II 

115TH CONGRESS 

1ST SESSION S. 2260 

To establish and fund an Opioids and STOP Pain Initiative to expand, 

intensify, and coordinate fundamental, translational, and clinical research 

of the National Institutes of Health with respect to opioid abuse, the 

understanding of pain, and the discovery and development of safer and 

more effective treatments and preventive interventions for pain. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 21, 2017 

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

to the Committee on Finance 

A BILL 

To establish and fund an Opioids and STOP Pain Initiative 

to expand, intensify, and coordinate fundamental, 

translational, and clinical research of the National Institutes of Health with respect to opioid abuse, the understanding of pain, and the discovery and development 

of safer and more effective treatments and preventive 

interventions for pain. 

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 ‘‘Opioids and STOP 

5 Pain Initiative Act’’. 


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1 SEC. 2. ESTABLISHMENT. 

2 There is established an Opioids and STOP Pain Ini3 tiative, to be administered by the Director of the National 

4 Institutes of Health, in coordination with other agencies, 

5 as appropriate, which shall include efforts to support re6 search on the following: 

7 (1) Section 108 of the Comprehensive Addiction 

8 and Recovery Act of 2016 (42 U.S.C. 284q–1), 

9 known as the STOP Pain Act, which directs the Na10 tional Institutes of Health to intensify and coordi11 nate fundamental, translational, and clinical re12 search with respect to— 

13 (A) the understanding of pain; 

14 (B) the discovery and development of 

15 therapies for chronic pain; and 

16 (C) the development of alternatives to 

17 opioids for effective pain treatments. 

18 (2) Developing improved options and evidence 

19 for medication-assisted treatment. 

20 (3) Developing improved options and evidence 

21 for opioid overdose reversal treatments. 

22 (4) The Federal Pain Research Strategy, in23 cluding research that focuses on— 

24 (A) novel drugs, non-addictive, and non25 pharmacological treatments for pain; 


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1 (B) screening tools and outcome measures 

2 for assessments across the continuum of pain; 

3 (C) national registries, datasets, and re4 search networks; 

5 (D) effective models of care delivery for 

6 pain management; and 

7 (E) precision medicine methodology to pre8 vent and treat pain. 

9 (5) The components of the Department of 

10 Health and Human Services five-point strategy to 

11 address the opioid crisis that states: ‘‘Providing sup12 port for cutting edge research on pain and addic13 tion’’. 

14 (6) The pain therapy screening program estab15 lished under section 4. 

16 (7) Other elements that the Secretary of Health 

17 and Human Services may designate, in consultation 

18 with the Director of the National Institutes of 

19 Health. 

20 SEC. 3. FUNDING FOR THE OPIOIDS AND STOP PAIN INITIA21 TIVE. 

22 (a) IN GENERAL.—There is authorized to be appro23 priated, and there is appropriated, $5,000,000,000, to be 

24 used during the 5-fiscal year period beginning in the fiscal 

25 year in which such funds are appropriated, to the National 


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1 Institutes of Health Innovation Account to be used to ad2 minister the Opioids and STOP Pain Initiative established 

3 under section 2. 

4 (b) EMERGENCY SPENDING.— 

5 (1) IN GENERAL.—Amounts appropriated under 

6 subsection (a) are designated as an emergency re7 quirement pursuant to section 4(g) of the Statutory 

8 Pay-As-You-Go Act of 2010 (2 U.S.C. 933(g)). 

9 (2) DESIGNATION IN THE SENATE.—In the 

10 Senate, amounts appropriated under subsection (a) 

11 are designated as an emergency requirement pursu12 ant to section 403(a) of S. Con. Res. 13 (111th 

13 Congress), the concurrent resolution on the budget 

14 for fiscal year 2010. 

15 SEC. 4. PAIN THERAPY SCREENING PROGRAM. 

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

17 Human Services (referred to in this section as the ‘‘Sec18 retary’’) shall carry out through the National Institutes 

19 of Health a program to be known as the ‘‘Pain Therapy 

20 Screening Program’’ that focuses on the development of 

21 pain therapeutics. 

22 (b) GRANTS.—The Secretary shall award grants 

23 under the program under subsection (a) to eligible public 

24 and private nonprofit entities to support the development 

25 of new pre-clinical models for pain disorders, and the apVerDate Sep 11 2014 00:43 Dec 23, 2017 Jkt 079200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2260.IS S2260

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1 plication of these models in drug, device, or other therapy 

2 screening. 

3 (c) MODEL.—The program under this section shall 

4 be modeled after the Epilepsy Therapy Screening Program 

5 carried out by the National Institute of Neurological Dis6 orders and Stroke. 

7 (d) FEES.—The Secretary of Health and Human 

8 Services may assess reasonable fees on private pharma9 ceutical or medical device industry entities that utilize the 

10 program under this section to screen proprietary molec11 ular compounds and devices. Such fees shall be paid to 

12 the Foundation for the National Institutes of Health and 

13 transferred to the NIH Innovation Account to be used for 

14 the Opioids and STOP Pain Initiative established under 

15 section 2. 

16 (e) FUNDING.—The Director of the National Insti17 tutes of Health shall determine the amount, and allocate, 

18 funds from the amount appropriated under section 3, to 

19 carry out this section. 

20 SEC. 5. FUNDING PROVISIONS. 

21 (a) SUPPLEMENT NOT SUPPLANT.—Amounts appro22 priated in this Act (including the amendments made by 

23 this Act) shall be used to supplement, not supplant, cur24 rent funding for pain and opioid research at the National 

25 Institutes of Health. 


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1 (b) ACCEPTANCE OF DONATIONS.—Notwithstanding 

2 section 1342 of title 31, United States Code, the Secretary 

3 of Health and Human Services may accept donations (in4 cluding from the pharmaceutical and medical device indus5 tries) to be used to assist in carrying out programs and 

6 activities under this Act (and the amendments made by 

7 this Act). Such donations shall be paid to the Foundation 

8 for the National Institutes of Health and transferred to 

9 the NIH Innovation Account to be used for the Opioids 

10 and STOP Pain Initiative established under section 2. 

11 (c) INCLUSION OF CONTRIBUTION AMOUNTS IN

12 BASIC RESEARCH FOR PURPOSES OF RESEARCH CRED13 IT.— 

14 (1) IN GENERAL.—Paragraph (6) of section 

15 41(e) of the Internal Revenue Code of 1986 is 

16 amended by adding at the end the following new 

17 subparagraph: 

18 ‘‘(E) OPIOIDS AND STOP PAIN INITIA19 TIVE.—The National Institutes of Health, if the 

20 payment is made in support of the Opioids and 

21 STOP Pain Initiative, as established by the 

22 Opioids and STOP Pain Initiative Act.’’. 

23 (2) EFFECTIVE DATE.—The amendments made 

24 by this subsection shall apply to taxable years begin25 ning after the date of the enactment of this Act. 


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1 SEC. 6. AUTHORITY. 

2 Notwithstanding any other provision of the law, the 

3 Director of the National Institutes of Health may use 

4 funds available under section 3 to enter into transactions 

5 (other than contracts, cooperative agreements, or grants) 

6 to carry out research identified pursuant to the Opioids 

7 and STOP Pain Initiative established under section 2. 

8 SEC. 7. REPORTS. 

9 (a) ANNUAL REPORTS.—Not later than October 1 of 

10 each of fiscal years 2019 through 2026, the Director of 

11 the National Institutes of Health shall submit to the Com12 mittee on Health, Education, Labor, and Pensions and the 

13 Committee on Appropriations of the Senate and the Com14 mittee on Energy and Commerce and the Committee on 

15 Appropriations of the House of Representatives, a report 

16 that includes— 

17 (1) the amount obligated or expended in the fis18 cal year prior to the fiscal year in which the report 

19 is being submitted for each program or activity de20 scribed in this Act (or an amendment made by this 

21 Act); 

22 (2) a description of all such programs or activi23 ties carried out using funds provided under this Act 

24 (or amendments); and 

25 (3) a description of how such programs or ac26 tivities are advancing public health, including the 


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1 impact on treating pain and addressing opioid mis2 use in the United States. 

3 (b) ADDITIONAL REPORTS.—At the request of the 

4 Committee on Health, Education, Labor, and Pensions or 

5 the Committee on Appropriations of the Senate, or the 

6 Committee on Energy and Commerce or the Committee 

7 on Appropriations of the House of Representatives, the 

8 Director of the National Institutes of Health shall provide 

9 to the relevant Committee an update in the form of testi10 mony and additional reports concerning the allocation of 

11 funding under this Act (or the amendments made by this 

12 Act) or the description of the programs and activities car13 ried out with such funding. 

Æ 


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