[House Report 114-193]
[From the U.S. Government Publishing Office]


114th Congress    }                                      {      Report
                        HOUSE OF REPRESENTATIVES
 1st Session      }                                      {     114-193

======================================================================

 
  PROVIDING FOR CONSIDERATION OF THE BILL (H.R. 6) TO ACCELERATE THE 
  DISCOVERY, DEVELOPMENT, AND DELIVERY OF 21ST CENTURY CURES, AND FOR 
                             OTHER PURPOSES

                                _______
                                

July 8, 2015.--Referred to the House Calendar and ordered to be printed

                                _______
                                

               Mr. Burgess, from the Committee on Rules, 
                        submitted the following

                              R E P O R T

                       [To accompany H. Res. 350]

    The Committee on Rules, having had under consideration 
House Resolution 350, by a nonrecord vote, report the same to 
the House with the recommendation that the resolution be 
adopted.

                SUMMARY OF PROVISIONS OF THE RESOLUTION

    The resolution provides for consideration of H.R. 6, the 
21st Century Cures Act, under a structured rule. The resolution 
provides one hour of general debate equally divided and 
controlled by the chair and ranking minority member of the 
Committee on Energy and Commerce. The resolution waives all 
points of order against consideration of the bill. The 
resolution provides that an amendment in the nature of a 
substitute consisting of the text of Rules Committee Print 114-
22 shall be considered as adopted and the bill, as amended, 
shall be considered as read. The resolution waives all points 
of order against provisions in the bill, as amended. The 
resolution makes in order only those further amendments printed 
in this report. Each such amendment may be offered only in the 
order printed in this report, may be offered only by a Member 
designated in this report, shall be considered as read, shall 
be debatable for the time specified in this report equally 
divided and controlled by the proponent and an opponent, shall 
not be subject to amendment, and shall not be subject to a 
demand for division of the question in the House or in the 
Committee of the Whole. The resolution waives all points of 
order against the amendments printed in this report. The 
resolution provides one motion to recommit with or without 
instructions.

                         EXPLANATION OF WAIVERS

    The waiver of all points of order against consideration of 
the bill includes waivers of the following:
     Clause 3(e)(1) of rule XIII (``Ramseyer''), 
requiring a committee report accompanying a bill amending or 
repealing statutes to show, by typographical device, parts of 
statute affected. The waiver is provided because the submission 
provided by the Committee on Energy and Commerce was 
insufficient to meet the standards established by the rule in 
its current form. The Committee on Rules continues to work with 
the House Office of Legislative Counsel and committees to 
determine the steps necessary to comply with the updated rule;
     Clause 10 of rule XXI, which prohibits the 
consideration of a bill if it has the net effect of increasing 
mandatory spending over the five-year or ten-year period. This 
waiver is necessary because the bill increases mandatory 
spending over the five-year period, however it is important to 
note that the bill complies with the rule over the ten-year 
period and reduces the deficit by more than $500 million over 
that ten-year period;
     Section 302(f) of the Congressional Budget Act, 
which prohibits consideration of legislation providing new 
budget authority in excess of a 302(a) allocation of such 
authority;
     Section 306 of the Congressional Budget Act, which 
prohibits consideration of legislation within the jurisdiction 
of the Committee on the Budget unless referred to or reported 
by the Budget Committee.
    The waiver of all points of order against provisions in the 
bill, as amended, includes a waiver of clause 4 of rule XXI, 
which prohibits reporting a bill or joint resolution carrying 
an appropriation from a committee not having jurisdiction to 
report an appropriation.
    Although the resolution waives all points of order against 
the amendments printed in this report, the Committee is not 
aware of any points of order. The waiver is prophylactic in 
nature.

                SUMMARY OF THE AMENDMENTS MADE IN ORDER

    1. Brat (VA), McClintock (CA), Garrett (NJ), Stutzman (IN), 
Perry (PA): Reforms the NIH and Cures Innovation Fund to make 
it a discretionary spending program. (10 minutes)
    2. Young (IN), Harris (MD): Creates authority within NIH to 
conduct a prize program. The intent of the program would be to 
incentivize health innovation by offering competitors the 
chance to win a prize for creating breakthrough research and 
technology. (10 minutes)
    3. Lee, Barbara (CA), Schakowsky (IL), Clarke (NY): Strikes 
the provision that applies any policy riders included in the 
annual LHHS Appropriations Bill to NIH funds in H.R. 6. Also 
strikes the provision that applies any policy riders applied to 
the FDA in the annual Agriculture Appropriations bill to FDA 
funding in H.R. 6. (10 minutes)
    4. Castro (TX): Ensures underrepresented individuals, such 
as women and minorities, are included in the Supporting Young 
Emerging Scientists Report. (10 minutes)
    5. Slaughter (NY): Directs the CDC to conduct a study to 
determine how the additional payments are affecting the 
development of drug resistance. (10 minutes)
    6. Fitzpatrick (PA): Expresses a sense of Congress that 
recording Unique Device Identifiers at the point-of-care in 
electronic health record systems could significantly enhance 
the availability of medical device data for post-market 
surveillance purposes. (10 minutes)
    7. Polis (CO): Directs the Food and Drug Administration to 
issue a report on the risks and benefits associated with a two-
tiered approval process that would permit certain medical 
devices to provisionally come to market if they have 
demonstrated safety but not efficacy. (10 minutes)
    8. Jackson Lee (TX): Directs the Secretary of Health and 
Human Services to conduct outreach to Historically Black 
Colleges and Universities; Hispanic Serving Institutions; 
Native American Colleges; and rural Colleges to ensure that 
health professionals from underrepresented populations are 
aware of research opportunities under this Act. (10 minutes)

                    TEXT OF AMENDMENTS MADE IN ORDER

1. An Amendment To Be Offered by Representative Brat of Virginia or His 
                   Designee, Debatable for 10 Minutes

  Page 5, beginning on line 6, strike paragraph (1) and insert 
the following:
          (1) Authorization of appropriations.--There is 
        authorized to be appropriated to the NIH and Cures 
        Innovation Fund $1,860,000,000 for each of fiscal years 
        2016 through 2020.
  Page 13, beginning on line 3, strike subsection (f).
                              ----------                              


2. An Amendment To Be Offered by Representative Young of Indiana or His 
                   Designee, Debatable for 10 Minutes

  Page 6, line 19, strike ``409K'' and insert ``409L''.
  Page 15, after line 6, insert the following:

SEC. 1002. PRIZE COMPETITIONS.

  Part B of title IV of the Public Health Service Act (42 
U.S.C. 284 et seq.) is amended by adding at the end the 
following:

``SEC. 409K. PRIZE COMPETITIONS FOR IMPROVING HEALTH OUTCOMES AND 
                    REDUCING FEDERAL EXPENDITURES.

  ``(a) Establishment; Goals.--The Director of NIH shall 
establish and implement an Innovation Prizes Program for one or 
both of the following goals:
          ``(1) Identifying and funding areas of biomedical 
        science that could realize significant advancements 
        through the creation of a prize competition.
          ``(2) Improving health outcomes, particularly with 
        respect to human diseases and conditions for which 
        public and private investment in research is 
        disproportionately small relative to Federal Government 
        expenditures on prevention and treatment activities, 
        thereby reducing Federal expenditures on health 
        programs.
  ``(b) Design of Prize Competitions.--Not later than 6 months 
after the date of enactment of this section, the Director of 
NIH shall--
          ``(1) design prize competitions--
                  ``(A) to cooperate with competitors to 
                realize innovations to identify and address 
                areas of biomedical science that could realize 
                significant advancements through the creation 
                of a prize competition; and
                  ``(B) to award one or more prizes--
                          ``(i) if appropriate, at the 
                        beginning of or during the 
                        competitions, to the competitors whose 
                        innovations are most promising or 
                        demonstrate progress; and
                          ``(ii) at the end of the 
                        competitions, to the competitors whose 
                        innovations prove to be the best 
                        solutions;
          ``(2) ensure that the design of such competitions--
                  ``(A) is realistic, given the amount of funds 
                to be awarded as prizes;
                  ``(B) does not reflect any bias concerning 
                the type of innovations which will prove to be 
                the best solutions; and
                  ``(C) allows any person to participate as a 
                competitor without regard to the person's place 
                of incorporation, primary place of business, 
                citizenship, and residency, as applicable; and
          ``(3) submit to the Congress a report on the design 
        of such competitions.
  ``(c) Innovation Prizes Advisory Board.--
          ``(1) Establishment.--The Director of NIH shall 
        establish and maintain a board, to be known as the I-
        Prize Board, to advise and assist the Director of NIH 
        in carrying out this section.
          ``(2) Composition; terms.--
                  ``(A) Composition.--The I-Prize Board shall 
                be composed of 9 voting members as follows:
                          ``(i) The Director of NIH (or the 
                        Director's designee).
                          ``(ii) Four members appointed by the 
                        Director of NIH.
                          ``(iii) One member appointed by the 
                        Speaker of the House of 
                        Representatives.
                          ``(iv) One member appointed by the 
                        majority leader of the Senate.
                          ``(v) One member appointed by the 
                        minority leader of the House of 
                        Representatives.
                          ``(vi) One member appointed by the 
                        minority leader in the Senate.
                  ``(B) Inclusion of certain experts.--The 
                members of the I-Prize Board appointed under 
                clauses (ii) through (vi) of subparagraph (A) 
                shall, collectively, include medical, economic, 
                budgetary, innovation, or venture capital 
                experts from for-profit and not-for-profit 
                private sector entities with experience in 
                awarding prizes similar to the prizes under 
                this section.
                  ``(C) Terms.--The appointed members of the I-
                Prize Board shall each be appointed for a term 
                of 5 years.
                  ``(D) Appointment of initial members.--The 
                initial appointed members of the I-Prize Board 
                shall be appointed not later than 120 days 
                after the date of enactment of this section.
          ``(3) Responsibilities.--The I-Prize Board shall be 
        responsible for advising the Director of NIH by--
                  ``(A) identifying areas of biomedical science 
                that could realize significant advancements 
                through the creation of a prize competition;
                  ``(B) making recommendations on establishing 
                the criteria for prize competitions under this 
                section;
                  ``(C) making recommendations on which 
                business organizations or other entities have 
                successfully met the criteria established for 
                the prize competition; and
                  ``(D) gaining insight from researchers, 
                health economists, academia, and industry on 
                how to conduct prize competitions.
  ``(d) Restrictions.--
          ``(1) No financial conflicts of interest.--Any member 
        of the I-Prize Board, and any officer or employee of 
        the National Institutes of Health responsible for 
        carrying out this section, may not personally or 
        substantially participate in the consideration or 
        determination by the I-Board of any matter that would 
        directly or predictably effect any financial interest 
        of--
                  ``(A) the individual or a relative (as such 
                term is defined in section 109(16) of the 
                Ethics in Government Act of 1978) of the 
                individual; or
                  ``(B) of any business organization or other 
                entity--
                          ``(i) of which the individual is an 
                        officer or employee;
                          ``(ii) with respect to which the 
                        individual is negotiating for 
                        employment; or
                          ``(iii) in which the individual has 
                        any other financial interest.
          ``(2) No awards to competitors likely to reap 
        financial benefit from innovation.--The Director of NIH 
        may not, with respect to an innovation, award a prize 
        under this section to any individual or entity that has 
        a vested financial interest in any product or procedure 
        that is likely to be developed or marketed because of 
        such innovation.
  ``(e) Process of Award.--The full monetary amount of any 
prize awarded under this section shall be made available to the 
prize winner not later than 90 days after the date of such 
award.
  ``(f) Simulation.--The Director of NIH may--
          ``(1) award one or more contracts--
                  ``(A) to perform a simulation of the prize 
                competitions to be conducted under this 
                section, based on the designs developed under 
                subsection (b); and
                  ``(B) to use the simulation to assess the 
                effectiveness of the design; and
          ``(2) not later than 4 months after awarding such one 
        or more contracts, submit to the Congress a report on 
        the results of the simulation and assessment.
  ``(g) Implementation of Prize Competitions.--
          ``(1) In general.--The Director of NIH may enter into 
        an agreement with one or more entities described in 
        section 501(c), and exempt from tax under section 
        501(a), of the Internal Revenue Code of 1986 to 
        implement prize competitions based on the designs 
        developed under subsection (b).
          ``(2) Minimum percentage for prizes.--If the Director 
        of NIH enters into an agreement under paragraph (1) to 
        provide funds or other assistance (including in-kind 
        contributions and testing or other technical support) 
        to an entity to implement a prize competition under 
        this section--
                  ``(A) not more than 15 percent of such 
                assistance shall be for administration of the 
                prize competition; and
                  ``(B) not less than 85 percent of such 
                assistance shall be for activities in direct 
                support of competitors such as demonstration, 
                testing, education, and prize awards.
  ``(h) Tracking; Reporting.--The Director of NIH shall--
          ``(1) collect information on--
                  ``(A) the medical efficacy of innovations 
                funded through the prize competitions under 
                this section; and
                  ``(B) the actual and potential effect of the 
                innovations on Federal expenditures; and
          ``(2) not later than one year after the conclusion of 
        the prize competitions under this section, and not 
        later than the end of each of the 4 succeeding years, 
        submit to the Congress a report on the information 
        collected under paragraph (1).
  ``(i) Intellectual Property.--
          ``(1) Prohibition on the government acquiring 
        intellectual property rights.--The Federal Government 
        may not gain an interest in intellectual property 
        developed by a participant in a prize competition under 
        this section without the written consent of the 
        participant.
          ``(2) Licenses.--The Federal Government may negotiate 
        a license for the use of intellectual property 
        developed by a participant in a prize competition under 
        this section.''.
  Page 26, line 11, insert ``, as amended by section 1002 of 
this Act,'' after ``et seq.)''
  Page 26, line 13, strike ``409K'' and insert ``409L''.
                              ----------                              


 3. An Amendment To Be Offered by Representative Lee of California or 
                 Her Designee, Debatable for 10 Minutes

  Page 13, strike lines 8 through 13 (and make such conforming 
changes as may be necessary).
                              ----------                              


4. An Amendment To Be Offered by Representative Castro of Texas or His 
                   Designee, Debatable for 10 Minutes

  Page 32, line 8, insert before the period the following: ``, 
including underrepresented individuals in the sciences, such as 
women and other minorities''.
                              ----------                              


 5. An Amendment To Be Offered by Representative Slaughter of New York 
               or Her Designee, Debatable for 10 Minutes

  Page 152, insert after line 9 the following new subsection:
  (c) Study and Report on the Impact of Additional Medicare 
Payment for DISARM Drugs on Usage Practices and Development of 
Resistance.--
          (1) Study.--The Director of the Centers for Disease 
        Control and Prevention shall conduct a study to examine 
        the effects of the additional payment for DISARM drugs 
        under the Medicare program provided under subparagraph 
        (M) of section 1886(d)(5) of the Social Security Act 
        (42 U.S.C. 1395ww(d)(5)), as added by subsection (a), 
        on--
                  (A) the usage of DISARM drugs (as defined by 
                clause (iii) of such subparagraph) by 
                subsection (d) hospitals (as defined in section 
                1886(d)(1)(B) of such Act); and
                  (B) the development of resistance by 
                individuals to such DISARM drugs.
          (2) Report.--Not later than three years after the 
        date of the enactment of this Act, such Director shall 
        submit to Congress a report on the study conducted 
        under paragraph (1).
                              ----------                              


    6. An Amendment To Be Offered by Representative Fitzpatrick of 
         Pennsylvania or His Designee, Debatable for 10 Minutes

  Page 235, after line 2, insert the following:

                      Subtitle R--Other Provisions

SEC. 2321. SENSE OF CONGRESS.

  It is the sense of the Congress that recording unique device 
identifiers at the point-of-care in electronic health record 
systems could significantly enhance the availability of medical 
device data for postmarket surveillance purposes.
                              ----------                              


 7. An Amendment To Be Offered by Representative Polis of Colorado or 
                 His Designee, Debatable for 10 Minutes

  Page 235, insert after line 2 the following new subtitle:

                      Subtitle R--Other Provisions

SEC. 2321. STUDY ON TWO-TIERED APPROVAL PROCESS FOR DEVICES BY FDA.

  (a) In General.--Not later than one year after the date of 
the enactment of this Act, the Secretary of Health and Human 
Services shall submit to Congress a report assessing the 
feasibility, benefits, and risks associated with establishing 
an expedited, two-tiered approval process for devices (as 
defined in section 201 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321)) that would enable devices to be lawfully 
marketed as of the date on which the device has been shown to 
be safe--
          (1) regardless of whether the device has been shown 
        to be effective; and
          (2) so long as the person submitting the application 
        for approval of the device has made no false claims 
        with respect to whether the device is safe or 
        effective.
  (b) Included Elements of Report.--The report described in 
subsection (a) shall include--
          (1) an analysis of the impact of such a process on 
        survival rates and quality of life measures for seniors 
        and individuals with disabilities;
          (2) an analysis of the impact of such a process on 
        survival rates and quality of life measures of 
        individuals suffering from life-threatening or 
        irreversibly debilitating human diseases or conditions;
          (3) an estimation of the impact such a process would 
        have on national health care costs;
          (4) an analysis of the extent to which such a process 
        could be designed so as to guarantee that patient 
        safety is not compromised;
          (5) an analysis of the extent to which fraudulent or 
        ineffective devices could be marketed to patients under 
        such a process and how such risks could be successfully 
        mitigated;
          (6) proposals for providing device manufacturers with 
        incentives to show the effectiveness of devices after 
        the Secretary of Health and Human Services has approved 
        such devices to be lawfully marketed under such a 
        system, such as--
                  (A) by permitting only limited marketing of a 
                device, the effectiveness of which has not yet 
                been shown; or
                  (B) by revoking approval of any device, the 
                effectiveness of which has not been shown 
                within a specified timeframe; and
          (7) recommendations for whether such a process should 
        be applicable to all devices or to only devices that 
        have been granted specific designations by the 
        Secretary or been determined eligible to be approved 
        under specific approval programs under the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
                              ----------                              


8. An Amendment To Be Offered by Representative Jackson Lee of Texas or 
                 Her Designee, Debatable for 10 Minutes

  Page 352, after line 8, insert the following:

SEC. 4062. OUTREACH TO HISTORICALLY BLACK COLLEGES AND UNIVERSITIES.

  The Secretary of Health and Human Services shall conduct 
outreach to historically Black colleges and universities, 
Hispanic-serving institutions, Native American colleges, and 
rural colleges to ensure that health professionals from 
underrepresented populations are aware of research 
opportunities under this Act.

                                  [all]