Title: Opioids and STOP Pain Initiative Act
Policy area: Health

Summary:
Opioids and STOP Pain Initiative Act
This bill establishes and provides funds for the Opioids and STOP Pain Initiative at the National Institutes of Health (NIH) to support pain-related research, including:
NIH must establish the Pain Therapy Screening Program to award grants to support the development of new pre-clinical models for pain disorders, and the application of these models in drug, device, or other therapy screening.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2260 Introduced in Senate (IS)]

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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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Opioids and STOP Pain Initiative 
Act''.

SEC. 2. ESTABLISHMENT.

    There is established an Opioids and STOP Pain Initiative, to be 
administered by the Director of the National Institutes of Health, in 
coordination with other agencies, as appropriate, which shall include 
efforts to support research on the following:
            (1) Section 108 of the Comprehensive Addiction and Recovery 
        Act of 2016 (42 U.S.C. 284q-1), known as the STOP Pain Act, 
        which directs the National Institutes of Health to intensify 
        and coordinate fundamental, translational, and clinical 
        research with respect to--
                    (A) the understanding of pain;
                    (B) the discovery and development of therapies for 
                chronic pain; and
                    (C) the development of alternatives to opioids for 
                effective pain treatments.
            (2) Developing improved options and evidence for 
        medication-assisted treatment.
            (3) Developing improved options and evidence for opioid 
        overdose reversal treatments.
            (4) The Federal Pain Research Strategy, including research 
        that focuses on--
                    (A) novel drugs, non-addictive, and non-
                pharmacological treatments for pain;
                    (B) screening tools and outcome measures for 
                assessments across the continuum of pain;
                    (C) national registries, datasets, and research 
                networks;
                    (D) effective models of care delivery for pain 
                management; and
                    (E) precision medicine methodology to prevent and 
                treat pain.
            (5) The components of the Department of Health and Human 
        Services five-point strategy to address the opioid crisis that 
        states: ``Providing support for cutting edge research on pain 
        and addiction''.
            (6) The pain therapy screening program established under 
        section 4.
            (7) Other elements that the Secretary of Health and Human 
        Services may designate, in consultation with the Director of 
        the National Institutes of Health.

SEC. 3. FUNDING FOR THE OPIOIDS AND STOP PAIN INITIATIVE.

    (a) In General.--There is authorized to be appropriated, and there 
is appropriated, $5,000,000,000, to be used during the 5-fiscal year 
period beginning in the fiscal year in which such funds are 
appropriated, to the National Institutes of Health Innovation Account 
to be used to administer the Opioids and STOP Pain Initiative 
established under section 2.
    (b) Emergency Spending.--
            (1) In general.--Amounts appropriated under subsection (a) 
        are designated as an emergency requirement pursuant to section 
        4(g) of the Statutory Pay-As-You-Go Act of 2010 (2 U.S.C. 
        933(g)).
            (2) Designation in the senate.--In the Senate, amounts 
        appropriated under subsection (a) are designated as an 
        emergency requirement pursuant to section 403(a) of S. Con. 
        Res. 13 (111th Congress), the concurrent resolution on the 
        budget for fiscal year 2010.

SEC. 4. PAIN THERAPY SCREENING PROGRAM.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall carry out 
through the National Institutes of Health a program to be known as the 
``Pain Therapy Screening Program'' that focuses on the development of 
pain therapeutics.
    (b) Grants.--The Secretary shall award grants under the program 
under subsection (a) to eligible public and private nonprofit entities 
to support the development of new pre-clinical models for pain 
disorders, and the application of these models in drug, device, or 
other therapy screening.
    (c) Model.--The program under this section shall be modeled after 
the Epilepsy Therapy Screening Program carried out by the National 
Institute of Neurological Disorders and Stroke.
    (d) Fees.--The Secretary of Health and Human Services may assess 
reasonable fees on private pharmaceutical or medical device industry 
entities that utilize the program under this section to screen 
proprietary molecular compounds and devices. Such fees shall be paid to 
the Foundation for the National Institutes of Health and transferred to 
the NIH Innovation Account to be used for the Opioids and STOP Pain 
Initiative established under section 2.
    (e) Funding.--The Director of the National Institutes of Health 
shall determine the amount, and allocate, funds from the amount 
appropriated under section 3, to carry out this section.

SEC. 5. FUNDING PROVISIONS.

    (a) Supplement Not Supplant.--Amounts appropriated in this Act 
(including the amendments made by this Act) shall be used to 
supplement, not supplant, current funding for pain and opioid research 
at the National Institutes of Health.
    (b) Acceptance of Donations.--Notwithstanding section 1342 of title 
31, United States Code, the Secretary of Health and Human Services may 
accept donations (including from the pharmaceutical and medical device 
industries) to be used to assist in carrying out programs and 
activities under this Act (and the amendments made by this Act). Such 
donations shall be paid to the Foundation for the National Institutes 
of Health and transferred to the NIH Innovation Account to be used for 
the Opioids and STOP Pain Initiative established under section 2.
    (c) Inclusion of Contribution Amounts in Basic Research for 
Purposes of Research Credit.--
            (1) In general.--Paragraph (6) of section 41(e) of the 
        Internal Revenue Code of 1986 is amended by adding at the end 
        the following new subparagraph:
                    ``(E) Opioids and stop pain initiative.--The 
                National Institutes of Health, if the payment is made 
                in support of the Opioids and STOP Pain Initiative, as 
                established by the Opioids and STOP Pain Initiative 
                Act.''.
            (2) Effective date.--The amendments made by this subsection 
        shall apply to taxable years beginning after the date of the 
        enactment of this Act.

SEC. 6. AUTHORITY.

    Notwithstanding any other provision of the law, the Director of the 
National Institutes of Health may use funds available under section 3 
to enter into transactions (other than contracts, cooperative 
agreements, or grants) to carry out research identified pursuant to the 
Opioids and STOP Pain Initiative established under section 2.

SEC. 7. REPORTS.

    (a) Annual Reports.--Not later than October 1 of each of fiscal 
years 2019 through 2026, the Director of the National Institutes of 
Health shall submit to the Committee on Health, Education, Labor, and 
Pensions and the Committee on Appropriations of the Senate and the 
Committee on Energy and Commerce and the Committee on Appropriations of 
the House of Representatives, a report that includes--
            (1) the amount obligated or expended in the fiscal year 
        prior to the fiscal year in which the report is being submitted 
        for each program or activity described in this Act (or an 
        amendment made by this Act);
            (2) a description of all such programs or activities 
        carried out using funds provided under this Act (or 
        amendments); and
            (3) a description of how such programs or activities are 
        advancing public health, including the impact on treating pain 
        and addressing opioid misuse in the United States.
    (b) Additional Reports.--At the request of the Committee on Health, 
Education, Labor, and Pensions or the Committee on Appropriations of 
the Senate, or the Committee on Energy and Commerce or the Committee on 
Appropriations of the House of Representatives, the Director of the 
National Institutes of Health shall provide to the relevant Committee 
an update in the form of testimony and additional reports concerning 
the allocation of funding under this Act (or the amendments made by 
this Act) or the description of the programs and activities carried out 
with such funding.
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