I 

115TH CONGRESS 

2D SESSION H. R. 7328 

To reauthorize certain programs under the Public Health Service Act and 

the Federal Food, Drug, and Cosmetic Act with respect to public health 

security and all-hazards preparedness and response, to clarify the regulatory framework with respect to certain nonprescription drugs that are 

marketed without an approved drug application, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 19, 2018 

Mrs. BROOKS of Indiana (for herself, Ms. ESHOO, Mr. LATTA, Ms. DEGETTE, 

Mr. GUTHRIE, and Mrs. DINGELL) introduced the following bill; which 

was referred to the Committee on Energy and Commerce, and in addition 

to the Committees on Veterans’ Affairs, the Judiciary, and Homeland Security, 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 reauthorize certain programs under the Public Health 

Service Act and the Federal Food, Drug, and Cosmetic 

Act with respect to public health security and all-hazards 

preparedness and response, to clarify the regulatory 

framework with respect to certain nonprescription drugs 

that are marketed without an approved drug application, 

and for other purposes. 

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


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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

2 (a) SHORT TITLE.—This Act may be cited as the 

3 ‘‘Pandemic and All-Hazards Preparedness and Advancing 

4 Innovation Act of 2018’’. 

5 (b) TABLE OF CONTENTS.—The table of contents for 

6 this Act is as follows: 

Sec. 1. Short title; table of contents. 

DIVISION A—PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND 

ADVANCING INNOVATION 

Sec. 100. References in division. 

TITLE I—STRENGTHENING THE NATIONAL HEALTH SECURITY 

STRATEGY 

Sec. 101. National Health Security Strategy. 

TITLE II—IMPROVING PREPAREDNESS AND RESPONSE 

Sec. 201. Improving benchmarks and standards for preparedness and response. 

Sec. 202. Amendments to preparedness and response programs. 

Sec. 203. Regional health care emergency preparedness and response systems. 

Sec. 204. Military and civilian partnership for trauma readiness. 

Sec. 205. Public health and health care system situational awareness and biosurveillance capabilities. 

Sec. 206. Strengthening and supporting the public health emergency rapid response fund. 

Sec. 207. Improving all-hazards preparedness and response by public health 

emergency volunteers. 

Sec. 208. Clarifying State liability law for volunteer health care professionals. 

Sec. 209. Report on adequate national blood supply. 

Sec. 210. Report on the public health preparedness and response capabilities 

and capacities of hospitals, long-term care facilities, and other 

health care facilities. 

TITLE III—REACHING ALL COMMUNITIES 

Sec. 301. Strengthening and assessing the emergency response workforce. 

Sec. 302. Health system infrastructure to improve preparedness and response. 

Sec. 303. Considerations for at-risk individuals. 

Sec. 304. Improving emergency preparedness and response considerations for 

children. 

Sec. 305. National advisory committees on disasters. 

Sec. 306. Guidance for participation in exercises and drills. 

TITLE IV—PRIORITIZING A THREAT-BASED APPROACH 

Sec. 401. Assistant Secretary for Preparedness and Response. 

Sec. 402. Public Health Emergency Medical Countermeasures Enterprise. 

Sec. 403. Strategic National Stockpile. 


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Sec. 404. Preparing for pandemic influenza, antimicrobial resistance, and other 

significant threats. 

Sec. 405. Reporting on the Federal Select Agent Program. 

TITLE V—INCREASING COMMUNICATION IN MEDICAL 

COUNTERMEASURE ADVANCED RESEARCH AND DEVELOPMENT 

Sec. 501. Medical countermeasure budget plan. 

Sec. 502. Material threat and medical countermeasure notifications. 

Sec. 503. Availability of regulatory management plans. 

Sec. 504. The Biomedical Advanced Research and Development Authority and 

the BioShield Special Reserve Fund. 

Sec. 505. Additional strategies for combating antibiotic resistance. 

TITLE VI—ADVANCING TECHNOLOGIES FOR MEDICAL 

COUNTERMEASURES 

Sec. 601. Administration of countermeasures. 

Sec. 602. Updating definitions of other transactions. 

Sec. 603. Medical countermeasure master files. 

Sec. 604. Animal rule report. 

Sec. 605. Review of the benefits of genomic engineering technologies and their 

potential role in national security. 

Sec. 606. Report on vaccines development. 

Sec. 607. Strengthening mosquito abatement for safety and health. 

TITLE VII—MISCELLANEOUS PROVISIONS 

Sec. 701. Reauthorizations and extensions. 

Sec. 702. Location of materials in the stockpile. 

Sec. 703. Cybersecurity. 

Sec. 704. Strategy and report. 

Sec. 705. Technical amendments. 

DIVISION B—OVER-THE-COUNTER MONOGRAPH SAFETY, 

INNOVATION, AND REFORM 

Sec. 1000. Short title; references in division. 

TITLE I—OTC DRUG REVIEW 

Sec. 1001. Regulation of certain nonprescription drugs that are marketed without an approved drug application. 

Sec. 1002. Misbranding. 

Sec. 1003. Drugs excluded from the over-the-counter drug review. 

Sec. 1004. Treatment of Sunscreen Innovation Act. 

Sec. 1005. Annual update to Congress on appropriate pediatric indication for 

certain OTC cough and cold drugs. 

Sec. 1006. Technical corrections. 

TITLE II—USER FEES 

Sec. 2001. Short title; finding. 

Sec. 2002. Fees relating to over-the-counter drugs. 


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1 DIVISION A—PANDEMIC AND 

2 ALL-HAZARDS PREPARED3 NESS AND ADVANCING INNO4 VATION 

5 SEC. 100. REFERENCES IN DIVISION. 

6 Except as otherwise specified— 

7 (1) amendments made by this division to a sec8 tion or other provision of law are amendments to 

9 such section or other provision of the Public Health 

10 Service Act (42 U.S.C. 201 et seq.); and 

11 (2) any reference to ‘‘this Act’’ contained in 

12 this division shall be treated as referring only to the 

13 provisions of this division. 

14 TITLE I—STRENGTHENING THE 

15 NATIONAL HEALTH SECURITY 

16 STRATEGY 

17 SEC. 101. NATIONAL HEALTH SECURITY STRATEGY. 

18 Section 2802 (42 U.S.C. 300hh–1) is amended— 

19 (1) in subsection (a)— 

20 (A) in paragraph (1)— 

21 (i) by striking ‘‘2014’’ and inserting 

22 ‘‘2018’’; and 

23 (ii) by striking the second sentence 

24 and inserting the following: ‘‘Such Na25 tional Health Security Strategy shall deVerDate Sep 11 2014 03:39 Dec 20, 2018 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H7328.IH H7328

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1 scribe potential emergency health security 

2 threats and identify the process for achiev3 ing the preparedness goals described in 

4 subsection (b) to be prepared to identify 

5 and respond to such threats and shall be 

6 consistent with the national preparedness 

7 goal (as described in section 504(a)(19) of 

8 the Homeland Security Act of 2002), the 

9 National Incident Management System (as 

10 defined in section 501(7) of such Act), and 

11 the National Response Plan developed pur12 suant to section 504 of such Act, or any 

13 successor plan.’’; 

14 (B) in paragraph (2), by inserting before 

15 the period at the end of the second sentence the 

16 following: ‘‘, and an analysis of any changes to 

17 the evidence-based benchmarks and objective 

18 standards under sections 319C–1 and 319C–2’’; 

19 and 

20 (C) in paragraph (3)— 

21 (i) by striking ‘‘2009’’ and inserting 

22 ‘‘2022’’; 

23 (ii) by inserting ‘‘(including gaps in 

24 the environmental health and animal 

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1 ing the status of such workforce’’ after 

2 ‘‘gaps in such workforce’’; 

3 (iii) by striking ‘‘and identifying strat4 egies’’ and inserting ‘‘identifying strate5 gies’’; and 

6 (iv) by inserting before the period at 

7 the end ‘‘, and identifying current capabili8 ties to meet the requirements of section 

9 2803’’; and 

10 (2) in subsection (b)— 

11 (A) in paragraph (2)— 

12 (i) in subparagraph (A), by striking 

13 ‘‘and investigation’’ and inserting ‘‘inves14 tigation, and related information tech15 nology activities’’; 

16 (ii) in subparagraph (B), by striking 

17 ‘‘and decontamination’’ and inserting ‘‘de18 contamination, relevant health care serv19 ices and supplies, and transportation and 

20 disposal of medical waste’’; and 

21 (iii) by adding at the end the fol22 lowing: 

23 ‘‘(E) Response to environmental hazards.’’; 

24 (B) in paragraph (3)— 


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1 (i) in the matter preceding subpara2 graph (A), by striking ‘‘including mental 

3 health’’ and inserting ‘‘including phar4 macies, mental health facilities,’’; and 

5 (ii) in subparagraph (F), by inserting 

6 ‘‘or exposures to agents that could cause a 

7 public health emergency’’ before the pe8 riod; 

9 (C) in paragraph (5), by inserting ‘‘and 

10 other applicable compacts’’ after ‘‘Compact’’; 

11 and 

12 (D) by adding at the end the following: 

13 ‘‘(9) ZOONOTIC DISEASE, FOOD, AND AGRI14 CULTURE.—Improving coordination among Federal, 

15 State, local, tribal, and territorial entities (including 

16 through consultation with the Secretary of Agri17 culture) to prevent, detect, and respond to outbreaks 

18 of plant or animal disease (including zoonotic dis19 ease) that could compromise national security result20 ing from a deliberate attack, a naturally occurring 

21 threat, the intentional adulteration of food, or other 

22 public health threats, taking into account inter23 actions between animal health, human health, and 

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1 rectly related to public health emergency prepared2 ness and response capabilities, as applicable. 

3 ‘‘(10) GLOBAL HEALTH SECURITY.—Assessing 

4 current or potential health security threats from 

5 abroad to inform domestic public health prepared6 ness and response capabilities.’’. 

7 TITLE II—IMPROVING 

8 PREPAREDNESS AND RESPONSE 

9 SEC. 201. IMPROVING BENCHMARKS AND STANDARDS FOR 

10 PREPAREDNESS AND RESPONSE. 

11 (a) EVALUATING MEASURABLE EVIDENCE-BASED

12 BENCHMARKS AND OBJECTIVE STANDARDS.—Section 

13 319C–1 (42 U.S.C. 247d–3a) is amended by inserting 

14 after subsection (j) the following: 

15 ‘‘(k) EVALUATION.— 

16 ‘‘(1) IN GENERAL.—Not later than 2 years 

17 after the date of enactment of the Pandemic and 

18 All-Hazards Preparedness and Advancing Innovation 

19 Act of 2018 and every 2 years thereafter, the Sec20 retary shall conduct an evaluation of the evidence21 based benchmarks and objective standards required 

22 under subsection (g). Such evaluation shall be sub23 mitted to the congressional committees of jurisdic24 tion together with the National Health Security 


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1 Strategy under section 2802, at such time as such 

2 strategy is submitted. 

3 ‘‘(2) CONTENT.—The evaluation under this 

4 paragraph shall include— 

5 ‘‘(A) a review of evidence-based bench6 marks and objective standards, and associated 

7 metrics and targets; 

8 ‘‘(B) a discussion of changes to any evi9 dence-based benchmarks and objective stand10 ards, and the effect of such changes on the abil11 ity to track whether entities are meeting or 

12 making progress toward the goals under this 

13 section and, to the extent practicable, the appli14 cable goals of the National Health Security 

15 Strategy under section 2802; 

16 ‘‘(C) a description of amounts received by 

17 eligible entities described in subsection (b) and 

18 section 319C–2(b), and amounts received by 

19 subrecipients and the effect of such funding on 

20 meeting evidence-based benchmarks and objec21 tive standards; and 

22 ‘‘(D) recommendations, as applicable and 

23 appropriate, to improve evidence-based bench24 marks and objective standards to more accu25 rately assess the ability of entities receiving 


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1 awards under this section to better achieve the 

2 goals under this section and section 2802.’’. 

3 (b) EVALUATING THE PARTNERSHIP FOR STATE AND

4 REGIONAL HOSPITAL PREPAREDNESS.—Section 319C– 

5 2(i)(1) (42 U.S.C. 247–3b(i)(1)) is amended by striking 

6 ‘‘section 319C–1(g), (i), and (j)’’ and inserting ‘‘section 

7 319C–1(g), (i), (j), and (k)’’. 

8 SEC. 202. AMENDMENTS TO PREPAREDNESS AND RE9 SPONSE PROGRAMS. 

10 (a) COOPERATIVE AGREEMENT APPLICATIONS FOR

11 IMPROVING STATE AND LOCAL PUBLIC HEALTH SECU12 RITY.—Section 319C–1 (42 U.S.C. 247d–3a) is amend13 ed— 

14 (1) in subsection (a), by inserting ‘‘, acting 

15 through the Director of the Centers for Disease 

16 Control and Prevention,’’ after ‘‘the Secretary’’; and 

17 (2) in subsection (b)(2)(A)— 

18 (A) in clause (vi), by inserting ‘‘, including 

19 public health agencies with specific expertise 

20 that may be relevant to public health security, 

21 such as environmental health agencies,’’ after 

22 ‘‘stakeholders’’; 

23 (B) by redesignating clauses (vii) through 

24 (ix) as clauses (viii) through (x); 


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1 (C) by inserting after clause (vi) the fol2 lowing: 

3 ‘‘(vii) a description of how, as applica4 ble, such entity may integrate information 

5 to account for individuals with behavioral 

6 health needs following a public health 

7 emergency;’’; 

8 (D) in clause (ix), as so redesignated, by 

9 striking ‘‘; and’’ and inserting a semicolon; and 

10 (E) by adding at the end the following: 

11 ‘‘(xi) a description of how the entity 

12 will partner with health care facilities, in13 cluding hospitals and nursing homes and 

14 other long-term care facilities, to promote 

15 and improve public health preparedness 

16 and response; and 

17 ‘‘(xii) a description of how, as appro18 priate and practicable, the entity will in19 clude critical infrastructure partners, such 

20 as utility companies within the entity’s ju21 risdiction, in planning pursuant to this 

22 subparagraph to help ensure that critical 

23 infrastructure will remain functioning dur24 ing, or return to function as soon as prac25 ticable after, a public health emergency;’’. 


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1 (b) EXCEPTION RELATING TO APPLICATION OF CER2 TAIN REQUIREMENTS.— 

3 (1) IN GENERAL.—Section 319C–1(g) (42 

4 U.S.C. 247d–3a(g)) is amended— 

5 (A) in paragraph (5)— 

6 (i) in the matter preceding subpara7 graph (A), by striking ‘‘Beginning with fis8 cal year 2009’’ and inserting ‘‘Beginning 

9 with fiscal year 2019’’; and 

10 (ii) in subparagraph (A)— 

11 (I) by striking ‘‘for the imme12 diately preceding fiscal year’’ and in13 serting ‘‘for either of the 2 imme14 diately preceding fiscal years’’; and 

15 (II) by striking ‘‘2008’’ and in16 serting ‘‘2018’’; and 

17 (B) in paragraph (6), by amending sub18 paragraph (A) to read as follows: 

19 ‘‘(A) IN GENERAL.—The amounts de20 scribed in this paragraph are the following 

21 amounts that are payable to an entity for ac22 tivities described in this section or section 

23 319C–2: 

24 ‘‘(i) For no more than 1 of each of 

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1 lowing a fiscal year in which an entity ex2 perienced a failure described in subpara3 graph (A) or (B) of paragraph (5), an 

4 amount equal to 10 percent of the amount 

5 the entity was eligible to receive for the re6 spective fiscal year. 

7 ‘‘(ii) For no more than 1 of the first 

8 2 fiscal years immediately following the 

9 third consecutive fiscal year in which an 

10 entity experienced such a failure, in lieu of 

11 applying clause (i), an amount equal to 15 

12 percent of the amount the entity was eligi13 ble to receive for the respective fiscal 

14 year.’’. 

15 (2) EFFECTIVE DATE.—The amendments made 

16 by paragraph (1) shall apply with respect to cooper17 ative agreements awarded on or after the date of en18 actment of this Act. 

19 (c) PARTNERSHIP FOR STATE AND REGIONAL HOS20 PITAL PREPAREDNESS TO IMPROVE SURGE CAPACITY.— 

21 Section 319C–2 (42 U.S.C. 247d–3b) is amended— 

22 (1) in subsection (a)— 

23 (A) by inserting ‘‘, acting through the As24 sistant Secretary for Preparedness and Re25 sponse,’’ after ‘‘The Secretary’’; and 


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1 (B) by striking ‘‘preparedness for public 

2 health emergencies’’ and inserting ‘‘prepared3 ness for, and response to, public health emer4 gencies in accordance with subsection (c)’’; 

5 (2) in subsection (b)(1)(A)— 

6 (A) by striking ‘‘partnership consisting of’’ 

7 and inserting ‘‘coalition that includes’’; 

8 (B) in clause (ii), by striking ‘‘; and’’ and 

9 inserting a semicolon; and 

10 (C) by adding at the end the following: 

11 ‘‘(iv) one or more emergency medical serv12 ice organizations or emergency management or13 ganizations; and’’; 

14 (3) in subsection (d)— 

15 (A) in paragraph (1)(B), by striking ‘‘part16 nership’’ each place it appears and inserting 

17 ‘‘coalition’’; and 

18 (B) in paragraph (2)(C), by striking ‘‘med19 ical preparedness’’ and inserting ‘‘preparedness 

20 and response’’; 

21 (4) in subsection (f), by striking ‘‘partnership’’ 

22 and inserting ‘‘coalition’’; 

23 (5) in subsection (g)(2)— 

24 (A) by striking ‘‘Partnerships’’ and insert25 ing ‘‘Coalitions’’; 


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1 (B) by striking ‘‘partnerships’’ and insert2 ing ‘‘coalitions’’; and 

3 (C) by inserting ‘‘and response’’ after 

4 ‘‘preparedness’’; and 

5 (6) in subsection (i)(1)— 

6 (A) by striking ‘‘An entity’’ and inserting 

7 ‘‘A coalition’’; and 

8 (B) by striking ‘‘such partnership’’ and in9 serting ‘‘such coalition’’. 

10 (d) PUBLIC HEALTH SECURITY GRANTS AUTHORIZA11 TION OF APPROPRIATIONS.—Section 319C–1(h)(1)(A) 

12 (42 U.S.C. 247d–3a(h)(1)(A)) is amended by striking 

13 ‘‘$641,900,000 for fiscal year 2014’’ and all that follows 

14 through the period at the end and inserting 

15 ‘‘$685,000,000 for each of fiscal years 2019 through 2023 

16 for awards pursuant to paragraph (3) (subject to the au17 thority of the Secretary to make awards pursuant to para18 graphs (4) and (5)).’’. 

19 (e) PARTNERSHIP FOR STATE AND REGIONAL HOS20 PITAL PREPAREDNESS AUTHORIZATION OF APPROPRIA21 TIONS.—Section 319C–2(j) (42 U.S.C. 247d–3b(j)) is 

22 amended— 

23 (1) by amending paragraph (1) to read as fol24 lows: 

25 ‘‘(1) IN GENERAL.— 


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1 ‘‘(A) AUTHORIZATION OF APPROPRIA2 TIONS.—For purposes of carrying out this sec3 tion and section 319C–3, in accordance with 

4 subparagraph (B), there is authorized to be ap5 propriated $385,000,000 for each of fiscal years 

6 2019 through 2023. 

7 ‘‘(B) RESERVATION OF AMOUNTS FOR RE8 GIONAL SYSTEMS.— 

9 ‘‘(i) IN GENERAL.—Subject to clause 

10 (ii), of the amount appropriated under sub11 paragraph (A) for a fiscal year, the Sec12 retary may reserve up to 5 percent for the 

13 purpose of carrying out section 319C–3. 

14 ‘‘(ii) RESERVATION CONTINGENT ON

15 CONTINUED APPROPRIATIONS FOR THIS

16 SECTION.—If for fiscal year 2019 or a sub17 sequent fiscal year, the amount appro18 priated under subparagraph (A) is such 

19 that, after application of clause (i), the 

20 amount remaining for the purpose of car21 rying out this section would be less than 

22 the amount available for such purpose for 

23 the previous fiscal year, the amount that 

24 may be reserved under clause (i) shall be 

25 reduced such that the amount remaining 


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1 for the purpose of carrying out this section 

2 is not less than the amount available for 

3 such purpose for the previous fiscal year. 

4 ‘‘(iii) SUNSET.—The authority to re5 serve amounts under clause (i) shall expire 

6 on September 30, 2023.’’; 

7 (2) in paragraph (2), by striking ‘‘paragraph 

8 (1) for a fiscal year’’ and inserting ‘‘paragraph 

9 (1)(A) for a fiscal year and not reserved for the pur10 pose described in paragraph (1)(B)(i)’’; and 

11 (3) in paragraph (3)(A), by striking ‘‘paragraph 

12 (1) and not reserved under paragraph (2)’’ and in13 serting ‘‘paragraph (1)(A) and not reserved under 

14 paragraph (1)(B)(i) or (2)’’. 

15 SEC. 203. REGIONAL HEALTH CARE EMERGENCY PRE16 PAREDNESS AND RESPONSE SYSTEMS. 

17 (a) IN GENERAL.—Part B of title III (42 U.S.C. 243 

18 et seq.) is amended by inserting after section 319C–2 the 

19 following: 

20 ‘‘SEC. 319C–3. GUIDELINES FOR REGIONAL HEALTH CARE 

21 EMERGENCY PREPAREDNESS AND RESPONSE 

22 SYSTEMS. 

23 ‘‘(a) PURPOSE.—It is the purpose of this section to 

24 identify and provide guidelines for regional systems of hos25 pitals, health care facilities, and other public and private 


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1 sector entities, with varying levels of capability to treat 

2 patients and increase medical surge capacity during, in ad3 vance of, and immediately following a public health emer4 gency, including threats posed by one or more chemical, 

5 biological, radiological, or nuclear agents, including emerg6 ing infectious diseases. 

7 ‘‘(b) GUIDELINES.—The Assistant Secretary for Pre8 paredness and Response, in consultation with the Director 

9 of the Centers for Disease Control and Prevention, the Ad10 ministrator of the Centers for Medicare & Medicaid Serv11 ices, the Administrator of the Health Resources and Serv12 ices Administration, the Commissioner of Food and 

13 Drugs, the Assistant Secretary for Mental Health and 

14 Substance Use, the Assistant Secretary of Labor for Occu15 pational Safety and Health, the Secretary of Veterans Af16 fairs, the heads of such other Federal agencies as the Sec17 retary determines to be appropriate, and State, local, trib18 al, and territorial public health officials, shall, not later 

19 than 2 years after the date of enactment of this section— 

20 ‘‘(1) identify and develop a set of guidelines re21 lating to practices and protocols for all-hazards pub22 lic health emergency preparedness and response for 

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1 ing from one or more chemical, biological, radio2 logical, or nuclear agents, including emerging infec3 tious diseases (which may include existing practices, 

4 such as trauma care and medical surge capacity and 

5 capabilities), with respect to— 

6 ‘‘(A) a regional approach to identifying 

7 hospitals and health care facilities based on 

8 varying capabilities and capacity to treat pa9 tients affected by such emergency, including— 

10 ‘‘(i) the manner in which the system 

11 will coordinate with and integrate the part12 nerships and health care coalitions estab13 lished under section 319C–2(b); and 

14 ‘‘(ii) informing and educating appro15 priate first responders and health care sup16 ply chain partners of the regional emer17 gency preparedness and response capabili18 ties and medical surge capacity of such 

19 hospitals and health care facilities in the 

20 community; 

21 ‘‘(B) physical and technological infrastruc22 ture, laboratory capacity, staffing, blood supply, 

23 and other supply chain needs, taking into ac24 count resiliency, geographic considerations, and 

25 rural considerations; 


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1 ‘‘(C) protocols or best practices for the 

2 safety and personal protection of workers who 

3 handle human remains and health care workers 

4 (including with respect to protective equipment 

5 and supplies, waste management processes, and 

6 decontamination), sharing of specialized experi7 ence among the health care workforce, behav8 ioral health, psychological resilience, and train9 ing of the workforce, as applicable; 

10 ‘‘(D) in a manner that allows for disease 

11 containment (within the meaning of section 

12 2802(b)(2)(B)), coordinated medical triage, 

13 treatment, and transportation of patients, based 

14 on patient medical need (including patients in 

15 rural areas), to the appropriate hospitals or 

16 health care facilities within the regional system 

17 or, as applicable and appropriate, between sys18 tems in different States or regions; and 

19 ‘‘(E) the needs of children and other at20 risk individuals; 

21 ‘‘(2) make such guidelines available on the 

22 internet website of the Department of Health and 

23 Human Services in a manner that does not com24 promise national security; and 


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1 ‘‘(3) update such guidelines as appropriate, in2 cluding based on input received pursuant to sub3 sections (c) and (e) and information resulting from 

4 applicable reports required under the Pandemic and 

5 All-Hazards Preparedness and Advancing Innovation 

6 Act of 2018 (including any amendments made by 

7 such Act), to address new and emerging public 

8 health threats. 

9 ‘‘(c) CONSIDERATIONS.—In identifying, developing, 

10 and updating guidelines under subsection (b), the Assist11 ant Secretary for Preparedness and Response shall— 

12 ‘‘(1) include input from hospitals and health 

13 care facilities (including health care coalitions under 

14 section 319C–2), State, local, tribal, and territorial 

15 public health departments, and health care or sub16 ject matter experts (including experts with relevant 

17 expertise in chemical, biological, radiological, or nu18 clear threats, including emerging infectious dis19 eases), as the Assistant Secretary determines appro20 priate, to meet the goals under section 2802(b)(3); 

21 ‘‘(2) consult and engage with appropriate 

22 health care providers and professionals, including 

23 physicians, nurses, first responders, health care fa24 cilities (including hospitals, primary care clinics, 

25 community health centers, mental health facilities, 


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1 ambulatory care facilities, and dental health facili2 ties), pharmacies, emergency medical providers, 

3 trauma care providers, environmental health agen4 cies, public health laboratories, poison control cen5 ters, blood banks, tissue banks, and other experts 

6 that the Assistant Secretary determines appropriate, 

7 to meet the goals under section 2802(b)(3); 

8 ‘‘(3) consider feedback related to financial im9 plications for hospitals, health care facilities, public 

10 health agencies, laboratories, blood banks, tissue 

11 banks, and other entities engaged in regional pre12 paredness planning to implement and follow such 

13 guidelines, as applicable; and 

14 ‘‘(4) consider financial requirements and poten15 tial incentives for entities to prepare for, and re16 spond to, public health emergencies as part of the 

17 regional health care emergency preparedness and re18 sponse system. 

19 ‘‘(d) TECHNICAL ASSISTANCE.—The Assistant Sec20 retary for Preparedness and Response, in consultation 

21 with the Director of the Centers for Disease Control and 

22 Prevention and the Assistant Secretary of Labor for Occu23 pational Safety and Health, may provide technical assist24 ance and consultation toward meeting the guidelines de25 scribed in subsection (b). 


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1 ‘‘(e) DEMONSTRATION PROJECT FOR REGIONAL

2 HEALTH CARE PREPAREDNESS AND RESPONSE SYS3 TEMS.— 

4 ‘‘(1) IN GENERAL.—The Assistant Secretary for 

5 Preparedness and Response may establish a dem6 onstration project pursuant to the development and 

7 implementation of guidelines under subsection (b) to 

8 award grants to improve medical surge capacity for 

9 all hazards, build and integrate regional medical re10 sponse capabilities, improve specialty care expertise 

11 for all-hazards response, and coordinate medical pre12 paredness and response across State, local, tribal, 

13 territorial, and regional jurisdictions. 

14 ‘‘(2) SUNSET.—The authority under this sub15 section shall expire on September 30, 2023.’’. 

16 (b) GAO REPORT TO CONGRESS.— 

17 (1) REPORT.—Not later than 3 years after the 

18 date of enactment of this Act, the Comptroller Gen19 eral of the United States (referred to in this sub20 section as the ‘‘Comptroller General’’) shall submit 

21 to the Committee on Health, Education, Labor, and 

22 Pensions and the Committee on Finance of the Sen23 ate and the Committee on Energy and Commerce 

24 and the Committee on Ways and Means of the 

25 House of Representatives, a report on the extent to 


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1 which hospitals and health care facilities have imple2 mented the recommended guidelines under section 

3 319C–3(b) of the Public Health Service Act (as 

4 added by subsection (a)), including an analysis and 

5 evaluation of any challenges hospitals or health care 

6 facilities experienced in implementing such guide7 lines. 

8 (2) CONTENT.—The Comptroller General shall 

9 include in the report under paragraph (1)— 

10 (A) data on the preparedness and response 

11 capabilities that have been informed by the 

12 guidelines under section 319C–3(b) of the Pub13 lic Health Service Act to improve regional emer14 gency health care preparedness and response 

15 capability, including hospital and health care 

16 facility capacity and medical surge capabilities 

17 to prepare for, and respond to, public health 

18 emergencies; and 

19 (B) recommendations to reduce gaps in in20 centives for regional health partners, including 

21 hospitals and health care facilities, to improve 

22 capacity and medical surge capabilities to pre23 pare for, and respond to, public health emer24 gencies, consistent with subsection (a), which 

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1 pating in programs under section 319C–2 of 

2 the Public Health Service Act (42 U.S.C. 

3 247d–3b) or in programs under the Centers for 

4 Medicare & Medicaid Services (including inno5 vative health care delivery and payment mod6 els), and input from private sector financial in7 stitutions. 

8 (3) CONSULTATION.—In carrying out para9 graphs (1) and (2), the Comptroller General shall 

10 consult with the heads of appropriate Federal agen11 cies, including— 

12 (A) the Assistant Secretary for Prepared13 ness and Response; 

14 (B) the Director of the Centers for Disease 

15 Control and Prevention; 

16 (C) the Administrator of the Centers for 

17 Medicare & Medicaid Services; 

18 (D) the Assistant Secretary for Mental 

19 Health and Substance Use; 

20 (E) the Assistant Secretary of Labor for 

21 Occupational Safety and Health; and 

22 (F) the Secretary of Veterans Affairs. 

23 (c) ANNUAL REPORTS.—Section 319C–2(i)(1) (42 

24 U.S.C. 247d–3b(i)(1)) is amended by inserting after the 

25 first sentence the following: ‘‘In submitting reports under 


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1 this paragraph, a coalition shall include information on the 

2 progress that the coalition has made toward the implemen3 tation of section 319C–3 (or barriers to progress, if 

4 any).’’. 

5 (d) NATIONAL HEALTH SECURITY STRATEGY INCOR6 PORATION OF REGIONALIZED EMERGENCY PREPARED7 NESS AND RESPONSE.—Subparagraph (G) of section 

8 2802(b)(3) (42 U.S.C. 300hh–1(b)(3)) is amended to read 

9 as follows: 

10 ‘‘(G) Optimizing a coordinated and flexible 

11 approach to the emergency response and med12 ical surge capacity of hospitals, other health 

13 care facilities, critical care, trauma care (which 

14 may include trauma centers), and emergency 

15 medical systems.’’. 

16 (e) IMPROVING STATE AND LOCAL PUBLIC HEALTH

17 SECURITY.— 

18 (1) STATE AND LOCAL SECURITY.—Section 

19 319C–1(e) (42 U.S.C. 247d–3a(e)) is amended by 

20 striking ‘‘, and local emergency plans.’’ and inserting 

21 ‘‘, local emergency plans, and any regional health 

22 care emergency preparedness and response system 

23 established pursuant to the applicable guidelines 

24 under section 319C–3.’’. 


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1 (2) PARTNERSHIPS.—Section 319C–2(d)(1)(A) 

2 (42 U.S.C. 247d–3b(d)(1)(A)) is amended— 

3 (A) in clause (i), by striking ‘‘; and’’ and 

4 inserting ‘‘;’’; 

5 (B) by redesignating clause (ii) as clause 

6 (iii); and 

7 (C) inserting after clause (i), the following: 

8 ‘‘(ii) among one or more facilities in a 

9 regional health care emergency system 

10 under section 319C–3; and’’. 

11 SEC. 204. MILITARY AND CIVILIAN PARTNERSHIP FOR 

12 TRAUMA READINESS. 

13 Title XII (42 U.S.C. 300d et seq.) is amended by 

14 adding at the end the following new part: 

15 ‘‘PART I—MILITARY AND CIVILIAN PARTNERSHIP 

16 FOR TRAUMA READINESS GRANT PROGRAM 

17 ‘‘SEC. 1291. MILITARY AND CIVILIAN PARTNERSHIP FOR 

18 TRAUMA READINESS GRANT PROGRAM. 

19 ‘‘(a) MILITARY TRAUMA TEAM PLACEMENT PRO20 GRAM.— 

21 ‘‘(1) IN GENERAL.—The Secretary, acting 

22 through the Assistant Secretary for Preparedness 

23 and Response and in consultation with the Secretary 

24 of Defense, shall award grants to not more than 20 

25 eligible high acuity trauma centers to enable military 


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1 trauma teams to provide, on a full-time basis, trau2 ma care and related acute care at such trauma cen3 ters. 

4 ‘‘(2) LIMITATIONS.—In the case of a grant 

5 awarded under paragraph (1) to an eligible high 

6 acuity trauma center, such grant— 

7 ‘‘(A) shall be for a period of at least 3 

8 years and not more than 5 years (and may be 

9 renewed at the end of such period); and 

10 ‘‘(B) shall be in an amount that does not 

11 exceed $1,000,000 per year. 

12 ‘‘(3) AVAILABILITY OF FUNDS.—Notwith13 standing section 1552 of title 31, United States 

14 Code, or any other provision of law, funds available 

15 to the Secretary for obligation for a grant under this 

16 subsection shall remain available for expenditure for 

17 100 days after the last day of the performance pe18 riod of such grant. 

19 ‘‘(b) MILITARY TRAUMA CARE PROVIDER PLACE20 MENT PROGRAM.— 

21 ‘‘(1) IN GENERAL.—The Secretary, acting 

22 through the Assistant Secretary for Preparedness 

23 and Response and in consultation with the Secretary 

24 of Defense, shall award grants to eligible trauma 

25 centers to enable military trauma care providers to 


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1 provide trauma care and related acute care at such 

2 trauma centers. 

3 ‘‘(2) LIMITATIONS.—In the case of a grant 

4 awarded under paragraph (1) to an eligible trauma 

5 center, such grant— 

6 ‘‘(A) shall be for a period of at least 1 year 

7 and not more than 3 years (and may be re8 newed at the end of such period); and 

9 ‘‘(B) shall be in an amount that does not 

10 exceed, in a year— 

11 ‘‘(i) $100,000 for each military trau12 ma care provider that is a physician at 

13 such eligible trauma center; and 

14 ‘‘(ii) $50,000 for each other military 

15 trauma care provider at such eligible trau16 ma center. 

17 ‘‘(c) GRANT REQUIREMENTS.— 

18 ‘‘(1) DEPLOYMENT AND PUBLIC HEALTH EMER19 GENCIES.—As a condition of receipt of a grant 

20 under this section, a grant recipient shall agree to 

21 allow military trauma care providers providing care 

22 pursuant to such grant to— 

23 ‘‘(A) be deployed by the Secretary of De24 fense for military operations, for training, or 

25 for response to a mass casualty incident; and 


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1 ‘‘(B) be deployed by the Secretary of De2 fense, in consultation with the Secretary of 

3 Health and Human Services, for response to a 

4 public health emergency pursuant to section 

5 319. 

6 ‘‘(2) USE OF FUNDS.—Grants awarded under 

7 this section to an eligible trauma center may be used 

8 to train and incorporate military trauma care pro9 viders into such trauma center, including incorpora10 tion into operational exercises and training drills re11 lated to public health emergencies, expenditures for 

12 malpractice insurance, office space, information 

13 technology, specialty education and supervision, 

14 trauma programs, research, and applicable license 

15 fees for such military trauma care providers. 

16 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec17 tion shall be construed to affect any other provision of law 

18 that preempts State licensing requirements for health care 

19 professionals, including with respect to military trauma 

20 care providers. 

21 ‘‘(e) REPORTING REQUIREMENTS.— 

22 ‘‘(1) REPORT TO THE SECRETARY AND THE

23 SECRETARY OF DEFENSE.—Each eligible trauma 

24 center or eligible high acuity trauma center awarded 

25 a grant under subsection (a) or (b) for a year shall 


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1 submit to the Secretary and the Secretary of De2 fense a report for such year that includes informa3 tion on— 

4 ‘‘(A) the number and types of trauma 

5 cases managed by military trauma teams or 

6 military trauma care providers pursuant to such 

7 grant during such year; 

8 ‘‘(B) the ability to maintain the integration 

9 of the military trauma providers or teams of 

10 providers as part of the trauma center, includ11 ing the financial effect of such grant on the 

12 trauma center; 

13 ‘‘(C) the educational effect on resident 

14 trainees in centers where military trauma teams 

15 are assigned; 

16 ‘‘(D) any research conducted during such 

17 year supported by such grant; and 

18 ‘‘(E) any other information required by the 

19 Secretaries for the purpose of evaluating the ef20 fect of such grant. 

21 ‘‘(2) REPORT TO CONGRESS.—Not less than 

22 once every 2 years, the Secretary, in consultation 

23 with the Secretary of Defense, shall submit a report 

24 to the congressional committees of jurisdiction that 

25 includes information on the effect of placing military 


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1 trauma care providers in trauma centers awarded 

2 grants under this section on— 

3 ‘‘(A) maintaining military trauma care 

4 providers’ readiness and ability to respond to 

5 and treat battlefield injuries; 

6 ‘‘(B) providing health care to civilian trau7 ma patients in urban and rural settings; 

8 ‘‘(C) the capability of trauma centers and 

9 military trauma care providers to increase med10 ical surge capacity, including as a result of a 

11 large scale event; 

12 ‘‘(D) the ability of grant recipients to 

13 maintain the integration of the military trauma 

14 providers or teams of providers as part of the 

15 trauma center; 

16 ‘‘(E) efforts to incorporate military trauma 

17 care providers into operational exercises and 

18 training and drills for public health emer19 gencies; and 

20 ‘‘(F) the capability of military trauma care 

21 providers to participate as part of a medical re22 sponse during or in advance of a public health 

23 emergency, as determined by the Secretary, or 

24 a mass casualty incident. 

25 ‘‘(f) DEFINITIONS.—For purposes of this part: 


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1 ‘‘(1) ELIGIBLE TRAUMA CENTER.—The term 

2 ‘eligible trauma center’ means a Level I, II, or III 

3 trauma center that satisfies each of the following: 

4 ‘‘(A) Such trauma center has an agree5 ment with the Secretary of Defense to enable 

6 military trauma care providers to provide trau7 ma care and related acute care at such trauma 

8 center. 

9 ‘‘(B) Such trauma center utilizes a risk-ad10 justed benchmarking system and metrics to 

11 measure performance, quality, and patient out12 comes. 

13 ‘‘(C) Such trauma center demonstrates a 

14 need for integrated military trauma care pro15 viders to maintain or improve the trauma clin16 ical capability of such trauma center. 

17 ‘‘(2) ELIGIBLE HIGH ACUITY TRAUMA CEN18 TER.—The term ‘eligible high acuity trauma center’ 

19 means a Level I trauma center that satisfies each of 

20 the following: 

21 ‘‘(A) Such trauma center has an agree22 ment with the Secretary of Defense to enable 

23 military trauma teams to provide trauma care 

24 and related acute care at such trauma center. 


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1 ‘‘(B) At least 20 percent of patients treat2 ed at such trauma center in the most recent 3- 

3 month period for which data are available are 

4 treated for a major trauma at such trauma cen5 ter. 

6 ‘‘(C) Such trauma center utilizes a risk-ad7 justed benchmarking system and metrics to 

8 measure performance, quality, and patient out9 comes. 

10 ‘‘(D) Such trauma center is an academic 

11 training center— 

12 ‘‘(i) affiliated with a medical school; 

13 ‘‘(ii) that maintains residency pro14 grams and fellowships in critical trauma 

15 specialties and subspecialties, and provides 

16 education and supervision of military trau17 ma team members according to those spe18 cialties and subspecialties; and 

19 ‘‘(iii) that undertakes research in the 

20 prevention and treatment of traumatic in21 jury. 

22 ‘‘(E) Such trauma center serves as a med23 ical and public health preparedness and re24 sponse leader for its community, such as by 

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1 gional hospital preparedness established under 

2 section 319C–2 or 319C–3. 

3 ‘‘(3) MAJOR TRAUMA.—The term ‘major trau4 ma’ means an injury that is greater than or equal 

5 to 15 on the injury severity score. 

6 ‘‘(4) MILITARY TRAUMA TEAM.—The term 

7 ‘military trauma team’ means a complete military 

8 trauma team consisting of military trauma care pro9 viders. 

10 ‘‘(5) MILITARY TRAUMA CARE PROVIDER.—The 

11 term ‘military trauma care provider’ means a mem12 ber of the Armed Forces who furnishes emergency, 

13 critical care, and other trauma acute care services 

14 (including a physician, surgeon, physician assistant, 

15 nurse, nurse practitioner, respiratory therapist, 

16 flight paramedic, combat medic, or enlisted medical 

17 technician) or other military trauma care provider as 

18 the Secretary determines appropriate. 

19 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To 

20 carry out this section, there are authorized to be appro21 priated $11,500,000 for each of fiscal years 2019 through 

22 2023.’’. 


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1 SEC. 205. PUBLIC HEALTH AND HEALTH CARE SYSTEM SIT2 UATIONAL AWARENESS AND BIOSURVEIL3 LANCE CAPABILITIES. 

4 (a) FACILITIES, CAPACITIES, AND BIOSURVEILLANCE

5 CAPABILITIES.—Section 319D (42 U.S.C. 247d–4) is 

6 amended— 

7 (1) in the section heading, by striking ‘‘REVI8 TALIZING’’ and inserting ‘‘FACILITIES AND CA9 PACITIES OF’’; 

10 (2) in subsection (a)— 

11 (A) in the subsection heading, by striking 

12 ‘‘FACILITIES; CAPACITIES’’ and inserting ‘‘IN

13 GENERAL’’; 

14 (B) in paragraph (1), by striking ‘‘and im15 proved’’ and inserting ‘‘, improved, and appro16 priately maintained’’; 

17 (C) in paragraph (3), in the matter pre18 ceding subparagraph (A), by striking ‘‘expand, 

19 enhance, and improve’’ and inserting ‘‘expand, 

20 improve, enhance, and appropriately maintain’’; 

21 and 

22 (D) by adding at the end the following: 

23 ‘‘(4) STUDY OF RESOURCES FOR FACILITIES

24 AND CAPACITIES.—Not later than June 1, 2022, the 

25 Comptroller General of the United States shall con26 duct a study on Federal spending in fiscal years 


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1 2013 through 2018 for activities authorized under 

2 this subsection. Such study shall include a review 

3 and assessment of obligations and expenditures di4 rectly related to each activity under paragraphs (2) 

5 and (3), including a specific accounting of, and de6 lineation between, obligations and expenditures in7 curred for the construction, renovation, equipping, 

8 and security upgrades of facilities and associated 

9 contracts under this subsection, and the obligations 

10 and expenditures incurred to establish and improve 

11 the situational awareness and biosurveillance net12 work under subsection (b), and shall identify the 

13 agency or agencies incurring such obligations and 

14 expenditures.’’; 

15 (3) in subsection (b)— 

16 (A) in the subsection heading, by striking 

17 ‘‘NATIONAL’’ and inserting ‘‘ESTABLISHMENT

18 OF SYSTEMS OF PUBLIC HEALTH’’; 

19 (B) in paragraph (1)(B), by inserting ‘‘im20 munization information systems,’’ after ‘‘cen21 ters,’’; and 

22 (C) in paragraph (2)— 

23 (i) by inserting ‘‘develop a plan to, 

24 and’’ after ‘‘The Secretary shall’’; and 


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1 (ii) by inserting ‘‘and in a form read2 ily usable for analytical approaches’’ after 

3 ‘‘in a secure manner’’; and 

4 (D) by amending paragraph (3) to read as 

5 follows: 

6 ‘‘(3) STANDARDS.— 

7 ‘‘(A) IN GENERAL.—Not later than 1 year 

8 after the date of the enactment of the Pan9 demic and All-Hazards Preparedness and Ad10 vancing Innovation Act of 2018, the Secretary, 

11 in cooperation with health care providers, State, 

12 local, tribal, and territorial public health offi13 cials, and relevant Federal agencies (including 

14 the Office of the National Coordinator for 

15 Health Information Technology and the Na16 tional Institute of Standards and Technology), 

17 shall, as necessary, adopt technical and report18 ing standards, including standards for inter19 operability as defined by section 3000, for net20 works under paragraph (1) and update such 

21 standards as necessary. Such standards shall be 

22 made available on the internet website of the 

23 Department of Health and Human Services, in 

24 a manner that does not compromise national se25 curity. 


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1 ‘‘(B) DEFERENCE TO STANDARDS DEVEL2 OPMENT ORGANIZATIONS.—In adopting and im3 plementing standards under this subsection and 

4 subsection (c), the Secretary shall give def5 erence to standards published by standards de6 velopment organizations and voluntary con7 sensus-based standards entities.’’; 

8 (4) in subsection (c)— 

9 (A) in paragraph (1)— 

10 (i) by striking ‘‘Not later than 2 years 

11 after the date of enactment of the Pan12 demic and All-Hazards Preparedness Re13 authorization Act of 2013, the Secretary’’ 

14 and inserting ‘‘The Secretary’’; 

15 (ii) by inserting ‘‘, and improve as ap16 plicable and appropriate,’’ after ‘‘shall es17 tablish’’; 

18 (iii) by striking ‘‘of rapid’’ and insert19 ing ‘‘of, rapid’’; and 

20 (iv) by striking ‘‘such connectivity’’ 

21 and inserting ‘‘such interoperability’’; 

22 (B) by amending paragraph (2) to read as 

23 follows: 


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1 ‘‘(2) COORDINATION AND CONSULTATION.—In 

2 establishing and improving the network under para3 graph (1) the Secretary shall— 

4 ‘‘(A) facilitate coordination among agencies 

5 within the Department of Health and Human 

6 Services that provide, or have the potential to 

7 provide, information and data to, and analyses 

8 for, the situational awareness and biosurveil9 lance network under paragraph (1), including 

10 coordination among relevant agencies related to 

11 health care services, the facilitation of health 

12 information exchange (including the Office of 

13 the National Coordinator for Health Informa14 tion Technology), and public health emergency 

15 preparedness and response; and 

16 ‘‘(B) consult with the Secretary of Agri17 culture, the Secretary of Commerce (and the 

18 Director of the National Institute of Standards 

19 and Technology), the Secretary of Defense, the 

20 Secretary of Homeland Security, the Secretary 

21 of Veterans Affairs, and the heads of other 

22 Federal agencies, as the Secretary determines 

23 appropriate.’’; 

24 (C) in paragraph (3)— 


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1 (i) by redesignating subparagraphs 

2 (A) through (E) as clauses (i) through (v), 

3 respectively, and adjusting the margins ac4 cordingly; 

5 (ii) in clause (iv), as so redesig6 nated— 

7 (I) by inserting ‘‘immunization 

8 information systems,’’ after ‘‘poison 

9 control,’’; and 

10 (II) by striking ‘‘and clinical lab11 oratories’’ and inserting ‘‘, clinical 

12 laboratories, and public environmental 

13 health agencies’’; 

14 (iii) by striking ‘‘The network’’ and 

15 inserting the following: 

16 ‘‘(A) IN GENERAL.—The network’’; and 

17 (iv) by adding at the end the fol18 lowing: 

19 ‘‘(B) REVIEW.—Not later than 2 years 

20 after the date of the enactment of the Pan21 demic and All-Hazards Preparedness and Ad22 vancing Innovation Act of 2018 and every 6 

23 years thereafter, the Secretary shall conduct a 

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1 sion of the addition of any elements pursuant to 

2 clause (v), including elements added to advanc3 ing new technologies, and identify any chal4 lenges in the incorporation of elements under 

5 subparagraph (A). The Secretary shall provide 

6 such review to the congressional committees of 

7 jurisdiction.’’; 

8 (D) in paragraph (5)— 

9 (i) by redesignating subparagraphs 

10 (A) through (D) as clauses (i) through 

11 (iv), respectively, and adjusting the mar12 gins accordingly; 

13 (ii) by striking ‘‘In establishing’’ and 

14 inserting the following: 

15 ‘‘(A) IN GENERAL.—In establishing’’; 

16 (iii) by adding at the end the fol17 lowing: 

18 ‘‘(B) PUBLIC MEETING.— 

19 ‘‘(i) IN GENERAL.—Not later than 

20 180 days after the date of enactment of 

21 the Pandemic and All-Hazards Prepared22 ness and Advancing Innovation Act of 

23 2018, the Secretary shall convene a public 

24 meeting for purposes of discussing and 

25 providing input on the potential goals, 


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1 functions, and uses of the network de2 scribed in paragraph (1) and incorporating 

3 the elements described in paragraph 

4 (3)(A). 

5 ‘‘(ii) EXPERTS.—The public meeting 

6 shall include representatives of relevant 

7 Federal agencies (including representatives 

8 from the Office of the National Coordi9 nator for Health Information Technology 

10 and the National Institute of Standards 

11 and Technology); State, local, tribal, and 

12 territorial public health officials; stake13 holders with expertise in biosurveillance 

14 and situational awareness; stakeholders 

15 with expertise in capabilities relevant to 

16 biosurveillance and situational awareness, 

17 such as experts in informatics and data 

18 analytics (including experts in prediction, 

19 modeling, or forecasting); and other rep20 resentatives as the Secretary determines 

21 appropriate. 

22 ‘‘(iii) TOPICS.—Such public meeting 

23 shall include a discussion of— 

24 ‘‘(I) data elements, including 

25 minimal or essential data elements, 


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1 that are voluntarily provided for such 

2 network, which may include elements 

3 from public health and public and pri4 vate health care entities, to the extent 

5 practicable; 

6 ‘‘(II) standards and implementa7 tion specifications that may improve 

8 the collection, analysis, and interpre9 tation of data during a public health 

10 emergency; 

11 ‘‘(III) strategies to encourage the 

12 access, exchange, and use of informa13 tion; 

14 ‘‘(IV) considerations for State, 

15 local, tribal, and territorial capabilities 

16 and infrastructure related to data ex17 change and interoperability; 

18 ‘‘(V) privacy and security protec19 tions provided at the Federal, State, 

20 local, tribal, and territorial levels, and 

21 by nongovernmental stakeholders; and 

22 ‘‘(VI) opportunities for the incor23 poration of innovative technologies to 

24 improve the network.’’; and 


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1 (iv) in subparagraph (A), as so des2 ignated by clause (ii)— 

3 (I) in clause (i), as so redesig4 nated— 

5 (aa) by striking ‘‘as deter6 mined’’ and inserting ‘‘as adopt7 ed’’; and 

8 (bb) by inserting ‘‘and the 

9 National Institute of Standards 

10 and Technology’’ after ‘‘Office of 

11 the National Coordinator for 

12 Health Information Technology’’; 

13 (II) in clause (iii), as so redesig14 nated, by striking ‘‘; and’’ and insert15 ing a semicolon; 

16 (III) in clause (iv), as so redesig17 nated, by striking the period and in18 serting ‘‘; and’’; and 

19 (IV) by adding at the end the fol20 lowing: 

21 ‘‘(v) pilot test standards and imple22 mentation specifications, consistent with 

23 the process described in section 

24 3002(b)(3)(C), which State, local, tribal, 

25 and territorial public health entities may 


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1 utilize, on a voluntary basis, as a part of 

2 the network.’’; 

3 (E) by redesignating paragraph (6) as 

4 paragraph (7); 

5 (F) by inserting after paragraph (5) the 

6 following: 

7 ‘‘(6) STRATEGY AND IMPLEMENTATION

8 PLAN.— 

9 ‘‘(A) IN GENERAL.—Not later than 18 

10 months after the date of enactment of the Pan11 demic and All-Hazards Preparedness and Ad12 vancing Innovation Act of 2018, the Secretary 

13 shall submit to the congressional committees of 

14 jurisdiction a coordinated strategy and an ac15 companying implementation plan that— 

16 ‘‘(i) is informed by the public meeting 

17 under paragraph (5)(B); 

18 ‘‘(ii) includes a review and assessment 

19 of existing capabilities of the network and 

20 related infrastructure, including input pro21 vided by the public meeting under para22 graph (5)(B); 

23 ‘‘(iii) identifies and demonstrates the 

24 measurable steps the Secretary will carry 

25 out to— 


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1 ‘‘(I) develop, implement, and 

2 evaluate the network described in 

3 paragraph (1), utilizing elements de4 scribed in paragraph (3)(A); 

5 ‘‘(II) modernize and enhance bio6 surveillance activities, including strat7 egies to include innovative tech8 nologies and analytical approaches 

9 (including prediction and forecasting 

10 for pandemics and all-hazards) from 

11 public and private entities; 

12 ‘‘(III) improve information shar13 ing, coordination, and communication 

14 among disparate biosurveillance sys15 tems supported by the Department of 

16 Health and Human Services, includ17 ing the identification of methods to 

18 improve accountability, better utilize 

19 resources and workforce capabilities, 

20 and incorporate innovative tech21 nologies within and across agencies; 

22 and 

23 ‘‘(IV) test and evaluate capabili24 ties of the interoperable network of 


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1 systems to improve situational aware2 ness and biosurveillance capabilities; 

3 ‘‘(iv) includes performance measures 

4 and the metrics by which performance 

5 measures will be assessed with respect to 

6 the measurable steps under clause (iii); 

7 and 

8 ‘‘(v) establishes dates by which each 

9 measurable step under clause (iii) will be 

10 implemented. 

11 ‘‘(B) ANNUAL BUDGET PLAN.—Not later 

12 than 2 years after the date of enactment of the 

13 Pandemic and All-Hazards Preparedness and 

14 Advancing Innovation Act of 2018 and on an 

15 annual basis thereafter, in accordance with the 

16 strategy and implementation plan under this 

17 paragraph, the Secretary shall, taking into ac18 count recommendations provided by the Na19 tional Biodefense Science Board, develop a 

20 budget plan based on the strategy and imple21 mentation plan under this section. Such budget 

22 plan shall include— 

23 ‘‘(i) a summary of resources pre24 viously expended to establish, improve, and 

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1 tional awareness and biosurveillance net2 work under paragraph (1); 

3 ‘‘(ii) estimates of costs and resources 

4 needed to establish and improve the net5 work under paragraph (1) according to the 

6 strategy and implementation plan under 

7 subparagraph (A); 

8 ‘‘(iii) the identification of gaps and in9 efficiencies in nationwide public health sit10 uational awareness and biosurveillance ca11 pabilities, resources, and authorities need12 ed to address such gaps; and 

13 ‘‘(iv) a strategy to minimize and ad14 dress such gaps and improve inefficien15 cies.’’; 

16 (G) in paragraph (7), as so redesignated— 

17 (i) in subparagraph (A), by inserting 

18 ‘‘(taking into account zoonotic disease, in19 cluding gaps in scientific understanding of 

20 the interactions between human, animal, 

21 and environmental health)’’ after ‘‘human 

22 health’’; 

23 (ii) in subparagraph (B)— 


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1 (I) by inserting ‘‘and gaps in sur2 veillance programs’’ after ‘‘surveil3 lance programs’’; and 

4 (II) by striking ‘‘; and’’ and in5 serting a semicolon; 

6 (iii) in subparagraph (C)— 

7 (I) by inserting ‘‘, animal health 

8 organizations related to zoonotic dis9 ease,’’ after ‘‘health care entities’’; 

10 and 

11 (II) by striking the period and 

12 inserting ‘‘; and’’; and 

13 (iv) by adding at the end the fol14 lowing: 

15 ‘‘(D) provide recommendations to the Sec16 retary on policies and procedures to complete 

17 the steps described in this paragraph in a man18 ner that is consistent with section 2802.’’; and 

19 (H) by adding at the end the following: 

20 ‘‘(8) SITUATIONAL AWARENESS AND BIO21 SURVEILLANCE AS A NATIONAL SECURITY PRI22 ORITY.—The Secretary, on a periodic basis as appli23 cable and appropriate, shall meet with the Director 

24 of National Intelligence to inform the development 


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1 and capabilities of the nationwide public health situ2 ational awareness and biosurveillance network.’’; 

3 (5) in subsection (d)— 

4 (A) in paragraph (1)— 

5 (i) by inserting ‘‘environmental health 

6 agencies,’’ after ‘‘public health agencies,’’; 

7 and 

8 (ii) by inserting ‘‘immunization pro9 grams,’’ after ‘‘poison control centers,’’; 

10 and 

11 (B) in paragraph (2)— 

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

13 ‘‘and’’ at the end; 

14 (ii) in subparagraph (C), by striking 

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

16 (iii) by adding after subparagraph (C) 

17 the following: 

18 ‘‘(D) an implementation plan that may in19 clude measurable steps to achieve the purposes 

20 described in paragraph (1).’’; and 

21 (C) by striking paragraph (5) and insert22 ing the following: 

23 ‘‘(5) TECHNICAL ASSISTANCE.—The Secretary 

24 may provide technical assistance to States, localities, 

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1 calities, tribes, and territories receiving an award 

2 under this subsection regarding interoperability and 

3 the technical standards set forth by the Secretary.’’; 

4 (6) by redesignating subsections (f) and (g) as 

5 subsections (i) and (j), respectively; and 

6 (7) by inserting after subsection (e) the fol7 lowing: 

8 ‘‘(f) PERSONNEL AUTHORITIES.— 

9 ‘‘(1) SPECIALLY QUALIFIED PERSONNEL.—In 

10 addition to any other personnel authorities, to carry 

11 out subsections (b) and (c), the Secretary may— 

12 ‘‘(A) appoint highly qualified individuals to 

13 scientific or professional positions at the Cen14 ters for Disease Control and Prevention, not to 

15 exceed 30 such employees at any time (specific 

16 to positions authorized by this subsection), with 

17 expertise in capabilities relevant to biosurveil18 lance and situational awareness, such as experts 

19 in informatics and data analytics (including ex20 perts in prediction, modeling, or forecasting), 

21 and other related scientific or technical fields; 

22 and 

23 ‘‘(B) compensate individuals appointed 

24 under subparagraph (A) in the same manner 

25 and subject to the same terms and conditions in 


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1 which individuals appointed under 9903 of title 

2 5, United States Code, are compensated, with3 out regard to the provisions of chapter 51 and 

4 subchapter III of chapter 53 of such title relat5 ing to classification and General Schedule pay 

6 rates. 

7 ‘‘(2) LIMITATIONS.—The Secretary shall exer8 cise the authority under paragraph (1) in a manner 

9 that is consistent with the limitations described in 

10 section 319F–1(e)(2). 

11 ‘‘(g) TIMELINE.—The Secretary shall accomplish the 

12 purposes under subsections (b) and (c) no later than Sep13 tember 30, 2023, and shall provide a justification to the 

14 congressional committees of jurisdiction for any missed or 

15 delayed implementation of measurable steps identified 

16 under subsection (c)(6)(A)(iii). 

17 ‘‘(h) INDEPENDENT EVALUATION.—Not later than 3 

18 years after the date of enactment of the Pandemic and 

19 All-Hazards Preparedness and Advancing Innovation Act 

20 of 2018, the Comptroller General of the United States 

21 shall conduct an independent evaluation and submit to the 

22 Secretary and the congressional committees of jurisdiction 

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1 plicable and appropriate, on necessary improvements to 

2 the biosurveillance and situational awareness network.’’. 

3 (b) AUTHORIZATION OF APPROPRIATIONS.—Sub4 section (i) of section 319D (42 U.S.C. 247d–4), as redes5 ignated by subsection (a)(6), is amended by striking 

6 ‘‘$138,300,000 for each of fiscal years 2014 through 

7 2018’’ and inserting ‘‘$161,800,000 for each of fiscal 

8 years 2019 through 2023’’. 

9 (c) BIOLOGICAL THREAT DETECTION REPORT.—The 

10 Secretary of Health and Human Services shall, in coordi11 nation with the Secretary of Defense and the Secretary 

12 of Homeland Security, not later than 180 days after the 

13 date of enactment of this Act, report to the Committee 

14 on Energy and Commerce, the Committee on Armed Serv15 ices, and the Committee on Homeland Security of the 

16 House of Representatives and the Committee on Health, 

17 Education, Labor, and Pensions, the Committee on Armed 

18 Services, and the Committee on Homeland Security and 

19 Governmental Affairs of the Senate on the state of Fed20 eral biological threat detection efforts, including the fol21 lowing— 

22 (1) an identification of technological, oper23 ational, and programmatic successes and failures of 

24 domestic detection programs supported by Federal 

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1 duced or accidentally-released biological threat 

2 agents and naturally occurring infectious diseases; 

3 (2) a description of Federal efforts to facilitate 

4 the exchange of information related to the informa5 tion described in paragraph (1) among Federal de6 partments and agencies that utilize biological threat 

7 detection technology; 

8 (3) a description of the capabilities of detection 

9 systems in use by Federal departments and agencies 

10 including the capability to— 

11 (A) rapidly detect, identify, characterize, 

12 and confirm the presence of biological threat 

13 agents; 

14 (B) recover live biological agents from col15 lection devices; 

16 (C) determine the geographical distribution 

17 of biological agents; 

18 (D) determine the extent of environmental 

19 contamination and persistence of biological 

20 agents; and 

21 (E) provide advanced molecular diagnostics 

22 to State, local, tribal, and territorial public 

23 health and other laboratories that support bio24 logical threat detection activities; 


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1 (4) a description of Federal interagency coordi2 nation related to biological threat detection; 

3 (5) a description of efforts by Federal depart4 ments and agencies that utilize biological threat de5 tection technology to collaborate with State, local, 

6 tribal, and territorial public health laboratories and 

7 other users of biological threat detection systems, in8 cluding collaboration regarding the development of— 

9 (A) biological threat detection require10 ments or standards; 

11 (B) a standardized integration strategy; 

12 (C) training requirements or guidelines; 

13 (D) guidelines for a coordinated public 

14 health response, including preparedness capa15 bilities, and, as applicable, for coordination with 

16 public health surveillance systems; and 

17 (E) a coordinated environmental remedi18 ation plan, as applicable; and 

19 (6) recommendations related to research, ad20 vanced research, development, and procurement for 

21 Federal departments and agencies to improve and 

22 enhance biological threat detection systems, includ23 ing recommendations on the transfer of biological 

24 threat detection technology among Federal depart25 ments and agencies, as necessary and appropriate. 


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1 SEC. 206. STRENGTHENING AND SUPPORTING THE PUBLIC 

2 HEALTH EMERGENCY RAPID RESPONSE 

3 FUND. 

4 Section 319 (42 U.S.C. 247d) is amended— 

5 (1) in subsection (b)— 

6 (A) in paragraph (1)— 

7 (i) in the first sentence, by inserting 

8 ‘‘or if the Secretary determines there is the 

9 significant potential for a public health 

10 emergency, to allow the Secretary to rap11 idly respond to the immediate needs result12 ing from such public health emergency or 

13 potential public health emergency’’ before 

14 the period; and 

15 (ii) by inserting ‘‘The Secretary shall 

16 plan for the expedited distribution of funds 

17 to appropriate agencies and entities.’’ after 

18 the first sentence; 

19 (B) by redesignating paragraph (2) as 

20 paragraph (3); 

21 (C) by inserting after paragraph (1) the 

22 following: 

23 ‘‘(2) USES.—The Secretary may use amounts 

24 in the Fund established under paragraph (1), to— 

25 ‘‘(A) facilitate coordination between and 

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1 torial entities and public and private health 

2 care entities that the Secretary determines may 

3 be affected by a public health emergency or po4 tential public health emergency referred to in 

5 paragraph (1) (including communication of 

6 such entities with relevant international enti7 ties, as applicable); 

8 ‘‘(B) make grants, provide for awards, 

9 enter into contracts, and conduct supportive in10 vestigations pertaining to a public health emer11 gency or potential public health emergency, in12 cluding further supporting programs under sec13 tion 319C–1, 319C–2, or 319C–3; 

14 ‘‘(C) facilitate and accelerate, as applica15 ble, advanced research and development of secu16 rity countermeasures (as defined in section 

17 319F–2), qualified countermeasures (as defined 

18 in section 319F–1), or qualified pandemic or 

19 epidemic products (as defined in section 319F– 

20 3), that are applicable to the public health 

21 emergency or potential public health emergency 

22 under paragraph (1); 

23 ‘‘(D) strengthen biosurveillance capabilities 

24 and laboratory capacity to identify, collect, and 

25 analyze information regarding such public 


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1 health emergency or potential public health 

2 emergency, including the systems under section 

3 319D; 

4 ‘‘(E) support initial emergency operations 

5 and assets related to preparation and deploy6 ment of intermittent disaster response per7 sonnel under section 2812 and the Medical Re8 serve Corps under section 2813; and 

9 ‘‘(F) carry out other activities, as the Sec10 retary determines applicable and appropriate.’’; 

11 and 

12 (D) by inserting after paragraph (3), as so 

13 redesignated, the following: 

14 ‘‘(4) REVIEW.—Not later than 2 years after the 

15 date of enactment of the Pandemic and All-Hazards 

16 Preparedness and Advancing Innovation Act of 

17 2018, the Secretary, in coordination with the Assist18 ant Secretary for Preparedness and Response, shall 

19 conduct a review of the Fund under this section and 

20 provide recommendations to the Committee on 

21 Health, Education, Labor, and Pensions and the 

22 Committee on Appropriations of the Senate and the 

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1 atives on policies to improve such Fund for the uses 

2 described in paragraph (2). 

3 ‘‘(5) GAO REPORT.—Not later than 4 years 

4 after the date of enactment of the Pandemic and 

5 All-Hazards Preparedness and Advancing Innovation 

6 Act of 2018, the Comptroller General of the United 

7 States shall— 

8 ‘‘(A) conduct a review of the Fund under 

9 this section, including its uses and the re10 sources available in the Fund; and 

11 ‘‘(B) submit to the Committee on Health, 

12 Education, Labor, and Pensions of the Senate 

13 and the Committee on Energy and Commerce 

14 of the House of Representatives a report on 

15 such review, including recommendations related 

16 to such review, as applicable.’’; and 

17 (2) in subsection (c)— 

18 (A) by inserting ‘‘rapidly respond to public 

19 health emergencies or potential public health 

20 emergencies and’’ after ‘‘used to’’; and 

21 (B) by striking ‘‘section.’’ and inserting 

22 ‘‘Act or funds otherwise provided for emergency 

23 response.’’. 


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1 SEC. 207. IMPROVING ALL-HAZARDS PREPAREDNESS AND 

2 RESPONSE BY PUBLIC HEALTH EMERGENCY 

3 VOLUNTEERS. 

4 (a) IN GENERAL.—Section 319I (42 U.S.C. 247d– 

5 7b) is amended— 

6 (1) in the section heading, by striking 

7 ‘‘HEALTH PROFESSIONS VOLUNTEERS’’ and in8 serting ‘‘VOLUNTEER HEALTH PROFESSIONAL’’; 

9 (2) in subsection (a), by adding at the end the 

10 following: ‘‘Such health care professionals may in11 clude members of the National Disaster Medical 

12 System, members of the Medical Reserve Corps, and 

13 individual health care professionals.’’; 

14 (3) in subsection (i) by adding at the end ‘‘In 

15 order to inform the development of such mechanisms 

16 by States, the Secretary shall make available infor17 mation and material provided by States that have 

18 developed mechanisms to waive the application of li19 censing requirements to applicable health profes20 sionals seeking to provide medical services during a 

21 public health emergency. Such information shall be 

22 made publicly available in a manner that does not 

23 compromise national security.’’; and 

24 (4) in subsection (k) by striking ‘‘2014 through 

25 2018’’ and inserting ‘‘2019 through 2023’’. 


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1 (b) ALL-HAZARDS PUBLIC HEALTH EMERGENCY

2 PREPAREDNESS AND RESPONSE PLAN.—Section 319C– 

3 1(b)(2)(A)(iv) (42 U.S.C. 247d–3a(b)(2)(A)(iv)) is 

4 amended to read as follows: 

5 ‘‘(iv) a description of the mechanism the 

6 entity will implement to utilize the Emergency 

7 Management Assistance Compact, or other mu8 tual aid agreement, for medical and public 

9 health mutual aid, and, as appropriate, the ac10 tivities such entity will implement pursuant to 

11 section 319I to improve enrollment and coordi12 nation of volunteer health care professionals 

13 seeking to provide medical services during a 

14 public health emergency, which may include— 

15 ‘‘(I) providing a public method of 

16 communication for purposes of volunteer 

17 coordination (such as a phone number); 

18 ‘‘(II) providing for optional registra19 tion to participate in volunteer services 

20 during processes related to State medical 

21 licensing, registration, or certification or 

22 renewal of such licensing, registration or 

23 certification; or 

24 ‘‘(III) other mechanisms as the State 

25 determines appropriate;’’. 


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1 SEC. 208. CLARIFYING STATE LIABILITY LAW FOR VOLUN2 TEER HEALTH CARE PROFESSIONALS. 

3 (a) IN GENERAL.—Title II (42 U.S.C. 202 et seq.) 

4 is amended by inserting after section 224 the following: 

5 ‘‘SEC. 225. HEALTH CARE PROFESSIONALS ASSISTING DUR6 ING A PUBLIC HEALTH EMERGENCY. 

7 ‘‘(a) LIMITATION ON LIABILITY.—Notwithstanding 

8 any other provision of law, a health care professional who 

9 is a member of the Medical Reserve Corps under section 

10 2813 or who is included in the Emergency System for Ad11 vance Registration of Volunteer Health Professionals 

12 under section 319I and who— 

13 ‘‘(1) is responding— 

14 ‘‘(A) to a public health emergency deter15 mined under section 319(a), during the initial 

16 period of not more than 90 days (as determined 

17 by the Secretary) of the public health emer18 gency determination (excluding any period cov19 ered by a renewal of such determination); or 

20 ‘‘(B) to a major disaster or an emergency 

21 as declared by the President under section 401 

22 of the Robert T. Stafford Disaster Relief and 

23 Emergency Assistance Act (42 U.S.C. 5170) or 

24 under section 201 of the National Emergencies 

25 Act (50 U.S.C.1621) during the initial period of 

26 such declaration; and 


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1 ‘‘(2) is alleged to be liable for an act or omis2 sion— 

3 ‘‘(A) during the initial period of a deter4 mination or declaration described in paragraph 

5 (1) and related to the treatment of individuals 

6 in need of health care services due to such pub7 lic health emergency, major disaster, or emer8 gency; 

9 ‘‘(B) in the State or States for which such 

10 determination or declaration is made; 

11 ‘‘(C) in the health care professional’s ca12 pacity as a member of the Medical Reserve 

13 Corps or a professional included in the Emer14 gency System for Advance Registration of Vol15 unteer Health Professionals under section 319I; 

16 and 

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

18 that are within the scope of the license, reg19 istration, or certification of the professional, as 

20 defined by the State of licensure, registration, 

21 or certification; and 

22 ‘‘(3) prior to the rendering of such act or omis23 sion, was authorized by the State’s authorization of 

24 deploying such State’s Emergency System for Ad25 vance Registration of Volunteer Health Professionals 


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1 described in section 319I or the Medical Reserve 

2 Corps established under section 2813, to provide 

3 health care services, 

4 shall be subject only to the State liability laws of the State 

5 in which such act or omission occurred, in the same man6 ner and to the same extent as a similar health care profes7 sional who is a resident of such State would be subject 

8 to such State laws, except with respect to the licensure, 

9 registration, and certification of such individual. 

10 ‘‘(b) VOLUNTEER PROTECTION ACT.—Nothing in 

11 this section shall be construed to affect an individual’s 

12 right to protections under the Volunteer Protection Act 

13 of 1997. 

14 ‘‘(c) PREEMPTION.—This section shall supersede the 

15 laws of any State that would subject a health care profes16 sional described in subsection (a) to the liability laws of 

17 any State other than the State liability laws to which such 

18 individual is subject pursuant to such subsection. 

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

20 ‘‘(1) The term ‘health care professional’ means 

21 an individual licensed, registered, or certified under 

22 Federal or State laws or regulations to provide 

23 health care services. 

24 ‘‘(2) The term ‘health care services’ means any 

25 services provided by a health care professional, or by 


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1 any individual working under the supervision of a 

2 health care professional, that relate to— 

3 ‘‘(A) the diagnosis, prevention, or treat4 ment of any human disease or impairment; or 

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

6 of human beings. 

7 ‘‘(e) EFFECTIVE DATE.— 

8 ‘‘(1) IN GENERAL.—This section shall take ef9 fect 90 days after the date of the enactment of the 

10 Pandemic and All-Hazards Preparedness and Ad11 vancing Innovation Act of 2018. 

12 ‘‘(2) APPLICATION.—This section shall apply to 

13 a claim for harm only if the act or omission that 

14 caused such harm occurred on or after the effective 

15 date described in paragraph (1).’’. 

16 (b) GAO STUDY.—Not later than one year after the 

17 date of enactment of this Act, the Comptroller General 

18 of the United States shall conduct a review of— 

19 (1) the number of health care providers who 

20 register under the Emergency System for Advance 

21 Registration of Volunteer Health Professionals 

22 under section 319I of the Public Health Service Act 

23 (42 U.S.C. 247d–7b) in advance to provide services 

24 during a public health emergency; 


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1 (2) the number of health care providers who are 

2 credentialed to provide services during the period of 

3 a public health emergency declaration, including 

4 those who are credentialed though programs estab5 lished in the Emergency System for Advance Reg6 istration of Volunteer Health Professionals under 

7 such section 319I and those credentialed by authori8 ties within the State in which the emergency oc9 curred; 

10 (3) the average time to verify the credentials of 

11 a health care provider during the period of a public 

12 health emergency declaration, including the average 

13 time pursuant to the Emergency System for Ad14 vance Registration of Volunteer Health Professionals 

15 under such section 319I and for an individual’s cre16 dentials to be verified by an authority within the 

17 State; and 

18 (4) the Emergency System for Advance Reg19 istration of Volunteer Health Professionals program 

20 in States, including whether physician or medical 

21 groups, associations, or other relevant provider orga22 nizations utilize such program for purposes of volun23 teering during public health emergencies. 


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1 SEC. 209. REPORT ON ADEQUATE NATIONAL BLOOD SUP2 PLY. 

3 Not later than 1 year after the date of the enactment 

4 of this Act, the Secretary of Health and Human Services 

5 shall submit to Congress a report containing recommenda6 tions related to maintaining an adequate national blood 

7 supply, including— 

8 (1) challenges associated with the continuous 

9 recruitment of blood donors (including those newly 

10 eligible to donate); 

11 (2) ensuring the adequacy of the blood supply 

12 in the case of public health emergencies; 

13 (3) implementation of the transfusion trans14 mission monitoring system; and 

15 (4) other measures to promote safety and inno16 vation, such as the development, use, or implementa17 tion of new technologies, processes, and procedures 

18 to improve the safety and reliability of the blood 

19 supply. 

20 SEC. 210. REPORT ON THE PUBLIC HEALTH PREPARED21 NESS AND RESPONSE CAPABILITIES AND CA22 PACITIES OF HOSPITALS, LONG-TERM CARE 

23 FACILITIES, AND OTHER HEALTH CARE FA24 CILITIES. 

25 (a) STUDY.— 


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1 (1) IN GENERAL.—Not later than one year 

2 after the date of enactment of this Act, the Sec3 retary of Health and Human Services shall enter 

4 into an agreement with an appropriate entity to con5 duct a study regarding the public health prepared6 ness and response capabilities and medical surge ca7 pacities of hospitals, long-term care facilities, and 

8 other health care facilities to prepare for, and re9 spond to, public health emergencies, including nat10 ural disasters. 

11 (2) CONSULTATION.—In conducting the study 

12 under paragraph (1), the entity shall consult with 

13 Federal, State, local, tribal, and territorial public 

14 health officials (as appropriate), and health care 

15 providers and facilities with experience in public 

16 health preparedness and response activities. 

17 (3) EVALUATION.—The study under paragraph 

18 (1) shall include— 

19 (A) an evaluation of the current bench20 marks and objective standards, as applicable, 

21 related to programs that support hospitals, 

22 long-term care facilities, and other health care 

23 facilities, and their effect on improving public 

24 health preparedness and response capabilities 

25 and medical surge capacities, including the 


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1 Hospital Preparedness Program, the Public 

2 Health Emergency Preparedness cooperative 

3 agreements, and the Regional Health Care 

4 Emergency Preparedness and Response Sys5 tems under section 319C–3 of the Public 

6 Health Service Act (as added by section 203); 

7 (B) the identification of gaps in prepared8 ness, including with respect to such benchmarks 

9 and objective standards, such as those identified 

10 during recent public health emergencies, for 

11 hospitals, long-term care facilities, and other 

12 health care facilities to address future potential 

13 public health threats; 

14 (C) an evaluation of coordination efforts 

15 between the recipients of Federal funding for 

16 programs described in subparagraph (A) and 

17 entities with expertise in emergency power sys18 tems and other critical infrastructure partners 

19 during a public health emergency, to ensure a 

20 functioning critical infrastructure, to the great21 est extent practicable, during a public health 

22 emergency; 

23 (D) an evaluation of coordination efforts 

24 between the recipients of Federal funding for 

25 programs described in subparagraph (A) and 


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1 environmental health agencies with expertise in 

2 emergency preparedness and response planning 

3 for hospitals, long-term care facilities, and other 

4 health care facilities; and 

5 (E) an evaluation of current public health 

6 preparedness and response capabilities and 

7 medical surge capacities related to at-risk indi8 viduals during public health emergencies, in9 cluding an identification of gaps in such pre10 paredness as they relate to such individuals. 

11 (b) REPORT.— 

12 (1) IN GENERAL.—The agreement under sub13 section (a) shall require the entity to submit to the 

14 Secretary of Health and Human Services and the 

15 congressional committees of jurisdiction, not later 

16 than 3 years after the date of enactment of this Act, 

17 a report on the results of the study conducted pur18 suant to this section. 

19 (2) CONTENTS.—The report under paragraph 

20 (1) shall— 

21 (A) describe the findings and conclusions 

22 of the evaluation conducted pursuant to sub23 section (a); and 

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1 pability and medical surge capacity for hos2 pitals, long-term care facilities, and other health 

3 care facilities, including— 

4 (i) improving the existing benchmarks 

5 and objective standards for the Federal 

6 grant programs described in subsection 

7 (a)(3)(A) or developing new benchmarks 

8 and standards for such programs; and 

9 (ii) identifying best practices for im10 proving public health preparedness and re11 sponse programs and medical surge capac12 ity at hospitals, long-term care facilities, 

13 and other health care facilities, including 

14 recommendations for the evaluation under 

15 subparagraphs (C) and (D) of subsection 

16 (a)(3). 

17 TITLE III—REACHING ALL 

18 COMMUNITIES 

19 SEC. 301. STRENGTHENING AND ASSESSING THE EMER20 GENCY RESPONSE WORKFORCE. 

21 (a) NATIONAL DISASTER MEDICAL SYSTEM.— 

22 (1) STRENGTHENING THE NATIONAL DISASTER

23 MEDICAL SYSTEM.—Clause (ii) of section 

24 2812(a)(3)(A) (42 U.S.C. 300hh–11(a)(3)(A)) is 

25 amended to read as follows: 


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1 ‘‘(ii) be present at locations, and for 

2 limited periods of time, specified by the 

3 Secretary on the basis that the Secretary 

4 has determined that a location is at risk of 

5 a public health emergency during the time 

6 specified, or there is a significant potential 

7 for a public health emergency.’’. 

8 (2) REVIEW OF THE NATIONAL DISASTER MED9 ICAL SYSTEM.—Section 2812(b)(2) (42 U.S.C. 

10 300hh–11(b)(2)) is amended to read as follows: 

11 ‘‘(2) JOINT REVIEW AND MEDICAL SURGE CA12 PACITY STRATEGIC PLAN.— 

13 ‘‘(A) REVIEW.—Not later than 180 days 

14 after the date of enactment of the Pandemic 

15 and All-Hazards Preparedness and Advancing 

16 Innovation Act of 2018, the Secretary, in co17 ordination with the Secretary of Homeland Se18 curity, the Secretary of Defense, and the Sec19 retary of Veterans Affairs, shall conduct a joint 

20 review of the National Disaster Medical System. 

21 Such review shall include— 

22 ‘‘(i) an evaluation of medical surge ca23 pacity, as described in section 2803(a); 

24 ‘‘(ii) an assessment of the available 

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1 sponse personnel described in subsection 

2 (c); 

3 ‘‘(iii) the capacity of the workforce de4 scribed in clause (ii) to respond to all haz5 ards, including capacity to simultaneously 

6 respond to multiple public health emer7 gencies and the capacity to respond to a 

8 nationwide public health emergency; 

9 ‘‘(iv) the effectiveness of efforts to re10 cruit, retain, and train such workforce; and 

11 ‘‘(v) gaps that may exist in such 

12 workforce and recommendations for ad13 dressing such gaps. 

14 ‘‘(B) UPDATES.—As part of the National 

15 Health Security Strategy under section 2802, 

16 the Secretary shall update the findings from the 

17 review under subparagraph (A) and provide rec18 ommendations to modify the policies of the Na19 tional Disaster Medical System as necessary.’’. 

20 (3) NOTIFICATION OF SHORTAGE.—Section 

21 2812(c) (42 U.S.C. 300hh–11(c)) is amended by 

22 adding at the end the following: 

23 ‘‘(3) NOTIFICATION.—Not later than 30 days 

24 after the date on which the Secretary determines the 

25 number of intermittent disaster-response personnel 


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1 of the National Disaster Medical System is insuffi2 cient to address a public health emergency or poten3 tial public health emergency, the Secretary shall sub4 mit to the congressional committees of jurisdiction a 

5 notification detailing— 

6 ‘‘(A) the impact such shortage could have 

7 on meeting public health needs and emergency 

8 medical personnel needs during a public health 

9 emergency; and 

10 ‘‘(B) any identified measures to address 

11 such shortage. 

12 ‘‘(4) CERTAIN APPOINTMENTS.— 

13 ‘‘(A) IN GENERAL.—If the Secretary deter14 mines that the number of intermittent disaster 

15 response personnel within the National Disaster 

16 Medical System under this section is insuffi17 cient to address a public health emergency or 

18 potential public health emergency, the Secretary 

19 may appoint candidates directly to personnel 

20 positions for intermittent disaster response 

21 within such system. The Secretary shall provide 

22 updates on the number of vacant or unfilled po23 sitions within such system to the congressional 

24 committees of jurisdiction each quarter for 

25 which this authority is in effect. 


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1 ‘‘(B) SUNSET.—The authority under this 

2 paragraph shall expire on September 30, 

3 2021.’’. 

4 (4) AUTHORIZATION OF APPROPRIATIONS.— 

5 Section 2812(g) (42 U.S.C. 300hh–11(g)) is amend6 ed by striking ‘‘$52,700,000 for each of fiscal years 

7 2014 through 2018’’ and inserting ‘‘$57,400,000 for 

8 each of fiscal years 2019 through 2023’’. 

9 (b) VOLUNTEER MEDICAL RESERVE CORPS.— 

10 (1) IN GENERAL.—Section 2813(a) (42 U.S.C. 

11 42 U.S.C. 300hh–15(a)) is amended by striking the 

12 second sentence and inserting ‘‘The Secretary may 

13 appoint a Director to head the Corps and oversee 

14 the activities of the Corps chapters that exist at the 

15 State, local, tribal, and territorial levels.’’. 

16 (2) AUTHORIZATION OF APPROPRIATIONS.— 

17 Section 2813(i) (42 U.S.C. 300hh–15(i)) is amended 

18 by striking ‘‘2014 through 2018’’ and inserting 

19 ‘‘2019 through 2023’’. 

20 (c) STRENGTHENING THE EPIDEMIC INTELLIGENCE

21 SERVICE.—Section 317F (42 U.S.C. Sec. 247b–7) is 

22 amended— 

23 (1) in subsection (a)— 

24 (A) in paragraph (1)— 


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1 (i) by inserting ‘‘or preparedness and 

2 response activities, including rapid re3 sponse to public health emergencies and 

4 significant public health threats’’ after 

5 ‘‘conduct prevention activities’’; and 

6 (ii) by striking ‘‘$35,000’’ and insert7 ing ‘‘$50,000’’; and 

8 (B) in paragraph (2)(B), by striking ‘‘3 

9 years’’ and inserting ‘‘2 years’’; and 

10 (2) in subsection (c)— 

11 (A) by striking ‘‘For the purpose of car12 rying out this section’’ and inserting the fol13 lowing: 

14 ‘‘(1) IN GENERAL.—For the purpose of car15 rying out this section, except as described in para16 graph (2)’’; and 

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

18 ‘‘(2) EPIDEMIC INTELLIGENCE SERVICE PRO19 GRAM.—For purposes of carrying out this section 

20 with respect to qualified health professionals serving 

21 in the Epidemic Intelligence Service, as authorized 

22 under section 317G, there are authorized to be ap23 propriated $1,000,000 for each of fiscal years 2019 

24 through 2023.’’. 


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1 (d) SERVICE BENEFIT FOR NATIONAL DISASTER

2 MEDICAL SYSTEM VOLUNTEERS.— 

3 (1) IN GENERAL.—Section 2812(c) (42 U.S.C. 

4 300hh–11(c)), as amended by subsection (a)(3), is 

5 further amended by adding at the end the following: 

6 ‘‘(5) SERVICE BENEFIT.—Individuals appointed 

7 to serve under this subsection shall be considered eli8 gible for benefits under part L of title I of the Om9 nibus Crime Control and Safe Streets Act of 1968. 

10 The Secretary shall provide notification to any eligi11 ble individual of any effect such designation may 

12 have on other benefits for which such individual is 

13 eligible, including benefits from private entities.’’. 

14 (2) PUBLIC SAFETY OFFICER BENEFITS.—Sec15 tion 1204(9) of title I of the Omnibus Crime Control 

16 and Safe Streets Act of 1968 (34 U.S.C. 10284(9)) 

17 is amended— 

18 (A) in subparagraph (C)(ii), by striking 

19 ‘‘or’’ at the end; 

20 (B) in subparagraph (D), by striking the 

21 period and inserting ‘‘; or’’; and 

22 (C) by inserting after subparagraph (D) 

23 the following: 

24 ‘‘(E) an individual appointed to the Na25 tional Disaster Medical System under section 


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1 2812 of the Public Health Service Act (42 

2 U.S.C. 300hh–11) who is performing official 

3 duties of the Department of Health and Human 

4 Services, if those official duties are— 

5 ‘‘(i) related to responding to a public 

6 health emergency or potential public health 

7 emergency, or other activities for which the 

8 Secretary of Health and Human Services 

9 has activated such National Disaster Med10 ical System; and 

11 ‘‘(ii) determined by the Secretary of 

12 Health and Human Services to be haz13 ardous.’’. 

14 (3) SUNSET.—The amendments made by para15 graphs (1) and (2) shall cease to have force or effect 

16 on October 1, 2021. 

17 (e) MISSION READINESS REPORT TO CONGRESS.— 

18 (1) REPORT.—Not later than one year after the 

19 date of enactment of this section, the Comptroller 

20 General of the United States (referred to in this 

21 subsection as the ‘‘Comptroller General’’) shall sub22 mit to the Committee on Health, Education, Labor, 

23 and Pensions of the Senate and the Committee on 

24 Energy and Commerce of the House of Representa25 tives, a report on the medical surge capacity of the 


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1 United States in the event of a public health emer2 gency, including the capacity and capability of the 

3 current health care workforce to prepare for, and re4 spond to the full range of public health emergencies 

5 or potential public health emergencies, and rec6 ommendations to address any gaps identified in such 

7 workforce. 

8 (2) CONTENTS.—The Comptroller General shall 

9 include in the report under paragraph (1)— 

10 (A) the number of health care providers 

11 who have volunteered to provide health care 

12 services during a public health emergency, in13 cluding members of the National Disaster Med14 ical System, the Disaster Medical Assistant 

15 Teams, the Medical Reserve Corps, and other 

16 volunteer health care professionals in the 

17 verification network pursuant to section 319I of 

18 the Public Health Service Act (42 U.S.C. 

19 247d–7b); 

20 (B) the capacity of the workforce described 

21 in subparagraph (A) to respond to a public 

22 health emergency or potential public health 

23 emergency, including the capacity to respond to 

24 multiple concurrent public health emergencies 


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1 and the capacity to respond to a nationwide 

2 public health emergency; 

3 (C) the preparedness and response capa4 bilities and mission readiness of the workforce 

5 described in subparagraph (A) taking into ac6 count areas of health care expertise and consid7 erations for at-risk individuals (as defined in 

8 section 2802(b)(4)(B) of the Public Health 

9 Service Act (42 U.S.C. 300hh–1(b)(4)(B))); 

10 (D) an assessment of the effectiveness of 

11 efforts to recruit, retain, and train such work12 force; and 

13 (E) identification of gaps that may exist in 

14 such workforce and recommendations for ad15 dressing such gaps, the extent to which the As16 sistant Secretary for Preparedness and Re17 sponse plans to address such gaps, and any rec18 ommendations from the Comptroller General to 

19 address such gaps. 

20 SEC. 302. HEALTH SYSTEM INFRASTRUCTURE TO IMPROVE 

21 PREPAREDNESS AND RESPONSE. 

22 (a) COORDINATION OF PREPAREDNESS.—Section 

23 2811(b)(5) (42 U.S.C. 300hh–10(b)(5)) is amended by 

24 adding at the end the following: ‘‘Such logistical support 

25 shall include working with other relevant Federal, State, 


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1 local, tribal, and territorial public health officials and pri2 vate sector entities to identify the critical infrastructure 

3 assets, systems, and networks needed for the proper func4 tioning of the health care and public health sectors that 

5 need to be maintained through any emergency or disaster, 

6 including entities capable of assisting with, responding to, 

7 and mitigating the effect of a public health emergency, 

8 including a public health emergency determined by the 

9 Secretary pursuant to section 319(a) or an emergency or 

10 major disaster declared by the President under the Robert 

11 T. Stafford Disaster Relief and Emergency Assistance Act 

12 or the National Emergencies Act, including by estab13 lishing methods to exchange critical information and de14 liver products consumed or used to preserve, protect, or 

15 sustain life, health, or safety, and sharing of specialized 

16 expertise.’’. 

17 (b) MANUFACTURING CAPACITY.—Section 

18 2811(d)(2)(C) (42 U.S.C. 300hh–10(d)(2)(C)) is amended 

19 by inserting ‘‘, and ancillary medical supplies to assist 

20 with the utilization of such countermeasures or products,’’ 

21 after ‘‘products’’. 

22 (c) EVALUATION OF BARRIERS TO RAPID DELIVERY

23 OF MEDICAL COUNTERMEASURES.— 

24 (1) RAPID DELIVERY STUDY.—The Assistant 

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1 duct a study on issues that have the potential to ad2 versely affect the handling and rapid delivery of 

3 medical countermeasures to individuals during public 

4 health emergencies occurring in the United States. 

5 (2) NOTICE TO CONGRESS.—Not later than 9 

6 months after the date of the enactment of this Act, 

7 the Assistant Secretary for Preparedness and Re8 sponse shall notify the Committee on Energy and 

9 Commerce of the House of Representatives and the 

10 Committee on Health, Education, Labor, and Pen11 sions of the Senate if the Assistant Secretary for 

12 Preparedness and Response does not plan to conduct 

13 the study under paragraph (1) and shall provide 

14 such committees a summary explanation for such de15 cision. 

16 (3) REPORT TO CONGRESS.—Not later than 1 

17 year after the Assistant Secretary for Preparedness 

18 and Response conducts the study under paragraph 

19 (1), such Assistant Secretary shall submit a report 

20 to the Committee on Energy and Commerce of the 

21 House of Representatives and the Committee on 

22 Health, Education, Labor, and Pensions of the Sen23 ate containing the findings of such study. 


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1 SEC. 303. CONSIDERATIONS FOR AT-RISK INDIVIDUALS. 

2 (a) AT-RISK INDIVIDUALS IN THE NATIONAL

3 HEALTH SECURITY STRATEGY.—Section 2802(b)(4)(B) 

4 (42 U.S.C. 300hh–1(b)(4)(B)) is amended— 

5 (1) by striking ‘‘this section and sections 319C– 

6 1, 319F, and 319L,’’ and inserting ‘‘this Act,’’; and 

7 (2) by striking ‘‘special’’ and inserting ‘‘access 

8 or functional’’. 

9 (b) COUNTERMEASURE CONSIDERATIONS.—Section 

10 319L(c)(6) (42 U.S.C. 247d–7e(c)(6)) is amended— 

11 (1) by striking ‘‘elderly’’ and inserting ‘‘older 

12 adults’’; and 

13 (2) by inserting ‘‘with relevant characteristics 

14 that warrant consideration during the process of re15 searching and developing such countermeasures and 

16 products’’ before the period. 

17 (c) BIOSURVEILLANCE OF EMERGING PUBLIC

18 HEALTH THREATS.—Section 2814 is amended— 

19 (1) in paragraph (7), by striking ‘‘; and’’ and 

20 inserting a semicolon; 

21 (2) in paragraph (8), by striking the period and 

22 inserting ‘‘; and’’; and 

23 (3) by adding at the end the following: 

24 ‘‘(9) facilitate coordination to ensure that, in 

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1 retary considers incorporating data and information 

2 from Federal, State, local, tribal, and territorial 

3 public health officials and entities relevant to detect4 ing emerging public health threats that may affect 

5 at-risk individuals, such as pregnant and postpartum 

6 women and infants, including adverse health out7 comes of such populations related to such emerging 

8 public health threats.’’. 

9 SEC. 304. IMPROVING EMERGENCY PREPAREDNESS AND 

10 RESPONSE CONSIDERATIONS FOR CHIL11 DREN. 

12 Part B of title III (42 U.S.C. 243 et seq.) is amended 

13 by inserting after section 319D the following: 

14 ‘‘SEC. 319D–1. CHILDREN’S PREPAREDNESS UNIT. 

15 ‘‘(a) ENHANCING EMERGENCY PREPAREDNESS FOR

16 CHILDREN.—The Secretary, acting through the Director 

17 of the Centers for Disease Control and Prevention (re18 ferred to in this subsection as the ‘Director’), shall main19 tain an internal team of experts, to be known as the Chil20 dren’s Preparedness Unit (referred to in this subsection 

21 as the ‘Unit’), to work collaboratively to provide guidance 

22 on the considerations for, and the specific needs of, chil23 dren before, during, and after public health emergencies. 

24 The Unit shall inform the Director regarding emergency 


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1 preparedness and response efforts pertaining to children 

2 at the Centers for Disease Control and Prevention. 

3 ‘‘(b) EXPERTISE.—The team described in subsection 

4 (a) shall include one or more pediatricians, which may be 

5 a developmental-behavioral pediatrician, and may also in6 clude behavioral scientists, child psychologists, epidemiolo7 gists, biostatisticians, health communications staff, and 

8 individuals with other areas of expertise, as the Secretary 

9 determines appropriate. 

10 ‘‘(c) DUTIES.—The team described in subsection (a) 

11 may— 

12 ‘‘(1) assist State, local, tribal, and territorial 

13 emergency planning and response activities related 

14 to children, which may include developing, identi15 fying, and sharing best practices; 

16 ‘‘(2) provide technical assistance, training, and 

17 consultation to Federal, State, local, tribal, and ter18 ritorial public health officials to improve prepared19 ness and response capabilities with respect to the 

20 needs of children, including providing such technical 

21 assistance, training, and consultation to eligible enti22 ties in order to support the achievement of measur23 able evidence-based benchmarks and objective stand24 ards applicable to sections 319C–1 and 319C–2; 


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1 ‘‘(3) improve the utilization of methods to in2 corporate the needs of children in planning for and 

3 responding to a public health emergency, including 

4 public awareness of such methods; 

5 ‘‘(4) coordinate with, and improve, public-pri6 vate partnerships, such as health care coalitions pur7 suant to sections 319C–2 and 319C–3, to address 

8 gaps and inefficiencies in emergency preparedness 

9 and response efforts for children; 

10 ‘‘(5) provide expertise and input during the de11 velopment of guidance and clinical recommendations 

12 to address the needs of children when preparing for, 

13 and responding to, public health emergencies, includ14 ing pursuant to section 319C–3; and 

15 ‘‘(6) carry out other duties related to prepared16 ness and response activities for children, as the Sec17 retary determines appropriate.’’. 

18 SEC. 305. NATIONAL ADVISORY COMMITTEES ON DISAS19 TERS. 

20 (a) REAUTHORIZING THE NATIONAL ADVISORY COM21 MITTEE ON CHILDREN AND DISASTERS.—Section 2811A 

22 (42 U.S.C. 300hh–10a) is amended— 

23 (1) in subsection (b)(2), by inserting ‘‘, mental 

24 and behavioral,’’ after ‘‘medical’’; 

25 (2) in subsection (d)— 


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1 (A) in paragraph (1), by striking ‘‘15’’ and 

2 inserting ‘‘25’’; and 

3 (B) by striking paragraph (2) and insert4 ing the following: 

5 ‘‘(2) REQUIRED NON-FEDERAL MEMBERS.—The 

6 Secretary, in consultation with such other heads of 

7 Federal agencies as may be appropriate, shall ap8 point to the Advisory Committee under paragraph 

9 (1) at least 13 individuals, including— 

10 ‘‘(A) at least 2 non-Federal professionals 

11 with expertise in pediatric medical disaster 

12 planning, preparedness, response, or recovery; 

13 ‘‘(B) at least 2 representatives from State, 

14 local, tribal, or territorial agencies with exper15 tise in pediatric disaster planning, prepared16 ness, response, or recovery; 

17 ‘‘(C) at least 4 members representing 

18 health care professionals, which may include 

19 members with expertise in pediatric emergency 

20 medicine; pediatric trauma, critical care, or sur21 gery; the treatment of pediatric patients af22 fected by chemical, biological, radiological, or 

23 nuclear agents, including emerging infectious 

24 diseases; pediatric mental or behavioral health 


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1 related to children affected by a public health 

2 emergency; or pediatric primary care; and 

3 ‘‘(D) other members as the Secretary de4 termines appropriate, of whom— 

5 ‘‘(i) at least one such member shall 

6 represent a children’s hospital; 

7 ‘‘(ii) at least one such member shall 

8 be an individual with expertise in schools 

9 or child care settings; 

10 ‘‘(iii) at least one such member shall 

11 be an individual with expertise in children 

12 and youth with special health care needs; 

13 and 

14 ‘‘(iv) at least one such member shall 

15 be an individual with expertise in the needs 

16 of parents or family caregivers, including 

17 the parents or caregivers of children with 

18 disabilities.’’. 

19 ‘‘(3) FEDERAL MEMBERS.—The Advisory Com20 mittee under paragraph (1) shall include the fol21 lowing Federal members or their designees (who 

22 may be non-voting members, as determined by the 

23 Secretary): 

24 ‘‘(A) The Assistant Secretary for Pre25 paredness and Response. 


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1 ‘‘(B) The Director of the Biomedical Ad2 vanced Research and Development Authority. 

3 ‘‘(C) The Director of the Centers for Dis4 ease Control and Prevention. 

5 ‘‘(D) The Commissioner of Food and 

6 Drugs. 

7 ‘‘(E) The Director of the National Insti8 tutes of Health. 

9 ‘‘(F) The Assistant Secretary of the Ad10 ministration for Children and Families. 

11 ‘‘(G) The Administrator of the Health Re12 sources and Services Administration. 

13 ‘‘(H) The Administrator of the Federal 

14 Emergency Management Agency. 

15 ‘‘(I) The Administrator of the Administra16 tion for Community Living. 

17 ‘‘(J) The Secretary of Education. 

18 ‘‘(K) Representatives from such Federal 

19 agencies (such as the Substance Abuse and 

20 Mental Health Services Administration and the 

21 Department of Homeland Security) as the Sec22 retary determines appropriate to fulfill the du23 ties of the Advisory Committee under sub24 sections (b) and (c).’’. 


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1 ‘‘(4) TERM OF APPOINTMENT.—Each member 

2 of the Advisory Committee appointed under para3 graph (2) shall serve for a term of 3 years, except 

4 that the Secretary may adjust the terms of the Advi5 sory Committee appointees serving on the date of 

6 enactment of the Pandemic and All-Hazards Pre7 paredness and Advancing Innovation Act of 2018, or 

8 appointees who are initially appointed after such 

9 date of enactment, in order to provide for a stag10 gered term of appointment for all members. 

11 ‘‘(5) CONSECUTIVE APPOINTMENTS; MAXIMUM

12 TERMS.—A member appointed under paragraph (2) 

13 may serve not more than 3 terms on the Advisory 

14 Committee, and not more than 2 of such terms may 

15 be served consecutively.’’; 

16 (3) in subsection (e), by adding at the end ‘‘At 

17 least one meeting per year shall be an in-person 

18 meeting.’’; 

19 (4) by redesignating subsection (f) as sub20 section (g); 

21 (5) by inserting after subsection (e) the fol22 lowing: 

23 ‘‘(f) COORDINATION.—The Secretary shall coordinate 

24 duties and activities authorized under this section in ac25 cordance with section 2811D.’’; and 


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1 (6) in subsection (g), as so redesignated, by 

2 striking ‘‘2018’’ and inserting ‘‘2023’’. 

3 (b) AUTHORIZING THE NATIONAL ADVISORY COM4 MITTEE ON SENIORS AND DISASTERS.—Subtitle B of title 

5 XXVIII (42 U.S.C. 300hh et seq.) is amended by inserting 

6 after section 2811A the following: 

7 ‘‘SEC. 2811B. NATIONAL ADVISORY COMMITTEE ON SEN8 IORS AND DISASTERS. 

9 ‘‘(a) ESTABLISHMENT.—The Secretary, in consulta10 tion with the Secretary of Homeland Security and the Sec11 retary of Veterans Affairs, shall establish an advisory com12 mittee to be known as the National Advisory Committee 

13 on Seniors and Disasters (referred to in this section as 

14 the ‘Advisory Committee’). 

15 ‘‘(b) DUTIES.—The Advisory Committee shall— 

16 ‘‘(1) provide advice and consultation with re17 spect to the activities carried out pursuant to section 

18 2814, as applicable and appropriate; 

19 ‘‘(2) evaluate and provide input with respect to 

20 the medical and public health needs of seniors re21 lated to preparation for, response to, and recovery 

22 from all-hazards emergencies; and 

23 ‘‘(3) provide advice and consultation with re24 spect to State emergency preparedness and response 

25 activities relating to seniors, including related drills 


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1 and exercises pursuant to the preparedness goals 

2 under section 2802(b). 

3 ‘‘(c) ADDITIONAL DUTIES.—The Advisory Committee 

4 may provide advice and recommendations to the Secretary 

5 with respect to seniors and the medical and public health 

6 grants and cooperative agreements as applicable to pre7 paredness and response activities under this title and title 

8 III. 

9 ‘‘(d) MEMBERSHIP.— 

10 ‘‘(1) IN GENERAL.—The Secretary, in consulta11 tion with such other heads of agencies as appro12 priate, shall appoint not more than 17 members to 

13 the Advisory Committee. In appointing such mem14 bers, the Secretary shall ensure that the total mem15 bership of the Advisory Committee is an odd num16 ber. 

17 ‘‘(2) REQUIRED MEMBERS.—The Advisory 

18 Committee shall include Federal members or their 

19 designees (who may be non-voting members, as de20 termined by the Secretary) and non-Federal mem21 bers, as follows: 

22 ‘‘(A) The Assistant Secretary for Pre23 paredness and Response. 

24 ‘‘(B) The Director of the Biomedical Ad25 vanced Research and Development Authority. 


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1 ‘‘(C) The Director of the Centers for Dis2 ease Control and Prevention. 

3 ‘‘(D) The Commissioner of Food and 

4 Drugs. 

5 ‘‘(E) The Director of the National Insti6 tutes of Health. 

7 ‘‘(F) The Administrator of the Centers for 

8 Medicare & Medicaid Services. 

9 ‘‘(G) The Administrator of the Administra10 tion for Community Living. 

11 ‘‘(H) The Administrator of the Federal 

12 Emergency Management Agency. 

13 ‘‘(I) The Under Secretary for Health of 

14 the Department of Veterans Affairs. 

15 ‘‘(J) At least 2 non-Federal health care 

16 professionals with expertise in geriatric medical 

17 disaster planning, preparedness, response, or 

18 recovery. 

19 ‘‘(K) At least 2 representatives of State, 

20 local, tribal, or territorial agencies with exper21 tise in geriatric disaster planning, preparedness, 

22 response, or recovery. 

23 ‘‘(L) Representatives of such other Federal 

24 agencies (such as the Department of Energy 

25 and the Department of Homeland Security) as 


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1 the Secretary determines necessary to fulfill the 

2 duties of the Advisory Committee. 

3 ‘‘(e) MEETINGS.—The Advisory Committee shall 

4 meet not less frequently than biannually. At least one 

5 meeting per year shall be an in-person meeting. 

6 ‘‘(f) COORDINATION.—The Secretary shall coordinate 

7 duties and activities authorized under this section in ac8 cordance with section 2811D. 

9 ‘‘(g) SUNSET.— 

10 ‘‘(1) IN GENERAL.—The Advisory Committee 

11 shall terminate on September 30, 2023. 

12 ‘‘(2) EXTENSION OF COMMITTEE.—Not later 

13 than October 1, 2022, the Secretary shall submit to 

14 Congress a recommendation on whether the Advisory 

15 Committee should be extended.’’. 

16 (c) NATIONAL ADVISORY COMMITTEE ON INDIVID17 UALS WITH DISABILITIES AND DISASTERS.—Subtitle B 

18 of title XXVIII (42 U.S.C. 300hh et seq.), as amended 

19 by subsection (b), is further amended by inserting after 

20 section 2811B the following: 

21 ‘‘SEC. 2811C. NATIONAL ADVISORY COMMITTEE ON INDIVID22 UALS WITH DISABILITIES AND DISASTERS. 

23 ‘‘(a) ESTABLISHMENT.—The Secretary, in consulta24 tion with the Secretary of Homeland Security, shall estab25 lish a national advisory committee to be known as the NaVerDate Sep 11 2014 03:39 Dec 20, 2018 Jkt 089200 PO 00000 Frm 00095 Fmt 6652 Sfmt 6201 E:\BILLS\H7328.IH H7328

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1 tional Advisory Committee on Individuals with Disabilities 

2 and Disasters (referred to in this section as the ‘Advisory 

3 Committee’). 

4 ‘‘(b) DUTIES.—The Advisory Committee shall— 

5 ‘‘(1) provide advice and consultation with re6 spect to activities carried out pursuant to section 

7 2814, as applicable and appropriate; 

8 ‘‘(2) evaluate and provide input with respect to 

9 the medical, public health, and accessibility needs of 

10 individuals with disabilities related to preparation 

11 for, response to, and recovery from all-hazards emer12 gencies; and 

13 ‘‘(3) provide advice and consultation with re14 spect to State emergency preparedness and response 

15 activities, including related drills and exercises pur16 suant to the preparedness goals under section 

17 2802(b). 

18 ‘‘(c) MEMBERSHIP.— 

19 ‘‘(1) IN GENERAL.—The Secretary, in consulta20 tion with such other heads of agencies and depart21 ments as appropriate, shall appoint not more than 

22 17 members to the Advisory Committee. In appoint23 ing such members, the Secretary shall ensure that 

24 the total membership of the Advisory Committee is 

25 an odd number. 


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1 ‘‘(2) REQUIRED MEMBERS.—The Advisory 

2 Committee shall include Federal members or their 

3 designees (who may be non-voting members, as de4 termined by the Secretary) and non-Federal mem5 bers, as follows: 

6 ‘‘(A) The Assistant Secretary for Pre7 paredness and Response. 

8 ‘‘(B) The Administrator of the Administra9 tion for Community Living. 

10 ‘‘(C) The Director of the Biomedical Ad11 vanced Research and Development Authority. 

12 ‘‘(D) The Director of the Centers for Dis13 ease Control and Prevention. 

14 ‘‘(E) The Commissioner of Food and 

15 Drugs. 

16 ‘‘(F) The Director of the National Insti17 tutes of Health. 

18 ‘‘(G) The Administrator of the Federal 

19 Emergency Management Agency. 

20 ‘‘(H) The Chair of the National Council on 

21 Disability. 

22 ‘‘(I) The Chair of the United States Access 

23 Board. 

24 ‘‘(J) The Under Secretary for Health of 

25 the Department of Veterans Affairs. 


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1 ‘‘(K) At least 2 non-Federal health care 

2 professionals with expertise in disability accessi3 bility before, during, and after disasters, med4 ical and mass care disaster planning, prepared5 ness, response, or recovery. 

6 ‘‘(L) At least 2 representatives from State, 

7 local, tribal, or territorial agencies with exper8 tise in disaster planning, preparedness, re9 sponse, or recovery for individuals with disabil10 ities. 

11 ‘‘(M) At least 2 individuals with a dis12 ability with expertise in disaster planning, pre13 paredness, response, or recovery for individuals 

14 with disabilities. 

15 ‘‘(d) MEETINGS.—The Advisory Committee shall 

16 meet not less frequently than biannually. At least one 

17 meeting per year shall be an in-person meeting. 

18 ‘‘(e) DISABILITY DEFINED.—For purposes of this 

19 section, the term ‘disability’ has the meaning given such 

20 term in section 3 of the Americans with Disabilities Act 

21 of 1990. 

22 ‘‘(f) COORDINATION.—The Secretary shall coordinate 

23 duties and activities authorized under this section in ac24 cordance with section 2811D. 

25 ‘‘(g) SUNSET.— 


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1 ‘‘(1) IN GENERAL.—The Advisory Committee 

2 shall terminate on September 30, 2023. 

3 ‘‘(2) RECOMMENDATION.—Not later than Octo4 ber 1, 2022, the Secretary shall submit to Congress 

5 a recommendation on whether the Advisory Com6 mittee should be extended.’’. 

7 (d) ADVISORY COMMITTEE COORDINATION.—Sub8 title B of title XXVIII (42 U.S.C. 300hh et seq.), as 

9 amended by subsection (c), is further amended by insert10 ing after section 2811C the following: 

11 ‘‘SEC. 2811D. ADVISORY COMMITTEE COORDINATION. 

12 ‘‘(a) IN GENERAL.—The Secretary shall coordinate 

13 duties and activities authorized under sections 2811A, 

14 2811B, and 2811C, and make efforts to reduce unneces15 sary or duplicative reporting, or unnecessary duplicative 

16 meetings and recommendations under such sections, as 

17 practicable. Members of the advisory committees author18 ized under such sections, or their designees, shall annually 

19 meet to coordinate any recommendations, as appropriate, 

20 that may be similar, duplicative, or overlapping with re21 spect to addressing the needs of children, seniors, and in22 dividuals with disabilities during public health emer23 gencies. If such coordination occurs through an in-person 

24 meeting, it shall not be considered the required in-person 


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1 meetings under any of sections 2811A(e), 2811B(e), or 

2 2811C(d). 

3 ‘‘(b) COORDINATION AND ALIGNMENT.—The Sec4 retary, acting through the employee designated pursuant 

5 to section 2814, shall align preparedness and response 

6 programs or activities to address similar, dual, or overlap7 ping needs of children, seniors, and individuals with dis8 abilities, and any challenges in preparing for and respond9 ing to such needs. 

10 ‘‘(c) NOTIFICATION.—The Secretary shall annually 

11 notify the congressional committees of jurisdiction regard12 ing the steps taken to coordinate, as appropriate, the rec13 ommendations under this section, and provide a summary 

14 description of such coordination.’’. 

15 SEC. 306. GUIDANCE FOR PARTICIPATION IN EXERCISES 

16 AND DRILLS. 

17 Not later than 2 years after the date of enactment 

18 of this Act, the Secretary of Health and Human Services 

19 shall issue final guidance regarding the ability of per20 sonnel funded by programs authorized under this Act (in21 cluding the amendments made by this Act) to participate 

22 in drills and operational exercises related to all-hazards 

23 medical and public health preparedness and response. 

24 Such drills and operational exercises may include activities 

25 that incorporate medical surge capacity planning, medical 


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1 countermeasure distribution and administration, and pre2 paring for and responding to identified threats for that 

3 region. Such personnel may include State, local, tribal, 

4 and territorial public health department or agency per5 sonnel funded under this Act (including the amendments 

6 made by this Act). The Secretary shall consult with the 

7 Department of Homeland Security, the Department of 

8 Defense, the Department of Veterans Affairs, and other 

9 applicable Federal departments and agencies as necessary 

10 and appropriate in the development of such guidance. The 

11 Secretary shall make the guidance available on the inter12 net website of the Department of Health and Human 

13 Services. 

14 TITLE IV—PRIORITIZING A 

15 THREAT-BASED APPROACH 

16 SEC. 401. ASSISTANT SECRETARY FOR PREPAREDNESS AND 

17 RESPONSE. 

18 Section 2811(b) (42 U.S.C. 300hh–10(b)) is amend19 ed— 

20 (1) in the matter preceding paragraph (1) by 

21 inserting ‘‘utilize experience related to public health 

22 emergency preparedness and response, biodefense, 

23 medical countermeasures, and other relevant topics 

24 to’’ after ‘‘shall’’; and 


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1 (2) in paragraph (4) by adding at the end the 

2 following: 

3 ‘‘(I) THREAT AWARENESS.—Coordinate 

4 with the Director of the Centers for Disease 

5 Control and Prevention, the Director of Na6 tional Intelligence, the Secretary of Homeland 

7 Security, the Assistant to the President for Na8 tional Security Affairs, the Secretary of De9 fense, and other relevant Federal officials, such 

10 as the Secretary of Agriculture, to maintain a 

11 current assessment of national security threats 

12 and inform preparedness and response capabili13 ties based on the range of the threats that have 

14 the potential to result in a public health emer15 gency.’’. 

16 SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUN17 TERMEASURES ENTERPRISE. 

18 (a) IN GENERAL.—Title XXVIII is amended by in19 serting after section 2811 (42 U.S.C. 300hh–10) the fol20 lowing: 

21 ‘‘SEC. 2811–1. PUBLIC HEALTH EMERGENCY MEDICAL 

22 COUNTERMEASURES ENTERPRISE. 

23 ‘‘(a) IN GENERAL.—The Secretary shall establish the 

24 Public Health Emergency Medical Countermeasures En25 terprise (referred to in this section as the ‘PHEMCE’). 


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1 The Assistant Secretary for Preparedness and Response 

2 shall serve as chair of the PHEMCE. 

3 ‘‘(b) MEMBERS.—The PHEMCE shall include each 

4 of the following members, or the designee of such mem5 bers: 

6 ‘‘(1) The Assistant Secretary for Preparedness 

7 and Response. 

8 ‘‘(2) The Director of the Centers for Disease 

9 Control and Prevention. 

10 ‘‘(3) The Director of the National Institutes of 

11 Health. 

12 ‘‘(4) The Commissioner of Food and Drugs. 

13 ‘‘(5) The Secretary of Defense. 

14 ‘‘(6) The Secretary of Homeland Security. 

15 ‘‘(7) The Secretary of Agriculture. 

16 ‘‘(8) The Secretary of Veterans Affairs. 

17 ‘‘(9) The Director of National Intelligence. 

18 ‘‘(10) Representatives of any other Federal 

19 agency, which may include the Director of the Bio20 medical Advanced Research and Development Au21 thority, the Director of the Strategic National Stock22 pile, the Director of the National Institute of Allergy 

23 and Infectious Diseases, and the Director of the Of24 fice of Public Health Preparedness and Response, as 

25 the Secretary determines appropriate. 


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1 ‘‘(c) FUNCTIONS.— 

2 ‘‘(1) IN GENERAL.—The functions of the 

3 PHEMCE shall include the following: 

4 ‘‘(A) Utilize a process to make rec5 ommendations to the Secretary regarding re6 search, advanced research, development, pro7 curement, stockpiling, deployment, distribution, 

8 and utilization with respect to countermeasures, 

9 as defined in section 319F–2(c), including 

10 prioritization based on the health security needs 

11 of the United States. Such recommendations 

12 shall be informed by, when available and prac13 ticable, the National Health Security Strategy 

14 pursuant to section 2802, the Strategic Na15 tional Stockpile needs pursuant to section 

16 319F–2, and assessments of current national 

17 security threats, including chemical, biological, 

18 radiological, and nuclear threats, including 

19 emerging infectious diseases. In the event that 

20 members of the PHEMCE do not agree upon a 

21 recommendation, the Secretary shall provide a 

22 determination regarding such recommendation. 

23 ‘‘(B) Identify national health security 

24 needs, including gaps in public health prepared25 ness and response related to countermeasures 


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1 and challenges to addressing such needs (in2 cluding any regulatory challenges), and support 

3 alignment of countermeasure procurement with 

4 recommendations to address such needs under 

5 subparagraph (A). 

6 ‘‘(C) Assist the Secretary in developing 

7 strategies related to logistics, deployment, dis8 tribution, dispensing, and use of counter9 measures that may be applicable to the activi10 ties of the strategic national stockpile under 

11 section 319F–2(a). 

12 ‘‘(D) Provide consultation for the develop13 ment of the strategy and implementation plan 

14 under section 2811(d). 

15 ‘‘(2) INPUT.—In carrying out subparagraphs 

16 (B) and (C) of paragraph (1), the PHEMCE shall 

17 solicit and consider input from State, local, tribal, 

18 and territorial public health departments or officials, 

19 as appropriate.’’. 

20 (b) PUBLIC HEALTH EMERGENCY MEDICAL COUN21 TERMEASURES ENTERPRISE STRATEGY AND IMPLEMEN22 TATION PLAN.—Section 2811(d) (42 U.S.C. 300hh– 

23 10(d)) is amended— 

24 (1) in paragraph (1)— 


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1 (A) by striking ‘‘Not later than 180 days 

2 after the date of enactment of this subsection, 

3 and every year thereafter’’ and inserting ‘‘Not 

4 later than March 15, 2020, and biennially 

5 thereafter’’; and 

6 (B) by striking ‘‘Director of the Bio7 medical’’ and all that follows through ‘‘Food 

8 and Drugs’’ and inserting ‘‘Public Health 

9 Emergency Medical Countermeasures Enter10 prise established under section 2811–1’’; and 

11 (2) in paragraph (2)(J)(v), by striking ‘‘one12 year period’’ and inserting ‘‘2-year period’’. 

13 SEC. 403. STRATEGIC NATIONAL STOCKPILE. 

14 (a) IN GENERAL.—Section 319F–2(a) (42 U.S.C. 

15 247d–6b(a)) is amended— 

16 (1) by redesignating paragraphs (2) and (3) as 

17 paragraphs (3) and (4), respectively; and 

18 (2) in paragraph (1)— 

19 (A) by inserting ‘‘the Assistant Secretary 

20 for Preparedness and Response and’’ after ‘‘col21 laboration with’’; 

22 (B) by inserting ‘‘and optimize’’ after 

23 ‘‘provide for’’; 

24 (C) by inserting ‘‘and, as informed by ex25 isting recommendations of, or consultations 


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1 with, the Public Health Emergency Medical 

2 Countermeasure Enterprise established under 

3 section 2811–1, make necessary additions or 

4 modifications to the contents of such stockpile 

5 or stockpiles based on the review conducted 

6 under paragraph (2)’’ before the period of the 

7 first sentence; and 

8 (D) by striking the second sentence; 

9 (3) by inserting after paragraph (1) the fol10 lowing: 

11 ‘‘(2) THREAT-BASED REVIEW.— 

12 ‘‘(A) IN GENERAL.—The Secretary shall 

13 conduct an annual threat-based review (taking 

14 into account at-risk individuals) of the contents 

15 of the stockpile under paragraph (1), including 

16 non-pharmaceutical supplies, and, in consulta17 tion with the Public Health Emergency Medical 

18 Countermeasures Enterprise established under 

19 section 2811–1, review contents within the 

20 stockpile and assess whether such contents are 

21 consistent with the recommendations made pur22 suant to section 2811–1(c)(1)(A). Such review 

23 shall be submitted on June 15, 2019, and on 

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1 sions and the Committee on Appropriations of 

2 the Senate and the Committee on Energy and 

3 Commerce and the Committee on Appropria4 tions of the House of Representatives, in a 

5 manner that does not compromise national se6 curity. 

7 ‘‘(B) ADDITIONS, MODIFICATIONS, AND

8 REPLENISHMENTS.—Each annual threat-based 

9 review under subparagraph (A) shall, for each 

10 new or modified countermeasure procurement 

11 or replenishment, provide— 

12 ‘‘(i) information regarding— 

13 ‘‘(I) the quantities of the addi14 tional or modified countermeasure 

15 procured for, or contracted to be pro16 cured for, the stockpile; 

17 ‘‘(II) planning considerations for 

18 appropriate manufacturing capacity 

19 and capability to meet the goals of 

20 such additions or modifications (with21 out disclosing proprietary informa22 tion), including consideration of the 

23 effect such additions or modifications 

24 may have on the availability of such 


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1 products and ancillary medical sup2 plies in the health care system; 

3 ‘‘(III) the presence or lack of a 

4 commercial market for the counter5 measure at the time of procurement; 

6 ‘‘(IV) the emergency health secu7 rity threat or threats such counter8 measure procurement is intended to 

9 address, including whether such pro10 curement is consistent with meeting 

11 emergency health security needs asso12 ciated with such threat or threats; 

13 ‘‘(V) an assessment of whether 

14 the emergency health security threat 

15 or threats described in subclause (IV) 

16 could be addressed in a manner that 

17 better utilizes the resources of the 

18 stockpile and permits the greatest 

19 possible increase in the level of emer20 gency preparedness to address such 

21 threats; 

22 ‘‘(VI) whether such counter23 measure is replenishing an expiring or 

24 expired countermeasure, is a different 

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1 tion that is replacing an expiring or 

2 expired countermeasure, or is a new 

3 addition to the stockpile; 

4 ‘‘(VII) a description of how such 

5 additions or modifications align with 

6 projected investments under previous 

7 countermeasures budget plans under 

8 section 2811(b)(7), including expected 

9 life-cycle costs, expenditures related to 

10 countermeasure procurement to ad11 dress the threat or threats described 

12 in subclause (IV), replenishment dates 

13 (including the ability to extend the 

14 maximum shelf life of a counter15 measure), and the manufacturing ca16 pacity required to replenish such 

17 countermeasure; and 

18 ‘‘(VIII) appropriate protocols and 

19 processes for the deployment, distribu20 tion, or dispensing of the counter21 measure at the State and local level, 

22 including plans for relevant capabili23 ties of State and local entities to dis24 pense, distribute, and administer the 

25 countermeasure; and 


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1 ‘‘(ii) an assurance, which need not be 

2 provided in advance of procurement, that 

3 for each countermeasure procured or re4 plenished under this subsection, the Sec5 retary completed a review addressing each 

6 item listed under this subsection in ad7 vance of such procurement or replenish8 ment.’’; 

9 (4) in paragraph (3), as so redesignated— 

10 (A) in subparagraph (A), by inserting 

11 ‘‘and the Public Health Emergency Medical 

12 Countermeasures Enterprise established under 

13 section 2811–1’’ before the semicolon; 

14 (B) in subparagraph (C), by inserting ‘‘, 

15 and the availability, deployment, dispensing, 

16 and administration of countermeasures’’ before 

17 the semicolon; 

18 (C) by amending subparagraph (E) to read 

19 as follows: 

20 ‘‘(E) devise plans for effective and timely 

21 supply-chain management of the stockpile, in 

22 consultation with the Director of the Centers 

23 for Disease Control and Prevention, the Assist24 ant Secretary for Preparedness and Response, 

25 the Secretary of Transportation, the Secretary 


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1 of Homeland Security, the Secretary of Vet2 erans Affairs, and the heads of other appro3 priate Federal agencies; State, local, tribal, and 

4 territorial agencies; and the public and private 

5 health care infrastructure, as applicable, taking 

6 into account the manufacturing capacity and 

7 other available sources of products and appro8 priate alternatives to supplies in the stockpile;’’; 

9 (D) in subparagraph (G), by striking ‘‘; 

10 and’’ and inserting a semicolon; 

11 (E) in subparagraph (H), by striking the 

12 period and inserting a semicolon; and 

13 (F) by adding at the end the following: 

14 ‘‘(I) ensure that each countermeasure or 

15 product under consideration for procurement 

16 pursuant to this subsection receives the same 

17 consideration regardless of whether such coun18 termeasure or product receives or had received 

19 funding under section 319L, including with re20 spect to whether the countermeasure or product 

21 is most appropriate to meet the emergency 

22 health security needs of the United States; and 

23 ‘‘(J) provide assistance, including technical 

24 assistance, to maintain and improve State and 

25 local public health preparedness capabilities to 


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1 distribute and dispense medical counter2 measures and products from the stockpile, as 

3 appropriate.’’; and 

4 (5) by adding at the end the following: 

5 ‘‘(5) GAO REPORT.— 

6 ‘‘(A) IN GENERAL.—Not later than 3 years 

7 after the date of enactment of the Pandemic 

8 and All-Hazards Preparedness and Advancing 

9 Innovation Act of 2018, and every 5 years 

10 thereafter, the Comptroller General of the 

11 United States shall conduct a review of any 

12 changes to the contents or management of the 

13 stockpile since January 1, 2015. Such review 

14 shall include— 

15 ‘‘(i) an assessment of the comprehen16 siveness and completeness of each annual 

17 threat-based review under paragraph (2), 

18 including whether all newly procured or re19 plenished countermeasures within the 

20 stockpile were described in each annual re21 view, and whether, consistent with para22 graph (2)(B), the Secretary conducted the 

23 necessary internal review in advance of 

24 such procurement or replenishment; 


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1 ‘‘(ii) an assessment of whether the 

2 Secretary established health security and 

3 science-based justifications, and a descrip4 tion of such justifications for procurement 

5 decisions related to health security needs 

6 with respect to the identified threat, for 

7 additions or modifications to the stockpile 

8 based on the information provided in such 

9 reviews under paragraph (2)(B), including 

10 whether such review was conducted prior 

11 to procurement, modification, or replenish12 ment; 

13 ‘‘(iii) an assessment of the plans de14 veloped by the Secretary for the deploy15 ment, distribution, and dispensing of coun16 termeasures procured, modified, or replen17 ished under paragraph (1), including 

18 whether such plans were developed prior to 

19 procurement, modification, or replenish20 ment; 

21 ‘‘(iv) an accounting of counter22 measures procured, modified, or replen23 ished under paragraph (1) that received 

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1 ing from the Biomedical Advanced Re2 search and Development Authority; 

3 ‘‘(v) an analysis of how such procure4 ment decisions made progress toward 

5 meeting emergency health security needs 

6 related to the identified threats for coun7 termeasures added, modified, or replen8 ished under paragraph (1); 

9 ‘‘(vi) a description of the resources ex10 pended related to the procurement of coun11 termeasures (including additions, modifica12 tions, and replenishments) in the stockpile, 

13 and how such expenditures relate to the 

14 ability of the stockpile to meet emergency 

15 health security needs; 

16 ‘‘(vii) an assessment of the extent to 

17 which additions, modifications, and replen18 ishments reviewed under paragraph (2) 

19 align with previous relevant reports or re20 views by the Secretary or the Comptroller 

21 General; 

22 ‘‘(viii) with respect to any change in 

23 the Federal organizational management of 

24 the stockpile, an assessment and compari25 son of the processes affected by such 


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1 change, including planning for potential 

2 countermeasure deployment, distribution, 

3 or dispensing capabilities and processes re4 lated to procurement decisions, use of 

5 stockpiled countermeasures, and use of re6 sources for such activities; and 

7 ‘‘(ix) an assessment of whether the 

8 processes and procedures described by the 

9 Secretary pursuant to section 403(b) of 

10 the Pandemic and All-Hazards Prepared11 ness and Advancing Innovation Act of 

12 2018 are sufficient to ensure counter13 measures and products under consideration 

14 for procurement pursuant to subsection (a) 

15 receive the same consideration regardless 

16 of whether such countermeasures and 

17 products receive or had received funding 

18 under section 319L, including with respect 

19 to whether such countermeasures and 

20 products are most appropriate to meet the 

21 emergency health security needs of the 

22 United States. 

23 ‘‘(B) SUBMISSION.—Not later than 6 

24 months after completing a classified version of 

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1 troller General shall submit an unclassified 

2 version of the review to the congressional com3 mittees of jurisdiction.’’. 

4 (b) ADDITIONAL REPORTING.—In the first threat5 based review submitted after the date of enactment of this 

6 Act pursuant to paragraph (2) of section 319F–2(a) of 

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

8 amended by subsection (a), the Secretary shall include a 

9 description of the processes and procedures through which 

10 the Director of Strategic National Stockpile and the Di11 rector of the Biomedical Advanced Research and Develop12 ment Authority coordinate with respect to counter13 measures and products procured under such section 

14 319F–2(a), including such processes and procedures in 

15 place to ensure countermeasures and products under con16 sideration for procurement pursuant to such section 

17 319F–2(a) receive the same consideration regardless of 

18 whether such countermeasures or products receive or had 

19 received funding under section 319L of the Public Health 

20 Service Act (42 U.S.C. 247d–7e), and whether such coun21 termeasures and products are the most appropriate to 

22 meet the emergency health security needs of the United 

23 States. 

24 (c) AUTHORIZATION OF APPROPRIATIONS, STRA25 TEGIC NATIONAL STOCKPILE.—Section 319F–2(f)(1) (42 


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1 U.S.C. 247d–6b(f)(1)) is amended by striking 

2 ‘‘$533,800,000 for each of fiscal years 2014 through 

3 2018’’ and inserting ‘‘$610,000,000 for each of fiscal 

4 years 2019 through 2023, to remain available until ex5 pended’’. 

6 SEC. 404. PREPARING FOR PANDEMIC INFLUENZA, ANTI7 MICROBIAL RESISTANCE, AND OTHER SIG8 NIFICANT THREATS. 

9 (a) STRATEGIC INITIATIVES.—Section 319L(c)(4) 

10 (247d–7e(c)(4)) is amended by adding at the end the fol11 lowing: 

12 ‘‘(F) STRATEGIC INITIATIVES.—The Sec13 retary, acting through the Director of BARDA, 

14 may implement strategic initiatives, including 

15 by building on existing programs and by award16 ing contracts, grants, and cooperative agree17 ments, or entering into other transactions, to 

18 support innovative candidate products in pre19 clinical and clinical development that address 

20 priority, naturally occurring and man-made 

21 threats that, as determined by the Secretary, 

22 pose a significant level of risk to national secu23 rity based on the characteristics of a chemical, 

24 biological, radiological or nuclear threat, or ex25 isting capabilities to respond to such a threat 


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1 (including medical response and treatment ca2 pabilities and manufacturing infrastructure). 

3 Such initiatives shall accelerate and support the 

4 advanced research, development, and procure5 ment of, countermeasures and products, as ap6 plicable, to address areas including— 

7 ‘‘(i) chemical, biological, radiological, 

8 or nuclear threats, including emerging in9 fectious diseases, for which insufficient ap10 proved, licensed, or authorized counter11 measures exist, or for which such threat, 

12 or the result of an exposure to such threat, 

13 may become resistant to countermeasures 

14 or existing countermeasures may be ren15 dered ineffective; 

16 ‘‘(ii) threats that consistently exist or 

17 continually circulate and have a significant 

18 potential to become a pandemic, such as 

19 pandemic influenza, which may include the 

20 advanced research and development, manu21 facturing, and appropriate stockpiling of 

22 qualified pandemic or epidemic products, 

23 and products, technologies, or processes to 

24 support the advanced research and devel25 opment of such countermeasures (including 


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1 multiuse platform technologies for 

2 diagnostics, vaccines, and therapeutics; 

3 virus seeds; clinical trial lots; novel virus 

4 strains; and antigen and adjuvant mate5 rial); and 

6 ‘‘(iii) threats that may result pri7 marily or secondarily from a chemical, bio8 logical, radiological, or nuclear agent, or 

9 emerging infectious diseases, and which 

10 may present increased treatment complica11 tions such as the occurrence of resistance 

12 to available countermeasures or potential 

13 countermeasures, including antimicrobial 

14 resistant pathogens.’’. 

15 (b) PROTECTION OF NATIONAL SECURITY FROM

16 THREATS.—Section 2811 (42 U.S.C. 300hh–10) is 

17 amended by adding at the end the following: 

18 ‘‘(f) PROTECTION OF NATIONAL SECURITY FROM

19 THREATS.— 

20 ‘‘(1) IN GENERAL.—In carrying out subsection 

21 (b)(3), the Assistant Secretary for Preparedness and 

22 Response shall implement strategic initiatives or ac23 tivities to address threats, including pandemic influ24 enza and which may include a chemical, biological, 

25 radiological, or nuclear agent (including any such 


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1 agent with a significant potential to become a pan2 demic), that pose a significant level of risk to public 

3 health and national security based on the character4 istics of such threat. Such initiatives shall include 

5 activities to— 

6 ‘‘(A) accelerate and support the advanced 

7 research, development, manufacturing capacity, 

8 procurement, and stockpiling of counter9 measures, including initiatives under section 

10 319L(c)(4)(F); 

11 ‘‘(B) support the development and manu12 facturing of virus seeds, clinical trial lots, and 

13 stockpiles of novel virus strains; and 

14 ‘‘(C) maintain or improve preparedness ac15 tivities, including for pandemic influenza. 

16 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

17 ‘‘(A) IN GENERAL.—To carry out this sub18 section, there is authorized to be appropriated 

19 $250,000,000 for each of fiscal years 2019 

20 through 2023. 

21 ‘‘(B) SUPPLEMENT, NOT SUPPLANT.— 

22 Amounts appropriated under this paragraph 

23 shall be used to supplement and not supplant 

24 funds provided under sections 319L(d) and 

25 319F–2(g). 


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1 ‘‘(C) DOCUMENTATION REQUIRED.—The 

2 Assistant Secretary for Preparedness and Re3 sponse, in accordance with subsection (b)(7), 

4 shall document amounts expended for purposes 

5 of carrying out this subsection, including 

6 amounts appropriated under the heading ‘Pub7 lic Health and Social Services Emergency 

8 Fund’ under the heading ‘Office of the Sec9 retary’ under title II of division H of the Con10 solidated Appropriations Act, 2018 (Public Law 

11 115–141) and allocated to carrying out section 

12 319L(c)(4)(F).’’. 

13 SEC. 405. REPORTING ON THE FEDERAL SELECT AGENT 

14 PROGRAM. 

15 Section 351A(k) (42 U.S.C. 262a(k)) is amended— 

16 (1) by striking ‘‘The Secretary’’ and inserting 

17 the following: 

18 ‘‘(1) IN GENERAL.—The Secretary’’; and 

19 (2) by adding at the end the following: 

20 ‘‘(2) IMPLEMENTATION OF RECOMMENDATIONS

21 OF THE FEDERAL EXPERTS SECURITY ADVISORY

22 PANEL AND THE FAST TRACK ACTION COMMITTEE

23 ON SELECT AGENT REGULATIONS.— 

24 ‘‘(A) IN GENERAL.—Not later than 1 year 

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1 demic and All-Hazards Preparedness and Ad2 vancing Innovation Act of 2018, the Secretary 

3 shall report to the congressional committees of 

4 jurisdiction on the implementation of rec5 ommendations of the Federal Experts Security 

6 Advisory Panel concerning the select agent pro7 gram. 

8 ‘‘(B) CONTINUED UPDATES.—The Sec9 retary shall report to the congressional commit10 tees of jurisdiction annually following the sub11 mission of the report under subparagraph (A) 

12 until the recommendations described in such 

13 subparagraph are fully implemented, or a jus14 tification is provided for the delay in, or lack of, 

15 implementation.’’. 

16 TITLE V—INCREASING COMMU17 NICATION IN MEDICAL COUN18 TERMEASURE ADVANCED RE19 SEARCH AND DEVELOPMENT 

20 SEC. 501. MEDICAL COUNTERMEASURE BUDGET PLAN. 

21 Section 2811(b)(7) (42 U.S.C. 300hh–10(b)(7)) is 

22 amended— 

23 (1) in the matter preceding subparagraph (A), 

24 by striking ‘‘March 1’’ and inserting ‘‘March 15’’; 

25 (2) in subparagraph (A)— 


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1 (A) in clause (ii), by striking ‘‘; and’’ and 

2 inserting ‘‘;’’; and 

3 (B) by striking clause (iii) and inserting 

4 the following: 

5 ‘‘(iii) procurement, stockpiling, main6 tenance, and potential replenishment (in7 cluding manufacturing capabilities) of all 

8 products in the Strategic National Stock9 pile; 

10 ‘‘(iv) the availability of technologies 

11 that may assist in the advanced research 

12 and development of countermeasures and 

13 opportunities to use such technologies to 

14 accelerate and navigate challenges unique 

15 to countermeasure research and develop16 ment; and 

17 ‘‘(v) potential deployment, distribu18 tion, and utilization of medical counter19 measures; development of clinical guidance 

20 and emergency use instructions for the use 

21 of medical countermeasures; and, as appli22 cable, potential post-deployment activities 

23 related to medical countermeasures;’’; 

24 (3) by redesignating subparagraphs (D) and 

25 (E) as subparagraphs (E) and (F), respectively; and 


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1 (4) by inserting after subparagraph (C), the fol2 lowing: 

3 ‘‘(D) identify the full range of anticipated 

4 medical countermeasure needs related to re5 search and development, procurement, and 

6 stockpiling, including the potential need for in7 dications, dosing, and administration tech8 nologies, and other countermeasure needs as 

9 applicable and appropriate;’’. 

10 SEC. 502. MATERIAL THREAT AND MEDICAL COUNTER11 MEASURE NOTIFICATIONS. 

12 (a) CONGRESSIONAL NOTIFICATION OF MATERIAL

13 THREAT DETERMINATION.—Section 319F–2(c)(2)(C) (42 

14 U.S.C. 247d–6b(c)(2)(C)) is amended by striking ‘‘The 

15 Secretary and the Homeland Security Secretary shall 

16 promptly notify the appropriate committees of Congress’’ 

17 and inserting ‘‘The Secretary and the Secretary of Home18 land Security shall send to Congress, on an annual basis, 

19 all current material threat determinations and shall 

20 promptly notify the Committee on Health, Education, 

21 Labor, and Pensions and the Committee on Homeland Se22 curity and Governmental Affairs of the Senate and the 

23 Committee on Energy and Commerce and the Committee 

24 on Homeland Security of the House of Representatives’’. 


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1 (b) CONTRACTING COMMUNICATION.—Section 319F– 

2 2(c)(7)(B)(ii)(III) (42 U.S.C. 247d–6b(c)(7)(B)(ii)(III)) 

3 is amended by adding at the end the following: ‘‘The Sec4 retary shall notify the vendor within 90 days of a deter5 mination by the Secretary to renew, extend, or terminate 

6 such contract.’’. 

7 SEC. 503. AVAILABILITY OF REGULATORY MANAGEMENT 

8 PLANS. 

9 Section 565(f) of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 360bbb–4(f)) is amended— 

11 (1) by redesignating paragraphs (3) through 

12 (6) as paragraphs (4) through (7), respectively; 

13 (2) by inserting after paragraph (2) the fol14 lowing: 

15 ‘‘(3) PUBLICATION.—The Secretary shall make 

16 available on the internet website of the Food and 

17 Drug Administration information regarding regu18 latory management plans, including— 

19 ‘‘(A) the process by which an applicant 

20 may submit a request for a regulatory manage21 ment plan; 

22 ‘‘(B) the timeframe by which the Secretary 

23 is required to respond to such request; 

24 ‘‘(C) the information required for the sub25 mission of such request; 


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1 ‘‘(D) a description of the types of develop2 ment milestones and performance targets that 

3 could be discussed and included in such plans; 

4 and 

5 ‘‘(E) contact information for beginning the 

6 regulatory management plan process.’’; 

7 (3) in paragraph (6), as so redesignated, in the 

8 matter preceding subparagraph (A)— 

9 (A) by striking ‘‘paragraph (4)(A)’’ and in10 serting ‘‘paragraph (5)(A)’’; and 

11 (B) by striking ‘‘paragraph (4)(B)’’ and 

12 inserting ‘‘paragraph (5)(B)’’; and 

13 (4) in paragraph (7)(A), as so redesignated, by 

14 striking ‘‘paragraph (3)(A)’’ and inserting ‘‘para15 graph (4)(A)’’. 

16 SEC. 504. THE BIOMEDICAL ADVANCED RESEARCH AND DE17 VELOPMENT AUTHORITY AND THE BIO18 SHIELD SPECIAL RESERVE FUND. 

19 (a) BIOSHIELD SPECIAL RESERVE FUND.—Section 

20 319F–2(g)(1) (42 U.S.C. 247d–6b(g)(1)) is amended— 

21 (1) by striking ‘‘$2,800,000,000 for the period 

22 of fiscal years 2014 through 2018’’ and inserting 

23 ‘‘$7,100,000,000 for the period of fiscal years 2019 

24 through 2028, to remain available until expended’’; 

25 and 


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1 (2) by striking the second sentence. 

2 (b) THE BIOMEDICAL ADVANCED RESEARCH AND

3 DEVELOPMENT AUTHORITY.—Section 319L(d)(2) (42 

4 U.S.C. 247d–7e(d)(2)) is amended by striking 

5 ‘‘$415,000,000 for each of fiscal years 2014 through 

6 2018’’ and inserting ‘‘$611,700,000 for each of fiscal 

7 years 2019 through 2023’’. 

8 SEC. 505. ADDITIONAL STRATEGIES FOR COMBATING ANTI9 BIOTIC RESISTANCE. 

10 (a) ADVISORY COUNCIL.—The Secretary of Health 

11 and Human Services (referred to in this section as the 

12 ‘‘Secretary’’) may continue the Presidential Advisory 

13 Council on Combating Antibiotic-Resistant Bacteria, re14 ferred to in this section as the ‘‘Advisory Council’’. 

15 (b) DUTIES.—The Advisory Council shall advise and 

16 provide information and recommendations to the Sec17 retary regarding programs and policies intended to reduce 

18 or combat antibiotic-resistant bacteria that may present 

19 a public health threat and improve capabilities to prevent, 

20 diagnose, mitigate, or treat such resistance. Such advice, 

21 information, and recommendations may be related to im22 proving— 

23 (1) the effectiveness of antibiotics; 

24 (2) research and advanced research on, and the 

25 development of, improved and innovative methods 


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1 for combating or reducing antibiotic resistance, in2 cluding new treatments, rapid point-of-care 

3 diagnostics, alternatives to antibiotics, including al4 ternatives to animal antibiotics, and antimicrobial 

5 stewardship activities; 

6 (3) surveillance of antibiotic-resistant bacterial 

7 infections, including publicly available and up-to8 date information on resistance to antibiotics; 

9 (4) education for health care providers and the 

10 public with respect to up-to-date information on an11 tibiotic resistance and ways to reduce or combat 

12 such resistance to antibiotics related to humans and 

13 animals; 

14 (5) methods to prevent or reduce the trans15 mission of antibiotic-resistant bacterial infections, 

16 including stewardship programs; and 

17 (6) coordination with respect to international 

18 efforts in order to inform and advance United States 

19 capabilities to combat antibiotic resistance. 

20 (c) MEETINGS AND COORDINATION.— 

21 (1) MEETINGS.—The Advisory Council shall 

22 meet not less than biannually and, to the extent 

23 practicable, in coordination with meetings of the 

24 Antimicrobial Resistance Task Force established in 

25 section 319E(a) of the Public Health Service Act. 


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1 (2) COORDINATION.—The Advisory Council 

2 shall, to the greatest extent practicable, coordinate 

3 activities carried out by the Council with the Anti4 microbial Resistance Task Force established under 

5 section 319E(a) of the Public Health Service Act 

6 (42 U.S.C. 247d–5(a)). 

7 (d) FACA.—The Federal Advisory Committee Act (5 

8 U.S.C. App.) shall apply to the activities and duties of 

9 the Advisory Council. 

10 (e) EXTENSION OF ADVISORY COUNCIL.—Not later 

11 than October 1, 2022, the Secretary shall submit to the 

12 Committee on Health, Education, Labor, and Pensions of 

13 the Senate and the Committee on Energy and Commerce 

14 of the House of Representatives a recommendation on 

15 whether the Advisory Council should be extended, and in 

16 addition, identify whether there are other committees, 

17 councils, or task forces that have overlapping or similar 

18 duties to that of the Advisory Council, and whether such 

19 committees, councils, or task forces should be combined, 

20 including with respect to section 319E(a) of the Public 

21 Health Service Act (42 U.S.C. 247d–5(a)). 


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1 TITLE VI—ADVANCING TECH2 NOLOGIES FOR MEDICAL 

3 COUNTERMEASURES 

4 SEC. 601. ADMINISTRATION OF COUNTERMEASURES. 

5 Section 319L(c)(4)(D)(iii) (42 U.S.C. 247d– 

6 7e(c)(4)(D)(iii)) is amended by striking ‘‘and platform 

7 technologies’’ and inserting ‘‘platform technologies, tech8 nologies to administer countermeasures, and technologies 

9 to improve storage and transportation of counter10 measures’’. 

11 SEC. 602. UPDATING DEFINITIONS OF OTHER TRANS12 ACTIONS. 

13 Section 319L (42 U.S.C. 247d–7e) is amended— 

14 (1) in subsection (a)(3), by striking ‘‘, such as’’ 

15 and all that follows through ‘‘Code’’; and 

16 (2) in subsection (c)(5)(A)— 

17 (A) in clause (i), by striking ‘‘under this 

18 subsection’’ and all that follows through ‘‘Code’’ 

19 and inserting ‘‘(as defined in subsection (a)(3)) 

20 under this subsection’’; and 

21 (B) in clause (ii)— 

22 (i) by amending subclause (I) to read 

23 as follows: 

24 ‘‘(I) IN GENERAL.—To the max25 imum extent practicable, competitive 


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1 procedures shall be used when enter2 ing into transactions to carry out 

3 projects under this subsection.’’; and 

4 (ii) in subclause (II)— 

5 (I) by striking ‘‘$20,000,000’’ 

6 and inserting ‘‘$100,000,000’’; 

7 (II) by striking ‘‘senior procure8 ment executive for the Department 

9 (as designated for purpose of section 

10 16(c) of the Office of Federal Pro11 curement Policy Act (41 U.S.C. 

12 414(c)))’’ and inserting ‘‘Assistant 

13 Secretary for Financial Resources’’; 

14 and 

15 (III) by striking ‘‘senior procure16 ment executive under’’ and inserting 

17 ‘‘Assistant Secretary for Financial Re18 sources under’’. 

19 SEC. 603. MEDICAL COUNTERMEASURE MASTER FILES. 

20 (a) IN GENERAL.—The purpose of this section (in21 cluding section 565B of the Federal Food, Drug, and Cos22 metic Act, as added by subsection (b)) is to support and 

23 advance the development or manufacture of security coun24 termeasures, qualified countermeasures, and qualified 

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1 aging submission of data and information to support the 

2 development of such products, and through clarifying the 

3 authority to cross-reference to data and information pre4 viously submitted to the Secretary of Health and Human 

5 Services (referred to in this section as the ‘‘Secretary’’), 

6 including data and information submitted to medical coun7 termeasure master files or other master files. 

8 (b) MEDICAL COUNTERMEASURE MASTER FILES.— 

9 Chapter V of the Federal Food, Drug, and Cosmetic Act 

10 (21 U.S.C. 351 et seq.) is amended by inserting after sec11 tion 565A the following: 

12 ‘‘SEC. 565B. MEDICAL COUNTERMEASURE MASTER FILES. 

13 ‘‘(a) APPLICABILITY OF REFERENCE.— 

14 ‘‘(1) IN GENERAL.—A person may submit data 

15 and information in a master file to the Secretary 

16 with the intent to reference, or to authorize, in writ17 ing, another person to reference, such data or infor18 mation to support a medical countermeasure submis19 sion (including a supplement or amendment to any 

20 such submission), without requiring the master file 

21 holder to disclose the data and information to any 

22 such persons authorized to reference the master file. 

23 Such data and information shall be available for ref24 erence by the master file holder or by a person au25 thorized by the master file holder, in accordance 


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1 with applicable privacy and confidentiality protocols 

2 and regulations. 

3 ‘‘(2) REFERENCE OF CERTAIN MASTER

4 FILES.—In the case that data or information within 

5 a medical countermeasure master file is used only to 

6 support the conditional approval of an application 

7 filed under section 571, such master file may be re8 lied upon to support the effectiveness of a product 

9 that is the subject of a subsequent medical counter10 measure submission only if such application is sup11 plemented by additional data or information to sup12 port review and approval in a manner consistent 

13 with the standards applicable to such review and ap14 proval for such countermeasure, qualified counter15 measure, or qualified pandemic or epidemic product. 

16 ‘‘(b) MEDICAL COUNTERMEASURE MASTER FILE

17 CONTENT.— 

18 ‘‘(1) IN GENERAL.—A master file under this 

19 section may include data or information to sup20 port— 

21 ‘‘(A) the development of medical counter22 measure submissions to support the approval, 

23 licensure, classification, clearance, conditional 

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1 measures, or qualified pandemic or epidemic 

2 products; and 

3 ‘‘(B) the manufacture of security counter4 measures, qualified countermeasures, or quali5 fied pandemic or epidemic products. 

6 ‘‘(2) REQUIRED UPDATES.—The Secretary may 

7 require, as appropriate, that the master file holder 

8 ensure that the contents of such master file are up9 dated during the time such master file is referenced 

10 for a medical countermeasure submission. 

11 ‘‘(c) SPONSOR REFERENCE.— 

12 ‘‘(1) IN GENERAL.—Each incorporation of data 

13 or information within a medical countermeasure 

14 master file shall describe the incorporated material 

15 in a manner in which the Secretary determines ap16 propriate and that permits the review of such infor17 mation within such master file without necessitating 

18 re-submission of such data or information. Master 

19 files shall be submitted in an electronic format in ac20 cordance with sections 512(b)(4), 571(a)(4), and 

21 745A, as applicable, and as specified in applicable 

22 guidance. 

23 ‘‘(2) REFERENCE BY A MASTER FILE HOLD24 ER.—A master file holder that is the sponsor of a 

25 medical countermeasure submission shall notify the 


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1 Secretary in writing of the intent to reference the 

2 medical countermeasure master file as a part of the 

3 submission. 

4 ‘‘(3) REFERENCE BY AN AUTHORIZED PER5 SON.—A person submitting an application for review 

6 may, where the Secretary determines appropriate, 

7 incorporate by reference all or part of the contents 

8 of a medical countermeasure master file, if the mas9 ter file holder authorizes the incorporation in writ10 ing. 

11 ‘‘(d) ACKNOWLEDGMENT OF AND RELIANCE UPON A

12 MASTER FILE BY THE SECRETARY.— 

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

14 the master file holder with a written notification in15 dicating that the Secretary has reviewed and relied 

16 upon specified data or information within a master 

17 file and the purposes for which such data or infor18 mation was incorporated by reference if the Sec19 retary has reviewed and relied upon such specified 

20 data or information to support the approval, classi21 fication, conditional approval, clearance, licensure, or 

22 authorization of a security countermeasure, qualified 

23 countermeasure, or qualified pandemic or epidemic 

24 product. The Secretary may rely upon the data and 

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1 ter file for which such written notification was pro2 vided in additional applications, as applicable and 

3 appropriate and upon the request of the master file 

4 holder so notified in writing or by an authorized per5 son of such holder. 

6 ‘‘(2) CERTAIN APPLICATIONS.—If the Secretary 

7 has reviewed and relied upon specified data or infor8 mation within a medical countermeasure master file 

9 to support the conditional approval of an application 

10 under section 571 to subsequently support the ap11 proval, clearance, licensure, or authorization of a se12 curity countermeasure, qualified countermeasure, or 

13 qualified pandemic or epidemic product, the Sec14 retary shall provide a brief written description to the 

15 master file holder regarding the elements of the ap16 plication fulfilled by the data or information within 

17 the master file and how such data or information 

18 contained in such application meets the standards of 

19 evidence under subsection (c) or (d) of section 505, 

20 subsection (d) of section 512, or section 351 of the 

21 Public Health Service Act (as applicable), which 

22 shall not include any trade secret or confidential 

23 commercial information. 

24 ‘‘(e) RULES OF CONSTRUCTION.—Nothing in this 

25 section shall be construed to— 


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1 ‘‘(1) limit the authority of the Secretary to ap2 prove, license, clear, conditionally approve, or au3 thorize drugs, biological products, or devices pursu4 ant to, as applicable, this Act or section 351 of the 

5 Public Health Service Act (as such applicable Act is 

6 in effect on the day before the date of enactment of 

7 the Pandemic and All-Hazards Preparedness and 

8 Advancing Innovation Act of 2018), including the 

9 standards of evidence, and applicable conditions, for 

10 approval under the applicable Act; 

11 ‘‘(2) alter the standards of evidence with re12 spect to approval, licensure, or clearance, as applica13 ble, of drugs, biological products, or devices under 

14 this Act or section 351 of the Public Health Service 

15 Act, including, as applicable, the substantial evi16 dence standards under sections 505(d) and 512(d) 

17 or this Act and section 351(a) of the Public Health 

18 Service Act; or 

19 ‘‘(3) alter the authority of the Secretary under 

20 this Act or the Public Health Service Act to deter21 mine the types of data or information previously 

22 submitted by a sponsor or any other person that 

23 may be incorporated by reference in an application, 

24 request, or notification for a drug, biological prod25 uct, or device submitted under sections 505(i), 


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1 505(b), 505(j), 512(b)(1), 512(b)(2), 512(j), 564, 

2 571, 520(g), 515(c), 513(f)(2), or 510(k) of this 

3 Act, or subsection (a) or (k) of section 351 of the 

4 Public Health Service Act, including a supplement 

5 or amendment to any such submission, and the re6 quirements associated with such reference. 

7 ‘‘(f) DEFINITIONS.—In this section: 

8 ‘‘(1) The term ‘master file holder’ means a per9 son who submits data and information to the Sec10 retary with the intent to reference or authorize an11 other person to reference such data or information 

12 to support a medical countermeasure submission, as 

13 described in subsection (a). 

14 ‘‘(2) The term ‘medical countermeasure submis15 sion’ means an investigational new drug application 

16 under section 505(i), a new drug application under 

17 section 505(b), or an abbreviated new drug applica18 tion under section 505(j) of this Act, a biological 

19 product license application under section 351(a) of 

20 the Public Health Service Act or a biosimilar biologi21 cal product license application under section 351(k) 

22 of the Public Health Service Act, a new animal drug 

23 application under section 512(b)(1) or abbreviated 

24 new animal drug application under section 

25 512(b)(2), an application for conditional approval of 


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1 a new animal drug under section 571, an investiga2 tional device application under section 520(g), an 

3 application with respect to a device under section 

4 515(c), a request for classification of a device under 

5 section 513(f)(2), a notification with respect to a de6 vice under section 510(k), or a request for an emer7 gency use authorization under section 564 to sup8 port— 

9 ‘‘(A) the approval, licensure, classification, 

10 clearance, conditional approval, or authorization 

11 of a security countermeasure, qualified counter12 measure, or qualified pandemic or epidemic 

13 product; or 

14 ‘‘(B) a new indication to an approved secu15 rity countermeasure, qualified countermeasure, 

16 or qualified pandemic or epidemic product. 

17 ‘‘(3) The terms ‘qualified countermeasure’, ‘se18 curity countermeasure’, and ‘qualified pandemic or 

19 epidemic product’ have the meanings given such 

20 terms in sections 319F–1, 319F–2, and 319F–3, re21 spectively, of the Public Health Service Act.’’. 

22 (c) STAKEHOLDER INPUT.—Not later than 18 

23 months after the date of enactment of this Act, the Sec24 retary, acting through the Commissioner of Food and 

25 Drugs and in consultation with the Assistant Secretary 


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1 for Preparedness and Response, shall solicit input from 

2 stakeholders, including stakeholders developing security 

3 countermeasures, qualified countermeasures, or qualified 

4 pandemic or epidemic products, and stakeholders devel5 oping technologies to assist in the development of such 

6 countermeasures with respect to how the Food and Drug 

7 Administration can advance the use of tools and tech8 nologies to support and advance the development or manu9 facture of security countermeasures, qualified counter10 measures, and qualified pandemic or epidemic products, 

11 including through reliance on cross-referenced data and 

12 information contained within master files and submissions 

13 previously submitted to the Secretary as set forth in sec14 tion 565B of the Federal Food, Drug, and Cosmetic Act, 

15 as added by subsection (b). 

16 (d) GUIDANCE.—Not later than 2 years after the 

17 date of enactment of this Act, the Secretary, acting 

18 through the Commissioner of Food and Drugs, shall pub19 lish draft guidance about how reliance on cross-referenced 

20 data and information contained within master files under 

21 section 565B of the Federal Food, Drug, and Cosmetic 

22 Act, as added by subsection (b) or submissions otherwise 

23 submitted to the Secretary may be used for specific tools 

24 or technologies (including platform technologies) that have 

25 the potential to support and advance the development or 


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1 manufacture of security countermeasures, qualified coun2 termeasures, and qualified pandemic or epidemic products. 

3 The Secretary, acting through the Commissioner of Food 

4 and Drugs, shall publish the final guidance not later than 

5 3 years after the enactment of this Act. 

6 SEC. 604. ANIMAL RULE REPORT. 

7 (a) STUDY.—The Comptroller General of the United 

8 States shall conduct a study on the application of the re9 quirements under subsections (c) and (d) of section 565 

10 of the of the Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 360bbb–4) (referred to in this section as the ‘‘ani12 mal rule’’) as a component of medical countermeasure ad13 vanced development under the Biomedical Advanced Re14 search and Development Authority and regulatory review 

15 by the Food and Drug Administration. In conducting such 

16 study, the Comptroller General shall examine the fol17 lowing: 

18 (1) The extent to which advanced development 

19 and review of a medical countermeasure are coordi20 nated between the Biomedical Advanced Research 

21 and Development Authority and the Food and Drug 

22 Administration, including activities that facilitate 

23 appropriate and efficient design of studies to sup24 port approval, licensure, and authorization under the 

25 animal rule, consistent with the recommendations in 


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1 the animal rule guidance, issued pursuant to section 

2 565(c) of the Federal Food Drug and Cosmetic Act 

3 (21 U.S.C. 360bbb–4(c)) and entitled ‘‘Product De4 velopment Under the Animal Rule: Guidance for In5 dustry’’ (issued in October 2015), to resolve discrep6 ancies in the design of adequate and well-controlled 

7 efficacy studies conducted in animal models related 

8 to the provision of substantial evidence of effective9 ness for the product approved, licensed, or author10 ized under the animal rule. 

11 (2) The consistency of the application of the 

12 animal rule among and between review divisions 

13 within the Food and Drug Administration. 

14 (3) The flexibility pursuant to the animal rule 

15 to address variations in countermeasure development 

16 and review processes, including the extent to which 

17 qualified animal models are adopted and used within 

18 the Food and Drug Administration in regulatory de19 cisionmaking with respect to medical counter20 measures. 

21 (4) The extent to which the guidance issued 

22 under section 565(c) of the Federal Food Drug and 

23 Cosmetic Act (21 U.S.C. 360bbb–4(c)), entitled, 

24 ‘‘Product Development Under the Animal Rule: 

25 Guidance for Industry’’ (issued in October 2015), 


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1 has assisted in achieving the purposes described in 

2 paragraphs (1), (2), and (3). 

3 (b) CONSULTATIONS.—In conducting the study under 

4 subsection (a), the Comptroller General of the United 

5 States shall consult with— 

6 (1) the Federal agencies responsible for advanc7 ing, reviewing, and procuring medical counter8 measures, including the Office of the Assistant Sec9 retary for Preparedness and Response, the Bio10 medical Advanced Research and Development Au11 thority, the Food and Drug Administration, and the 

12 Department of Defense; 

13 (2) manufacturers involved in the research and 

14 development of medical countermeasures to address 

15 biological, chemical, radiological, or nuclear threats; 

16 and 

17 (3) other biodefense stakeholders, as applicable. 

18 (c) REPORT.—Not later than 3 years after the date 

19 of enactment of this Act, the Comptroller General of the 

20 United States shall submit to the Committee on Health, 

21 Education, Labor, and Pensions of the Senate and the 

22 Committee on Energy and Commerce of the House of 

23 Representatives a report containing the results of the 

24 study conducted under subsection (a) and recommenda25 tions to improve the application and consistency of the reVerDate Sep 11 2014 03:39 Dec 20, 2018 Jkt 089200 PO 00000 Frm 00144 Fmt 6652 Sfmt 6201 E:\BILLS\H7328.IH H7328

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1 quirements under subsections (c) and (d) of section 565 

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

3 360bbb–4) to support and expedite the research and devel4 opment of medical countermeasures, as applicable. 

5 (d) PROTECTION OF NATIONAL SECURITY.—The 

6 Comptroller General of the United States shall conduct 

7 the study and issue the assessment and report under this 

8 section in a manner that does not compromise national 

9 security. 

10 SEC. 605. REVIEW OF THE BENEFITS OF GENOMIC ENGI11 NEERING TECHNOLOGIES AND THEIR POTEN12 TIAL ROLE IN NATIONAL SECURITY. 

13 (a) MEETING.— 

14 (1) IN GENERAL.—Not later than 1 year after 

15 the date of enactment of this Act, the Secretary of 

16 Health and Human Services (referred to in this sec17 tion as the ‘‘Secretary’’) shall convene a meeting to 

18 discuss the potential role advancements in genomic 

19 engineering technologies (including genome editing 

20 technologies) may have in advancing national health 

21 security. Such meeting shall be held in a manner 

22 that does not compromise national security. 

23 (2) ATTENDEES.—The attendees of the meeting 

24 under paragraph (1)— 

25 (A) shall include— 


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1 (i) representatives from the Office of 

2 the Assistant Secretary for Preparedness 

3 and Response, the National Institutes of 

4 Health, the Centers for Disease Control 

5 and Prevention, and the Food and Drug 

6 Administration; and 

7 (ii) representatives from academic, 

8 private, and nonprofit entities with exper9 tise in genome engineering technologies, 

10 biopharmaceuticals, medicine, or bio11 defense, and other relevant stakeholders; 

12 and 

13 (B) may include— 

14 (i) other representatives from the De15 partment of Health and Human Services, 

16 as the Secretary determines appropriate; 

17 and 

18 (ii) representatives from the Depart19 ment of Homeland Security, the Depart20 ment of Defense, the Department of Agri21 culture, and other departments, as the Sec22 retary may request for the meeting. 

23 (3) TOPICS.—The meeting under paragraph (1) 

24 shall include a discussion of— 


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1 (A) the current state of the science of 

2 genomic engineering technologies related to na3 tional health security, including— 

4 (i) medical countermeasure develop5 ment, including potential efficiencies in the 

6 development pathway and detection tech7 nologies; and 

8 (ii) the international and domestic 

9 regulation of products utilizing genome ed10 iting technologies; and 

11 (B) national security implications, includ12 ing— 

13 (i) capabilities of the United States to 

14 leverage genomic engineering technologies 

15 as a part of the medical countermeasure 

16 enterprise, including current applicable re17 search, development, and application ef18 forts underway within the Department of 

19 Defense; 

20 (ii) the potential for state and non21 state actors to utilize genomic engineering 

22 technologies as a national health security 

23 threat; and 

24 (iii) security measures to monitor and 

25 assess the potential threat that may result 


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1 from utilization of genomic engineering 

2 technologies and related technologies for 

3 the purpose of compromising national 

4 health security. 

5 (b) REPORT.—Not later than 270 days after the 

6 meeting described in subsection (a) is held, the Assistant 

7 Secretary for Preparedness and Response shall issue a re8 port to the congressional committees of jurisdiction on the 

9 topics discussed at such meeting, and provide rec10 ommendations, as applicable, to utilize innovations in 

11 genomic engineering (including genome editing) and re12 lated technologies as a part of preparedness and response 

13 activities to advance national health security. Such report 

14 shall be issued in a manner that does not compromise na15 tional security. 

16 SEC. 606. REPORT ON VACCINES DEVELOPMENT. 

17 Not later than one year after the date of the enact18 ment of this Act, the Secretary of Health and Human 

19 Services shall submit to the Committee on Health, Edu20 cation, Labor, and Pensions of the Senate and the Com21 mittee on Energy and Commerce of the House of Rep22 resentatives a report describing efforts and activities to 

23 coordinate with other countries and international partners 

24 during recent public health emergencies with respect to 

25 the research and advanced research on, and development 


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1 of, qualified pandemic or epidemic products (as defined 

2 in section 319F–3 of the Public Health Service Act (42 

3 U.S.C. 247d–6d)). Such report may include information 

4 regarding relevant work carried out under section 

5 319L(c)(5)(E) of the Public Health Service Act (42 

6 U.S.C. 247d–7e(c)(5)(E)), through public-private partner7 ships, and through collaborations with other countries to 

8 assist with or expedite the research and development of 

9 qualified pandemic or epidemic products. Such report shall 

10 not include information that may compromise national se11 curity. 

12 SEC. 607. STRENGTHENING MOSQUITO ABATEMENT FOR 

13 SAFETY AND HEALTH. 

14 (a) REAUTHORIZATION OF MOSQUITO ABATEMENT

15 FOR SAFETY AND HEALTH PROGRAM.—Section 317S (42 

16 U.S.C. 247b–21) is amended— 

17 (1) in subsection (a)(1)(B)— 

18 (A) by inserting ‘‘including programs to 

19 address emerging infectious mosquito-borne dis20 eases,’’ after ‘‘subdivisions for control pro21 grams,’’; and 

22 (B) by inserting ‘‘or improving existing 

23 control programs’’ before the period at the end; 

24 (2) in subsection (b)— 


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1 (A) in paragraph (1), by inserting ‘‘, in2 cluding improvement,’’ after ‘‘operation’’; 

3 (B) in paragraph (2)— 

4 (i) in subparagraph (A)— 

5 (I) in clause (ii), by striking ‘‘or’’ 

6 at the end; 

7 (II) in clause (iii), by striking the 

8 semicolon at the end and inserting ‘‘, 

9 including an emerging infectious mos10 quito-borne disease that presents a se11 rious public health threat; or’’; and 

12 (III) by adding at the end the 

13 following: 

14 ‘‘(iv) a public health emergency due to 

15 the incidence or prevalence of a mosquito16 borne disease that presents a serious pub17 lic health threat;’’; and 

18 (ii) by amending subparagraph (D) to 

19 read as follows: 

20 ‘‘(D)(i) is located in a State that has re21 ceived a grant under subsection (a); or 

22 ‘‘(ii) that demonstrates to the Secretary 

23 that the control program is consistent with ex24 isting State mosquito control plans or policies, 

25 or other applicable State preparedness plans.’’; 


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1 (C) in paragraph (4)(C), by striking ‘‘that 

2 extraordinary’’ and all that follows through the 

3 period at the end and inserting the following: 

4 ‘‘that— 

5 ‘‘(i) extraordinary economic conditions 

6 in the political subdivision or consortium of 

7 political subdivisions involved justify the 

8 waiver; or 

9 ‘‘(ii) the geographical area covered by 

10 a political subdivision or consortium for a 

11 grant under paragraph (1) has an extreme 

12 mosquito control need due to— 

13 ‘‘(I) the size or density of the po14 tentially impacted human population; 

15 ‘‘(II) the size or density of a 

16 mosquito population that requires 

17 heightened control; or 

18 ‘‘(III) the severity of the mos19 quito-borne disease, such that ex20 pected serious adverse health out21 comes for the human population jus22 tify the waiver.’’; and 

23 (D) by amending paragraph (6) to read as 

24 follows: 


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1 ‘‘(6) NUMBER OF GRANTS.—A political subdivi2 sion or a consortium of political subdivisions may 

3 not receive more than one grant under paragraph 

4 (1).’’; and 

5 (3) in subsection (f)— 

6 (A) in paragraph (1) by striking ‘‘for fiscal 

7 year 2003, and such sums as may be necessary 

8 for each of fiscal years 2004 through 2007’’ 

9 and inserting ‘‘for each of fiscal years 2019 

10 through 2023’’; 

11 (B) in paragraph (2), by striking ‘‘the 

12 Public Health Security and Bioterrorism Pre13 paredness and Response Act of 2002’’ and in14 serting ‘‘this Act and other medical and public 

15 health preparedness and response laws’’; and 

16 (C) in paragraph (3)— 

17 (i) in the paragraph heading, by strik18 ing ‘‘2004’’ and inserting ‘‘2019’’; and 

19 (ii) by striking ‘‘2004,’’ and inserting 

20 ‘‘2019,’’. 

21 (b) EPIDEMIOLOGY-LABORATORY CAPACITY

22 GRANTS.—Section 2821 (42 U.S.C. 300hh–31) is amend23 ed— 


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1 (1) in subsection (a)(1), by inserting ‘‘, includ2 ing mosquito and other vector-borne diseases,’’ after 

3 ‘‘infectious diseases’’; and 

4 (2) in subsection (b), by striking ‘‘2010 through 

5 2013’’ and inserting ‘‘2019 through 2023’’. 

6 TITLE VII—MISCELLANEOUS 

7 PROVISIONS 

8 SEC. 701. REAUTHORIZATIONS AND EXTENSIONS. 

9 (a) VETERANS AFFAIRS.—Section 8117(g) of title 

10 38, United States Code, is amended by striking ‘‘2014 

11 through 2018’’ and inserting ‘‘2019 through 2023’’. 

12 (b) VACCINE TRACKING AND DISTRIBUTION.—Sec13 tion 319A(e) (42 U.S.C. 247d–1(e)) is amended by strik14 ing ‘‘2014 through 2018’’ and inserting ‘‘2019 through 

15 2023’’. 

16 (c) TEMPORARY REASSIGNMENT.—Section 319(e)(8) 

17 (42 U.S.C. 247d(e)(8)) is amended by striking ‘‘2018’’ 

18 and inserting ‘‘2023’’. 

19 (d) STRATEGIC INNOVATION PARTNER.—Section 

20 319L(c)(4)(E)(ix) (42 U.S.C. 247d–7e(c)(4)(E)(ix)) is 

21 amended by striking ‘‘2022’’ and inserting ‘‘2023’’. 

22 (e) LIMITED ANTITRUST EXEMPTION.— 

23 (1) IN GENERAL.—Section 405 of the Pandemic 

24 and All-Hazards Preparedness Act (Public Law 

25 109–417; 42 U.S.C. 247d–6a note) is amended— 


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1 (A) in subsection (a)(1)(A)— 

2 (i) by striking ‘‘Secretary of Health 

3 and Human Services (referred to in this 

4 subsection as the ‘Secretary’)’’ and insert5 ing ‘‘Secretary’’; 

6 (ii) by striking ‘‘of the Public Health 

7 Service Act (42 U.S.C. 247d–6b)) (as 

8 amended by this Act’’; 

9 (iii) by striking ‘‘of the Public Health 

10 Service Act (42 U.S.C. 247d–6a)) (as 

11 amended by this Act’’; and 

12 (iv) by striking ‘‘of the Public Health 

13 Service Act (42 U.S.C. 247d–6d)’’; 

14 (B) in subsection (b), by striking ‘‘12- 

15 year’’ and inserting ‘‘17-year’’; 

16 (C) by redesignating such section 405 as 

17 section 319L–1; and 

18 (D) by transferring such section 319L–1, 

19 as redesignated, to the Public Health Service 

20 Act (42 U.S.C. 201 et seq.), to appear after 

21 section 319L of such Act (42 U.S.C. 247d–7e). 

22 (2) CONFORMING AMENDMENT.—The table of 

23 contents in section 1(b) of the Pandemic and All24 Hazards Preparedness Act (Public Law 109–417) is 

25 amended by striking the item related to section 405. 


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1 (f) INAPPLICABILITY OF CERTAIN PROVISIONS.— 

2 Subsection (e)(1) of section 319L (42 U.S.C. 247d– 

3 7e(e)(1)) is amended— 

4 (1) by amending subparagraph (A) to read as 

5 follows: 

6 ‘‘(A) NON-DISCLOSURE OF INFORMA7 TION.— 

8 ‘‘(i) IN GENERAL.—Information de9 scribed in clause (ii) shall be deemed to be 

10 information described in section 552(b)(3) 

11 of title 5, United States Code. 

12 ‘‘(ii) INFORMATION DESCRIBED.—The 

13 information described in this clause is in14 formation relevant to programs of the De15 partment of Health and Human Services 

16 that could compromise national security 

17 and reveal significant and not otherwise 

18 publicly known vulnerabilities of existing 

19 medical or public health defenses against 

20 chemical, biological, radiological, or nuclear 

21 threats, and is comprised of— 

22 ‘‘(I) specific technical data or sci23 entific information that is created or 

24 obtained during the countermeasure 

25 and product advanced research and 


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1 development carried out under sub2 section (c); 

3 ‘‘(II) information pertaining to 

4 the location security, personnel, and 

5 research materials and methods of 

6 high-containment laboratories con7 ducting research with select agents, 

8 toxins, or other agents with a material 

9 threat determination under section 

10 319F–2(c)(2); or 

11 ‘‘(III) security and vulnerability 

12 assessments.’’; 

13 (2) by redesignating subparagraph (C) as sub14 paragraph (D); 

15 (3) by inserting after subparagraph (B) the fol16 lowing: 

17 ‘‘(C) REPORTING.—One year after the 

18 date of enactment of the Pandemic and All19 Hazards Preparedness and Advancing Innova20 tion Act of 2018, and annually thereafter, the 

21 Secretary shall report to the Committee on 

22 Health, Education, Labor, and Pensions of the 

23 Senate and the Committee on Energy and Com24 merce of the House of Representatives on the 

25 number of instances in which the Secretary has 


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1 used the authority under this subsection to 

2 withhold information from disclosure, as well as 

3 the nature of any request under section 552 of 

4 title 5, United States Code that was denied 

5 using such authority.’’; and 

6 (4) in subparagraph (D), as so redesignated, by 

7 striking ‘‘12’’ and inserting ‘‘17’’. 

8 SEC. 702. LOCATION OF MATERIALS IN THE STOCKPILE. 

9 Subsection (d) of section 319F–2 (42 U.S.C. 247d– 

10 6b) is amended to read as follows: 

11 ‘‘(d) DISCLOSURES.—No Federal agency may dis12 close under section 552 of title 5, United States Code any 

13 information identifying the location at which materials in 

14 the stockpile described in subsection (a) are stored, or 

15 other information regarding the contents or deployment 

16 capability of the stockpile that could compromise national 

17 security.’’. 

18 SEC. 703. CYBERSECURITY. 

19 (a) STRATEGY FOR PUBLIC HEALTH PREPAREDNESS

20 AND RESPONSE TO CYBERSECURITY THREATS.— 

21 (1) STRATEGY.—Not later than 18 months 

22 after the date of enactment of this Act, the Sec23 retary of Health and Human Services (referred to in 

24 this section as the ‘‘Secretary’’) shall prepare and 

25 submit to the relevant committees of Congress a 


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1 strategy for public health preparedness and response 

2 to address cybersecurity threats (as defined in sec3 tion 102 of Cybersecurity Information Sharing Act 

4 of 2015 (6 U.S.C. 1501)) that present a threat to 

5 national health security. Such strategy shall in6 clude— 

7 (A) identifying the duties, functions, and 

8 preparedness goals for which the Secretary is 

9 responsible in order to prepare for and respond 

10 to such cybersecurity threats, including metrics 

11 by which to measure success in meeting pre12 paredness goals; 

13 (B) identifying gaps in public health capa14 bilities to achieve such preparedness goals; and 

15 (C) strategies to address identified gaps 

16 and strengthen public health emergency pre17 paredness and response capabilities to address 

18 such cybersecurity threats. 

19 (2) PROTECTION OF NATIONAL SECURITY.— 

20 The Secretary shall make such strategy available to 

21 the Committee on Health, Education, Labor, and 

22 Pensions of the Senate, the Committee on Energy 

23 and Commerce of the House of Representatives, and 

24 other congressional committees of jurisdiction, in a 

25 manner that does not compromise national security. 


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1 (b) COORDINATION OF PREPAREDNESS FOR AND RE2 SPONSE TO ALL-HAZARDS PUBLIC HEALTH EMER3 GENCIES.—Subparagraph (D) of section 2811(b)(4) (42 

4 U.S.C. 300hh–10(b)(4)) is amended to read as follows: 

5 ‘‘(D) POLICY COORDINATION AND STRA6 TEGIC DIRECTION.—Provide integrated policy 

7 coordination and strategic direction, before, 

8 during, and following public health emergencies, 

9 with respect to all matters related to Federal 

10 public health and medical preparedness and 

11 execution and deployment of the Federal re12 sponse for public health emergencies and inci13 dents covered by the National Response Plan 

14 described in section 504(a)(6) of the Homeland 

15 Security Act of 2002 (6 U.S.C. 314(a)(6)), or 

16 any successor plan; and such Federal responses 

17 covered by the National Cybersecurity Incident 

18 Response Plan developed under section 228(c) 

19 of the Homeland Security Act of 2002 (6 

20 U.S.C. 149(c)), including public health emer21 gencies or incidents related to cybersecurity 

22 threats that present a threat to national health 

23 security.’’. 


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1 SEC. 704. STRATEGY AND REPORT. 

2 Not later than 14 days after the date of the enact3 ment of this Act, the Secretary of Health and Human 

4 Services, in coordination with the Assistant Secretary for 

5 Preparedness and Response and the Assistant Secretary 

6 for the Administration on Children and Families or other 

7 appropriate office, and in collaboration with other depart8 ments, as appropriate, shall submit to the Committee on 

9 Energy and Commerce of the House of Representatives, 

10 the Committee on Health, Education, Labor, and Pen11 sions of the Senate, and other relevant congressional com12 mittees— 

13 (1) a formal strategy, including interdepart14 mental actions and efforts to reunify children with 

15 their parents or guardians, in all cases in which such 

16 children have been separated from their parents or 

17 guardians as a result of the initiative announced on 

18 April 6, 2018, and due to prosecution under section 

19 275(a) of the Immigration and Nationality Act (8 

20 U.S.C. 1325(a)), if the parent or guardian chooses 

21 such reunification and the child— 

22 (A) was separated from a parent or guard23 ian and placed into a facility funded by the De24 partment of Health and Human Services; 


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1 (B) as of the date of the enactment of this 

2 Act, remains in the care of the Department of 

3 Health and Human Services; and 

4 (C) can be safely reunited with such parent 

5 or guardian; and 

6 (2) a report on challenges and deficiencies re7 lated to the oversight of, and care for, unaccom8 panied alien children and appropriately reuniting 

9 such children with their parents or guardians, and 

10 the actions taken to address any challenges and defi11 ciencies related to unaccompanied alien children in 

12 the custody of the Department of Health and 

13 Human Services, including deficiencies identified 

14 and publicly reported by Congress, the Government 

15 Accountability Office, or the Inspectors General of 

16 the Department of Health and Human Services or 

17 other Federal departments. 

18 SEC. 705. TECHNICAL AMENDMENTS. 

19 (a) PUBLIC HEALTH SERVICE ACT.—Title III (42 

20 U.S.C. 241 et seq.) is amended— 

21 (1) in paragraphs (1) and (5) of section 319F– 

22 1(a) (42 U.S.C. 247d–6a(a)), by striking ‘‘section 

23 319F(h)’’ each place such term appears and insert24 ing ‘‘section 319F(e)’’; and 


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1 (2) in section 319K(a) (42 U.S.C. 247d–7d(a)), 

2 by striking ‘‘section 319F(h)(4)’’ and inserting ‘‘sec3 tion 319F(e)(4)’’. 

4 (b) PUBLIC HEALTH SECURITY GRANTS.—Section 

5 319C–1(b)(2) (42 U.S.C. 247d–3a(b)(2)) is amended— 

6 (1) in subparagraph (C), by striking ‘‘individ7 uals,,’’ and inserting ‘‘individuals,’’; and 

8 (2) in subparagraph (F), by striking ‘‘make sat9 isfactory annual improvement and describe’’ and in10 serting ‘‘makes satisfactory annual improvement and 

11 describes’’. 

12 (c) EMERGENCY USE INSTRUCTIONS.—Subpara13 graph (A) of section 564A(e)(2) of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 360bbb–3a(e)(2)) is 

15 amended by striking ‘‘subsection (a)(1)(C)(i)’’ and insert16 ing ‘‘subsection (a)(1)(C)’’. 

17 (d) PRODUCTS HELD FOR EMERGENCY USE.—Sec18 tion 564B(2) of the Federal Food, Drug, and Cosmetic 

19 Act (21 U.S.C. 360bbb–3b) is amended— 

20 (1) in subparagraph (B), by inserting a comma 

21 after ‘‘505’’; and 

22 (2) in subparagraph (C), by inserting ‘‘or sec23 tion 564A’’ before the period at the end. 


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1 (e) TRANSPARENCY.—Section 507(c)(3) of the Fed2 eral Food, Drug, and Cosmetic Act (21 U.S.C. 357(c)(3)) 

3 is amended— 

4 (1) by striking ‘‘Nothing in’’ and inserting the 

5 following: 

6 ‘‘(A) IN GENERAL.—Nothing in’’; 

7 (2) by inserting ‘‘or directing’’ after ‘‘author8 izing’’; 

9 (3) by striking ‘‘disclose any’’ and inserting 

10 ‘‘disclose— 

11 ‘‘(i) any’’; 

12 (4) by striking the period and inserting ‘‘; or’’; 

13 and 

14 (5) by adding at the end the following: 

15 ‘‘(ii) in the case of a drug develop16 ment tool that may be used to support the 

17 development of a qualified countermeasure, 

18 security countermeasure, or qualified pan19 demic or epidemic product, as defined in 

20 sections 319F–1, 319F–2, and 319F–3, 

21 respectively, of the Public Health Service 

22 Act, any information that the Secretary 

23 determines has a significant potential to 

24 affect national security. 


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1 ‘‘(B) PUBLIC ACKNOWLEDGMENT.—In the 

2 case that the Secretary, pursuant to subpara3 graph (A)(ii), does not make information pub4 licly available, the Secretary shall provide on 

5 the internet website of the Food and Drug Ad6 ministration an acknowledgment of the informa7 tion that has not been disclosed, pursuant to 

8 subparagraph (A)(ii).’’. 

9 DIVISION B—OVER-THE10 COUNTER MONOGRAPH SAFE11 TY, INNOVATION, AND RE12 FORM 

13 SEC. 1000. SHORT TITLE; REFERENCES IN DIVISION. 

14 (a) SHORT TITLE.—This division may be cited as the 

15 ‘‘Over-the-Counter Monograph Safety, Innovation, and 

16 Reform Act of 2018’’. 

17 (b) REFERENCES.—Except as otherwise specified, 

18 any reference to ‘‘this Act’’ contained in this division shall 

19 be treated as referring only to the provisions of this divi20 sion. 


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1 TITLE I—OTC DRUG REVIEW 

2 SEC. 1001. REGULATION OF CERTAIN NONPRESCRIPTION 

3 DRUGS THAT ARE MARKETED WITHOUT AN 

4 APPROVED DRUG APPLICATION. 

5 (a) IN GENERAL.—Chapter V of the Federal Food, 

6 Drug, and Cosmetic Act is amended by inserting after sec7 tion 505F of such Act (21 U.S.C. 355g) the following: 

8 ‘‘SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION 

9 DRUGS THAT ARE MARKETED WITHOUT AN 

10 APPROVED DRUG APPLICATION. 

11 ‘‘(a) NONPRESCRIPTION DRUGS MARKETED WITH12 OUT AN APPROVED APPLICATION.—Nonprescription 

13 drugs marketed without an approved drug application 

14 under section 505, as of the date of the enactment of this 

15 section, shall be treated in accordance with this sub16 section. 

17 ‘‘(1) DRUGS SUBJECT TO A FINAL MONOGRAPH; 

18 CATEGORY I DRUGS SUBJECT TO A TENTATIVE

19 FINAL MONOGRAPH.—A drug is deemed to be gen20 erally recognized as safe and effective under section 

21 201(p)(1), not a new drug under section 201(p), and 

22 not subject to section 503(b)(1), if— 

23 ‘‘(A) the drug is— 

24 ‘‘(i) in conformity with the require25 ments for nonprescription use of a final 


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1 monograph issued under part 330 of title 

2 21, Code of Federal Regulations (except as 

3 provided in paragraph (2)), the general re4 quirements for nonprescription drugs, and 

5 conditions or requirements under sub6 sections (b), (c), and (k); and 

7 ‘‘(ii) except as permitted by an order 

8 issued under subsection (b) or, in the case 

9 of a minor change in the drug, in con10 formity with an order issued under sub11 section (c), in a dosage form that, imme12 diately prior to the date of the enactment 

13 of this section, has been used to a material 

14 extent and for a material time under sec15 tion 201(p)(2); or 

16 ‘‘(B) the drug is— 

17 ‘‘(i) classified in category I for safety 

18 and effectiveness under a tentative final 

19 monograph that is the most recently appli20 cable proposal or determination issued 

21 under part 330 of title 21, Code of Federal 

22 Regulations; 

23 ‘‘(ii) in conformity with the proposed 

24 requirements for nonprescription use of 

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1 cable subsequent determination by the Sec2 retary, the general requirements for non3 prescription drugs, and conditions or re4 quirements under subsections (b), (c), and 

5 (k); and 

6 ‘‘(iii) except as permitted by an order 

7 issued under subsection (b) or, in the case 

8 of a minor change in the drug, in con9 formity with an order issued under sub10 section (c), in a dosage form that, imme11 diately prior to the date of the enactment 

12 of this section, has been used to a material 

13 extent and for a material time under sec14 tion 201(p)(2). 

15 ‘‘(2) TREATMENT OF SUNSCREEN DRUGS.— 

16 With respect to sunscreen drugs subject to this sec17 tion, the applicable requirements in terms of con18 formity with a final monograph, for purposes of 

19 paragraph (1)(A)(i), shall be the requirements speci20 fied in part 352 of title 21, Code of Federal Regula21 tions, as published on May 21, 1999, beginning on 

22 page 27687 of volume 64 of the Federal Register, 

23 except that the applicable requirements governing ef24 fectiveness and labeling shall be those specified in 


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1 section 201.327 of title 21, Code of Federal Regula2 tions. 

3 ‘‘(3) CATEGORY III DRUGS SUBJECT TO A TEN4 TATIVE FINAL MONOGRAPH; CATEGORY I DRUGS

5 SUBJECT TO PROPOSED MONOGRAPH OR ADVANCE

6 NOTICE OF PROPOSED RULEMAKING.—A drug that 

7 is not described in paragraph (1), (2), or (4) is not 

8 required to be the subject of an application approved 

9 under section 505, and is not subject to section 

10 503(b)(1), if— 

11 ‘‘(A) the drug is— 

12 ‘‘(i) classified in category III for safe13 ty or effectiveness in the preamble of a 

14 proposed rule establishing a tentative final 

15 monograph that is the most recently appli16 cable proposal or determination for such 

17 drug issued under part 330 of title 21, 

18 Code of Federal Regulations; 

19 ‘‘(ii) in conformity with— 

20 ‘‘(I) the conditions of use, includ21 ing indication and dosage strength, if 

22 any, described for such category III 

23 drug in such preamble or in an appli24 cable subsequent proposed rule; 


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1 ‘‘(II) the proposed requirements 

2 for drugs classified in such tentative 

3 final monograph in category I in the 

4 most recently proposed rule estab5 lishing requirements related to such 

6 tentative final monograph and in any 

7 final rule establishing requirements 

8 that are applicable to the drug; and 

9 ‘‘(III) the general requirements 

10 for nonprescription drugs and condi11 tions or requirements under sub12 section (b) or (k); and 

13 ‘‘(iii) in a dosage form that, imme14 diately prior to the date of the enactment 

15 of this section, had been used to a material 

16 extent and for a material time under sec17 tion 201(p)(2); or 

18 ‘‘(B) the drug is— 

19 ‘‘(i) classified in category I for safety 

20 and effectiveness under a proposed mono21 graph or advance notice of proposed rule22 making that is the most recently applicable 

23 proposal or determination for such drug 

24 issued under part 330 of title 21, Code of 

25 Federal Regulations; 


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1 ‘‘(ii) in conformity with the require2 ments for nonprescription use of such pro3 posed monograph or advance notice of pro4 posed rulemaking, any applicable subse5 quent determination by the Secretary, the 

6 general requirements for nonprescription 

7 drugs, and conditions or requirements 

8 under subsection (b) or (k); and 

9 ‘‘(iii) in a dosage form that, imme10 diately prior to the date of the enactment 

11 of this section, has been used to a material 

12 extent and for a material time under sec13 tion 201(p)(2). 

14 ‘‘(4) CATEGORY II DRUGS DEEMED NEW

15 DRUGS.—A drug that is classified in category II for 

16 safety or effectiveness under a tentative final mono17 graph or that is subject to a determination to be not 

18 generally recognized as safe and effective in a pro19 posed rule that is the most recently applicable pro20 posal issued under part 330 of title 21, Code of Fed21 eral Regulations, shall be deemed to be a new drug 

22 under section 201(p), misbranded under section 

23 502(ee), and subject to the requirement for an ap24 proved new drug application under section 505 be25 ginning on the day that is 180 calendar days after 


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1 the date of the enactment of this section, unless, be2 fore such day, the Secretary determines that it is in 

3 the interest of public health to extend the period 

4 during which the drug may be marketed without 

5 such an approved new drug application. 

6 ‘‘(5) DRUGS NOT GRASE DEEMED NEW

7 DRUGS.—A drug that the Secretary has determined 

8 not to be generally recognized as safe and effective 

9 under section 201(p)(1) under a final determination 

10 issued under part 330 of title 21, Code of Federal 

11 Regulations, shall be deemed to be a new drug under 

12 section 201(p), misbranded under section 502(ee), 

13 and subject to the requirement for an approved new 

14 drug application under section 505. 

15 ‘‘(6) OTHER DRUGS DEEMED NEW DRUGS.— 

16 Except as provided in subsection (m), a drug is 

17 deemed to be a new drug under section 201(p) and 

18 misbranded under section 502(ee) if the drug— 

19 ‘‘(A) is not subject to section 503(b)(1); 

20 and 

21 ‘‘(B) is not described in paragraph (1), 

22 (2), (3), (4), or (5), or subsection (b)(1)(B). 

23 ‘‘(b) ADMINISTRATIVE ORDERS.— 

24 ‘‘(1) IN GENERAL.— 


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1 ‘‘(A) DETERMINATION.—The Secretary 

2 may, on the initiative of the Secretary or at the 

3 request of one or more requestors, issue an ad4 ministrative order determining whether there 

5 are conditions under which a specific drug, a 

6 class of drugs, or a combination of drugs, is de7 termined to be— 

8 ‘‘(i) not subject to section 503(b)(1); 

9 and 

10 ‘‘(ii) generally recognized as safe and 

11 effective under section 201(p)(1). 

12 ‘‘(B) EFFECT.—A drug or combination of 

13 drugs shall be deemed to not require approval 

14 under section 505 if such drug or combination 

15 of drugs— 

16 ‘‘(i) is determined by the Secretary to 

17 meet the conditions specified in clauses (i) 

18 and (ii) of subparagraph (A); 

19 ‘‘(ii) is marketed in conformity with 

20 an administrative order under this sub21 section; 

22 ‘‘(iii) meets the general requirements 

23 for nonprescription drugs; and 

24 ‘‘(iv) meets the requirements under 

25 subsections (c) and (k). 


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1 ‘‘(C) STANDARD.—The Secretary shall find 

2 that a drug is not generally recognized as safe 

3 and effective under section 201(p)(1) if— 

4 ‘‘(i) the evidence shows that the drug 

5 is not generally recognized as safe and ef6 fective under section 201(p)(1); or 

7 ‘‘(ii) the evidence is inadequate to 

8 show that the drug is generally recognized 

9 as safe and effective under section 

10 201(p)(1). 

11 ‘‘(2) ADMINISTRATIVE ORDERS INITIATED BY

12 THE SECRETARY.— 

13 ‘‘(A) IN GENERAL.—In issuing an adminis14 trative order under paragraph (1) upon the 

15 Secretary’s initiative, the Secretary shall— 

16 ‘‘(i) make reasonable efforts to notify 

17 informally, not later than 2 business days 

18 before the issuance of the proposed order, 

19 the sponsors of drugs who have a listing in 

20 effect under section 510(j) for the drugs or 

21 combination of drugs that will be subject 

22 to the administrative order; 

23 ‘‘(ii) after any such reasonable efforts 

24 of notification— 


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1 ‘‘(I) issue a proposed administra2 tive order by publishing it on the 

3 website of the Food and Drug Admin4 istration and include in such order the 

5 reasons for the issuance of such order; 

6 and 

7 ‘‘(II) publish a notice of avail8 ability of such proposed order in the 

9 Federal Register; 

10 ‘‘(iii) except as provided in subpara11 graph (B), provide for a public comment 

12 period with respect to such proposed order 

13 of not less than 45 calendar days; and 

14 ‘‘(iv) if, after completion of the pro15 ceedings specified in clauses (i) through 

16 (iii), the Secretary determines that it is ap17 propriate to issue a final administrative 

18 order— 

19 ‘‘(I) issue the final administrative 

20 order, together with a detailed state21 ment of reasons, which order shall not 

22 take effect until the time for request23 ing judicial review under paragraph 

24 (3)(D)(ii) has expired; 


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1 ‘‘(II) publish a notice of such 

2 final administrative order in the Fed3 eral Register; 

4 ‘‘(III) afford requestors of drugs 

5 that will be subject to such order the 

6 opportunity for formal dispute resolu7 tion up to the level of the Director of 

8 the Center for Drug Evaluation and 

9 Research, which initially must be re10 quested within 45 calendar days of 

11 the issuance of the order, and, for 

12 subsequent levels of appeal, within 30 

13 calendar days of the prior decision; 

14 and 

15 ‘‘(IV) except with respect to 

16 drugs described in paragraph (3)(B), 

17 upon completion of the formal dispute 

18 resolution procedure, inform the per19 sons which sought such dispute reso20 lution of their right to request a hear21 ing. 

22 ‘‘(B) EXCEPTIONS.—When issuing an ad23 ministrative order under paragraph (1) on the 

24 Secretary’s initiative proposing to determine 

25 that a drug described in subsection (a)(3) is not 


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1 generally recognized as safe and effective under 

2 section 201(p)(1), the Secretary shall follow the 

3 procedures in subparagraph (A), except that— 

4 ‘‘(i) the proposed order shall include 

5 notice of— 

6 ‘‘(I) the general categories of 

7 data the Secretary has determined 

8 necessary to establish that the drug is 

9 generally recognized as safe and effec10 tive under section 201(p)(1); and 

11 ‘‘(II) the format for submissions 

12 by interested persons; 

13 ‘‘(ii) the Secretary shall provide for a 

14 public comment period of no less than 180 

15 calendar days with respect to such pro16 posed order, except when the Secretary de17 termines, for good cause, that a shorter pe18 riod is in the interest of public health; and 

19 ‘‘(iii) any person who submits data in 

20 such comment period shall include a cer21 tification that the person has submitted all 

22 evidence created, obtained, or received by 

23 that person that is both within the cat24 egories of data identified in the proposed 

25 order and relevant to a determination as to 


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1 whether the drug is generally recognized as 

2 safe and effective under section 201(p)(1). 

3 ‘‘(3) HEARINGS; JUDICIAL REVIEW.— 

4 ‘‘(A) IN GENERAL.—Only a person who 

5 participated in each stage of formal dispute res6 olution under subclause (III) of paragraph 

7 (2)(A)(iv) of an administrative order with re8 spect to a drug may request a hearing con9 cerning a final administrative order issued 

10 under such paragraph with respect to such 

11 drug. If a hearing is sought, such person must 

12 submit a request for a hearing, which shall be 

13 based solely on information in the administra14 tive record, to the Secretary not later than 30 

15 calendar days after receiving notice of the final 

16 decision of the formal dispute resolution proce17 dure. 

18 ‘‘(B) NO HEARING REQUIRED WITH RE19 SPECT TO ORDERS RELATING TO CERTAIN

20 DRUGS.— 

21 ‘‘(i) IN GENERAL.—The Secretary 

22 shall not be required to provide notice and 

23 an opportunity for a hearing pursuant to 

24 paragraph (2)(A)(iv) if the final adminis25 trative order involved relates to a drug— 


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1 ‘‘(I) that is described in sub2 section (a)(3)(A); and 

3 ‘‘(II) with respect to which no 

4 human or non-human data studies rel5 evant to the safety or effectiveness of 

6 such drug have been submitted to the 

7 administrative record since the 

8 issuance of the most recent tentative 

9 final monograph relating to such 

10 drug. 

11 ‘‘(ii) HUMAN DATA STUDIES AND

12 NON-HUMAN DATA DEFINED.—In this sub13 paragraph: 

14 ‘‘(I) The term ‘human data stud15 ies’ means clinical trials of safety or 

16 effectiveness (including actual use 

17 studies), pharmacokinetics studies, or 

18 bioavailability studies. 

19 ‘‘(II) The term ‘non-human data’ 

20 means data from testing other than 

21 with human subjects which provides 

22 information concerning safety or ef23 fectiveness. 

24 ‘‘(C) HEARING PROCEDURES.— 


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1 ‘‘(i) DENIAL OF REQUEST FOR HEAR2 ING.—If the Secretary determines that in3 formation submitted in a request for a 

4 hearing under subparagraph (A) with re5 spect to a final administrative order issued 

6 under paragraph (2)(A)(iv), does not iden7 tify the existence of a genuine and sub8 stantial question of material fact, the Sec9 retary may deny such request. In making 

10 such a determination, the Secretary may 

11 consider only information and data that 

12 are based on relevant and reliable scientific 

13 principles and methodologies. 

14 ‘‘(ii) SINGLE HEARING FOR MULTIPLE

15 RELATED REQUESTS.—If more than one 

16 request for a hearing is submitted with re17 spect to the same administrative order 

18 under subparagraph (A), the Secretary 

19 may direct that a single hearing be con20 ducted in which all persons whose hearing 

21 requests were granted may participate. 

22 ‘‘(iii) PRESIDING OFFICER.—The pre23 siding officer of a hearing requested under 

24 subparagraph (A) shall— 


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1 ‘‘(I) be designated by the Sec2 retary; 

3 ‘‘(II) not be an employee of the 

4 Center for Drug Evaluation and Re5 search; and 

6 ‘‘(III) not have been previously 

7 involved in the development of the ad8 ministrative order involved or pro9 ceedings relating to that administra10 tive order. 

11 ‘‘(iv) RIGHTS OF PARTIES TO HEAR12 ING.—The parties to a hearing requested 

13 under subparagraph (A) shall have the 

14 right to present testimony, including testi15 mony of expert witnesses, and to cross-ex16 amine witnesses presented by other parties. 

17 Where appropriate, the presiding officer 

18 may require that cross-examination by par19 ties representing substantially the same in20 terests be consolidated to promote effi21 ciency and avoid duplication. 

22 ‘‘(v) FINAL DECISION.— 

23 ‘‘(I) At the conclusion of a hear24 ing requested under subparagraph 

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1 ing shall issue a decision containing 

2 findings of fact and conclusions of 

3 law. The decision of the presiding offi4 cer shall be final. 

5 ‘‘(II) The final decision may not 

6 take effect until the period under sub7 paragraph (D)(ii) for submitting a re8 quest for judicial review of such deci9 sion expires. 

10 ‘‘(D) JUDICIAL REVIEW OF FINAL ADMIN11 ISTRATIVE ORDER.— 

12 ‘‘(i) IN GENERAL.—The procedures 

13 described in section 505(h) shall apply 

14 with respect to judicial review of final ad15 ministrative orders issued under this sub16 section in the same manner and to the 

17 same extent as such section applies to an 

18 order described in such section except that 

19 the judicial review shall be taken by filing 

20 in an appropriate district court of the 

21 United States in lieu of the appellate 

22 courts specified in such section. 

23 ‘‘(ii) PERIOD TO SUBMIT A REQUEST

24 FOR JUDICIAL REVIEW.—A person eligible 

25 to request a hearing under this paragraph 


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1 and seeking judicial review of a final ad2 ministrative order issued under this sub3 section shall file such request for judicial 

4 review not later than 60 calendar days 

5 after the latest of— 

6 ‘‘(I) the date on which notice of 

7 such order is published; 

8 ‘‘(II) the date on which a hearing 

9 with respect to such order is denied 

10 under subparagraph (B) or (C)(i); 

11 ‘‘(III) the date on which a final 

12 decision is made following a hearing 

13 under subparagraph (C)(v); or 

14 ‘‘(IV) if no hearing is requested, 

15 the date on which the time for re16 questing a hearing expires. 

17 ‘‘(4) EXPEDITED PROCEDURE WITH RESPECT

18 TO ADMINISTRATIVE ORDERS INITIATED BY THE

19 SECRETARY.— 

20 ‘‘(A) IMMINENT HAZARD TO THE PUBLIC

21 HEALTH.— 

22 ‘‘(i) IN GENERAL.—In the case of a 

23 determination by the Secretary that a 

24 drug, class of drugs, or combination of 

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1 minent hazard to the public health, the 

2 Secretary, after first making reasonable ef3 forts to notify, not later than 48 hours be4 fore issuance of such order under this sub5 paragraph, sponsors who have a listing in 

6 effect under section 510(j) for such drug 

7 or combination of drugs— 

8 ‘‘(I) may issue an interim final 

9 administrative order for such drug, 

10 class of drugs, or combination of 

11 drugs under paragraph (1), together 

12 with a detailed statement of the rea13 sons for such order; 

14 ‘‘(II) shall publish in the Federal 

15 Register a notice of availability of any 

16 such order; and 

17 ‘‘(III) shall provide for a public 

18 comment period of at least 45 cal19 endar days with respect to such in20 terim final order. 

21 ‘‘(ii) NONDELEGATION.—The Sec22 retary may not delegate the authority to 

23 issue an interim final administrative order 

24 under this subparagraph. 

25 ‘‘(B) SAFETY LABELING CHANGES.— 


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1 ‘‘(i) IN GENERAL.—In the case of a 

2 determination by the Secretary that a 

3 change in the labeling of a drug, class of 

4 drugs, or combination of drugs subject to 

5 this section is reasonably expected to miti6 gate a significant or unreasonable risk of 

7 a serious adverse event associated with use 

8 of the drug, the Secretary may— 

9 ‘‘(I) make reasonable efforts to 

10 notify informally, not later than 48 

11 hours before the issuance of the in12 terim final order, the sponsors of 

13 drugs who have a listing in effect 

14 under section 510(j) for such drug or 

15 combination of drugs; 

16 ‘‘(II) after reasonable efforts of 

17 notification, issue an interim final ad18 ministrative order in accordance with 

19 paragraph (1) to require such change, 

20 together with a detailed statement of 

21 the reasons for such order; 

22 ‘‘(III) publish in the Federal 

23 Register a notice of availability of 

24 such order; and 


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1 ‘‘(IV) provide for a public com2 ment period of at least 45 calendar 

3 days with respect to such interim final 

4 order. 

5 ‘‘(ii) CONTENT OF ORDER.—An in6 terim final order issued under this sub7 paragraph with respect to the labeling of a 

8 drug may provide for new warnings and 

9 other information required for safe use of 

10 the drug. 

11 ‘‘(C) EFFECTIVE DATE.—An order under 

12 subparagraph (A) or (B) shall take effect on a 

13 date specified by the Secretary. 

14 ‘‘(D) FINAL ORDER.—After the completion 

15 of the proceedings in subparagraph (A) or (B), 

16 the Secretary shall— 

17 ‘‘(i) issue a final order in accordance 

18 with paragraph (1); 

19 ‘‘(ii) publish a notice of availability of 

20 such final administrative order in the Fed21 eral Register; and 

22 ‘‘(iii) afford sponsors of such drugs 

23 that will be subject to such an order the 

24 opportunity for formal dispute resolution 

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1 ter for Drug Evaluation and Research, 

2 which must initially be within 45 calendar 

3 days of the issuance of the order, and for 

4 subsequent levels of appeal, within 30 cal5 endar days of the prior decision. 

6 ‘‘(E) HEARINGS.—A sponsor of a drug 

7 subject to a final order issued under subpara8 graph (D) and that participated in each stage 

9 of formal dispute resolution under clause (iii) of 

10 such subparagraph may request a hearing on 

11 such order. The provisions of subparagraphs 

12 (A), (B), and (C) of paragraph (3), other than 

13 paragraph (3)(C)(v)(II), shall apply with re14 spect to a hearing on such order in the same 

15 manner and to the same extent as such provi16 sions apply with respect to a hearing on an ad17 ministrative order issued under paragraph 

18 (2)(A)(iv). 

19 ‘‘(F) TIMING.— 

20 ‘‘(i) FINAL ORDER AND HEARING.— 

21 The Secretary shall— 

22 ‘‘(I) not later than 6 months 

23 after the date on which the comment 

24 period closes under subparagraph (A) 


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1 or (B), issue a final order in accord2 ance with paragraph (1); and 

3 ‘‘(II) not later than 12 months 

4 after the date on which such final 

5 order is issued, complete any hearing 

6 under subparagraph (E). 

7 ‘‘(ii) DISPUTE RESOLUTION RE8 QUEST.—The Secretary shall specify in an 

9 interim final order issued under subpara10 graph (A) or (B) such shorter periods for 

11 requesting dispute resolution under sub12 paragraph (D)(iii) as are necessary to 

13 meet the requirements of this subpara14 graph. 

15 ‘‘(G) JUDICIAL REVIEW.—A final order 

16 issued pursuant to subparagraph (F) shall be 

17 subject to judicial review in accordance with 

18 paragraph (3)(D). 

19 ‘‘(5) ADMINISTRATIVE ORDER INITIATED AT

20 THE REQUEST OF A REQUESTOR.— 

21 ‘‘(A) IN GENERAL.—In issuing an adminis22 trative order under paragraph (1) at the re23 quest of a requestor with respect to certain 

24 drugs, classes of drugs, or combinations of 

25 drugs— 


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1 ‘‘(i) the Secretary shall, after receiv2 ing a request under this subparagraph, de3 termine whether the request is sufficiently 

4 complete and formatted to permit a sub5 stantive review; 

6 ‘‘(ii) if the Secretary determines that 

7 the request is sufficiently complete and for8 matted to permit a substantive review, the 

9 Secretary shall— 

10 ‘‘(I) file the request; and 

11 ‘‘(II) initiate proceedings with re12 spect to issuing an administrative 

13 order in accordance with paragraphs 

14 (2) and (3); and 

15 ‘‘(iii) except as provided in paragraph 

16 (6), if the Secretary determines that a re17 quest does not meet the requirements for 

18 filing or is not sufficiently complete and 

19 formatted to permit a substantive review, 

20 the requestor may demand that the request 

21 be filed over protest, and the Secretary 

22 shall initiate proceedings to review the re23 quest in accordance with paragraph (2)(A). 

24 ‘‘(B) REQUEST TO INITIATE PRO25 CEEDINGS.— 


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1 ‘‘(i) IN GENERAL.—A requestor seek2 ing an administrative order under para3 graph (1) with respect to certain drugs, 

4 classes of drugs, or combinations of drugs, 

5 shall submit to the Secretary a request to 

6 initiate proceedings for such order in the 

7 form and manner as specified by the Sec8 retary. Such requestor may submit a re9 quest under this subparagraph for the 

10 issuance of an administrative order— 

11 ‘‘(I) determining whether a drug 

12 is generally recognized as safe and ef13 fective under section 201(p)(1), ex14 empt from section 503(b)(1), and not 

15 required to be the subject of an ap16 proved application under section 505; 

17 or 

18 ‘‘(II) determining whether a 

19 change to a condition of use of a drug 

20 is generally recognized as safe and ef21 fective under section 201(p)(1), ex22 empt from section 503(b)(1), and not 

23 required to be the subject of an ap24 proved application under section 505, 


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1 if, absent such a changed condition of 

2 use, such drug is— 

3 ‘‘(aa) generally recognized 

4 as safe and effective under sec5 tion 201(p)(1) in accordance with 

6 subsection (a)(1), (a)(2), or an 

7 order under this subsection; or 

8 ‘‘(bb) subject to subsection 

9 (a)(3), but only if such requestor 

10 initiates such request in conjunc11 tion with a request for the Sec12 retary to determine whether such 

13 drug is generally recognized as 

14 safe and effective under section 

15 201(p)(1), which is filed by the 

16 Secretary under subparagraph 

17 (A)(ii). 

18 ‘‘(ii) EXCEPTION.—The Secretary is 

19 not required to complete review of a re20 quest for a change described in clause 

21 (i)(II) if the Secretary determines that 

22 there is an inadequate basis to find the 

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1 graph (1) and issues a final order an2 nouncing that determination. 

3 ‘‘(iii) WITHDRAWAL.—The requestor 

4 may withdraw a request under this para5 graph, according to the procedures set 

6 forth pursuant to subsection (d)(2)(B). 

7 Notwithstanding any other provision of 

8 this section, if such request is withdrawn, 

9 the Secretary may cease proceedings under 

10 this subparagraph. 

11 ‘‘(C) EXCLUSIVITY.— 

12 ‘‘(i) IN GENERAL.—A final adminis13 trative order issued in response to a re14 quest under this section shall have the ef15 fect of authorizing solely the order re16 questor (or the licensees, assignees, or suc17 cessors in interest of such requestor with 

18 respect to the subject of such order), for a 

19 period of 18 months following the effective 

20 date of such final order and beginning on 

21 the date the requestor may lawfully market 

22 such drugs pursuant to the order, to mar23 ket drugs— 

24 ‘‘(I) incorporating changes de25 scribed in clause (ii); and 


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1 ‘‘(II) subject to the limitations 

2 under clause (iv). 

3 ‘‘(ii) CHANGES DESCRIBED.—A 

4 change described in this clause is a change 

5 subject to an order specified in clause (i), 

6 which— 

7 ‘‘(I) provides for a drug to con8 tain an active ingredient (including 

9 any ester or salt of the active ingre10 dient) not previously incorporated in a 

11 drug described in clause (iii); or 

12 ‘‘(II) provides for a change in the 

13 conditions of use of a drug, for which 

14 new human data studies conducted or 

15 sponsored by the requestor (or for 

16 which the requestor has an exclusive 

17 right of reference) were essential to 

18 the issuance of such order. 

19 ‘‘(iii) DRUGS DESCRIBED.—The drugs 

20 described in this clause are drugs— 

21 ‘‘(I) specified in subsection 

22 (a)(1), (a)(2), or (a)(3); 

23 ‘‘(II) subject to a final order 

24 issued under this section; 


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1 ‘‘(III) subject to a final sun2 screen order (as defined in section 

3 586(2)(A)); or 

4 ‘‘(IV) described in subsection 

5 (m)(1), other than drugs subject to an 

6 active enforcement action under chap7 ter III of this Act. 

8 ‘‘(iv) LIMITATIONS ON EXCLU9 SIVITY.— 

10 ‘‘(I) IN GENERAL.—Only one 18- 

11 month period under this subpara12 graph shall be granted, under each 

13 order described in clause (i), with re14 spect to changes (to the drug subject 

15 to such order) which are either— 

16 ‘‘(aa) changes described in 

17 clause (ii)(I), relating to active 

18 ingredients; or 

19 ‘‘(bb) changes described in 

20 clause (ii)(II), relating to condi21 tions of use. 

22 ‘‘(II) NO EXCLUSIVITY AL23 LOWED.—No exclusivity shall apply to 

24 changes to a drug which are— 


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1 ‘‘(aa) the subject of a Tier 2 

2 OTC monograph order request 

3 (as defined in section 744L); 

4 ‘‘(bb) safety-related changes, 

5 as defined by the Secretary, or 

6 any other changes the Secretary 

7 considers necessary to assure 

8 safe use; or 

9 ‘‘(cc) changes related to 

10 methods of testing safety or effi11 cacy. 

12 ‘‘(v) NEW HUMAN DATA STUDIES DE13 FINED.—In this subparagraph, the term 

14 ‘new human data studies’ means clinical 

15 trials of safety or effectiveness (including 

16 actual use studies), pharmacokinetics stud17 ies, or bioavailability studies, the results of 

18 which— 

19 ‘‘(I) have not been relied on by 

20 the Secretary to support— 

21 ‘‘(aa) a proposed or final de22 termination that a drug described 

23 in subclause (I), (II), or (III) of 

24 clause (iii) is generally recognized 


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1 as safe and effective under sec2 tion 201(p)(1); or 

3 ‘‘(bb) approval of a drug 

4 that was approved under section 

5 505; and 

6 ‘‘(II) do not duplicate the results 

7 of another study that was relied on by 

8 the Secretary to support— 

9 ‘‘(aa) a proposed or final de10 termination that a drug described 

11 in subclause (I), (II), or (III) of 

12 clause (iii) is generally recognized 

13 as safe and effective under sec14 tion 201(p)(1); or 

15 ‘‘(bb) approval of a drug 

16 that was approved under section 

17 505. 

18 ‘‘(6) INFORMATION REGARDING SAFE NON19 PRESCRIPTION MARKETING AND USE AS CONDITION

20 FOR FILING A GENERALLY RECOGNIZED AS SAFE

21 AND EFFECTIVE REQUEST.— 

22 ‘‘(A) IN GENERAL.—In response to a re23 quest under this section that a drug described 

24 in subparagraph (B) be generally recognized as 

25 safe and effective, the Secretary— 


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1 ‘‘(i) may file such request, if the re2 quest includes information specified under 

3 subparagraph (C) with respect to safe non4 prescription marketing and use of such 

5 drug; or 

6 ‘‘(ii) if the request fails to include in7 formation specified under subparagraph 

8 (C), shall refuse to file such request and 

9 require that nonprescription marketing of 

10 the drug be pursuant to a new drug appli11 cation as described in subparagraph (D). 

12 ‘‘(B) DRUG DESCRIBED.—A drug de13 scribed in this subparagraph is a nonprescrip14 tion drug which contains an active ingredient 

15 not previously incorporated in a drug— 

16 ‘‘(i) specified in subsection (a)(1), 

17 (a)(2), or (a)(3); 

18 ‘‘(ii) subject to a final order under 

19 this section; or 

20 ‘‘(iii) subject to a final sunscreen 

21 order (as defined in section 586(2)(A)). 

22 ‘‘(C) INFORMATION DEMONSTRATING

23 PRIMA FACIE SAFE NONPRESCRIPTION MAR24 KETING AND USE.—Information specified in 


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1 this subparagraph, with respect to a request de2 scribed in subparagraph (A)(i), is— 

3 ‘‘(i) information sufficient for a prima 

4 facie demonstration that the drug subject 

5 to such request has a verifiable history of 

6 being marketed and safely used by con7 sumers in the United States as a non8 prescription drug under comparable condi9 tions of use; 

10 ‘‘(ii) if the drug has not been pre11 viously marketed in the United States as a 

12 nonprescription drug, information suffi13 cient for a prima facie demonstration that 

14 the drug was marketed and safely used 

15 under comparable conditions of marketing 

16 and use in a country listed in section 

17 802(b)(1)(A) or designated by the Sec18 retary in accordance with section 

19 802(b)(1)(B)— 

20 ‘‘(I) for such period as needed to 

21 provide reasonable assurances con22 cerning the safe nonprescription use 

23 of the drug; and 

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1 ulatory body considered acceptable by 

2 the Secretary for such monitoring 

3 purposes, including for adverse events 

4 associated with nonprescription use of 

5 the drug; or 

6 ‘‘(iii) if the Secretary determines that 

7 information described in clause (i) or (ii) is 

8 not needed to provide a prima facie dem9 onstration that the drug can be safely mar10 keted and used as a nonprescription drug, 

11 such other information the Secretary deter12 mines is sufficient for such purposes. 

13 ‘‘(D) MARKETING PURSUANT TO NEW

14 DRUG APPLICATION.—In the case of a request 

15 described in subparagraph (A)(ii), the drug 

16 subject to such request may be re-submitted for 

17 filing only if— 

18 ‘‘(i) the drug is marketed as a non19 prescription drug, under conditions of use 

20 comparable to the conditions specified in 

21 the request, for such period as the Sec22 retary determines appropriate (not to ex23 ceed 5 consecutive years) pursuant to an 

24 application approved under section 505; 

25 and 


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1 ‘‘(ii) during such period, 1,000,000 

2 retail packages of the drug, or an equiva3 lent quantity as determined by the Sec4 retary, were distributed for retail sale, as 

5 determined in such manner as the Sec6 retary finds appropriate. 

7 ‘‘(E) RULE OF APPLICATION.—Except in 

8 the case of a request involving a drug described 

9 in section 586(9), as in effect on January 1, 

10 2017, if the Secretary refuses to file a request 

11 under this paragraph, the requestor may not 

12 file such request over protest under paragraph 

13 (5)(A)(iii). 

14 ‘‘(7) PACKAGING.—An administrative order 

15 issued under paragraph (2), (4)(A), or (5) may in16 clude requirements for the packaging of a drug to 

17 encourage use in accordance with labeling. Such re18 quirements may include unit dose packaging, re19 quirements for products intended for use by pedi20 atric populations, requirements to reduce risk of 

21 harm from unsupervised ingestion, and other appro22 priate requirements. This paragraph does not au23 thorize the Food and Drug Administration to re24 quire standards or testing procedures as described in 

25 part 1700 of title 16, Code of Federal Regulations. 


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1 ‘‘(8) FINAL AND TENTATIVE FINAL MONO2 GRAPHS FOR CATEGORY I DRUGS DEEMED FINAL

3 ADMINISTRATIVE ORDERS.— 

4 ‘‘(A) IN GENERAL.—A final monograph or 

5 tentative final monograph described in subpara6 graph (B) shall be deemed to be a final admin7 istrative order under this subsection and may 

8 be amended, revoked, or otherwise modified in 

9 accordance with the procedures of this sub10 section. 

11 ‘‘(B) MONOGRAPHS DESCRIBED.—For pur12 poses of subparagraph (A), a final monograph 

13 or tentative final monograph is described in this 

14 subparagraph if it— 

15 ‘‘(i) establishes conditions of use for a 

16 drug described in paragraph (1) or (2) of 

17 subsection (a); and 

18 ‘‘(ii) represents the most recently pro19 mulgated version of such conditions, in20 cluding as modified, in whole or in part, by 

21 any proposed or final rule. 

22 ‘‘(C) DEEMED ORDERS INCLUDE HARMO23 NIZING TECHNICAL AMENDMENTS.—The 

24 deemed establishment of a final administrative 

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1 strued to include any technical amendments to 

2 such order as the Secretary determines nec3 essary to ensure that such order is appro4 priately harmonized, in terms of terminology or 

5 cross-references, with the applicable provisions 

6 of this Act (and regulations thereunder) and 

7 any other orders issued under this section. 

8 ‘‘(c) PROCEDURE FOR MINOR CHANGES.— 

9 ‘‘(1) IN GENERAL.—Minor changes in the dos10 age form of a drug that is described in paragraph 

11 (1) or (2) of subsection (a) or the subject of an 

12 order issued under subsection (b) may be made by 

13 a requestor without the issuance of an order under 

14 subsection (b) if— 

15 ‘‘(A) the requestor maintains such infor16 mation as is necessary to demonstrate that the 

17 change— 

18 ‘‘(i) will not affect the safety or effec19 tiveness of the drug; and 

20 ‘‘(ii) will not materially affect the ex21 tent of absorption or other exposure to the 

22 active ingredient in comparison to a suit23 able reference product; and 

24 ‘‘(B) the change is in conformity with the 

25 requirements of an applicable administrative 


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1 order issued by the Secretary under paragraph 

2 (3). 

3 ‘‘(2) ADDITIONAL INFORMATION.— 

4 ‘‘(A) ACCESS TO RECORDS.—A sponsor 

5 shall submit records requested by the Secretary 

6 relating to such a minor change under section 

7 704(a)(4), within 15 business days of receiving 

8 such a request, or such longer period as the 

9 Secretary may provide. 

10 ‘‘(B) INSUFFICIENT INFORMATION.—If the 

11 Secretary determines that the information con12 tained in such records is not sufficient to dem13 onstrate that the change does not affect the 

14 safety or effectiveness of the drug or materially 

15 affect the extent of absorption or other expo16 sure to the active ingredient, the Secretary— 

17 ‘‘(i) may so inform the sponsor of the 

18 drug in writing; and 

19 ‘‘(ii) if the Secretary so informs the 

20 sponsor, shall provide the sponsor of the 

21 drug with a reasonable opportunity to pro22 vide additional information. 

23 ‘‘(C) FAILURE TO SUBMIT SUFFICIENT IN24 FORMATION.—If the sponsor fails to provide 

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1 scribed by the Secretary, or if the Secretary de2 termines that such additional information does 

3 not demonstrate that the change does not— 

4 ‘‘(i) affect the safety or effectiveness 

5 of the drug; or 

6 ‘‘(ii) materially affect the extent of 

7 absorption or other exposure to the active 

8 ingredient in comparison to a suitable ref9 erence product, 

10 the drug as modified is a new drug under sec11 tion 201(p) and shall be deemed to be mis12 branded under section 502(ee). 

13 ‘‘(3) DETERMINING WHETHER A CHANGE WILL

14 AFFECT SAFETY OR EFFECTIVENESS.— 

15 ‘‘(A) IN GENERAL.—The Secretary shall 

16 issue one or more administrative orders speci17 fying requirements for determining whether a 

18 minor change made by a sponsor pursuant to 

19 this subsection will affect the safety or effective20 ness of a drug or materially affect the extent of 

21 absorption or other exposure to an active ingre22 dient in the drug in comparison to a suitable 

23 reference product, together with guidance for 

24 applying those orders to specific dosage forms. 


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1 ‘‘(B) STANDARD PRACTICES.—The orders 

2 and guidance issued by the Secretary under 

3 subparagraph (A) shall take into account rel4 evant public standards and standard practices 

5 for evaluating the quality of drugs, and may 

6 take into account the special needs of popu7 lations, including children. 

8 ‘‘(d) CONFIDENTIALITY OF INFORMATION SUB9 MITTED TO THE SECRETARY.— 

10 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

11 any information, including reports of testing con12 ducted on the drug or drugs involved, that is sub13 mitted by a requestor in connection with proceedings 

14 on an order under this section (including any minor 

15 change under subsection (c)) and is a trade secret 

16 or confidential information subject to section 

17 552(b)(4) of title 5, United States Code, or section 

18 1905 of title 18, United States Code, shall not be 

19 disclosed to the public unless the requestor consents 

20 to that disclosure. 

21 ‘‘(2) PUBLIC AVAILABILITY.— 

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

23 subparagraph (B), the Secretary shall— 

24 ‘‘(i) make any information submitted 

25 by a requestor in support of a request 


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1 under subsection (b)(5)(A) available to the 

2 public not later than the date on which the 

3 proposed order is issued; and 

4 ‘‘(ii) make any information submitted 

5 by any other person with respect to an 

6 order requested (or initiated by the Sec7 retary) under subsection (b), available to 

8 the public upon such submission. 

9 ‘‘(B) LIMITATIONS ON PUBLIC AVAIL10 ABILITY.—Information described in subpara11 graph (A) shall not be made public if— 

12 ‘‘(i) the information pertains to phar13 maceutical quality information, unless such 

14 information is necessary to establish stand15 ards under which a drug is generally rec16 ognized as safe and effective under section 

17 201(p)(1); 

18 ‘‘(ii) the information is submitted in a 

19 requestor-initiated request, but the re20 questor withdraws such request, in accord21 ance with withdrawal procedures estab22 lished by the Secretary, before the Sec23 retary issues the proposed order; 

24 ‘‘(iii) the Secretary requests and ob25 tains the information under subsection (c) 


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1 and such information is not submitted in 

2 relation to an order under subsection (b); 

3 or 

4 ‘‘(iv) the information is of the type 

5 contained in raw datasets. 

6 ‘‘(e) UPDATES TO DRUG LISTING INFORMATION.— 

7 A sponsor who makes a change to a drug subject to this 

8 section shall submit updated drug listing information for 

9 the drug in accordance with section 510(j) within 30 cal10 endar days of the date when the drug is first commercially 

11 marketed, except that a sponsor who was the order re12 questor with respect to an order subject to subsection 

13 (b)(5)(C) (or a licensee, assignee, or successor in interest 

14 of such requestor) shall submit updated drug listing infor15 mation on or before the date when the drug is first com16 mercially marketed. 

17 ‘‘(f) APPROVALS UNDER SECTION 505.—The provi18 sions of this section shall not be construed to preclude a 

19 person from seeking or maintaining the approval of an ap20 plication for a drug under sections 505(b)(1), 505(b)(2), 

21 and 505(j). A determination under this section that a drug 

22 is not subject to section 503(b)(1), is generally recognized 

23 as safe and effective under section 201(p)(1), and is not 

24 a new drug under section 201(p) shall constitute a finding 

25 that the drug is safe and effective that may be relied upon 


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1 for purposes of an application under section 505(b)(2), so 

2 that the applicant shall be required to submit for purposes 

3 of such application only information needed to support any 

4 modification of the drug that is not covered by such deter5 mination under this section. 

6 ‘‘(g) PUBLIC AVAILABILITY OF ADMINISTRATIVE OR7 DERS.—The Secretary shall establish, maintain, update 

8 (as determined necessary by the Secretary but no less fre9 quently than annually), and make publicly available, with 

10 respect to orders issued under this section— 

11 ‘‘(1) a repository of each final order and in12 terim final order in effect, including the complete 

13 text of the order; and 

14 ‘‘(2) a listing of all orders proposed and under 

15 development under subsection (b)(2), including— 

16 ‘‘(A) a brief description of each such order; 

17 and 

18 ‘‘(B) the Secretary’s expectations, if re19 sources permit, for issuance of proposed orders 

20 over a 3-year period. 

21 ‘‘(h) DEVELOPMENT ADVICE TO SPONSORS OR RE22 QUESTORS.—The Secretary shall establish procedures 

23 under which sponsors or requestors may meet with appro24 priate officials of the Food and Drug Administration to 

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1 essary to support submissions under this section and other 

2 matters relevant to the regulation of nonprescription 

3 drugs and the development of new nonprescription drugs 

4 under this section. 

5 ‘‘(i) PARTICIPATION OF MULTIPLE SPONSORS OR RE6 QUESTORS.—The Secretary shall establish procedures to 

7 facilitate efficient participation by multiple sponsors or re8 questors in proceedings under this section, including provi9 sion for joint meetings with multiple sponsors or reques10 tors or with organizations nominated by sponsors or re11 questors to represent their interests in a proceeding. 

12 ‘‘(j) ELECTRONIC FORMAT.—All submissions under 

13 this section shall be in electronic format. 

14 ‘‘(k) EFFECT ON EXISTING REGULATIONS GOV15 ERNING NONPRESCRIPTION DRUGS.— 

16 ‘‘(1) REGULATIONS OF GENERAL APPLICA17 BILITY TO NONPRESCRIPTION DRUGS.—Except as 

18 provided in this subsection, nothing in this section 

19 supersedes regulations establishing general require20 ments for nonprescription drugs, including regula21 tions of general applicability contained in parts 201, 

22 250, and 330 of title 21, Code of Federal Regula23 tions, or any successor regulations. The Secretary 

24 shall establish or modify such regulations by means 


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1 of rulemaking in accordance with section 553 of title 

2 5, United States Code. 

3 ‘‘(2) REGULATIONS ESTABLISHING REQUIRE4 MENTS FOR SPECIFIC NONPRESCRIPTION DRUGS.— 

5 ‘‘(A) The provisions of section 310.545 of 

6 title 21, Code of Federal Regulations, as in ef7 fect on the day before the date of the enact8 ment of this section, shall be deemed to be a 

9 final order under subsection (b). 

10 ‘‘(B) Regulations in effect on the day be11 fore the date of the enactment of this section, 

12 establishing requirements for specific non13 prescription drugs marketed pursuant to this 

14 section (including such requirements in parts 

15 201 and 250 of title 21, Code of Federal Regu16 lations), shall be deemed to be final orders 

17 under subsection (b), only as they apply to 

18 drugs— 

19 ‘‘(i) subject to paragraph (1), (2), (3), 

20 or (4) of subsection (a); or 

21 ‘‘(ii) otherwise subject to an order 

22 under this section. 

23 ‘‘(3) WITHDRAWAL OF REGULATIONS.—The 

24 Secretary shall withdraw regulations establishing 

25 final monographs and the procedures governing the 


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1 over-the-counter drug review under part 330 and 

2 other relevant parts of title 21, Code of Federal 

3 Regulations (as in effect on the day before the date 

4 of the enactment of this section), or make technical 

5 changes to such regulations to ensure conformity 

6 with appropriate terminology and cross references. 

7 Notwithstanding subchapter II of chapter 5 of title 

8 5, United States Code, any such withdrawal or tech9 nical changes shall be made without public notice 

10 and comment and shall be effective upon publication 

11 through notice in the Federal Register (or upon such 

12 date as specified in such notice). 

13 ‘‘(l) GUIDANCE.—The Secretary shall issue guidance 

14 that specifies— 

15 ‘‘(1) the procedures and principles for formal 

16 meetings between the Secretary and sponsors or re17 questors for drugs subject to this section; 

18 ‘‘(2) the format and content of data submis19 sions to the Secretary under this section; 

20 ‘‘(3) the format of electronic submissions to the 

21 Secretary under this section; 

22 ‘‘(4) consolidated proceedings for appeal and 

23 the procedures for such proceedings where appro24 priate; and 


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1 ‘‘(5) for minor changes in drugs, recommenda2 tions on how to comply with the requirements in or3 ders issued under subsection (c)(3). 

4 ‘‘(m) RULE OF CONSTRUCTION.— 

5 ‘‘(1) IN GENERAL.—This section shall not af6 fect the treatment or status of a nonprescription 

7 drug— 

8 ‘‘(A) that is marketed without an applica9 tion approved under section 505 as of the date 

10 of the enactment of this section; 

11 ‘‘(B) that is not subject to an order issued 

12 under this section; and 

13 ‘‘(C) to which paragraphs (1), (2), (3), (4), 

14 or (5) of subsection (a) do not apply. 

15 ‘‘(2) TREATMENT OF PRODUCTS PREVIOUSLY

16 FOUND TO BE SUBJECT TO TIME AND EXTENT RE17 QUIREMENTS.— 

18 ‘‘(A) Notwithstanding subsection (a), a 

19 drug described in subparagraph (B) may only 

20 be lawfully marketed, without an application 

21 approved under section 505, pursuant to an 

22 order issued under this section. 

23 ‘‘(B) A drug described in this subpara24 graph is a drug which, prior to the date of the 

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1 mined in a proposed or final rule to be ineligible 

2 for review under the OTC drug review (as such 

3 phrase ‘OTC drug review’ was used in section 

4 330.14 of title 21, Code of Federal Regulations, 

5 as in effect on the day before the date of the 

6 enactment of this section). 

7 ‘‘(3) PRESERVATION OF AUTHORITY.— 

8 ‘‘(A) Nothing in paragraph (1) shall be 

9 construed to preclude or limit the applicability 

10 of any provision of this Act other than this sec11 tion. 

12 ‘‘(B) Nothing in subsection (a) shall be 

13 construed to prohibit the Secretary from issuing 

14 an order under this section finding a drug to be 

15 not generally recognized as safe and effective 

16 under section 201(p)(1), as the Secretary deter17 mines appropriate. 

18 ‘‘(n) INVESTIGATIONAL NEW DRUGS.—A drug is not 

19 subject to this section if an exemption for investigational 

20 use under section 505(i) is in effect for such drug. 

21 ‘‘(o) INAPPLICABILITY OF PAPERWORK REDUCTION

22 ACT.—Chapter 35 of title 44, United States Code, shall 

23 not apply to collections of information made under this 

24 section. 


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1 ‘‘(p) INAPPLICABILITY OF NOTICE AND COMMENT

2 RULEMAKING AND OTHER REQUIREMENTS.—The re3 quirements of subsection (b) shall apply with respect to 

4 orders issued under this section instead of the require5 ments of subchapter II of chapter 5 of title 5, United 

6 States Code. 

7 ‘‘(q) DEFINITIONS.—In this section: 

8 ‘‘(1) The term ‘nonprescription drug’ refers to 

9 a drug not subject to the requirements of section 

10 503(b)(1). 

11 ‘‘(2) The term ‘sponsor’ refers to any person 

12 marketing, manufacturing, or processing a drug 

13 that— 

14 ‘‘(A) is listed pursuant to section 510(j); 

15 and 

16 ‘‘(B) is or will be subject to an administra17 tive order under this section of the Food and 

18 Drug Administration. 

19 ‘‘(3) The term ‘requestor’ refers to any person 

20 or group of persons marketing, manufacturing, proc21 essing, or developing a drug.’’. 

22 (b) GAO STUDY.—Not later than 4 years after the 

23 date of enactment of this Act, the Comptroller General 

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1 resentatives and the Committee on Health, Education, 

2 Labor, and Pensions of the Senate addressing the effec3 tiveness and overall impact of exclusivity under section 

4 505G of the Federal Food, Drug, and Cosmetic Act, as 

5 added by subsection (a), and section 586C of such Act 

6 (21 U.S.C. 360fff–3), including the impact of such exclu7 sivity on consumer access. Such study shall include— 

8 (1) an analysis of the impact of exclusivity 

9 under such section 505G for nonprescription drug 

10 products, including— 

11 (A) the number of nonprescription drug 

12 products that were granted exclusivity and the 

13 indication for which the nonprescription drug 

14 products were determined to be generally recog15 nized as safe and effective; 

16 (B) whether the exclusivity for such drug 

17 products was granted for— 

18 (i) a new active ingredient (including 

19 any ester or salt of the active ingredient); 

20 or 

21 (ii) changes in the conditions of use of 

22 a drug, for which new human data studies 

23 conducted or sponsored by the requestor 

24 were essential; 


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1 (C) whether, and to what extent, the exclu2 sivity impacted the requestor’s or sponsor’s de3 cision to develop the drug product; 

4 (D) an analysis of the implementation of 

5 the exclusivity provision in such section 505G, 

6 including— 

7 (i) the resources used by the Food 

8 and Drug Administration; 

9 (ii) the impact of such provision on 

10 innovation, as well as research and devel11 opment in the nonprescription drug mar12 ket; 

13 (iii) the impact of such provision on 

14 competition in the nonprescription drug 

15 market; 

16 (iv) the impact of such provision on 

17 consumer access to nonprescription drug 

18 products; 

19 (v) the impact of such provision on 

20 the prices of nonprescription drug prod21 ucts; and 

22 (vi) whether the administrative orders 

23 initiated by requestors under such section 

24 505G have been sufficient to encourage the 

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1 ucts that would likely not be otherwise de2 veloped, or developed in as timely a man3 ner; and 

4 (E) whether the administrative orders ini5 tiated by requestors under such section 505G 

6 have been sufficient incentive to encourage in7 novation in the nonprescription drug market; 

8 and 

9 (2) an analysis of the impact of exclusivity 

10 under such section 586C for sunscreen ingredients, 

11 including— 

12 (A) the number of sunscreen ingredients 

13 that were granted exclusivity and the specific 

14 ingredient that was determined to be generally 

15 recognized as safe and effective; 

16 (B) whether, and to what extent, the exclu17 sivity impacted the requestor’s or sponsor’s de18 cision to develop the sunscreen ingredient; 

19 (C) whether, and to what extent, the sun20 screen ingredient granted exclusivity had pre21 viously been available outside of the United 

22 States; 

23 (D) an analysis of the implementation of 

24 the exclusivity provision in such section 586C, 

25 including— 


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1 (i) the resources used by the Food 

2 and Drug Administration; 

3 (ii) the impact of such provision on 

4 innovation, as well as research and devel5 opment in the sunscreen market; 

6 (iii) the impact of such provision on 

7 competition in the sunscreen market; 

8 (iv) the impact of such provision on 

9 consumer access to sunscreen products; 

10 (v) the impact of such provision on 

11 the prices of sunscreen products; and 

12 (vi) whether the administrative orders 

13 initiated by requestors under such section 

14 505G have been utilized by sunscreen in15 gredient sponsors and whether such proc16 ess has been sufficient to encourage the 

17 development of sunscreen ingredients that 

18 would likely not be otherwise developed, or 

19 developed in as timely a manner; and 

20 (E) whether the administrative orders ini21 tiated by requestors under such section 586C 

22 have been sufficient incentive to encourage in23 novation in the sunscreen market. 


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1 (c) CONFORMING AMENDMENT.—Section 751(d)(1) 

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

3 379r(d)(1)) is amended— 

4 (1) in the matter preceding subparagraph (A)— 

5 (A) by striking ‘‘final regulation promul6 gated’’ and inserting ‘‘final order under section 

7 505G’’; and 

8 (B) by striking ‘‘and not misbranded’’; and 

9 (2) in subparagraph (A), by striking ‘‘regula10 tion in effect’’ and inserting ‘‘regulation or order in 

11 effect’’. 

12 SEC. 1002. MISBRANDING. 

13 Section 502 of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 352) is amended by adding at the end the 

15 following: 

16 ‘‘(ee) If it is a nonprescription drug that is subject 

17 to section 505G, is not the subject of an application ap18 proved under section 505, and does not comply with the 

19 requirements under section 505G. 

20 ‘‘(ff) If it is a drug and it was manufactured, pre21 pared, propagated, compounded, or processed in a facility 

22 for which fees have not been paid as required by section 

23 744M.’’. 


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1 SEC. 1003. DRUGS EXCLUDED FROM THE OVER-THE2 COUNTER DRUG REVIEW. 

3 (a) IN GENERAL.—Nothing in this Act (or the 

4 amendments made by this Act) shall apply to any non5 prescription drug (as defined in section 505G(q) of the 

6 Federal Food, Drug, and Cosmetic Act, as added by sec7 tion 1001 of this Act) which was excluded by the Food 

8 and Drug Administration from the Over-the-Counter 

9 Drug Review in accordance with the paragraph numbered 

10 25 on page 9466 of volume 37 of the Federal Register, 

11 published on May 11, 1972. 

12 (b) RULE OF CONSTRUCTION.—Nothing in this sec13 tion shall be construed to preclude or limit the applica14 bility of any other provision of the Federal Food, Drug, 

15 and Cosmetic Act (21 U.S.C. 301 et seq.). 

16 SEC. 1004. TREATMENT OF SUNSCREEN INNOVATION ACT. 

17 (a) REVIEW OF NONPRESCRIPTION SUNSCREEN AC18 TIVE INGREDIENTS.— 

19 (1) APPLICABILITY OF SECTION 505G FOR

20 PENDING SUBMISSIONS.— 

21 (A) IN GENERAL.—A sponsor of a non22 prescription sunscreen active ingredient or com23 bination of nonprescription sunscreen active in24 gredients that, as of the date of enactment of 

25 this Act, is subject to a proposed sunscreen 

26 order under section 586C of the Federal Food, 


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1 Drug, and Cosmetic Act (21 U.S.C. 360fff–3) 

2 may elect, by means of giving written notifica3 tion to the Secretary of Health and Human 

4 Services within 180 calendar days of the enact5 ment of this Act, to transition into the review 

6 of such ingredient or combination of ingredients 

7 pursuant to the process set out in section 505G 

8 of the Federal Food, Drug, and Cosmetic Act, 

9 as added by section 1001 of this Act. 

10 (B) ELECTION EXERCISED.—Upon receipt 

11 by the Secretary of Health and Human Services 

12 of a timely notification under subparagraph 

13 (A)— 

14 (i) the proposed sunscreen order in15 volved is deemed to be a request for an 

16 order under subsection (b) of section 505G 

17 of the Federal Food, Drug, and Cosmetic 

18 Act, as added by section 1001 of this Act; 

19 and 

20 (ii) such order is deemed to have been 

21 accepted for filing under subsection 

22 (b)(6)(A)(i) of such section 505G. 

23 (C) ELECTION NOT EXERCISED.—If a noti24 fication under subparagraph (A) is not received 

25 by the Secretary of Health and Human Services 


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1 within 180 calendar days of the date of enact2 ment of this Act, the review of the proposed 

3 sunscreen order described in subparagraph 

4 (A)— 

5 (i) shall continue under section 586C 

6 of the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 360fff–3); and 

8 (ii) shall not be eligible for review 

9 under section 505G, added by section 1001 

10 of this Act. 

11 (2) DEFINITIONS.—In this subsection, the 

12 terms ‘‘sponsor’’, ‘‘nonprescription’’, ‘‘sunscreen ac13 tive ingredient’’, and ‘‘proposed sunscreen order’’ 

14 have the meanings given to those terms in section 

15 586 of the Federal Food, Drug, and Cosmetic Act 

16 (21 U.S.C. 360fff). 

17 (b) AMENDMENTS TO SUNSCREEN PROVISIONS.— 

18 (1) FINAL SUNSCREEN ORDERS.—Paragraph 

19 (3) of section 586C(e) of the Federal Food, Drug, 

20 and Cosmetic Act (21 U.S.C. 360fff–3(e)) is amend21 ed to read as follows: 

22 ‘‘(3) RELATIONSHIP TO ORDERS UNDER SEC23 TION 505G.—A final sunscreen order shall be deemed 

24 to be a final order under section 505G.’’. 


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1 (2) MEETINGS.—Paragraph (7) of section 

2 586C(b) of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 360fff–3(b)) is amended— 

4 (A) by striking ‘‘A sponsor may request’’ 

5 and inserting the following: 

6 ‘‘(A) IN GENERAL.—A sponsor may re7 quest’’; and 

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

9 ‘‘(B) CONFIDENTIAL MEETINGS.—A spon10 sor may request one or more confidential meet11 ings with respect to a proposed sunscreen order, 

12 including a letter deemed to be a proposed sun13 screen order under paragraph (3), to discuss 

14 matters relating to data requirements to sup15 port a general recognition of safety and effec16 tiveness involving confidential information and 

17 public information related to such proposed 

18 sunscreen order, as appropriate. The Secretary 

19 shall convene a confidential meeting with such 

20 sponsor in a reasonable time period. If a spon21 sor requests more than one confidential meeting 

22 for the same proposed sunscreen order, the Sec23 retary may refuse to grant an additional con24 fidential meeting request if the Secretary deter25 mines that such additional confidential meeting 


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1 is not reasonably necessary for the sponsor to 

2 advance its proposed sunscreen order, or if the 

3 request for a confidential meeting fails to in4 clude sufficient information upon which to base 

5 a substantive discussion. The Secretary shall 

6 publish a post-meeting summary of each con7 fidential meeting under this subparagraph that 

8 does not disclose confidential commercial infor9 mation or trade secrets. This subparagraph 

10 does not authorize the disclosure of confidential 

11 commercial information or trade secrets subject 

12 to 552(b)(4) of title 5, United States Code, or 

13 section 1905 of title 18, United States Code.’’. 

14 (3) EXCLUSIVITY.—Section 586C of the Fed15 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

16 360fff–3) is amended by adding at the end the fol17 lowing: 

18 ‘‘(f) EXCLUSIVITY.— 

19 ‘‘(1) IN GENERAL.—A final sunscreen order 

20 shall have the effect of authorizing solely the order 

21 requestor (or the licensees, assignees, or successors 

22 in interest of such requestor with respect to the sub23 ject of such request and listed under paragraph (5)) 

24 for a period of 18 months, to market a sunscreen in25 gredient under this section incorporating changes 


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1 described in paragraph (2) subject to the limitations 

2 under paragraph (4), beginning on the date the re3 questor (or any licensees, assignees, or successors in 

4 interest of such requestor with respect to the subject 

5 of such request and listed under paragraph (5)) may 

6 lawfully market such sunscreen ingredient pursuant 

7 to the order. 

8 ‘‘(2) CHANGES DESCRIBED.—A change de9 scribed in this paragraph is a change subject to an 

10 order specified in paragraph (1) that permits a sun11 screen to contain an active sunscreen ingredient not 

12 previously incorporated in a marketed sunscreen list13 ed in paragraph (3). 

14 ‘‘(3) MARKETED SUNSCREEN.—The marketed 

15 sunscreen ingredients described in this paragraph 

16 are sunscreen ingredients— 

17 ‘‘(A) marketed in accordance with a final 

18 monograph for sunscreen drug products set 

19 forth at part 352 of title 21, Code of Federal 

20 Regulations (as published at 64 Fed. Reg. 

21 27687); or 

22 ‘‘(B) marketed in accordance with a final 

23 order issued under this section. 


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1 ‘‘(4) LIMITATIONS ON EXCLUSIVITY.—Only one 

2 18-month period may be granted per ingredient 

3 under paragraph (1). 

4 ‘‘(5) LISTING OF LICENSEES, ASSIGNEES, OR

5 SUCCESSORS IN INTEREST.—Requestors shall submit 

6 to the Secretary at the time when a drug subject to 

7 such request is introduced or delivered for introduc8 tion into interstate commerce, a list of licensees, as9 signees, or successors in interest under paragraph 

10 (1).’’. 

11 (4) SUNSET PROVISION.—Subchapter I of chap12 ter V of the Federal Food, Drug, and Cosmetic Act 

13 (21 U.S.C. 360fff et seq.) is amended by adding at 

14 the end the following: 

15 ‘‘SEC. 586H. SUNSET. 

16 ‘‘This subchapter shall cease to be effective at the end 

17 of fiscal year 2022.’’. 

18 (5) TREATMENT OF FINAL SUNSCREEN

19 ORDER.—The Federal Food, Drug, and Cosmetic 

20 Act is amended by striking section 586E of such Act 

21 (21 U.S.C. 360fff–5). 

22 (c) TREATMENT OF AUTHORITY REGARDING FINAL23 IZATION OF SUNSCREEN MONOGRAPH.— 

24 (1) IN GENERAL.— 


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1 (A) REVISION OF FINAL SUNSCREEN

2 ORDER.—Not later than November 26, 2019, 

3 the Secretary of Health and Human Services 

4 (referred to in this subsection as the ‘‘Sec5 retary’’) shall amend and revise the final ad6 ministrative order concerning nonprescription 

7 sunscreen (referred to in this subsection as the 

8 ‘‘sunscreen order’’) for which the content, prior 

9 to the date of enactment of this Act, was rep10 resented by the final monograph for sunscreen 

11 drug products set forth in part 352 of title 21, 

12 Code of Federal Regulations (as in effect on 

13 May 21, 1999). 

14 (B) ISSUANCE OF REVISED SUNSCREEN

15 ORDER; EFFECTIVE DATE.—A revised sunscreen 

16 order described in subparagraph (A) shall be— 

17 (i) issued in accordance with the pro18 cedures described in section 505G(c)(2) of 

19 the Federal Food, Drug, and Cosmetic 

20 Act; 

21 (ii) issued in proposed form not later 

22 than May 28, 2019; 

23 (iii) effective not later than November 

24 26, 2020; and 


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1 (iv) issued by the Secretary at least 1 

2 year prior to the effective date of the re3 vised order. 

4 (2) REPORTS.—If a revised sunscreen order 

5 issued under paragraph (1) does not include provi6 sions related to the effectiveness of various sun pro7 tection factor levels, and does not address all dosage 

8 forms known to the Secretary to be used in sun9 screens marketed in the United States without a 

10 new drug application approved under section 505 of 

11 the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 355), the Secretary shall submit a report to 

13 the Committee on Energy and Commerce of the 

14 House of Representatives and the Committee on 

15 Health, Education, Labor, and Pensions of the Sen16 ate on the rationale for omission of such provisions 

17 from such order, and a plan and timeline to compile 

18 any information necessary to address such provisions 

19 through such order. 

20 (d) TREATMENT OF NON-SUNSCREEN TIME AND EX21 TENT APPLICATIONS.— 

22 (1) IN GENERAL.—Any application described in 

23 section 586F of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 360fff–6) that was submitted 

25 to the Secretary pursuant to section 330.14 of title 


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1 21, Code of Federal Regulations, as such provisions 

2 were in effect immediately prior to the date of enact3 ment date of this Act, shall be extinguished as of 

4 such date of enactment, subject to paragraph (2). 

5 (2) ORDER REQUEST.—Nothing in paragraph 

6 (1) precludes the submission of an order request 

7 under section 505G(b) of the Federal Food, Drug, 

8 and Cosmetic Act, as added by section 1001 of this 

9 Act, with respect to a drug that was the subject of 

10 an application extinguished under paragraph (1). 

11 SEC. 1005. ANNUAL UPDATE TO CONGRESS ON APPRO12 PRIATE PEDIATRIC INDICATION FOR CER13 TAIN OTC COUGH AND COLD DRUGS. 

14 (a) IN GENERAL.—Subject to subsection (c), the Sec15 retary of Health and Human Services shall, beginning not 

16 later than 1 year after the date of enactment of this Act, 

17 annually submit to the Committee on Energy and Com18 merce of the House of Representatives and the Committee 

19 on Health, Education, Labor, and Pensions of the Senate 

20 a letter describing the progress of the Food and Drug Ad21 ministration— 

22 (1) in evaluating the cough and cold monograph 

23 described in subsection (b) with respect to children 

24 under age 6; and 


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1 (2) as appropriate, revising such cough and cold 

2 monograph to address such children through the 

3 order process under section 505G(b) of the Federal 

4 Food, Drug, and Cosmetic Act, as added by section 

5 1001 of this Act. 

6 (b) COUGH AND COLD MONOGRAPH DESCRIBED.— 

7 The cough and cold monograph described in this sub8 section consists of the conditions under which nonprescrip9 tion drugs containing antitussive, expectorant, nasal de10 congestant, or antihistamine active ingredients (or com11 binations thereof) are generally recognized as safe and ef12 fective, as specified in part 341 of title 21, Code of Federal 

13 Regulations (as in effect immediately prior to the date of 

14 enactment of this Act), and included in an order deemed 

15 to be established under section 505G(b) of the Federal 

16 Food, Drug, and Cosmetic Act, as added by section 1001 

17 of this Act. 

18 (c) DURATION OF AUTHORITY.—The requirement 

19 under subsection (a) shall terminate as of the date of a 

20 letter submitted by the Secretary of Health and Human 

21 Services pursuant to such subsection in which the Sec22 retary indicates that the Food and Drug Administration 

23 has completed its evaluation and revised, in a final order, 

24 as applicable, the cough and cold monograph as described 

25 in subsection (a)(2). 


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1 SEC. 1006. TECHNICAL CORRECTIONS. 

2 (a) IMPORTS AND EXPORTS.—Section 

3 801(e)(4)(E)(iii) of the Federal Food, Drug, and Cosmetic 

4 Act (21 U.S.C. 381(e)(4)(E)(iii)) is amended by striking 

5 ‘‘subparagraph’’ each place such term appears and insert6 ing ‘‘paragraph’’. 

7 (b) FDA REAUTHORIZATION ACT OF 2017.— 

8 (1) IN GENERAL.—Section 905(b)(4) of the 

9 FDA Reauthorization Act of 2017 (Public Law115– 

10 52) is amended by striking ‘‘Section 744H(e)(2)(B)’’ 

11 and inserting ‘‘Section 744H(f)(2)(B)’’. 

12 (2) EFFECTIVE DATE.—The amendment made 

13 by paragraph (1) shall take effect as of the enact14 ment of the FDA Reauthorization Act of 2017 

15 (Public Law 115–52). 

16 TITLE II—USER FEES 

17 SEC. 2001. SHORT TITLE; FINDING. 

18 (a) SHORT TITLE.—This title may be cited as the 

19 ‘‘Over-the-Counter Monograph User Fee Act of 2018’’. 

20 (b) FINDING.—The Congress finds that the fees au21 thorized by the amendments made in this title will be dedi22 cated to OTC monograph drug activities, as set forth in 

23 the goals identified for purposes of part 10 of subchapter 

24 C of chapter VII of the Federal Food, Drug, and Cosmetic 

25 Act, in the letters from the Secretary of Health and 

26 Human Services to the Chairman of the Committee on 


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1 Health, Education, Labor, and Pensions of the Senate and 

2 the Chairman of the Committee on Energy and Commerce 

3 of the House of Representatives, as set forth in the Con4 gressional Record. 

5 SEC. 2002. FEES RELATING TO OVER-THE-COUNTER DRUGS. 

6 Subchapter C of chapter VII of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 379f et seq.) is 

8 amended by inserting after part 9 the following: 

9 ‘‘PART 10—FEES RELATING TO OVER-THE10 COUNTER DRUGS 

11 ‘‘SEC. 744L. DEFINITIONS. 

12 ‘‘In this part: 

13 ‘‘(1) The term ‘affiliate’ means a business enti14 ty that has a relationship with a second business en15 tity if, directly or indirectly— 

16 ‘‘(A) one business entity controls, or has 

17 the power to control, the other business entity; 

18 or 

19 ‘‘(B) a third party controls, or has power 

20 to control, both of the business entities. 

21 ‘‘(2) The term ‘contract manufacturing organi22 zation facility’ means an OTC monograph drug facil23 ity where neither the owner of such manufacturing 

24 facility nor any affiliate of such owner or facility 

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1 cility directly to wholesalers, retailers, or consumers 

2 in the United States. 

3 ‘‘(3) The term ‘costs of resources allocated for 

4 OTC monograph drug activities’ means the expenses 

5 in connection with OTC monograph drug activities 

6 for— 

7 ‘‘(A) officers and employees of the Food 

8 and Drug Administration, contractors of the 

9 Food and Drug Administration, advisory com10 mittees, and costs related to such officers, em11 ployees, and committees and costs related to 

12 contracts with such contractors; 

13 ‘‘(B) management of information, and the 

14 acquisition, maintenance, and repair of com15 puter resources; 

16 ‘‘(C) leasing, maintenance, renovation, and 

17 repair of facilities and acquisition, maintenance, 

18 and repair of fixtures, furniture, scientific 

19 equipment, and other necessary materials and 

20 supplies; and 

21 ‘‘(D) collecting fees under section 744M 

22 and accounting for resources allocated for OTC 

23 monograph drug activities. 

24 ‘‘(4) The term ‘FDA establishment identifier’ is 

25 the unique number automatically generated by Food 


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1 and Drug Administration’s Field Accomplishments 

2 and Compliance Tracking System (FACTS) (or any 

3 successor system). 

4 ‘‘(5) The term ‘OTC monograph drug’ means a 

5 nonprescription drug without an approved new drug 

6 application which is governed by the provisions of 

7 section 505G. 

8 ‘‘(6) The term ‘OTC monograph drug activities’ 

9 means activities of the Secretary associated with 

10 OTC monograph drugs and inspection of facilities 

11 associated with such products, including the fol12 lowing activities: 

13 ‘‘(A) The activities necessary for review 

14 and evaluation of OTC monographs and OTC 

15 monograph order requests, including— 

16 ‘‘(i) orders proposing or finalizing ap17 plicable conditions of use for OTC mono18 graph drugs; 

19 ‘‘(ii) orders affecting status regarding 

20 general recognition of safety and effective21 ness of an OTC monograph ingredient or 

22 combination of ingredients under specified 

23 conditions of use; 


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1 ‘‘(iii) all OTC monograph drug devel2 opment and review activities, including 

3 intra-agency collaboration; 

4 ‘‘(iv) regulation and policy develop5 ment activities related to OTC monograph 

6 drugs; 

7 ‘‘(v) development of product standards 

8 for products subject to review and evalua9 tion; 

10 ‘‘(vi) meetings referred to in section 

11 505G(i); 

12 ‘‘(vii) review of labeling prior to 

13 issuance of orders related to OTC mono14 graph drugs or conditions of use; and 

15 ‘‘(viii) regulatory science activities re16 lated to OTC monograph drugs. 

17 ‘‘(B) Inspections related to OTC mono18 graph drugs. 

19 ‘‘(C) Monitoring of clinical and other re20 search conducted in connection with OTC 

21 monograph drugs. 

22 ‘‘(D) Safety activities with respect to OTC 

23 monograph drugs, including— 


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1 ‘‘(i) collecting, developing, and review2 ing safety information on OTC monograph 

3 drugs, including adverse event reports; 

4 ‘‘(ii) developing and using improved 

5 adverse event data-collection systems, in6 cluding information technology systems; 

7 and 

8 ‘‘(iii) developing and using improved 

9 analytical tools to assess potential safety 

10 risks, including access to external data11 bases. 

12 ‘‘(E) Other activities necessary for imple13 mentation of section 505G. 

14 ‘‘(7) The term ‘OTC monograph order request’ 

15 means a request for an order submitted under sec16 tion 505G(b)(5). 

17 ‘‘(8) The term ‘Tier 1 OTC monograph order 

18 request’ means any OTC monograph order request 

19 not determined to be a Tier 2 OTC monograph 

20 order request. 

21 ‘‘(9)(A) The term ‘Tier 2 OTC monograph 

22 order request’ means, subject to subparagraph (B), 

23 an OTC monograph order request for— 


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1 ‘‘(i) the reordering of existing information 

2 in the drug facts label of an OTC monograph 

3 drug; 

4 ‘‘(ii) the addition of information to the 

5 other information section of the drug facts label 

6 of an OTC monograph drug, as limited by sec7 tion 201.66(c)(7) of title 21, Code of Federal 

8 Regulations (or any successor regulations); 

9 ‘‘(iii) modification to the directions for use 

10 section of the drug facts label of an OTC mono11 graph drug, if such changes conform to changes 

12 made pursuant to section 505G(c)(3)(A); 

13 ‘‘(iv) the standardization of the concentra14 tion or dose of a specific finalized ingredient 

15 within a particular finalized monograph; 

16 ‘‘(v) a change to ingredient nomenclature 

17 to align with nomenclature of a standards-set18 ting organization; or 

19 ‘‘(vi) addition of an interchangeable term 

20 in accordance with section 330.1 of title 21, 

21 Code of Federal Regulations (or any successor 

22 regulations). 

23 ‘‘(B) The Secretary may, based on program im24 plementation experience or other factors found ap25 propriate by the Secretary, characterize any OTC 


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1 monograph order request as a Tier 2 OTC mono2 graph order request (including recharacterizing a re3 quest from Tier 1 to Tier 2) and publish such deter4 mination in a proposed order issued pursuant to sec5 tion 505G. 

6 ‘‘(10)(A) The term ‘OTC monograph drug facil7 ity’ means a foreign or domestic business or other 

8 entity that— 

9 ‘‘(i) is— 

10 ‘‘(I) under one management, either di11 rect or indirect; and 

12 ‘‘(II) at one geographic location or ad13 dress engaged in manufacturing or proc14 essing the finished dosage form of an OTC 

15 monograph drug; 

16 ‘‘(ii) includes a finished dosage form man17 ufacturer facility in a contractual relationship 

18 with the sponsor of one or more OTC mono19 graph drugs to manufacture or process such 

20 drugs; and 

21 ‘‘(iii) does not include a business or other 

22 entity whose only manufacturing or processing 

23 activities are one or more of the following: pro24 duction of clinical research supplies, testing, or 

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1 taining multiple products, for such purposes as 

2 creating multipacks, when each monograph 

3 drug product contained within the overpack4 aging is already in a final packaged form prior 

5 to placement in the outer overpackaging. 

6 ‘‘(B) For purposes of subparagraph (A)(i)(II), 

7 separate buildings or locations within close proximity 

8 are considered to be at one geographic location or 

9 address if the activities conducted in such buildings 

10 or locations are— 

11 ‘‘(i) closely related to the same business 

12 enterprise; 

13 ‘‘(ii) under the supervision of the same 

14 local management; and 

15 ‘‘(iii) under a single FDA establishment 

16 identifier and capable of being inspected by the 

17 Food and Drug Administration during a single 

18 inspection. 

19 ‘‘(C) If a business or other entity would meet 

20 criteria specified in subparagraph (A), but for being 

21 under multiple management, the business or other 

22 entity is deemed to constitute multiple facilities, one 

23 per management entity, for purposes of this para24 graph. 


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1 ‘‘(11) The term ‘OTC monograph drug meet2 ing’ means any meeting regarding the content of a 

3 proposed OTC monograph order request. 

4 ‘‘(12) The term ‘person’ includes an affiliate of 

5 a person. 

6 ‘‘(13) The terms ‘requestor’ and ‘sponsor’ have 

7 the meanings given such terms in section 505G. 

8 ‘‘SEC. 744M. AUTHORITY TO ASSESS AND USE OTC MONO9 GRAPH FEES. 

10 ‘‘(a) TYPES OF FEES.—Beginning with fiscal year 

11 2019, the Secretary shall assess and collect fees in accord12 ance with this section as follows: 

13 ‘‘(1) FACILITY FEE.— 

14 ‘‘(A) IN GENERAL.—Each person that 

15 owns a facility identified as an OTC monograph 

16 drug facility on December 31 of the fiscal year 

17 or at any time during the preceding 12-month 

18 period shall be assessed an annual fee for each 

19 such facility as determined under subsection 

20 (c). 

21 ‘‘(B) EXCEPTIONS.— 

22 ‘‘(i) A fee shall not be assessed under 

23 subparagraph (A) if the identified OTC 

24 monograph drug facility— 


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1 ‘‘(I) has ceased all activities re2 lated to OTC monograph drugs prior 

3 to January 31, 2019, for the first pro4 gram year, and December 31 of the 

5 fiscal year for subsequent fiscal years; 

6 and 

7 ‘‘(II) has updated its registration 

8 to reflect such change under the re9 quirements for drug establishment 

10 registration set forth in section 510. 

11 ‘‘(ii) The amount of the fee for a con12 tract manufacturing organization facility 

13 shall be equal to two-thirds of the amount 

14 of the fee for an OTC monograph drug fa15 cility that is not a contract manufacturing 

16 organization facility. 

17 ‘‘(C) AMOUNT.—The amount of fees estab18 lished under subparagraph (A) shall be estab19 lished under subsection (c). 

20 ‘‘(D) DUE DATE.— 

21 ‘‘(i) FOR FIRST PROGRAM YEAR.—For 

22 fiscal year 2019, the facility fees required 

23 under subparagraph (A) shall be due 45 

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1 eral Register notice provided for under 

2 subsection (c)(4)(A). 

3 ‘‘(ii) SUBSEQUENT FISCAL YEARS.— 

4 For each fiscal year after fiscal year 2019, 

5 the facility fees required under subpara6 graph (A) shall be due on the later of— 

7 ‘‘(I) the first business day of 

8 June of such year; or 

9 ‘‘(II) the first business day after 

10 the enactment of an appropriations 

11 Act providing for the collection and 

12 obligation of fees under this section 

13 for such year. 

14 ‘‘(2) OTC MONOGRAPH ORDER REQUEST

15 FEE.— 

16 ‘‘(A) IN GENERAL.—Each person that sub17 mits an OTC monograph order request shall be 

18 subject to a fee for an OTC monograph order 

19 request. The amount of such fee shall be— 

20 ‘‘(i) for a Tier 1 OTC monograph 

21 order request, $500,000, adjusted for in22 flation for the fiscal year (as determined 

23 under subsection (c)(1)(B)); and 

24 ‘‘(ii) for a Tier 2 OTC monograph 

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1 tion for the fiscal year (as determined 

2 under subsection (c)(1)(B)). 

3 ‘‘(B) DUE DATE.—The OTC monograph 

4 order request fees required under subparagraph 

5 (A) shall be due on the date of submission of 

6 the OTC monograph order request. 

7 ‘‘(C) EXCEPTION FOR CERTAIN SAFETY

8 CHANGES.—A person who is named as the re9 questor in an OTC monograph order shall not 

10 be subject to a fee under subparagraph (A) if 

11 the Secretary finds that the OTC monograph 

12 order request seeks to change the drug facts la13 beling of an OTC monograph drug in a way 

14 that would add to or strengthen— 

15 ‘‘(i) a contraindication, warning, or 

16 precaution; 

17 ‘‘(ii) a statement about risk associated 

18 with misuse or abuse; or 

19 ‘‘(iii) an instruction about dosage and 

20 administration that is intended to increase 

21 the safe use of the OTC monograph drug. 

22 ‘‘(D) REFUND OF FEE IF ORDER REQUEST

23 IS RECATEGORIZED AS A TIER 2 OTC MONO24 GRAPH ORDER REQUEST.—If the Secretary de25 termines that an OTC monograph request iniVerDate Sep 11 2014 03:39 Dec 20, 2018 Jkt 089200 PO 00000 Frm 00242 Fmt 6652 Sfmt 6201 E:\BILLS\H7328.IH H7328

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1 tially characterized as Tier 1 shall be re-charac2 terized as a Tier 2 OTC monograph order re3 quest, and the requestor has paid a Tier 1 fee 

4 in accordance with subparagraph (A)(i), the 

5 Secretary shall refund the requestor the dif6 ference between the Tier 1 and Tier 2 fees de7 termined under subparagraphs (A)(i) and 

8 (A)(ii), respectively. 

9 ‘‘(E) REFUND OF FEE IF ORDER REQUEST

10 REFUSED FOR FILING OR WITHDRAWN BEFORE

11 FILING.—The Secretary shall refund 75 percent 

12 of the fee paid under subparagraph (B) for any 

13 order request which is refused for filing or was 

14 withdrawn before being accepted or refused for 

15 filing. 

16 ‘‘(F) FEES FOR ORDER REQUESTS PRE17 VIOUSLY REFUSED FOR FILING OR WITHDRAWN

18 BEFORE FILING.—An OTC monograph order 

19 request that was submitted but was refused for 

20 filing, or was withdrawn before being accepted 

21 or refused for filing, shall be subject to the full 

22 fee under subparagraph (A) upon being resub23 mitted or filed over protest. 

24 ‘‘(G) REFUND OF FEE IF ORDER REQUEST

25 WITHDRAWN.—If an order request is withdrawn 


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1 after the order request was filed, the Secretary 

2 may refund the fee or a portion of the fee if no 

3 substantial work was performed on the order 

4 request after the application was filed. The Sec5 retary shall have the sole discretion to refund a 

6 fee or a portion of the fee under this subpara7 graph. A determination by the Secretary con8 cerning a refund under this subparagraph shall 

9 not be reviewable. 

10 ‘‘(3) REFUNDS.— 

11 ‘‘(A) IN GENERAL.—Other than refunds 

12 provided pursuant to any of subparagraphs (D) 

13 through (G) of paragraph (2), the Secretary 

14 shall not refund any fee paid under paragraph 

15 (1) except as provided in subparagraph (B). 

16 ‘‘(B) DISPUTES CONCERNING FEES.—To 

17 qualify for the return of a fee claimed to have 

18 been paid in error under paragraph (1) or (2), 

19 a person shall submit to the Secretary a written 

20 request justifying such return within 180 cal21 endar days after such fee was paid. 

22 ‘‘(4) NOTICE.—Within the timeframe specified 

23 in subsection (c), the Secretary shall publish in the 

24 Federal Register the amount of the fees under para25 graph (1) for such fiscal year. 


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1 ‘‘(b) FEE REVENUE AMOUNTS.— 

2 ‘‘(1) FISCAL YEAR 2019.—For fiscal year 2019, 

3 fees under subsection (a)(1) shall be established to 

4 generate a total facility fee revenue amount equal to 

5 the sum of— 

6 ‘‘(A) the annual base revenue for fiscal 

7 year 2019 (as determined under paragraph 

8 (3)); 

9 ‘‘(B) the dollar amount equal to the oper10 ating reserve adjustment for the fiscal year, if 

11 applicable (as determined under subsection 

12 (c)(2)); and 

13 ‘‘(C) additional direct cost adjustments (as 

14 determined under subsection (c)(3)). 

15 ‘‘(2) SUBSEQUENT FISCAL YEARS.—For each of 

16 the fiscal years 2020 through 2023, fees under sub17 section (a)(1) shall be established to generate a total 

18 facility fee revenue amount equal to the sum of— 

19 ‘‘(A) the annual base revenue for the fiscal 

20 year (as determined under paragraph (3)); 

21 ‘‘(B) the dollar amount equal to the infla22 tion adjustment for the fiscal year (as deter23 mined under subsection (c)(1)); 

24 ‘‘(C) the dollar amount equal to the oper25 ating reserve adjustment for the fiscal year, if 


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1 applicable (as determined under subsection 

2 (c)(2)); 

3 ‘‘(D) additional direct cost adjustments (as 

4 determined under subsection (c)(3)); and 

5 ‘‘(E) additional dollar amounts for each 

6 fiscal year as follows: 

7 ‘‘(i) $7,000,000 for fiscal year 2020. 

8 ‘‘(ii) $6,000,000 for fiscal year 2021. 

9 ‘‘(iii) $7,000,000 for fiscal year 2022. 

10 ‘‘(iv) $3,000,000 for fiscal year 2023. 

11 ‘‘(3) ANNUAL BASE REVENUE.—For purposes 

12 of paragraphs (1)(A) and (2)(A), the dollar amount 

13 of the annual base revenue for a fiscal year shall 

14 be— 

15 ‘‘(A) for fiscal year 2019, $8,000,000; and 

16 ‘‘(B) for fiscal years 2020 through 2023, 

17 the dollar amount of the total revenue amount 

18 established under this subsection for the pre19 vious fiscal year, not including any adjustments 

20 made under subsection (c)(2) or (c)(3). 

21 ‘‘(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 

22 ‘‘(1) INFLATION ADJUSTMENT.— 

23 ‘‘(A) IN GENERAL.—For purposes of sub24 section (b)(2)(B), the dollar amount of the in25 flation adjustment to the annual base revenue 


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1 for fiscal year 2020 and each subsequent fiscal 

2 year shall be equal to the product of— 

3 ‘‘(i) such annual base revenue for the 

4 fiscal year under subsection (b)(2); and 

5 ‘‘(ii) the inflation adjustment percent6 age under subparagraph (C). 

7 ‘‘(B) OTC MONOGRAPH ORDER REQUEST

8 FEES.—For purposes of subsection (a)(2), the 

9 dollar amount of the inflation adjustment to the 

10 fee for OTC monograph order requests for fis11 cal year 2020 and each subsequent fiscal year 

12 shall be equal to the product of— 

13 ‘‘(i) the applicable fee under sub14 section (a)(2) for the preceding fiscal year; 

15 and 

16 ‘‘(ii) the inflation adjustment percent17 age under subparagraph (C). 

18 ‘‘(C) INFLATION ADJUSTMENT PERCENT19 AGE.—The inflation adjustment percentage 

20 under this subparagraph for a fiscal year is 

21 equal to— 

22 ‘‘(i) for each of fiscal years 2020 and 

23 2021, the average annual percent change 

24 that occurred in the Consumer Price Index 

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1 more, DC–MD–VA–WV; Not Seasonally 

2 Adjusted; All items; Annual Index) for the 

3 first 3 years of the preceding 4 years of 

4 available data; and 

5 ‘‘(ii) for each of fiscal years 2022 and 

6 2023, the sum of— 

7 ‘‘(I) the average annual percent 

8 change in the cost, per full-time equiv9 alent position of the Food and Drug 

10 Administration, of all personnel com11 pensation and benefits paid with re12 spect to such positions for the first 3 

13 years of the preceding 4 fiscal years, 

14 multiplied by the proportion of per15 sonnel compensation and benefits 

16 costs to total costs of OTC mono17 graph drug activities for the first 3 

18 years of the preceding 4 fiscal years; 

19 and 

20 ‘‘(II) the average annual percent 

21 change that occurred in the Consumer 

22 Price Index for urban consumers 

23 (Washington-Baltimore, DC–MD–VA– 

24 WV; Not Seasonally Adjusted; All 

25 items; Annual Index) for the first 3 


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1 years of the preceding 4 years of 

2 available data multiplied by the pro3 portion of all costs other than per4 sonnel compensation and benefits 

5 costs to total costs of OTC mono6 graph drug activities for the first 3 

7 years of the preceding 4 fiscal years. 

8 ‘‘(2) OPERATING RESERVE ADJUSTMENT.— 

9 ‘‘(A) IN GENERAL.—For fiscal year 2019 

10 and subsequent fiscal years, for purposes of 

11 subsections (b)(1)(B) and (b)(2)(C), the Sec12 retary may, in addition to adjustments under 

13 paragraph (1), further increase the fee revenue 

14 and fees if such an adjustment is necessary to 

15 provide operating reserves of carryover user 

16 fees for OTC monograph drug activities for not 

17 more than the number of weeks specified in 

18 subparagraph (B). 

19 ‘‘(B) NUMBER OF WEEKS.—The number of 

20 weeks specified in this subparagraph is— 

21 ‘‘(i) 3 weeks for fiscal year 2019; 

22 ‘‘(ii) 7 weeks for fiscal year 2020; 

23 ‘‘(iii) 10 weeks for fiscal year 2021; 

24 ‘‘(iv) 10 weeks for fiscal year 2022; 

25 and 


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1 ‘‘(v) 10 weeks for fiscal year 2023. 

2 ‘‘(C) DECREASE.—If the Secretary has 

3 carryover balances for such process in excess of 

4 10 weeks of the operating reserves referred to 

5 in subparagraph (A), the Secretary shall de6 crease the fee revenue and fees referred to in 

7 such subparagraph to provide for not more than 

8 10 weeks of such operating reserves. 

9 ‘‘(D) RATIONALE FOR ADJUSTMENT.—If 

10 an adjustment under this paragraph is made, 

11 the rationale for the amount of the increase or 

12 decrease (as applicable) in fee revenue and fees 

13 shall be contained in the annual Federal Reg14 ister notice under paragraph (4) establishing 

15 fee revenue and fees for the fiscal year involved. 

16 ‘‘(3) ADDITIONAL DIRECT COST ADJUST17 MENT.—The Secretary shall, in addition to adjust18 ments under paragraphs (1) and (2), further in19 crease the fee revenue and fees for purposes of sub20 section (b)(2)(D) by an amount equal to— 

21 ‘‘(A) $14,000,000 for fiscal year 2019; 

22 ‘‘(B) $7,000,000 for fiscal year 2020; 

23 ‘‘(C) $4,000,000 for fiscal year 2021; 

24 ‘‘(D) $3,000,000 for fiscal year 2022; and 

25 ‘‘(E) $3,000,000 for fiscal year 2023. 


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1 ‘‘(4) ANNUAL FEE SETTING.— 

2 ‘‘(A) FISCAL YEAR 2019.—The Secretary 

3 shall, not later than the second Monday in 

4 March of 2019— 

5 ‘‘(i) establish OTC monograph drug 

6 facility fees for fiscal year 2019 under sub7 section (a), based on the revenue amount 

8 for such year under subsection (b) and the 

9 adjustments provided under this sub10 section; and 

11 ‘‘(ii) publish fee revenue, facility fees, 

12 and OTC monograph order requests in the 

13 Federal Register. 

14 ‘‘(B) SUBSEQUENT FISCAL YEARS.—The 

15 Secretary shall, not later than the second Mon16 day in March of each fiscal year that begins 

17 after September 30, 2019— 

18 ‘‘(i) establish for each such fiscal 

19 year, based on the revenue amounts under 

20 subsection (b) and the adjustments pro21 vided under this subsection— 

22 ‘‘(I) OTC monograph drug facil23 ity fees under subsection (a)(1); and 


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1 ‘‘(II) OTC monograph order re2 quest fees under subsection (a)(2); 

3 and 

4 ‘‘(ii) publish such fee revenue 

5 amounts, facility fees, and OTC mono6 graph order request fees in the Federal 

7 Register. 

8 ‘‘(d) IDENTIFICATION OF FACILITIES.—Each person 

9 that owns an OTC monograph drug facility shall submit 

10 to the Secretary the information required under this sub11 section each year. Such information shall, for each fiscal 

12 year— 

13 ‘‘(1) be submitted as part of the requirements 

14 for drug establishment registration set forth in sec15 tion 510; and 

16 ‘‘(2) include for each such facility, at a min17 imum, identification of the facility’s business oper18 ation as that of an OTC monograph drug facility. 

19 ‘‘(e) EFFECT OF FAILURE TO PAY FEES.— 

20 ‘‘(1) OTC MONOGRAPH DRUG FACILITY FEE.— 

21 ‘‘(A) IN GENERAL.—Failure to pay the fee 

22 under subsection (a)(1) within 20 calendar days 

23 of the due date as specified in subparagraph 

24 (D) of such subsection shall result in the fol25 lowing: 


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1 ‘‘(i) The Secretary shall place the fa2 cility on a publicly available arrears list. 

3 ‘‘(ii) All OTC monograph drugs man4 ufactured in such a facility or containing 

5 an ingredient manufactured in such a facil6 ity shall be deemed misbranded under sec7 tion 502(ff). 

8 ‘‘(B) APPLICATION OF PENALTIES.—The 

9 penalties under this paragraph shall apply until 

10 the fee established by subsection (a)(1) is paid. 

11 ‘‘(2) ORDER REQUESTS.—An OTC monograph 

12 order request submitted by a person subject to fees 

13 under subsection (a) shall be considered incomplete 

14 and shall not be accepted for filing by the Secretary 

15 until all fees owed by such person under this section 

16 have been paid. 

17 ‘‘(3) MEETINGS.—A person subject to fees 

18 under this section shall be considered ineligible for 

19 OTC monograph drug meetings until all such fees 

20 owed by such person have been paid. 

21 ‘‘(f) CREDITING AND AVAILABILITY OF FEES.— 

22 ‘‘(1) IN GENERAL.—Fees authorized under sub23 section (a) shall be collected and available for obliga24 tion only to the extent and in the amount provided 

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1 thorized to remain available until expended. Such 

2 sums as may be necessary may be transferred from 

3 the Food and Drug Administration salaries and ex4 penses appropriation account without fiscal year lim5 itation to such appropriation account for salaries 

6 and expenses with such fiscal year limitation. The 

7 sums transferred shall be available solely for OTC 

8 monograph drug activities. 

9 ‘‘(2) COLLECTIONS AND APPROPRIATION

10 ACTS.— 

11 ‘‘(A) IN GENERAL.—Subject to subpara12 graph (C), the fees authorized by this section 

13 shall be collected and available in each fiscal 

14 year in an amount not to exceed the amount 

15 specified in appropriation Acts, or otherwise 

16 made available for obligation, for such fiscal 

17 year. 

18 ‘‘(B) USE OF FEES AND LIMITATION.— 

19 The fees authorized by this section shall be 

20 available to defray increases in the costs of the 

21 resources allocated for OTC monograph drug 

22 activities (including increases in such costs for 

23 an additional number of full-time equivalent po24 sitions in the Department of Health and 

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1 ties), only if the Secretary allocates for such 

2 purpose an amount for such fiscal year (exclud3 ing amounts from fees collected under this sec4 tion) no less than $12,000,000, multiplied by 

5 the adjustment factor applicable to the fiscal 

6 year involved under subsection (c)(1). 

7 ‘‘(C) COMPLIANCE.—The Secretary shall 

8 be considered to have met the requirements of 

9 subparagraph (B) in any fiscal year if the costs 

10 funded by appropriations and allocated for OTC 

11 monograph drug activities are not more than 15 

12 percent below the level specified in such sub13 paragraph. 

14 ‘‘(D) PROVISION FOR EARLY PAYMENTS IN

15 SUBSEQUENT YEARS.—Payment of fees author16 ized under this section for a fiscal year (after 

17 fiscal year 2019), prior to the due date for such 

18 fees, may be accepted by the Secretary in ac19 cordance with authority provided in advance in 

20 a prior year appropriations Act. 

21 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

22 For each of the fiscal years 2019 through 2023, 

23 there is authorized to be appropriated for fees under 

24 this section an amount equal to the total amount of 

25 fees assessed for such fiscal year under this section. 


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1 ‘‘(g) COLLECTION OF UNPAID FEES.—In any case 

2 where the Secretary does not receive payment of a fee as3 sessed under subsection (a) within 30 calendar days after 

4 it is due, such fee shall be treated as a claim of the United 

5 States Government subject to subchapter II of chapter 37 

6 of title 31, United States Code. 

7 ‘‘(h) CONSTRUCTION.—This section may not be con8 strued to require that the number of full-time equivalent 

9 positions in the Department of Health and Human Serv10 ices, for officers, employers, and advisory committees not 

11 engaged in OTC monograph drug activities, be reduced 

12 to offset the number of officers, employees, and advisory 

13 committees so engaged. 

14 ‘‘SEC. 744N. REAUTHORIZATION; REPORTING REQUIRE15 MENTS. 

16 ‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 

17 year 2019, and not later than 120 calendar days after the 

18 end of each fiscal year thereafter for which fees are col19 lected under this part, the Secretary shall prepare and 

20 submit to the Committee on Energy and Commerce of the 

21 House of Representatives and the Committee on Health, 

22 Education, Labor, and Pensions of the Senate a report 

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1 graph Safety, Innovation, and Reform Act of 2018 during 

2 such fiscal year and the future plans of the Food and 

3 Drug Administration for meeting such goals. 

4 ‘‘(b) FISCAL REPORT.—Not later than 120 calendar 

5 days after the end of fiscal year 2019 and each subsequent 

6 fiscal year for which fees are collected under this part, 

7 the Secretary shall prepare and submit to the Committee 

8 on Energy and Commerce of the House of Representatives 

9 and the Committee on Health, Education, Labor, and 

10 Pensions of the Senate a report on the implementation 

11 of the authority for such fees during such fiscal year and 

12 the use, by the Food and Drug Administration, of the fees 

13 collected for such fiscal year. 

14 ‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall 

15 make the reports required under subsections (a) and (b) 

16 available to the public on the internet website of the Food 

17 and Drug Administration. 

18 ‘‘(d) REAUTHORIZATION.— 

19 ‘‘(1) CONSULTATION.—In developing rec20 ommendations to present to the Congress with re21 spect to the goals described in subsection (a), and 

22 plans for meeting the goals, for OTC monograph 

23 drug activities for the first 5 fiscal years after fiscal 

24 year 2023, and for the reauthorization of this part 


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1 for such fiscal years, the Secretary shall consult 

2 with— 

3 ‘‘(A) the Committee on Energy and Com4 merce of the House of Representatives; 

5 ‘‘(B) the Committee on Health, Education, 

6 Labor, and Pensions of the Senate; 

7 ‘‘(C) scientific and academic experts; 

8 ‘‘(D) health care professionals; 

9 ‘‘(E) representatives of patient and con10 sumer advocacy groups; and 

11 ‘‘(F) the regulated industry. 

12 ‘‘(2) PUBLIC REVIEW OF RECOMMENDA13 TIONS.—After negotiations with the regulated indus14 try, the Secretary shall— 

15 ‘‘(A) present the recommendations devel16 oped under paragraph (1) to the congressional 

17 committees specified in such paragraph; 

18 ‘‘(B) publish such recommendations in the 

19 Federal Register; 

20 ‘‘(C) provide for a period of 30 calendar 

21 days for the public to provide written comments 

22 on such recommendations; 

23 ‘‘(D) hold a meeting at which the public 

24 may present its views on such recommenda25 tions; and 


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1 ‘‘(E) after consideration of such public 

2 views and comments, revise such recommenda3 tions as necessary. 

4 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 

5 Not later than January 15, 2023, the Secretary 

6 shall transmit to the Congress the revised rec7 ommendations under paragraph (2), a summary of 

8 the views and comments received under such para9 graph, and any changes made to the recommenda10 tions in response to such views and comments.’’. 

Æ 


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