7 after the date of enactment of this Act, the Task 

8 Force shall hold the initial meeting of the Task 

9 Force. 

10 (e) PRELIMINARY ORDER EVALUATION PROGRAM.— 

11 (1) IN GENERAL.— 

12 (A) DESIGN.—Not later than 60 days after 

13 the date on which the Task Force holds the ini14 tial meeting required under subsection (d)(2), 

15 the Task Force shall begin to design a program 

16 in accordance with paragraph (2). 

17 (B) PURPOSE.—The program described in 

18 subparagraph (A) shall be designed to share 

19 necessary data, in a limited capacity, with reg20 istrants in order to provide registrants with in21 formation to identify suspicious ordering in real 

22 time. 

23 (C) DEADLINE FOR COMPLETION.—Not 

24 later than 8 months after the date of enactment 


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1 of this Act, the Task Force shall complete the 

2 design required under subparagraph (A). 

3 (2) REQUIREMENTS.— 

4 (A) IN GENERAL.—The program required 

5 under paragraph (1) shall establish a process 

6 for— 

7 (i) transitioning to a requirement to 

8 report in real time to the Attorney General 

9 under section 307(d) of the Controlled 

10 Substances Act (21 U.S.C. 827(d)) every 

11 sale, delivery, or other disposal by a reg12 istrant of any controlled substance; 

13 (ii) limited sharing in real time of Au14 tomation of Reports and Consolidated Or15 ders System (commonly known as 

16 ‘‘ARCOS’’) data with registrants to share 

17 necessary data, in a limited capacity, with 

18 registrants in order to provide registrants 

19 with information to identify suspicious or20 dering in real time; and 

21 (iii) ensuring data privacy, data de22 identification, protection of trade secrets 

23 and purchasing history. 


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1 (B) OTHER CONSIDERATIONS.—In design2 ing the program under paragraph (1), the Task 

3 Force shall take into consideration— 

4 (i) the inclusion of a waiver process 

5 for pharmacies and other registrants un6 able to transmit orders electronically on 

7 the date of enactment of this Act; 

8 (ii) a mechanism to ensure that the 

9 costs of running the program are not 

10 passed through to customers of registrants, 

11 unless the registrants are customers of 

12 other registrants; 

13 (iii) technical requirements for ensur14 ing that registrants may access all relevant 

15 de-identified data, with output provided in 

16 a standard database file format; and 

17 (iv) a mechanism to ensure that the 

18 program required to be designed under 

19 subparagraph (A) is updated based on 

20 feedback from industry members and other 

21 relevant entities. 

22 (3) IMPLEMENTATION.—Not later than 1 year 

23 after the date of enactment of this Act, the Attorney 

24 General shall— 


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1 (A) implement the program designed under 

2 paragraph (1) to collect and share in real time 

3 data for registrants to evaluate the orders of 

4 controlled substances from distributors to man5 ufacturers and from pharmacies to distributors; 

6 or 

7 (B) otherwise implement a program to col8 lect and share in real time data for drug manu9 facturers and distributors, by providing access 

10 to anonymized information to help drug manu11 facturers and distributors identify, report, and 

12 stop suspicious orders of controlled substances 

13 and reduce diversion rates. 

14 (4) RECOMMENDED STATUTORY AND REGU15 LATORY CHANGES.—In designing the program re16 quired under paragraph (1), the Task Force— 

17 (A) shall submit to the Attorney General 

18 any recommendations for necessary amend19 ments to regulations of the Department of Jus20 tice relating to the requirements for ordering 

21 schedule II controlled substances, so as to allow 

22 uniform electronic ordering of controlled sub23 stances in schedules II, III, IV, and V electroni24 cally through the program; and 


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1 (B) may submit to Congress any rec2 ommendations for necessary legislative changes 

3 so that a real-time data analytics solution can 

4 be used across the United States. 

5 (5) RESPONSIBILITY OF REGISTRANTS.—All 

6 registered drug manufacturers and distributors shall 

7 be responsible for reviewing any information made 

8 available by the Attorney General and complying 

9 with any regulations regarding the program designed 

10 under paragraph (1) and implemented under para11 graph (3). 

12 (f) FUNDING.— 

13 (1) IN GENERAL.—The Attorney General, act14 ing through the Administrator, shall use amounts 

15 collected as fees for distributors and registrants 

16 under section 303 of the Controlled Substances Act 

17 (21 U.S.C. 823) and section 1007 of the Controlled 

18 Substances Import and Export Act (21 U.S.C. 957) 

19 to carry out this section. 

20 (2) OFFSET.— 

21 (A) IN GENERAL.—The Administrator 

22 may, on an equal basis and in accordance with 

23 subparagraph (B), increase the fees described 

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1 istrants to the extent necessary to defray the 

2 costs of this section. 

3 (B) TIERED FEE.—The Administrator 

4 shall establish a tiered user fee for distributors 

5 and registrants in proportion to the volume of 

6 sales and purchases. 

7 (g) APPLICABILITY OF FACA.— 

8 (1) IN GENERAL.—Except as provided in para9 graph (2), the Federal Advisory Committee Act (5 

10 U.S.C. App.) shall apply to the Task Force. 

11 (2) TERMINATION.—The Task Force shall ter12 minate on the date on which the program is fully 

13 implemented under subsection (e)(3). 

14 (h) RULES OF CONSTRUCTION.—Nothing in this sub15 title shall be construed as relieving any manufacturer, dis16 tributor, or other registrant from the responsibilities of 

17 the manufacturer, distributor, or other registrant, as the 

18 case may be, to— 

19 (1) identify, stop, and report suspicious orders; 

20 (2) maintain effective controls against diversion 

21 in accordance with section 303 of the Controlled 

22 Substances Act (21 U.S.C. 823); and 

23 (3) comply with the requirements established in 

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1 ulations, or any successor regulation thereto, with 

2 respect to suspicious orders. 

3 Subtitle J—Stop the Importation 

4 and Manufacturing of Synthetic 

5 Analogues 

6 SEC. 7091. ESTABLISHMENT OF SCHEDULE A. 

7 Section 202 of the Controlled Substances Act (21 

8 U.S.C. 812) is amended— 

9 (1) in subsection (a), by striking ‘‘five schedules 

10 of controlled substances, to be known as schedules I, 

11 II, III, IV, and V’’ and inserting ‘‘six schedules of 

12 controlled substances, to be known as schedules I, 

13 II, III, IV, V, and A’’; 

14 (2) in subsection (b), by adding at the end the 

15 following: 

16 ‘‘(6) SCHEDULE A.— 

17 ‘‘(A) IN GENERAL.—The drug or substance— 

18 ‘‘(i) is or has been imported, or is offered 

19 for import, into the United States; 

20 ‘‘(ii) has— 

21 ‘‘(I) a chemical structure that is sub22 stantially similar to the chemical structure 

23 of a controlled substance in schedule I, II, 

24 III, IV, or V; and 


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1 ‘‘(II) an actual or predicted stimulant, 

2 depressant, or hallucinogenic effect on the 

3 central nervous system that is substantially 

4 similar to or greater than the stimulant, 

5 depressant, or hallucinogenic effect on the 

6 central nervous system of a controlled sub7 stance in schedule I, II, III, IV, or V; and 

8 ‘‘(iii) is not— 

9 ‘‘(I) listed or otherwise included in 

10 any other schedule in this section or by 

11 regulation of the Attorney General; and 

12 ‘‘(II) with respect to a particular per13 son, subject to an exemption that is in ef14 fect for investigational use, for that person, 

15 under section 505 of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 355) 

17 to the extent conduct with respect to such 

18 substance is pursuant to such exemption. 

19 ‘‘(B) PREDICTED STIMULANT, DEPRESSANT, OR

20 HALLUCINOGENIC EFFECT.—For purposes of this 

21 paragraph, a predicted stimulant, depressant, or hal22 lucinogenic effect on the central nervous system may 

23 be based on— 

24 ‘‘(i)(I) the chemical structure; and 


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1 ‘‘(II)(aa) the structure activity relation2 ships; or 

3 ‘‘(bb) binding receptor assays and other 

4 relevant scientific information about the sub5 stance; 

6 ‘‘(ii)(I) the current or relative potential for 

7 abuse of the substance; and 

8 ‘‘(II) the clandestine importation, manu9 facture, or distribution, or diversion from legiti10 mate channels, of the substance; or 

11 ‘‘(iii) the capacity of the substance to 

12 cause a state of dependence, including physical 

13 or psychological dependence that is similar to or 

14 greater than that of a controlled substance in 

15 schedule I, II, III, IV, or V.’’; and 

16 (3) in subsection (c)— 

17 (A) in the matter preceding schedule I, by 

18 striking ‘‘IV, and V’’ and inserting ‘‘IV, V, and 

19 A’’; and 

20 (B) by adding at the end the following: 

21 ‘‘SCHEDULE A

22 ‘‘Any substance temporarily or permanently sched23 uled by the Attorney General in accordance with section 

24 201(k).’’. 


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1 SEC. 7092. TEMPORARY AND PERMANENT SCHEDULING OF 

2 SCHEDULE A SUBSTANCES. 

3 Section 201 of the Controlled Substances Act (21 

4 U.S.C. 811) is amended by adding at the end the fol5 lowing: 

6 ‘‘(k) TEMPORARY AND PERMANENT SCHEDULING OF

7 SCHEDULE A SUBSTANCES.— 

8 ‘‘(1) IN GENERAL.—The Attorney General may 

9 issue a temporary order adding a drug or substance 

10 to schedule A if the Attorney General finds that— 

11 ‘‘(A) the drug or other substance satisfies 

12 the criteria for being considered a schedule A 

13 substance; and 

14 ‘‘(B) adding such drug or substance to 

15 schedule A will assist in preventing abuse of the 

16 drug or other substance. 

17 ‘‘(2) DURATION OF TEMPORARY SCHEDULING

18 ORDER.—A temporary scheduling order issued under 

19 paragraph (1) shall— 

20 ‘‘(A) not take effect until 30 days after the 

21 date of the publication by the Attorney General 

22 of a notice in the Federal Register of the inten23 tion to issue such order and the grounds upon 

24 which such order is to be issued; and 

25 ‘‘(B) expire not later than 5 years after 

26 the date on which the order becomes effective, 


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1 except that the Attorney General may, during 

2 the pendency of proceedings under paragraph 

3 (5), extend the temporary scheduling order for 

4 up to 180 days. 

5 ‘‘(3) EFFECT OF ISSUANCE OF PERMANENT

6 SCHEDULING ORDER.—A temporary scheduling 

7 order issued under paragraph (1) shall be vacated 

8 upon the issuance of a permanent order issued 

9 under paragraph (5) with regard to the same sub10 stance, or upon the subsequent issuance of any 

11 scheduling order under this section. 

12 ‘‘(4) LIMITATION ON JUDICIAL REVIEW.—A 

13 temporary scheduling order issued under paragraph 

14 (1) shall not be subject to judicial review. 

15 ‘‘(5) PERMANENT SCHEDULING ORDER.— 

16 ‘‘(A) IN GENERAL.—Except as provided in 

17 subparagraph (B), not earlier than 3 years 

18 after the date on which the Attorney General 

19 issues an order temporarily scheduling a drug 

20 or substance under this subsection, the Attor21 ney General may, by rule, issue a permanent 

22 order adding the drug or other substance to 

23 schedule A if such drug or substance satisfies 

24 the criteria for being considered a schedule A 

25 substance. 


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1 ‘‘(B) LIMITATION.—If the Secretary of 

2 Health and Human Services has determined, 

3 based on relevant scientific studies and nec4 essary data requested by the Secretary of 

5 Health and Human Services and gathered by 

6 the Attorney General, that a drug or other sub7 stance that has been temporarily placed in 

8 schedule A does not have sufficient potential for 

9 abuse to warrant control in any schedule, and 

10 provides written notice of such determination to 

11 the Attorney General, the Attorney General— 

12 ‘‘(i) may not issue a permanent sched13 uling order under subparagraph (A); and 

14 ‘‘(ii) not later than 30 days after the 

15 date on which the Attorney General re16 ceives such notice, shall issue an order im17 mediately terminating the temporary 

18 scheduling order for the drug or other sub19 stance. 

20 ‘‘(6) NOTICE TO HHS.—Before initiating pro21 ceedings under paragraph (1), the Attorney General 

22 shall transmit notice of a temporary order proposed 

23 to be issued to the Secretary of Health and Human 

24 Services. In issuing an order under paragraph (1), 

25 the Attorney General shall take into consideration 


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1 any comments submitted by the Secretary of Health 

2 and Human Services in response to a notice trans3 mitted pursuant to this paragraph.’’. 

4 SEC. 7093. PENALTIES. 

5 Section 1010 of the Controlled Substances Import 

6 and Export Act (21 U.S.C. 960) is amended— 

7 (1) in subsection (a), by inserting ‘‘or a drug or 

8 substance in schedule A’’ after ‘‘controlled sub9 stance’’ each place it appears; and 

10 (2) in subsection (b), by adding at the end the 

11 following: 

12 ‘‘(8) In the case of a violation under subsection (a) 

13 involving a controlled substance in schedule A, the person 

14 committing such violation shall be sentenced to a term of 

15 imprisonment of not more than 20 years and if death or 

16 serious bodily injury results from the use of such sub17 stance shall be sentenced to a term of imprisonment for 

18 any term of years or for life, a fine not to exceed the great19 er of that authorized in accordance with the provisions of 

20 title 18, United States Code, or $1,000,000 if the defend21 ant is an individual or $5,000,000 if the defendant is other 

22 than an individual, or both. If any person commits such 

23 a violation after a prior conviction for a felony drug of24 fense has become final, such person shall be sentenced to 

25 a term of imprisonment of not more than 30 years and 


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1 if death or serious bodily injury results from the use of 

2 such substance shall be sentenced to a term of imprison3 ment for any term of years or for life, a fine not to exceed 

4 the greater of twice that authorized in accordance with 

5 the provisions of title 18, United States Code, or 

6 $2,000,000 if the defendant is an individual or 

7 $10,000,000 if the defendant is other than an individual, 

8 or both. Notwithstanding section 3583 of title 18, United 

9 States Code, any sentence imposing a term of imprison10 ment under this paragraph shall, in the absence of such 

11 a prior conviction, impose a term of supervised release of 

12 not less than 3 years in addition to such term of imprison13 ment and shall, if there was such a prior conviction, im14 pose a term of supervised release of not less than 6 years 

15 in addition to such term of imprisonment. Notwith16 standing the prior sentence, and notwithstanding any 

17 other provision of law, the court shall not place on proba18 tion or suspend the sentence of any person sentenced 

19 under the provisions of this paragraph which provide for 

20 a mandatory term of imprisonment if death or serious 

21 bodily injury results.’’. 


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1 SEC. 7094. FALSE LABELING OF SCHEDULE A CONTROLLED 

2 SUBSTANCES. 

3 (a) IN GENERAL.—Section 305 of the Controlled 

4 Substances Act (21 U.S.C. 825) is amended by adding at 

5 the end the following: 

6 ‘‘(f) FALSE LABELING OF SCHEDULE A CON7 TROLLED SUBSTANCES.— 

8 ‘‘(1) It shall be unlawful to import or export, 

9 with intent to manufacture, distribute, or dispense, 

10 a schedule A substance or product containing a 

11 schedule A substance, unless the substance or prod12 uct bears a label clearly identifying a schedule A 

13 substance or product containing a schedule A sub14 stance by the nomenclature used by the Inter15 national Union of Pure and Applied Chemistry 

16 (IUPAC). 

17 ‘‘(2)(A) A product described in subparagraph 

18 (B) is exempt from the International Union of Pure 

19 and Applied Chemistry nomenclature requirement of 

20 this subsection if such product is labeled in the man21 ner required under the Federal Food, Drug, and 

22 Cosmetic Act. 

23 ‘‘(B) A product is described in this subpara24 graph if the product— 


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1 ‘‘(i) is the subject of an approved applica2 tion as described in section 505(b) or (j) of the 

3 Federal Food, Drug, and Cosmetic Act; or 

4 ‘‘(ii) is exempt from the provisions of sec5 tion 505 of such Act relating to new drugs be6 cause— 

7 ‘‘(I) it is intended solely for investiga8 tional use as described in section 505(i) of 

9 such Act; and 

10 ‘‘(II) such product is being used ex11 clusively for purposes of a clinical trial 

12 that is the subject of an effective investiga13 tional new drug application.’’. 

14 (b) PENALTIES.—Section 402 of the Controlled Sub15 stances Act (21 U.S.C. 842) is amended— 

16 (1) in subsection (a)— 

17 (A) in paragraph (16), by striking ‘‘or’’ at 

18 the end; 

19 (B) by redesignating paragraph (17) as 

20 paragraph (18); and 

21 (C) by inserting after paragraph (16) the 

22 following: 

23 ‘‘(17) to violate section 305(f); or’’; and 

24 (2) in subsection (c)— 

25 (A) in paragraph (1)— 


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1 (i) in subparagraph (B)(i), by striking 

2 ‘‘(17)’’ and inserting ‘‘(18)’’; and 

3 (ii) in subparagraph (C), by inserting 

4 ‘‘or (17)’’ after ‘‘paragraph (16)’’ each 

5 place it appears; and 

6 (B) in paragraph (2)(D), by striking 

7 ‘‘(17)’’ and inserting ‘‘(18)’’. 

8 SEC. 7095. REGISTRATION REQUIREMENTS FOR IMPORT9 ERS AND EXPORTERS OF SCHEDULE A SUB10 STANCES. 

11 Section 1008 of the Controlled Substances Import 

12 and Export Act (21 U.S.C. 958) is amended by adding 

13 at the end the following: 

14 ‘‘(j)(1) The Attorney General shall register an appli15 cant to import or export a schedule A substance if— 

16 ‘‘(A) the applicant demonstrates that the sched17 ule A substance will be used for research, analytical, 

18 or industrial purposes approved by the Attorney 

19 General; and 

20 ‘‘(B) the Attorney General determines that such 

21 registration is consistent with the public interest and 

22 with the United States obligations under inter23 national treaties, conventions, or protocols in effect 

24 on the date of enactment of this subsection. 


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1 ‘‘(2) In determining the public interest under para2 graph (1)(B), the Attorney General shall consider— 

3 ‘‘(A) maintenance of effective controls against 

4 diversion of particular controlled substances and any 

5 controlled substance in schedule A compounded 

6 therefrom into other than legitimate medical, sci7 entific, research, or industrial channels, by limiting 

8 the importation and bulk manufacture of such con9 trolled substances to a number of establishments 

10 which can produce an adequate and uninterrupted 

11 supply of these substances under adequately com12 petitive conditions for legitimate medical, scientific, 

13 research, and industrial purposes; 

14 ‘‘(B) compliance with applicable State and local 

15 law; 

16 ‘‘(C) promotion of technical advances in the art 

17 of manufacturing substances described in subpara18 graph (A) and the development of new substances; 

19 ‘‘(D) prior conviction record of applicant under 

20 Federal and State laws relating to the importation, 

21 manufacture, distribution, or dispensing of sub22 stances described in subparagraph (A); 

23 ‘‘(E) past experience in the importation and 

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1 ence in the establishment of effective control against 

2 diversion; and 

3 ‘‘(F) such other factors as may be relevant to 

4 and consistent with the public health and safety. 

5 ‘‘(3) If an applicant is registered to import or export 

6 a controlled substance in schedule I or II under subsection 

7 (a), the applicant shall not be required to apply for a sepa8 rate registration under this subsection.’’. 

9 SEC. 7096. ADDITIONAL CONFORMING AMENDMENTS. 

10 The Controlled Substances Import and Export Act 

11 (21 U.S.C. 951 et seq.) is amended— 

12 (1) in section 1002(a) (21 U.S.C. 952(a))— 

13 (A) in the matter preceding paragraph (1), 

14 by inserting ‘‘or drug or substance in schedule 

15 A’’ after ‘‘schedule I or II’’; and 

16 (B) in paragraph (2), by inserting ‘‘or 

17 drug or substances in schedule A’’ after ‘‘sched18 ule I or II’’; 

19 (2) in section 1003 (21 U.S.C. 953)— 

20 (A) in subsection (c), in the matter pre21 ceding paragraph (1), by inserting ‘‘or drug or 

22 substance in schedule A’’ after ‘‘schedule I or 

23 II’’; and 


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1 (B) in subsection (d), by inserting ‘‘or 

2 drug or substance in schedule A’’ after ‘‘sched3 ule I or II’’; 

4 (3) in section 1004(1) (21 U.S.C. 954(1)), in 

5 the matter preceding subparagraph (A), by inserting 

6 ‘‘or drug or substance in schedule A’’ after ‘‘sched7 ule I’’; 

8 (4) in section 1005 (21 U.S.C. 955), by insert9 ing ‘‘or drug or substance in schedule A’’ after 

10 ‘‘schedule I or II’’; and 

11 (5) in section 1009(a) (21 U.S.C. 959(a)), by 

12 inserting ‘‘or drug or substance in schedule A’’ after 

13 ‘‘schedule I or II’’. 

14 SEC. 7097. SENTENCING REVIEW. 

15 (a) COVERED OFFENSE DEFINED.—In this section, 

16 the term ‘‘covered offense’’ means an offense involving a 

17 schedule A substance for which the penalty was estab18 lished under section 7093 or 7094 of this subtitle. 

19 (b) SENTENCING REVIEW.— 

20 (1) PETITION FOR REVIEW.—If a schedule A 

21 substance that is temporarily or permanently sched22 uled under section 201(k) of the Controlled Sub23 stances Act, as added by this subtitle, is subse24 quently descheduled or rescheduled on a schedule 

25 with lower penalties, any individual convicted of a 


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1 covered offense involving such schedule A substance 

2 who is awaiting sentencing or is still serving a term 

3 of imprisonment for such covered offense on the date 

4 of the descheduling or rescheduling may petition the 

5 court that imposed the sentence for a sentencing re6 duction hearing for such covered offense. 

7 (2) SENTENCING REVIEW.—Not later than 30 

8 days after the date on which a petition is filed under 

9 paragraph (1), the court shall conduct a sentencing 

10 reduction hearing and may modify the sentence of 

11 the petitioner as if the descheduling or rescheduling 

12 described in paragraph (1) had been in effect on the 

13 date the covered offense was committed. 

14 SEC. 7098. RULES OF CONSTRUCTION. 

15 Nothing in this subtitle, or the amendments made by 

16 this subtitle, may be construed to limit— 

17 (1) the prosecution of offenses involving con18 trolled substance analogues under the Controlled 

19 Substances Act (21 U.S.C. 801 et seq.); or 

20 (2) the authority of the Attorney General to 

21 temporarily or permanently schedule, reschedule, or 

22 decontrol controlled substances under provisions of 

23 section 201 of the Controlled Substances Act (21 

24 U.S.C. 811) that are in effect on the day before the 

25 date of enactment of this Act. 


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1 SEC. 7099. CLARIFICATION OF CERTAIN REGISTRATION RE2 QUIREMENTS RELATED TO RESEARCH. 

3 (a) EXCEPTION FOR AGENTS OR EMPLOYEES OF

4 REGISTERED RESEARCHERS.—Section 302(c) of the Con5 trolled Substances Act (21 U.S.C. 822(c)) is amended in 

6 paragraph (1) by striking ‘‘or dispenser’’ and inserting 

7 ‘‘dispenser, or researcher’’. 

8 (b) CONFORMING AMENDMENT.—Section 102(3) of 

9 the Controlled Substances Act (21 U.S.C. 802(3)) is 

10 amended by striking ‘‘or dispenser’’ and inserting ‘‘dis11 penser, or researcher’’. 

12 (c) SINGLE REGISTRATION FOR CONTIGUOUS RE13 SEARCH SITES.—Section 302(e) of the Controlled Sub14 stances Act (21 U.S.C. 822(e)) is amended by adding at 

15 the end the following new paragraph: 

16 ‘‘(3) Notwithstanding paragraph (1), a person 

17 registered to conduct research with a controlled sub18 stance under section 303(f) may conduct such re19 search under a single registration if such research 

20 occurs exclusively on a single, contiguous campus 

21 and the registrant notifies the Attorney General in 

22 writing of all sites on the campus where the research 

23 will be conducted or where the controlled substance 

24 will be stored or administered. The registrant must 

25 so notify the Attorney General prior to conducting 

26 research at such additional sites.’’. 


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1 (d) NEW INSPECTION NOT REQUIRED IN CERTAIN

2 SITUATIONS.—Section 303(f) of the Controlled Sub3 stances Act (21 U.S.C. 823(f)) is amended— 

4 (1) by redesignating paragraphs (1) through 

5 (5) as subparagraphs (A) through (E), respectively, 

6 and by moving the margins of such subparagraphs 

7 two ems to the right; 

8 (2) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 

9 The’’; and 

10 (3) by adding at the end, after the matter fol11 lowing subparagraph (E), as so redesignated, the 

12 following new paragraph: 

13 ‘‘(2)(A) If a person is registered to conduct research 

14 with a controlled substance and applies for a registration, 

15 or a modification of a registration to conduct research 

16 with a second controlled substance that is in the same 

17 schedule or in a schedule with a higher numerical designa18 tion, a new inspection by the Attorney General of the reg19 istered location is not required. 

20 ‘‘(B) Nothing in this paragraph shall prohibit the At21 torney General from conducting any inspection if the At22 torney General deems it necessary.’’. 

23 (e) CONTINUATION OF RESEARCH ON SUBSTANCES

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1 ULE I.—Section 302 of the Controlled Substances Act (21 

2 U.S.C. 822) is amended by adding at the end the following 

3 new subsection: 

4 ‘‘(h) CONTINUATION OF RESEARCH ON SUBSTANCES

5 NEWLY ADDED TO SCHEDULE I; AUTHORITY TO CON6 DUCT RESEARCH WITH OTHER SUBSTANCES IN SCHED7 ULE I.— 

8 ‘‘(1) If a person is conducting research on a 

9 substance at the time the substance is added to 

10 schedule I, and such person is already registered to 

11 conduct research with a controlled substance in 

12 schedule I or II then— 

13 ‘‘(A) the person shall, within 30 days of 

14 the scheduling of the newly scheduled sub15 stance, submit a completed application for reg16 istration or modification of existing registration, 

17 to conduct research on such substance, in ac18 cordance with the regulations issued by the At19 torney General; 

20 ‘‘(B) the person may, notwithstanding sub21 sections (a) and (b), continue to conduct the re22 search on such substance until the application 

23 referred to in subparagraph (A) is withdrawn 

24 by the applicant or until the Attorney General 

25 serves on the applicant an order to show cause 


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1 proposing the denial of the application pursuant 

2 to section 304(c); and 

3 ‘‘(C) if the Attorney General serves such 

4 an order to show cause and the applicant re5 quests a hearing, such hearing shall be held on 

6 an expedited basis and not later than 45 days 

7 after the request is made, except that the hear8 ing may be held at a later time if so requested 

9 by the applicant. 

10 ‘‘(2)(A) A person who is registered to conduct 

11 research with a controlled substance in schedule I 

12 may, notwithstanding subsections (a) and (b), con13 duct research with another controlled substance in 

14 schedule I, provided the following conditions are 

15 met: 

16 ‘‘(i) The person has applied for a modifica17 tion of the person’s registration to authorize re18 search with such other controlled substance in 

19 accordance with the regulations issued by the 

20 Attorney General. 

21 ‘‘(ii) The Attorney General has obtained 

22 verification from the Secretary that the re23 search protocol submitted with the application 

24 is meritorious. 


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1 ‘‘(iii) The Attorney General has deter2 mined that such activity is consistent with 

3 United States obligations under the Single Con4 vention on Narcotic Drugs, 1961. The Attorney 

5 General shall make such determination not 

6 later than 30 days after receiving the applica7 tion referred to in clause (i). 

8 ‘‘(B) Nothing in this section shall be construed 

9 to alter the authority of the Attorney General to ini10 tiate proceedings to deny, suspend, or revoke any 

11 registration in accordance with sections 303 and 

12 304.’’. 

13 (f) TREATMENT OF CERTAIN ACTIVITIES AS COINCI14 DENT TO RESEARCH.—Section 302 of the Controlled Sub15 stances Act (21 U.S.C. 822), as amended by subsection 

16 (d), is further amended by adding at the end the following 

17 new subsection: 

18 ‘‘(i) TREATMENT OF CERTAIN ACTIVITIES AS COIN19 CIDENT TO RESEARCH.— 

20 ‘‘(1) IN GENERAL.—Except as specified in 

21 paragraph (2), a person who is registered to perform 

22 research with a controlled substance may perform 

23 the following activities with small quantities of that 

24 substance, as set forth in the relevant statement or 

25 protocol filed with the application for registration 


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1 approved by the Attorney General without being re2 quired to obtain a manufacturing registration: 

3 ‘‘(A) Processing the substance to create ex4 tracts, tinctures, oils, solutions, derivatives, or 

5 other forms of the substance consistent with the 

6 approved research protocol. 

7 ‘‘(B) Dosage form development for the 

8 purpose of satisfying regulatory requirements 

9 implemented by the Food and Drug Adminis10 tration for submitting an investigational new 

11 drug application. 

12 ‘‘(2) EXCEPTION REGARDING MARIHUANA.— 

13 The authority under paragraph (1) does not include 

14 authority to grow marihuana.’’. 

15 SEC. 7100. REVIEW OF RESEARCH REGISTRATION PROCESS. 

16 (a) REVIEW.—Not later than one year after the date 

17 of the enactment of this section, the Attorney General and 

18 the Secretary of Health and Human Services shall conduct 

19 a review of the processes used to obtain or modify Federal 

20 authorization to conduct research with controlled sub21 stances, including— 

22 (1) an evaluation of the impacts of the amend23 ments made by section 7099 on the risk of the diver24 sion of controlled substances used in research and 

25 related public safety considerations; and 


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1 (2) identification of opportunities to reduce any 

2 unnecessary burden on persons seeking registration, 

3 potential redundancies, and inefficiencies in the 

4 process to obtain or modify Federal authorization to 

5 conduct research with controlled substances, includ6 ing the process for obtaining a registration under 

7 section 303 of the Controlled Substances Act (21 

8 U.S.C. 823) and the process by which the Secretary 

9 of Health and Human Services reviews research pro10 tocols. 

11 (b) GUIDANCE.—Following the review described in 

12 subsection (a), the Attorney General and the Secretary of 

13 Health and Human Services shall, as appropriate, jointly 

14 issue guidance to registrants and potential registrants 

15 clarifying the process for registration under section 303 

16 of the Controlled Substances Act (21 U.S.C. 823). 

17 TITLE VIII—TAX INCENTIVES TO 

18 IMPROVE HEALTH CARE 

19 SEC. 8001. DOMESTIC MEDICAL AND DRUG MANUFAC20 TURING CREDIT. 

21 (a) IN GENERAL.—Subpart D of part IV of sub22 chapter A of chapter 1 of the Internal Revenue Code of 

23 1986 is amended by adding at the end the following new 

24 section: 


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1 ‘‘SEC. 45U. DOMESTIC MEDICAL AND DRUG MANUFAC2 TURING CREDIT. 

3 ‘‘(a) IN GENERAL.—For purposes of section 38, the 

4 domestic medical and drug manufacturing credit deter5 mined under this section for any taxable year is an amount 

6 equal to 10.5 percent of the lesser of— 

7 ‘‘(1) the qualified medical and drug manufac8 turing income of the taxpayer for the taxable year, 

9 or 

10 ‘‘(2) taxable income of the taxpayer for the tax11 able year. 

12 ‘‘(b) CREDIT LIMITED TO WAGES PAID.— 

13 ‘‘(1) IN GENERAL.—The amount of the credit 

14 allowable under subsection (a) for any taxable year 

15 shall not exceed 50 percent of the W–2 wages of the 

16 taxpayer for the taxable year. 

17 ‘‘(2) W–2 WAGES.—For purposes of this sec18 tion— 

19 ‘‘(A) IN GENERAL.—The term ‘W–2 

20 wages’ means, with respect to any person for 

21 any taxable year of such person, the sum of the 

22 amounts described in paragraphs (3) and (8) of 

23 section 6051(a) paid by such person with re24 spect to employment of employees by such per25 son during the calendar year ending during 

26 such taxable year. 


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1 ‘‘(B) LIMITATION TO WAGES ATTRIB2 UTABLE TO DOMESTIC PRODUCTION.—Such 

3 term shall not include any amount which is not 

4 properly allocable to domestic medical and drug 

5 manufacturing gross receipts for purposes of 

6 subsection (c)(1). 

7 ‘‘(C) RETURN REQUIREMENT.—Such term 

8 shall not include any amount which is not prop9 erly included in a return filed with the Social 

10 Security Administration on or before the 60th 

11 day after the due date (including extensions) 

12 for such return. 

13 ‘‘(3) ACQUISITIONS, DISPOSITIONS, AND SHORT

14 TAXABLE YEARS.—The Secretary shall provide for 

15 the application of this subsection in cases of a short 

16 taxable year or where the taxpayer acquires, or dis17 poses of, the major portion of a trade or business or 

18 the major portion of a separate unit of a trade or 

19 business during the taxable year. 

20 ‘‘(c) QUALIFIED MEDICAL AND DRUG MANUFAC21 TURING INCOME.—For purposes of this section— 

22 ‘‘(1) IN GENERAL.—The term ‘qualified medical 

23 and drug manufacturing income’ for any taxable 

24 year means an amount equal to the excess (if any) 

25 of— 


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1 ‘‘(A) the taxpayer’s domestic medical and 

2 drug manufacturing gross receipts for the tax3 able year, over 

4 ‘‘(B) the sum of— 

5 ‘‘(i) the cost of goods sold that are al6 locable to such receipts, and 

7 ‘‘(ii) other expenses, losses, or deduc8 tions which are properly allocable to such 

9 receipts. 

10 ‘‘(2) ALLOCATION METHOD.—The Secretary 

11 shall prescribe rules for the proper allocation of 

12 items described in paragraph (1)(B) for purposes of 

13 determining qualified medical and drug manufac14 turing income. Such rules shall provide for the prop15 er allocation of items whether or not such items are 

16 directly allocable to domestic medical and drug man17 ufacturing gross receipts. 

18 ‘‘(3) SPECIAL RULES FOR DETERMINING

19 COSTS.— 

20 ‘‘(A) IN GENERAL.—For purposes of deter21 mining costs under clause (i) of paragraph 

22 (1)(B), any item or service brought into the 

23 United States shall be treated as acquired by 

24 purchase, and its cost shall be treated as not 


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1 less than its value immediately after it entered 

2 the United States. 

3 ‘‘(B) EXPORTS FOR FURTHER MANUFAC4 TURE.—In the case of any property described 

5 in subparagraph (A) that had been exported by 

6 the taxpayer for further manufacture, the in7 crease in cost or adjusted basis under subpara8 graph (A) shall not exceed the difference be9 tween the value of the property when exported 

10 and the value of the property when brought 

11 back into the United States after the further 

12 manufacture. 

13 ‘‘(4) DOMESTIC MEDICAL AND DRUG MANUFAC14 TURING GROSS RECEIPTS.— 

15 ‘‘(A) IN GENERAL.—The term ‘domestic 

16 medical and drug manufacturing gross receipts’ 

17 means the gross receipts of the taxpayer which 

18 are derived from any sale, exchange, or other 

19 disposition of— 

20 ‘‘(i) any active pharmaceutical ingre21 dient, or 

22 ‘‘(ii) any qualified countermeasure, 

23 which was manufactured or produced by the 

24 taxpayer in whole or in significant part within 

25 the United States. 


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1 ‘‘(B) ACTIVE PHARMACEUTICAL INGRE2 DIENT.—The term ‘active pharmaceutical ingre3 dient’ means any substance or mixture of sub4 stances intended to be used in the manufacture 

5 of a drug product and (when so used) becomes 

6 an active ingredient in the drug product. 

7 ‘‘(C) QUALIFIED COUNTERMEASURE.—The 

8 term ‘qualified countermeasure’ has the mean9 ing given such term in section 319F–1(a)(2) of 

10 the Public Health Service Act (42 U.S.C. 

11 247d–6a(a)(2)).’’ 

12 ‘‘(D) PARTNERSHIPS OWNED BY EX13 PANDED AFFILIATED GROUPS.—For purposes 

14 of this paragraph, if all of the interests in the 

15 capital and profits of a partnership are owned 

16 by members of a single expanded affiliated 

17 group at all times during the taxable year of 

18 such partnership, the partnership and all mem19 bers of such group shall be treated as a single 

20 taxpayer during such period. 

21 ‘‘(d) DEFINITIONS AND SPECIAL RULES.—For pur22 poses of this section— 

23 ‘‘(1) APPLICATION OF SECTION TO PASS-THRU

24 ENTITIES.— 


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1 ‘‘(A) PARTNERSHIPS AND S CORPORA2 TIONS.—In the case of a partnership or S cor3 poration— 

4 ‘‘(i) this section shall be applied at the 

5 partner or shareholder level, 

6 ‘‘(ii) each partner or shareholder shall 

7 take into account such person’s allocable 

8 share of each item described in subpara9 graph (A) or (B) of subsection (c)(1) (de10 termined without regard to whether the 

11 items described in such subparagraph (A) 

12 exceed the items described in such sub13 paragraph (B)), and 

14 ‘‘(iii) each partner or shareholder 

15 shall be treated for purposes of subsection 

16 (b) as having W–2 wages for the taxable 

17 year in an amount equal to such person’s 

18 allocable share of the W–2 wages of the 

19 partnership or S corporation for the tax20 able year (as determined under regulations 

21 prescribed by the Secretary). 

22 ‘‘(B) TRUSTS AND ESTATES.—In the case 

23 of a trust or estate— 

24 ‘‘(i) the items referred to in subpara25 graph (A)(ii) (as determined therein) and 


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1 the W–2 wages of the trust or estate for 

2 the taxable year, shall be apportioned be3 tween the beneficiaries and the fiduciary 

4 (and among the beneficiaries) under regu5 lations prescribed by the Secretary, and 

6 ‘‘(ii) for purposes of paragraph (2), 

7 adjusted gross income of the trust or es8 tate shall be determined as provided in sec9 tion 67(e) with the adjustments described 

10 in such paragraph. 

11 ‘‘(C) REGULATIONS.—The Secretary may 

12 prescribe rules requiring or restricting the allo13 cation of items and wages under this paragraph 

14 and may prescribe such reporting requirements 

15 as the Secretary determines appropriate. 

16 ‘‘(2) APPLICATION TO INDIVIDUALS.—In the 

17 case of an individual, subsection (a)(2) shall be ap18 plied by substituting ‘adjusted gross income’ for 

19 ‘taxable income’. For purposes of the preceding sen20 tence, adjusted gross income shall be determined 

21 after application of sections 86, 135, 137, 219, 221, 

22 222, and 469. 

23 ‘‘(3) SPECIAL RULE FOR AFFILIATED

24 GROUPS.— 


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1 ‘‘(A) IN GENERAL.—All members of an ex2 panded affiliated group shall be treated as a 

3 single corporation for purposes of this section. 

4 ‘‘(B) EXPANDED AFFILIATED GROUP.— 

5 For purposes of this section, the term ‘ex6 panded affiliated group’ means an affiliated 

7 group as defined in section 1504(a), deter8 mined— 

9 ‘‘(i) by substituting ‘more than 50 

10 percent’ for ‘at least 80 percent’ each place 

11 it appears, and 

12 ‘‘(ii) without regard to paragraphs (2) 

13 and (4) of section 1504(b). 

14 ‘‘(C) ALLOCATION OF CREDIT.—Except as 

15 provided in regulations, the credit under sub16 section (a) shall be allocated among the mem17 bers of the expanded affiliated group in propor18 tion to each member’s respective amount (if 

19 any) of qualified medical and drug manufac20 turing income. 

21 ‘‘(4) TRADE OR BUSINESS REQUIREMENT.— 

22 This section shall be applied by only taking into ac23 count items which are attributable to the actual con24 duct of a trade or business. 


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1 ‘‘(5) COORDINATION WITH MINIMUM TAX.—For 

2 purposes of determining alternative minimum tax3 able income under section 55, qualified medical and 

4 drug manufacturing income shall be determined 

5 without regard to any adjustments under sections 56 

6 through 59. 

7 ‘‘(6) UNRELATED BUSINESS TAXABLE IN8 COME.—For purposes of determining the tax im9 posed by section 511, subsection (a)(1)(B) shall be 

10 applied by substituting ‘unrelated business taxable 

11 income’ for ‘taxable income’. 

12 ‘‘(7) REGULATIONS.—The Secretary shall pre13 scribe such regulations as are necessary to carry out 

14 the purposes of this section, including regulations 

15 which prevent more than 1 taxpayer from being al16 lowed a credit under this section with respect to any 

17 activity described in subsection (c)(4)(A).’’. 

18 (b) TREATMENT UNDER BASE EROSION TAX.—Sec19 tion 59A(b)(1)(B)(ii) of such Code is amended by striking 

20 ‘‘plus’’ at the end of subclause (I), by redesignating sub21 clause (II) as subclause (III), and by inserting after sub22 clause (I) the following new subclause: 

23 ‘‘(II) the credit allowed under 

24 section 38 for the taxable year which 

25 is properly allocable to the domestic 


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1 medical and drug manufacturing cred2 it determined under section 45U(a), 

3 plus’’. 

4 (c) PART OF GENERAL BUSINESS CREDIT.—Section 

5 38(b) of such Code is amended by striking ‘‘plus’’ at the 

6 end of paragraph (32), by striking the period at the end 

7 of paragraph (33) and inserting ‘‘, plus’’, and by adding 

8 at the end the following new paragraph: 

9 ‘‘(34) the domestic medical and drug manufac10 turing credit determined under section 45U(a).’’. 

11 (d) CREDIT ALLOWED AGAINST ALTERNATIVE MIN12 IMUM TAX.—Section 38(c)(4)(B) of such Code is amended 

13 by redesignating clauses (x) through (xii) as clauses (xi) 

14 through (xiii), respectively, and by inserting after clause 

15 (ix) the following new clause: 

16 ‘‘(x) the credit determined under sec17 tion 45U,’’. 

18 (e) CLERICAL AMENDMENT.—The table of sections 

19 for subpart D of part IV of subchapter A of chapter 1 

20 of such Code is amended by adding at the end the fol21 lowing new item: 

‘‘Sec. 45U. Domestic medical and drug manufacturing credit.’’. 

22 (f) EFFECTIVE DATE.—The amendments made by 

23 this section shall apply to taxable years beginning after 

24 December 31, 2020. 


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1 SEC. 8002. QUALIFYING ADVANCED MEDICAL MANUFAC2 TURING EQUIPMENT CREDIT. 

3 (a) IN GENERAL.—Subpart E of part IV of sub4 chapter A of chapter 1 of the Internal Revenue Code of 

5 1986 is amended by adding at the end the following new 

6 section: 

7 ‘‘SEC. 48D. QUALIFYING ADVANCED MEDICAL MANUFAC8 TURING EQUIPMENT CREDIT. 

9 ‘‘(a) IN GENERAL.—For purposes of section 46, the 

10 qualifying advanced medical manufacturing equipment 

11 credit determined under this section for any taxable year 

12 is the applicable percentage of the basis of any qualifying 

13 advanced medical manufacturing equipment placed in 

14 service during such taxable year. 

15 ‘‘(b) APPLICABLE PERCENTAGE.—For purposes of 

16 subsection (a), the applicable percentage is— 

17 ‘‘(1) 30 percent in the case of equipment which 

18 is placed in service before January 1, 2028, 

19 ‘‘(2) 20 percent in the case of equipment which 

20 is placed in service during calendar year 2028, 

21 ‘‘(3) 10 percent in the case of equipment which 

22 is placed in service during calendar year 2029, and 

23 ‘‘(4) 0 percent in the case of equipment which 

24 is placed in service after December 31, 2029. 

25 ‘‘(c) QUALIFYING ADVANCED MEDICAL MANUFAC26 TURING EQUIPMENT.—For purposes of this section, the 


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1 term ‘qualifying advanced medical manufacturing equip2 ment’ means property of a character subject to the allow3 ance for depreciation— 

4 ‘‘(1) which is machinery or equipment that is 

5 designed and used to manufacture a— 

6 ‘‘(A) drug (as such term is defined in sec7 tion 201(g)(1) of the Federal Food, Drug, and 

8 Cosmetic Act), 

9 ‘‘(B) device (as such term is defined in sec10 tion 201(h) of such Act), or 

11 ‘‘(C) biological product (as such term is 

12 defined in section 351(i) of the Public Health 

13 Service Act), 

14 ‘‘(2) which has been identified by the Secretary 

15 (after consultation with the Secretary of Health and 

16 Human Services) as machinery or equipment that— 

17 ‘‘(A) incorporates novel technology or uses 

18 an established technique or technology in a new 

19 or innovative way, or 

20 ‘‘(B) that can improve medical product 

21 quality, address shortages of medicines, and 

22 speed time-to-market, 

23 ‘‘(3) which is placed in service in the United 

24 States by the taxpayer, and 


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1 ‘‘(4) with respect to which depreciation is allow2 able. 

3 ‘‘(d) CERTAIN QUALIFIED PROGRESS EXPENDI4 TURES RULES MADE APPLICABLE.—Rules similar to the 

5 rules of subsections (c)(4) and (d) of section 46 (as in 

6 effect on the day before the enactment of the Revenue 

7 Reconciliation Act of 1990) shall apply for purposes of 

8 this section. 

9 ‘‘(e) REGULATIONS.—The Secretary shall prescribe 

10 such regulations or other guidance as may be necessary 

11 to carry out the purposes of this section, including regula12 tions which prevent abuse or fraud.’’. 

13 (b) TREATMENT UNDER BASE EROSION TAX.—Sec14 tion 59A(b)(1)(B)(ii) of such Code, as amended by section 

15 8001 of this Act, is further amended by striking ‘‘plus’’ 

16 at the end of subclause (II), by redesignating subclause 

17 (III) as subclause (IV), and by inserting after subclause 

18 (II) the following new subclause: 

19 ‘‘(III) the credit allowed under 

20 section 46 for the taxable year which 

21 is properly allocable to the qualifying 

22 advanced medical manufacturing 

23 equipment credit determined under 

24 section 48D(a), plus’’. 


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1 (c) PART OF INVESTMENT CREDIT.—Section 46 of 

2 such Code is amended by striking ‘‘and’’ at the end of 

3 paragraph (5), by striking the period at the end of para4 graph (6) and inserting ‘‘, and’’, and by adding at the 

5 end the following new paragraph: 

6 ‘‘(7) the qualifying advanced medical manufac7 turing equipment credit.’’. 

8 (d) CLERICAL AMENDMENT.—The table of sections 

9 for subpart D of part IV of subchapter A of chapter 1 

10 of such Code is amended by adding at the end the fol11 lowing new item: 

‘‘Sec. 48D. Qualifying advanced medical manufacturing equipment credit.’’. 

12 (e) EFFECTIVE DATE.—The amendments made by 

13 this section shall apply to periods after the date of the 

14 enactment of this section under rules similar to the rules 

15 of section 48(m) of the Internal Revenue Code of 1986 

16 (as in effect on the date of the enactment fo the Revenue 

17 Reconciliation Act of 1990). 

18 SEC. 8003. NEW MEDICAL RESEARCH EXPENDITURE COM19 PONENT OF CREDIT FOR INCREASING RE20 SEARCH ACTIVITIES. 

21 (a) IN GENERAL.—Section 41(a) of the Internal Rev22 enue Code of 1986 is amended by striking ‘‘and’’ at the 

23 end of paragraph (2), by striking the period at the end 

24 of paragraph (3) and inserting ‘‘, and’’, and by adding 

25 at the end the following new paragraph: 


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1 ‘‘(4) 14 percent of specified medical research 

2 expenditures.’’. 

3 (b) SPECIFIED MEDICAL RESEARCH EXPENDI4 TURES.—Section 41(f) of such Code is amended by adding 

5 at the end the following new paragraph: 

6 ‘‘(7) SPECIFIED MEDICAL RESEARCH EXPENDI7 TURES.— 

8 ‘‘(A) IN GENERAL.—The term ‘specified 

9 medical research expenditures’ means amounts 

10 paid or incurred for qualified research with re11 spect to any qualified countermeasure. 

12 ‘‘(B) QUALIFIED COUNTERMEASURE.—The 

13 term ‘qualified countermeasure’ has the mean14 ing given to such term in section 319F–1(a)(2) 

15 of the Public Health Service Act (42 U.S.C. 

16 247d–6a(a)(2)).’’. 

17 (c) DENIAL OF DOUBLE BENEFIT.— 

18 (1) TAXABLE YEARS BEGINNING BEFORE JANU19 ARY 1, 2021.—In the case of specified medical re20 search expenditures (as defined in section 41(f)(7) 

21 of such Code (as added by this section)) paid or in22 curred in taxable years beginning before January 1, 

23 2021— 

24 (A) such expenditures shall be treated in 

25 the same manner as qualified research expenses 


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1 and basic research expenses under section 

2 280C(c)(1) of such Code (as in effect on the 

3 day before the enactment of the Tax Cuts and 

4 Jobs Act), and 

5 (B) the amount determined under section 

6 280C(c)(2)(A) (as in effect on such day) for the 

7 taxable year shall be increased by the amount 

8 of credit determined for the taxable year under 

9 section 41(a)(4) (as added by this section). 

10 (2) TAXABLE YEARS BEGINNING AFTER DECEM11 BER 31, 2020.—Section 280C(c)(1) of such Code is 

12 amended by striking ‘‘section 41(a)(1)’’ and insert13 ing ‘‘paragraphs (1) and (4) of section 41(a)’’. 

14 (d) CONFORMING AMENDMENT.—Section 41(f)(1) of 

15 such Code is amended by striking ‘‘and amounts paid or 

16 incurred to energy research consortiums’’ each place it ap17 pears and inserting ‘‘, amounts paid or incurred to energy 

18 research consortiums, and specified medical research ex19 penditures’’. 

20 (e) EFFECTIVE DATE.—The amendments made by 

21 this section shall apply to amounts paid or incurred after 

22 the date of the enactment of this Act, in taxable years 

23 ending after such date. 


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1 SEC. 8004. REFUNDABLE PORTION OF RESEARCH CREDIT 

2 FOR SMALL BUSINESSES ENGAGING IN SPEC3 IFIED MEDICAL RESEARCH. 

4 (a) IN GENERAL.—Section 41 of the Internal Rev5 enue Code of 1986 is amended by adding at the end the 

6 following new subsection: 

7 ‘‘(i) REFUNDABLE PORTION FOR SMALL BUSI8 NESSES ENGAGING IN SPECIFIED MEDICAL RESEARCH.— 

9 ‘‘(1) IN GENERAL.—At the election of a medical 

10 research small business, the portion of the credit de11 termined under this section for the taxable year 

12 which is properly allocable to specified medical re13 search shall be treated (other than for purposes of 

14 section 280C) as a credit allowed under subpart C 

15 (and not this subpart). 

16 ‘‘(2) MEDICAL RESEARCH SMALL BUSINESS.— 

17 For purposes of this subsection, the term ‘medical 

18 research small business’ means any domestic C cor19 poration— 

20 ‘‘(A) which conducts any specified medical 

21 research during the taxable year, and 

22 ‘‘(B) the gross receipts of which (deter23 mined under the rules of subsection (c)) for the 

24 taxable year do not exceed $1,000,000. 

25 ‘‘(3) SPECIFIED MEDICAL RESEARCH.—For 

26 purposes of this subsection, the term ‘specified medVerDate Sep 11 2014 19:08 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00327 Fmt 6652 Sfmt 6201 E:\BILLS\H14.IH H14

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1 ical research’ means any qualified research with re2 spect to qualified countermeasures (as defined in 

3 section 319F–1(a)(2) of the Public Health Service 

4 Act (42 U.S.C. 247d–6a(a)(2))). 

5 ‘‘(4) ELECTION.—Any election under this sub6 section for any taxable year— 

7 ‘‘(A) shall specify the amount of the credit 

8 to which such election applies, 

9 ‘‘(B) shall be made on or before the due 

10 date (including extensions) of the return of tax 

11 for the taxable year, 

12 ‘‘(C) may not be made for any taxable year 

13 with respect to any portion of the credit deter14 mined under this section with respect to which 

15 an election is made under subsection (h), and 

16 ‘‘(D) may be revoked only with the consent 

17 of the Secretary. 

18 ‘‘(5) REGULATIONS.—The Secretary shall pre19 scribe such regulations for purposes of this sub20 section as may be necessary or appropriate for de21 termining proper allocation to specified medical re22 search of the portion of any credit allowed to a tax23 payer for a taxable year under this section.’’. 


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1 (b) CONFORMING AMENDMENT.—Section 1324(b) of 

2 title 31, United States Code, is amended by inserting 

3 ‘‘41(i),’’ after ‘‘6428,’’. 

4 (c) EFFECTIVE DATE.—The amendments made by 

5 this section shall apply to taxable years beginning after 

6 December 31, 2020. 

7 SEC. 8005. EXCEPTION FROM PASSIVE LOSS RULES FOR IN8 VESTMENTS IN SPECIFIED MEDICAL RE9 SEARCH SMALL BUSINESS PASS-THRU ENTI10 TIES. 

11 (a) IN GENERAL.—Subsection (c) of section 469 of 

12 the Internal Revenue Code of 1986 is amended by redesig13 nating paragraphs (4) through (7) as paragraphs (5) 

14 through (8), respectively, and by inserting after paragraph 

15 (3) the following new paragraph: 

16 ‘‘(4) SPECIFIED MEDICAL RESEARCH ACTIVI17 TIES.— 

18 ‘‘(A) IN GENERAL.—The term ‘passive ac19 tivity’ shall not include any qualified medical re20 search activity of the taxpayer carried on by a 

21 specified medical research small business pass22 thru entity. 

23 ‘‘(B) TREATMENT OF LOSSES AND DEDUC24 TIONS.— 


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1 ‘‘(i) IN GENERAL.—Losses or deduc2 tions of a taxpayer in connection with 

3 qualified medical research activities carried 

4 on by a specified medical research small 

5 business pass-thru entity shall not be 

6 treated as losses or deductions, respec7 tively, from a passive activity except as 

8 provided in clause (ii) and subparagraph 

9 (C). 

10 ‘‘(ii) LIMITATION.—Clause (i) shall 

11 apply to losses and deductions of a tax12 payer in connection with a specified med13 ical small business pass-thru entity for a 

14 taxable year only to the extent that the ag15 gregate losses and deductions of the tax16 payer in connection with qualified medical 

17 research activities of such entity for such 

18 taxable year do not exceed the portion of 

19 the taxpayer’s adjusted basis in the tax20 payer’s ownership interest in such entity 

21 that is attributable to money or other 

22 property contributed— 

23 ‘‘(I) in exchange for such owner24 ship interest, and 


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1 ‘‘(II) specifically for use in con2 nection with qualified medical re3 search activities. 

4 For purposes of the preceding sentence, 

5 the taxpayer’s basis shall not include any 

6 portion of such basis which is attributable 

7 to an increase in a partner’s share of the 

8 liabilities of a partnership that is consid9 ered under section 752(a) as a contribution 

10 of money. 

11 ‘‘(C) TREATMENT OF CARRYOVERS.—Sub12 paragraph (B)(i) shall not apply to the portion 

13 of any loss or deduction that is carried over 

14 under subsection (b) into a taxable year other 

15 than the taxable year in which such loss or de16 duction arose. 

17 ‘‘(D) QUALIFIED MEDICAL RESEARCH AC18 TIVITY.—For purposes of this paragraph, the 

19 term ‘qualified medical research activity’ means 

20 any qualified research (within the meaning of 

21 section 41(d)) with respect to qualified counter22 measures (as defined in section 319F–1(a)(2) 

23 of the Public Health Service Act (42 U.S.C. 

24 247d–6a(a)(2))). 


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1 ‘‘(E) SPECIFIED MEDICAL RESEARCH

2 SMALL BUSINESS PASS-THRU ENTITY.—For 

3 purposes of this paragraph, the term ‘specified 

4 medical research small business pass-thru enti5 ty’ means any domestic pass-thru entity for any 

6 taxable year if— 

7 ‘‘(i) more than 80 percent of such en8 tity’s expenditures on qualified research for 

9 such taxable year are paid or incurred in 

10 connection with qualified medical research 

11 activities, and 

12 ‘‘(ii) the gross receipts (as determined 

13 under the rules of section 41(h)(3)) of 

14 such entity for the taxable year (and each 

15 preceding taxable year) is less than 

16 $1,000,000. 

17 ‘‘(F) CAPITAL EXPENDITURES TAKEN INTO

18 ACCOUNT FOR EXPENDITURES TEST.—An ex19 penditure shall not fail to be taken into account 

20 under subparagraph (E)(i) merely because such 

21 expenditure is chargeable to capital account. 

22 ‘‘(G) PASS-THRU ENTITY.—For purposes 

23 of this paragraph, the term ‘pass-thru entity’ 

24 means any partnership, S corporation, or other 


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1 entity identified by the Secretary as a pass-thru 

2 entity for purposes of this paragraph. 

3 ‘‘(H) AGGREGATION RULES.— 

4 ‘‘(i) IN GENERAL.—All persons treat5 ed as a single employer under subsection 

6 (a) or (b) of section 52, or subsection (m) 

7 or (o) of section 414, shall be treated as a 

8 single entity for purposes of subparagraphs 

9 (E) and (F)(iii). 

10 ‘‘(ii) LIMITATION WHERE ENTITY

11 WOULD NOT QUALIFY.—No entity shall be 

12 treated as a specified medical research 

13 small business pass-thru entity unless such 

14 entity qualifies as such both with and with15 out the application of clause (i).’’. 

16 (b) MATERIAL PARTICIPATION NOT REQUIRED.— 

17 Paragraph (5) of section 469(c) of the Internal Revenue 

18 Code of 1986, as redesignated by subsection (a), is amend19 ed by striking ‘‘and (3)’’ in the heading and text and in20 serting ‘‘, (3), and (4)’’. 

21 (c) CERTAIN RESEARCH-RELATED DEDUCTIONS AND

22 CREDITS OF SPECIFIED MEDICAL RESEARCH SMALL

23 BUSINESS PASS-THRU ENTITIES ALLOWED FOR PUR24 POSES OF DETERMINING ALTERNATIVE MINIMUM TAX.— 


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1 (1) DEDUCTION FOR RESEARCH AND EXPERI2 MENTAL EXPENDITURES.—Paragraph (2) of section 

3 56(b) of the Internal Revenue Code of 1986 is 

4 amended by adding at the end the following new 

5 subparagraph: 

6 ‘‘(E) EXCEPTION FOR SPECIFIED MEDICAL

7 RESEARCH SMALL BUSINESS PASS-THRU ENTI8 TIES.—In the case of a specified medical re9 search small business pass-thru entity (as de10 fined in section 469(c)(4)), this paragraph shall 

11 not apply to any amount allowable as a deduc12 tion under section 174(a).’’. 

13 (2) ALLOWANCE OF CERTAIN RESEARCH-RE14 LATED CREDITS.—Subparagraph (B) of section 

15 38(c)(4) of such Code is amended by redesignating 

16 clauses (ii) through (ix) as clauses (iii) through (x), 

17 respectively, and by inserting after clause (i) the fol18 lowing new clause: 

19 ‘‘(ii) the credit of an individual tax20 payer determined under section 41 to the 

21 extent attributable to a specified medical 

22 research small business pass-thru entity 

23 (as defined in section 469(c)(4)),’’. 

24 (d) EXCEPTION TO LIMITATION ON PASS-THRU OF

25 RESEARCH CREDIT.—Subsection (g) of section 41 of such 


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1 Code is amended by adding at the end the following: 

2 ‘‘Paragraphs (2) and (4) shall not apply with respect to 

3 any specified medical research small business pass-thru 

4 entity (as defined in section 469(c)(4)).’’. 

5 (e) EFFECTIVE DATE.—The amendments made by 

6 this section shall apply to losses and credits arising in tax7 able years beginning after December 31, 2020. 

8 SEC. 8006. TEMPORARY CARRYOVER FOR HEALTH AND DE9 PENDENT CARE FLEXIBLE SPENDING AR10 RANGEMENTS. 

11 (a) IN GENERAL.—With respect to the 2020 plan 

12 year for any health flexible spending arrangement or any 

13 dependent care flexible spending arrangement, an em14 ployer may elect to amend its cafeteria plan to permit any 

15 unused amounts remaining in such flexible spending ar16 rangement at the end of such plan year to be carried over 

17 to the 2021 plan year, pursuant to rules similar to the 

18 rules established for health flexible spending arrangements 

19 under Internal Revenue Service Notice 2013–71. 

20 (b) RETROACTIVE APPLICATION.—An employer shall 

21 be permitted to amend its cafeteria plan to effectuate the 

22 rule described in subsection (a), provided that such 

23 amendment— 

24 (1) is adopted before January 1, 2021; and 


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1 (2) provides that the rule described in such sub2 section shall be in effect as of the first day of the 

3 2020 plan year. 

4 (c) DEFINITIONS.—Any term used in this section 

5 which is also used in section 125 of the Internal Revenue 

6 Code of 1986 or the regulations thereunder shall have the 

7 same meaning as when used in such section or regulations. 

8 SEC. 8007. INCREASE IN EXCLUSION FOR EMPLOYER-PRO9 VIDED DEPENDENT CARE ASSISTANCE. 

10 (a) IN GENERAL.—Section 129(a)(2) of the Internal 

11 Revenue Code of 1986 is amended by adding at the end 

12 the following new subparagraph: 

13 ‘‘(D) SPECIAL RULE FOR 2020 AND 2021.— 

14 In the case of any taxable year beginning dur15 ing 2020 or 2021, subparagraph (A) shall be 

16 applied by substituting ‘$10,500 ($5,250’ for 

17 ‘$5,000 ($2,500’.’’. 

18 (b) EFFECTIVE DATE.—The amendment made by 

19 this section shall apply to taxable years beginning after 

20 December 31, 2019. 

21 (c) RETROACTIVE PLAN AMENDMENTS.—A plan or 

22 other arrangement that otherwise satisfies all applicable 

23 requirements of sections 106, 125, and 129 of the Internal 

24 Revenue Code of 1986 (including any rules or regulations 

25 thereunder) shall not fail to be treated as a cafeteria plan 


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1 or dependent care flexible spending arrangement merely 

2 because such plan or arrangement is amended pursuant 

3 to a provision under this section and such amendment is 

4 retroactive, if— 

5 (1) such amendment is adopted no later than 

6 the last day of the plan year in which the amend7 ment is effective, and 

8 (2) the plan or arrangement is operated con9 sistent with the terms of such amendment during 

10 the period beginning on the effective date of the 

11 amendment and ending on the date the amendment 

12 is adopted. 

13 SEC. 8008. TEMPORARY INCREASE IN CONTRIBUTION LIM14 ITS FOR HEALTH SAVINGS ACCOUNTS. 

15 (a) IN GENERAL.—Section 223(b) of the Internal 

16 Revenue Code of 1986 is amended by adding at the end 

17 the following new paragraph: 

18 ‘‘(9) INCREASE IN MONTHLY LIMITATIONS FOR

19 TAXABLE YEARS 2020 AND 2021.—In the case of any 

20 month during a taxable year which begins after De21 cember 31, 2019, and before January 1, 2022, the 

22 dollar amount in effect under subparagraph (A) or 

23 (B) of paragraph (2) for such month shall be twice 

24 the amount otherwise applicable under such sub25 paragraph, as determined— 


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1 ‘‘(A) before application of paragraph (3), 

2 ‘‘(B) after application of subsection (g), 

3 and 

4 ‘‘(C) without regard to this paragraph.’’. 

5 (b) EFFECTIVE DATE.—The amendment made by 

6 this section shall apply with respect to taxable years begin7 ning after December 31, 2019. 

8 SEC. 8009. TEMPORARY ALLOWANCE OF PAYMENTS FOR 

9 EMPLOYMENT-RELATED EXPENSES UNDER 

10 HEALTH SAVINGS ACCOUNTS. 

11 (a) IN GENERAL.—Section 223(d)(2) of the Internal 

12 Revenue Code of 1986 is amended by adding at the end 

13 the following new subparagraph: 

14 ‘‘(E) INCLUSION OF EMPLOYMENT-RE15 LATED EXPENSES FOR TAXABLE YEARS 2020

16 AND 2021.—In the case of any taxable year 

17 which begins after December 31, 2019, and be18 fore January 1, 2022, the term ‘qualified med19 ical expenses’ includes, with respect to an ac20 count beneficiary, any amounts paid by such 

21 beneficiary for employment-related expenses (as 

22 defined in section 21(b)(2)) which are incurred 

23 during such taxable year.’’. 

24 (b) CONFORMING AMENDMENT.—Section 21(c) of 

25 the Internal Revenue Code of 1986 is amended by insertVerDate Sep 11 2014 19:08 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00338 Fmt 6652 Sfmt 6201 E:\BILLS\H14.IH H14

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1 ing ‘‘and any amounts paid or distributed out of a health 

2 savings account which are used exclusively to pay expenses 

3 described in section 223(d)(2)(E) which are incurred by 

4 the taxpayer during such taxable year’’ before the period 

5 at the end of the second sentence. 

6 (c) EFFECTIVE DATE.—The amendments made by 

7 this section shall apply with respect to taxable years begin8 ning after December 31, 2019. 

9 SEC. 8010. TREATMENT OF DIRECT PRIMARY CARE SERV10 ICE ARRANGEMENTS. 

11 (a) IN GENERAL.—Section 223(c)(1) of the Internal 

12 Revenue Code of 1986 is amended by adding at the end 

13 the following new subparagraph: 

14 ‘‘(D) TREATMENT OF DIRECT PRIMARY

15 CARE SERVICE ARRANGEMENTS.— 

16 ‘‘(i) IN GENERAL.—A direct primary 

17 care service arrangement shall not be 

18 treated as a health plan for purposes of 

19 subparagraph (A)(ii). 

20 ‘‘(ii) DIRECT PRIMARY CARE SERVICE

21 ARRANGEMENT.—For purposes of this 

22 paragraph— 

23 ‘‘(I) IN GENERAL.—The term ‘di24 rect primary care service arrange25 ment’ means, with respect to any indiVerDate Sep 11 2014 19:08 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00339 Fmt 6652 Sfmt 6201 E:\BILLS\H14.IH H14

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1 vidual, an arrangement under which 

2 such individual is provided medical 

3 care (as defined in section 213(d)) 

4 consisting solely of primary care serv5 ices provided by primary care practi6 tioners (as defined in section 

7 1833(x)(2)(A) of the Social Security 

8 Act, determined without regard to 

9 clause (ii) thereof), if the sole com10 pensation for such care is a fixed peri11 odic fee. 

12 ‘‘(II) LIMITATION.—With respect 

13 to any individual for any month, such 

14 term shall not include any arrange15 ment if the aggregate fees for all di16 rect primary care service arrange17 ments (determined without regard to 

18 this subclause) with respect to such 

19 individual for such month exceed 

20 $150 (twice such dollar amount in the 

21 case of an individual with any direct 

22 primary care service arrangement (as 

23 so determined) that covers more than 

24 one individual). 


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1 ‘‘(iii) CERTAIN SERVICES SPECIFI2 CALLY EXCLUDED FROM TREATMENT AS

3 PRIMARY CARE SERVICES.—For purposes 

4 of this subparagraph, the term ‘primary 

5 care services’ shall not include— 

6 ‘‘(I) procedures that require the 

7 use of general anesthesia, and 

8 ‘‘(II) laboratory services not typi9 cally administered in an ambulatory 

10 primary care setting. 

11 The Secretary, after consultation with the 

12 Secretary of Health and Human Services, 

13 shall issue regulations or other guidance 

14 regarding the application of this clause.’’. 

15 (b) DIRECT PRIMARY CARE SERVICE ARRANGEMENT

16 FEES TREATED AS MEDICAL EXPENSES.—Section 

17 223(d)(2)(C) of the Internal Revenue Code of 1986 is 

18 amended by striking ‘‘or’’ at the end of clause (iii), by 

19 striking the period at the end of clause (iv) and inserting 

20 ‘‘, or’’, and by adding at the end the following new clause: 

21 ‘‘(v) any direct primary care service arrangement.’’. 

22 (c) INFLATION ADJUSTMENT.—Section 223(g)(1) of 

23 the Internal Revenue Code of 1986 is amended— 

24 (1) by inserting ‘‘, (c)(1)(D)(ii)(II),’’ after 

25 ‘‘(b)(2),’’ each place such term appears, and 


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1 (2) in subparagraph (B), by inserting ‘‘and 

2 (iii)’’ after ‘‘clause (ii)’’ in clause (i), by striking 

3 ‘‘and’’ at the end of clause (i), by striking the period 

4 at the end of clause (ii) and inserting ‘‘, and’’, and 

5 by inserting after clause (ii) the following new 

6 clause: 

7 ‘‘(iii) in the case of the dollar amount 

8 in subsection (c)(1)(D)(ii)(II) for taxable 

9 years beginning in calendar years after 

10 2020, ‘calendar year 2019’.’’. 

11 (d) REPORTING OF DIRECT PRIMARY CARE SERVICE

12 ARRANGEMENT FEES ON W–2.—Section 6051(a) of the 

13 Internal Revenue Code of 1986 is amended by striking 

14 ‘‘and’’ at the end of paragraph (16), by striking the period 

15 at the end of paragraph (17) and inserting ‘‘, and’’, and 

16 by inserting after paragraph (17) the following new para17 graph: 

18 ‘‘(18) in the case of a direct primary care serv19 ice arrangement (as defined in section 

20 223(c)(1)(D)(ii)) which is provided in connection 

21 with employment, the aggregate fees for such ar22 rangement for such employee.’’. 

23 (e) EFFECTIVE DATE.— 

24 (1) IN GENERAL.—Except as provided under 

25 paragraph (2), the amendments made by this section 


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1 shall apply to months beginning after December 31, 

2 2019, in taxable years ending after such date. 

3 (2) INFLATION ADJUSTMENT.—The amend4 ments made by subsection (c) shall apply to taxable 

5 years beginning in calendar years beginning after 

6 December 31, 2020. 

7 SEC. 8011. ALLOW BOTH SPOUSES TO MAKE CATCH-UP CON8 TRIBUTIONS TO THE SAME HSA ACCOUNT. 

9 (a) IN GENERAL.—Paragraph (5) of section 223(b) 

10 of the Internal Revenue Code of 1986 is amended to read 

11 as follows: 

12 ‘‘(5) SPECIAL RULE FOR MARRIED INDIVIDUALS

13 WITH FAMILY COVERAGE.— 

14 ‘‘(A) IN GENERAL.—In the case of individ15 uals who are married to each other, if both 

16 spouses are eligible individuals and either 

17 spouse has family coverage under a high de18 ductible health plan as of the first day of any 

19 month— 

20 ‘‘(i) the limitation under paragraph 

21 (1) shall be applied by not taking into ac22 count any other high deductible health 

23 plan coverage of either spouse (and if such 

24 spouses both have family coverage under 

25 separate high deductible health plans, only 


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1 one such coverage shall be taken into ac2 count), 

3 ‘‘(ii) such limitation (after application 

4 of clause (i)) shall be reduced by the ag5 gregate amount paid to Archer MSAs of 

6 such spouses for the taxable year, and 

7 ‘‘(iii) such limitation (after application 

8 of clauses (i) and (ii)) shall be divided 

9 equally between such spouses unless they 

10 agree on a different division. 

11 ‘‘(B) TREATMENT OF ADDITIONAL CON12 TRIBUTION AMOUNTS.—If both spouses referred 

13 to in subparagraph (A) have attained age 55 

14 before the close of the taxable year, the limita15 tion referred to in subparagraph (A)(iii) which 

16 is subject to division between the spouses shall 

17 include the additional contribution amounts de18 termined under paragraph (3) for both spouses. 

19 In any other case, any additional contribution 

20 amount determined under paragraph (3) shall 

21 not be taken into account under subparagraph 

22 (A)(iii) and shall not be subject to division be23 tween the spouses.’’. 


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1 (b) EFFECTIVE DATE.—The amendment made by 

2 this section shall apply to taxable years beginning after 

3 December 31, 2019. 

4 SEC. 8012. REPEAL OF CEILING ON DEDUCTIBLE AND OUT5 OF-POCKET EXPENSES UNDER A HIGH DE6 DUCTIBLE HEALTH PLAN. 

7 (a) IN GENERAL.—Subparagraph (A) of section 

8 223(c)(2) of the Internal Revenue Code of 1986 is amend9 ed to read as follows: 

10 ‘‘(A) HIGH DEDUCTIBLE HEALTH PLAN.— 

11 The term ‘high deductible health plan’ means a 

12 health plan which has an annual deductible 

13 which is not less than— 

14 ‘‘(i) $1,000 for self-only coverage, and 

15 ‘‘(ii) twice the dollar amount in clause 

16 (i) for family coverage.’’. 

17 (b) CONFORMING AMENDMENTS.— 

18 (1) Subparagraph (D) of section 223(c)(2) of 

19 the Internal Revenue Code of 1986 is amended to 

20 read as follows: 

21 ‘‘(D) SPECIAL RULE FOR NETWORK

22 PLANS.—In the case of a plan using a network 

23 of providers, such plan’s annual deductible for 

24 services provided outside of such network shall 


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1 not be taken into account for purposes of sub2 section (b)(2).’’. 

3 (2) Clause (ii) of section 223(g)(1)(B) of such 

4 Code is amended by striking ‘‘each dollar amount in 

5 subsection (c)(2)(A)’’ and inserting ‘‘the dollar 

6 amount in subsection (c)(2)(A)(i)’’. 

7 (c) EFFECTIVE DATE.—The amendments made by 

8 this section shall apply with respect to taxable years begin9 ning after December 31, 2019. 

10 SEC. 8013. ON-SITE EMPLOYEE CLINICS. 

11 (a) IN GENERAL.—Paragraph (1) of section 223(c) 

12 of the Internal Revenue Code of 1986, as amended by sec13 tion 8010 of this Act, is amended by adding at the end 

14 the following new subparagraph: 

15 ‘‘(E) SPECIAL RULE FOR QUALIFIED

16 ITEMS AND SERVICES.— 

17 ‘‘(i) IN GENERAL.—For purposes of 

18 subparagraph (A)(ii), an individual shall 

19 not be treated as covered under a health 

20 plan described in subclauses (I) and (II) of 

21 such subparagraph merely because the in22 dividual is eligible to receive, or receives, 

23 qualified items and services— 

24 ‘‘(I) at a healthcare facility lo25 cated at a facility owned or leased by 


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1 the employer of the individual (or of 

2 the individual’s spouse), or 

3 ‘‘(II) at a healthcare facility op4 erated primarily for the benefit of em5 ployees of the employer of the indi6 vidual (or of the individual’s spouse). 

7 ‘‘(ii) QUALIFIED ITEMS AND SERVICES

8 DEFINED.—For purposes of this subpara9 graph, the term ‘qualified items and serv10 ices’ means the following: 

11 ‘‘(I) Physical examination. 

12 ‘‘(II) Immunizations, including 

13 injections of antigens provided by em14 ployees. 

15 ‘‘(III) Drugs or biologicals other 

16 than a prescribed drug (as such term 

17 is defined in section 213(d)(3)). 

18 ‘‘(IV) Treatment for injuries oc19 curring in the course of employment. 

20 ‘‘(V) Preventive care for chronic 

21 conditions (as defined in clause (iv)). 

22 ‘‘(VI) Drug testing. 

23 ‘‘(VII) Hearing or vision 

24 screenings and related services. 


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1 ‘‘(iii) AGGREGATION.—For purposes 

2 of clause (i), all persons treated as a single 

3 employer under subsection (b), (c), (m), or 

4 (o) of section 414 shall be treated as a sin5 gle employer. 

6 ‘‘(iv) PREVENTIVE CARE FOR CHRON7 IC CONDITIONS.—For purposes of this sub8 paragraph, the term ‘preventive care for 

9 chronic conditions’ means any item or 

10 service specified in the Appendix of Inter11 nal Revenue Service Notice 2019–45 which 

12 is prescribed to treat an individual diag13 nosed with the associated chronic condition 

14 specified in such Appendix for the purpose 

15 of preventing the exacerbation of such 

16 chronic condition or the development of a 

17 secondary condition, including any amend18 ment, addition, removal, or other modifica19 tion made by the Secretary (pursuant to 

20 the authority granted to the Secretary 

21 under paragraph (2)(C)) to the items or 

22 services specified in such Appendix subse23 quent to the date of enactment of this sub24 paragraph.’’. 


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1 (b) EFFECTIVE DATE.—The amendments made by 

2 this section shall apply to months in taxable years begin3 ning after the date of enactment of this Act. 

4 SEC. 8014. ADJUSTMENT OF MEDICAL EXPENSE DEDUC5 TION. 

6 (a) IN GENERAL.—Section 213 of the Internal Rev7 enue Code of 1986 is amended— 

8 (1) in subsection (a), by striking ‘‘10 percent’’ 

9 and inserting ‘‘7.5 percent’’, and 

10 (2) by striking subsection (f) and inserting the 

11 following: 

12 ‘‘(f) TEMPORARY SPECIAL RULE.—In the case of any 

13 taxable year beginning after December 31, 2019, and end14 ing before January 1, 2022, subsection (a) shall be applied 

15 with respect to a taxpayer by substituting ‘5 percent’ for 

16 ‘7.5 percent’.’’. 

17 (b) EFFECTIVE DATE.—The amendments made by 

18 this section shall apply to taxable years beginning after 

19 December 31, 2019. 

20 SEC. 8015. HEALTHY WORKPLACE TAX CREDIT. 

21 (a) IN GENERAL.—In the case of an employer, there 

22 shall be allowed as a credit against applicable employment 

23 taxes for each calendar quarter an amount equal to 50 

24 percent of the sum of— 


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1 (1) the qualified employee protection expenses 

2 paid or incurred by the employer during such cal3 endar quarter, 

4 (2) the qualified workplace reconfiguration ex5 penses paid or incurred by the employer during such 

6 calendar quarter, 

7 (3) the qualified workplace technology expenses 

8 paid or incurred by the employer during such cal9 endar quarter, and 

10 (4) the qualified workplace training expenses 

11 paid or incurred by the employer during such cal12 endar quarter. 

13 (b) LIMITATIONS AND REFUNDABILITY.— 

14 (1) OVERALL DOLLAR LIMITATION ON CRED15 IT.— 

16 (A) IN GENERAL.—The amount of the 

17 credit allowed under subsection (a) with respect 

18 to any employer for any calendar quarter shall 

19 not exceed the excess (if any) of— 

20 (i) the applicable dollar limit with re21 spect to such employer for such calendar 

22 quarter, over 

23 (ii) the aggregate credits allowed 

24 under subsection (a) with respect to such 


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1 employer for all preceding calendar quar2 ters. 

3 (B) APPLICABLE DOLLAR LIMIT.—The 

4 term ‘‘applicable dollar limit’’ means, with re5 spect to any employer for any calendar quarter, 

6 the sum of— 

7 (i) $1,000, multiplied so much of the 

8 average number of employees employed by 

9 such employer during such calendar quar10 ter as does not exceed 500, plus 

11 (ii) $750, multiplied by so much of 

12 such average number of employees as ex13 ceeds 500 but does not exceed 1,000, plus 

14 (iii) $500, multiplied by so much of 

15 such average number of employees as ex16 ceeds 1,000. 

17 (2) CREDIT LIMITED TO EMPLOYMENT

18 TAXES.—The credit allowed by subsection (a) with 

19 respect to any calendar quarter shall not exceed the 

20 applicable employment taxes (reduced by any credits 

21 allowed under subsections (e) and (f) of section 

22 3111 of the Internal Revenue Code of 1986, sections 

23 7001 and 7003 of the Families First Coronavirus 

24 Response Act, and section 2301 of the CARES Act) 

25 on the wages paid with respect to the employment 


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1 of all the employees of the eligible employer for such 

2 calendar quarter. 

3 (3) REFUNDABILITY OF EXCESS CREDIT.— 

4 (A) IN GENERAL.—If the amount of the 

5 credit under subsection (a) exceeds the limita6 tion of paragraph (2) for any calendar quarter, 

7 such excess shall be treated as an overpayment 

8 that shall be refunded under sections 6402(a) 

9 and 6413(b) of the Internal Revenue Code of 

10 1986. 

11 (B) TREATMENT OF PAYMENTS.—For pur12 poses of section 1324 of title 31, United States 

13 Code, any amounts due to the employer under 

14 this paragraph shall be treated in the same 

15 manner as a refund due from a credit provision 

16 referred to in subsection (b)(2) of such section. 

17 (c) QUALIFIED EMPLOYEE PROTECTION EX18 PENSES.—For purposes of this section, the term ‘‘quali19 fied employee protection expenses’’ means amounts paid 

20 or incurred by the employer for— 

21 (1) testing employees of the employer for 

22 COVID–19 (including on a periodic basis), 

23 (2) equipment to protect employees of the em24 ployer from contracting COVID–19, including 

25 masks, gloves, and disinfectants, and 


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1 (3) cleaning products or services (whether pro2 vided by an employee of the taxpayer or a cleaning 

3 service provider) related to preventing the spread of 

4 COVID–19. 

5 (d) QUALIFIED WORKPLACE RECONFIGURATION EX6 PENSES.—For purposes of this section— 

7 (1) IN GENERAL.—The term ‘‘qualified work8 place reconfiguration expenses’’ means amounts paid 

9 or incurred by the employer to design and recon10 figure retail space, work areas, break areas, or other 

11 areas that employees or customers regularly use in 

12 the ordinary course of the employer’s trade or busi13 ness if such design and reconfiguration— 

14 (A) has a primary purpose of preventing 

15 the spread of COVID–19, 

16 (B) is with respect to an area that is lo17 cated in the United States and that is leased or 

18 owned by the employer, 

19 (C) is consistent with the purpose of the 

20 property immediately before the reconfigura21 tion, 

22 (D) is commensurate with the risks faced 

23 by the employees or customers or is consistent 

24 with recommendations made by the Centers for 


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1 Disease Control and Prevention or the Occupa2 tional Safety and Health Administration, 

3 (E) is completed pursuant to a reconfig4 uration plan and no comparable reconfiguration 

5 plan was in place before March 13, 2020, and 

6 (F) is completed before January 1, 2021. 

7 (2) REGULATIONS.—The Secretary shall pre8 scribe such regulations and other guidance as may 

9 be necessary or appropriate to carry out the pur10 poses of this subsection, including guidance defining 

11 primary purpose and reconfiguration plan. 

12 (e) QUALIFIED WORKPLACE TECHNOLOGY EX13 PENSES.—For purposes of this section— 

14 (1) IN GENERAL.—The term ‘‘qualified work15 place technology expenses’’ means amounts paid or 

16 incurred by the employer for technology systems 

17 that employees or customers use in the ordinary 

18 course of the employer’s trade or business if such 

19 technology system— 

20 (A) has a primary purpose of preventing 

21 the spread of COVID–19, 

22 (B) is used for limiting physical contact 

23 between customers and employees in the United 

24 States, 


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1 (C) is commensurate with the risks faced 

2 by the employees or customers or is consistent 

3 with recommendations made by the Centers for 

4 Disease Control and Prevention or the Occupa5 tional Safety and Health Administration, 

6 (D) is acquired by the taxpayer after 

7 March 12, 2020, and is not acquired pursuant 

8 to a written binding contract entered into be9 fore such date, and 

10 (E) is placed in service by the taxpayer be11 fore January 1, 2021. 

12 (2) TECHNOLOGY SYSTEMS.—The term ‘‘tech13 nology systems’’ means computer software (as de14 fined in section 167(f)(1)) and qualified techno15 logical equipment (as defined in section 168(i)(2)). 

16 (3) REGULATIONS.—The Secretary shall pre17 scribe such regulations and other guidance as may 

18 be necessary or appropriate to carry out the pur19 poses of this subsection, including guidance defining 

20 primary purpose. 

21 (f) QUALIFIED WORKPLACE TRAINING EXPENSES.— 

22 For purposes of this section, the term ‘‘qualified workplace 

23 training expenses’’ means amounts paid or incurred by the 

24 employer for education and training with respect to indus25 try best practices that ensure— 


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1 (1) the health and safety of employees in the 

2 workplace with respect to COVID–19, and 

3 (2) the prevention of the spread of COVID–19 

4 in the workplace. 

5 (g) OTHER DEFINITIONS.—For purposes of this sec6 tion— 

7 (1) APPLICABLE EMPLOYMENT TAXES.—The 

8 term ‘‘applicable employment taxes’’ means the fol9 lowing: 

10 (A) The taxes imposed under section 

11 3111(a) of the Internal Revenue Code of 1986. 

12 (B) So much of the taxes imposed under 

13 section 3221(a) of such Code as are attrib14 utable to the rate in effect under section 

15 3111(a) of such Code. 

16 (2) COVID–19.—Except where the context 

17 clearly indicates otherwise, any reference in this sec18 tion to COVID–19 shall be treated as including a 

19 reference to the virus which causes COVID–19. 

20 (3) SECRETARY.—The term ‘‘Secretary’’ means 

21 the Secretary of the Treasury or the Secretary’s del22 egate. 

23 (4) OTHER TERMS.—Any term used in this sec24 tion (other than subsection (b)(1)(B)) which is also 

25 used in chapter 21 or 22 of the Internal Revenue 


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1 Code of 1986 shall have the same meaning as when 

2 used in such chapter. 

3 (h) CERTAIN GOVERNMENTAL EMPLOYERS.—This 

4 credit shall not apply to the Government of the United 

5 States, the government of any State or political subdivi6 sion thereof, or any agency or instrumentality of any of 

7 the foregoing. 

8 (i) SPECIAL RULES.— 

9 (1) AGGREGATION RULE.—All persons treated 

10 as a single employer under subsection (a) or (b) of 

11 section 52 of the Internal Revenue Code of 1986, or 

12 subsection (m) or (o) of section 414 of such Code, 

13 shall be treated as one employer for purposes of this 

14 section. 

15 (2) DENIAL OF DOUBLE BENEFIT.— 

16 (A) IN GENERAL.—Rules similar to the 

17 rules of paragraphs (1) and (2) of section 

18 280C(b) shall apply for purposes of this section. 

19 (B) EXPENSES NOT TAKEN INTO ACCOUNT

20 MORE THAN ONCE.—Any qualified workplace 

21 reconfiguration expense or qualified workplace 

22 technology expense shall not be treated as a 

23 qualified employee protection expense and any 

24 qualified workplace technology expense shall not 


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1 be treated as a qualified workplace reconfigura2 tion expense. 

3 (3) THIRD-PARTY PAYORS.—Any credit allowed 

4 under this section shall be treated as a credit de5 scribed in section 3511(d)(2) of such Code. 

6 (4) ELECTION NOT TO HAVE SECTION APPLY.— 

7 This section shall not apply with respect to any eligi8 ble employer for any calendar quarter if such em9 ployer elects (at such time and in such manner as 

10 the Secretary may prescribe) not to have this section 

11 apply. 

12 (j) TRANSFERS TO CERTAIN TRUST FUNDS.—There 

13 are hereby appropriated to the Federal Old-Age and Sur14 vivors Insurance Trust Fund and the Federal Disability 

15 Insurance Trust Fund established under section 201 of 

16 the Social Security Act (42 U.S.C. 401) and the Social 

17 Security Equivalent Benefit Account established under 

18 section 15A(a) of the Railroad Retirement Act of 1974 

19 (45 U.S.C. 231n–1(a)) amounts equal to the reduction in 

20 revenues to the Treasury by reason of this section (without 

21 regard to this subsection). Amounts appropriated by the 

22 preceding sentence shall be transferred from the general 

23 fund at such times and in such manner as to replicate 

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1 curred to such Trust Fund or Account had this section 

2 not been enacted. 

3 (k) TREATMENT OF DEPOSITS.—The Secretary shall 

4 waive any penalty under section 6656 of the Internal Rev5 enue Code of 1986 for any failure to make a deposit of 

6 any applicable employment taxes if the Secretary deter7 mines that such failure was due to the reasonable anticipa8 tion of the credit allowed under this section. 

9 (l) REGULATIONS AND GUIDANCE.—The Secretary 

10 shall prescribe such regulations and other guidance as 

11 may be necessary or appropriate to carry out the purposes 

12 of this section, including— 

13 (1) with respect to the application of the credit 

14 under subsection (a) to third-party payors (including 

15 professional employer organizations, certified profes16 sional employer organizations, or agents under sec17 tion 3504 of the Internal Revenue Code of 1986), 

18 regulations or other guidance allowing such payors 

19 to submit documentation necessary to substantiate 

20 the amount of the credit allowed under subsection 

21 (a), and 

22 (2) regulations or other guidance to prevent 

23 abusive transactions. 


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1 (m) APPLICATION.—This section shall only apply to 

2 amounts paid or incurred after March 12, 2020, and be3 fore January 1, 2021. 

4 TITLE IX—MEDICARE 

5 PROVISIONS 

6 Subtitle A—Telehealth 

7 SEC. 9001. REMOVING CERTAIN GEOGRAPHIC AND ORIGI8 NATING SITE RESTRICTIONS ON THE FUR9 NISHING OF TELEHEALTH SERVICES UNDER 

10 THE MEDICARE PROGRAM. 

11 Section 1834(m)(4)(C) of the Social Security Act (42 

12 U.S.C. 1395m(m)(4)(C)) is amended— 

13 (1) in clause (i), by inserting ‘‘, with respect to 

14 services furnished on or after January 1, 2024,’’ 

15 after ‘‘telecommunications system and’’; and 

16 (2) in clause (ii)(X), by inserting ‘‘, with re17 spect to services furnished on or after January 1, 

18 2024,’’ after ‘‘but’’. 

19 SEC. 9002. MAKING PERMANENT FQHC AND RHC TELE20 HEALTH PAYMENTS. 

21 Section 1834(m)(6) of the Social Security Act (42 

22 U.S.C. 1395m(m)(8)), as so redesignated by section 2(7), 

23 is amended— 

24 (1) in the header, by striking ‘‘DURING EMER25 GENCY PERIOD’’; 


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1 (2) in subparagraph (A), in the matter pre2 ceding clause (i), by striking ‘‘During’’ and inserting 

3 ‘‘With respect to services furnished on or after the 

4 first day of’’; and 

5 (3) in subparagraph (B)(i), by striking ‘‘during 

6 such emergency period’’. 

7 SEC. 9003. EXPANDING THE LIST OF PRACTITIONERS ELIGI8 BLE TO FURNISH TELEHEALTH SERVICES. 

9 Section 1834(m) of the Social Security Act (42 

10 U.S.C. 1395m(m)) is amended— 

11 (1) in paragraph (1), by striking ‘‘described in 

12 section 1842(b)(18)(C)’’ and inserting ‘‘as defined in 

13 paragraph (4)(E)’’; 

14 (2) in paragraph (3)(B), by inserting ‘‘de15 scribed in subparagraph (C) of such section’’ after 

16 ‘‘practitioners’’; and 

17 (3) in paragraph (4), by amending subpara18 graph (E) to read as follows: 

19 ‘‘(E) PRACTITIONER.—The term ‘practi20 tioner’ means a practitioner described in section 

21 1842(b)(18)(C) and includes, with respect to 

22 services furnished before January 1, 2024, any 

23 supplier (other than a physician) permitted to 

24 receive payment for a telehealth service under 

25 this section as of the date of the enactment of 


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1 this subparagraph pursuant to a waiver in ef2 fect as of such date under section 1135.’’. 

3 SEC. 9004. ALLOWING FOR THE PROVISION OF TELE4 HEALTH SERVICES VIA AUDIO-ONLY TELE5 COMMUNICATIONS SYSTEMS. 

6 Section 1834(m)(4) of the Social Security Act (42 

7 U.S.C. 1395m(m)(4)) is amended by adding at the end 

8 the following new subparagraph: 

9 ‘‘(G) TELECOMMUNICATIONS SYSTEM.— 

10 ‘‘(i) IN GENERAL.—The term ‘tele11 communications system’ includes, in the 

12 case of a telehealth service furnished by a 

13 qualified provider (as defined in clause (ii)) 

14 to an individual located at an originating 

15 site before January 1, 2024, a communica16 tions system consisting of only audio capa17 bilities, but only if such individual does not 

18 have access to a communications system 

19 with audio-visual capabilities at such site. 

20 ‘‘(ii) QUALIFIED PROVIDER.—For 

21 purposes of clause (i), the term ‘qualified 

22 provider’ means, with respect a telehealth 

23 service furnished to an individual, a physi24 cian or practitioner who— 


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1 ‘‘(I) furnished to such individual 

2 an item or service (other than such 

3 telehealth service) for which payment 

4 was made under any group health 

5 plan (as defined in section 2791 of 

6 the Public Health Service Act), health 

7 insurance coverage (as so defined), 

8 Federal health care program (as de9 fined in section 1128B(f)), or the 

10 health care program under chapter 89 

11 of title 5, United States Code, during 

12 the 3-year period ending on the date 

13 such telehealth service was furnished; 

14 or 

15 ‘‘(II) is in the same practice (as 

16 determined by tax identification num17 ber) of a physician or practitioner who 

18 furnished such an item or service to 

19 such individual during such period.’’. 

20 SEC. 9005. MAKING PERMANENT THE SAFE HARBOR FOR 

21 ABSENCE OF DEDUCTIBLE FOR TELEHEALTH. 

22 (a) IN GENERAL.—Section 223(c)(2)(E) of the Inter23 nal Revenue Code of 1986 is amended by striking ‘‘In the 

24 case of plan years beginning on or before December 31, 

25 2021, a’’ and inserting ‘‘A’’. 


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1 (b) CERTAIN COVERAGE DISREGARDED.—Section 

2 223(c)(1)(B)(ii) of the Internal Revenue Code of 1986 is 

3 amended by striking ‘‘(in the case of plan years beginning 

4 on or before December 31, 2021)’’. 

5 SEC. 9006. REMOVING REQUIREMENT FOR FACE-TO-FACE 

6 VISITS BETWEEN HOME DIALYSIS PATIENTS 

7 AND PHYSICIANS. 

8 (a) IN GENERAL.—Section 1881(b)(3)(B) of the So9 cial Security Act (42 U.S.C. 1395rr(b)(3)(B)) is amend10 ed— 

11 (1) in clause (i), by striking ‘‘clauses (ii) and 

12 (iii)’’ and inserting ‘‘clause (ii)’’; 

13 (2) in clause (ii), by inserting ‘‘or (iv)’’ after 

14 ‘‘clause (iii)’’; 

15 (3) by moving clause (iii) 6 ems to the left; and 

16 (4) by adding at the end the following new 

17 clause: 

18 ‘‘(iv) Clause (ii) shall not apply to monthly end stage 

19 renal disease-related clinical assessments furnished before 

20 January 1, 2024, in the case of an individual who has 

21 received in-person training with respect to home dialysis.’’. 

22 (b) WAIVER AUTHORITY.— 

23 (1) IN GENERAL.—Notwithstanding any provi24 sion of section 1135 of the Social Security Act (42 

25 U.S.C. 1320b–5), the Secretary of Health and 


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1 Human Services may, with respect to a specified 

2 waiver (as defined in paragraph (2)), continue such 

3 waiver in effect for any period of time before Janu4 ary 1, 2024. 

5 (2) DEFINITION.—In this subsection, the term 

6 ‘‘specified waiver’’ means a waiver in effect on the 

7 date of the enactment of this Act that, with respect 

8 to any provision of title XVIII of the Social Security 

9 Act (42 U.S.C. 1395 et seq.) that requires an in-per10 son visit with a provider of services or supplier (as 

11 such terms are defined in section 1861 of such Act 

12 (42 U.S.C. 1395x)) as a prerequisite for payment of 

13 any item or service under such title or for any other 

14 purpose, modifies such provision to allow such visit 

15 to be conducted through the use of telehealth. 

16 SEC. 9007. REPORT ON TELEHEALTH PAYMENT INTEGRITY. 

17 Not later than 1 year after the date of the enactment 

18 of this Act, the Inspector General of the Department of 

19 Health and Human Services shall review claims for pay20 ment for telehealth services furnished under the Medicare 

21 program during the emergency period described in section 

22 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 

23 1320b–5(g)(1)(B)) and submit to Congress a report on 

24 any instances of waste, fraud, or abuse identified through 

25 such review. 


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1 SEC. 9008. INCREASING FUNDING FOR REVIEW OF TELE2 HEALTH CLAIMS. 

3 There are authorized to be appropriated to the In4 spector General of the Department of Health and Human 

5 Services $10,000,000 for fiscal years 2021 through 2023 

6 for purposes of conducting audits and other oversight ac7 tivities with respect to payments made under section 

8 1834(m) of the Social Security Act (42 U.S.C. 

9 1395m(m)). 

10 SEC. 9009. TELEHEALTH RESOURCES. 

11 Not later than 6 months after the last day of the 

12 emergency period described in section 1135(g)(1)(B) of 

13 the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B)), the 

14 Secretary of Health and Human Services shall develop and 

15 make available to physicians (as defined in section 1861(r) 

16 of such Act (42 U.S.C. 1395x(r))) and practitioners (as 

17 defined in section 1834(m)(4)(E) of such Act (42 U.S.C. 

18 1395m(m)(4)(E))) educational resources and training ses19 sions on requirements relating to the furnishing of tele20 health services under section 1834(m) of such Act (42 

21 U.S.C. 1395m(m)). 


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1 Subtitle B—Protecting Access to 

2 Innovation During COVID–19 

3 SEC. 9011. AUTHORIZING THE EXTENSION OF PASS4 THROUGH STATUS UNDER THE MEDICARE 

5 PROGRAM FOR CERTAIN DRUGS AND DE6 VICES IMPACTED BY COVID–19. 

7 Section 1833(t)(6) of the Social Security Act (42 

8 U.S.C. 1395l(t)(6)) is amended by adding at the end the 

9 following new subparagraph: 

10 ‘‘(K) AUTHORITY TO EXTEND PASS11 THROUGH STATUS FOR CERTAIN DRUGS AND

12 DEVICES IMPACTED BY COVID–19.— 

13 ‘‘(i) IN GENERAL.—Notwithstanding 

14 the preceding provisions of this paragraph, 

15 in the case of an eligible drug or device (as 

16 defined in clause (iv)), if the Secretary de17 termines, prior to or on the date of the ex18 piration of pass-through status for such 

19 drug or device (or, in the case of such a 

20 drug or device whose pass-through status 

21 expired before the date of the enactment of 

22 this subparagraph, not later than 30 days 

23 after such date), that the cost of such drug 

24 or device is unable to be accurately cal25 culated due to the effects of COVID–19, 


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1 the Secretary may extend the pass-through 

2 status of such eligible drug or device in ac3 cordance with clause (ii). 

4 ‘‘(ii) EXTENSION.—The Secretary 

5 may extend the pass-through status of an 

6 eligible drug or device described in clause 

7 (i) with respect to which a determination 

8 has been made under such clause— 

9 ‘‘(I) in the case of a drug or de10 vice whose period of pass-through sta11 tus expired during the emergency pe12 riod described in section 

13 1135(g)(1)(B) before the date of the 

14 enactment of this subparagraph, for a 

15 period beginning on the first day after 

16 such period of up to the number of 

17 days occurring during such period 

18 during which such drug or device had 

19 pass-through status; 

20 ‘‘(II) in the case of a drug or de21 vice whose period of pass-through sta22 tus would otherwise expire during 

23 such emergency period on or after 

24 such date of enactment— 


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1 ‘‘(aa) for the remainder of 

2 such period; and 

3 ‘‘(bb) for a period beginning 

4 on the first day after such period 

5 of up to the number of days oc6 curring during such period dur7 ing which such drug or device 

8 had pass-through status (not tak9 ing into account any extension of 

10 such status pursuant to this sub11 clause); and 

12 ‘‘(III) in the case of a drug or 

13 device not described in subclause (I) 

14 or (II), by the number of days occur15 ring during such emergency period 

16 during which such drug or device had 

17 pass-through status. 

18 ‘‘(iii) SPECIAL RULES FOR ALREADY19 EXPIRED DRUGS AND DEVICES.—In the 

20 case of an eligible drug or device described 

21 in clause (ii)(I) for which payment under 

22 this subsection was packaged into a pay23 ment for a covered OPD service (or group 

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1 through status is extended in accordance 

2 with such clause, the Secretary— 

3 ‘‘(I) shall, for the period during 

4 which such extension is in effect for 

5 such drug or device— 

6 ‘‘(aa) remove, during such 

7 period, the packaged costs of 

8 such drug or device (as deter9 mined by the Secretary) from the 

10 payment amount under this sub11 section for the covered OPD serv12 ice (or group of services) with 

13 which it is packaged; and 

14 ‘‘(bb) not make any adjust15 ments to payment amounts under 

16 this subsection for a covered 

17 OPD service (or group of serv18 ices) for which no costs were re19 moved under subclause (I); and 

20 ‘‘(II) may not, when calculating 

21 the cost of such drug or device at the 

22 end of such extension, take into ac23 count claims for such drug or device 

24 made while such drug or device was 

25 so packaged. 


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1 ‘‘(iv) ELIGIBLE DRUG OR DEVICE DE2 FINED.—For purposes of this subpara3 graph, the term ‘eligible drug or device’ 

4 means a drug, biological, or device with 

5 pass-through status in effect during any 

6 portion of the emergency period described 

7 in section 1135(g)(1)(B) that will not be 

8 (or was not) separately payable upon the 

9 expiration of such status, but only if, in 

10 the case of a drug or biological, such drug 

11 or biological— 

12 ‘‘(I) was payable based upon the 

13 wholesale acquisition cost of such 

14 drug or biological in lieu of the aver15 age sales price of such drug or biologi16 cal on the first date of such emer17 gency period; and 

18 ‘‘(II) will be (or was) packaged 

19 into a payment for a covered OPD 

20 service (or group of services) upon ex21 piration of such status.’’. 


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1 Subtitle C—Reducing Unnecessary 

2 Senior Hospitalizations 

3 SEC. 9021. SNF-BASED PROVISION OF PREVENTIVE ACUTE 

4 CARE AND HOSPITALIZATION REDUCTION 

5 PROGRAM. 

6 Title XVIII of the Social Security Act is amended by 

7 adding at the end the following new section: 

8 ‘‘SEC. 1899C. SNF-BASED PROVISION OF PREVENTIVE 

9 ACUTE CARE AND HOSPITALIZATION REDUC10 TION PROGRAM. 

11 ‘‘(a) ESTABLISHMENT.—There is established a pro12 gram to be known as the ‘SNF-based Provision of Preven13 tive Acute Care and Hospitalization Reduction Program’ 

14 (in this section referred to as the ‘Program’), to be admin15 istered by the Secretary, for purposes of reducing unneces16 sary hospitalizations and emergency department visits by 

17 allowing qualified group practices (as defined in section 

18 1877(h)(4)) on or after January 1, 2022, to furnish items 

19 and services identified under subsection (b)(3) to individ20 uals entitled to benefits under part A and enrolled under 

21 part B residing in qualified skilled nursing facilities. 

22 ‘‘(b) OPERATION OF PROGRAM.—Under the Pro23 gram, the Secretary shall provide for the following: 


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1 ‘‘(1) Certification of skilled nursing facilities as 

2 qualified skilled nursing facilities under subsection 

3 (c)(1). 

4 ‘‘(2) Certification of group practices as quali5 fied group practices under subsection (c)(2). 

6 ‘‘(3) Identification of minimum required non7 surgical items and services furnished at a hospital 

8 emergency department that may be safely furnished 

9 by a qualified group practice at a qualified skilled 

10 nursing facility under the Program, as determined 

11 as clinically appropriate by the Secretary, and that 

12 such qualified group practice shall offer to furnish 

13 under the Program. 

14 ‘‘(4) Annual identification of additional items 

15 and services furnished at a hospital emergency de16 partment that may be safely furnished by a qualified 

17 group practice at a qualified skilled nursing facility 

18 under the Program during a year and that such 

19 qualified group practice may offer to furnish under 

20 the Program during such year. 

21 ‘‘(5) Establishment of qualifications for non22 physician employees who may furnish such items 

23 and services at a qualified skilled nursing facility. 

24 Such qualifications shall include the requirement 

25 that such an employee— 


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1 ‘‘(A) be certified in basic life support by a 

2 nationally recognized specialty board of certifi3 cation or equivalent certification board; and 

4 ‘‘(B) have— 

5 ‘‘(i) clinical experience furnishing 

6 medical care— 

7 ‘‘(I) in a skilled nursing facility; 

8 ‘‘(II) in a hospital emergency de9 partment setting; or 

10 ‘‘(III) as an employee of a pro11 vider or supplier of ambulance serv12 ices; or 

13 ‘‘(ii) a certification in paramedicine. 

14 ‘‘(6) Payment under this title for items and 

15 services identified under paragraph (3) or (4) fur16 nished by such qualified group practices at such a 

17 facility in amounts determined under subsection (d). 

18 ‘‘(c) CERTIFICATIONS.— 

19 ‘‘(1) QUALIFIED SKILLED NURSING FACILI20 TIES.—For purposes of this section, the Secretary 

21 shall certify a skilled nursing facility as a qualified 

22 skilled nursing facility if the facility submits an ap23 plication in a time and manner specified by the Sec24 retary and meets the following requirements: 


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1 ‘‘(A) The facility has on-site diagnostic 

2 equipment necessary for a qualified group prac3 tice to furnish items and services under the 

4 Program and real-time audio and visual capa5 bilities. 

6 ‘‘(B) The facility has at least one indi7 vidual who meets the qualifications described in 

8 paragraph (5) or a physician present 24 hours 

9 a day and 7 days a week to work with the 

10 qualified group practice. Such individual may 

11 be a member of the staff of the qualified skilled 

12 nursing facility or of the qualified group prac13 tice. 

14 ‘‘(C) The facility ensures that residents of 

15 such facility, upon entering such facility, are al16 lowed to specify in an advanced care directive 

17 whether the resident wishes to receive items 

18 and services furnished at the facility under the 

19 Program in a case where communication with 

20 the resident is not possible. 

21 ‘‘(D) The facility ensures that individuals 

22 to be furnished such items and services under 

23 the Program at such facility have the oppor24 tunity, at their request, to instead be trans25 ported to a hospital emergency department. 


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1 ‘‘(E) The facility is not part of the Special 

2 Focus Facility program of the Centers for 

3 Medicare & Medicaid Services (although the fa4 cility may, at the discretion of the Secretary, be 

5 a candidate for selection under such program). 

6 Nothing in this paragraph shall affect the require7 ments under section 1819(b)(4). 

8 ‘‘(2) QUALIFIED GROUP PRACTICES.—For pur9 poses of this section, the Secretary shall certify a 

10 group practice as a qualified group practice for a pe11 riod of 3 years if the group practice submits an ap12 plication in a time and manner specified by the Sec13 retary and meets the following requirements: 

14 ‘‘(A) The group practice offers to furnish 

15 all minimum required items and services identi16 fied under subsection (b)(3) under the Pro17 gram. 

18 ‘‘(B) The group practice submits a notifi19 cation to the Secretary annually specifying 

20 which (if any) additional items and services 

21 identified under subsection (b)(4) for a year the 

22 group practice will offer to furnish for such 

23 year under the Program. 

24 ‘‘(C) The group practice ensures that only 

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1 lished under subsection (b)(5) or a physician 

2 who is part of such group practice may furnish 

3 such minimum required items and services and 

4 such additional items and services. 

5 ‘‘(D) The group practice ensures that, in 

6 the case where such minimum required items 

7 and services or such additional items and serv8 ices are furnished by such an individual, such 

9 individual furnishes such minimum required 

10 items and services or additional items and serv11 ices under the supervision, either in-person or 

12 through the use of telehealth (not including 

13 store-and-forward technologies), of— 

14 ‘‘(i) a physician— 

15 ‘‘(I) who is board certified or 

16 board eligible in emergency medicine, 

17 family medicine, geriatrics, or internal 

18 medicine; or 

19 ‘‘(II) who has been certified by a 

20 nationally recognized specialty board 

21 of certification or equivalent certifi22 cation board in basic life support; 

23 ‘‘(ii) a nurse practitioner who has 

24 been certified by a nationally recognized 

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1 lent certification board in basic life sup2 port; or 

3 ‘‘(iii) a physician assistant who has 

4 been certified by a nationally recognized 

5 specialty board of certification or equiva6 lent certification board in basic life sup7 port. 

8 ‘‘(E) With respect to any year in which the 

9 qualified group practice would participate in the 

10 Program, the Chief Actuary for the Centers for 

11 Medicare & Medicaid Services determines that 

12 such participation during such year will not re13 sult in total estimated expenditures under this 

14 title for such year being greater than total esti15 mated expenditures under such title for such 

16 year without such participation. 

17 ‘‘(d) PAYMENTS.— 

18 ‘‘(1) IN GENERAL.—For 2022 and each subse19 quent year, the Secretary shall develop a schedule of 

20 payments to apply for items and services identified 

21 under paragraph (3) or paragraph (4) of subsection 

22 (b) furnished during such year under the Program. 

23 Such payments shall be in lieu of any other pay24 ments that may be made under this title for such 

25 items and services. 


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1 ‘‘(2) SHARED SAVINGS.—In the case of a year 

2 for which the Secretary determines that participa3 tion in the Program resulted in a reduction in ex4 penditures under this title compared to what such 

5 expenditures would have been without such partici6 pation, the Secretary shall— 

7 ‘‘(A) pay to such qualified group practice 

8 an amount equal to 37.5 percent of the esti9 mated amount of such reduction; and 

10 ‘‘(B) in the case of each qualified skilled 

11 nursing facility where such qualified group 

12 practice furnished items and services under the 

13 Program during such year— 

14 ‘‘(i) if the qualified skilled nursing fa15 cility has at least a three-star rating under 

16 the Five Star Quality Rating System (or a 

17 successor system), pay to the facility an 

18 amount that bears the same ratio to 12.5 

19 percent of the estimated amount of such 

20 reduction as the amount of expenditures 

21 under the Program for such items and 

22 services furnished with respect to individ23 uals at such facility by such qualified 

24 group practice during such year bears to 

25 the total amount of expenditures under the 


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1 Program for such items and services fur2 nished with respect to all individuals by 

3 such qualified group practice during such 

4 year; and 

5 ‘‘(ii) in the case of a qualified skilled 

6 nursing facility that is not described in 

7 clause (i), retain in the Federal Hospital 

8 Insurance Trust Fund under section 1817 

9 the amount that the facility would have 

10 been paid pursuant to clause (i) if the fa11 cility were described in such clause until 

12 such time as the facility has at least a 

13 three-star rating under the Five Star Qual14 ity Rating System (or a successor system), 

15 at which point the Secretary shall pay such 

16 amount to the facility. 

17 ‘‘(3) ADVANCED ALTERNATIVE PAYMENT MOD18 ELS.—Paragraph (2) shall not apply to items and 

19 services furnished to an individual entitled to bene20 fits under part A and enrolled under part B for 

21 whom shared savings would otherwise be attributed 

22 through an advanced alternative payment model as 

23 authorized under section 1115A or section 1899. 

24 ‘‘(e) EVALUATION.— 


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1 ‘‘(1) IN GENERAL.—With respect to a qualified 

2 group practice and a qualified skilled nursing facil3 ity, not later than 6 months after such group prac4 tice begins furnishing items and services under the 

5 Program (or, in the case of a qualified skilled nurs6 ing facility, not less than 6 months after a qualified 

7 group practice first furnishes such items and serv8 ices at such facility), and not less than once every 

9 2 years thereafter, the Secretary shall evaluate such 

10 qualified group practice and such qualified facility 

11 using information received under paragraph (2) on 

12 such criteria as determined appropriate by the Sec13 retary. 

14 ‘‘(2) REPORTING OF INFORMATION.—In a time 

15 and manner specified by the Secretary, a qualified 

16 group practice and a qualified skilled nursing facility 

17 shall submit to the Secretary a report containing the 

18 following information with respect to items and serv19 ices furnished under the Program during a reporting 

20 period (as specified by the Secretary): 

21 ‘‘(A) The number of individuals with re22 spect to whom such group practice furnished 

23 such items and services in such period (or, in 

24 the case of a qualified skilled nursing facility, 

25 the number of individuals with respect to whom 


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1 such a group practice furnished such items and 

2 services at such facility in such period). 

3 ‘‘(B) The number of such individuals who 

4 were admitted to a hospital or treated in the 

5 emergency department of a hospital within 24 

6 hours of being furnished such items and serv7 ices. 

8 ‘‘(C) Other information determined appro9 priate by the Secretary. 

10 ‘‘(3) LOSS OF QUALIFIED CERTIFICATION.— 

11 ‘‘(A) IN GENERAL.—Not later than 3 

12 months after a determination described in this 

13 sentence is made, the Secretary may revoke the 

14 certification of a qualified skilled nursing facil15 ity or a qualified group practice made under 

16 subsection (c) if— 

17 ‘‘(i) the Chief Actuary of the Centers 

18 for Medicare & Medicaid Services deter19 mines that the participation of such skilled 

20 nursing facility or such group practice in 

21 the Program during a year resulted in 

22 total expenditures under this title for such 

23 period being greater than total expendi24 tures under such title would have been 


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1 during such period without such participa2 tion; or 

3 ‘‘(ii) a facility is selected for the Spe4 cial Focus Facility program or, if the facil5 ity is a candidate for the Special Focus 

6 Facility program, the Secretary determines 

7 that the participation of such facility in the 

8 Program should be terminated. 

9 ‘‘(B) EXCLUSION FROM CERTIFICATION.— 

10 ‘‘(i) IN GENERAL.—In the case that 

11 the Secretary revokes the certification of a 

12 qualified skilled nursing facility or a quali13 fied group practice under subparagraph 

14 (A), such skilled nursing facility or such 

15 group practice shall be ineligible for certifi16 cation as a qualified skilled nursing facility 

17 or a qualified group practice (as applica18 ble) under subsection (c) for the applicable 

19 period (as defined under clause (ii)). 

20 ‘‘(ii) APPLICABLE PERIOD DE21 FINED.—In this subparagraph, the term 

22 ‘applicable period’ means— 

23 ‘‘(I) if the revocation of a facility 

24 or group practice under subparagraph 

25 (A) is due to the application of clause 


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1 (i) of such subparagraph, a 1-year pe2 riod beginning on the date of such 

3 revocation; and 

4 ‘‘(II) in the revocation of a facil5 ity under subparagraph (A) is due to 

6 the application of clause (ii) of such 

7 subparagraph, the period beginning 

8 on the date of such revocation and 

9 ending on the date on which the facil10 ity graduates from the Special Focus 

11 Facility program (or, in the case of a 

12 facility that is a candidate for such 

13 program, the date on which the facil14 ity is no longer such a candidate, as 

15 determined by the Secretary). 

16 ‘‘(f) DETERMINATION OF BUDGET NEUTRALITY; 

17 TERMINATION OF PROGRAM.— 

18 ‘‘(1) DETERMINATION.—Not later than July 1, 

19 2027, the Chief Actuary of the Centers for Medicare 

20 & Medicaid Services shall determine whether the 

21 Program has resulted in an increase in total expend22 itures under this title with respect to the period be23 ginning on January 1, 2022, and ending on Decem24 ber 31, 2026, compared to what such expenditures 


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1 would have been during such period had the Pro2 gram not been in operation. 

3 ‘‘(2) TERMINATION.—If the Chief Actuary 

4 makes a determination under paragraph (1) that the 

5 Program has resulted in an increase in total expend6 itures under this title, the Secretary shall terminate 

7 the Program as of January 1 of the first year begin8 ning after such determination.’’. 

9 TITLE X—APPROPRIATIONS 

10 APPROPRIATIONS

11 SEC. 10001. The following sums are hereby appro12 priated, out of any money in the Treasury not otherwise 

13 appropriated, for the fiscal year ending September 30, 

14 2021, and for other purposes, namely: 

15 Subtitle A—Health Programs 

16 DEPARTMENT OF HEALTH AND HUMAN 

17 SERVICES 

18 OFFICE OF THE SECRETARY 

19 PUBLIC HEALTH AND SOCIAL SERVICES EMERGENCY

20 FUND

21 (INCLUDING TRANSFER OF FUNDS)

22 For an additional amount for ‘‘Public Health and So23 cial Services Emergency Fund’’, $31,000,000,000, to re24 main available until September 30, 2025, to prevent, pre25 pare for, and respond to coronavirus, domestically or 


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1 internationally, including the development of necessary 

2 countermeasures and vaccines, prioritizing platform-based 

3 technologies with United States-based manufacturing ca4 pabilities, the purchase of vaccines, therapeutics, 

5 diagnostics, necessary medical supplies, as well as medical 

6 surge capacity, addressing blood supply chain, workforce 

7 modernization, telehealth access and infrastructure, initial 

8 advanced manufacturing, novel dispensing, enhancements 

9 to the United States Commissioned Corps, and other pre10 paredness and response activities: Provided, That funds 

11 appropriated under this paragraph in this title may be 

12 used to develop and demonstrate innovations and enhance13 ments to manufacturing platforms to support such capa14 bilities: Provided further, That the Secretary of Health 

15 and Human Services shall purchase vaccines developed 

16 using funds made available under this paragraph in this 

17 title to respond to an outbreak or pandemic related to 

18 coronavirus in quantities determined by the Secretary to 

19 be adequate to address the public health need: Provided 

20 further, That products purchased by the Federal Govern21 ment with funds made available under this paragraph in 

22 this title, including vaccines, therapeutics, and diagnostics, 

23 shall be purchased in accordance with Federal Acquisition 

24 Regulation guidance on fair and reasonable pricing: Pro25 vided further, That the Secretary may take such measures 


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1 authorized under current law to ensure that vaccines, 

2 therapeutics, and diagnostics developed from funds pro3 vided in this title will be affordable in the commercial mar4 ket: Provided further, That in carrying out the previous 

5 proviso, the Secretary shall not take actions that delay the 

6 development of such products: Provided further, That the 

7 Secretary shall ensure that protections remain for individ8 uals enrolled in group or individual health care coverage 

9 with pre-existing conditions, including those linked to 

10 coronavirus: Provided further, That products purchased 

11 with funds appropriated under this paragraph in this title 

12 may, at the discretion of the Secretary of Health and 

13 Human Services, be deposited in the Strategic National 

14 Stockpile under section 319F–2 of the Public Health Serv15 ice Act: Provided further, That of the amount appropriated 

16 under this paragraph in this title, not more than 

17 $2,000,000,000 shall be for the Strategic National Stock18 pile under section 319F–2(a) of such Act: Provided fur19 ther, That funds appropriated under this paragraph in this 

20 title may be transferred to, and merged with, the fund 

21 authorized by section 319F–4, the Covered Counter meas22 ure Process Fund, of the Public Health Service Act: Pro23 vided further, That of the amount appropriated under this 

24 paragraph in this title, not more than $2,000,000,000, to 

25 remain available until September 30, 2023, shall be for 


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1 activities to improve and sustain State medical stockpiles: 

2 Provided further, That of the amount appropriated under 

3 this paragraph in this title, $20,000,000,000 shall be 

4 available to the Biomedical Advanced Research and Devel5 opment Authority for necessary expenses of manufac6 turing, production, and purchase, at the discretion of the 

7 Secretary, of vaccines, therapeutics, diagnostics, and small 

8 molecule active pharmaceutical ingredients, including the 

9 development, translation, and demonstration at scale of 

10 innovations in manufacturing platforms: Provided further, 

11 That funds in the previous proviso may be used for the 

12 construction or renovation of United States-based next 

13 generation manufacturing facilities, other than facilities 

14 owned by the United States Government: Provided further, 

15 That amounts provided in the eleventh proviso may be for 

16 necessary expenses related to the sustained on-shore man17 ufacturing capacity for public health emergencies: Pro18 vided further, That of the amount appropriated under this 

19 paragraph in this title, $6,000,000,000 shall be for activi20 ties to plan, prepare for, promote, distribute, administer, 

21 monitor, and track coronavirus vaccines to ensure broad22 based distribution, access, and vaccine coverage: Provided 

23 further, That the Secretary shall coordinate funding and 

24 activities outlined in the previous proviso through the Di25 rector of the Centers for Disease Control and Prevention: 


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1 Provided further, That the Secretary, through the Director 

2 of the Centers for Disease Control and Prevention, shall 

3 report to the Committees on Appropriations of the House 

4 of Representatives and the Senate within 60 days of the 

5 date of enactment of this title on a comprehensive 

6 coronavirus vaccine distribution strategy and spend plan 

7 that includes how existing infrastructure will be leveraged, 

8 enhancements or new infrastructure that may be built, 

9 considerations for moving and storing vaccines, guidance 

10 for how States and health care providers should prepare 

11 for, store, and administer vaccines, nationwide vaccination 

12 targets, funding that will be distributed to States, how an 

13 informational campaign to both the public and health care 

14 providers will be executed, and how the vaccine distribu15 tion plan will focus efforts on high risk, underserved, and 

16 minority populations: Provided further, That such plan 

17 shall be updated and provided to the Committees on Ap18 propriations of the House of Representatives and the Sen19 ate 90 days after submission of the first plan: Provided 

20 further, That the Secretary shall notify the Committees 

21 on Appropriations of the House of Representatives and the 

22 Senate 2 days in advance of any obligation in excess of 

23 $50,000,000, including contracts and interagency agree24 ments, from funds provided in this paragraph in this title: 

25 Provided further, That funds appropriated under this 


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1 paragraph in this title may be used for the construction, 

2 alteration, or renovation of nonfederally owned facilities 

3 for the production of vaccines, therapeutics, diagnostics, 

4 and medical supplies where the Secretary determines that 

5 such a contract is necessary to secure sufficient amounts 

6 of such supplies: Provided further, That not later than 30 

7 days after enactment of this title, and every 30 days there8 after until funds are expended, the Secretary shall report 

9 to the Committees on Appropriations of the House of Rep10 resentatives and the Senate on uses of funding for Oper11 ation Warp Speed, detailing current obligations by De12 partment or Agency, or component thereof broken out by 

13 the coronavirus supplemental appropriations Act that pro14 vided the source of funds: Provided further, That the plan 

15 outlined in the previous proviso shall include funding by 

16 contract, grant, or other transaction in excess of 

17 $20,000,000 with a notation of which Department or 

18 Agency, and component thereof is managing the contract: 

19 Provided further, That such amount is designated by the 

20 Congress as being for an emergency requirement pursuant 

21 to section 251(b)(2)(A)(i) of the Balanced Budget and 

22 Emergency Deficit Control Act of 1985. 

23 For an additional amount for ‘‘Public Health and So24 cial Services Emergency Fund’’, $16,000,000,000, to re25 main available until September 30, 2023, to prevent, preVerDate Sep 11 2014 19:08 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00390 Fmt 6652 Sfmt 6201 E:\BILLS\H14.IH H14

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1 pare for, and respond to coronavirus, domestically or 

2 internationally, which shall be for necessary expenses for 

3 testing, contact tracing, surveillance, containment, and 

4 mitigation to monitor and suppress COVID–19, including 

5 tests for both active infection and prior exposure, includ6 ing molecular, antigen, and serological tests, the manufac7 turing, procurement and distribution of tests, testing 

8 equipment and testing supplies, including personal protec9 tive equipment needed for administering tests, the devel10 opment and validation of rapid, molecular point-of-care 

11 tests, and other tests, support for workforce, epidemiology, 

12 to scale up academic, commercial, public health, and hos13 pital laboratories, to conduct surveillance and contact 

14 tracing, support development of COVID–19 testing plans, 

15 and other related activities related to COVID–19 testing: 

16 Provided, That of the amount appropriated under this 

17 paragraph in this title, not less than $15,000,000,000 

18 shall be for States, localities, territories, Tribes, Tribal or19 ganizations, urban Indian health organizations, or health 

20 service providers to Tribes for necessary expenses for test21 ing, contact tracing, surveillance, containment, and miti22 gation, including support for workforce, epidemiology, use 

23 by employers, elementary and secondary schools, child 

24 care facilities, institutions of higher education, long-term 

25 care facilities, or in other settings, scale up of testing by 


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1 public health, academic, commercial, and hospital labora2 tories, and community-based testing sites, health care fa3 cilities, and other entities engaged in COVID–19 testing, 

4 and other related activities related to COVID–19 testing, 

5 contact tracing, surveillance, containment, and mitigation: 

6 Provided further, That the amount provided in the pre7 ceding proviso shall be made available within 30 days of 

8 the date of enactment of this title: Provided further, That 

9 the amount identified in the first proviso under this para10 graph in this title shall be allocated to States, localities, 

11 and territories according to the formula that applied to 

12 the Public Health Emergency Preparedness cooperative 

13 agreement in fiscal year 2019: Provided further, That not 

14 less than $500,000,000 shall be allocated in coordination 

15 with the Director of the Indian Health Service, to Tribes, 

16 Tribal organizations, urban Indian health organizations, 

17 or health service providers to Tribes: Provided further, 

18 That the Secretary of Health and Human Services (re19 ferred to in this paragraph as the ‘‘Secretary’’) may sat20 isfy the funding thresholds outlined in the first and fourth 

21 provisos under this paragraph in this title by making 

22 awards through other grant or cooperative agreement 

23 mechanisms: Provided further, That the Governor or des24 ignee of each State, locality, territory, Tribe, or Tribal or25 ganization receiving funds pursuant to this title shall upVerDate Sep 11 2014 19:08 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00392 Fmt 6652 Sfmt 6201 E:\BILLS\H14.IH H14

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1 date their plans, as applicable, for COVID–19 testing and 

2 contact tracing submitted to the Secretary pursuant to the 

3 Paycheck Protection Program and Health Care Enhance4 ment Act (Public Law 116–139) and submit such updates 

5 to the Secretary not later than 60 days after funds appro6 priated in this paragraph in this title have been awarded 

7 to such recipient: Provided further, That not later than 

8 60 days after the date of enactment, and every quarter 

9 thereafter until funds are expended, the Governor or des10 ignee of each State, locality, territory, Tribe, or Tribal or11 ganization receiving funds shall report to the Secretary on 

12 uses of funding, detailing current commitments and obli13 gations broken out by the coronavirus supplemental appro14 priations Act that provided the source of funds: Provided 

15 further, That not later than 15 days after receipt of such 

16 reports, the Secretary shall summarize and report to the 

17 Committees on Appropriations of the House of Represent18 atives and the Senate on States’ commitments and obliga19 tions of funding: Provided further, That funds an entity 

20 receives from amounts described in the first proviso in this 

21 paragraph may also be used for the rent, lease, purchase, 

22 acquisition, construction, alteration, renovation, or equip23 ping of nonfederally owned facilities to improve 

24 coronavirus preparedness and response capability at the 

25 State and local level: Provided further, That such amount 


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1 is designated by the Congress as being for an emergency 

2 requirement pursuant to section 251(b)(2)(A)(i) of the 

3 Balanced Budget and Emergency Deficit Control Act of 

4 1985. 

5 Subtitle B—General Provisions–This Title 

6 SEC. 10101. Each amount appropriated or made 

7 available by this title is in addition to amounts otherwise 

8 appropriated for the fiscal year involved. 

9 SEC. 10102. No part of any appropriation contained 

10 in this title shall remain available for obligation beyond 

11 the current fiscal year unless expressly so provided herein. 

12 SEC. 10103. Unless otherwise provided for by this 

13 title, the additional amounts appropriated by this title to 

14 appropriations accounts shall be available under the au15 thorities and conditions applicable to such appropriations 

16 accounts for fiscal year 2020. 

17 SEC. 10104. In this title, the term ‘‘coronavirus’’ 

18 means SARS–CoV–2 or another coronavirus with pan19 demic potential. 

20 SEC. 10105. Each amount designated in this title by 

21 the Congress as being for an emergency requirement pur22 suant to section 251(b)(2)(A)(i) of the Balanced Budget 

23 and Emergency Deficit Control Act of 1985 shall be avail24 able (or rescinded or transferred, if applicable) only if the 


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1 President subsequently so designates all such amounts 

2 and transmits such designations to the Congress. 

3 SEC. 10106. Any amount appropriated by this title, 

4 designated by the Congress as an emergency requirement 

5 pursuant to section 251(b)(2)(A)(i) of the Balanced Budg6 et and Emergency Deficit Control Act of 1985 and subse7 quently so designated by the President, and transferred 

8 pursuant to transfer authorities provided by this title shall 

9 retain such designation. 

10 SEC. 10107. (a) STATUTORY PAYGO SCORECARDS.— 

11 The budgetary effects of this title shall not be entered on 

12 either PAYGO scorecard maintained pursuant to section 

13 4(d) of the Statutory Pay As-You-Go Act of 2010. 

14 (b) SENATE PAYGO SCORECARDS.—The budgetary 

15 effects of this title shall not be entered on any PAYGO 

16 scorecard maintained for purposes of section 4106 of H. 

17 Con. Res. 71 (115th Congress). 

18 (c) CLASSIFICATION OF BUDGETARY EFFECTS.— 

19 Notwithstanding Rule 3 of the Budget Scorekeeping 

20 Guidelines set forth in the joint explanatory statement of 

21 the committee of conference accompanying Conference Re22 port 105–217 and section 250(c)(7) and (c)(8) of the Bal23 anced Budget and Emergency Deficit Control Act of 1985, 

24 the budgetary effects of this title shall be estimated for 

25 purposes of section 251 of such Act. 


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1 (d) ENSURING NO WITHIN-SESSION SEQUESTRA2 TION.—Solely for the purpose of calculating a breach with3 in a category for fiscal year 2020 pursuant to section 

4 251(a)(6) or section 254(g) of the Balanced Budget and 

5 Emergency Deficit Control Act of 1985, and notwith6 standing any other provision of this title, the budgetary 

7 effects from this title shall be counted as amounts des8 ignated as being for an emergency requirement pursuant 

9 to section 251(b)(2)(A) of such Act. 

10 This title may be cited as the ‘‘Coronavirus Response 

11 Additional Supplemental Appropriations Act, 2020’’. 

Æ 


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