II 

116TH CONGRESS 

2D SESSION S. 3780 

To encourage domestic advanced manufacturing of critical drugs and devices 

in order to address economic, health, and security concerns, combat 

shortages of critical drugs and devices, and promote increased domestic 

diversification of, and independence from foreign reliance on, pharmaceutical and medical device supply chains. 

IN THE SENATE OF THE UNITED STATES 

MAY 20, 2020 

Mr. PETERS introduced the following bill; which was read twice and referred 

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

A BILL 

To encourage domestic advanced manufacturing of critical 

drugs and devices in order to address economic, health, 

and security concerns, combat shortages of critical drugs 

and devices, and promote increased domestic diversification of, and independence from foreign reliance on, pharmaceutical and medical device supply chains. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Help Onshore Manu5 facturing Efficiencies for Drugs and Devices Act’’ or the 

6 ‘‘HOME Act’’. 


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1 SEC. 2. INVESTMENTS IN DOMESTIC ADVANCED MANUFAC2 TURING AND PREPAREDNESS. 

3 Part A of title III of the Public Health Service Act 

4 (42 U.S.C. 241 et seq.) is amended by adding at the end 

5 the following: 

6 ‘‘SEC. 310B. INVESTMENTS IN DOMESTIC ADVANCED MANU7 FACTURING FOR CRITICAL DRUGS AND DE8 VICES. 

9 ‘‘(a) ESTABLISHMENT.—There is established within 

10 the Office of the Assistant Secretary for Preparedness and 

11 Response of the Department of Health and Human Serv12 ices, the ‘Center for Domestic Advanced Manufacturing 

13 of Critical Drugs and Devices’ (referred to in this section 

14 as the ‘Center’). 

15 ‘‘(b) PURPOSE.—The purpose of the Center for Do16 mestic Advanced Manufacturing of Critical Drugs and De17 vices shall be to implement a program to invest in the ad18 vanced manufacturing for critical drugs and devices, and 

19 to increase domestic production of critical drugs and de20 vices, throughout the United States. 

21 ‘‘(c) DIRECTOR.—The Center shall be headed by a 

22 Director (referred to in this section as the ‘Director’) who 

23 shall be appointed by the Secretary and to whom the Sec24 retary shall delegate such functions and authorities as 

25 may be necessary to implement this section. 

26 ‘‘(d) PROGRAM.— 


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1 ‘‘(1) IN GENERAL.—The Center for Domestic 

2 Advanced Manufacturing of Critical Drugs and De3 vices shall— 

4 ‘‘(A) not later than 18 months after the 

5 date of enactment of this section— 

6 ‘‘(i) establish an advisory board of ex7 perts from governmental entities, manufac8 turers, other private industry entities, non9 profit entities, and institutions of higher 

10 education, and any other entity as deter11 mined by the Center; and 

12 ‘‘(ii) compile a list of critical drugs 

13 and devices that should be prioritized for 

14 domestic advanced manufacturing and in15 creased domestic production under the pro16 gram described in paragraph (2), based on 

17 reports to the Secretary under sections 

18 506C and 506J of the Federal Food, 

19 Drug, and Cosmetic Act, the drug shortage 

20 list under section 506E of such Act, the 

21 device shortage list under section 506J(g) 

22 of such Act, and the annual risk assess23 ments described in section 5 of the HOME 

24 Act, if available, and update such list quar25 terly; 


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1 ‘‘(B) establish and oversee the grant and 

2 forgivable loan program described in paragraph 

3 (2), including by establishing requirements for 

4 participation in such program, including— 

5 ‘‘(i) target goals to substantially in6 crease advanced manufacturing production 

7 for critical drugs and devices within the 

8 United States; and 

9 ‘‘(ii) conditioning the receipt of fund10 ing under such program on an entity’s 

11 agreement to commercially distribute the 

12 drug or device in the United States; and 

13 ‘‘(C) review the effects of the program de14 scribed in paragraph (2) on the percentage 

15 change in domestic manufacturing of critical 

16 drugs, devices, and active pharmaceutical ingre17 dients. 

18 ‘‘(2) GRANT AND FORGIVABLE LOAN PRO19 GRAM.— 

20 ‘‘(A) IN GENERAL.—The Center for Do21 mestic Advanced Manufacturing of Critical 

22 Drugs and Devices shall establish a grant and 

23 forgivable loan program in order to support in24 vestment in— 


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1 ‘‘(i) advanced manufacturing and fa2 cilities upgrades for the domestic produc3 tion of critical drugs, devices, and active 

4 pharmaceutical ingredients; and 

5 ‘‘(ii) increased domestic production 

6 and diversification of critical drugs, de7 vices, and active pharmaceutical ingredi8 ents. 

9 ‘‘(B) ELIGIBLE ENTITIES.— 

10 ‘‘(i) IN GENERAL.—To be eligible to 

11 receive a grant or forgivable loan under 

12 this paragraph, an entity shall meet the re13 quirements established under paragraphs 

14 (1)(A)(ii) and (1)(B) and such criteria as 

15 the Center shall develop and, as applica16 ble— 

17 ‘‘(I) with respect to a critical 

18 drug, shall be the holder of an appli19 cation approved under section 505 of 

20 the Federal Food, Drug, and Cos21 metic Act or section 351 of this Act, 

22 or a contract manufacturer of the 

23 drug for such holder of an approved 

24 application; 


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1 ‘‘(II) with respect to an active 

2 pharmaceutical ingredient, shall be 

3 the manufacturer of an active phar4 maceutical ingredient of a drug ap5 proved under section 505 of the Fed6 eral Food, Drug, and Cosmetic Act or 

7 section 351 of this Act; 

8 ‘‘(III) with respect to a critical 

9 device, shall have received approval 

10 under section 515 of the Federal 

11 Food, Drug, and Cosmetic Act, clear12 ance under section 510(k) of such Act 

13 (or be exempt from the requirements 

14 of such section 510(k)), or authoriza15 tion under section 513(f)(2) of such 

16 Act, or shall be a contract manufac17 turer of the device for such an entity; 

18 or 

19 ‘‘(IV) with respect to a drug or 

20 device, shall have submitted an appli21 cation under section 505 or 515 of the 

22 Federal Food, Drug, and Cosmetic 

23 Act or under section 351 of this Act, 

24 a report under section 510(k), or a re25 quest under section 513(f)(2). 


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1 ‘‘(ii) PRIORITY.—In awarding grants 

2 and forgivable loans under this paragraph 

3 the Center for Domestic Advanced Manu4 facturing of Critical Drugs and Devices 

5 shall give priority— 

6 ‘‘(I) in the case of manufacturers 

7 of drugs or active pharmaceutical in8 gredients, to entities— 

9 ‘‘(aa) described in sub10 clauses (I) and (II) of clause (i); 

11 and 

12 ‘‘(bb) whose application for 

13 an award under this paragraph 

14 relates to a drug that was ap15 proved under section 505(j) of 

16 the Federal Food, Drug, and 

17 Cosmetic Act; and 

18 ‘‘(II) in the case of manufactur19 ers of devices, to entities described in 

20 clause (i)(III). 

21 ‘‘(C) USE OF FUNDS.—Awards received 

22 under this paragraph shall be used for the ad23 vanced manufacturing and increased production 

24 of critical drugs and devices in the United 

25 States. 


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1 ‘‘(D) FORGIVABLE LOANS.—The Center 

2 may award forgivable loans under this para3 graph under which a recipient shall receive a 

4 loan and be eligible for forgiveness of indebted5 ness on such loan, under such conditions for re6 ceipt and forgiveness as the Center may estab7 lish. 

8 ‘‘(E) GRANTS.—The Center may award 

9 grants under this section, which shall be condi10 tioned upon the recipient matching Federal 

11 funds so awarded. 

12 ‘‘(F) FUNDING.—Out of amounts made 

13 available to carry out this section, the Secretary 

14 shall allocate $500,000,000 toward awards of 

15 forgivable loans and grants under this para16 graph. 

17 ‘‘(e) ANNUAL REPORTING.—The Secretary shall sub18 mit to the relevant committees of Congress annual reports 

19 on the program under this section. At a minimum, each 

20 such report shall— 

21 ‘‘(1) identify the list of critical drugs and de22 vices under subsection (d)(1)(A)(ii) and account for 

23 any alterations in the list; 


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1 ‘‘(2) describe the participants in the program 

2 under subsection (d)(2) and criteria for eligibility for 

3 such participation; 

4 ‘‘(3) address target goals for substantially in5 creased advanced manufacturing production for crit6 ical drugs and devices; and 

7 ‘‘(4) review the percentage change in domestic 

8 manufacturing of critical drugs, devices, and active 

9 pharmaceutical ingredients since the most recent re10 port. 

11 ‘‘(f) INTERAGENCY COOPERATION.— 

12 ‘‘(1) IN GENERAL.—In carrying out activities 

13 under this section, the Center is authorized, subject 

14 to paragraph (2), to enter into interagency agree15 ments and other collaborative undertakings with 

16 other Federal agencies. 

17 ‘‘(2) LIMITATION.—An agreement or under18 taking under this subsection shall not authorize an19 other agency to exercise the authorities provided by 

20 this section. 

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

22 carry out this section, there is authorized to be appro23 priated such funds as may be necessary, for each of fiscal 

24 years 2021 through 2031. 

25 ‘‘(h) DEFINITIONS.—In this section— 


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1 ‘‘(1) the terms ‘drug’ and ‘device’ have the 

2 meanings given such terms in section 201 of the 

3 Federal Food, Drug, and Cosmetic Act; 

4 ‘‘(2) the term ‘institution of higher education’ 

5 has the meaning given such term in section 101(a) 

6 of the Higher Education Act of 1965; and 

7 ‘‘(3) the term ‘relevant committees of Congress’ 

8 means the Committee on Homeland Security and 

9 Governmental Affairs, the Committee on Health, 

10 Education, Labor, and Pensions, and the Committee 

11 on Armed Services of the Senate and the Committee 

12 on Homeland Security, the Committee on Energy 

13 and Commerce, and the Committee on Armed Serv14 ices of the House of Representatives.’’. 

15 SEC. 3. EXPEDITED REVIEW OF CERTAIN SUPPLEMENTAL 

16 APPLICATIONS. 

17 Section 506 of the Federal Food, Drug, and Cosmetic 

18 Act (21 U.S.C. 356) is amended by adding at the end the 

19 following: 

20 ‘‘(i) EXPEDITED REVIEW OF CERTAIN SUPPLE21 MENTAL APPLICATIONS.— 

22 ‘‘(1) IN GENERAL.—The holder of an applica23 tion approved under section 505 of this Act or li24 cense under section 351 of the Public Health Service 

25 Act who submits a supplemental application with reVerDate Sep 11 2014 23:15 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S3780.IS S3780

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1 spect to such application or license may request an 

2 expedited review of such supplemental application 

3 under this subsection. 

4 ‘‘(2) APPLICATION.—To be eligible for expe5 dited review under this subsection, the holder of the 

6 approved application or license with respect to a 

7 drug included on the most recent list of critical 

8 drugs and devices compiled under section 

9 310B(d)(1)(A)(ii) of the Public Health Service Act, 

10 shall demonstrate in the supplemental application 

11 that— 

12 ‘‘(A) approval of such supplemental appli13 cation would enable the incorporation of a man14 ufacturing change that is intended to enhance 

15 drug quality, increase domestic manufacturing 

16 of the drug, or incorporate the use of advanced 

17 manufacturing; and 

18 ‘‘(B) the applicant’s plan for producing the 

19 drug domestically after approval of the supple20 mental application. 

21 ‘‘(3) REVIEW BY SECRETARY.—If the Secretary 

22 determines, after preliminary evaluation of a supple23 mental application, that the application dem24 onstrates that the manufacturing change would en25 hance the ability of the holder of the application to 


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1 domestically manufacture a drug on the list of crit2 ical drugs and devices described in paragraph (2), 

3 the Secretary shall evaluate for filing, and may com4 mence review of portions of, such supplemental ap5 plication before the sponsor submits a complete ap6 plication. The Secretary shall commence such review 

7 only if the applicant provides a schedule for submis8 sion of information necessary to make the applica9 tion complete.’’. 

10 SEC. 4. LONG-TERM, HIGH-VOLUME CONTRACTS TO PUR11 CHASE CRITICAL DRUGS AND DEVICES. 

12 (a) CONTRACTING GOALS.— In order to further the 

13 needs of the Department of Health and Human Services 

14 and the Department of Defense, invest in preparedness 

15 and the strategic national stockpile, and mitigate drug and 

16 device shortages, each of the Secretary of Health and 

17 Human Services and the Assistant Secretary of Defense 

18 for Health Affairs may enter into contracts to purchase 

19 a drug or device included on the list of critical drugs and 

20 devices compiled under section 310B(d)(1)(A)(ii) of the 

21 Public Health Service Act (as added by section 2), includ22 ing multi-year, high-volume contracts, as set forth in sub23 section (b), and otherwise in accordance with procurement 

24 laws and regulations. 


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1 (b) RESPONSIBILITY DETERMINATIONS.—For pur2 poses of meeting the goals under subsection (a), a con3 tracting officer of the Department of Health and Human 

4 Services or the Department of Defense may give pref5 erence and award a contract to a program participant 

6 under section 310B(d)(2) of the Public Health Service Act 

7 (as added by section 2), if— 

8 (1) the program participant is determined by 

9 the contracting officer, in consultation with the Cen10 ter for Domestic Advanced Manufacturing of Critical 

11 Drugs and Devices with respect to the participant’s 

12 performance in the program under section 

13 310B(d)(2) of the Public Health Service Act, to be 

14 a responsible source with respect to performance of 

15 the contract; and 

16 (2) in the estimation of the contracting officer, 

17 the contract award can be made at a fair and rea18 sonable price that offers best value to the United 

19 States. 

20 SEC. 5. ANNUAL RISK ASSESSMENT. 

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

22 date of enactment of this Act, and annually thereafter, 

23 the Secretary of Homeland Security, the Secretary of 

24 Health and Human Services, and the Secretary of Defense 

25 shall each conduct separate independent risk assessments 


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1 of the medical supply chain and report to the relevant 

2 committees of Congress on the findings of such assess3 ments. At a minimum, each risk assessment shall— 

4 (1) identify drugs and devices critical to each 

5 agency in responding to a public health emergency, 

6 biological or chemical threat, or other national secu7 rity threat; 

8 (2) identify the drugs and devices identified 

9 under paragraph (1) for which there is a single man10 ufacturer or distributer in the United States; 

11 (3) list the drugs and devices identified under 

12 paragraph (1) that are sourced exclusively from for13 eign sources; 

14 (4) assess current domestic manufacturing ca15 pability with respect to drugs and devices identified 

16 under paragraph (1), including advanced manufac17 turing capabilities; and 

18 (5) identify critical vulnerabilities and establish 

19 contingency plans in the event of a public health 

20 emergency, biological or chemical threat, or other 

21 national security threat. 

22 (b) RISK ASSESSMENT REPORT CONCLUSIONS.— 

23 Each risk assessment of each secretary under subsection 

24 (a) shall indicate, at a minimum— 


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1 (1) the existing statutory authorities the de2 partment has to address public health or national se3 curity risks that may arise as a result of vulnerabili4 ties in the medical supply chain; 

5 (2) any deficiencies, lack of authorities, or limi6 tations in policy or process that limit the depart7 ment’s ability to address vulnerabilities identified in 

8 the applicable risk assessment; and 

9 (3) the secretary’s plans to address drug and 

10 device shortages, control costs, and prepare for pub11 lic health emergencies, biological or chemical threats, 

12 and other national security threats. 

13 (c) REVIEW BY SECRETARIES.—The Secretary of 

14 Homeland Security, the Secretary of Health and Human 

15 Services, and the Secretary of Defense, in providing the 

16 risk assessments under subsection (a) may consult with 

17 each other, as appropriate, regarding any similarities in 

18 vulnerabilities experienced by each such secretary and any 

19 coordination among the secretaries that may address such 

20 vulnerabilities. 

21 (d) DEFINITIONS.—In this section— 

22 (1) the terms ‘‘device’’ and ‘‘drug’’ have the 

23 meanings given such terms in section 201 of the 

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

25 321); and 


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1 (2) the term ‘‘relevant committees of Congress’’ 

2 means the Committee on Homeland Security and 

3 Governmental Affairs, the Committee on Health, 

4 Education, Labor, and Pensions, and the Committee 

5 on Armed Services of the Senate and the Committee 

6 on Homeland Security, the Committee on Energy 

7 and Commerce, and the Committee on Armed Serv8 ices of the House of Representatives. 

Æ 


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