II 

116TH CONGRESS 

2D SESSION S. 3847 

To amend the Public Health Service Act to establish an Emergency Office 

of Manufacturing for Public Health, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JUNE 1, 2020 

Ms. WARREN introduced the following bill; which was read twice and referred 

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

A BILL 

To amend the Public Health Service Act to establish an 

Emergency Office of Manufacturing for Public Health, 

and for other purposes. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘COVID–19 Emergency 

5 Manufacturing Act of 2020’’. 

6 SEC. 2. PUBLIC MANUFACTURING OF PHARMACEUTICALS. 

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

8 (42 U.S.C. 241 et seq.) is amended by adding at the end 

9 the following: 


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1 ‘‘SEC. 310B. MANUFACTURING OF DRUGS, BIOLOGICAL 

2 PRODUCTS, DEVICES, AND PERSONAL PRO3 TECTIVE EQUIPMENT. 

4 ‘‘(a) EMERGENCY OFFICE OF MANUFACTURING FOR

5 PUBLIC HEALTH.— 

6 ‘‘(1) ESTABLISHMENT.—There is established 

7 within the Department of Health and Human Serv8 ices an office to be known as the Emergency Office 

9 of Manufacturing for Public Health (referred to in 

10 this section as the ‘Office’). 

11 ‘‘(2) PURPOSE.—The purposes of the Office 

12 are— 

13 ‘‘(A) to ensure an adequate supply of, and 

14 increase access to, prescription drugs, biological 

15 products, devices, and other supplies, including 

16 personal protective equipment, necessary to, as 

17 appropriate, diagnose, mitigate, prevent, or 

18 treat COVID–19 and to mitigate the harm the 

19 COVID–19 pandemic might otherwise cause for 

20 the strategic national stockpile under section 

21 319F–2, Federal, State, local, and Native 

22 health programs, and the commercial market; 

23 ‘‘(B) to address shortages in the strategic 

24 national stockpile and commercial market of 

25 prescription drugs, biological products, devices, 


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1 and personal protective equipment used to treat 

2 conditions other than COVID–19; and 

3 ‘‘(C) to provide prescription drugs, biologi4 cal products, devices, and personal protective 

5 equipment necessary to diagnose, mitigate, pre6 vent, and treat COVID–19 and to mitigate the 

7 harm the COVID–19 pandemic might otherwise 

8 cause, to Federal, State, local, and Native 

9 health programs, at no cost, and to consumers 

10 in the commercial market and other inter11 national entities at cost. 

12 ‘‘(3) PERSONNEL.— 

13 ‘‘(A) DIRECTOR.— 

14 ‘‘(i) IN GENERAL.—The Office shall 

15 be headed by a Director, who shall be ap16 pointed by the President, not later than 15 

17 days after the date of enactment of the 

18 COVID–19 Emergency Manufacturing Act 

19 of 2020, by and with the advice and con20 sent of the Senate. 

21 ‘‘(ii) ACTING DIRECTOR.—The Assist22 ant Secretary for Preparedness and Re23 sponse, if in compliance with subparagraph 

24 (C), may serve as Director of the Office in 

25 an acting capacity until the later of Senate 


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1 confirmation of a Director or 3 months 

2 after date of enactment of the COVID–19 

3 Emergency Manufacturing Act of 2020. 

4 ‘‘(iii) COMPENSATION.—The Director 

5 shall be compensated at the rate prescribed 

6 for level III of the Executive Schedule 

7 under section 5314 of title 5, United 

8 States Code. 

9 ‘‘(B) EMPLOYEES.—The Director of the 

10 Office, in consultation with the Secretary, may 

11 fix the number of, and appoint and direct, all 

12 employees of the Office. 

13 ‘‘(C) BANNED INDIVIDUALS.— 

14 ‘‘(i) DRUG COMPANY LOBBYISTS.—No 

15 former registered drug manufacturer lob16 byist— 

17 ‘‘(I) may be appointed to the po18 sition of Director of the Office; or 

19 ‘‘(II) may be employed by the Of20 fice during the 6-year period begin21 ning on the date on which the reg22 istered lobbyist terminates its reg23 istration in accordance with section 

24 4(d) of the Lobbying Disclosure Act 


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1 of 1995 or the agent terminates its 

2 status, as applicable. 

3 ‘‘(ii) SENIOR EXECUTIVES OF LAW4 BREAKING COMPANIES.—No former senior 

5 executive of a covered entity— 

6 ‘‘(I) may be appointed to the po7 sition of Director of the Office; or 

8 ‘‘(II) may be employed by the Of9 fice during the 6-year period begin10 ning on the later of— 

11 ‘‘(aa) the date of the settle12 ment; and 

13 ‘‘(bb) the date on which the 

14 enforcement action has con15 cluded. 

16 ‘‘(iii) COVERED ENTITY.—For pur17 poses of clause (ii), the term ‘covered enti18 ty’ means any entity that is— 

19 ‘‘(I) a drug manufacturer; and 

20 ‘‘(II)(aa) operating under Fed21 eral settlement, including a Federal 

22 consent decree; or 

23 ‘‘(bb) the subject of an enforce24 ment action in a court of the United 

25 States or by an agency. 


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1 ‘‘(4) DUTIES.— 

2 ‘‘(A) IN GENERAL.—The Office shall— 

3 ‘‘(i) prepare and submit applications 

4 for approval to the Food and Drug Admin5 istration, or enter into contracts for such 

6 submission, for the manufacture of appli7 cable COVID–19 products and other appli8 cable drugs, biological products, and de9 vices when authorized under this section; 

10 ‘‘(ii) obtain rights to manufacture ap11 plicable COVID–19 products and applica12 ble drugs, biological products, and devices 

13 as authorized under this section; 

14 ‘‘(iii) manufacture, or enter into con15 tracts with entities to manufacture, appli16 cable COVID–19 products and other appli17 cable drugs, biological products, and de18 vices as authorized under this section; 

19 ‘‘(iv) determine a fair price for each 

20 applicable drug, biological product, and de21 vice, in accordance with subparagraph 

22 (B)(ii); 

23 ‘‘(v) sell manufactured applicable 

24 drugs, biological products, and devices at a 

25 fair price, as authorized under this section; 


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1 ‘‘(vi) provide, at no cost, applicable 

2 COVID–19 products to Federal, State, 

3 local, and Native health programs, and 

4 other domestic health care providers and 

5 suppliers, as determined by the Secretary; 

6 ‘‘(vii) sell, at-cost, applicable COVID– 

7 19 products to other commercial entities 

8 and international entities, in accordance 

9 with subparagraph (B)(i); and 

10 ‘‘(viii) manufacture, or enter into con11 tracts with entities to manufacture, active 

12 pharmaceutical ingredients for use by the 

13 Office or for sale to other entities. 

14 ‘‘(B) PRICING DETERMINATIONS.— 

15 ‘‘(i) AT-COST PRICE.—In determining 

16 an at-cost price for an applicable COVID– 

17 19 product under subparagraph (A)(vii) 

18 the Office shall consider— 

19 ‘‘(I) the cost to the Federal Gov20 ernment of manufacturing the appli21 cable COVID–19 product; 

22 ‘‘(II) the administrative costs of 

23 operating the Office; and 


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1 ‘‘(III) the cost to acquire or man2 ufacture applicable COVID–19 prod3 uct under this section. 

4 ‘‘(ii) FAIR PRICE.—In determining a 

5 fair price for an applicable drug, biological 

6 product, or device under subparagraph 

7 (A)(iv) the Office shall consider— 

8 ‘‘(I) the impact of price on pa9 tient access to the applicable drug, bi10 ological product, or device; 

11 ‘‘(II) the cost of the applicable 

12 drug, biological product, or device to 

13 Federal or State health care pro14 grams; 

15 ‘‘(III) the cost to the Federal 

16 Government of manufacturing the ap17 plicable drug, biological product, or 

18 device; 

19 ‘‘(IV) the administrative costs of 

20 operating the Office; 

21 ‘‘(V) the cost to acquire or manu22 facture the applicable drug, biological 

23 product, or device under this section; 

24 and 


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1 ‘‘(VI) the impact of price on 

2 market competition for the applicable 

3 drug, biological product, or device. 

4 ‘‘(iii) TRANSPARENCY.—All prices 

5 charged for applicable COVID–19 products 

6 and applicable drugs, biological products, 

7 or devices shall be made publicly available 

8 by the Office. 

9 ‘‘(C) OBTAINING RIGHTS TO MANUFAC10 TURE AND MARKET.— 

11 ‘‘(i) IN GENERAL.—When necessary to 

12 fulfill the Office’s duties under this section, 

13 the Office shall acquire the rights to manu14 facture and market applicable COVID–19 

15 products and applicable drugs, biological 

16 products, and devices as authorized under 

17 this section. 

18 ‘‘(ii) LICENSING AUTHORITY.— 

19 ‘‘(I) IN GENERAL.—Notwith20 standing any other provision of law, 

21 the Secretary may issue licenses, as 

22 useful for fulfilling the duties under 

23 this Act, allowing the Office to prac24 tice or have practiced (which may in25 clude licensure of retroactive practice) 


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1 any invention in the United States or 

2 territories of the United States, in3 cluding making, using, offering to sell 

4 or selling, importing, or exporting 

5 such invention, to reference or rely 

6 upon clinical trial data submitted to a 

7 regulatory authority or the grant of 

8 marketing approval, and to access and 

9 use otherwise confidential informa10 tion, including know-how, related to 

11 the manufacture of an applicable 

12 COVID–19 product or applicable 

13 drug, biological product, or device. 

14 ‘‘(II) NON-VOLUNTARY LICENS15 ING.—For any license that involves a 

16 non-voluntary authorization to use 

17 patented inventions, regulatory test 

18 data, data, know-how or other intel19 lectual property rights, the license 

20 shall provide for reasonable remunera21 tion to rights holders such as a rea22 sonable royalty on the sales of prod23 uct, a 1-time payment, or some com24 bination, provided that the combined 

25 royalty payments to all rights holders 


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1 shall not exceed the percentage of 

2 sales that is the average percent of all 

3 royalty payments reported to the In4 ternal Revenue Service by companies 

5 in the pharmaceutical and medicines 

6 sector, North American Industry Clas7 sification System code 325410, pro8 vided that when products are distrib9 uted for free, the royalty shall be 

10 based upon the cost of goods. When 

11 there are multiple rights holders, the 

12 allocation of the total royalty pay13 ments shall be determined by— 

14 ‘‘(aa) agreement among the 

15 rights holders; 

16 ‘‘(bb) allocation by arbitra17 tion among the rights holders; or 

18 ‘‘(cc) if neither item (aa) 

19 nor (bb) applies, by the Office. 

20 ‘‘(iii) TRANSPARENCY.—Subject to 

21 clause (iv), the Secretary shall post any 

22 contract agreement under subparagraph 

23 (A) or license issued under clause (ii) on 

24 the public internet website of the Depart25 ment of Health and Human Services, on 


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1 the date on which such agreement or li2 cense takes effect. 

3 ‘‘(iv) PROTECTED INFORMATION.—In 

4 carrying out this section, the Secretary 

5 shall enforce applicable law concerning the 

6 protection of confidential commercial infor7 mation and trade secrets. 

8 ‘‘(D) ACTIVE PHARMACEUTICAL INGREDI9 ENTS.— 

10 ‘‘(i) IN GENERAL.—The Office shall 

11 manufacture, or enter into contracts with 

12 entities to manufacture, an active pharma13 ceutical ingredient applicable to a drug or 

14 biological product that is either an applica15 ble COVID–19 product or an applicable 

16 drug or biological product if— 

17 ‘‘(I) the Office determines that 

18 such ingredient is not readily available 

19 from existing suppliers or the existing 

20 supply of such ingredient to the do21 mestic market is vulnerable to disrup22 tion; 

23 ‘‘(II) the manufacture of such in24 gredient would improve the ability of 

25 other entities to enter the market for 


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1 the manufacture of applicable 

2 COVID–19 products or applicable 

3 drugs, biological products, or devices, 

4 or otherwise expand the manufacture 

5 of applicable COVID–19 products or 

6 applicable drugs, biological products, 

7 or devices; or 

8 ‘‘(III) the manufacture of such 

9 ingredient is necessary for the Office 

10 to carry out its duties under this sec11 tion. 

12 ‘‘(ii) PRICE DETERMINATIONS.—In 

13 determining the price at which to sell an 

14 active pharmaceutical ingredient manufac15 tured in accordance with clause (i), the Of16 fice shall consider the cost to manufacture 

17 the ingredient, the administrative costs of 

18 the Office with respect to the ingredient, 

19 and the impact of such price on market 

20 competition for the ingredient. 

21 ‘‘(E) PRIORITY.—In awarding contracts 

22 under this paragraph, the Office shall prioritize 

23 entities manufacturing applicable COVID–19 

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1 ucts, and devices using components originating 

2 and manufactured in the United States. 

3 ‘‘(F) CONTRACT REQUIREMENTS.—All con4 tracts issued under this paragraph shall include 

5 a requirement that the contract recipients rea6 sonably price products produced under the con7 tract. 

8 ‘‘(b) MANUFACTURING OF PRODUCTS.— 

9 ‘‘(1) IN GENERAL.—As soon as practicable 

10 after the date of enactment of this section, but no 

11 later than 1 month after such date of enactment, the 

12 Office shall begin— 

13 ‘‘(A) manufacturing, or entering into con14 tracts with entities for the manufacture of ap15 plicable COVID–19 products and applicable 

16 drugs, biological products, and devices, 

17 prioritizing drugs, biological products, devices 

18 or personal protective equipment the manufac19 ture of which would provide the greatest public 

20 health impact; and 

21 ‘‘(B) constructing, or entering into con22 tracts to construct, manufacturing facilities, in23 cluding the construction of advanced manufac24 turing technology, RNA vaccines, DNA vac25 cines, recombinant protein vaccines, and other 


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1 therapeutics, viral vector-based vaccines, live at2 tenuated vaccines, inactivated vaccines, or other 

3 therapeutics, after clinical data relating to such 

4 products have demonstrated strong positive in5 dications of safety and efficacy, to ensure im6 mediate production at-scale upon Federal ap7 proval. 

8 ‘‘(2) SUBMISSION OF APPLICATIONS.—For each 

9 applicable COVID–19 product, and for each applica10 ble drug, biological product, or device that the Office 

11 determines should be manufactured, as provided for 

12 under this section, the Secretary shall— 

13 ‘‘(A) submit an application under section 

14 505(b), 505(j), or 515 of the Federal Food, 

15 Drug, and Cosmetic Act or section 351(a) or 

16 351(k) of this Act or submit a notification 

17 under section 510(k) of the Federal Food, 

18 Drug, and Cosmetic Act (or enter into a con19 tract with another entity to submit such an ap20 plication or notification); 

21 ‘‘(B) request an emergency use authoriza22 tion of the product under section 564A of the 

23 Federal Food, Drug, and Cosmetic Act (or 

24 enter into a contract with another entity to sub25 mit an application for such use); or 


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1 ‘‘(C) obtain from the holder of an applica2 tion approved under subsection (c) or (j) of sec3 tion 505 or section 515 of the Federal Food, 

4 Drug, and Cosmetic Act or subsection (a) or 

5 (k) of section 351 of the Public Health Service 

6 Act, or cleared under section 510(k) of the Fed7 eral Food, Drug, and Cosmetic Act, rights to 

8 manufacture such applicable drug. 

9 ‘‘(3) MANUFACTURING TIMELINES.— 

10 ‘‘(A) PERSONAL PROTECTIVE EQUIP11 MENT.—Not later than 1 month after the date 

12 of enactment of this section, the Secretary shall 

13 begin the public manufacturing of personal pro14 tective equipment, including surgical masks, 

15 surgical gowns, face shields, and N95 masks, 

16 meeting the definition of applicable COVID–19 

17 product and in accordance with this section. 

18 ‘‘(B) COVID–19 DIAGNOSTIC TEST MATE19 RIALS.—Not later than 1 month after the date 

20 of enactment of this section, the Secretary shall 

21 begin the public manufacturing of materials 

22 necessary for the development of COVID–19 di23 agnostic tests, including chemical reagents, test 

24 swabs, and materials necessary to develop sero25 logical COVID–19 tests, meeting the definition 


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1 of applicable COVID–19 product and in accord2 ance with this section. 

3 ‘‘(C) COVID–19 TREATMENT DRUGS.—As 

4 soon as practicable after the date of enactment 

5 of this section, the Secretary shall begin the 

6 public manufacturing of drugs and biological 

7 products in shortage, and any devices used to 

8 administer such drugs and biological products, 

9 that are used for treatment of severe COVID– 

10 19 cases, including albuterol, drugs used to 

11 intubate patients, antibiotics, and antivirals, 

12 meeting the definition of applicable COVID–19 

13 product and in accordance with this section. 

14 ‘‘(4) PRIORITY MANUFACTURING.—The Office 

15 shall prioritize the manufacturing of applicable 

16 COVID–19 products and applicable drugs, biological 

17 products, and devices that would have the greatest 

18 impact on— 

19 ‘‘(A) diagnosing, mitigating, preventing, 

20 treating, or curing COVID–19; 

21 ‘‘(B) limiting the harm the COVID–19 

22 pandemic might otherwise cause to public 

23 health and the economy; 

24 ‘‘(C) addressing shortages of drugs, bio25 logical, products, and devices; 


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1 ‘‘(D) reducing the cost of combating 

2 COVID–19 to Federal, State, local, and Native 

3 health programs; and 

4 ‘‘(E) alleviating demographic disparities in 

5 COVID–19 outcomes or access to diagnosis, 

6 mitigation, prevention, and treatment. 

7 ‘‘(c) PROVISION OF PRODUCTS.— 

8 ‘‘(1) PROVISION OF APPLICABLE COVID–19

9 PRODUCTS.—The Secretary shall provide applicable 

10 COVID–19 products at no cost to Federal, State, 

11 local, and Native health programs, and other domes12 tic health care providers and suppliers, including do13 mestic commercial health care providers, as deter14 mined by the Secretary, and sell at cost applicable 

15 COVID–19 products to other commercial entities 

16 and international entities. Amounts received from 

17 the sale of such drugs shall be used for the activities 

18 of the Office. 

19 ‘‘(2) PROVISION OF APPLICABLE DRUGS, BIO20 LOGICAL PRODUCTS AND DEVICES.—The Secretary 

21 shall sell applicable drugs, biological products, and 

22 devices produced under this section at a fair price to 

23 other entities. Amounts received from the sale of 

24 such drugs shall be used to replenish the national 

25 strategic stockpile under section 319F–2. 


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1 ‘‘(d) OVERSIGHT OF CONTRACTS.—In the case of ap2 plicable COVID–19 products and applicable drugs, bio3 logical products, and devices manufactured via contracts, 

4 the Inspector General of the Department of Health and 

5 Human Services shall conduct a review of not fewer than 

6 1 of every 3 contracts entered into under this section, and 

7 of the entities entering into such contracts, to ensure that 

8 the Office is issuing contracts under fair and reasonable 

9 terms and conditions, including facilitating the procure10 ment by the Federal Government of applicable COVID– 

11 19 products and applicable drugs, biological products, and 

12 medical devices at fair and reasonable prices. The Inspec13 tor General shall make each such review public and, in 

14 cases where such a review identifies unreasonable prices, 

15 submit recommendations to Congress on how the Office 

16 should improve its contracting systems to ensure reason17 able pricing. 

18 ‘‘(e) REPORTS TO CONGRESS.—The Director shall 

19 prepare and submit to the President, the Committee on 

20 Health, Education, Labor, and Pensions of the Senate, 

21 and the Committee on Energy and Commerce of the 

22 House of Representatives, a monthly report during the 

23 public health emergency declared by the Secretary under 

24 section 319 on January 31, 2020, with respect to COVID– 


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1 19, and a final report 3 months after the public health 

2 emergency has concluded, that includes— 

3 ‘‘(1) an assessment of the major supply chain 

4 challenges facing hospitals, medical providers, the 

5 Federal government, State, local, and tribal govern6 ments, and the private sector in procuring drugs, bi7 ological products, devices, and personal protective 

8 equipment to combat and prevent the spread of 

9 COVID–19; and 

10 ‘‘(2) a description of the status of all drugs, bi11 ological products, devices, active pharmaceutical in12 gredients, and personal protective equipment for 

13 which manufacturing has been authorized under this 

14 section, including drugs, biological products, devices, 

15 active pharmaceutical ingredients, and personal pro16 tective equipment being manufactured, drugs, bio17 logical products, devices, active pharmaceutical in18 gredients, and personal protective equipment for 

19 which the Office has submitted an application for 

20 approval or a notification for clearance or classifica21 tion to the Food and Drug Administration but has 

22 not yet received approval, clearance, or classification, 

23 and drugs, biological products, devices, active phar24 maceutical ingredients, and personal protective 

25 equipment for which the Office has received apVerDate Sep 11 2014 21:18 Jun 20, 2020 Jkt 099200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\S3847.IS S3847

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1 proval, clearance, or classification from the Food 

2 and Drug Administration but are not being manu3 factured. 

4 ‘‘(f) DEFINITIONS.—In this section: 

5 ‘‘(1) APPLICABLE DRUG, BIOLOGICAL PRODUCT, 

6 OR DEVICE DEFINITION.—The term ‘applicable drug, 

7 biological product, or device’ means a drug (as de8 fined in section 201(g) of the Federal Food, Drug, 

9 and Cosmetic Act), biological product (as defined in 

10 section 351(i) of the Public Health Service Act), 

11 combination product (as described in section 503(g) 

12 of the Federal Food, Drug, and Cosmetic Act), or 

13 device (as defined in section 201(h) of the Federal 

14 Food Drug and Cosmetic Act) for which an ap15 proved application under section 505 or 515 of the 

16 Federal Food, Drug, and Cosmetic Act or section 

17 351 of the Public Health Service Act, or clearance 

18 under section 510(k) of the Federal Food, Drug, 

19 and Cosmetic Act, is in effect, and— 

20 ‘‘(A) is included in the drug shortage list 

21 under section 506E of the Federal Food, Drug, 

22 and Cosmetic Act; or 

23 ‘‘(B) is vulnerable to shortage. 

24 ‘‘(2) APPLICABLE COVID–19 PRODUCT DEFINI25 TION.— 


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1 ‘‘(A) IN GENERAL.—The term ‘applicable 

2 COVID–19 product’ means a product that is 

3 included on a list that the Secretary of Health 

4 and Human Services, in consultation with the 

5 Commissioner of Food and Drugs, the Assist6 ant Secretary for Preparedness and Response, 

7 and the Director of the Centers for Disease 

8 Control and Prevention, shall compile not later 

9 than 2 weeks after the date of enactment of 

10 this section and shall review and update, as 

11 necessary, every 2 weeks of— 

12 ‘‘(i) qualified pandemic or epidemic 

13 products, as defined under section 319F– 

14 3, that are— 

15 ‘‘(I)(aa) drugs, biological prod16 ucts, and devices that are manufac17 tured, used, designed, developed, 

18 modified, licensed or procured— 

19 ‘‘(AA) to diagnose, mitigate, 

20 prevent, treat, or cure COVID– 

21 19; or 

22 ‘‘(BB) to limit the harm the 

23 COVID–19 pandemic might oth24 erwise cause; 


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1 ‘‘(bb) drugs, biological products, 

2 and devices that are manufactured, 

3 used, designed, developed, modified, li4 censed, or procured to diagnose, miti5 gate, prevent, treat, or cure a serious 

6 or life-threatening disease or condition 

7 caused by a product described in item 

8 (aa); or 

9 ‘‘(cc) drugs, biological products, 

10 devices or technologies intended to en11 hance the use or effect of a drug, bio12 logical product, or device described in 

13 item (aa) or (bb); and 

14 ‘‘(ii) personal protective equipment, 

15 including protective equipment for eyes, 

16 face, head, and extremities, protective 

17 clothing, respiratory devices, and protective 

18 shields and barriers, used to protect people 

19 from COVID–19 infection. 

20 ‘‘(B) CONSULTATION.—In developing the 

21 list described in subparagraph (A), the Sec22 retary shall consult with the Administrator of 

23 the Federal Emergency Management Adminis24 tration and the Secretary of Defense to ensure 

25 that, in instances where the President has enVerDate Sep 11 2014 21:18 Jun 20, 2020 Jkt 099200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\S3847.IS S3847

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1 acted the Defense Production Act to produce 

2 applicable COVID–19 products, the Office does 

3 not replicate or overproduce products being de4 veloped under the Act. 

5 ‘‘(3) NATIVE HEALTH PROGRAM.—The term 

6 ‘Native health program’ shall include— 

7 ‘‘(A) a program provided through the In8 dian Health Service; 

9 ‘‘(B) any health program operated by— 

10 ‘‘(i) an Indian tribe, or Tribal organi11 zation, as such terms are defined in section 

12 4 of the Indian Self-Determination and 

13 Education Assistance Act; 

14 ‘‘(ii) an inter-tribal consortium, as de15 fined in section 501(a) of the Indian Self16 Determination and Education Assistance 

17 Act; or 

18 ‘‘(iii) an urban Indian organization, as 

19 defined in section 4 of the Indian Health 

20 Care Improvement Act; and 

21 ‘‘(C) any health program provided through 

22 a Native Hawaiian health care system, as de23 fined in section 12 of the Native Hawaiian 

24 Health Care Improvement Act. 


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1 ‘‘(4) DOMESTIC HEALTH CARE PROVIDER.—The 

2 term ‘domestic health care provider’ shall include the 

3 direct support professional, home health, and per4 sonal care attendant workforce. 

5 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

6 are authorized to be appropriated such sums as may be 

7 necessary to carry out this section.’’. 

Æ 


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