[Congressional Record (Bound Edition), Volume 161 (2015), Part 8]
[House]
[Pages 11281-11330]
[From the U.S. Government Publishing Office, www.gpo.gov]




                         21ST CENTURY CURES ACT


                             General Leave

  Mr. UPTON. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days to revise and extend their remarks and to 
include extraneous material therein on H.R. 6.
  The SPEAKER pro tempore (Mr. Fitzpatrick). Is there objection to the 
request of the gentleman from Michigan?
  There was no objection.
  The SPEAKER pro tempore. Pursuant to House Resolution 350 and rule 
XVIII, the Chair declares the House in the Committee of the Whole House 
on the state of the Union for the further consideration of the bill, 
H.R. 6.
  Will the gentlewoman from North Carolina (Ms. Foxx) kindly retake the 
chair.

                              {time}  0916


                     In the Committee of the Whole

  Accordingly, the House resolved itself into the Committee of the 
Whole House on the state of the Union for the further consideration of 
the bill (H.R. 6) to accelerate the discovery, development, and 
delivery of 21st century cures, and for other purposes, with Ms. Foxx 
(Acting Chair) in the chair.
  The Clerk read the title of the bill.
  The Acting CHAIR. When the Committee of the Whole rose on Thursday, 
July 9, 2015, all time for general debate had expired.
  Pursuant to the rule, the bill shall be considered for amendment 
under the 5-minute rule.
  In lieu of the amendment in the nature of a substitute recommended by 
the Committee on Energy and Commerce, printed in the bill, an amendment 
in the nature of a substitute consisting of the text of Rules Committee 
Print 114-22 is adopted.
  The bill, as amended, shall be considered as the original bill for 
the purpose of further amendment under the 5-minute rule and shall be 
considered as read.
  The text of the bill, as amended, is as follows:

                                 H.R. 6

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

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``21st 
     Century Cures Act''.
       (b) Table of Contents.--The table of contents for this Act 
     is as follows:

Sec. 1. Short title; table of contents.
Sec. 2. NIH and Cures Innovation Fund.

                           TITLE I--DISCOVERY

           Subtitle A--National Institutes of Health Funding

Sec. 1001. National Institutes of Health reauthorization.

 Subtitle B--National Institutes of Health Planning and Administration

Sec. 1021. NIH research strategic plan.
Sec. 1022. Increasing accountability at the National Institutes of 
              Health.
Sec. 1023. Reducing administrative burdens of researchers.
Sec. 1024. Exemption for the National Institutes of Health from the 
              Paperwork Reduction Act requirements.
Sec. 1025. NIH travel.
Sec. 1026. Other transactions authority.
Sec. 1027. NCATS phase IIB restriction.
Sec. 1028. High-risk, high-reward research.
Sec. 1029. Sense of Congress on increased inclusion of underrepresented 
              communities in clinical trials.

            Subtitle C--Supporting Young Emerging Scientists

Sec. 1041. Improvement of loan repayment programs of the National 
              Institutes of Health.
Sec. 1042. Report.

                   Subtitle D--Capstone Grant Program

Sec. 1061. Capstone award.

     Subtitle E--Promoting Pediatric Research Through the National 
                          Institutes of Health

Sec. 1081. National pediatric research network.
Sec. 1082. Global pediatric clinical study network sense of Congress.
Sec. 1083. Appropriate age groupings in clinical research.

 Subtitle F--Advancement of the National Institutes of Health Research 
                            and Data Access

Sec. 1101. Standardization of data in Clinical Trial Registry Data Bank 
              on eligibility for clinical trials.

            Subtitle G--Facilitating Collaborative Research

Sec. 1121. Clinical trial data system.
Sec. 1122. National neurological diseases surveillance system.
Sec. 1123. Data on natural history of diseases.
Sec. 1124. Accessing, sharing, and using health data for research 
              purposes.

               Subtitle H--Council for 21st Century Cures

Sec. 1141. Council for 21st Century Cures.

                         TITLE II--DEVELOPMENT

              Subtitle A--Patient-Focused Drug Development

Sec. 2001. Development and use of patient experience data to enhance 
              structured risk-benefit assessment framework.

      Subtitle B--Qualification and Use of Drug Development Tools

Sec. 2021. Qualification of drug development tools.
Sec. 2022. Accelerated approval development plan.

           Subtitle C--FDA Advancement of Precision Medicine

Sec. 2041. Precision medicine guidance and other programs of Food and 
              Drug Administration.

        Subtitle D--Modern Trial Design and Evidence Development

Sec. 2061. Broader application of Bayesian statistics and adaptive 
              trial designs.
Sec. 2062. Utilizing evidence from clinical experience.
Sec. 2063. Streamlined data review program.

                 Subtitle E--Expediting Patient Access

Sec. 2081. Sense of Congress.
Sec. 2082. Expanded access policy.
Sec. 2083. Finalizing draft guidance on expanded access.

    Subtitle F--Facilitating Responsible Manufacturer Communications

Sec. 2101. Facilitating dissemination of health care economic 
              information.
Sec. 2102. Facilitating responsible communication of scientific and 
              medical developments.

                Subtitle G--Antibiotic Drug Development

Sec. 2121. Approval of certain drugs for use in a limited population of 
              patients.
Sec. 2122. Susceptibility test interpretive criteria for 
              microorganisms.
Sec. 2123. Encouraging the development and use of DISARM drugs.

         Subtitle H--Vaccine Access, Certainty, and Innovation

Sec. 2141. Timely review of vaccines by the Advisory Committee on 
              Immunization Practices.
Sec. 2142. Review of processes and consistency of ACIP recommendations.
Sec. 2143. Meetings between CDC and vaccine developers.

   Subtitle I--Orphan Product Extensions Now; Incentives for Certain 
                    Products for Limited Populations

Sec. 2151. Extension of exclusivity periods for a drug approved for a 
              new indication for a rare disease or condition.
Sec. 2152. Reauthorization of rare pediatric disease priority review 
              voucher incentive program.

       Subtitle J--Domestic Manufacturing and Export Efficiencies

Sec. 2161. Grants for studying the process of continuous drug 
              manufacturing.

[[Page 11282]]

Sec. 2162. Re-exportation among members of the European Economic Area.

           Subtitle K--Enhancing Combination Products Review

Sec. 2181. Enhancing combination products review.

          Subtitle L--Priority Review for Breakthrough Devices

Sec. 2201. Priority review for breakthrough devices.

       Subtitle M--Medical Device Regulatory Process Improvements

Sec. 2221. Third-party quality system assessment.
Sec. 2222. Valid scientific evidence.
Sec. 2223. Training and oversight in least burdensome appropriate means 
              concept.
Sec. 2224. Recognition of standards.
Sec. 2225. Easing regulatory burden with respect to certain class I and 
              class II devices.
Sec. 2226. Advisory committee process.
Sec. 2227. Humanitarian device exemption application.
Sec. 2228. CLIA waiver study design guidance for in vitro diagnostics.

Subtitle N--Sensible Oversight for Technology Which Advances Regulatory 
                               Efficiency

Sec. 2241. Health software.
Sec. 2242. Applicability and inapplicability of regulation.
Sec. 2243. Exclusion from definition of device.

                Subtitle O--Streamlining Clinical Trials

Sec. 2261. Protection of human subjects in research; applicability of 
              rules.
Sec. 2262. Use of non-local institutional review boards for review of 
              investigational device exemptions and human device 
              exemptions.
Sec. 2263. Alteration or waiver of informed consent for clinical 
              investigations.

     Subtitle P--Improving Scientific Expertise and Outreach at FDA

Sec. 2281. Silvio O. Conte Senior Biomedical Research Service.
Sec. 2282. Enabling FDA scientific engagement.
Sec. 2283. Reagan-Udall Foundation for the Food and Drug 
              Administration.
Sec. 2284. Collection of certain voluntary information exempted from 
              Paperwork Reduction Act.
Sec. 2285. Hiring authority for scientific, technical, and professional 
              personnel.

       Subtitle Q--Exempting From Sequestration Certain User Fees

Sec. 2301. Exempting from sequestration certain user fees of Food and 
              Drug Administration.

                          TITLE III--DELIVERY

                      Subtitle A--Interoperability

Sec. 3001. Ensuring interoperability of health information technology.

                         Subtitle B--Telehealth

Sec. 3021. Telehealth services under the Medicare program.

  Subtitle C--Encouraging Continuing Medical Education for Physicians

Sec. 3041. Exempting from manufacturer transparency reporting certain 
              transfers used for educational purposes.

              Subtitle D--Disposable Medical Technologies

Sec. 3061. Treatment of certain items and devices.

              Subtitle E--Local Coverage Decision Reforms

Sec. 3081. Improvements in the Medicare local coverage determination 
              (LCD) process.

      Subtitle F--Medicare Pharmaceutical and Technology Ombudsman

Sec. 3101. Medicare pharmaceutical and technology ombudsman.

        Subtitle G--Medicare Site-of-Service Price Transparency

Sec. 3121. Medicare site-of-Service price transparency.

  Subtitle H--Medicare Part D Patient Safety and Drug Abuse Prevention

Sec. 3141. Programs to prevent prescription drug abuse under Medicare 
              parts C and D.

            TITLE IV--MEDICAID, MEDICARE, AND OTHER REFORMS

               Subtitle A--Medicaid and Medicare Reforms

Sec. 4001. Limiting Federal Medicaid reimbursement to States for 
              durable medical equipment (DME) to Medicare payment 
              rates.
Sec. 4002. Excluding authorized generics from calculation of average 
              manufacturer price.
Sec. 4003. Medicare payment incentive for the transition from 
              traditional x-ray imaging to digital radiography and 
              other Medicare imaging payment provision.
Sec. 4004. Treatment of infusion drugs furnished through durable 
              medical equipment.
Sec. 4005. Extension and expansion of prior authorization for power 
              mobility devices (PMDs) and accessories and prior 
              authorization audit limitations.
Sec. 4006. Civil monetary penalties for violations related to grants, 
              contracts, and other agreements.

                       Subtitle B--Other Reforms

Sec. 4041. SPR drawdown.

                       Subtitle C--Miscellaneous

Sec. 4061. Lyme disease and other tick-borne diseases.

     SEC. 2. NIH AND CURES INNOVATION FUND.

       (a) Establishment.--There is hereby established in the 
     Treasury of the United States a fund to be known as the NIH 
     and Cures Innovation Fund.
       (b) Amounts Made Available to Fund.--
       (1) In general.--There is authorized to be appropriated, 
     and appropriated, to the NIH and Cures Innovation Fund, out 
     of any funds in the Treasury not otherwise appropriated, 
     $1,860,000,000 for each of fiscal years 2016 through 2020. 
     The amounts appropriated to the NIH and Cures Innovation Fund 
     by the preceding sentence shall be in addition to any amounts 
     otherwise made available to the Department of Health and 
     Human Services.
       (2) Allocation of amounts.--Of the amounts made available 
     from the NIH and Cures Innovation Fund for a fiscal year--
       (A) $1,750,000,000 shall be for biomedical research of the 
     National Institutes of Health under subsection (c)(1), of 
     which--
       (i) not less than $500,000,000 shall be for the 
     Accelerating Advancement Program under subsection (d)(2);
       (ii) not less than 35 percent of such amounts remaining 
     after subtracting the allocation for the Accelerating 
     Advancement Program shall be for early stage investigators as 
     defined in subsection (g);
       (iii) not less than 20 percent of such amounts remaining 
     after subtracting the allocation for the Accelerating 
     Advancement Program shall be for high-risk, high-reward 
     research under section 409K of the Public Health Service Act, 
     as added by section 1028; and
       (iv) not more than 10 percent of such amounts (without 
     subtracting the allocation for the Accelerating Advancement 
     Program) shall be for intramural research; and
       (B) $110,000,000 shall be for carrying out the provisions 
     listed in subsection (c)(2).
       (3) Inapplicability of certain provisions.--Amounts in the 
     NIH and Cures Innovation Fund (including amounts made 
     available to the National Institutes of Health) shall not be 
     subject to--
       (A) any transfer authority of the Secretary of Health and 
     Human Services or the Director of the National Institutes of 
     Health under sections 241, 402A(c), or 402A(d) of the Public 
     Health Service Act (42 U.S.C. 238j, 282a(c) and (d)) or any 
     other provision of law (other than this section); or
       (B) the Nonrecurring expenses fund under section 223 of 
     division G of the Consolidated Appropriations Act, 2008 (42 
     U.S.C. 3514a).
       (c) Authorized Uses.--
       (1) NIH biomedical research.--Amounts in the NIH and Cures 
     Innovation Fund that are allocated pursuant to subsection 
     (b)(2)(A) may only be used for the purpose of conducting or 
     supporting biomedical research (including basic, 
     translational, and clinical research) through the following:
       (A) Research in which--
       (i) a principal investigator has a specific project or 
     specific objectives; and
       (ii) funding is tied to pursuit of such project or 
     objectives.
       (B) Research in which--
       (i) a principal investigator has shown promise in 
     biomedical research; and
       (ii) funding is not tied to a specific project or specific 
     objectives.
       (C) Research to be carried out by an early stage 
     investigator (as defined in subsection (g)).
       (D) Research to be carried out by a small business concern 
     (as defined in section 3 of the Small Business Act).
       (E) The Accelerating Advancement Program under subsection 
     (d)(2).
       (F) Development and implementation of the strategic plan 
     under subsection (d)(3).
       (2) Cures development.--Amounts in the NIH and Cures 
     Innovation Fund that are allocated pursuant to subsection 
     (b)(2)(B) may only be used for the purpose of carrying out 
     the following provisions:
       (A) Section 229A of the Public Health Service Act, as added 
     by section 1123 (relating to data on natural history of 
     diseases).
       (B) Section 2001 and the amendments made by such section 
     (relating to development and use of patient experience data 
     to enhance structured risk-benefit assessment framework).
       (C) Section 2021 and the amendments made by such section 
     (relating to qualification of drug development tools).
       (D) Section 2062 and the amendments made by such section 
     (relating to utilizing evidence from clinical experience).
       (E) Section 2161 (relating to grants for studying the 
     process of continuous drug manufacturing).
       (F) Section 2201 and the amendments made by such section 
     (relating to priority review for breakthrough devices).
       (G) Section 2221 and the amendments made by such section 
     (relating to third-party quality system assessments).
       (H) Sections 2241, 2242, and 2243 and the amendments made 
     by such sections (relating to health software).
       (I) Section 513(j) of the Federal Food, Drug, and Cosmetic 
     Act, as added by section 2223 (relating to training and 
     oversight in least burdensome appropriate means concept).
       (d) NIH Innovation Fund.--
       (1) Coordination.--In conducting or supporting biomedical 
     research pursuant to funds allocated pursuant to subsection 
     (b)(2)(A), the

[[Page 11283]]

     Secretary of Health and Human Services, acting through the 
     Director of the National Institutes of Health, shall--
       (A) ensure coordination among the national research 
     institutes, the national centers, and other departments, 
     agencies, and offices of the Federal Government; and
       (B) minimize unnecessary duplication.
       (2) Accelerating advancement program.--The Director of the 
     National Institutes of Health shall establish a program, to 
     be known as the Accelerating Advancement Program, under 
     which--
       (A) the Director partners with national research institutes 
     and national centers to accomplish important biomedical 
     research objectives; and
       (B) for every $1 made available by the Director to a 
     national research institute or national center for a research 
     project, the institute or center makes $1 available for such 
     project from funds that are not derived from the NIH and 
     Cures Innovation Fund.
       (3) Strategic plan.--
       (A) In general.--The Director of the National Institutes of 
     Health shall ensure that scientifically based strategic 
     planning is implemented in support of research priorities, 
     including through development, use, and updating of a 
     research strategic plan that--
       (i) is designed to increase the efficient and effective 
     focus of biomedical research in a manner that leverages the 
     best scientific opportunities through a deliberative planning 
     process;
       (ii) identifies areas, to be known as strategic focus 
     areas, in which the resources of the NIH and Cures Innovation 
     Fund can contribute to the goals of expanding knowledge to 
     address, and find more effective treatments for, unmet 
     medical needs in the United States, including the areas of--

       (I) biomarkers;
       (II) precision medicine;
       (III) infectious diseases, including pathogens listed as a 
     qualifying pathogen under section 505E(f) of the Federal 
     Food, Drug, and Cosmetic Act or listed or designated as a 
     tropical disease under section 524 of such Act; and
       (IV) antibiotics;

       (iii) includes objectives for each such strategic focus 
     area; and
       (iv) ensures that basic research remains a priority.
       (B) Updates and reviews.--The Director of the National 
     Institutes of Health shall review and, as appropriate, update 
     the research strategic plan under subparagraph (A) not less 
     than every 18 months.
       (e) Transfer Authority.--The Committee on Appropriations of 
     the Senate and the Committee on Appropriations of the House 
     of Representatives may provide for the transfer of funds in 
     the NIH and Cures Innovation Fund for the purposes specified 
     in subsection (c).
       (f) Supplement, Not Supplant; Limitations.--Funds 
     appropriated by subsection (b)--
       (1) shall be used to supplement, not supplant, amounts 
     otherwise made available to the Department of Health and 
     Human Services;
       (2) are subject to the requirements and limitations of the 
     most recently enacted regular or full-year continuing 
     appropriation Act or resolution (as of the date of 
     obligation) for programs of the National Institutes of Health 
     or the Food and Drug Administration, as applicable; and
       (3) notwithstanding any transfer authority in any 
     appropriation Act, shall not be used for any purpose other 
     than the purposes specified in subsection (c).
       (g) Definition.--In this subsection:
       (1) The term ``early stage investigator'' means an 
     investigator who--
       (A) will be the principal investigator or the program 
     director of the proposed research;
       (B) has never been awarded, or has been awarded only once, 
     a substantial, competing grant by the National Institutes of 
     Health for independent research; and
       (C) is within 10 years of having completed--
       (i) the investigator's terminal degree; or
       (ii) a medical residency (or the equivalent).
       (2) The terms ``national center'' and ``national research 
     institute'' have the meanings given to those terms in section 
     401(g) of the Public Health Service Act (42 U.S.C. 281(g)).

                           TITLE I--DISCOVERY

           Subtitle A--National Institutes of Health Funding

     SEC. 1001. NATIONAL INSTITUTES OF HEALTH REAUTHORIZATION.

       Section 402A(a)(1) of the Public Health Service Act (42 
     U.S.C. 282a(a)(1)) is amended--
       (1) in subparagraph (B), by striking at the end ``and'';
       (2) in subparagraph (C), by striking at the end the period 
     and inserting a semicolon; and
       (3) by adding at the end the following new subparagraphs:
       ``(D) $31,811,000,000 for fiscal year 2016;
       ``(E) $33,331,000,000 for fiscal year 2017; and
       ``(F) $34,851,000,000 for fiscal year 2018.''.

 Subtitle B--National Institutes of Health Planning and Administration

     SEC. 1021. NIH RESEARCH STRATEGIC PLAN.

       Section 402 of the Public Health Service Act (42 U.S.C. 
     282) is amended--
       (1) in subsection (b), by amending paragraph (5) to read as 
     follows:
       ``(5) shall ensure that scientifically based strategic 
     planning is implemented in support of research priorities as 
     determined by the agencies of the National Institutes of 
     Health, including through development, use, and updating of 
     the research strategic plan under subsection (m);''; and
       (2) by adding at the end the following:
       ``(m) Research Strategic Plan.--
       ``(1) Five-year plans for biomedical research strategy.--
       ``(A) In general.--For each successive five-year period 
     beginning with the period of fiscal years 2016 through 2020, 
     the Director of NIH, in consultation with the entities 
     described in subparagraph (B), shall develop and maintain a 
     biomedical research strategic plan that--
       ``(i) is designed to increase the efficient and effective 
     focus of biomedical research in a manner that leverages the 
     best scientific opportunities through a deliberative planning 
     process;
       ``(ii) identifies areas, to be known as strategic focus 
     areas, in which the resources of the National Institutes of 
     Health can best contribute to the goal of expanding knowledge 
     on human health in the United States through biomedical 
     research; and
       ``(iii) includes objectives for each such strategic focus 
     area.
       ``(B) Entities described.--The entities described in this 
     subparagraph are the directors of the national research 
     institutes and national centers, researchers, patient 
     advocacy groups, and industry leaders.
       ``(2) Use of plan.--The Director of NIH and the directors 
     of the national research institutes and national centers 
     shall use the strategic plan--
       ``(A) to identify research opportunities; and
       ``(B) to develop individual strategic plans for the 
     research activities of each of the national research 
     institutes and national centers that--
       ``(i) have a common template; and
       ``(ii) identify strategic focus areas in which the 
     resources of the national research institutes and national 
     centers can best contribute to the goal of expanding 
     knowledge on human health in the United States through 
     biomedical research.
       ``(3) Contents of plans.--
       ``(A) Strategic focus areas.--The strategic focus areas 
     identified pursuant to paragraph (1)(A)(ii) shall--
       ``(i) be identified in a manner that--

       ``(I) considers the return on investment to the United 
     States public through the investments of the National 
     Institutes of Health in biomedical research; and
       ``(II) contributes to expanding knowledge to improve the 
     United States public's health through biomedical research; 
     and

       ``(ii) include overarching and trans-National Institutes of 
     Health strategic focus areas, to be known as Mission Priority 
     Focus Areas, which best serve the goals of preventing or 
     eliminating the burden of a disease or condition and 
     scientifically merit enhanced and focused research over the 
     next 5 years.
       ``(B) Rare and pediatric diseases and conditions.--In 
     developing and maintaining a strategic plan under this 
     subsection, the Director of NIH shall ensure that rare and 
     pediatric diseases and conditions remain a priority.
       ``(C) Workforce.--In developing and maintaining a strategic 
     plan under this subsection, the Director of NIH shall ensure 
     that maintaining the biomedical workforce of the future, 
     including the participation by scientists from groups 
     traditionally underrepresented in the scientific workforce, 
     remains a priority.
       ``(4) Initial plan.--Not later than 270 days after the date 
     of enactment of this subsection, the Director of NIH and the 
     directors of the national research institutes and national 
     centers shall--
       ``(A) complete the initial strategic plan required by 
     paragraphs (1) and (2); and
       ``(B) make such initial strategic plan publicly available 
     on the website of the National Institutes of Health.
       ``(5) Review; updates.--
       ``(A) Progress reviews.--Not less than annually, the 
     Director of NIH, in consultation with the directors of the 
     national research institutes and national centers, shall 
     conduct progress reviews for each strategic focus area 
     identified under paragraph (1)(A)(ii).
       ``(B) Updates.--Not later than the end of the 5-year period 
     covered by the initial strategic plan under this subsection, 
     and every 5 years thereafter, the Director of NIH, in 
     consultation with the directors of the national research 
     institutes and national centers, stakeholders in the 
     scientific field, advocates, and the public at large, shall--
       ``(i) conduct a review of the plan, including each 
     strategic focus area identified under paragraph (2)(B); and
       ``(ii) update such plan in accordance with this section.''.

     SEC. 1022. INCREASING ACCOUNTABILITY AT THE NATIONAL 
                   INSTITUTES OF HEALTH.

       (a) Appointment and Terms of Directors of National Research 
     Institutes and National Centers.--Subsection (a) of section 
     405 of the Public Health Service Act (42 U.S.C. 284) is 
     amended to read as follows: ``(a) Appointment; Terms.--
       ``(1) Appointment.--The Director of the National Cancer 
     Institute shall be appointed by the President and the 
     directors of the other national research institutes, as well 
     as the directors of the national centers, shall be appointed 
     by the Director of NIH. The directors of the national 
     research institutes, as well as national centers, shall 
     report directly to the Director of NIH.
       ``(2) Terms.--
       ``(A) In general.--The term of office of a director of a 
     national research institute or national center shall be 5 
     years.
       ``(B) Removal.--The director of a national research 
     institute or national center may be removed from office by 
     the Director of NIH prior to the expiration of such 
     director's 5-year term.

[[Page 11284]]

       ``(C) Reappointment.--At the end of the term of a director 
     of a national research institute or national center, the 
     director may be reappointed. There is no limit on the number 
     of terms a director may serve.
       ``(D) Vacancies.--If the office of a director of a national 
     research institute or national center becomes vacant before 
     the end of such director's term, the director appointed to 
     fill the vacancy shall be appointed for a 5-year term 
     starting on the date of such appointment.
       ``(E) Transitional provision.--Each director of a national 
     research institute or national center serving on the date of 
     enactment of the 21st Century Cures Act is deemed to be 
     appointed for a 5-year term under this subsection starting on 
     such date of enactment.''.
       (b) Compensation to Consultants or Individual Scientists.--
     Section 202 of the Departments of Labor, Health and Human 
     Services, and Education, and Related Agencies Appropriations 
     Act, 1993 (Public Law 102-394; 42 U.S.C. 238f note) is 
     amended by striking ``portable structures;'' and all that 
     follows and inserting ``portable structures.''.
       (c) Review of Certain Awards by Directors.--Section 405(b) 
     of the Public Health Service Act (42 U.S.C. 284(b)) is 
     amended by adding at the end the following:
       ``(3) Before an award is made by a national research 
     institute or by a national center for a grant for a research 
     program or project (commonly referred to as an `R-series 
     grant'), other than an award constituting a noncompeting 
     renewal of such grant, or a noncompeting administrative 
     supplement to such grant, the director of such national 
     research institute or national center--
       ``(A) shall review and approve the award; and
       ``(B) shall take into consideration--
       ``(i) the mission of the national research institute or 
     national center and the scientific priorities identified in 
     the strategic plan under section 402(m); and
       ``(ii) whether other agencies are funding programs or 
     projects to accomplish the same goal.''.
       (d) IOM Study on Duplication in Federal Biomedical 
     Research.--The Secretary of Health and Human Services shall 
     enter into an arrangement with the Institute of Medicine of 
     the National Academies (or, if the Institute declines, 
     another appropriate entity) under which the Institute (or 
     other appropriate entity) not later than 2 years after the 
     date of enactment of this Act will--
       (1) complete a study on the extent to which biomedical 
     research conducted or supported by Federal agencies is 
     duplicative; and
       (2) submit a report to the Congress on the results of such 
     study, including recommendations on how to prevent such 
     duplication.

     SEC. 1023. REDUCING ADMINISTRATIVE BURDENS OF RESEARCHERS.

       (a) Plan Preparation and Implementation of Measures To 
     Reduce Administrative Burdens.--The Director of the National 
     Institutes of Health shall prepare a plan, including time 
     frames, and implement measures to reduce the administrative 
     burdens of researchers funded by the National Institutes of 
     Health, taking into account the recommendations, evaluations, 
     and plans researched by the following entities:
       (1) The Scientific Management Review Board.
       (2) The National Academy of Sciences.
       (3) The 2007 and 2012 Faculty Burden Survey conducted by 
     The Federal Demonstration Partnership.
       (4) Relevant recommendations from the Research Business 
     Models Working Group.
       (b) Report.--Not later than two years after the date of 
     enactment of this Act, the Director of the National 
     Institutes of Health shall submit to Congress a report on the 
     extent to which the Director has implemented measures 
     pursuant to subsection (a).

     SEC. 1024. EXEMPTION FOR THE NATIONAL INSTITUTES OF HEALTH 
                   FROM THE PAPERWORK REDUCTION ACT REQUIREMENTS.

       Section 3518(c)(1) of title 44, United States Code, is 
     amended--
       (1) in subparagraph (C), by striking ``; or'' and inserting 
     a semicolon;
       (2) in subparagraph (D), by striking the period at the end 
     and inserting ``; or''; and
       (3) by inserting at the end the following new subparagraph:
       ``(E) during the conduct of research by the National 
     Institutes of Health.''.

     SEC. 1025. NIH TRAVEL.

       It is the sense of Congress that participation in or 
     sponsorship of scientific conferences and meetings is 
     essential to the mission of the National Institutes of 
     Health.

     SEC. 1026. OTHER TRANSACTIONS AUTHORITY.

       Section 480 of the Public Health Service Act (42 U.S.C. 
     287a) is amended--
       (1) in subsection (b), by striking ``the appropriation of 
     funds as described in subsection (g)'' and inserting ``the 
     availability of funds as described in subsection (f)'';
       (2) in subsection (e)(3), by amending subparagraph (C) to 
     read as follows:
       ``(C) Other transactions authority.--The Director of the 
     Center shall have other transactions authority in entering 
     into transactions to fund projects in accordance with the 
     terms and conditions of this section.'';
       (3) by striking subsection (f); and
       (4) by redesignating subsection (g) as subsection (f).

     SEC. 1027. NCATS PHASE IIB RESTRICTION.

       Section 479 of the Public Health Service Act (42 U.S.C. 
     287) is amended--
       (1) prior to making the amendments under paragraph (2), by 
     striking ``IIB'' each place it appears and inserting ``III''; 
     and
       (2) by striking ``IIA'' each place it appears and inserting 
     ``IIB''.

     SEC. 1028. HIGH-RISK, HIGH-REWARD RESEARCH.

       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. HIGH-RISK, HIGH-REWARD RESEARCH PROGRAM.

       ``The director of each national research institute shall, 
     as appropriate--
       ``(1) establish programs to conduct or support research 
     projects that pursue innovative approaches to major 
     contemporary challenges in biomedical research that involve 
     inherent high risk, but have the potential to lead to 
     breakthroughs; and
       ``(2) set aside a specific percentage of funding, to be 
     determined by the Director of NIH for each national research 
     institute, for such projects.''.

     SEC. 1029. SENSE OF CONGRESS ON INCREASED INCLUSION OF 
                   UNDERREPRESENTED COMMUNITIES IN CLINICAL 
                   TRIALS.

       It is the sense of Congress that the National Institute on 
     Minority Health and Health Disparities (NIMHD) should include 
     within its strategic plan ways to increase representation of 
     underrepresented communities in clinical trials.

            Subtitle C--Supporting Young Emerging Scientists

     SEC. 1041. IMPROVEMENT OF LOAN REPAYMENT PROGRAMS OF THE 
                   NATIONAL INSTITUTES OF HEALTH.

       (a) In General.--Part G of title IV of the Public Health 
     Service (42 U.S.C. 288 et seq.) is amended--
       (1) by redesignating the second section 487F (42 U.S.C. 
     288-6; relating to pediatric research loan repayment program) 
     as section 487G; and
       (2) by inserting after section 487G, as so redesignated, 
     the following:

     ``SEC. 487H. LOAN REPAYMENT PROGRAM.

       ``(a) In General.--The Secretary shall establish a program, 
     based on workforce and scientific needs, of entering into 
     contracts with qualified health professionals under which 
     such health professionals agree to engage in research in 
     consideration of the Federal Government agreeing to pay, for 
     each year of engaging in such research, not more than $50,000 
     of the principal and interest of the educational loans of 
     such health professionals.
       ``(b) Adjustment for Inflation.--Beginning with respect to 
     fiscal year 2017, the Secretary may increase the maximum 
     amount specified in subsection (a) by an amount that is 
     determined by the Secretary, on an annual basis, to reflect 
     inflation.
       ``(c) Limitation.--The Secretary may not enter into a 
     contract with a health professional pursuant to subsection 
     (a) unless such professional has a substantial amount of 
     educational loans relative to income.
       ``(d) Applicability of Certain Provisions Regarding 
     Obligated Service.--Except to the extent inconsistent with 
     this section, the provisions of sections 338B, 338C, and 338E 
     shall apply to the program established under this section to 
     the same extent and in the same manner as such provisions 
     apply to the National Health Service Corps Loan Repayment 
     Program established under section 338B.
       ``(e) Availability of Appropriations.--Amounts appropriated 
     for a fiscal year for contracts under subsection (a) are 
     authorized to remain available until the expiration of the 
     second fiscal year beginning after the fiscal year for which 
     the amounts were appropriated.''.
       (b) Update of Other Loan Repayment Programs.--
       (1) Section 464z-5(a) of the Public Health Service Act (42 
     U.S.C.285t-2(a)) is amended--
       (A) by striking ``$35,000'' and inserting ``$50,000''; and
       (B) by adding at the end the following new sentence: 
     ``Subsection (b) of section 487H shall apply with respect to 
     the maximum amount specified in this subsection in the same 
     manner as it applies to the maximum amount specified in 
     subsection (a) of such section.''.
       (2) Section 487A(a) of such Act (42 U.S.C. 288-1(a)) is 
     amended--
       (A) by striking ``$35,000'' and inserting ``$50,000''; and
       (B) by adding at the end the following new sentence: 
     ``Subsection (b) of section 487H shall apply with respect to 
     the maximum amount specified in this subsection in the same 
     manner as it applies to the maximum amount specified in 
     subsection (a) of such section.''.
       (3) Section 487B(a) of such Act (42 U.S.C. 288-2(a)) is 
     amended--
       (A) by striking ``$35,000'' and inserting ``$50,000''; and
       (B) by adding at the end the following new sentence: 
     ``Subsection (b) of section 487H shall apply with respect to 
     the maximum amount specified in this subsection in the same 
     manner as it applies to the maximum amount specified in such 
     subsection (a) of such section.''.
       (4) Section 487C(a)(1) of such Act (42 U.S.C. 288-3(a)(1)) 
     is amended--
       (A) by striking ``$35,000'' and inserting ``$50,000''; and
       (B) by adding at the end the following new sentence: 
     ``Subsection (b) of section 487H shall apply with respect to 
     the maximum amount specified in this paragraph in the same 
     manner as it applies to the maximum amount specified in such 
     subsection (a) of such section.''.
       (5) Section 487E(a)(1) of such Act (42 U.S.C. 288-5(a)(1)) 
     is amended--
       (A) by striking ``$35,000'' and inserting ``$50,000''; and
       (B) by adding at the end the following new sentence: 
     ``Subsection (b) of section 487H shall

[[Page 11285]]

     apply with respect to the maximum amount specified in this 
     paragraph in the same manner as it applies to the maximum 
     amount specified in such subsection (a) of such section.''.
       (6) Section 487F(a) of such Act (42 U.S.C. 288-5a(a)), as 
     added by section 205 of Public Law 106-505, is amended--
       (A) by striking ``$35,000'' and inserting ``$50,000''; and
       (B) by adding at the end the following new sentence: 
     ``Subsection (b) of section 487H shall apply with respect to 
     the maximum amount specified in this subsection in the same 
     manner as it applies to the maximum amount specified in such 
     subsection (a) of such section.''.
       (7) Section 487G of such Act (42 U.S.C. 288-6, as 
     redesignated by subsection (a)(1)), is further amended--
       (A) in subsection (a)(1), by striking ``$35,000'' and 
     inserting ``$50,000''; and
       (B) in subsection (b), by adding at the end the following 
     new sentence: ``Subsection (b) of section 487H shall apply 
     with respect to the maximum amount specified in subsection 
     (a)(1) in the same manner as it applies to the maximum amount 
     specified in such subsection (a) of such section.''.

     SEC. 1042. REPORT.

       Not later than 18 months after the date of the enactment of 
     this Act, the Director of the National Institutes of Health 
     shall submit to Congress a report on efforts of the National 
     Institutes of Health to attract, retain, and develop emerging 
     scientists.

                   Subtitle D--Capstone Grant Program

     SEC. 1061. CAPSTONE AWARD.

       Part G of title IV of the Public Health Service Act (42 
     U.S.C. 288 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 490. CAPSTONE AWARD.

       ``(a) In General.--The Secretary may make awards (each of 
     which, hereafter in this section, referred to as a `Capstone 
     Award') to support outstanding scientists who have been 
     funded by the National Institutes of Health.
       ``(b) Purpose.--Capstone Awards shall be made to facilitate 
     the successful transition or conclusion of research programs, 
     or for other purposes, as determined by the Director of NIH, 
     in consultation with the directors of the national research 
     institutes and national centers.
       ``(c) Duration and Amount.--The duration and amount of each 
     Capstone Award shall be determined by the Director of NIH in 
     consultation with the directors of the national research 
     institutes and national centers.
       ``(d) Limitation.--Individuals who have received a Capstone 
     Award shall not be eligible to have principle investigator 
     status on subsequent awards from the National Institutes of 
     Health.''.

     Subtitle E--Promoting Pediatric Research Through the National 
                          Institutes of Health

     SEC. 1081. NATIONAL PEDIATRIC RESEARCH NETWORK.

       Section 409D(d) of the Public Health Service Act (42 U.S.C. 
     284h(d)) is amended--
       (1) in paragraph (1)--
       (A) by striking ``in consultation with the Director of the 
     Eunice Kennedy Shriver National Institute of Child Health and 
     Human Development and in collaboration with other appropriate 
     national research institutes and national centers that carry 
     out activities involving pediatric research'' and inserting 
     ``in collaboration with the national research institutes and 
     national centers that carry out activities involving 
     pediatric research'';
       (B) by striking subparagraph (B);
       (C) by striking ``may be comprised of, as appropriate'' and 
     all that follows through ``the pediatric research consortia'' 
     and inserting ``may be comprised of, as appropriate, the 
     pediatric research consortia''; and
       (D) by striking ``; or'' at the end and inserting a period; 
     and
       (2) in paragraph (1), paragraph (2)(A), the first sentence 
     of paragraph (2)(E), and paragraph (4), by striking ``may'' 
     each place it appears and inserting ``shall''.

     SEC. 1082. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK SENSE OF 
                   CONGRESS.

       It is the sense of Congress that--
       (1) the National Institutes of Health should encourage a 
     global pediatric clinical study network through the 
     allocation of grants, contracts, or cooperative agreements to 
     supplement the salaries of new and early investigators who 
     participate in the global pediatric clinical study network;
       (2) National Institutes of Health grants, contracts, or 
     cooperative agreements should be awarded, solely for the 
     purpose of supplementing the salaries of new and early 
     investigators, to entities that participate in the global 
     pediatric clinical study network;
       (3) the Food and Drug Administration should engage the 
     European Medicines Agency and other foreign regulatory 
     entities during the formation of the global pediatric 
     clinical study network to encourage their participation; and
       (4) once a global pediatric clinical study network is 
     established and becomes operational, the Food and Drug 
     Administration should continue to engage the European 
     Medicines Agency and other foreign regulatory entities to 
     encourage and facilitate their participation in the network 
     with the goal of enhancing the global reach of the network.

     SEC. 1083. APPROPRIATE AGE GROUPINGS IN CLINICAL RESEARCH.

       (a) Input From Experts.--Not later than 180 days after the 
     date of enactment of this Act, the Director of the National 
     Institutes of Health shall convene a workshop of experts on 
     pediatrics and experts on geriatrics to provide input on--
       (1) appropriate age groupings to be included in research 
     studies involving human subjects; and
       (2) acceptable scientific justifications for excluding 
     participants from a range of age groups from human subjects 
     research studies.
       (b) Guidelines.--Not later than 180 days after the 
     conclusion of the workshop under subsection (a), the Director 
     of the National Institutes of Health shall publish 
     guidelines--
       (1) addressing the consideration of age as an inclusion 
     variable in research involving human subjects; and
       (2) identifying criteria for justifications for any age-
     related exclusions in such research.
       (c) Public Availability of Findings and Conclusions.--The 
     Director of the National Institutes of Health shall--
       (1) make the findings and conclusions resulting from the 
     workshop under subsection (a) available to the public on the 
     website of the National Institutes of Health; and
       (2) not less than biennially, disclose to the public on 
     such website the number of children included in research that 
     is conducted or supported by the National Institutes of 
     Health, disaggregated by developmentally appropriate age 
     group, race, and gender.

 Subtitle F--Advancement of the National Institutes of Health Research 
                            and Data Access

     SEC. 1101. STANDARDIZATION OF DATA IN CLINICAL TRIAL REGISTRY 
                   DATA BANK ON ELIGIBILITY FOR CLINICAL TRIALS.

       (a) Standardization.--
       (1) In general.--Section 402(j) of the Public Health 
     Service Act (42 U.S.C. 282(j)) is amended--
       (A) by redesignating paragraph (7) as paragraph (8); and
       (B) by inserting after paragraph (6) the following:
       ``(7) Standardization.--The Director of NIH shall--
       ``(A) ensure that the registry and results data bank is 
     easily used by the public;
       ``(B) ensure that entries in the registry and results data 
     bank are easily compared;
       ``(C) ensure that information required to be submitted to 
     the registry and results data bank, including recruitment 
     information under paragraph (2)(A)(ii)(II), is submitted by 
     persons and posted by the Director of NIH in a standardized 
     format and includes at least--
       ``(i) the disease or indication being studied;
       ``(ii) inclusion criteria such as age, gender, diagnosis or 
     diagnoses, laboratory values, or imaging results; and
       ``(iii) exclusion criteria such as specific diagnosis or 
     diagnoses, laboratory values, or prohibited medications; and
       ``(D) to the extent possible, in carrying out this 
     paragraph, make use of standard health care terminologies, 
     such as the International Classification of Diseases or the 
     Current Procedural Terminology, that facilitate electronic 
     matching to data in electronic health records or other 
     relevant health information technologies.''.
       (2) Conforming amendment.--Clause (iv) of section 
     402(j)(2)(B) of the Public Health Service Act (42 U.S.C. 
     282(j)(2)(B)) is hereby stricken.
       (b) Consultation.--Not later than 90 days after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall consult with stakeholders (including patients, 
     researchers, physicians, industry representatives, health 
     information technology providers, the Food and Drug 
     Administration, and standard setting organizations such as 
     CDISC that have experience working with Federal agencies to 
     standardize health data submissions) to receive advice on 
     enhancements to the clinical trial registry data bank under 
     section 402(j) of the Public Health Service Act (42 U.S.C. 
     282(j)) (including enhancements to usability, functionality, 
     and search capability) that are necessary to implement 
     paragraph (7) of section 402(j) of such Act, as added by 
     subsection (a).
       (c) Applicability.--Not later than 18 months after the date 
     of enactment of this Act, the Secretary of Health and Human 
     Services shall begin implementation of paragraph (7) of 
     section 402(j) of the Public Health Service Act, as added by 
     subsection (a).

            Subtitle G--Facilitating Collaborative Research

     SEC. 1121. CLINICAL TRIAL DATA SYSTEM.

       (a) Establishment.--The Secretary, acting through the 
     Commissioner of Food and Drugs and the Director of the 
     National Institutes of Health, shall enter into a cooperative 
     agreement, contract, or grant for a period of 7 years, to be 
     known as the Clinical Trial Data System Agreement, with one 
     or more eligible entities to implement a pilot program with 
     respect to all clinical trial data obtained from qualified 
     clinical trials for purposes of registered users conducting 
     further research on such data.
       (b) Application.--Eligible entities seeking to enter into a 
     cooperative agreement, contract, or grant with the Secretary 
     under this section shall submit to the Secretary an 
     application in such time and manner, and containing such 
     information, as the Secretary may require in accordance with 
     this section. The Secretary shall not enter into a 
     cooperative agreement, contract, or grant under this section 
     with an eligible entity unless such entity submits an 
     application including the following:
       (1) A certification that the eligible entity is not 
     currently and does not plan to be involved in sponsoring, 
     operating, or participating in a clinical trial nor 
     collaborating with another entity for the purposes of 
     sponsoring, operating, or participating in a clinical trial.

[[Page 11286]]

       (2) Information demonstrating that the eligible entity can 
     compile clinical trial data in standardized formats using 
     terminologies and standards that have been developed by 
     recognized standards developing organizations with input from 
     diverse stakeholder groups, and information demonstrating 
     that the eligible entity can de-identify clinical trial data 
     consistent with the requirements of section 164.514 of title 
     45, Code of Federal Regulations (or successor regulations).
       (3) A description of the system the eligible entity will 
     use to store and maintain such data, and information 
     demonstrating that this system will comply with applicable 
     standards and requirements for ensuring the security of the 
     clinical trial data.
       (4) A certification that the eligible entity will allow 
     only registered users to access and use de-identified 
     clinical trial data, gathered from qualified clinical trials, 
     and that the eligible entity will allow each registered user 
     to access and use such data only after such registered user 
     agrees in writing to the terms described in (e)(4)(B), and 
     such other carefully controlled contractual terms as may be 
     defined by the Secretary.
       (5) Evidence demonstrating the ability of the eligible 
     entity to ensure that registered users disseminate the 
     results of the research conducted in accordance with this 
     section to interested parties to serve as a guide to future 
     medical product development or scientific research.
       (6) The plan of the eligible entity for securing funding 
     for the activities it would conduct under the clinical trial 
     data system agreement from governmental sources and private 
     foundations, entities, and individuals.
       (7) Evidence demonstrating a proven track record of--
       (A) being a neutral third party in working with medical 
     product manufacturers, academic institutions, and the Food 
     and Drug Administration; and
       (B) having the ability to protect confidential data.
       (8) An agreement that the eligible entity will work with 
     the Comptroller General of the United States for purposes of 
     the study and report under subsection (d).
       (c) Extension, Expansion, Termination.--The Secretary, 
     acting through the Commissioner of Food and Drugs and the 
     Director of the National Institutes of Health, upon the 
     expiration of the 7-year period referred to in subsection 
     (a), may extend (including permanently), expand, or terminate 
     the pilot program established under such subsection, in whole 
     or in part.
       (d) Study and Report.--
       (1) In general.--The Comptroller General of the United 
     States shall conduct a study and issue a report to the 
     Congress and the Secretary with respect to the pilot program 
     established under subsection (a), not later than 6 years 
     after the date on which the pilot program is established 
     under subsection (a).
       (2) Study.--The study under paragraph (1) shall--
       (A) review the effectiveness of the pilot program 
     established under subsection (a); and
       (B) be designed to formulate recommendations on 
     improvements to the program.
       (3) Report.--The report under paragraph (1) shall contain 
     at least the following information:
       (A) The new discoveries, research inquiries, or clinical 
     trials that have resulted from accessing clinical trial data 
     under the pilot program established under subsection (a).
       (B) The number of times scientists have accessed such data, 
     disaggregated by research area and clinical trial phase.
       (C) An analysis of whether the program has helped to reduce 
     adverse events in clinical trials.
       (D) An analysis of whether scientists have raised any 
     concerns about the burden of having to share data with the 
     system established under the program and, if so, a 
     description of such concerns.
       (E) An analysis of privacy and data integrity practices 
     used in the program.
       (e) Definitions.--In this section:
       (1) The term ``eligible entity'' means an entity that has 
     experienced personnel with clinical and other technical 
     expertise in the biomedical sciences and biomedical ethics 
     and that is--
       (A) an institution of higher education (as such term is 
     defined in section 1001 of the Higher Education Act of 1965 
     (20 U.S.C. 1001)) or a consortium of such institutions; or
       (B) an organization described in section 501(c)(3) of title 
     26 of the Internal Revenue Code of 1986 and exempt from tax 
     under section 501(a) of such title.
       (2) The term ``medical product'' means a drug (as defined 
     in section 201(g) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 331(g))), a device (as defined in section 201(h) 
     of such Act (21 U.S.C. 331(h)), a biological product (as 
     defined in section 351 of the Public Health Service Act (42 
     U.S.C. 262)), or any combination thereof.
       (3) The term ``qualified clinical trial'' means a clinical 
     trial sponsored solely by an agency of the Department of 
     Health and Human Services with respect to a medical product--
       (A) that--
       (i) was approved or cleared under section 505, 510(k), or 
     515, or has an exemption for investigational use in effect 
     under section 505 or 520(m), of the Federal Food, Drug, and 
     Cosmetic Act (42 U.S.C. 301 et seq.); or
       (ii) was licensed under section 351 of the Public Health 
     Service Act (42 U.S.C. 262) or has an exemption for 
     investigational use in effect under such section 351; or
       (B) that is an investigational product for which the 
     original development was discontinued and with respect to 
     which--
       (i) no additional work to support approval, licensure, or 
     clearance of such medical product is being or is planned to 
     be undertaken by the sponsor of the original development 
     program, its successors, assigns, or collaborators; and
       (ii) the sponsor of the original investigational 
     development program has provided its consent to the Secretary 
     for inclusion of data regarding such product in the system 
     established under this section.
       (4) The term ``registered user'' means a scientific or 
     medical researcher who has--
       (A) a legitimate biomedical research purpose for accessing 
     information from the clinical trials data system and has 
     appropriate qualifications to conduct such research; and
       (B) agreed in writing not to transfer to any other person 
     that is not a registered user de-identified clinical trial 
     data from qualified clinical trials accessed through an 
     eligible entity, use such data for reasons not specified in 
     the research proposal, or seek to re-identify qualified 
     clinical trial participants.
       (5) The term ``Secretary'' means the Secretary of Health 
     and Human Services.

     SEC. 1122. NATIONAL NEUROLOGICAL DISEASES SURVEILLANCE 
                   SYSTEM.

       Part P of title III of the Public Health Service Act (42 
     U.S.C. 280g et seq.) is amended by adding at the end the 
     following:

     ``SEC. 399V-6 SURVEILLANCE OF NEUROLOGICAL DISEASES.

       ``(a) In General.--The Secretary, acting through the 
     Director of the Centers for Disease Control and Prevention 
     and in coordination with other agencies as determined 
     appropriate by the Secretary, shall--
       ``(1) enhance and expand infrastructure and activities to 
     track the epidemiology of neurological diseases, including 
     multiple sclerosis and Parkinson's disease; and
       ``(2) incorporate information obtained through such 
     activities into a statistically sound, scientifically 
     credible, integrated surveillance system, to be known as the 
     National Neurological Diseases Surveillance System.
       ``(b) Research.--The Secretary shall ensure that the 
     National Neurological Diseases Surveillance System is 
     designed in a manner that facilitates further research on 
     neurological diseases.
       ``(c) Content.--In carrying out subsection (a), the 
     Secretary--
       ``(1) shall provide for the collection and storage of 
     information on the incidence and prevalence of neurological 
     diseases in the United States;
       ``(2) to the extent practicable, shall provide for the 
     collection and storage of other available information on 
     neurological diseases, such as information concerning--
       ``(A) demographics and other information associated or 
     possibly associated with neurological diseases, such as age, 
     race, ethnicity, sex, geographic location, and family 
     history;
       ``(B) risk factors associated or possibly associated with 
     neurological diseases, including genetic and environmental 
     risk factors; and
       ``(C) diagnosis and progression markers;
       ``(3) may provide for the collection and storage of 
     information relevant to analysis on neurological diseases, 
     such as information concerning--
       ``(A) the epidemiology of the diseases;
       ``(B) the natural history of the diseases;
       ``(C) the prevention of the diseases;
       ``(D) the detection, management, and treatment approaches 
     for the diseases; and
       ``(E) the development of outcomes measures; and
       ``(4) may address issues identified during the consultation 
     process under subsection (d).
       ``(d) Consultation.--In carrying out this section, the 
     Secretary shall consult with individuals with appropriate 
     expertise, including--
       ``(1) epidemiologists with experience in disease 
     surveillance or registries;
       ``(2) representatives of national voluntary health 
     associations that--
       ``(A) focus on neurological diseases, including multiple 
     sclerosis and Parkinson's disease; and
       ``(B) have demonstrated experience in research, care, or 
     patient services;
       ``(3) health information technology experts or other 
     information management specialists;
       ``(4) clinicians with expertise in neurological diseases; 
     and
       ``(5) research scientists with experience conducting 
     translational research or utilizing surveillance systems for 
     scientific research purposes.
       ``(e) Grants.--The Secretary may award grants to, or enter 
     into contracts or cooperative agreements with, public or 
     private nonprofit entities to carry out activities under this 
     section.
       ``(f) Coordination With Other Federal, State, and Local 
     Agencies.--Subject to subsection (h), the Secretary shall 
     make information and analysis in the National Neurological 
     Diseases Surveillance System available, as appropriate--
       ``(1) to Federal departments and agencies, such as the 
     National Institutes of Health, the Food and Drug 
     Administration, the Centers for Medicare & Medicaid Services, 
     the Agency for Healthcare Research and Quality, the 
     Department of Veterans Affairs, and the Department of 
     Defense; and
       ``(2) to State and local agencies.
       ``(g) Public Access.--Subject to subsection (h), the 
     Secretary shall make information and analysis in the National 
     Neurological Diseases Surveillance System available, as 
     appropriate, to the public, including researchers.
       ``(h) Privacy.--The Secretary shall ensure that privacy and 
     security protections applicable

[[Page 11287]]

     to the National Neurological Diseases Surveillance System are 
     at least as stringent as the privacy and security protections 
     under HIPAA privacy and security law (as defined in section 
     3009(a)(2)).
       ``(i) Report.--Not later than 4 years after the date of the 
     enactment of this section, the Secretary shall submit a 
     report to the Congress concerning the implementation of this 
     section. Such report shall include information on--
       ``(1) the development and maintenance of the National 
     Neurological Diseases Surveillance System;
       ``(2) the type of information collected and stored in the 
     System;
       ``(3) the use and availability of such information, 
     including guidelines for such use; and
       ``(4) the use and coordination of databases that collect or 
     maintain information on neurological diseases.
       ``(j) Definition.--In this section, the term `national 
     voluntary health association' means a national nonprofit 
     organization with chapters, other affiliated organizations, 
     or networks in States throughout the United States.
       ``(k) Authorization of Appropriations.--To carry out this 
     section, there is authorized to be appropriated $5,000,000 
     for each of fiscal years 2016 through 2020.''.

     SEC. 1123. DATA ON NATURAL HISTORY OF DISEASES.

       (a) Sense of Congress.--It is the sense of the Congress 
     that studies on the natural history of diseases can help to 
     facilitate and expedite the development of medical products 
     for such diseases.
       (b) Authority.--Part A of title II of the Public Health 
     Service Act (42 U.S.C. 202 et seq.) is amended by adding at 
     the end the following:

     ``SEC. 229A. DATA ON NATURAL HISTORY OF DISEASES.

       ``(a) In General.--The Secretary, acting through the 
     Commissioner of Food and Drugs, may, for the purposes 
     described in subsection (b)--
       ``(1) participate in public-private partnerships engaged in 
     one or more activities specified in subsection (c); and
       ``(2) award grants to patient advocacy groups or other 
     organizations determined appropriate by the Secretary.
       ``(b) Purposes Described.--The purposes described in this 
     subsection are to establish or facilitate the collection, 
     maintenance, analysis, and interpretation of data regarding 
     the natural history of diseases, with a particular focus on 
     rare diseases.
       ``(c) Activities of Public-Private Partnerships.--The 
     activities of public-private partnerships in which the 
     Secretary may participate for purposes of this section 
     include--
       ``(1) cooperating with other entities that sponsor or 
     maintain disease registries, including disease registries and 
     disease registry platforms for rare diseases;
       ``(2) developing or enhancing a secure information 
     technology system that--
       ``(A) has the capacity to support data needs across a wide 
     range of disease studies;
       ``(B) is easily modified as knowledge is gained during such 
     studies; and
       ``(C) is capable of handling increasing amounts of data as 
     more studies are carried out; and
       ``(3) providing advice to clinical researchers, patient 
     advocacy groups, and other entities with respect to--
       ``(A) the design and conduct of disease studies;
       ``(B) the modification of any such ongoing studies; and
       ``(C) addressing associated patient privacy issues.
       ``(d) Availability of Data on Natural History of 
     Diseases.--Data relating to the natural history of diseases 
     obtained, aggregated, or otherwise maintained by a public-
     private partnership in which the Secretary participates under 
     subsection (a) shall be made available, consistent with 
     otherwise applicable Federal and State privacy laws, to the 
     public (including patient advocacy groups, researchers, and 
     drug developers) to help to facilitate and expedite medical 
     product development programs.
       ``(e) Confidentiality.--Notwithstanding subsection (d), 
     nothing in this section authorizes the disclosure of any 
     information that is a trade secret or commercial or financial 
     information that is privileged or confidential and subject to 
     section 552(b)(4) of title 5, United States Code, or section 
     1905 of title 18, United States Code.
       ``(f) Authorization of Appropriations.--There is authorized 
     to be appropriated to carry out this section $5,000,000 for 
     each of fiscal years 2016 through 2020.''.

     SEC. 1124. ACCESSING, SHARING, AND USING HEALTH DATA FOR 
                   RESEARCH PURPOSES.

       (a) In General.--(1) The HITECH Act (title XIII of division 
     A of Public Law 111-5) is amended by adding at the end of 
     subtitle D of such Act (42 U.S.C. 17921 et seq.) the 
     following:

   ``PART 4--ACCESSING, SHARING, AND USING HEALTH DATA FOR RESEARCH 
                                PURPOSES

     ``SEC. 13441. REFERENCES.

       ``In this part:
       ``(1) The rule.--References to `the Rule' refer to part 160 
     or part 164, as appropriate, of title 45, Code of Federal 
     Regulations (or any successor regulation).
       ``(2) Part 164.--References to a specified section of `part 
     164', refer to such specified section of part 164 of title 
     45, Code of Federal Regulations (or any successor section).

     ``SEC. 13442. DEFINING HEALTH DATA RESEARCH AS PART OF HEALTH 
                   CARE OPERATIONS.

       ``(a) In General.--Subject to subsection (b), the Secretary 
     shall revise or clarify the Rule to allow the use and 
     disclosure of protected health information by a covered 
     entity for research purposes, including studies whose purpose 
     is to obtain generalizable knowledge, to be treated as the 
     use and disclosure of such information for health care 
     operations described in subparagraph (1) of the definition of 
     health care operations in section 164.501 of part 164.
       ``(b) Modifications to Rules for Disclosures for Health 
     Care Operations.--In applying section 164.506 of part 164 to 
     the disclosure of protected health information described in 
     subsection (a)--
       ``(1) the Secretary shall revise or clarify the Rule so 
     that the disclosure may be made by the covered entity to 
     only--
       ``(A) another covered entity for health care operations (as 
     defined in section 164.501 of part 164);
       ``(B) a business associate that has entered into a contract 
     under section 164.504(e) of part 164 with a disclosing 
     covered entity to perform health care operations; or
       ``(C) a business associate that has entered into a contract 
     under section 164.504(e) of part 164 for the purpose of data 
     aggregation (as defined in section 164.501 of part 164); and
       ``(2) the Secretary shall further revise or clarify the 
     Rule so that the limitation specified by section 
     164.506(c)(4) of part 164 does not apply to disclosures that 
     are described by subsection (a).
       ``(c) Rule of Construction.--This section shall not be 
     construed as prohibiting or restricting a use or disclosure 
     of protected health information for research purposes that is 
     otherwise permitted under part 164.

     ``SEC. 13443. TREATING DISCLOSURES OF PROTECTED HEALTH 
                   INFORMATION FOR RESEARCH SIMILARLY TO 
                   DISCLOSURES OF SUCH INFORMATION FOR PUBLIC 
                   HEALTH PURPOSES.

       ``(a) Remuneration.--The Secretary shall revise or clarify 
     the Rule so that disclosures of protected health information 
     for research purposes are not subject to the limitation on 
     remuneration described in section 164.502(a)(5)(ii)(B)(2)(ii) 
     of part 164.
       ``(b) Permitted Uses and Disclosures.--The Secretary shall 
     revise or clarify the Rule so that research activities, 
     including comparative research activities, related to the 
     quality, safety, or effectiveness of a product or activity 
     that is regulated by the Food and Drug Administration are 
     included as public health activities for purposes of which a 
     covered entity may disclose protected health information to a 
     person described in section 164.512(b)(1)(iii) of part 164.

     ``SEC. 13444. PERMITTING REMOTE ACCESS TO PROTECTED HEALTH 
                   INFORMATION BY RESEARCHERS.

       ``The Secretary shall revise or clarify the Rule so that 
     subparagraph (B) of section 164.512(i)(1)(ii) of part 164 
     (prohibiting the removal of protected health information by a 
     researcher) does not prohibit remote access to health 
     information by a researcher so long as--
       ``(1) appropriate security and privacy safeguards are 
     maintained by the covered entity and the researcher; and
       ``(2) the protected health information is not copied or 
     otherwise retained by the researcher.

     ``SEC. 13445. ALLOWING ONE-TIME AUTHORIZATION OF USE AND 
                   DISCLOSURE OF PROTECTED HEALTH INFORMATION FOR 
                   RESEARCH PURPOSES.

       ``(a) In General.--The Secretary shall revise or clarify 
     the Rule to specify that an authorization for the use or 
     disclosure of protected health information, with respect to 
     an individual, for future research purposes shall be deemed 
     to contain a sufficient description of the purpose of the use 
     or disclosure if the authorization--
       ``(1) sufficiently describes the purposes such that it 
     would be reasonable for the individual to expect that the 
     protected health information could be used or disclosed for 
     such future research;
       ``(2) either--
       ``(A) states that the authorization will expire on a 
     particular date or on the occurrence of a particular event; 
     or
       ``(B) states that the authorization will remain valid 
     unless and until it is revoked by the individual; and
       ``(3) provides instruction to the individual on how to 
     revoke such authorization at any time.
       ``(b) Revocation of Authorization.--The Secretary shall 
     revise or clarify the Rule to specify that, if an individual 
     revokes an authorization for future research purposes such as 
     is described by subsection (a), the covered entity may not 
     make any further uses or disclosures based on that 
     authorization, except, as provided in paragraph (b)(5) of 
     section 164.508 of part 164, to the extent that the covered 
     entity has taken action in reliance on the authorization.''.
       (2) The table of sections in section 13001(b) of such Act 
     is amended by adding at the end of the items relating to 
     subtitle D the following new items:

[[Page 11288]]



   ``Part 4--Accessing, Sharing, and Using Health Data for Research 
                                Purposes

       ``Sec. 13441. References.
       ``Sec. 13442. Defining health data research as part of 
           health care operations.
       ``Sec. 13443. Treating disclosures of protected health 
           information for research similarly to disclosures of 
           such information for public health purposes.
       ``Sec. 13444. Permitting remote access to protected health 
           information by researchers.
       ``Sec. 13445. Allowing one-time authorization of use and 
           disclosure of protected health information for research 
           purposes.''.
       (b) Revision of Regulations.--Not later than 12 months 
     after the date of the enactment of this Act, the Secretary of 
     Health and Human Services shall revise and clarify the 
     provisions of title 45, Code of Federal Regulations, for 
     consistency with part 4 of subtitle D of the HITECH Act, as 
     added by subsection (a).

               Subtitle H--Council for 21st Century Cures

     SEC. 1141. COUNCIL FOR 21ST CENTURY CURES.

       Title II of the Public Health Service Act (42 U.S.C. 202 et 
     seq.) is amended by adding at the end the following:

                ``PART E--COUNCIL FOR 21ST CENTURY CURES

     ``SEC. 281. ESTABLISHMENT.

       ``A nonprofit corporation to be known as the Council for 
     21st Century Cures (referred to in this part as the 
     `Council') shall be established in accordance with this 
     section. The Council shall be a public-private partnership 
     headed by an Executive Director (referred to in this part as 
     the `Executive Director'), appointed by the members of the 
     Board of Directors. The Council shall not be an agency or 
     instrumentality of the United States Government.

     ``SEC. 281A. PURPOSE.

       ``The purpose of the Council is to accelerate the 
     discovery, development, and delivery in the United States of 
     innovative cures, treatments, and preventive measures for 
     patients.

     ``SEC. 281B. DUTIES.

       ``For the purpose described in section 281A, the Council 
     shall--
       ``(1) foster collaboration and coordination among the 
     entities that comprise the Council, including academia, 
     government agencies, industry, health care payors and 
     providers, patient advocates, and others engaged in the cycle 
     of discovery, development, and delivery of life-saving and 
     health-enhancing innovative interventions;
       ``(2) undertake communication and dissemination activities;
       ``(3) publish information on the activities funded under 
     section 281D;
       ``(4) establish a strategic agenda for accelerating the 
     discovery, development, and delivery in the United States of 
     innovative cures, treatments, and preventive measures for 
     patients;
       ``(5) identify gaps and opportunities within and across the 
     discovery, development, and delivery cycle;
       ``(6) develop and propose recommendations based on the gaps 
     and opportunities so identified;
       ``(7) facilitate the interoperability of the components of 
     the discovery, development, and delivery cycle;
       ``(8) propose recommendations that will facilitate 
     precompetitive collaboration;
       ``(9) identify opportunities to work with, but not 
     duplicate the efforts of, nonprofit organizations and other 
     public-private partnerships; and
       ``(10) identify opportunities for collaboration with 
     organizations operating outside of the United States, such as 
     the Innovative Medicines Initiative of the European Union.

     ``SEC. 281C. ORGANIZATION; ADMINISTRATION.

       ``(a) Board of Directors.--
       ``(1) Establishment.--
       ``(A) In general.--The Council shall have a Board of 
     Directors (in this part referred to as the `Board of 
     Directors'), which shall be composed of the ex officio 
     members under subparagraph (B) and the appointed members 
     under subparagraph (C). All members of the Board shall be 
     voting members.
       ``(B) Ex officio members.--The ex officio members of the 
     Board shall be the following individuals or their designees:
       ``(i) The Director of the National Institutes of Health.
       ``(ii) The Commissioner of Food and Drugs.
       ``(iii) The Administrator of the Centers for Medicare & 
     Medicaid Services.
       ``(iv) The heads of five other Federal agencies deemed by 
     the Secretary to be engaged in biomedical research and 
     development.
       ``(C) Appointed members.--The appointed members of the 
     Board shall consist of 17 individuals, of whom--
       ``(i) 8 shall be appointed by the Comptroller General of 
     the United States from a list of nominations submitted by 
     leading trade associations--

       ``(I) 4 of whom shall be representatives of the 
     biopharmaceutical industry;
       ``(II) 2 of whom shall be representatives of the medical 
     device industry; and
       ``(III) 2 of whom shall be representatives of the 
     information and digital technology industry; and

       ``(ii) 9 shall be appointed by the Comptroller General of 
     the United States, after soliciting nominations--

       ``(I) 2 of whom shall be representatives of academic 
     researchers;
       ``(II) 3 of whom shall be representatives of patients;
       ``(III) 2 of whom shall be representatives of health care 
     providers; and
       ``(IV) 2 of whom shall be representatives of health care 
     plans and insurers.

       ``(D) Chair.--The Chair of the Board shall be selected by 
     the members of the Board by majority vote from among the 
     members of the Board.
       ``(2) Terms and vacancies.--
       ``(A) In general.--The term of office of each member of the 
     Board appointed under paragraph (1)(C) shall be 5 years.
       ``(B) Vacancy.--Any vacancy in the membership of the 
     Board--
       ``(i) shall not affect the power of the remaining members 
     to execute the duties of the Board; and
       ``(ii) shall be filled by appointment by the appointed 
     members described in paragraph (1)(C) by majority vote.
       ``(C) Partial term.--If a member of the Board does not 
     serve the full term applicable under subparagraph (A), the 
     individual appointed under subparagraph (B) to fill the 
     resulting vacancy shall be appointed for the remainder of the 
     term of the predecessor of the individual.
       ``(3) Responsibilities.--Not later than 90 days after the 
     date on which the Council is incorporated and its Board of 
     Directors is fully constituted, the Board of Directors shall 
     establish bylaws and policies for the Council that--
       ``(A) are published in the Federal Register and available 
     for public comment;
       ``(B) establish policies for the selection and, as 
     applicable, appointment of--
       ``(i) the officers, employees, agents, and contractors of 
     the Council; and
       ``(ii) the members of any committees of the Council;
       ``(C) establish policies, including ethical standards, for 
     the conduct of programs and other activities under section 
     281D; and
       ``(D) establish specific duties of the Executive Director.
       ``(4) Meetings.--
       ``(A) In general.--The Board of Directors shall--
       ``(i) meet on a quarterly basis; and
       ``(ii) submit to Congress, and make publicly available, the 
     minutes of such meetings.
       ``(B) Agenda.--The Board of Directors shall, not later than 
     3 months after the incorporation of the Council--
       ``(i) issue an agenda (in this part referred to as the 
     `agenda') outlining how the Council will achieve the purpose 
     described in section 281A; and
       ``(ii) annually thereafter, in consultation with the 
     Executive Director, review and update such agenda.
       ``(b) Appointment and Incorporation.--Not later than 6 
     months after the date of enactment of the 21st Century Cures 
     Act--
       ``(1) the Comptroller General of the United States shall 
     appoint the appointed members of the Board of Directors under 
     subsection (a)(1)(C); and
       ``(2) the ex officio members of the Board of Directors 
     under subsection (a)(1)(B) shall serve as incorporators and 
     shall take whatever actions are necessary to incorporate the 
     Council.
       ``(c) Nonprofit Status.--In carrying out this part, the 
     Board of Directors shall establish such policies and bylaws, 
     and the Executive Director shall carry out such activities, 
     as may be necessary to ensure that the Council maintains 
     status as an organization that--
       ``(1) is described in subsection (c)(3) of section 501 of 
     the Internal Revenue Code of 1986; and
       ``(2) is, under subsection (a) of such section, exempt from 
     taxation.
       ``(d) Executive Director.--The Executive Director shall--
       ``(1) be the chief executive officer of the Council; and
       ``(2) subject to the oversight of the Board of Directors, 
     be responsible for the day-to-day management of the Council.

     ``SEC. 281D. OPERATIONAL ACTIVITIES AND ASSISTANCE.

       ``(a) In General.--The Council shall establish a sufficient 
     operational infrastructure to fulfill the duties specified in 
     section 281B.
       ``(b) Private Sector Matching Funds.--The Council may 
     accept financial or in-kind support from participating 
     entities or private foundations or organizations when such 
     support is deemed appropriate.

     ``SEC. 281E. TERMINATION; REPORT.

       ``(a) In General.--The Council shall terminate on September 
     30, 2023.
       ``(b) Report.--Not later than one year after the date on 
     which the Council is established and each year thereafter, 
     the Executive Director shall submit to the appropriate 
     congressional committees a report on the performance of the 
     Council. In preparing such report, the Council shall consult 
     with a nongovernmental consultant with appropriate expertise.

     ``SEC. 281F. FUNDING.

       ``For the each of fiscal years 2016 through 2023, there is 
     authorized to be appropriated $10,000,000 to the Council for 
     purposes of carrying out the duties of the Council under this 
     part.''.

                         TITLE II--DEVELOPMENT

              Subtitle A--Patient-Focused Drug Development

     SEC. 2001. DEVELOPMENT AND USE OF PATIENT EXPERIENCE DATA TO 
                   ENHANCE STRUCTURED RISK-BENEFIT ASSESSMENT 
                   FRAMEWORK.

       (a) In General.--Section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355) is amended--
       (1) in subsection (d), by striking ``The Secretary shall 
     implement'' and all that follows through ``premarket approval 
     of a drug.''; and

[[Page 11289]]

       (2) by adding at the end the following new subsections:
       ``(x) Structured Risk-Benefit Assessment Framework.--
       ``(1) In general.--The Secretary shall implement a 
     structured risk-benefit assessment framework in the new drug 
     approval process--
       ``(A) to facilitate the balanced consideration of benefits 
     and risks; and
       ``(B) to develop and implement a consistent and systematic 
     approach to the discussion of, regulatory decisionmaking with 
     respect to, and the communication of, the benefits and risks 
     of new drugs.
       ``(2) Rule of construction.--Nothing in paragraph (1) shall 
     alter the criteria for evaluating an application for 
     premarket approval of a drug.
       ``(y) Development and Use of Patient Experience Data To 
     Enhance Structured Risk-Benefit Assessment Framework.--
       ``(1) In general.--Not later than two years after the date 
     of the enactment of this subsection, the Secretary shall 
     establish and implement processes under which--
       ``(A) an entity seeking to develop patient experience data 
     may submit to the Secretary--
       ``(i) initial research concepts for feedback from the 
     Secretary; and
       ``(ii) with respect to patient experience data collected by 
     the entity, draft guidance documents, completed data, and 
     summaries and analyses of such data;
       ``(B) the Secretary may request such an entity to submit 
     such documents, data, and summaries and analyses; and
       ``(C) patient experience data may be developed and used to 
     enhance the structured risk-benefit assessment framework 
     under subsection (x).
       ``(2) Patient experience data.--In this subsection, the 
     term `patient experience data' means data collected by 
     patients, parents, caregivers, patient advocacy 
     organizations, disease research foundations, medical 
     researchers, research sponsors, or other parties determined 
     appropriate by the Secretary that is intended to facilitate 
     or enhance the Secretary's risk-benefit assessments, 
     including information about the impact of a disease or a 
     therapy on patients' lives.''.
       (b) Guidance.--
       (1) In general.--The Secretary of Health and Human Services 
     shall publish guidance on the implementation of subsection 
     (y) of section 505 of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355), as added by subsection (a). Such 
     guidance shall include--
       (A) with respect to draft guidance documents, data, or 
     summaries and analyses submitted to the Secretary under 
     paragraph (1)(A) of such subsection, guidance--
       (i) specifying the timelines for the review of such 
     documents, data, or summaries and analyses by the Secretary; 
     and
       (ii) on how the Secretary will use such documents, data, or 
     summaries and analyses to update any guidance documents 
     published under this subsection or publish new guidance;
       (B) with respect to the collection and analysis of patient 
     experience data (as defined in paragraph (2) of such 
     subsection (y)), guidance on--
       (i) methodological considerations for the collection of 
     patient experience data, which may include structured 
     approaches to gathering information on--

       (I) the experience of a patient living with a particular 
     disease;
       (II) the burden of living with or managing the disease;
       (III) the impact of the disease on daily life and long-term 
     functioning; and
       (IV) the effect of current therapeutic options on different 
     aspects of the disease; and

       (ii) the establishment and maintenance of registries 
     designed to increase understanding of the natural history of 
     a disease;
       (C) methodological approaches that may be used to assess 
     patients' beliefs with respect to the benefits and risks in 
     the management of the patient's disease; and
       (D) methodologies, standards, and potential experimental 
     designs for patient-reported outcomes.
       (2) Timing.--Not later than 3 years after the date of the 
     enactment of this Act, the Secretary of Health and Human 
     Services shall issue draft guidance on the implementation of 
     subsection (y) of section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355), as added by subsection (a). The 
     Secretary shall issue final guidance on the implementation of 
     such subsection not later than one year after the date on 
     which the comment period for the draft guidance closes.
       (3) Workshops.--
       (A) In general.--Not later than 6 months after the date of 
     the enactment of this Act and once every 6 months during the 
     following 12-month period, the Secretary of Health and Human 
     Services shall convene a workshop to obtain input regarding 
     methodologies for developing the guidance under paragraph 
     (1), including the collection of patient experience data.
       (B) Attendees.--A workshop convened under this paragraph 
     shall include--
       (i) patients;
       (ii) representatives from patient advocacy organizations, 
     biopharmaceutical companies, and disease research 
     foundations;
       (iii) representatives of the reviewing divisions of the 
     Food and Drug Administration; and
       (iv) methodological experts with significant expertise in 
     patient experience data.
       (4) Public meeting.--Not later than 90 days after the date 
     on which the draft guidance is published under this 
     subsection, the Secretary of Health and Human Services shall 
     convene a public meeting to solicit input on the guidance.

      Subtitle B--Qualification and Use of Drug Development Tools

     SEC. 2021. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.

       (a) Findings.--Congress finds the following:
       (1) Development of new drugs has become increasingly 
     challenging and resource intensive.
       (2) Development of drug development tools can benefit the 
     availability of new medical therapies by helping to translate 
     scientific discoveries into clinical applications.
       (3) Biomedical research consortia (as defined in section 
     507(f) of the Federal Food, Drug, and Cosmetic Act, as added 
     by subsection (c)) can play a valuable role in helping to 
     develop and qualify drug development tools.
       (b) Sense of Congress.--It is the sense of Congress that--
       (1) Congress should promote and facilitate a collaborative 
     effort among the biomedical research consortia described in 
     subsection (a)(3)--
       (A) to develop, through a transparent public process, data 
     standards and scientific approaches to data collection 
     accepted by the medical and clinical research community for 
     purposes of qualifying drug development tools;
       (B) to coordinate efforts toward developing and qualifying 
     drug development tools in key therapeutic areas; and
       (C) to encourage the development of accessible databases 
     for collecting relevant drug development tool data for such 
     purposes; and
       (2) an entity seeking to qualify a drug development tool 
     should be encouraged, in addition to consultation with the 
     Secretary, to consult with biomedical research consortia and 
     other individuals and entities with expert knowledge and 
     insights that may assist the requestor and benefit the 
     process for such qualification.
       (c) Qualification of Drug Development Tools.--Chapter V of 
     the Federal Food, Drug, and Cosmetic Act is amended by 
     inserting after section 506F the following new section:

     ``SEC. 507. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.

       ``(a) Process for Qualification.--
       ``(1) In general.--The Secretary shall establish a process 
     for the qualification of drug development tools for a 
     proposed context of use under which--
       ``(A)(i) a requestor initiates such process by submitting a 
     letter of intent to the Secretary; and
       ``(ii) the Secretary accepts or declines to accept such 
     letter of intent;
       ``(B)(i) if the Secretary accepts the letter of intent, a 
     requestor submits a qualification plan to the Secretary; and
       ``(ii) the Secretary accepts or declines to accept the 
     qualification plan; and
       ``(C)(i) if the Secretary accepts the qualification plan, 
     the requestor submits to the Secretary a full qualification 
     package;
       ``(ii) the Secretary determines whether to accept such 
     qualification package for review; and
       ``(iii) if the Secretary accepts such qualification package 
     for review, the Secretary conducts such review in accordance 
     with this section.
       ``(2) Acceptance and review of submissions.--
       ``(A) In general.--The succeeding provisions of this 
     paragraph shall apply with respect to the treatment of a 
     letter of intent, a qualification plan, or a full 
     qualification package submitted under paragraph (1) (referred 
     to in this paragraph as `qualification submissions').
       ``(B) Acceptance factors; nonacceptance.--The Secretary 
     shall determine whether to accept a qualification submission 
     based on factors which may include the scientific merit of 
     the submission and the available resources of the Food and 
     Drug Administration to review the qualification submission. A 
     determination not to accept a submission under paragraph (1) 
     shall not be construed as a final determination by the 
     Secretary under this section regarding the qualification of a 
     drug development tool for its proposed context of use.
       ``(C) Prioritization of qualification review.--The 
     Secretary may prioritize the review of a full qualification 
     package submitted under paragraph (1) with respect to a drug 
     development tool, based on factors determined appropriate by 
     the Secretary, including--
       ``(i) as applicable, the severity, rarity, or prevalence of 
     the disease or condition targeted by the drug development 
     tool and the availability or lack of alternative treatments 
     for such disease or condition; and
       ``(ii) the identification, by the Secretary or by 
     biomedical research consortia and other expert stakeholders, 
     of such a drug development tool and its proposed context of 
     use as a public health priority.
       ``(D) Engagement of external experts.--The Secretary may, 
     for purposes of the review of qualification submissions, 
     through the use of cooperative agreements, grants, or other 
     appropriate mechanisms, consult with biomedical research 
     consortia and may consider the recommendations of such 
     consortia with respect to the review of any qualification 
     plan submitted under paragraph (1) or the review of any full 
     qualification package under paragraph (3).
       ``(3) Review of full qualification package.--The Secretary 
     shall--
       ``(A) conduct a comprehensive review of a full 
     qualification package accepted under paragraph (1)(C); and
       ``(B) determine whether the drug development tool at issue 
     is qualified for its proposed context of use.
       ``(4) Qualification.--The Secretary shall determine whether 
     a drug development tool is qualified for a proposed context 
     of use based on the scientific merit of a full qualification 
     package reviewed under paragraph (3).
       ``(b) Effect of Qualification.--

[[Page 11290]]

       ``(1) In general.--A drug development tool determined to be 
     qualified under subsection (a)(4) for a proposed context of 
     use specified by the requestor may be used by any person in 
     such context of use for the purposes described in paragraph 
     (2).
       ``(2) Use of a drug development tool.--Subject to paragraph 
     (3), a drug development tool qualified under this section may 
     be used for--
       ``(A) supporting or obtaining approval or licensure (as 
     applicable) of a drug or biological product (including in 
     accordance with section 506(c)) under section 505 of this Act 
     or section 351 of the Public Health Service Act; or
       ``(B) supporting the investigational use of a drug or 
     biological product under section 505(i) of this Act or 
     section 351(a)(3) of the Public Health Service Act.
       ``(3) Rescission or modification.--
       ``(A) In general.--The Secretary may rescind or modify a 
     determination under this section to qualify a drug 
     development tool if the Secretary determines that the drug 
     development tool is not appropriate for the proposed context 
     of use specified by the requestor. Such a determination may 
     be based on new information that calls into question the 
     basis for such qualification.
       ``(B) Meeting for review.--If the Secretary rescinds or 
     modifies under subparagraph (A) a determination to qualify a 
     drug development tool, the requestor involved shall, on 
     request, be granted a meeting with the Secretary to discuss 
     the basis of the Secretary's decision to rescind or modify 
     the determination before the effective date of the rescission 
     or modification.
       ``(c) Transparency.--
       ``(1) In general.--Subject to paragraph (3), the Secretary 
     shall make publicly available, and update on at least a 
     biannual basis, on the Internet website of the Food and Drug 
     Administration the following:
       ``(A) Information with respect to each qualification 
     submission under the qualification process under subsection 
     (a), including--
       ``(i) the stage of the review process applicable to the 
     submission;
       ``(ii) the date of the most recent change in stage status;
       ``(iii) whether the external scientific experts were 
     utilized in the development of a qualification plan or the 
     review of a full qualification package; and
       ``(iv) submissions from requestors under the qualification 
     process under subsection (a), including any data and evidence 
     contained in such submissions, and any updates to such 
     submissions.
       ``(B) The Secretary's formal written determinations in 
     response to such qualification submissions.
       ``(C) Any rescissions or modifications under subsection 
     (b)(3) of a determination to qualify a drug development tool.
       ``(D) Summary reviews that document conclusions and 
     recommendations for determinations to qualify drug 
     development tools under subsection (a).
       ``(E) A comprehensive list of--
       ``(i) all drug development tools qualified under subsection 
     (a); and
       ``(ii) all surrogate endpoints which were the basis of 
     approval or licensure (as applicable) of a drug or biological 
     product (including in accordance with section 506(c)) under 
     section 505 of this Act or section 351 of the Public Health 
     Service Act.
       ``(2) Relation to trade secrets act.--Information made 
     publicly available by the Secretary under paragraph (1) shall 
     be considered a disclosure authorized by law for purposes of 
     section 1905 of title 18, United States Code.
       ``(3) Applicability.--Nothing in this section shall be 
     construed as authorizing the Secretary to disclose any 
     information contained in an application submitted under 
     section 505 of this Act or section 351 of the Public Health 
     Service Act that is confidential commercial or trade secret 
     information subject to section 552(b)(4) of title 5, United 
     States Code, or section 1905 of title 18, United States Code.
       ``(d) Rule of Construction.--Nothing in this section shall 
     be construed--
       ``(1) to alter the standards of evidence under subsection 
     (c) or (d) of section 505, including the substantial evidence 
     standard in such subsection (d), or under section 351 of the 
     Public Health Service Act (as applicable); or
       ``(2) to limit the authority of the Secretary to approve or 
     license products under this Act or the Public Health Service 
     Act, as applicable (as in effect before the date of the 
     enactment of the 21st Century Cures Act).
       ``(e) Definitions.--In this section:
       ``(1) Biomarker.--(A) The term `biomarker' means a 
     characteristic (such as a physiologic, pathologic, or 
     anatomic characteristic or measurement) that is objectively 
     measured and evaluated as an indicator of normal biologic 
     processes, pathologic processes, or biological responses to a 
     therapeutic intervention; and
       ``(B) such term includes a surrogate endpoint.
       ``(2) Biomedical research consortia.--The term `biomedical 
     research consortia' means collaborative groups that may take 
     the form of public-private partnerships and may include 
     government agencies, institutions of higher education (as 
     defined in section 101(a) of the Higher Education Act of 
     1965, patient advocacy groups, industry representatives, 
     clinical and scientific experts, and other relevant entities 
     and individuals.
       ``(3) Clinical outcome assessment.--(A) The term `clinical 
     outcome assessment' means a measurement of a patient's 
     symptoms, overall mental state, or the effects of a disease 
     or condition on how the patient functions; and
       ``(B) such term includes a patient-reported outcome.
       ``(4) Context of use.--The term `context of use' means, 
     with respect to a drug development tool, the circumstances 
     under which the drug development tool is to be used in drug 
     development and regulatory review.
       ``(5) Drug development tool.--The term `drug development 
     tool' includes--
       ``(A) a biomarker;
       ``(B) a clinical outcome assessment; and
       ``(C) any other method, material, or measure that the 
     Secretary determines aids drug development and regulatory 
     review for purposes of this section.
       ``(6) Patient-reported outcome.--The term `patient-reported 
     outcome' means a measurement based on a report from a patient 
     regarding the status of the patient's health condition 
     without amendment or interpretation of the patient's report 
     by a clinician or any other person.
       ``(7) Qualification.--The terms `qualification' and 
     `qualified' mean a determination by the Secretary that a drug 
     development tool and its proposed context of use can be 
     relied upon to have a specific interpretation and application 
     in drug development and regulatory review under this Act.
       ``(8) Requestor.--The term `requestor' means an entity or 
     entities, including a drug sponsor or a biomedical research 
     consortia, seeking to qualify a drug development tool for a 
     proposed context of use under this section.
       ``(9) Surrogate endpoint.--The term `surrogate endpoint' 
     means a marker, such as a laboratory measurement, 
     radiographic image, physical sign, or other measure, that is 
     not itself a direct measurement of clinical benefit, and--
       ``(A) is known to predict clinical benefit and could be 
     used to support traditional approval of a drug or biological 
     product; or
       ``(B) is reasonably likely to predict clinical benefit and 
     could be used to support the accelerated approval of a drug 
     or biological product in accordance with section 506(c).
       ``(f) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section, 
     $10,000,000 for each of fiscal years 2016 through 2020.''.
       (d) Guidance.--
       (1) In general.--The Secretary of Health and Human Services 
     shall, in consultation with biomedical research consortia (as 
     defined in subsection (f) of section 507 the Federal Food, 
     Drug, and Cosmetic Act (as added by subsection (c))) and 
     other interested parties through a collaborative public 
     process, issue guidance to implement such section 507 that--
       (A) provides a conceptual framework describing appropriate 
     standards and scientific approaches to support the 
     development of biomarkers delineated under the taxonomy 
     established under paragraph (3);
       (B) makes recommendations for demonstrating that a 
     surrogate endpoint is reasonably likely to predict clinical 
     benefit for the purpose of supporting the accelerated 
     approval of a drug under section 506(c) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 356(c));
       (C) with respect to the qualification process under such 
     section 507--
       (i) describes the requirements that entities seeking to 
     qualify a drug development tool under such section shall 
     observe when engaging in such process;
       (ii) outlines reasonable timeframes for the Secretary's 
     review of letters, qualification plans, or full qualification 
     packages submitted under such process; and
       (iii) establishes a process by which such entities or the 
     Secretary may consult with biomedical research consortia and 
     other individuals and entities with expert knowledge and 
     insights that may assist the Secretary in the review of 
     qualification plans and full qualification submissions under 
     such section; and
       (D) includes such other information as the Secretary 
     determines appropriate.
       (2) Timing.--Not later than 24 months after the date of the 
     enactment of this Act, the Secretary of Health and Human 
     Services shall issue draft guidance under paragraph (1) on 
     the implementation of section 507 of the Federal Food, Drug, 
     and Cosmetic Act (as added by subsection (c)). The Secretary 
     shall issue final guidance on the implementation of such 
     section not later than 6 months after the date on which the 
     comment period for the draft guidance closes.
       (3) Taxonomy.--
       (A) In general.--For purposes of informing guidance under 
     this subsection, the Secretary of Health and Human Services 
     shall, in consultation with biomedical research consortia and 
     other interested parties through a collaborative public 
     process, establish a taxonomy for the classification of 
     biomarkers (and related scientific concepts) for use in drug 
     development.
       (B) Public availability.--Not later than 12 months after 
     the date of the enactment of this Act, the Secretary of 
     Health and Human Services shall make such taxonomy publicly 
     available in draft form for public comment. The Secretary 
     shall finalize the taxonomy not later than 12 months after 
     the close of the public comment period.
       (e) Meeting and Report.--
       (1) Meeting.--Not later than 12 months after the date of 
     the enactment of this Act, the Secretary of Health and Human 
     Services shall convene a public meeting to describe and 
     solicit public input regarding the qualification process 
     under section 507 of the Federal Food, Drug, and Cosmetic 
     Act, as added by subsection (c).
       (2) Report.--Not later than 5 years after the date of the 
     enactment of this Act, the Secretary

[[Page 11291]]

     shall make publicly available on the Internet website of the 
     Food and Drug Administration a report. Such report shall 
     include, with respect to the qualification process under 
     section 507 of the Federal Food, Drug, and Cosmetic Act, as 
     added by subsection (c), information on--
       (A) the number of requests submitted, as a letter of 
     intent, for qualification of a drug development tool (as 
     defined in subsection (f) of such section);
       (B) the number of such requests accepted and determined to 
     be eligible for submission of a qualification plan or full 
     qualification package (as such terms are defined in such 
     subsection), respectively;
       (C) the number of such requests for which external 
     scientific experts were utilized in the development of a 
     qualification plan or review of a full qualification package; 
     and
       (D) the number of qualification plans and full 
     qualification packages, respectively, submitted to the 
     Secretary; and
       (3) the drug development tools qualified through such 
     qualification process, specified by type of tool, such as a 
     biomarker or clinical outcome assessment (as such terms are 
     defined in subsection (f) of such section 507).

     SEC. 2022. ACCELERATED APPROVAL DEVELOPMENT PLAN.

       (a) In General.--Section 506 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 356) is amended by adding the 
     following subsection:
       ``(g) Accelerated Approval Development Plan.--
       ``(1) In general.--In the case of a drug that the Secretary 
     determines may be eligible for accelerated approval in 
     accordance with subsection (c), the sponsor of such drug may 
     request, at any time after the submission of an application 
     for the investigation of the drug under section 505(i) of 
     this Act or section 351(a)(3) of the Public Health Service 
     Act, that the Secretary agree to an accelerated approval 
     development plan described in paragraph (2).
       ``(2) Plan described.--A plan described in this paragraph, 
     with respect to a drug described in paragraph (1), is an 
     accelerated approval development plan, which shall include 
     agreement on--
       ``(A) the surrogate endpoint to be assessed under such 
     plan;
       ``(B) the design of the study that will utilize the 
     surrogate endpoint; and
       ``(C) the magnitude of the effect of the drug on the 
     surrogate endpoint that is the subject of the agreement that 
     would be sufficient to form the primary basis of a claim that 
     the drug is effective.
       ``(3) Modification; termination.--The Secretary may require 
     the sponsor of a drug that is the subject of an accelerated 
     approval development plan to modify or terminate the plan if 
     additional data or information indicates that--
       ``(A) the plan as originally agreed upon is no longer 
     sufficient to demonstrate the safety and effectiveness of the 
     drug involved; or
       ``(B) the drug is no longer eligible for accelerated 
     approval under subsection (c).
       ``(4) Sponsor consultation.--If the Secretary requires the 
     modification or termination of an accelerated approval 
     development plan under paragraph (3), the sponsor shall be 
     granted a request for a meeting to discuss the basis of the 
     Secretary's decision before the effective date of the 
     modification or termination.
       ``(5) Definition.--In this section, the term `accelerated 
     approval development plan' means a development plan agreed 
     upon by the Secretary and the sponsor submitting the plan 
     that contains study parameters for the use of a surrogate 
     endpoint that--
       ``(A) is reasonably likely to predict clinical benefit; and
       ``(B) is intended to be the basis of the accelerated 
     approval of a drug in accordance with subsection (c).''.
       (b) Technical Amendments.--Section 506 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 356) is amended--
       (1) by striking ``(f) Awareness Efforts'' and inserting 
     ``(e) Awareness Efforts''; and
       (2) by striking ``(e) Construction'' and inserting ``(f) 
     Construction''.

           Subtitle C--FDA Advancement of Precision Medicine

     SEC. 2041. PRECISION MEDICINE GUIDANCE AND OTHER PROGRAMS OF 
                   FOOD AND DRUG ADMINISTRATION.

       Chapter V of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 351 et seq.) is amended by adding at the end the 
     following:

                   ``Subchapter J--Precision Medicine

     ``SEC. 591. GENERAL AGENCY GUIDANCE ON PRECISION MEDICINE.

       ``(a) In General.--The Secretary shall issue and 
     periodically update guidance to assist sponsors in the 
     development of a precision drug or biological product. Such 
     guidance shall--
       ``(1) define the term `precision drug or biological 
     product'; and
       ``(2) address the topics described in subsection (b).
       ``(b) Certain Issues.--The topics to be addressed by 
     guidance under subsection (a) are--
       ``(1) the evidence needed to support the use of biomarkers 
     (as defined in section 507(e)) that identify subsets of 
     patients as likely responders to therapies in order to 
     streamline the conduct of clinical trials;
       ``(2) recommendations for the design of studies to 
     demonstrate the validity of a biomarker as a predictor of 
     drug or biological product response;
       ``(3) the manner and extent to which a benefit-risk 
     assessment may be affected when clinical trials are limited 
     to patient population subsets that are identified using 
     biomarkers;
       ``(4) the development of companion diagnostics in the 
     context of a drug development program; and
       ``(5) considerations for developing biomarkers that inform 
     prescribing decisions for a drug or biological product, and 
     when information regarding a biomarker may be included in the 
     approved prescription labeling for a precision drug or 
     biological product.
       ``(c) Date Certain for Initial Guidance.--The Secretary 
     shall issue guidance under subsection (a) not later than 18 
     months after the date of the enactment of the 21st Century 
     Cures Act.

     ``SEC. 592. PRECISION MEDICINE REGARDING ORPHAN-DRUG AND 
                   EXPEDITED-APPROVAL PROGRAMS.

       ``(a) In General.--In the case of a precision drug or 
     biological product that is the subject of an application 
     submitted under section 505(b)(1), or section 351(a) of the 
     Public Health Service Act, for the treatment of a serious or 
     life-threatening disease or condition and has been designated 
     under section 526 as a drug for a rare disease or condition, 
     the Secretary may--
       ``(1) consistent with applicable standards for approval, 
     rely upon data or information previously submitted by the 
     sponsor of the precision drug or biological product, or 
     another sponsor, provided that the sponsor of the precision 
     drug or biological product has obtained a contractual right 
     of reference to such other sponsor's data and information, in 
     an application approved under section 505(c) or licensed 
     under section 351(a) of the Public Health Service Act, as 
     applicable--
       ``(A) for a different drug or biological product; or
       ``(B) for a different indication for such precision drug or 
     biological product,
     in order to expedite clinical development for a precision 
     drug or biological product that is using the same or similar 
     approach as that used to support approval of the prior 
     approved application or license, as appropriate; and
       ``(2) as appropriate, consider the application for approval 
     of such precision drug or biological product to be eligible 
     for expedited review and approval programs described in 
     section 506, including accelerated approval in accordance 
     with subsection (c) of such section.
       ``(b) Rule of Construction.--Nothing in this section shall 
     be construed to--
       ``(1) limit the authority of the Secretary to approve 
     products pursuant to this Act and the Public Health Service 
     Act as authorized prior to the date of enactment of this 
     section; or
       ``(2) confer any new rights, beyond those authorized under 
     this Act prior to enactment of this section, with respect to 
     a sponsor's ability to reference information contained in 
     another application submitted under section 505(b)(1) of this 
     Act or section 351(a) of the Public Health Service Act.''.

        Subtitle D--Modern Trial Design and Evidence Development

     SEC. 2061. BROADER APPLICATION OF BAYESIAN STATISTICS AND 
                   ADAPTIVE TRIAL DESIGNS.

       (a) Proposals for Use of Innovative Statistical Methods in 
     Clinical Protocols for Drugs and Biological Products.--For 
     purposes of assisting sponsors in incorporating adaptive 
     trial design and Bayesian methods into proposed clinical 
     protocols and applications for new drugs under section 505 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and 
     biological products under section 351 of the Public Health 
     Service Act (42 U.S.C. 262), the Secretary shall conduct a 
     public meeting and issue guidance in accordance with 
     subsection (b).
       (b) Guidance Addressing Use of Adaptive Trial Designs and 
     Bayesian Methods.--
       (1) In general.--The Secretary of Health and Human 
     Services, acting through the Commissioner of Food and Drugs 
     (in this subsection referred to as the ``Secretary''), 
     shall--
       (A) update and finalize the draft guidance addressing the 
     use of adaptive trial design for drugs and biological 
     products; and
       (B) issue draft guidance on the use of Bayesian methods in 
     the development and regulatory review and approval or 
     licensure of drugs and biological products.
       (2) Contents.--The guidances under paragraph (1) shall 
     address--
       (A) the use of adaptive trial designs and Bayesian methods 
     in clinical trials, including clinical trials proposed or 
     submitted to help to satisfy the substantial evidence 
     standard under section 505(d) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(d));
       (B) how sponsors may obtain feedback from the Secretary on 
     technical issues related to modeling and simulations prior 
     to--
       (i) completion of such modeling or simulations; or
       (ii) the submission of resulting information to the 
     Secretary;
       (C) the types of quantitative and qualitative information 
     that should be submitted for review; and
       (D) recommended analysis methodologies.
       (3) Public meeting.--Prior to updating or developing the 
     guidances required by paragraph (1), the Secretary shall 
     consult with stakeholders, including representatives of 
     regulated industry, academia, patient advocacy organizations, 
     and disease research foundations, through a public meeting to 
     be held not later than 1 year after the date of enactment of 
     this Act.
       (4) Schedule.--The Secretary shall publish--
       (A) the final guidance required by paragraph (1)(A) not 
     later than 18 months after the date of the public meeting 
     required by paragraph (3); and
       (B) the guidance required by paragraph (1)(B) not later 
     than 48 months after the date of the public meeting required 
     by paragraph (3).

[[Page 11292]]



     SEC. 2062. UTILIZING EVIDENCE FROM CLINICAL EXPERIENCE.

       Chapter V of the Federal Food, Drug, and Cosmetic Act is 
     amended by inserting after section 505E of such Act (21 
     U.S.C. 355f) the following:

     ``SEC. 505F. UTILIZING EVIDENCE FROM CLINICAL EXPERIENCE.

       ``(a) In General.--The Secretary shall establish a program 
     to evaluate the potential use of evidence from clinical 
     experience--
       ``(1) to help to support the approval of a new indication 
     for a drug approved under section 505(b); and
       ``(2) to help to support or satisfy postapproval study 
     requirements.
       ``(b) Evidence From Clinical Experience Defined.--In this 
     section, the term `evidence from clinical experience' means 
     data regarding the usage, or the potential benefits or risks, 
     of a drug derived from sources other than randomized clinical 
     trials, including from observational studies, registries, and 
     therapeutic use.
       ``(c) Program Framework.--
       ``(1) In general.--Not later than 18 months after the date 
     of enactment of this section, the Secretary shall establish a 
     draft framework for implementation of the program under this 
     section.
       ``(2) Contents of framework.--The framework shall include 
     information describing--
       ``(A) the current sources of data developed through 
     clinical experience, including ongoing safety surveillance, 
     registry, claims, and patient-centered outcomes research 
     activities;
       ``(B) the gaps in current data collection activities;
       ``(C) the current standards and methodologies for 
     collection and analysis of data generated through clinical 
     experience; and
       ``(D) the priority areas, remaining challenges, and 
     potential pilot opportunities that the program established 
     under this section will address.
       ``(3) Consultation.--
       ``(A) In general.--In developing the program framework 
     under this subsection, the Secretary shall consult with 
     regulated industry, academia, medical professional 
     organizations, representatives of patient advocacy 
     organizations, disease research foundations, and other 
     interested parties.
       ``(B) Process.--The consultation under subparagraph (A) may 
     be carried out through approaches such as--
       ``(i) a public-private partnership with the entities 
     described in such subparagraph in which the Secretary may 
     participate; or
       ``(ii) a contract, grant, or other arrangement, as 
     determined appropriate by the Secretary with such a 
     partnership or an independent research organization.
       ``(d) Program Implementation.--The Secretary shall, not 
     later than 24 months after the date of enactment of this 
     section and in accordance with the framework established 
     under subsection (c), implement the program to evaluate the 
     potential use of evidence from clinical experience.
       ``(e) Guidance for Industry.--The Secretary shall--
       ``(1) utilize the program established under subsection (a), 
     its activities, and any subsequent pilots or written reports, 
     to inform a guidance for industry on--
       ``(A) the circumstances under which sponsors of drugs and 
     the Secretary may rely on evidence from clinical experience 
     for the purposes described in subsection (a)(1) or (a)(2); 
     and
       ``(B) the appropriate standards and methodologies for 
     collection and analysis of evidence from clinical experience 
     submitted for such purposes;
       ``(2) not later than 36 months after the date of enactment 
     of this section, issue draft guidance for industry as 
     described in paragraph (1); and
       ``(3) not later than 48 months after the date of enactment 
     of this section, after providing an opportunity for public 
     comment on the draft guidance, issue final guidance.
       ``(f) Rule of Construction.--
       ``(1) Subject to paragraph (2), nothing in this section 
     prohibits the Secretary from using evidence from clinical 
     experience for purposes not specified in this section, 
     provided the Secretary determines that sufficient basis 
     exists for any such nonspecified use.
       ``(2) This section shall not be construed to alter--
       ``(A) the standards of evidence under--
       ``(i) subsection (c) or (d) of section 505, including the 
     substantial evidence standard in such subsection (d); or
       ``(ii) section 351(a) of the Public Health Service Act; or
       ``(B) the Secretary's authority to require postapproval 
     studies or clinical trials, or the standards of evidence 
     under which studies or trials are evaluated.

     ``SEC. 505G. COLLECTING EVIDENCE FROM CLINICAL EXPERIENCE 
                   THROUGH TARGETED EXTENSIONS OF THE SENTINEL 
                   SYSTEM.

       ``(a) In General.--The Secretary shall, in parallel to 
     implementing the program established under section 505F and 
     in order to build capacity for utilizing the evidence from 
     clinical experience described in that section, identify and 
     execute pilot demonstrations to extend existing use of the 
     Sentinel System surveillance infrastructure authorized under 
     section 505(k).
       ``(b) Pilot Demonstrations.--
       ``(1) In general.--The Secretary--
       ``(A) shall design and implement pilot demonstrations to 
     utilize data captured through the Sentinel System 
     surveillance infrastructure authorized under section 505(k) 
     for purposes of, as appropriate--
       ``(i) generating evidence from clinical experience to 
     improve characterization or assessment of risks or benefits 
     of a drug approved under section 505(c);
       ``(ii) protecting the public health; or
       ``(iii) advancing patient-centered care; and
       ``(B) may make strategic linkages with sources of 
     complementary public health data and infrastructure the 
     Secretary determines appropriate and necessary.
       ``(2) Consultation.--In developing the pilot demonstrations 
     under this subsection, the Secretary shall--
       ``(A) consult with regulated industry, academia, medical 
     professional organizations, representatives of patient 
     advocacy organizations, disease research foundations, and 
     other interested parties through a public process; and
       ``(B) develop a framework to promote appropriate 
     transparency and dialogue about research conducted under 
     these pilot demonstrations, including by--
       ``(i) providing adequate notice to a sponsor of a drug 
     approved under section 505 or section 351 of the Public 
     Health Service Act of the Secretary's intent to conduct 
     analyses of such sponsor's drug or drugs under these pilot 
     demonstrations;
       ``(ii) providing adequate notice of the findings related to 
     analyses described in clause (i) and an opportunity for the 
     sponsor of such drug or drugs to comment on such findings; 
     and
       ``(iii) ensuring the protection from public disclosure of 
     any information that is a trade secret or confidential 
     information subject to section 552(b)(4) of title 5, United 
     States Code, or section 1905 of title 18, United States Code.
       ``(3) HIPAA privacy rule; human subject research 
     regulation.--The Secretary may deem such pilot 
     demonstrations--
       ``(A) public health activities, for purposes of which a use 
     or disclosure of protected health information would be 
     permitted as described in section 164.512(b)(1) of title 45, 
     Code of Federal Regulations (or any successor regulation); 
     and
       ``(B) outside the scope of `research' as defined in section 
     46.102(d) of title 45, Code of Federal Regulations (or any 
     successor regulation).
       ``(c) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section 
     $3,000,000 for each of fiscal years 2016 through 2020.''.

     SEC. 2063. STREAMLINED DATA REVIEW PROGRAM.

       (a) In General.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act, as amended by section 2062, is further amended 
     by inserting after section 505G of such Act the following:

     ``SEC. 505H. STREAMLINED DATA REVIEW PROGRAM.

       ``(a) In General.--The Secretary shall establish a 
     streamlined data review program under which a holder of an 
     approved application submitted under section 505(b)(1) or 
     under section 351(a) of the Public Health Service Act may, to 
     support the approval or licensure (as applicable) of the use 
     of the drug that is the subject of such approved application 
     for a new qualified indication, submit qualified data 
     summaries.
       ``(b) Eligibility.--In carrying out the streamlined data 
     review program under subsection (a), the Secretary may 
     authorize the holder of the approved application to include 
     one or more qualified data summaries described in subsection 
     (a) in a supplemental application if--
       ``(1) the drug has been approved under section 505(c) of 
     this Act or licensed under section 351(a) of the Public 
     Health Service Act for one or more indications, and such 
     approval or licensure remains in effect;
       ``(2) the supplemental application is for approval or 
     licensure (as applicable) under such section 505(c) or 351(a) 
     of the use of the drug for a new qualified indication under 
     such section 505(c) or 351(a);
       ``(3) there is an existing database acceptable to the 
     Secretary regarding the safety of the drug developed for one 
     or more indications of the drug approved under such section 
     505(c) or licensed under such section 351(a);
       ``(4) the supplemental application incorporates or 
     supplements the data submitted in the application for 
     approval or licensure referred to in paragraph (1); and
       ``(5) the full data sets used to develop the qualified data 
     summaries are submitted, unless the Secretary determines that 
     the full data sets are not required.
       ``(c) Public Availability of Information on Program.--The 
     Secretary shall post on the public website of the Food and 
     Drug Administration and update annually--
       ``(1) the number of applications reviewed under the 
     streamlined data review program;
       ``(2) the average time for completion of review under the 
     streamlined data review program versus other review of 
     applications for new indications; and
       ``(3) the number of applications reviewed under the 
     streamlined data review program for which the Food and Drug 
     Administration made use of full data sets in addition to the 
     qualified data summary.
       ``(d) Definitions.--In this section:
       ``(1) The term `qualified indication' means--
       ``(A) an indication for the treatment of cancer, as 
     determined appropriate by the Secretary; or
       ``(B) such other types of indications as the Secretary 
     determines to be subject to the streamlined data review 
     program under this section.
       ``(2) The term `qualified data summary' means a summary of 
     clinical data intended to demonstrate safety and 
     effectiveness with respect to a qualified indication for use 
     of a drug.''.
       (b) Sense of Congress.--It is the sense of Congress that 
     the streamlined data review program under section 505H of the 
     Federal Food,

[[Page 11293]]

     Drug, and Cosmetic Act, as added by subsection (a), should 
     enable the Food and Drug Administration to make approval 
     decisions for certain supplemental applications based on 
     qualified data summaries (as defined in such section 505H).
       (c) Guidance; Regulations.--The Commissioner of Food and 
     Drugs--
       (1) shall--
       (A) issue final guidance for implementation of the 
     streamlined data review program established under section 
     505H of the Federal Food, Drug, and Cosmetic Act, as added by 
     subsection (a), not later than 24 months after the date of 
     enactment of this Act; and
       (B) include in such guidance the process for expanding the 
     types of indications to be subject to the streamlined data 
     review program, as authorized by section 505H(c)(1)(B) of 
     such Act; and
       (2) in addition to issuing guidance under paragraph (1), 
     may issue such regulations as may be necessary for 
     implementation of the program.

                 Subtitle E--Expediting Patient Access

     SEC. 2081. SENSE OF CONGRESS.

       It is the sense of Congress that the Food and Drug 
     Administration should continue to expedite the approval of 
     drugs designated as breakthrough therapies pursuant to 
     section 506(a) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 356(a)) by approving drugs so designated as early 
     as possible in the clinical development process, regardless 
     of the phase of development, provided that the Secretary of 
     Health and Human Services determines that an application for 
     such a drug meets the standards of evidence of safety and 
     effectiveness under section 505 of such Act (21 U.S.C. 355), 
     including the substantial evidence standard under subsection 
     (d) of such section or under section 351(a) of the Public 
     Health Service Act (42 U.S.C. 262(a)).

     SEC. 2082. EXPANDED ACCESS POLICY.

       Chapter V of the Federal Food, Drug, and Cosmetic Act is 
     amended by inserting after section 561 (21 U.S.C. 360bbb) the 
     following:

     ``SEC. 561A. EXPANDED ACCESS POLICY REQUIRED FOR 
                   INVESTIGATIONAL DRUGS.

       ``(a) In General.--The manufacturer or distributor of one 
     or more investigational drugs for the diagnosis, monitoring, 
     or treatment of one or more serious diseases or conditions 
     shall make publicly available the policy of the manufacturer 
     or distributor on evaluating and responding to requests 
     submitted under section 561(b) for provision of such a drug. 
     A manufacturer or distributor may satisfy the requirement of 
     the preceding sentence by posting such policy as generally 
     applicable to all of such manufacturer's or distributor's 
     investigational drugs.
       ``(b) Content of Policy.--A policy described in subsection 
     (a) shall include making publicly available--
       ``(1) contact information for the manufacturer or 
     distributor to facilitate communication about requests 
     described in subsection (a);
       ``(2) procedures for making such requests;
       ``(3) the general criteria the manufacturer or distributor 
     will consider or use to approve such requests; and
       ``(4) the length of time the manufacturer or distributor 
     anticipates will be necessary to acknowledge receipt of such 
     requests.
       ``(c) No Guarantee of Access.--The posting of policies by 
     manufacturers and distributors under subsection (a) shall not 
     serve as a guarantee of access to any specific 
     investigational drug by any individual patient.
       ``(d) Revised Policy.--A manufacturer or distributor that 
     has made a policy publicly available as required by this 
     section may revise the policy at any time.
       ``(e) Application.--This section shall apply to a 
     manufacturer or distributor with respect to an 
     investigational drug beginning on the later of--
       ``(1) the date that is 60 days after the date of enactment 
     of the 21st Century Cures Act; or
       ``(2) the first initiation of a phase 2 or phase 3 study 
     (as such terms are defined in section 312.21(b) and (c) of 
     title 21, Code of Federal Regulations (or any successor 
     regulations)) with respect to such investigational new 
     drug.''.

     SEC. 2083. FINALIZING DRAFT GUIDANCE ON EXPANDED ACCESS.

       (a) In General.--Not later than 12 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall finalize the draft guidance entitled 
     ``Expanded Access to Investigational Drugs for Treatment 
     Use--Qs & As'' and dated May 2013.
       (b) Contents.--The final guidance referred to in subsection 
     (a) shall clearly define how the Secretary of Health and 
     Human Services interprets and uses adverse drug event data 
     reported by investigators in the case of data reported from 
     use under a request submitted under section 561(b) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)).

    Subtitle F--Facilitating Responsible Manufacturer Communications

     SEC. 2101. FACILITATING DISSEMINATION OF HEALTH CARE ECONOMIC 
                   INFORMATION.

       Section 502(a) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 352(a)) is amended--
       (1) by striking ``(a) If its'' and inserting ``(a)(1) If 
     its'';
       (2) by striking ``a formulary committee, or other similar 
     entity, in the course of the committee or the entity carrying 
     out its responsibilities for the selection of drugs for 
     managed care or other similar organizations'' and inserting 
     ``a payor, formulary committee, or other similar entity with 
     knowledge and expertise in the area of health care economic 
     analysis, carrying out its responsibilities for the selection 
     of drugs for coverage or reimbursement'';
       (3) by striking ``directly relates'' and inserting 
     ``relates'';
       (4) by striking ``and is based on competent and reliable 
     scientific evidence. The requirements set forth in section 
     505(a) or in section 351(a) of the Public Health Service Act 
     shall not apply to health care economic information provided 
     to such a committee or entity in accordance with this 
     paragraph'' and inserting ``, is based on competent and 
     reliable scientific evidence, and includes, where applicable, 
     a conspicuous and prominent statement describing any material 
     differences between the health care economic information and 
     the labeling approved for the drug under section 505 or under 
     section 351 of the Public Health Service Act. The 
     requirements set forth in section 505(a) or in subsections 
     (a) and (k) of section 351 of the Public Health Service Act 
     shall not apply to health care economic information provided 
     to such a payor, committee, or entity in accordance with this 
     paragraph''; and
       (5) by striking ``In this paragraph, the term'' and all 
     that follows and inserting the following:
       ``(2)(A) For purposes of this paragraph, the term `health 
     care economic information' means any analysis (including the 
     clinical data, inputs, clinical or other assumptions, 
     methods, results, and other components underlying or 
     comprising the analysis) that identifies, measures, or 
     describes the economic consequences, which may be based on 
     the separate or aggregated clinical consequences of the 
     represented health outcomes, of the use of a drug. Such 
     analysis may be comparative to the use of another drug, to 
     another health care intervention, or to no intervention.
       ``(B) Such term does not include any analysis that relates 
     only to an indication that is not approved under section 505 
     or under section 351 of the Public Health Service Act for 
     such drug.''.

     SEC. 2102. FACILITATING RESPONSIBLE COMMUNICATION OF 
                   SCIENTIFIC AND MEDICAL DEVELOPMENTS.

       (a) Guidance.--Not later than 18 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall issue draft guidance on facilitating the 
     responsible dissemination of truthful and nonmisleading 
     scientific and medical information not included in the 
     approved labeling of drugs and devices.
       (b) Definition.--In this section, the terms ``drug'' and 
     ``device'' have the meaning given to such terms in section 
     201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     321).

                Subtitle G--Antibiotic Drug Development

     SEC. 2121. APPROVAL OF CERTAIN DRUGS FOR USE IN A LIMITED 
                   POPULATION OF PATIENTS.

       (a) Purpose.--The purpose of this section is to help to 
     expedite the development and availability of treatments for 
     serious or life-threatening bacterial or fungal infections in 
     patients with unmet needs, while maintaining safety and 
     effectiveness standards for such treatments, taking into 
     account the severity of the infection and the availability or 
     lack of alternative treatments.
       (b) Approval of Certain Antibacterial and Antifungal 
     Drugs.--Section 505 of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355), as amended by section 2001, is further 
     amended by adding at the end the following new subsection:
       ``(z) Approval of Certain Antibacterial and Antifungal 
     Drugs for Use in a Limited Population of Patients.--
       ``(1) Process.--At the request of the sponsor of an 
     antibacterial or antifungal drug that is intended to treat a 
     serious or life-threatening infection, the Secretary--
       ``(A) may execute a written agreement with the sponsor on 
     the process for developing data to support an application for 
     approval of such drug, for use in a limited population of 
     patients in accordance with this subsection;
       ``(B) shall proceed in accordance with this subsection only 
     if a written agreement is reached under subparagraph (A);
       ``(C) shall provide the sponsor with an opportunity to 
     request meetings under paragraph (2);
       ``(D) if a written agreement is reached under subparagraph 
     (A), may approve the drug under this subsection for such 
     use--
       ``(i) in a limited population of patients for which there 
     is an unmet medical need;
       ``(ii) based on a streamlined development program; and
       ``(iii) only if the standards for approval under 
     subsections (c) and (d) of this section or licensure under 
     section 351 of the Public Health Service Act, as applicable, 
     are met; and
       ``(E) in approving a drug in accordance with this 
     subsection, subject to subparagraph (D)(iii), may rely upon--
       ``(i) traditional endpoints, alternate endpoints, or a 
     combination of traditional and alternate endpoints, and, as 
     appropriate, data sets of a limited size; and
       ``(ii)(I) additional data, including preclinical, 
     pharmacologic, or pathophysiologic evidence;
       ``(II) nonclinical susceptibility and pharmacokinetic data;
       ``(III) data from phase 2 clinical trials; and
       ``(IV) such other confirmatory evidence as the Secretary 
     determines appropriate to approve the drug.
       ``(2) Formal meetings.--
       ``(A) In general.--To help to expedite and facilitate the 
     development and review of a drug for which a sponsor intends 
     to request approval in accordance with this subsection, the 
     Secretary may, at the request of the sponsor, conduct 
     meetings that provide early consultation,

[[Page 11294]]

     timely advice, and sufficient opportunities to develop an 
     agreement described in paragraph (1)(A) and help the sponsor 
     design and conduct a drug development program as efficiently 
     as possible, including the following types of meetings:
       ``(i) An early consultation meeting.
       ``(ii) An assessment meeting.
       ``(iii) A postapproval meeting.
       ``(B) No altering of goals.--Nothing in this paragraph 
     shall be construed to alter agreed upon goals and procedures 
     identified in the letters described in section 101(b) of the 
     Prescription Drug User Fee Amendments of 2012.
       ``(C) Breakthrough therapies.--In the case of a drug 
     designated as a breakthrough therapy under section 506(a), 
     the sponsor of such drug may elect to utilize meetings 
     provided under such section with respect to such drug in lieu 
     of meetings described in subparagraph (A).
       ``(3) Labeling requirement.--The labeling of an 
     antibacterial or antifungal drug approved in accordance with 
     this subsection shall contain the statement `Limited 
     Population' in a prominent manner and adjacent to, and not 
     more prominent than, the brand name of the product. The 
     prescribing information for such antibacterial or antifungal 
     drug required by section 201.57 of title 21, Code of Federal 
     Regulations (or any successor regulation) shall also include 
     the following statement: `This drug is indicated for use in a 
     limited and specific population of patients.'.
       ``(4) Promotional materials.--The provisions of section 
     506(c)(2)(B) shall apply with respect to approval in 
     accordance with this subsection to the same extent and in the 
     same manner as such provisions apply with respect to 
     accelerated approval in accordance with section 506(c)(1).
       ``(5) Termination of requirements or conditions.--If a drug 
     is approved in accordance with this subsection for an 
     indication in a limited population of patients and is 
     subsequently approved or licensed under this section or 
     section 351 of the Public Health Service Act, other than in 
     accordance with this subsection, for--
       ``(A) the same indication and the same conditions of use, 
     the Secretary shall remove any labeling requirements or 
     postmarketing conditions that were made applicable to the 
     drug under this subsection; or
       ``(B) a different indication or condition of use, the 
     Secretary shall not apply the labeling requirements and 
     postmarketing conditions that were made applicable to the 
     drug under this subsection to the subsequent approval of the 
     drug for such different indication or condition of use.
       ``(6) Relation to other provisions.--Nothing in this 
     subsection shall be construed to prohibit the approval of a 
     drug for use in a limited population of patients in 
     accordance with this subsection, in combination with--
       ``(A) an agreement on the design and size of a clinical 
     trial pursuant to subparagraphs (B) and (C) of subsection 
     (b)(5);
       ``(B) designation and treatment of the drug as a 
     breakthrough therapy under section 506(a);
       ``(C) designation and treatment of the drug as a fast track 
     product under section 506(b); or
       ``(D) accelerated approval of the drug in accordance with 
     section 506(c).
       ``(7) Rule of construction.--Nothing in this subsection 
     shall be construed--
       ``(A) to alter the standards of evidence under subsection 
     (c) or (d) (including the substantial evidence standard in 
     subsection (d));
       ``(B) to waive or otherwise preclude the application of 
     requirements under subsection (o);
       ``(C) to otherwise, in any way, limit the authority of the 
     Secretary to approve products pursuant to this Act and the 
     Public Health Service Act as authorized prior to the date of 
     enactment of this subsection; or
       ``(D) to restrict in any manner, the prescribing of 
     antibiotics or other products by health care providers, or to 
     otherwise limit or restrict the practice of health care.
       ``(8) Effective immediately.--The Secretary shall have the 
     authorities vested in the Secretary by this subsection 
     beginning on the date of enactment of this subsection, 
     irrespective of when and whether the Secretary promulgates 
     final regulations or guidance.
       ``(9) Definitions.--In this subsection:
       ``(A) Early consultation meeting.--The term `early 
     consultation meeting' means a pre-investigational new drug 
     meeting or an end-of-phase-1 meeting that--
       ``(i) is conducted to review and reach a written 
     agreement--

       ``(I) on the scope of the streamlined development plan for 
     a drug for which a sponsor intends to request approval in 
     accordance with this subsection; and
       ``(II) which, as appropriate, may include agreement on the 
     design and size of necessary preclinical and clinical studies 
     early in the development process, including clinical trials 
     whose data are intended to form the primary basis for an 
     effectiveness claim; and

       ``(ii) provides an opportunity to discuss expectations of 
     the Secretary regarding studies or other information that the 
     Secretary deems appropriate for purposes of applying 
     paragraph (5), relating to the termination of labeling 
     requirements or postmarketing conditions.
       ``(B) Assessment meeting.--The term `assessment meeting' 
     means an end-of-phase 2 meeting, pre-new drug application 
     meeting, or pre-biologics license application meeting 
     conducted to resolve questions and issues raised during the 
     course of clinical investigations, and details addressed in 
     the written agreement regarding postapproval commitments or 
     expansion of approved uses.
       ``(C) Postapproval meeting.--The term `postapproval 
     meeting' means a meeting following initial approval or 
     licensure of the drug for use in a limited population, to 
     discuss any issues identified by the Secretary or the sponsor 
     regarding postapproval commitments or expansion of approved 
     uses.''.
       (c) Guidance.--Not later than 18 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services, acting through the Commissioner of Food and Drugs, 
     shall issue draft guidance describing criteria, process, and 
     other general considerations for demonstrating the safety and 
     effectiveness of antibacterial and antifungal drugs to be 
     approved for use in a limited population in accordance with 
     section 505(z) of the Federal Food, Drug, and Cosmetic Act, 
     as added by subsection (b).
       (d) Conforming Amendments.--
       (1) Licensure of certain biological products.--Section 
     351(j) of the Public Health Service Act (42 U.S.C. 262(j)) is 
     amended--
       (A) by striking ``(j)'' and inserting ``(j)(1)'';
       (B) by inserting ``505(z),'' after ``505(p),''; and
       (C) by adding at the end the following new paragraph:
       ``(2) In applying section 505(z) of the Federal Food, Drug, 
     and Cosmetic Act to the licensure of biological products 
     under this section--
       ``(A) references to an antibacterial or antifungal drug 
     that is intended to treat a serious or life-threatening 
     infection shall be construed to refer to a biological product 
     intended to treat a serious or life-threatening bacterial or 
     fungal infection; and
       ``(B) references to approval of a drug under section 505(c) 
     of such Act shall be construed to refer to a licensure of a 
     biological product under subsection (a) of this section.''.
       (2) Misbranding.--Section 502 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352) is amended by adding at the 
     end the following new subsection:
       ``(dd) If it is a drug approved in accordance with section 
     505(z) and its labeling does not meet the requirements under 
     paragraph (3) of such subsection, subject to paragraph (5) of 
     such subsection.''.
       (e) Evaluation.--
       (1) Assessment.--Not later than 48 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall publish for public comment an assessment of 
     the program established under section 505(z) of the Federal 
     Food, Drug, and Cosmetic Act, as added by subsection (b). 
     Such assessment shall determine if the limited-use pathway 
     established under such section 505(z) has improved or is 
     likely to improve patient access to novel antibacterial or 
     antifungal treatments and assess how the pathway could be 
     expanded to cover products for serious or life-threatening 
     diseases or conditions beyond bacterial and fungal 
     infections.
       (2) Meeting.--Not later than 90 days after the date of the 
     publication of such assessment, the Secretary, acting through 
     the Commissioner of Food and Drugs, shall hold a public 
     meeting to discuss the findings of the assessment, during 
     which public stakeholders may present their views on the 
     success of the program established under section 505(z) of 
     the Federal Food, Drug, and Cosmetic Act, as added by 
     subsection (b), and the appropriateness of expanding such 
     program.
       (f) Expansion of Program.--If the Secretary of Health and 
     Human Services determines, based on the assessment under 
     subsection (e)(1), evaluation of the assessment, and any 
     other relevant information, that the public health would 
     benefit from expansion of the limited-use pathway established 
     under section 505(z) of the Federal Food, Drug, and Cosmetic 
     Act (as added by subsection (b)) beyond the drugs approved in 
     accordance with such section, the Secretary may expand such 
     limited-use pathway in accordance with such a determination. 
     The approval of any drugs under any such expansion shall be 
     subject to the considerations and requirements described in 
     such section 505(z) for purposes of expansion to other 
     serious or life-threatening diseases or conditions.
       (g) Monitoring.--The Public Health Service Act is amended 
     by inserting after section 317T (42 U.S.C. 247b-22) the 
     following:

     ``SEC. 317U. MONITORING ANTIBACTERIAL AND ANTIFUNGAL DRUG USE 
                   AND RESISTANCE.

       ``(a) Monitoring.--The Secretary shall use an appropriate 
     monitoring system to monitor--
       ``(1) the use of antibacterial and antifungal drugs, 
     including those receiving approval or licensure for a limited 
     population pursuant to section 505(z) of the Federal Food, 
     Drug, and Cosmetic Act; and
       ``(2) changes in bacterial and fungal resistance to drugs.
       ``(b) Public Availability of Data.--The Secretary shall 
     make summaries of the data derived from monitoring under this 
     section publicly available for the purposes of--
       ``(1) improving the monitoring of important trends in 
     antibacterial and antifungal resistance; and
       ``(2) ensuring appropriate stewardship of antibacterial and 
     antifungal drugs, including those receiving approval or 
     licensure for a limited population pursuant to section 505(z) 
     of the Federal Food, Drug, and Cosmetic Act.''.

     SEC. 2122. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR 
                   MICROORGANISMS.

       (a) In General.--Section 511 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360a) is amended to read as follows:

     ``SEC. 511. IDENTIFYING AND UPDATING SUSCEPTIBILITY TEST 
                   INTERPRETIVE CRITERIA FOR MICROORGANISMS.

       ``(a) Purpose; Identification of Criteria.--

[[Page 11295]]

       ``(1) Purpose.--The purpose of this section is to provide 
     the Secretary with an expedited, flexible method for--
       ``(A) clearance or premarket approval of antimicrobial 
     susceptibility testing devices utilizing updated, recognized 
     susceptibility test interpretive criteria to characterize the 
     in vitro susceptibility of particular bacteria, fungi, or 
     other microorganisms to antimicrobial drugs; and
       ``(B) providing public notice of the availability of 
     recognized interpretive criteria to meet premarket submission 
     requirements or other requirements under this Act for 
     antimicrobial susceptibility testing devices.
       ``(2) In general.--The Secretary shall identify appropriate 
     susceptibility test interpretive criteria with respect to 
     antimicrobial drugs--
       ``(A) if such criteria are available on the date of 
     approval of the drug under section 505 of this Act or 
     licensure of the drug under section 351 of the Public Health 
     Service Act (as applicable), upon such approval or licensure; 
     or
       ``(B) if such criteria are unavailable on such date, on the 
     date on which such criteria are available for such drug.
       ``(3) Bases for initial identification.--The Secretary 
     shall identify appropriate susceptibility test interpretive 
     criteria under paragraph (2), based on the Secretary's review 
     of, to the extent available and relevant--
       ``(A) preclinical and clinical data, including 
     pharmacokinetic, pharmacodynamic, and epidemiological data;
       ``(B) Bayesian and pharmacometric statistical 
     methodologies; and
       ``(C) such other evidence and information as the Secretary 
     considers appropriate.
       ``(b) Susceptibility Test Interpretive Criteria Website.--
       ``(1) In general.--Not later than 1 year after the date of 
     the enactment of the 21st Century Cures Act, the Secretary 
     shall establish, and maintain thereafter, on the website of 
     the Food and Drug Administration, a dedicated website that 
     contains a list of any appropriate new or updated 
     susceptibility test interpretive criteria standards in 
     accordance with paragraph (2) (referred to in this section as 
     the `Interpretive Criteria Website').
       ``(2) Listing of susceptibility test interpretive criteria 
     standards.--
       ``(A) In general.--The list described in paragraph (1) 
     shall consist of any new or updated susceptibility test 
     interpretive criteria standards that are--
       ``(i) established by a nationally or internationally 
     recognized standard development organization that--

       ``(I) establishes and maintains procedures to address 
     potential conflicts of interest and ensure transparent 
     decisionmaking;
       ``(II) holds open meetings to ensure that there is an 
     opportunity for public input by interested parties, and 
     establishes and maintains processes to ensure that such input 
     is considered in decisionmaking; and
       ``(III) permits its standards to be made publicly 
     available, through the National Library of Medicine or 
     another similar source acceptable to the Secretary; and

       ``(ii) recognized in whole, or in part, by the Secretary 
     under subsection (c).
       ``(B) Other list.--The Interpretive Criteria Website shall, 
     in addition to the list described in subparagraph (A), 
     include a list of interpretive criteria, if any, that the 
     Secretary has determined to be appropriate with respect to 
     legally marketed antimicrobial drugs, where--
       ``(i) the Secretary does not recognize, in whole or in 
     part, an interpretive criteria standard described under 
     subparagraph (A) otherwise applicable to such a drug;
       ``(ii) the Secretary withdraws under subsection (c)(1)(B) 
     recognition of a standard, in whole or in part, otherwise 
     applicable to such a drug;
       ``(iii) the Secretary approves an application under section 
     505 of this Act or section 351 of the Public Health Service 
     Act, as applicable, with respect to marketing of such a drug 
     for which there are no relevant interpretive criteria 
     included in a standard recognized by the Secretary under 
     subsection (c); or
       ``(iv) because the characteristics of such a drug differ 
     from other drugs with the same active ingredient, the 
     interpretive criteria with respect to such drug--

       ``(I) differ from otherwise applicable interpretive 
     criteria included in a standard listed under subparagraph (A) 
     or interpretive criteria otherwise listed under this 
     subparagraph; and
       ``(II) are determined by the Secretary to be appropriate 
     for the drug.

       ``(C) Required statements of limitations of information.--
     The Interpretive Criteria Website shall include the 
     following:
       ``(i) A statement that--

       ``(I) the website provides information about the 
     susceptibility of bacteria, fungi, or other microorganisms to 
     a certain drug (or drugs); and
       ``(II) the safety and efficacy of the drug in treating 
     clinical infections due to such bacteria, fungi, or other 
     microorganisms may not have been established in adequate and 
     well-controlled clinical trials and the clinical significance 
     of such susceptibility information in such trials is unknown.

       ``(ii) A statement that directs health care practitioners 
     to consult the approved product labeling for specific drugs 
     to determine the uses for which the Food and Drug 
     Administration has approved the product.
       ``(iii) Any other statement that the Secretary determines 
     appropriate to adequately convey the limitations of the data 
     supporting susceptibility test interpretive criteria standard 
     listed on the website.
       ``(3) Notice.--Not later than the date on which the 
     Interpretive Criteria Website is established, the Secretary 
     shall publish a notice of that establishment in the Federal 
     Register.
       ``(4) Inapplicability of misbranding provision.--The 
     inclusion in the approved labeling of an antimicrobial drug 
     of a reference or hyperlink to the Interpretive Criteria 
     Website, in and of itself, shall not cause the drug to be 
     misbranded in violation of section 502, or the regulations 
     promulgated thereunder.
       ``(5) Trade secrets and confidential information.--Nothing 
     in this section shall be construed as authorizing the 
     Secretary to disclose any information that is a trade secret 
     or confidential information subject to section 552(b)(4) of 
     title 5, United States Code.
       ``(c) Recognition of Susceptibility Test Interpretive 
     Criteria From Standard Development Organizations.--
       ``(1) In general.--Beginning on the date of the 
     establishment of the Interpretive Criteria Website, and at 
     least every 6 months thereafter, the Secretary shall--
       ``(A) evaluate any appropriate new or updated 
     susceptibility test interpretive criteria standards 
     established by a nationally or internationally recognized 
     standard development organization described in subsection 
     (b)(2)(A)(i); and
       ``(B) publish on the public website of the Food and Drug 
     Administration a notice--
       ``(i) withdrawing recognition of any different 
     susceptibility test interpretive criteria standard, in whole 
     or in part;
       ``(ii) recognizing the new or updated standards;
       ``(iii) recognizing one or more parts of the new or updated 
     interpretive criteria specified in such a standard and 
     declining to recognize the remainder of such standard; and
       ``(iv) making any necessary updates to the lists under 
     subsection (b)(2).
       ``(2) Bases for updating interpretive criteria standards.--
     In evaluating new or updated susceptibility test interpretive 
     criteria standards under paragraph (1)(A), the Secretary may 
     consider--
       ``(A) the Secretary's determination that such a standard is 
     not applicable to a particular drug because the 
     characteristics of the drug differ from other drugs with the 
     same active ingredient;
       ``(B) information provided by interested third parties, 
     including public comment on the annual compilation of notices 
     published under paragraph (3);
       ``(C) any bases used to identify susceptibility test 
     interpretive criteria under subsection (a)(2); and
       ``(D) such other information or factors as the Secretary 
     determines appropriate.
       ``(3) Annual compilation of notices.--Each year, the 
     Secretary shall compile the notices published under paragraph 
     (1)(B) and publish such compilation in the Federal Register 
     and provide for public comment. If the Secretary receives 
     comments, the Secretary shall review such comments and, if 
     the Secretary determines appropriate, update pursuant to this 
     subsection susceptibility test interpretive criteria 
     standards--
       ``(A) recognized by the Secretary under this subsection; or
       ``(B) otherwise listed on the Interpretive Criteria Website 
     under subsection (b)(2).
       ``(4) Relation to section 514(c).--Any susceptibility test 
     interpretive standard recognized under this subsection or any 
     criteria otherwise listed under subsection (b)(2)(B) shall be 
     deemed to be recognized as a standard by the Secretary under 
     section 514(c)(1).
       ``(5) Voluntary use of interpretive criteria.--Nothing in 
     this section prohibits a person from seeking approval or 
     clearance of a drug or device, or changes to the drug or the 
     device, on the basis of susceptibility test interpretive 
     criteria standards which differ from those recognized 
     pursuant to paragraph (1).
       ``(d) Antimicrobial Drug Labeling.--
       ``(1) Drugs marketed prior to establishment of interpretive 
     criteria website.--With respect to an antimicrobial drug 
     lawfully introduced or delivered for introduction into 
     interstate commerce for commercial distribution before the 
     establishment of the Interpretive Criteria Website, a holder 
     of an approved application under section 505 of this Act or 
     section 351 of the Public Health Service Act, as applicable, 
     for each such drug--
       ``(A) not later than 1 year after establishment of the 
     Interpretive Criteria Website, shall submit to the Secretary 
     a supplemental application for purposes of changing the 
     drug's labeling to substitute a reference or hyperlink to 
     such Website for any susceptibility test interpretive 
     criteria and related information; and
       ``(B) may begin distribution of the drug involved upon 
     receipt by the Secretary of the supplemental application for 
     such change.
       ``(2) Drugs marketed subsequent to establishment of 
     interpretive criteria website.--With respect to antimicrobial 
     drugs lawfully introduced or delivered for introduction into 
     interstate commerce for commercial distribution on or after 
     the date of the establishment of the Interpretive Criteria 
     Website, the labeling for such a drug shall include, in lieu 
     of susceptibility test interpretive criteria and related 
     information, a reference to such Website.
       ``(e) Special Condition for Marketing of Antimicrobial 
     Susceptibility Testing Devices.--
       ``(1) In general.--Notwithstanding sections 501, 502, 510, 
     513, and 515, if the conditions specified in paragraph (2) 
     are met (in addition to

[[Page 11296]]

     other applicable provisions under this chapter) with respect 
     to an antimicrobial susceptibility testing device described 
     in subsection (f)(1), the Secretary may authorize the 
     marketing of such device for a use described in such 
     subsection.
       ``(2) Conditions applicable to antimicrobial susceptibility 
     testing devices.--The conditions specified in this paragraph 
     are the following:
       ``(A) The device is used to make a determination of 
     susceptibility using susceptibility test interpretive 
     criteria that are--
       ``(i) included in a standard recognized by the Secretary 
     under subsection (c); or
       ``(ii) otherwise listed on the Interpretive Criteria 
     Website under subsection (b)(2).
       ``(B) The labeling of such device prominently and 
     conspicuously--
       ``(i)  includes a statement that--

       ``(I) the device provides information about the 
     susceptibility of bacteria and fungi to certain drugs; and
       ``(II) the safety and efficacy of such drugs in treating 
     clinical infections due to such bacteria or fungi may not 
     have been established in adequate and well-controlled 
     clinical trials and the clinical significance of such 
     susceptibility information in those instances is unknown;

       ``(ii) includes a statement directing health care 
     practitioners to consult the approved labeling for drugs 
     tested using such a device, to determine the uses for which 
     the Food and Drug Administration has approved such drugs; and
       ``(iii) includes any other statement the Secretary 
     determines appropriate to adequately convey the limitations 
     of the data supporting the interpretive criteria described in 
     subparagraph (A).
       ``(f) Definitions.--In this section:
       ``(1) The term `antimicrobial susceptibility testing 
     device' means a device that utilizes susceptibility test 
     interpretive criteria to determine and report the in vitro 
     susceptibility of certain microorganisms to a drug (or 
     drugs).
       ``(2) The term `qualified infectious disease product' means 
     a qualified infectious disease product designated under 
     section 505E(d).
       ``(3) The term `susceptibility test interpretive criteria' 
     means--
       ``(A) one or more specific numerical values which 
     characterize the susceptibility of bacteria or other 
     microorganisms to the drug tested; and
       ``(B) related categorizations of such susceptibility, 
     including categorization of the drug as susceptible, 
     intermediate, resistant, or such other term as the Secretary 
     determines appropriate.
       ``(4)(A) The term `antimicrobial drug' means, subject to 
     subparagraph (B), a systemic antibacterial or antifungal drug 
     that--
       ``(i) is intended for human use in the treatment of a 
     disease or condition caused by a bacterium or fungus;
       ``(ii) may include a qualified infectious disease product 
     designated under section 505E(d); and
       ``(iii) is subject to section 503(b)(1).
       ``(B) If provided by the Secretary through regulations, 
     such term may include--
       ``(i) drugs other than systemic antibacterial and 
     antifungal drugs; and
       ``(ii) biological products (as such term is defined in 
     section 351 of the Public Health Service Act) to the extent 
     such products exhibit antimicrobial activity. 
       ``(g) Rule of Construction.--Nothing in this section shall 
     be construed--
       ``(1) to alter the standards of evidence--
       ``(A) under subsection (c) or (d) of section 505, including 
     the substantial evidence standard in section 505(d), or under 
     section 351 of the Public Health Service Act (as applicable); 
     or
       ``(B) with respect to marketing authorization for devices, 
     under section 510, 513, or 515;
       ``(2) to apply with respect to any drug, device, or 
     biological product, in any context other than--
       ``(A) an antimicrobial drug; or
       ``(B) an antimicrobial susceptibility testing device that 
     uses susceptibility test interpretive criteria to 
     characterize and report the in vitro susceptibility of 
     certain bacteria, fungi, or other microorganisms to 
     antimicrobial drugs in accordance with this section; or
       ``(3) unless specifically stated, to have any effect on 
     authorities provided under other sections of this Act, 
     including any regulations issued under such sections.''.
       (b) Conforming Amendments.--
       (1) Repeal of related authority.--Section 1111 of the Food 
     and Drug Administration Amendments Act of 2007 (42 U.S.C. 
     247d-5a; relating to identification of clinically susceptible 
     concentrations of antimicrobials) is repealed.
       (2) Clerical amendment.--The table of contents in section 2 
     of the Food and Drug Administration Amendments Act of 2007 is 
     amended by striking the item relating to section 1111.
       (3) Misbranding.--Section 502 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352), as amended by section 2121, 
     is further amended by adding at the end the following:
       ``(ee) If it is an antimicrobial drug and its labeling 
     fails to conform with the requirements under section 
     511(d).''.
       (4) Recognition of interpretive criteria as device 
     standard.--Section 514(c)(1)(A) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended by 
     inserting after ``the Secretary shall, by publication in the 
     Federal Register'' the following: ``(or, with respect to 
     susceptibility test interpretive criteria or standards 
     recognized or otherwise listed under section 511, by posting 
     on the Interpretive Criteria Website in accordance with such 
     section)''.
       (c) Report to Congress.--Not later than two years after the 
     date of enactment of this Act, the Secretary of Health and 
     Human Services shall submit to the Committee on Energy and 
     Commerce of the House of Representatives and the Committee on 
     Health, Education, Labor and Pensions of the Senate a report 
     on the progress made in implementing section 511 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360a), as 
     amended by this section.
       (d) Requests for Updates to Interpretive Criteria 
     Website.--Chapter 35 of title 44, United States Code, shall 
     not apply to the collection of information from interested 
     parties regarding the updating of lists under paragraph (2) 
     of subsection (b) section 511 of the Federal Food, Drug, and 
     Cosmetic Act (as amended by subsection (a)) and posted on the 
     Interpretive Criteria Website established under paragraph (1) 
     of such subsection (b).
       (e) No Effect on Health Care Practice.--Nothing in this 
     subtitle (including the amendments made by this subtitle) 
     shall be construed to restrict, in any manner, the 
     prescribing or administering of antibiotics or other products 
     by health care practitioners, or to limit the practice of 
     health care.

     SEC. 2123. ENCOURAGING THE DEVELOPMENT AND USE OF DISARM 
                   DRUGS.

       (a) Additional Payment for DISARM Drugs Under Medicare.--
       (1) In general.--Section 1886(d)(5) of the Social Security 
     Act (42 U.S.C. 1395ww(d)(5)) is amended by adding at the end 
     the following new subparagraph:
       ``(M)(i) As part of the annual rulemaking conducted with 
     respect to payment for subsection (d) hospitals for each 
     fiscal year beginning with fiscal year 2018, the Secretary 
     shall--
       ``(I) include a list of the DISARM drugs for such fiscal 
     year; and
       ``(II) with respect to discharges by eligible hospitals 
     that involve a drug so listed, provide for an additional 
     payment to be made under this subsection in accordance with 
     the provisions of this subparagraph.
       ``(ii) Additional payments may not be made for a drug under 
     this subparagraph--
       ``(I) other than during the 5-fiscal-year period beginning 
     with the fiscal year for which the drug is first included in 
     the list described in clause (i)(I); and
       ``(II) with respect to which payment has ever been made 
     pursuant to subparagraph (K).
       ``(iii) For purposes of this subparagraph, the term `DISARM 
     drug' means a product that is approved for use, or a product 
     for which an indication is first approved for use, by the 
     Food and Drug Administration on or after December 1, 2014, 
     and that the Food and Drug Administration determines is an 
     antimicrobial product (as defined in clause (iv)) and is 
     intended to treat an infection--
       ``(I) for which there is an unmet medical need; and
       ``(II) which is associated with high rates of mortality or 
     significant patient morbidity, as determined in consultation 
     with the Director of the Centers for Disease Control and 
     Prevention and the infectious disease professional community.
       ``(iv) For purposes of clause (iii), the term 
     `antimicrobial product' means a product that either--
       ``(I) is intended to treat an infection caused by, or 
     likely to be caused by, a qualifying pathogen (as defined 
     under section 505E(f) of the Federal Food, Drug, and Cosmetic 
     Act); or
       ``(II) meets the definition of a qualified infectious 
     disease product under section 505E(g) of the Federal Food, 
     Drug, and Cosmetic Act.
     Such determination may be revoked only upon a finding that 
     the request for such determination contained an untrue 
     statement of material fact.
       ``(v) For purposes of this subparagraph, the term `eligible 
     hospital' means a subsection (d) hospital that participates 
     in the National Healthcare Safety Network of the Centers for 
     Disease Control and Prevention (or, to the extent a similar 
     surveillance system that includes reporting about 
     antimicrobial drugs is determined by the Secretary to be 
     available to such hospitals, such similar surveillance system 
     as the Secretary may specify).
       ``(vi) Subject to the succeeding provisions of this 
     subparagraph, the additional payment under this subparagraph, 
     with respect to a drug, shall be in the amount provided for 
     such drug under section 1847A.
       ``(vii) As part of the rulemaking referred to in clause (i) 
     for each fiscal year, the Secretary shall estimate--
       ``(I) total add-on payments (as defined in subclause (I) of 
     clause (ix)); and
       ``(II) total hospital payments (as defined in subclause 
     (II) of such clause).
       ``(viii) If the total add-on payments estimated pursuant to 
     clause (vii)(I) for a fiscal year exceed 0.02 percent of the 
     total hospital payments estimated pursuant to clause 
     (vii)(II) for such fiscal year, the Secretary shall reduce in 
     a pro rata manner the amount of each additional payment under 
     this subsection pursuant to this subparagraph for such fiscal 
     year in order to ensure that the total add-on payments 
     estimated for such fiscal year do not exceed 0.02 percent of 
     the total hospital payments estimated for such fiscal year.
       ``(ix) In this subparagraph:
       ``(I) The term `total add-on payments' means, with respect 
     to a fiscal year, the total amount of the additional payments 
     under this subsection pursuant to this subparagraph for 
     discharges in such fiscal year without regard to the 
     application of clause (viii).
       ``(II) The term `total hospital payments' means, with 
     respect to a fiscal year, the total amount of payments made 
     under this subsection for all discharges in such fiscal 
     year.''.
       (2) Conforming amendments.--

[[Page 11297]]

       (A) No duplicative ntap payments.--Section 
     1886(d)(5)(K)(vi) of the Social Security Act (42 U.S.C. 
     1395ww(d)(5)(K)(vi)) is amended by inserting ``and if 
     additional payment has never been made under this subsection 
     pursuant to subparagraph (M) with respect to the service or 
     technology'' before the period at the end.
       (B) Access to price information.--Section 1927(b)(3)(A) of 
     the Social Security Act (42 U.S.C. 1396r-8(b)(3)(A)) is 
     amended--
       (i) in clause (ii)--

       (I) by striking ``for each'' and inserting ``, for each''; 
     and
       (II) by striking ``and'' at the end;

       (ii) in clause (iii)--

       (I) in subclause (II), by inserting ``or under section 
     1886(d) pursuant to paragraph (5)(M) of such section,'' after 
     ``1847A,'';
       (II) in the matter following subclause (III), by striking 
     ``or 1881(b)(13)(A)(ii)'' and inserting ``, section 
     1881(b)(13)(A)(ii), or section 1886(d)(5)(M)''; and
       (III) by striking the period at the end and inserting ``; 
     and''; and

       (iii) in clause (iv), by striking the semicolon at the end 
     and inserting a period.
       (b) Study and Report on Removing Barriers to Development of 
     DISARM Drugs.--
       (1) Study.--The Comptroller General of the United States 
     shall, in consultation with the Director of the National 
     Institutes of Health, the Commissioner of Food and Drugs, and 
     the Director of the Centers for Disease Control and 
     Prevention, conduct a study to--
       (A) identify and examine the barriers that prevent the 
     development of DISARM drugs, as defined in section 
     1886(d)(5)(M)(iii) of the Social Security Act (42 U.S.C. 
     1395ww(d)(5)(M)(iii)), as added by subsection (a)(1); and
       (B) develop recommendations for actions to be taken in 
     order to overcome any barriers identified under subparagraph 
     (A).
       (2) Report.--Not later than 1 year after the date of the 
     enactment of this Act, the Comptroller General shall submit 
     to Congress a report on the study conducted under paragraph 
     (1).

         Subtitle H--Vaccine Access, Certainty, and Innovation

     SEC. 2141. TIMELY REVIEW OF VACCINES BY THE ADVISORY 
                   COMMITTEE ON IMMUNIZATION PRACTICES.

       Section 2102(a) of the Public Health Service Act (42 U.S.C. 
     300aa-2(a)) is amended by adding at the end the following:
       ``(10) Advisory committee on immunization practices.--
       ``(A) Standard periods of time for making 
     recommendations.--Upon the licensure of any vaccine or any 
     new indication for a vaccine, the Director of the Program 
     shall direct the Advisory Committee on Immunization 
     Practices, at its next regularly scheduled meeting, to 
     consider the use of the vaccine.
       ``(B) Expedited review pursuant to request by sponsor or 
     manufacturer.--If the Advisory Committee does not make 
     recommendations with respect to the use of a vaccine at the 
     Advisory Committee's first regularly scheduled meeting after 
     the licensure of the vaccine or any new indication for the 
     vaccine, the Advisory Committee, at the request of the 
     sponsor of the vaccine, shall make such recommendations on an 
     expedited basis.
       ``(C) Expedited review for breakthrough therapies and for 
     use during public health emergencies.--If a vaccine is 
     designated as a breakthrough therapy under section 506 of the 
     Federal Food, Drug, and Cosmetic Act and is licensed under 
     section 351 of this Act, the Advisory Committee shall make 
     recommendations with respect to the use of the vaccine on an 
     expedited basis.
       ``(D) Definition.--In this paragraph, the terms `Advisory 
     Committee on Immunization Practices' and `Advisory Committee' 
     mean the advisory committee on immunization practices 
     established by the Secretary pursuant to section 222, acting 
     through the Director of the Centers for Disease Control and 
     Prevention.''.

     SEC. 2142. REVIEW OF PROCESSES AND CONSISTENCY OF ACIP 
                   RECOMMENDATIONS.

       (a) Review.--The Director of the Centers for Disease 
     Control and Prevention shall conduct a review of the process 
     used by the Advisory Committee on Immunization Practices to 
     evaluate consistency in formulating and issuing 
     recommendations pertaining to vaccines.
       (b) Considerations.--The review under subsection (a) shall 
     include assessment of--
       (1) the criteria used to evaluate new and existing 
     vaccines;
       (2) the Grading of Recommendations, Assessment, 
     Development, and Evaluation (GRADE) approach to the review 
     and analysis of scientific and economic data, including the 
     scientific basis for such approach; and
       (3) the extent to which the processes used by the working 
     groups of the Advisory Committee on Immunization Practices 
     are consistent among groups.
       (c) Stakeholders.--In carrying out the review under 
     subsection (a), the Director of the Centers for Disease 
     Control and Prevention shall solicit input from vaccine 
     stakeholders.
       (d) Report.--Not later than 18 months after the date of 
     enactment of this Act, the Director of the Centers for 
     Disease Control and Prevention shall submit to the 
     appropriate committees of the Congress and make publicly 
     available a report on the results of the review under 
     subsection (a), including recommendations on improving the 
     consistency of the process described in such subsection.
       (e) Definition.--In this section, the term ``Advisory 
     Committee on Immunization Practices'' means the advisory 
     committee on immunization practices established by the 
     Secretary of Health and Human Services pursuant to section 
     222 of the Public Health Service Act (42 U.S.C. 217a), acting 
     through the Director of the Centers for Disease Control and 
     Prevention.

     SEC. 2143. MEETINGS BETWEEN CDC AND VACCINE DEVELOPERS.

       Section 310 of the Public Health Service Act (42 U.S.C. 
     242o) is amended by adding at the end the following:
       ``(c)(1) In this subsection, the term `vaccine developer' 
     means a nongovernmental entity engaged in--
       ``(A)(i) the development of a vaccine with the intent to 
     pursue licensing of the vaccine by the Food and Drug 
     Administration; or
       ``(ii) the production of a vaccine licensed by the Food and 
     Drug Administration; and
       ``(B) vaccine research.
       ``(2)(A) Upon the submission of a written request for a 
     meeting by a vaccine developer, that includes a valid 
     justification for the meeting, the Secretary, acting through 
     the Director of the Centers for Disease Control and 
     Prevention, shall convene a meeting of representatives of the 
     vaccine developer and experts from the Centers for Disease 
     Control and Prevention in immunization programs, 
     epidemiology, and other relevant areas at which the Director 
     (or the Director's designee), for the purpose of informing 
     the vaccine developer's understanding of public health needs 
     and priorities, shall provide the perspectives of the Centers 
     for Disease Control and Prevention and other relevant Federal 
     agencies regarding--
       ``(i) public health needs, epidemiology, and implementation 
     considerations with regard to a vaccine developer's potential 
     vaccine profile; and
       ``(ii) potential implications of such perspectives for the 
     vaccine developer's vaccine research and development 
     planning.
       ``(B) In addition to the representatives specified in 
     subparagraph (A), the Secretary may, with the agreement of 
     the vaccine developer requesting a meeting under such 
     subparagraph, include in such meeting representatives of--
       ``(i) the Food and Drug Administration; and
       ``(ii) the National Vaccine Program.
       ``(C) The Secretary shall convene a meeting requested with 
     a valid justification under subparagraph (A) not later than 
     120 days after receipt of the request for the meeting.
       ``(3)(A) Upon the submission of a written request by a 
     vaccine developer, the Secretary, acting through the Director 
     of the Centers for Disease Control and Prevention, shall 
     provide to the vaccine developer any age-based or other 
     demographically assessed disease epidemiological analyses or 
     data that--
       ``(i) are specified in the request;
       ``(ii) have been published;
       ``(iii) have been performed by or are in the possession of 
     the Centers;
       ``(iv) are not a trade secret or commercial or financial 
     information that is privileged or confidential and subject to 
     section 552(b)(4) of title 5, United States Code, or section 
     1905 of title 18, United States Code; and
       ``(v) do not contain individually identifiable information.
       ``(B) The Secretary shall provide analyses requested by a 
     vaccine manufacturer under subparagraph (A) not later than 
     120 calendar days after receipt of the request for the 
     analyses.
       ``(4) The Secretary shall promptly notify a vaccine 
     developer if--
       ``(A) the Secretary becomes aware of any significant change 
     to information that was--
       ``(i) shared by the Secretary with the vaccine developer 
     during a meeting under paragraph (2); or
       ``(ii) provided by the Secretary to the vaccine developer 
     in one or more analyses under paragraph (3); and
       ``(B) the change to such information may have implications 
     for the vaccine developer's vaccine research and 
     development.''.

   Subtitle I--Orphan Product Extensions Now; Incentives for Certain 
                    Products for Limited Populations

     SEC. 2151. EXTENSION OF EXCLUSIVITY PERIODS FOR A DRUG 
                   APPROVED FOR A NEW INDICATION FOR A RARE 
                   DISEASE OR CONDITION.

       (a) In General.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act, as amended by sections 2062 and 2063, is 
     further amended by inserting after section 505H of such Act 
     the following:

     ``SEC. 505I. EXTENSION OF EXCLUSIVITY PERIODS FOR A DRUG 
                   APPROVED FOR A NEW INDICATION FOR A RARE 
                   DISEASE OR CONDITION.

       ``(a) Designation.--
       ``(1) In general.--The Secretary shall designate a drug as 
     a drug approved for a new indication to prevent, diagnose, or 
     treat a rare disease or condition for purposes of granting 
     the extensions under subsection (b) if--
       ``(A) prior to approval of an application or supplemental 
     application for the new indication, the drug was approved or 
     licensed for marketing under section 505(c) of this Act or 
     section 351(a) of the Public Health Service Act but was not 
     so approved or licensed for the new indication;
       ``(B)(i) the sponsor of the approved or licensed drug files 
     an application or a supplemental application for approval of 
     the new indication for use of the drug to prevent, diagnose, 
     or treat the rare disease or condition; and
       ``(ii) the Secretary approves the application or 
     supplemental application; and
       ``(C) the application or supplemental application for the 
     new indication contains the consent

[[Page 11298]]

     of the applicant to notice being given by the Secretary under 
     paragraph (4) respecting the designation of the drug.
       ``(2) Revocation of designation.--
       ``(A) In general.--Except as provided in subparagraph (B), 
     a designation under paragraph (1) shall not be revoked for 
     any reason.
       ``(B) Exception.--The Secretary may revoke a designation of 
     a drug under paragraph (1) if the Secretary finds that the 
     application or supplemental application resulting in such 
     designation contained an untrue statement of material fact.
       ``(3) Notification prior to discontinuance of production 
     for solely commercial reasons.--A designation of a drug under 
     paragraph (1) shall be subject to the condition that the 
     sponsor of the drug will notify the Secretary of any 
     discontinuance of the production of the drug for solely 
     commercial reasons at least one year before such 
     discontinuance.
       ``(4) Notice to public.--Notice respecting the designation 
     of a drug under paragraph (1) shall be made available to the 
     public.
       ``(b) Extension.--If the Secretary designates a drug as a 
     drug approved for a new indication for a rare disease or 
     condition, as described in subsection (a)(1)--
       ``(1)(A) the 4-, 5-, and 7\1/2\-year periods described in 
     subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, 
     the 3-year periods described in clauses (iii) and (iv) of 
     subsection (c)(3)(E) and clauses (iii) and (iv) of subsection 
     (j)(5)(F) of section 505, and the 7-year period described in 
     section 527, as applicable, shall be extended by 6 months; or
       ``(B) the 4- and 12-year periods described in subparagraphs 
     (A) and (B) of section 351(k)(7) of the Public Health Service 
     Act and the 7-year period described in section 527, as 
     applicable, shall be extended by 6 months; and
       ``(2)(A) if the drug is the subject of a listed patent for 
     which a certification has been submitted under subsection 
     (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 or a 
     listed patent for which a certification has been submitted 
     under subsections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of 
     section 505, the period during which an application may not 
     be approved under section 505(c)(3) or section 505(j)(5)(B) 
     shall be extended by a period of 6 months after the date the 
     patent expires (including any patent extensions); or
       ``(B) if the drug is the subject of a listed patent for 
     which a certification has been submitted under subsection 
     (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in 
     the patent infringement litigation resulting from the 
     certification the court determines that the patent is valid 
     and would be infringed, the period during which an 
     application may not be approved under section 505(c)(3) or 
     section 505(j)(5)(B) shall be extended by a period of 6 
     months after the date the patent expires (including any 
     patent extensions).
       ``(c) Relation to Pediatric and Qualified Infectious 
     Disease Product Exclusivity.--Any extension under subsection 
     (b) of a period shall be in addition to any extension of the 
     periods under sections 505A and 505E of this Act and section 
     351(m) of the Public Health Service Act, as applicable, with 
     respect to the drug.
       ``(d) Limitations.--The extension described in subsection 
     (b) shall not apply if the drug designated under subsection 
     (a)(1) has previously received an extension by operation of 
     subsection (b).
       ``(e) Definition.--In this section, the term `rare disease 
     or condition' has the meaning given to such term in section 
     526(a)(2).''.
       (b) Application.--Section 505G of the Federal Food, Drug, 
     and Cosmetic Act, as added by subsection (a), applies only 
     with respect to a drug for which an application or 
     supplemental application described in subsection (a)(1)(B)(i) 
     of such section 505G is first approved under section 505(c) 
     of such Act (21 U.S.C. 355(c)) or section 351(a) of the 
     Public Health Service Act (42 U.S.C. 262(a)) on or after the 
     date of the enactment of this Act.
       (c) Conforming Amendments.--
       (1) Relation to pediatric exclusivity for drugs.--Section 
     505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355a) is amended--
       (A) in subsection (b), by adding at the end the following:
       ``(3) Relation to exclusivity for a drug approved for a new 
     indication for a rare disease or condition.--Notwithstanding 
     the references in paragraph (1) to the lengths of the 
     exclusivity periods after application of pediatric 
     exclusivity, the 6-month extensions described in paragraph 
     (1) shall be in addition to any extensions under section 
     505G.''; and
       (B) in subsection (c), by adding at the end the following:
       ``(3) Relation to exclusivity for a drug approved for a new 
     indication for a rare disease or condition.--Notwithstanding 
     the references in paragraph (1) to the lengths of the 
     exclusivity periods after application of pediatric 
     exclusivity, the 6-month extensions described in paragraph 
     (1) shall be in addition to any extensions under section 
     505G.''.
       (2) Relation to exclusivity for new qualified infectious 
     disease products that are drugs.--Subsection (b) of section 
     505E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355f) is amended--
       (A) by amending the subsection heading to read as follows: 
     ``Relation to Pediatric Exclusivity and Exclusivity for a 
     Drug Approved for a New Indication for a Rare Disease or 
     Condition.--''; and
       (B) by striking ``any extension of the period under section 
     505A'' and inserting ``any extension of the periods under 
     sections 505A and 505G, as applicable,''.
       (3) Relation to pediatric exclusivity for biological 
     products.--Section 351(m) of the Public Health Service Act 
     (42 U.S.C. 262(m)) is amended by adding at the end the 
     following:
       ``(5) Relation to exclusivity for a biological product 
     approved for a new indication for a rare disease or 
     condition.--Notwithstanding the references in paragraphs 
     (2)(A), (2)(B), (3)(A), and (3)(B) to the lengths of the 
     exclusivity periods after application of pediatric 
     exclusivity, the 6-month extensions described in such 
     paragraphs shall be in addition to any extensions under 
     section 505G.''.

     SEC. 2152. REAUTHORIZATION OF RARE PEDIATRIC DISEASE PRIORITY 
                   REVIEW VOUCHER INCENTIVE PROGRAM.

       (a) In General.--Section 529 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360ff) is amended--
       (1) in subsection (a)--
       (A) in paragraph (3), by amending subparagraph (A) to read 
     as follows:
       ``(A) The disease is a serious or life-threatening disease 
     in which the serious or life-threatening manifestations 
     primarily affect individuals aged from birth to 18 years, 
     including age groups often called neonates, infants, 
     children, and adolescents.''; and
       (B) in paragraph (4)--
       (i) in subparagraph (E), by striking ``and'' at the end;
       (ii) in subparagraph (F), by striking the period at the end 
     and inserting ``; and''; and
       (iii) by adding at the end the following:
       ``(G) is for a drug or biological product for which a 
     priority review voucher has not been issued under section 524 
     (relating to tropical disease products).''; and
       (2) in subsection (b), by striking paragraph (5) and 
     inserting the following:
       ``(5) Termination of authority.--
       ``(A) In general.--The Secretary may not award any priority 
     review vouchers under paragraph (1) after December 31, 2018.
       ``(B) Exception.--Notwithstanding subparagraph (A), the 
     sponsor of a drug that is designated under subsection (d) as 
     a drug for a rare pediatric disease and that is the subject 
     of a rare pediatric disease product application that is 
     submitted during the period beginning on the date of 
     enactment of the 21st Century Cures Act and ending the date 
     specified in subparagraph (A) shall remain eligible to 
     receive a priority review voucher under paragraph (1) 
     irrespective of whether the rare pediatric disease product 
     application with respect to such drug is approved after the 
     end of such period.''.
       (b) GAO Study and Report.--
       (1) Study.--The Comptroller General of the United States 
     shall conduct a study on the effectiveness of awarding 
     priority review vouchers under section 529 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360ff) in providing 
     incentives for the development of drugs that treat or prevent 
     rare pediatric diseases (as defined in subsection (a)(3) of 
     such section) that would not otherwise have been developed. 
     In conducting such study, the Comptroller General shall 
     examine the following:
       (A) The indications for which each drug for which a 
     priority review voucher was awarded under such section 529 
     was approved under section 505 of such Act (21 U.S.C. 355) or 
     section 351 of the Public Health Service Act (42 U.S.C. 262).
       (B) Whether the priority review voucher impacted a 
     sponsor's decision to invest in developing a drug to treat or 
     prevent a rare pediatric disease.
       (C) An analysis of the drugs that utilized such priority 
     review vouchers, which shall include--
       (i) the indications for which such drugs were approved 
     under section 505 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355) or section 351 of the Public Health Service 
     Act (42 U.S.C. 262);
       (ii) whether unmet medical needs were addressed through the 
     approval of such drugs, including, for each such drug--

       (I) if an alternative therapy was previously available to 
     treat the indication; and
       (II) the benefit or advantage the drug provided over 
     another available therapy;

       (iii) the number of patients potentially treated by such 
     drugs;
       (iv) the value of the priority review voucher if 
     transferred; and
       (v) the length of time between the date on which a priority 
     review voucher was awarded and the date on which it was used.
       (D) With respect to the priority review voucher program 
     under section 529 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360ff)--
       (i) the resources used by, and burden placed on, the Food 
     and Drug Administration in implementing such program, 
     including the effect of such program on the Food and Drug 
     Administration's review of drugs for which a priority review 
     voucher was not awarded or used;
       (ii) the impact of the program on the public health as a 
     result of the expedited review of applications for drugs that 
     treat or prevent non-serious indications that are generally 
     used by the broader public; and
       (iii) alternative approaches to improving such program so 
     that the program is appropriately targeted toward providing 
     incentives for the development of clinically important drugs 
     that--

       (I) prevent or treat rare pediatric diseases; and
       (II) would likely not otherwise have been developed to 
     prevent or treat such diseases.

       (2) Report.--Not later than December 31, 2017, the 
     Comptroller General of the United

[[Page 11299]]

     States shall submit to the Committee on Energy and Commerce 
     of the House of Representatives and the Committee on Health, 
     Education, Labor and Pensions of the Senate a report 
     containing the results of the study of conducted under 
     paragraph (1).

       Subtitle J--Domestic Manufacturing and Export Efficiencies

     SEC. 2161. GRANTS FOR STUDYING THE PROCESS OF CONTINUOUS DRUG 
                   MANUFACTURING.

       (a) In General.--The Commissioner of Food and Drugs may 
     award grants to institutions of higher education and 
     nonprofit organizations for the purpose of studying and 
     recommending improvements to the process of continuous 
     manufacturing of drugs and biological products and similar 
     innovative monitoring and control techniques.
       (b) Definitions.--In this section:
       (1) The term ``drug'' has the meaning given to such term in 
     section 201 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 321).
       (2) The term ``biological product'' has the meaning given 
     to such term in section 351(i) of the Public Health Service 
     Act (42 U.S.C. 262(i)).
       (3) The term ``institution of higher education'' has the 
     meaning given to such term in section 101 of the Higher 
     Education Act of 1965 (20 U.S.C. 1001).
       (c) Authorization of Appropriations.--There is authorized 
     to be appropriated to carry out this section $5,000,000 for 
     each of fiscal years 2016 through 2020.

     SEC. 2162. RE-EXPORTATION AMONG MEMBERS OF THE EUROPEAN 
                   ECONOMIC AREA.

       Section 1003 of the Controlled Substances Import and Export 
     Act (21 U.S.C. 953) is amended--
       (1) in subsection (f)--
       (A) in paragraph (5)--
       (i) by striking ``(5)'' and inserting ``(5)(A)'';
       (ii) by inserting ``, except that the controlled substance 
     may be exported from the second country to another country 
     that is a member of the European Economic Area'' before the 
     period at the end; and
       (iii) by adding at the end the following:
       ``(B) Subsequent to any re-exportation described in 
     subparagraph (A), a controlled substance may continue to be 
     exported from any country that is a member of the European 
     Economic Area to any other such country, provided that--
       ``(i) the conditions applicable with respect to the first 
     country under paragraphs (1), (2), (3), (4), (6), and (7) are 
     met by each subsequent country from which the controlled 
     substance is exported pursuant to this paragraph; and
       ``(ii) the conditions applicable with respect to the second 
     country under such paragraphs are met by each subsequent 
     country to which the controlled substance is exported 
     pursuant to this paragraph.''; and
       (B) in paragraph (6)--
       (i) by striking ``(6)'' and inserting ``(6)(A)''; and
       (ii) by adding at the end the following:
       ``(B) In the case of re-exportation among members of the 
     European Economic Area, within 30 days after each re-
     exportation, the person who exported the controlled substance 
     from the United States delivers to the Attorney General--
       ``(i) documentation certifying that such re-exportation has 
     occurred; and
       ``(ii) information concerning the consignee, country, and 
     product.''; and
       (2) by adding at the end the following:
       ``(g) Limitation.--Subject to paragraphs (5) and (6) of 
     subsection (f) in the case of any controlled substance in 
     schedule I or II or any narcotic drug in schedule III or IV, 
     the Attorney General shall not promulgate nor enforce any 
     regulation, subregulatory guidance, or enforcement policy 
     which impedes re-exportation of any controlled substance 
     among European Economic Area countries, including by 
     promulgating or enforcing any requirement that--
       ``(1) re-exportation from the first country to the second 
     country or re-exportation from the second country to another 
     country occur within a specified period of time; or
       ``(2) information concerning the consignee, country, and 
     product be provided prior to exportation of the controlled 
     substance from the United States or prior to each re-
     exportation among members of the European Economic Area.''.

           Subtitle K--Enhancing Combination Products Review

     SEC. 2181. ENHANCING COMBINATION PRODUCTS REVIEW.

       Section 503(g)(4)(C) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 353(g)(4)(C)) is amended by adding at 
     the end the following new clause:
       ``(iii) Not later than 18 months after the date of the 
     enactment of the 21st Century Cures Act, the Secretary shall 
     issue final guidance that describes the responsibilities of 
     each agency center regarding its review of combination 
     products. The Secretary shall, after soliciting public 
     comment, review and update the guidance periodically.''.

          Subtitle L--Priority Review for Breakthrough Devices

     SEC. 2201. PRIORITY REVIEW FOR BREAKTHROUGH DEVICES.

       (a) In General.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act is amended--
       (1) in section 515(d)--
       (A) by striking paragraph (5); and
       (B) by redesignating paragraph (6) as paragraph (5); and
       (2) by inserting after section 515A (21 U.S.C. 360e-1) the 
     following:

     ``SEC. 515B. PRIORITY REVIEW FOR BREAKTHROUGH DEVICES.

       ``(a) In General.--In order to provide for more effective 
     treatment or diagnosis of life-threatening or irreversibly 
     debilitating human diseases or conditions, the Secretary 
     shall establish a program to provide priority review for 
     devices--
       ``(1) representing breakthrough technologies;
       ``(2) for which no approved alternatives exist;
       ``(3) offering significant advantages over existing 
     approved or cleared alternatives, including the potential to, 
     compared to existing approved or cleared alternatives, reduce 
     or eliminate the need for hospitalization, improve patient 
     quality of life, facilitate patients' ability to manage their 
     own care (such as through self-directed personal assistance), 
     or establish long-term clinical efficiencies; or
       ``(4) the availability of which is in the best interest of 
     patients.
       ``(b) Request for Designation.--A sponsor of a device may 
     request that the Secretary designate the device for priority 
     review under this section. Any such request for designation 
     may be made at any time prior to the submission of an 
     application under section 515(c), a petition for 
     classification under section 513(f)(2), or a notification 
     under section 510(k).
       ``(c) Designation Process.--
       ``(1) In general.--Not later than 60 calendar days after 
     the receipt of a request under subsection (b), the Secretary 
     shall determine whether the device that is the subject of the 
     request meets the criteria described in subsection (a). If 
     the Secretary determines that the device meets the criteria, 
     the Secretary shall designate the device for priority review.
       ``(2) Review.--Review of a request under subsection (b) 
     shall be undertaken by a team that is composed of experienced 
     staff and managers of the Food and Drug Administration and is 
     chaired by a senior manager. 
       ``(3) Designation determination.--A determination approving 
     or denying a request under subsection (b) shall be considered 
     a significant decision under section 517A and the Secretary 
     shall provide a written, substantive summary of the basis for 
     the determination in accordance with section 517A(a).
       ``(4) Reconsideration.--
       ``(A) Request for reconsideration.--Any person whose 
     request under subsection (b) is denied may, within 30 days of 
     the denial, request reconsideration of the denial in 
     accordance with section 517A(b)--
       ``(i) based upon the submission of documents by such 
     person; or
       ``(ii) based upon such documents and a meeting or 
     teleconference.
       ``(B) Response.--Reconsideration of a designation 
     determination under this paragraph shall be conducted in 
     accordance with section 517A(b).
       ``(5) Withdrawal.--If the Secretary approves a priority 
     review designation for a device under this section, the 
     Secretary may not withdraw the designation based on the fact 
     that the criteria specified in subsection (a) are no longer 
     met because of the subsequent clearance or approval of 
     another device that was designated under--
       ``(A) this section; or
       ``(B) section 515(d)(5) (as in effect immediately prior to 
     the enactment of the 21st Century Cures Act).
       ``(d) Priority Review.--
       ``(1) Actions.--For purposes of expediting the development 
     and review of devices designated under subsection (c), the 
     Secretary shall--
       ``(A) assign a team of staff, including a team leader with 
     appropriate subject matter expertise and experience, for each 
     device for which a request is submitted under subsection (b);
       ``(B) provide for oversight of the team by senior agency 
     personnel to facilitate the efficient development of the 
     device and the efficient review of any submission described 
     in subsection (b) for the device;
       ``(C) adopt an efficient process for timely dispute 
     resolution;
       ``(D) provide for interactive communication with the 
     sponsor of the device during the review process;
       ``(E) expedite the Secretary's review of manufacturing and 
     quality systems compliance, as applicable;
       ``(F) disclose to the sponsor in advance the topics of any 
     consultation concerning the sponsor's device that the 
     Secretary intends to undertake with external experts or an 
     advisory committee and provide the sponsor an opportunity to 
     recommend such external experts;
       ``(G) for applications submitted under section 515(c), 
     provide for advisory committee input, as the Secretary 
     determines appropriate (including in response to the request 
     of the sponsor); and
       ``(H) assign staff to be available within a reasonable time 
     to address questions posed by institutional review committees 
     concerning the conditions and clinical testing requirements 
     applicable to the investigational use of the device pursuant 
     to an exemption under section 520(g).
       ``(2) Additional actions.--In addition to the actions 
     described in paragraph (1), for purposes of expediting the 
     development and review of devices designated under subsection 
     (c), the Secretary, in collaboration with the device sponsor, 
     may, as appropriate--
       ``(A) coordinate with the sponsor regarding early agreement 
     on a data development plan;
       ``(B) take steps to ensure that the design of clinical 
     trials is as efficient as practicable, such as through 
     adoption of shorter or smaller clinical trials, application 
     of surrogate endpoints,

[[Page 11300]]

     and use of adaptive trial designs and Bayesian statistics, to 
     the extent scientifically appropriate;
       ``(C) facilitate, to the extent scientifically appropriate, 
     expedited and efficient development and review of the device 
     through utilization of timely postmarket data collection, 
     with regard to applications for approval under section 
     515(c); and
       ``(D) agree to clinical protocols that the Secretary will 
     consider binding on the Secretary and the sponsor, subject 
     to--
       ``(i) changes agreed to by the sponsor and the Secretary;
       ``(ii) changes that the Secretary determines are required 
     to prevent an unreasonable risk to the public health; or
       ``(iii) the identification of a substantial scientific 
     issue determined by the Secretary to be essential to the 
     safety or effectiveness of the device involved.
       ``(e) Priority Review Guidance.--
       ``(1) Content.--The Secretary shall issue guidance on the 
     implementation of this section. Such guidance shall include 
     the following:
       ``(A) The process for a person to seek a priority review 
     designation.
       ``(B) A template for requests under subsection (b).
       ``(C) The criteria the Secretary will use in evaluating a 
     request for priority review.
       ``(D) The standards the Secretary will use in assigning a 
     team of staff, including team leaders, to review devices 
     designated for priority review, including any training 
     required for such personnel on effective and efficient 
     review.
       ``(2) Process.--Prior to finalizing the guidance under 
     paragraph (1), the Secretary shall propose such guidance for 
     public comment.
       ``(f) Construction.--
       ``(1) Purpose.--This section is intended to encourage the 
     Secretary and provide the Secretary sufficient authorities to 
     apply efficient and flexible approaches to expedite the 
     development of, and prioritize the agency's review of, 
     devices that represent breakthrough technologies.
       ``(2) Construction.--Nothing in this section shall be 
     construed to alter the criteria and standards for evaluating 
     an application pursuant to section 515(c), a report and 
     request for classification under section 513(f)(2), or a 
     report under section 510(k), including the recognition of 
     valid scientific evidence as described in section 
     513(a)(3)(B), and consideration of the least burdensome means 
     of evaluating device effectiveness or demonstrating 
     substantial equivalence between devices with differing 
     technological characteristics, as applicable. Nothing in this 
     section alters the authority of the Secretary to act on an 
     application pursuant to section 515(d) before completion of 
     an establishment inspection, as the Secretary deems 
     appropriate.''.
       (b) Conforming Amendment Related to Designation 
     Determinations.--Section 517A(a)(1) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360g-1(a)(1)) is amended by 
     inserting ``a request for designation under section 515B,'' 
     after ``an application under section 515,''.

       Subtitle M--Medical Device Regulatory Process Improvements

     SEC. 2221. THIRD-PARTY QUALITY SYSTEM ASSESSMENT.

       (a) Establishment of Third-Party Quality System Assessment 
     Program.--Chapter V of the Federal Food, Drug, and Cosmetic 
     Act is amended by inserting after section 524A (21 U.S.C. 
     360n-1) the following new section:

     ``SEC. 524B. THIRD-PARTY QUALITY SYSTEM ASSESSMENT.

       ``(a) Accreditation and Assessment.--
       ``(1) In general; certification of device quality system.--
     The Secretary shall, in accordance with this section, 
     establish a third-party quality system assessment program--
       ``(A) to accredit persons to assess whether a requestor's 
     quality system, including its design controls, can reasonably 
     assure the safety and effectiveness of in-scope devices 
     subject to device-related changes;
       ``(B) under which accredited persons shall (as applicable) 
     certify that a requestor's quality system meets the criteria 
     included in the guidance issued under paragraph (5) with 
     respect to the in-scope devices at issue; and
       ``(C) under which the Secretary shall rely on such 
     certifications for purposes of determining the safety and 
     effectiveness (or as applicable, substantial equivalence) of 
     in-scope devices subject to the device-related changes 
     involved, in lieu of compliance with the following submission 
     requirements:
       ``(i) A premarket notification.
       ``(ii) A thirty-day notice.
       ``(iii) A Special PMA supplement.
       ``(2) Definitions.--For purposes of this sectionU
       ``(A) the term `device-related changes' means changes made 
     by a requestor with respect to in-scope devices, which are--
       ``(i) changes to a device found to be substantially 
     equivalent under sections 513(i) and 510(k) to a predicate 
     device, that--

       ``(I) would otherwise be subject to a premarket 
     notification; and
       ``(II) do not alter--

       ``(aa) the intended use of the changed device; or
       ``(bb) the fundamental scientific technology of such 
     device;
       ``(ii) manufacturing changes subject to a 30-day notice;
       ``(iii) changes that qualify for a Special PMA Supplement; 
     and
       ``(iv) such other changes relating to the devices or the 
     device manufacturing process as the Secretary determines 
     appropriate;
       ``(B) the term `in-scope device' means a device within the 
     scope of devices agreed to by the requestor and the 
     accredited person for purposes of a request for certification 
     under this section;
       ``(C) the term `premarket notification' means a premarket 
     notification under section 510(k);
       ``(D) the term `quality system' means the methods used in, 
     and the facilities and controls used for, the design, 
     manufacture, packaging, labeling, storage, installation, and 
     servicing of devices, as described in section 520(f);
       ``(E) the term `requestor' means a device manufacturer that 
     is seeking certification under this section of a quality 
     system used by such manufacturer;
       ``(F) the term `Special PMA' means a Special PMA supplement 
     under section 814.39(d) of title 21, Code of Federal 
     Regulations (or any successor regulations); and
       ``(G) the term `thirty-day notice' means a notice described 
     in section 515(d)(6).
       ``(3) Accreditation process; accreditation renewal.--Except 
     as inconsistent with this section, the process and 
     qualifications for accreditation of persons and renewal of 
     such accreditation under section 704(g) shall apply with 
     respect to accreditation of persons and renewal of such 
     accreditation under this section.
       ``(4) Use of accredited parties to conduct assessments.--
       ``(A) Initiation of assessment services.--
       ``(i) Date assessments authorized.--Beginning after the 
     date on which the final guidance is issued under paragraph 
     (5), an accredited person may conduct an assessment under 
     this section.
       ``(ii) Initiation of assessments.--Use of one or more 
     accredited persons to assess a requestor's quality system 
     under this section with respect to in-scope devices shall be 
     at the initiation of the person who registers and lists the 
     devices at issue under section 510.
       ``(B) Compensation.--Compensation for such accredited 
     persons shall--
       ``(i) be determined by agreement between the accredited 
     person and the person who engages the services of the 
     accredited person; and
       ``(ii) be paid by the person who engages such services.
       ``(C) Accredited person selection.--Each person who chooses 
     to use an accredited person to assess a requestor's quality 
     system, as described in this section, shall select the 
     accredited person from a list of such persons published by 
     the Secretary in accordance with section 704(g)(4).
       ``(5) Guidance; criteria for certification.--
       ``(A) In general.--The criteria for certification of a 
     quality system under this section shall be as specified by 
     the Secretary in guidance issued under this paragraph.
       ``(B) Contents; criteria.--The guidance under this 
     paragraph shall include specification of--
       ``(i) evaluative criteria to be used by an accredited 
     person to assess and, as applicable, certify a requestor's 
     quality system under this section with respect to in-scope 
     devices; and
       ``(ii) criteria for accredited persons to apply for a 
     waiver of, and exemptions from, the criteria under clause 
     (i).
       ``(C) Timeframe for issuing guidance.--The Secretary shall 
     issue under this paragraph--
       ``(i) draft guidance not later than 12 months after the 
     enactment of the 21st Century Cures Act; and
       ``(ii) final guidance not later than 12 months after 
     issuance of the draft guidance under clause (i).
       ``(b) Use of Third-Party Assessment.--
       ``(1) Assessment summary; certification.--
       ``(A) Submission of assessment to secretary.--An accredited 
     person who assesses a requestor's quality system under 
     subsection (a) shall submit to the Secretary a summary of the 
     assessment--
       ``(i) within 30 days of the assessment; and
       ``(ii) which shall include (as applicable)--

       ``(I) the accredited person's certification that the 
     requestor has satisfied the criteria specified in the 
     guidance issued under subsection (a)(5) for quality system 
     certification with respect to the in-scope devices at issue; 
     and
       ``(II) any waivers or exemptions from such criteria applied 
     by the accredited person.

       ``(B) Treatment of assessments.--Subject to action by the 
     Secretary under subparagraph (C), with respect to assessments 
     which include a certification under this section--
       ``(i) the Secretary's review of the assessment summary 
     shall be deemed complete on the day that is 30 days after the 
     date on which the Secretary receives the summary under 
     subparagraph (A); and
       ``(ii) the assessment summary and certification of the 
     quality system of a requestor shall be deemed accepted by the 
     Secretary on such 30th day.
       ``(C) Actions by secretary.--
       ``(i) In general.--Within 30 days of receiving an 
     assessment summary and certification under subparagraph (A), 
     the Secretary may, by written notice to the accredited person 
     submitting such assessment certification, deem any such 
     certification to be provisional beyond such 30-day period, 
     suspended pending further review by the Secretary, or 
     otherwise qualified or cancelled, based on the Secretary's 
     determination that (as applicable)--

       ``(I) additional information is needed to support such 
     certification;
       ``(II) such assessment or certification is unwarranted; or
       ``(III) such action with regard to the certification is 
     otherwise justified according to such

[[Page 11301]]

     factors and criteria as the Secretary finds appropriate.

       ``(ii) Acceptance of certification.--If following action by 
     the Secretary under clause (i) with respect to a 
     certification, the Secretary determines that such 
     certification is acceptable, the Secretary shall issue 
     written notice to the applicable accredited person indicating 
     such acceptance.
       ``(2) Notifications to secretary by certified requestors or 
     accredited persons for program evaluation purposes.--
       ``(A) Annual summary report for device-related changes 
     otherwise subject to premarket notification.--A requestor 
     whose quality system is certified under this section that 
     effectuates device-related changes with respect to in-scope 
     devices, without prior submission of a premarket 
     notification, shall ensure that an annual summary report is 
     submitted to the Secretary by the accredited person which--
       ``(i) describes the changes made to the in-scope device; 
     and
       ``(ii) indicates the effective dates of such changes.
       ``(B) Periodic notification for manufacturing changes 
     otherwise subject to thirty-day notice.--A requestor whose 
     quality system is certified under this section that 
     effectuates device-related changes with respect to in-scope 
     devices, without prior submission of a thirty-day notice, 
     shall provide notification to the Secretary of such changes 
     in the requestor's next periodic report under section 
     814.84(b) of title 21, Code of Federal Regulations (or any 
     successor regulation). Such notification shall--
       ``(i) describe the changes made; and
       ``(ii) indicate the effective dates of such changes.
       ``(C) Periodic notification for device-related changes 
     otherwise subject to special pma supplement.--A requestor 
     whose quality system is certified under this section that 
     effectuates device-related changes with respect to in-scope 
     devices, without prior submission of a Special PMA 
     Supplement, shall provide notification to the Secretary of 
     such changes in the requestor's next periodic report under 
     section 814.84(b) of title 21, Code of Federal Regulations 
     (or any successor regulation). Such notification shall--
       ``(i) describe the changes made, including a full 
     explanation of the basis for the changes; and
       ``(ii) indicate the effective dates of such changes.
       ``(D) Use of notifications for program evaluation 
     purposes.--Information submitted to the Secretary under 
     subparagraphs (A) through (C) shall be used by the Secretary 
     for purposes of the program evaluation under subsection (d).
       ``(c) Duration and Effect of Certification.--A 
     certification under this section--
       ``(1) shall remain in effect for a period of 2 years from 
     the date such certification is accepted by the Secretary, 
     subject to paragraph (6);
       ``(2) may be renewed through the process described in 
     subsection (a)(3);
       ``(3) shall continue to apply with respect to device-
     related changes made during such 2-year period, provided the 
     certification remains in effect, irrespective of whether such 
     certification is renewed after such 2-year period;
       ``(4) shall have no effect on the need to comply with 
     applicable submission requirements specified in subsection 
     (a)(1)(C) with respect to any change pertaining to in-scope 
     devices which is not a device-related change under subsection 
     (a)(2);
       ``(5) shall have no effect on the authority of the 
     Secretary to conduct an inspection or otherwise determine 
     whether the requestor has complied with the applicable 
     requirements of this Act; and
       ``(6) may be revoked by the Secretary upon a determination 
     that the requestor's quality system no longer meets the 
     criteria specified in the guidance issued under subsection 
     (a)(5) with respect to the in-scope devices at issue.
       ``(d) Notice of Revocation.--The Secretary shall provide 
     written notification to the requestor of a revocation 
     pursuant to subsection (c)(6) not later than 10 business days 
     after the determination described in such subsection. Upon 
     receipt of the written notification, the requestor shall 
     satisfy the applicable submission requirements specified in 
     subsection (a)(1)(C) for any device-related changes 
     effectuated after the date of such determination. After such 
     revocation, such requestor is eligible to seek re-
     certification under this section of its quality system.
       ``(e) Program Evaluation; Sunset.--
       ``(1) Program evaluation and report.--
       ``(A) Evaluation.--The Secretary shall complete an 
     evaluation of the third-party quality system assessment 
     program under this section no later than January 31, 2021, 
     based on--
       ``(i) analysis of information from a representative group 
     of device manufacturers obtained from notifications provided 
     by certified requestors or accredited persons under 
     subsection (b)(2); and
       ``(ii) such other available information and data as the 
     Secretary determines appropriate.
       ``(B) Report.--No later than 1 year after completing the 
     evaluation under subparagraph (A), the Secretary shall issue 
     a report of the evaluation's findings on the website of the 
     Food and Drug Administration, which shall include the 
     Secretary's recommendations with respect to continuation and 
     as applicable expansion of the program under this section to 
     encompass--
       ``(i) device submissions beyond those identified in 
     subsection (a)(1)(C); and
       ``(ii) device changes beyond those described in subsection 
     (a)(2)(A).
       ``(2) Sunset.--This section shall cease to be effective 
     October 1, 2022.
       ``(f) Rule of Construction.--Nothing in this section shall 
     be construed to limit the authority of the Secretary to 
     request and review the complete assessment of a certified 
     requestor under this section on a for-cause basis.''.
       (b) Conforming Amendments.--
       (1) Requirements for premarket approval supplements.--
     Section 515(d)(5)(A)(i) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360e(d)(5)(A)(i)), as redesignated by 
     section 2201, is further amended by inserting ``, subject to 
     section 524B'' after ``that affects safety or 
     effectiveness''.
       (2) Requirements for thirty-day notice.--Section 
     515(d)(5)(A)(ii) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360e(d)(5)(A)(ii)), as redesignated by section 
     2201, is further amended by inserting ``, subject to section 
     524B'' after ``the date on which the Secretary receives the 
     notice''.
       (3) Requirements for premarket notification; technical 
     correction to reference to section 510(k).--Section 510(l) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) 
     is amended by striking ``of this subsection under subsection 
     (m)'' and inserting ``of subsection (k) under subsection (m) 
     or section 524B''.
       (4) Misbranded devices.--Section 502(t) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 352(t)) is amended by 
     inserting ``or 524B'' after ``section 519''.

     SEC. 2222. VALID SCIENTIFIC EVIDENCE.

       Section 513(a)(3)(B) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360c(a)(3)(B)) is amended--
       (1) by redesignating clauses (i) and (ii) as subclauses (I) 
     and (II), respectively;
       (2) by striking ``(B) If the Secretary'' and inserting 
     ``(B)(i) If the Secretary''; and
       (3) by adding at the end the following:
       ``(ii) For purposes of clause (i), valid scientific 
     evidence may include--
       ``(I) evidence described in well-documented case histories, 
     including registry data, that are collected and monitored 
     under a protocol determined to be acceptable by the 
     Secretary;
       ``(II) studies published in peer-reviewed journals; and
       ``(III) data collected in countries other than the United 
     States so long as such data otherwise meet the criteria 
     specified in this subparagraph.
       ``(iii) In the case of a study published in a peer-reviewed 
     journal that is offered as valid scientific evidence for 
     purposes of clause (i), the Secretary may request data 
     underlying the study if--
       ``(I) the Secretary, in making such request, complies with 
     the requirement of subparagraph (D)(ii) to consider the least 
     burdensome appropriate means of evaluating device 
     effectiveness or subsection (i)(1)(D) to consider the least 
     burdensome means of determining substantial equivalence, as 
     applicable;
       ``(II) the Secretary furnishes a written rationale for so 
     requesting the underlying data together with such request; 
     and
       ``(III) if the requested underlying data for such a study 
     are unavailable, the Secretary shall consider such study to 
     be part of the totality of the evidence with respect to the 
     device, as the Secretary determines appropriate.''.

     SEC. 2223. TRAINING AND OVERSIGHT IN LEAST BURDENSOME 
                   APPROPRIATE MEANS CONCEPT.

       (a) In General.--Section 513 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end 
     the following:
       ``(j) Training and Oversight in Least Burdensome 
     Appropriate Means Concept.--
       ``(1) Training.--Each employee of the Food and Drug 
     Administration who is involved in the review of premarket 
     submissions under section 515 or section 510(k), including 
     supervisors, shall receive training regarding the meaning and 
     implementation of the least burdensome appropriate means 
     concept in the context of the use of that term in subsections 
     (a)(3)(D) and (i)(1)(D) of this section and in section 
     515(c)(5).
       ``(2) Guidance documents.--
       ``(A) Draft updated guidance.--Not later than 12 months 
     after the date of enactment of the 21st Century Cures Act, 
     the Secretary shall issue a draft guidance document updating 
     the October 4, 2002, guidance document entitled `The Least 
     Burdensome Provision of the FDA Modernization Act of 1997: 
     Concept and Principles; Final Guidance for FDA and Industry'.
       ``(B) Meeting of stakeholders.--In developing such draft 
     guidance document, the Secretary shall convene a meeting of 
     stakeholders to ensure a full record to support the 
     publication of such document.
       ``(3) Ombudsman audit.--Not later than 18 months after the 
     date of issuance of final version of the draft guidance under 
     paragraph (2), the ombudsman for the organizational unit of 
     the Food and Drug Administration responsible for the 
     premarket review of devices shall--
       ``(A) conduct, or have conducted, an audit of the training 
     described in paragraph (1); and
       ``(B) include in such audit interviews with a 
     representative sample of persons from industry regarding 
     their experience in the device premarket review process.''.
       (b) Additional Information Regarding Premarket 
     Applications.--Subsection (c) of section 515 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360e) is amended by 
     adding at the end the following:
       ``(5)(A) Whenever the Secretary requests additional 
     information from an applicant regarding an application under 
     paragraph (1), the Secretary shall consider the least 
     burdensome appropriate means necessary to demonstrate device

[[Page 11302]]

     safety and effectiveness, and request information 
     accordingly.
       ``(B) For purposes of subparagraph (A), the term 
     `necessary' means the minimum required information that would 
     support a determination by the Secretary that an application 
     provides a reasonable assurance of the safety and 
     effectiveness of the device.
       ``(C) Nothing in this paragraph alters the standards for 
     premarket approval of a device.''.

     SEC. 2224. RECOGNITION OF STANDARDS.

       Section 514(c) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360d(c)) is amended--
       (1) in paragraph (1), by inserting after subparagraph (B) 
     the following new subparagraphs:
       ``(C)(i) Any person may submit a request for recognition 
     under subparagraph (A) of all or part of an appropriate 
     standard established by a nationally or internationally 
     recognized standard organization.
       ``(ii) Not later than 60 days after the Secretary receives 
     such a request, the Secretary shall--
       ``(I) make a determination to recognize all, part, or none 
     of the standard that is the subject of the request; and
       ``(II) issue to the person who submitted such request a 
     response in writing that states the Secretary's rationale for 
     that determination, including the scientific, technical, 
     regulatory, or other basis for such determination.
       ``(iii) The Secretary shall make a response issued under 
     clause (ii)(II) publicly available, in such manner as the 
     Secretary determines appropriate.
       ``(iv) The Secretary shall take such actions as may be 
     necessary to implement all or part of a standard recognized 
     under clause (i)(I), in accordance with subparagraph (A). 
       ``(D) The Secretary shall make publicly available, in such 
     manner as the Secretary determines appropriate, the rationale 
     for recognition under subparagraph (A) of part of a standard, 
     including the scientific, technical, regulatory, or other 
     basis for such recognition.''; and
       (2) by adding at the end the following new paragraphs:
       ``(4) Training on use of standards.--The Secretary shall 
     provide to all employees of the Food and Drug Administration 
     who review premarket submissions for devices periodic 
     training on the concept and use of recognized standards for 
     purposes of meeting a premarket submission requirement or 
     other applicable requirement under this Act, including 
     standards relevant to an employee's area of device review.
       ``(5) Guidance.--
       ``(A) Draft guidance.--The Secretary shall publish guidance 
     identifying the principles for recognizing standards under 
     this section. In publishing such guidance, the Secretary 
     shall consider--
       ``(i) the experience with, and reliance on, a standard by 
     other Federal regulatory authorities and the device industry; 
     and
       ``(ii) whether recognition of a standard will promote 
     harmonization among regulatory authorities in the regulation 
     of devices.
       ``(B) Timing.--The Secretary shall publish--
       ``(i) draft guidance under subparagraph (A) not later than 
     12 months after the date of the enactment of the 21st Century 
     Cures Act; and
       ``(ii) final guidance not later than 12 months after the 
     close of the public comment period for the draft guidance 
     under clause (i).''.

     SEC. 2225. EASING REGULATORY BURDEN WITH RESPECT TO CERTAIN 
                   CLASS I AND CLASS II DEVICES.

       (a) Class I Devices.--Section 510(l) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360(l)) is amended--
       (1) by striking ``A report under subsection (k)'' and 
     inserting ``(1) A report under subsection (k)''; and
       (2) by adding at the end the following new paragraph:
       ``(2) Not later than 120 days after the date of the 
     enactment of the 21st Century Cures Act, the Secretary shall 
     identify, through publication in the Federal Register, any 
     type of class I device that the Secretary determines no 
     longer requires a report under subsection (k) to provide 
     reasonable assurance of safety and effectiveness. Upon such 
     publication--
       ``(A) each type of class I device so identified shall be 
     exempt from the requirement for a report under subsection 
     (k); and
       ``(B) the classification regulation applicable to each such 
     type of device shall be deemed amended to incorporate such 
     exemption.''.
       (b) Class II Devices.--Section 510(m) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360(m)) is amended--
       (1) by striking paragraph (1) and inserting the following 
     new paragraph: ``(1) The Secretary shall--
       ``(A) not later than 60 days after the date of the 
     enactment of the 21st Century Cures Act--
       ``(i) publish in the Federal Register a notice that 
     contains a list of each type of class II device that the 
     Secretary determines no longer requires a report under 
     subsection (k) to provide reasonable assurance of safety and 
     effectiveness; and
       ``(ii) provide for a period of not less than 60 days for 
     public comment beginning on the date of the publication of 
     such notice; and
       ``(B) not later than 180 days after the date of the 
     enactment of 21st Century Cures Act, publish in the Federal 
     Register a list representing the Secretary's final 
     determination with respect to the devices included in the 
     list published under subparagraph (A).'';
       (2) in paragraph (2)--
       (A) by striking ``1 day after the date of the publication 
     of a list under this subsection,'' and inserting ``1 day 
     after the date of publication of the final list under 
     paragraph (1)(B),''; and
       (B) by striking ``30-day period'' and inserting ``60-day 
     period''; and
       (3) by adding at the end the following new paragraph:
       ``(3) Upon the publication of the final list under 
     paragraph (1)(B)--
       ``(A) each type of class II device so listed shall be 
     exempt from the requirement for a report under subsection 
     (k); and
       ``(B) the classification regulation applicable to each such 
     type of device shall be deemed amended to incorporate such 
     exemption.''.

     SEC. 2226. ADVISORY COMMITTEE PROCESS.

       (a) Classification Panels.--Paragraph (5) of section 513(b) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     360c(b)) is amended--
       (1) by striking ``(5)'' and inserting ``(5)(A)''; and
       (2) by adding at the end the following:
       ``(B) When a device is specifically the subject of review 
     by a classification panel, the Secretary shall--
       ``(i) ensure that adequate expertise is represented on the 
     classification panel to assess--
       ``(I) the disease or condition which the device is intended 
     to cure, treat, mitigate, prevent, or diagnose; and
       ``(II) the technology of the device; and
       ``(ii) as part of the process to ensure adequate expertise 
     under clause (i), give due consideration to the 
     recommendations of the person whose premarket submission is 
     subject to panel review on the expertise needed among the 
     voting members of the panel.
       ``(C) For purposes of subparagraph (B)(ii), the term 
     `adequate expertise' means, with respect to the membership of 
     the classification panel reviewing a premarket submission, 
     that such membership includes--
       ``(i) two or more voting members, with a specialty or other 
     expertise clinically relevant to the device under review; and
       ``(ii) at least one voting member who is knowledgeable 
     about the technology of the device.''.
       (b) Panel Review Process.--Section 513(b)(6) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is 
     amended--
       (1) in subparagraph (A)(iii), by inserting before the 
     period at the end ``, including by designating a 
     representative who will be provided a time during the panel 
     meeting to address the panel individually (or accompanied by 
     experts selected by such representative) for the purpose of 
     correcting misstatements of fact or providing clarifying 
     information, subject to the discretion of the panel 
     chairperson''; and
       (2) by striking subparagraph (B) and inserting the 
     following new subparagraph:
       ``(B)(i) Any meeting of a classification panel for a device 
     that is specifically the subject of review shall--
       ``(I) provide adequate time for initial presentations by 
     the person whose device is specifically the subject of a 
     classification panel review and by the Secretary; and
       ``(II) encourage free and open participation by all 
     interested persons.
       ``(ii) Following the initial presentations described in 
     clause (i), the panel may--
       ``(I) pose questions to a designated representative 
     described in subparagraph (A)(iii); and
       ``(II) consider the responses to such questions in the 
     panel's review of the device that is specifically the subject 
     of review by the panel.''.

     SEC. 2227. HUMANITARIAN DEVICE EXEMPTION APPLICATION.

       (a) In General.--Section 520(m) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360j) is amended--
       (1) in paragraph (1) by striking ``fewer than 4,000'' and 
     inserting ``not more than 8,000'';
       (2) in paragraph (2)(A) by striking ``fewer than 4,000'' 
     and inserting ``not more than 8,000''; and
       (3) in paragraph (6)(A)(ii), by striking ``4,000'' and 
     inserting ``8,000''
       (b) Guidance Document on Probable Benefit.--Not later than 
     18 months after the date of enactment of this Act, the 
     Secretary of Health and Human Services, acting through the 
     Commissioner of Food and Drugs, shall publish a draft 
     guidance document that defines the criteria for establishing 
     ``probable benefit'' as that term is used in section 
     520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360j(m)(2)(C)).

     SEC. 2228. CLIA WAIVER STUDY DESIGN GUIDANCE FOR IN VITRO 
                   DIAGNOSTICS.

       (a) Draft Revised Guidance.--Not later than 12 months after 
     the date of the enactment of this Act, the Secretary of 
     Health and Human Services shall publish a draft guidance 
     that--
       (1) revises ``Section V. Demonstrating Insignificant Risk 
     of an Erroneous Result--`Accuracy''' of the guidance entitled 
     ``Recommendations for Clinical Laboratory Improvement 
     Amendments of 1988 (CLIA) Waiver Applications for 
     Manufacturers of In Vitro Diagnostic Devices'' and dated 
     January 30, 2008; and
       (2) includes guidance on the appropriate use of comparable 
     performance between a waived user and a moderately complex 
     laboratory user to demonstrate accuracy.
       (b) Final Revised Guidance.--The Secretary of Health and 
     Human Services shall finalize the draft guidance published 
     under subsection (a) not later than 12 months after the 
     comment period for such draft guidance closes.

Subtitle N--Sensible Oversight for Technology Which Advances Regulatory 
                               Efficiency

     SEC. 2241. HEALTH SOFTWARE.

       Section 201 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 321) is amended by adding at the end the following:
       ``(ss)(1) The term `health software' means software that 
     does not, through use of an in vitro

[[Page 11303]]

     diagnostic device or signal acquisition system, acquire, 
     process, or analyze an image or physiological signal, is not 
     an accessory, is not an integral part of a device necessary 
     to support the use of the device, is not used in the 
     manufacture and transfusion of blood and blood components to 
     assist in the prevention of disease in humans, and--
       ``(A) is intended for use for administrative or operational 
     support or the processing and maintenance of financial 
     records;
       ``(B) is intended for use in clinical, laboratory, or 
     administrative workflow and related recordkeeping;
       ``(C)(i) is intended for use solely in the transfer, 
     aggregation, conversion (in accordance with a present 
     specification), storage, management, retrieval, or 
     transmission of data or information;
       ``(ii) utilizes a connectivity software platform, 
     electronic or electrical hardware, or a physical 
     communications infrastructure; and
       ``(iii) is not intended for use--
       ``(I) in active patient monitoring; or
       ``(II) in controlling or altering the functions or 
     parameters of a device that is connected to such software;
       ``(D) is intended for use to organize and present 
     information for health or wellness education or for use in 
     maintaining a healthy lifestyle, including medication 
     adherence and health management tools;
       ``(E) is intended for use to analyze information to provide 
     general health information that does not include patient-
     specific recommended options to consider in the prevention, 
     diagnosis, treatment, cure, or mitigation of a particular 
     disease or condition; or
       ``(F) is intended for use to analyze information to provide 
     patient-specific recommended options to consider in the 
     prevention, diagnosis, treatment, cure, or mitigation of a 
     particular disease or condition.
       ``(2) The term `accessory' means a product that--
       ``(A) is intended for use with one or more parent devices;
       ``(B) is intended to support, supplement, or augment the 
     performance of one or more parent devices; and
       ``(C) shall be classified by the Secretary--
       ``(i) according to its intended use; and
       ``(ii) independently of any classification of any parent 
     device with which it is used.''.

     SEC. 2242. APPLICABILITY AND INAPPLICABILITY OF REGULATION.

       Subchapter A of chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 351 et seq.), as amended by section 
     2221(a), is further amended by adding at the end the 
     following:

     ``SEC. 524C. HEALTH SOFTWARE.

       ``(a) Inapplicability of Regulation to Health Software.--
     Except as provided in subsection (b), health software shall 
     not be subject to regulation under this Act.
       ``(b) Exception.--
       ``(1) In general.--Subsection (a) shall not apply with 
     respect to a software product--
       ``(A) of a type described in subparagraph (F) of section 
     201(ss)(1); and
       ``(B) that the Secretary determines poses a significant 
     risk to patient safety.
       ``(2) Considerations.--In making a determination under 
     subparagraph (B) of paragraph (1) with respect to a product 
     to which such paragraph applies, the Secretary shall consider 
     the following:
       ``(A) The likelihood and severity of patient harm if the 
     product were to not perform as intended.
       ``(B) The extent to which the product is intended to 
     support the clinical judgment of a medical professional.
       ``(C) Whether there is a reasonable opportunity for a 
     medical professional to review the basis of the information 
     or treatment recommendation provided by the product.
       ``(D) The intended user and user environment, such as 
     whether a medical professional will use a software product of 
     a type described in subparagraph (F) of section 201(ss)(1).
       ``(c) Delegation.--The Secretary shall delegate primary 
     jurisdiction for regulating a software product determined 
     under subsection (b) to be subject to regulation under this 
     Act to the center at the Food and Drug Administration charged 
     with regulating devices. 
       ``(d) Regulation of Software.--
       ``(1) In general.--The Secretary shall review existing 
     regulations and guidance regarding the regulation of software 
     under this Act. The Secretary may implement a new framework 
     for the regulation of software and shall, as appropriate, 
     modify such regulations and guidance or issue new regulations 
     or guidance.
       ``(2) Issuance by order.--Notwithstanding subchapter II of 
     chapter 5 of title 5, United States Code, the Secretary may 
     modify or issue regulations for the regulation of software 
     under this Act by administrative order published in the 
     Federal Register following the publication of a proposed 
     order.
       ``(3) Areas under review.--The review of existing 
     regulations and guidance under paragraph (1) may include 
     review of the following areas:
       ``(A) Classification of software.
       ``(B) Standards for development of software.
       ``(C) Standards for validation and verification of 
     software.
       ``(D) Review of software.
       ``(E) Modifications to software.
       ``(F) Manufacturing of software.
       ``(G) Quality systems for software.
       ``(H) Labeling requirements for software.
       ``(I) Postmarketing requirements for reporting of adverse 
     events.
       ``(4) Process for issuing proposed regulations, 
     administrative order, and guidance.--Not later than 18 months 
     after the date of enactment of this section, the Secretary 
     shall consult with external stakeholders (including patients, 
     industry, health care providers, academia, and government) to 
     gather input before issuing regulations, an administrative 
     order, and guidance under this subsection.
       ``(e) Rule of Construction.--Nothing in this section shall 
     be construed as providing the Secretary with the authority to 
     regulate under this Act any health software product of the 
     type described in subparagraph (F) of section 201(ss)(1) 
     unless and until the Secretary has made a determination 
     described in subsection (b)(1)(B) with respect to such 
     product.''.

     SEC. 2243. EXCLUSION FROM DEFINITION OF DEVICE.

       Section 201(h) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 321) is amended--
       (1) in subparagraph (2), by striking ``or'' after ``or 
     other animals,'';
       (2) in subparagraph (3), by striking ``and'' and inserting 
     ``or''; and
       (3) by inserting after subparagraph (3) the following:
       ``(4) not health software (other than software determined 
     to be a risk to patient safety under section 524B(b)), and''.

                Subtitle O--Streamlining Clinical Trials

     SEC. 2261. PROTECTION OF HUMAN SUBJECTS IN RESEARCH; 
                   APPLICABILITY OF RULES.

       (a) In General.--In order to simplify and facilitate 
     compliance by researchers with applicable regulations for the 
     protection of human subjects in research, the Secretary of 
     Health and Human Services shall, to the extent possible and 
     consistent with other statutory provisions, harmonize 
     differences between the HHS Human Subject Regulations and the 
     FDA Human Subject Regulations in accordance with subsection 
     (b).
       (b) Avoiding Regulatory Duplication and Unnecessary 
     Delays.--
       (1) In general.--The Secretary shall--
       (A) make such modifications to the provisions of the HHS 
     Human Subject Regulations, the FDA Human Subject Regulations, 
     and the vulnerable-populations rules as may be necessary--
       (i) to reduce regulatory duplication and unnecessary 
     delays;
       (ii) to modernize such provisions in the context of 
     multisite and cooperative research projects; and
       (iii) to incorporate local considerations, community 
     values, and mechanisms to protect vulnerable populations; and
       (B) ensure that human subject research that is subject to 
     the HHS Human Subject Regulations or to the FDA Human Subject 
     Regulations may--
       (i) use joint or shared review;
       (ii) rely upon the review of--

       (I) an independent institutional review board; or
       (II) an institutional review board of an entity other than 
     the sponsor of the research; or

       (iii) use similar arrangements to avoid duplication of 
     effort.
       (2) Regulations and guidance.--Not later than 36 months 
     after the date of enactment of this Act, the Secretary, 
     acting through the relevant agencies and offices of the 
     Department of Health and Human Services, including the Office 
     for Human Research Protections and relevant agencies and 
     offices of the Food and Drug Administration, shall issue such 
     regulations and guidance and take such other actions as may 
     be necessary to implement this section and help to facilitate 
     the broader use of single, central, or lead institutional 
     review boards. Such regulations and guidance shall clarify 
     the requirements and policies relating to the following:
       (A) Arrangements to avoid duplication described in 
     paragraph (1)(A)(i), including--
       (i) delineating the roles of institutional review boards in 
     multisite or cooperative, multisite studies where one or more 
     local institutional review boards are relied upon, or similar 
     arrangements are used;
       (ii) the risks and benefits to human subjects;
       (iii) standardizing the informed consent and other 
     processes and legal documents; and
       (iv) incorporating community values through the use of 
     local institutional review boards while continuing to use 
     central or lead institutional review boards.
       (B) Concerns about regulatory and legal liability 
     contributing to decisions by the sponsors of research to rely 
     on local institutional review boards for multisite research.
       (3) Consultation.--In issuing regulations or guidance under 
     paragraph (2), the Secretary shall consult with stakeholders 
     (including researchers, academic organizations, hospitals, 
     institutional research boards, pharmaceutical, biotechnology 
     and medical device developers, clinical research 
     organizations, patient groups, and others).
       (c) Timing.--The Secretary shall complete the harmonization 
     described in subsection (a) not later than 36 months after 
     the date of enactment of this Act.
       (d) Progress Report.--Not later than 24 months after the 
     date of enactment of this Act, the Secretary shall submit to 
     Congress a report on the progress made toward completing such 
     harmonization.
       (e) Draft NIH Policy.--Not later than 12 months after the 
     date of enactment of this Act, the Secretary, acting through 
     the Director of the National Institutes of Health, shall 
     finalize the draft policy entitled ``Draft NIH Policy on Use 
     of a Single Institutional Review Board for Multi-Site 
     Research''.

[[Page 11304]]

       (f) Definitions.--
       (1) Human subject regulations.--In this section:
       (A) FDA human subject regulations.--The term ``FDA Human 
     Subject Regulations'' means the provisions of parts 50, 56, 
     312, and 812 of title 21, Code of Federal Regulations (or any 
     successor regulations).
       (B) HHS human subject regulations.--The term ``HHS Human 
     Subject Regulations'' means the provisions of subpart A of 
     part 46 of title 45, Code of Federal Regulations (or any 
     successor regulations).
       (C) Vulnerable-populations rules.--The term ``vulnerable-
     populations rules''--
       (i) subject to clause (ii), means the provisions of 
     subparts B through D of such part 46 (or any successor 
     regulations); or
       (ii) as applicable to research that is subject to the FDA 
     Human Subject Regulations, means the provisions applicable to 
     vulnerable populations under part 56 of such title 21 (or any 
     successor regulations) and subpart D of part 50 of such title 
     21 (or any successor regulations).
       (2) Other definitions.--In this section:
       (A) Institutional review board.--The term ``institutional 
     review board'' has the meaning that applies to the term 
     ``institutional review board'' under the HHS Human Subject 
     Regulations.
       (B) Lead institutional review board.--The term ``lead 
     institutional review board'' means an institutional review 
     board that otherwise meets the requirements of the HHS Human 
     Subject Regulations and enters into a written agreement with 
     an institution, another institutional review board, a 
     sponsor, or a principal investigator to approve and oversee 
     human subject research that is conducted at multiple 
     locations. References to an institutional review board 
     include an institutional review board that serves a single 
     institution as well as a lead institutional review board.

     SEC. 2262. USE OF NON-LOCAL INSTITUTIONAL REVIEW BOARDS FOR 
                   REVIEW OF INVESTIGATIONAL DEVICE EXEMPTIONS AND 
                   HUMAN DEVICE EXEMPTIONS.

       (a) In General.--Section 520 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360(j)) is amended--
       (1) in subsection (g)(3)--
       (A) by striking ``local'' each place it appears; and
       (B) in subparagraph (A)(i), by striking ``which has been''; 
     and
       (2) in subsection (m)(4)--
       (A) by striking ``local'' each place it appears; and
       (B) by striking subparagraph (A) and inserting the 
     following new subparagraph:
       ``(A) in facilities in which clinical testing of devices is 
     supervised by an institutional review committee established 
     in accordance with the regulations of the Secretary, and''.
       (b) Regulations.--Not later than 12 months after the date 
     of the enactment of this Act, the Secretary of Health and 
     Human Services shall revise or issue such regulations or 
     guidance as may be necessary to carry out the amendments made 
     by subsection (a).

     SEC. 2263. ALTERATION OR WAIVER OF INFORMED CONSENT FOR 
                   CLINICAL INVESTIGATIONS.

       (a) Devices.--Section 520(g)(3) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended--
       (1) in subparagraph (D), by striking ``except where subject 
     to such conditions as the Secretary may prescribe, the 
     investigator'' and inserting the following: ``except where, 
     subject to such conditions as the Secretary may prescribe--
       ``(i) the proposed clinical testing poses no more than 
     minimal risk to the human subject and includes appropriate 
     safeguards to protect the rights, safety, and welfare of the 
     human subject; or
       ``(ii) the investigator''; and
       (2) in the matter following subparagraph (D), by striking 
     ``subparagraph (D)'' and inserting ``subparagraph (D)(ii)''.
       (b) Drugs.--Section 505(i)(4) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking 
     ``except where it is not feasible or it is contrary to the 
     best interests of such human beings'' and inserting ``except 
     where it is not feasible, it is contrary to the best 
     interests of such human beings, or the proposed clinical 
     testing poses no more than minimal risk to such human beings 
     and includes appropriate safeguards as prescribed to protect 
     the rights, safety, and welfare of such human beings''.

     Subtitle P--Improving Scientific Expertise and Outreach at FDA

     SEC. 2281. SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH 
                   SERVICE.

       (a) Hiring and Retention Authority.--Section 228 of the 
     Public Health Service Act (42 U.S.C. 237) is amended--
       (1) in the section heading, by inserting ``and biomedical 
     product assessment'' after ``research'';
       (2) in subsection (a)(1), by striking ``Silvio O. Conte 
     Senior Biomedical Research Service, not to exceed 500 
     members'' and inserting ``Silvio O. Conte Senior Biomedical 
     Research and Biomedical Product Assessment Service (in this 
     section referred to as the `Service'), the purpose of which 
     is to recruit and retain competitive and qualified scientific 
     and technical experts outstanding in the field of biomedical 
     research, clinical research evaluation, and biomedical 
     product assessment'';
       (3) by amending subsection (a)(2) to read as follows:
       ``(2) The authority established in paragraph (1) may not be 
     construed to require the Secretary to reduce the number of 
     employees serving under any other employment system in order 
     to offset the number of members serving in the Service.'';
       (4) in subsection (b)--
       (A) in the matter preceding paragraph (1), by striking ``or 
     clinical research evaluation'' and inserting ``, clinical 
     research evaluation or biomedical product assessment''; and
       (B) in paragraph (1), by inserting ``or a master's level 
     degree in engineering, bioinformatics, or a related or 
     emerging field,'' after the comma;
       (5) in subsection (d)(2), by striking ``and shall not 
     exceed the rate payable for level I of the Executive Schedule 
     unless approved by the President under section 5377(d)(2) of 
     title 5, United States Code'' and inserting ``and shall not 
     exceed the rate payable for the President'';
       (6) by striking subsection (e); and
       (7) by redesignating subsections (f) and (g) as subsections 
     (e) and (f), respectively.
       (b) Report.--Not later than 3 years after the date of the 
     enactment of this Act, the Secretary of Health and Human 
     Services shall submit, and publish on the website of the 
     Department of Health and Human Services a report on the 
     implementation of the amendments made by subsection (a), 
     including whether the amendments have improved the ability of 
     the Food and Drug Administration to hire and retain qualified 
     experts to fulfill obligations specified under user fee 
     agreements.

     SEC. 2282. ENABLING FDA SCIENTIFIC ENGAGEMENT.

       It is the sense of Congress that the participation in, or 
     sponsorship of, scientific conferences and meetings is 
     essential to the mission of the Food and Drug Administration.

     SEC. 2283. REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG 
                   ADMINISTRATION.

       (a) Board of Directors.--
       (1) Composition and size.--Section 770(d)(1)(C) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379dd(d)(1)(C)) is amended--
       (A) by redesignating clause (ii) as clause (iii);
       (B) by inserting after clause (i) the following:
       ``(ii) Additional members.--The Board, through amendments 
     to the bylaws of the Foundation, may provide that the number 
     of voting members of the Board shall be a number (to be 
     specified in such amendment) greater than 14. Any Board 
     positions that are established by any such amendment shall be 
     appointed (by majority vote) by the individuals who, as of 
     the date of such amendment, are voting members of the Board 
     and persons so appointed may represent any of the categories 
     specified in subclauses (I) through (V) of clause (i), so 
     long as no more than 30 percent of the total voting members 
     of the Board (including members whose positions are 
     established by such amendment) are representatives of the 
     general pharmaceutical, device, food, cosmetic, and 
     biotechnology industries.''; and
       (C) in clause (iii)(I), as redesignated by subparagraph 
     (A), by striking ``The ex officio members shall ensure'' and 
     inserting ``The ex officio members, acting pursuant to clause 
     (i), and the Board, acting pursuant to clause (ii), shall 
     ensure''.
       (2) Federal employees allowed to serve on board.--Clause 
     (iii)(II) of section 770(d)(1)(C) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)), as redesignated 
     by paragraph (1)(A), is amended by adding at the end the 
     following: ``For purposes of this section, the term `employee 
     of the Federal Government' does not include a `special 
     Government employee', as that term is defined in section 
     202(a) of title 18, United States Code.''.
       (3) Staggered terms.--Subparagraph (A) of section 770(d)(3) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379dd(d)(3)) is amended to read as follows:
       ``(A) Term.--The term of office of each member of the Board 
     appointed under paragraph (1)(C)(i), and the term of office 
     of any member of the Board whose position is established 
     pursuant to paragraph (1)(C)(ii), shall be 4 years, except 
     that--
       ``(i) the terms of offices for the members of the Board 
     initially appointed under paragraph (1)(C)(i) shall expire on 
     a staggered basis as determined by the ex officio members; 
     and
       ``(ii) the terms of office for the persons initially 
     appointed to positions established pursuant to paragraph 
     (1)(C)(ii) may be made to expire on a staggered basis, as 
     determined by the individuals who, as of the date of the 
     amendment establishing such positions, are members of the 
     Board.''.
       (b) Executive Director Compensation.--Section 770(g)(2) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379dd(g)(2)) is amended by striking ``but shall not be 
     greater than the compensation of the Commissioner''.
       (c) Separation of Funds.--Section 770(m) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(m)) is amended 
     by striking ``are held in separate accounts from funds 
     received from entities under subsection (i)'' and inserting 
     ``are managed as individual programmatic funds under 
     subsection (i), according to best accounting practices''.

     SEC. 2284. COLLECTION OF CERTAIN VOLUNTARY INFORMATION 
                   EXEMPTED FROM PAPERWORK REDUCTION ACT.

        Chapter VII of the Federal Food, Drug, and Cosmetic Act is 
     amended by inserting after section 708 of such Act (21 U.S.C. 
     379) the following:

     ``SEC. 708A. COLLECTION OF CERTAIN VOLUNTARY INFORMATION 
                   EXEMPTED FROM PAPERWORK REDUCTION ACT.

       ``Chapter 35 of title 44, United States Code, shall not 
     apply to the collection from patients,

[[Page 11305]]

     industry, academia, and other stakeholders, of voluntary 
     information such as through voluntary surveys or 
     questionnaires, initiated by the Secretary.''.

     SEC. 2285. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND 
                   PROFESSIONAL PERSONNEL.

       (a) In General.--The Federal Food, Drug, and Cosmetic Act 
     is amended by inserting after section 714 (21 U.S.C. 379d-3) 
     the following:

     ``SEC. 714A. ADDITIONAL HIRING AUTHORITY.

       ``(a) In General.--The Secretary may, without regard to the 
     provisions of title 5, United States Code, governing 
     appointments in the competitive service, appoint qualified 
     candidates to scientific, technical, or professional 
     positions within the following centers of the Food and Drug 
     Administration:
       ``(1) The Center for Drug Evaluation and Research.
       ``(2) The Center for Biologics Evaluation and Research.
       ``(3) The Center for Devices and Radiological Health.
     Such positions shall be within the competitive service.
       ``(b) Compensation.--
       ``(1) In general.--Notwithstanding any other provision of 
     law, including any requirement with respect to General 
     Schedule pay rates under subchapter III of chapter 53 of 
     title 5, United States Code, and consistent with the 
     requirements of paragraph (2), the Secretary may determine 
     and fix--
       ``(A) the annual rate of pay of any individual appointed 
     under subsection (a); and
       ``(B) for purposes of retaining qualified employees, the 
     annual rate of pay for any highly qualified scientific, 
     technical, or professional personnel appointed to a position 
     at any of the centers listed under subsection (a) before the 
     date of enactment of this section.
       ``(2) Limitation.--The annual rate of pay established 
     pursuant to paragraph (1) may not exceed the annual rate of 
     pay of the President.
       ``(c) Report.--
       ``(1) In general.--Not later than September 30, 2021, the 
     Secretary shall submit a report to Congress that examines the 
     extent to which the authority to appoint and retain personnel 
     under this section enhanced the Food and Drug 
     Administration's ability to meet the agency's critical need 
     for highly qualified individuals for scientific, technical, 
     or professional positions.
       ``(2) Recommendations.--The report under paragraph (1) 
     shall include the recommendations of the Secretary on--
       ``(A) whether the authority to appoint personnel under this 
     section should be reauthorized; and
       ``(B) other personnel authorities that would help the Food 
     and Drug Administration to better recruit and retain highly 
     qualified individuals for scientific, technical, or 
     professional positions in the agency's medical product 
     centers.''.
       (b) Rule of Construction.--The authority provided by 
     section 714A of the Federal Food, Drug, and Cosmetic Act (as 
     added by subsection (a)) shall not be construed to affect the 
     authority provided under section 714 of such Act.

       Subtitle Q--Exempting From Sequestration Certain User Fees

     SEC. 2301. EXEMPTING FROM SEQUESTRATION CERTAIN USER FEES OF 
                   FOOD AND DRUG ADMINISTRATION.

       The Balanced Budget and Emergency Deficit Control Act of 
     1985 is amended--
       (1) in section 255(g)(1)(A) (2 U.S.C. 905(g)(1)(A)), by 
     inserting after the item relating to ``Financial Agent 
     Services'' the following new item:
       ``Food and Drug Administration, Salaries and Expenses, but 
     only the portion of appropriations under such account 
     corresponding to fees collected under sections 736, 738, 740, 
     741, 744B, and 744H of the Federal Food, Drug, and Cosmetic 
     Act (75-9911-0-1-554).''; and
       (2) in section 256(h) (2 U.S.C. 906(h)), by adding at the 
     end the following new paragraph:
       ``(5) Notwithstanding any other provision of law, this 
     subsection shall not apply with respect to the portion of 
     administrative expenses incurred by the Food and Drug 
     Administration that are funded through fees collected under 
     sections 736, 738, 740, 741, 744B, and 744H of the Federal 
     Food, Drug, and Cosmetic Act.''.

                          TITLE III--DELIVERY

                      Subtitle A--Interoperability

     SEC. 3001. ENSURING INTEROPERABILITY OF HEALTH INFORMATION 
                   TECHNOLOGY.

       (a) Interoperability Standards.--
       (1) In general.--Subtitle A of title XXX of the Public 
     Health Service Act (42 U.S.C. 300jj-11 et seq.) is amended by 
     adding at the end the following new section:

     ``SEC. 3010. ENSURING INTEROPERABILITY OF HEALTH INFORMATION 
                   TECHNOLOGY.

       ``(a) Interoperability.--In order for health information 
     technology to be considered interoperable, such technology 
     must satisfy the following criteria:
       ``(1) Secure transfer.--The technology allows the secure 
     transfer of all electronically accessible health information 
     to and from any and all health information technology for 
     authorized use under applicable State or Federal law.
       ``(2) Complete access to health information.--The 
     technology allows for complete access, exchange, and use of 
     all electronically accessible health information for 
     authorized use under applicable State or Federal law without 
     special effort by the requestor of such health information.
       ``(3) No information blocking.--The technology is not 
     configured, set up, or implemented to information block, as 
     defined in section 3010A(d).
       ``(b) Categories for Interoperability Standards.--The 
     categories described in this subsection, with respect to 
     standards and the corresponding implementation specifications 
     for determining if health information technology is 
     interoperable, consistent with the criteria described in 
     subsection (a), include at least categories of standards and 
     implementation specifications with respect to the following:
       ``(1) Vocabulary and terminology.
       ``(2) Content and structure.
       ``(3) Transport.
       ``(4) Security.
       ``(5) Services.
       ``(6) Querying and requesting health information for 
     access, exchange, and use.
       ``(c) Allowing for Flexibility.--A standard and 
     implementation specification, with respect to such standard, 
     that is determined under section 3001(c)(5)(D) to be 
     compatible with baseline standards and implementation 
     specifications (as defined in clause (ii) of such section) 
     shall be treated as in compliance with this section.''.
       (2) Guidance.--Not later than January 1, 2017, the 
     Secretary of Health and Human Services, in consultation with 
     the National Coordinator of the Office of the National 
     Coordinator for Health Information Technology, shall issue 
     guidance with respect to the implementation of section 3010 
     of the Public Health Service Act, as added by paragraph (1), 
     including with respect to defining and providing examples of 
     authorized use under applicable State or Federal law of 
     health information.
       (b) Improvements to Recommendation Process.--
       (1) HIT policy committee to incorporate policies for 
     updates to interoperability standards.--Section 3002 of the 
     Public Health Service Act (42 U.S.C. 300jj-12) is amended--
       (A) in subsection (a)--
       (i) by striking ``National Coordinator'' and inserting 
     ``Secretary, in consultation with the National 
     Coordinator,''; and
       (ii) by adding at the end the following new sentence: ``The 
     HIT Policy Committee is authorized only to provide policy and 
     priority recommendations to the Secretary and not authorized 
     to otherwise affect the development or modification of any 
     standard, implementation specification, or certification 
     criterion under this title.''; and
       (B) in subsection (b)(2)--
       (i) in subparagraph (A), in the first sentence--

       (I) by striking ``The HIT Policy Committee'' and inserting 
     ``Subject to subparagraph (D), the HIT Policy Committee''; 
     and
       (II) by inserting ``(including the areas in which 
     modifications and additions to interoperability standards and 
     implementation specifications, with respect to such 
     interoperability standards, under section 3010 are needed for 
     the electronic access, exchange, and use of health 
     information for purposes of adoption of such modifications 
     and additions under section 3004)'' after ``section 3004''.

       (ii) by adding at the end the following new subparagraph:
       ``(D) Special rule related to interoperability.--Any 
     recommendation made by the HIT Policy Committee on or after 
     the date of the enactment of this subparagraph with respect 
     to interoperability of health information technology shall be 
     consistent with the criteria described in subsection (a) of 
     section 3010.''.
       (2) Sunset of hit standards committee.--Section 3003 of the 
     Public Health Service Act (42 U.S.C. 300jj-13) is amended by 
     adding at the end the following new subsection:
       ``(f) Termination.--The HIT Standards Committee shall 
     terminate on the date that is 90 days after the date of the 
     enactment of this subsection.''.
       (3) Standards development organizations.--Title XXX of the 
     Public Health Service Act is amended by inserting after 
     section 3003 the following new section:

     ``SEC. 3003A. RECOMMENDATIONS FOR STANDARDS THROUGH CONTRACTS 
                   WITH STANDARDS DEVELOPMENT ORGANIZATIONS.

       ``(a) Contracts.--
       ``(1) In general.--For purposes of activities conducted 
     under this title, the Secretary shall enter into one or more 
     contracts with health care standards development 
     organizations accredited by the American National Standards 
     Institute (or with the American National Standards Institute) 
     to carry out, directly or through contracts with 
     subcontractors, the duties described in subsection (b), as 
     applicable.
       ``(2) Timing for first contract.--As soon as practicable 
     after the date of the enactment of this section, the 
     Secretary shall enter into the first contracts under 
     paragraph (1).
       ``(3) Period of contract.--Each contract under paragraph 
     (1) shall be for a period determined necessary by the 
     Secretary, in consultation with the National Coordinator, to 
     carry out the applicable duties described in subsection (b).
       ``(4) Appropriate entities.--The Secretary shall ensure the 
     most appropriate entities described in paragraph (1) are 
     selected for each contract under such paragraph.
       ``(b) Duties.--
       ``(1) Initial contract.--The Secretary shall initially 
     enter into one or more contracts under subsection (a)(1) with 
     entities described in such subsection, under which the 
     entities--
       ``(A) shall recommend to the Secretary--
       ``(i) for adoption under section 3004, an initial set of 
     interoperability standards and implementation specifications, 
     with respect to such standards, identified or, as 
     appropriate, developed by

[[Page 11306]]

     such entities that are consistent with the criteria described 
     in subsection (a) of section 3010, and with respect to the 
     categories described in subsection (b) of such section; and
       ``(ii) as applicable, for purposes of section 
     3001(c)(5)(D), methods to test if health information 
     technology is compatible with health information technology 
     that applies baseline standards and implementation 
     specifications (as defined in clause (ii) of such section); 
     and
       ``(B) may provide to the Secretary recommendations 
     described in paragraph (2).
       ``(2) Subsequent contracts.--Under each subsequent contract 
     entered into under this section with entities described in 
     subsection (a)(1) pursuant to subsection (c), the entities 
     shall recommend to the Secretary--
       ``(A) for adoption under section 3004 any standards 
     (including interoperability standards), implementation 
     specifications, and, to the extent necessary, certification 
     criteria (and modifications, including additions, to such 
     standards, specifications, and, to the extent necessary, 
     criteria), which are in accordance with the criteria 
     described in section 3010; and
       ``(B) as applicable, for purposes of section 3001(c)(5)(D), 
     methods to test if health information technology is 
     compatible with baseline standards and implementation 
     specifications (as defined in clause (ii) of such section).
       ``(3) Submission to nist.--Under each contract with an 
     entity under this section, the entity shall submit to the 
     Director of the National Institute of Standards and 
     Technology each recommendation submitted to the Secretary by 
     such entity under this section.
       ``(4) Consultation.--For the purposes of developing methods 
     to test interoperability standards and implementation 
     specifications with respect to such standards, the entities 
     with a contract under this section may consult with the 
     Director of the National Institute of Standards and 
     Technology.
       ``(c) Modifications and Subsequent Contracts.--
       ``(1) In general.--The Secretary, in consultation with the 
     National Coordinator, shall periodically conduct hearings to 
     evaluate and review the standards, implementation 
     specifications, and certification criteria adopted under 
     section 3004 for purposes of determining if modifications, 
     including any additions, are needed with respect to such 
     standards, specifications, and criteria.
       ``(2) Contract trigger.--Based on the needs for standards, 
     implementation specifications, and certification criteria 
     (and modifications, including additions, to such standards, 
     specifications, and criteria) under this title, as determined 
     by the Secretary, with due consideration to section 3010(b) 
     and in consultation with the National Coordinator, the 
     Secretary shall, as needed, enter into contracts under 
     subsection (a) to carry out the duties described in 
     subsection (b)(2) in addition to any contract entered into to 
     carry out the duties described in subsection (b)(1).
       ``(d) Authorization of Appropriations.--There is authorized 
     to be appropriated $10,000,000 for contracts under subsection 
     (a), to remain available until expended.''.
       (4) Modifications to role of the national coordinator.--
     Section 3001(c)(1)(A) of the Public Health Service Act (42 
     U.S.C. 300jj-11(c)(1)(A)) is amended by inserting ``for 
     recommendations made before the date of the enactment of the 
     21st Century Cures Act,'' before ``review and determine''.
       (c) Adoption.--Section 3004 of the Public Health Service 
     Act (42 U.S.C. 300jj-14) is amended--
       (1) in subsection (a)--
       (A) in paragraph (1), by inserting after ``section 
     3001(c)'' the following: ``(or, subject to subsection (c), in 
     the case of a standard, implementation specification, or 
     criterion recommended on or after the date of the enactment 
     of the 21st Century Cures Act, after the date of submission 
     of the recommendation to the Secretary under section 
     3003A)''; and
       (B) in paragraph (2)(B), by striking ``and the HIT 
     Standards Committee'';
       (2) in subsection (b)--
       (A) in paragraph (3), by striking ``with the schedule 
     published under section 3003(b)(2)'' and inserting ``with 
     subsection (d)''; and
       (B) by adding at the end the following new paragraph:
       ``(4) Limitation.--The Secretary may not adopt any 
     policies, priorities, standards, implementation 
     specifications, or certification criteria under this 
     subsection or subsection (a) that are inconsistent with or 
     duplicative of an interoperability standard or implementation 
     specification with respect to such standard adopted under 
     this section, in accordance with subsections (c) and (d). In 
     the case of a standard, specification, or criterion that has 
     been adopted under this section and is inconsistent or 
     duplicative of such an interoperability standard or 
     specification that is subsequently adopted under this 
     section, such interoperability standard or specification 
     shall supercede such other standard, specification, or 
     criterion and such other standard, specification, or 
     criterion shall no longer be considered adopted under this 
     section beginning on the date that such interoperability 
     standard or specification becomes effective.''; and
       (3) by adding at the end the following new subsections:
       ``(c) Adoption of Initial Interoperability Standards and 
     Implementation Specifications.--Notwithstanding the previous 
     subsections of this section, the following shall apply in the 
     case of the initial set of interoperability standards and 
     implementation specifications with respect to such standards 
     recommended under section 3003A:
       ``(1) Review of standards.--Not later than 90 days after 
     the date of receipt of recommendations for such 
     interoperability standards and implementation specifications, 
     the Secretary, in consultation with the National Coordinator 
     and representatives of other relevant Federal agencies, such 
     as the National Institute of Standards and Technology, shall 
     jointly review such standards and implementation 
     specifications and shall determine whether or not to propose 
     adoption of such standards and implementation specifications.
       ``(2) Determination to adopt.--If, subject to subsection 
     (d)(3), the Secretary determines--
       ``(A) to propose adoption of such standards and 
     implementation specifications, the Secretary shall, by 
     regulation under section 553 of title 5, United States Code, 
     determine whether or not to adopt such standards and 
     implementation specifications; or
       ``(B) not to propose adoption of such standards and 
     implementation specifications, the Secretary shall notify the 
     applicable entity with a contract under section 3003A in 
     writing of such determination and the reasons for not 
     proposing the adoption of the recommendation for such 
     standards and implementation specifications.
       ``(3) Publication.--The Secretary shall provide for 
     publication in the Federal Register of all determinations 
     made by the Secretary under paragraph (1).
       ``(d) Rules for Adoption.--In the case of a standard 
     (including interoperability standard), implementation 
     specification, or certification criterion adopted under this 
     section on or after the date of the enactment of the 21st 
     Century Cures Act, the following shall apply:
       ``(1) In general.--Except as provided in paragraphs (2) and 
     (3), any such standard (including interoperability standard), 
     implementation specification, or certification criterion 
     shall be a standard, specification, or criterion that has 
     been recommended by the entities with which the Secretary has 
     entered into a contract under section 3003A.
       ``(2) Special rule if no standard, specification, or 
     criterion recommended.--If no standard, implementation 
     specification, or, to the extent necessary, certification 
     criterion is recommended under paragraph (1)--
       ``(A) in the case of interoperability standards and 
     implementation specifications with respect to such standards, 
     relating to a category described in section 3010(b)--
       ``(i) paragraph (1) shall not apply; and
       ``(ii) paragraph (4) shall apply; or
       ``(B) in the case of any other standard, implementation 
     specification, or, to the extent necessary, certification 
     criterion, relating to a policy or priority to carry out this 
     title, as determined by the Secretary, in consultation with 
     the National Coordinator--
       ``(i) paragraph (1) shall not apply; and
       ``(ii) paragraph (4) shall apply.
       ``(3) Authority to modify implementation specifications.--
     If, following public comment pursuant to subsection (c), the 
     Secretary would propose adoption of interoperability 
     standards recommended under section 3003A but for the 
     implementation specifications, with respect to such 
     standards, so recommended, the Secretary may modify such 
     implementation specifications and adopt such standards and 
     specifications in accordance with subsection (c)(2).
       ``(4) Effective date.--In the case of a standard, 
     implementation specification, or certification criterion for 
     which there is a determination to adopt such standard, 
     implementation specification, or certification criterion, 
     such standard, implementation specification, or certification 
     criterion shall be considered adopted under this section and 
     shall be effective beginning on the date that is 12 months 
     after the date of publication of the final rule to adopt such 
     standard, implementation specification, or certification 
     criterion.
       ``(5) Assistance to the secretary.--In complying with the 
     requirements of this subsection, the Secretary shall give due 
     consideration to any recommendations of the National 
     Committee on Vital and Health Statistics established under 
     section 306(k), and shall consult with appropriate Federal 
     and State agencies and private organizations. The Secretary 
     shall publish in the Federal Register any recommendation of 
     the National Committee on Vital and Health Statistics 
     regarding the adoption of a standard, implementation 
     specification, or certification criterion under this section. 
     Any standard, implementation specification, or certification 
     criterion adopted pursuant to this paragraph shall be 
     promulgated in accordance with the rulemaking procedures of 
     subchapter III of chapter 5 of title 5, United States Code.
       ``(e) Allowing for Flexibility Through Compatibility With 
     Baseline Standards and Implementation Specifications.--For 
     purposes of this title, title XVIII of the Social Security 
     Act, title XIX of such Act, and any other provision of law, a 
     standard and implementation specification, with respect to 
     such standard, that is determined under section 3001(c)(5)(D) 
     to be compatible with baseline standards and implementation 
     specifications (as defined in clause (ii) of such section) 
     shall be treated as if such standard and specification were 
     an interoperability standard and implementation 
     specification, with respect to such interoperability 
     standard, adopted under this section.''.
       (d) Reports and Notifications.--Section 3010 of the Public 
     Health Service Act, as added by subsection (a), is amended by 
     adding at the end the following new subsection:

[[Page 11307]]

       ``(c) Dissemination of Information.--
       ``(1) Initial summary report.--Not later than July 1, 2017, 
     the Secretary, after consultation with relevant stakeholders, 
     shall submit to Congress and provide for publication in the 
     Federal Register and the posting on the Internet website of 
     the Office of the National Coordinator for Health Information 
     Technology a report on the following:
       ``(A) The initial set of interoperability standards and 
     implementation specifications adopted under section 3004(c).
       ``(B) The strategies for achieving widespread 
     interoperability.
       ``(C) Any barriers that are preventing widespread 
     interoperability.
       ``(D) The plan and milestones, including specific steps, to 
     achieve widespread interoperability.
       ``(2) Ongoing publication of recommendations.--The 
     Secretary shall provide for publication in the Federal 
     Register, and the posting on the Internet website of the 
     Office of the National Coordinator for Health Information 
     Technology, of all recommendations made under this 
     section.''.
       (e) Certification and Other Enforcement Provisions.--
       (1) Certification of qualified electronic health records.--
       (A) In general.--Section 3007(b) of the Public Health 
     Service Act (42 U.S.C. 300jj-17(b)) is amended by striking 
     ``under section 3001(c)(3) to be in compliance with'' and all 
     that follows through the period at the end and inserting 
     ``under section 3001(c)(3)--
       ``(1) for certifications made before January 1, 2018, to be 
     in compliance with applicable standards adopted under 
     subsections (a) and (b) of section 3004; and
       ``(2) for certifications made on or after January 1, 2018, 
     to be in compliance with applicable standards adopted under 
     subsections (a) and (b) of section 3004 and to be 
     interoperable in accordance with section 3010 and in 
     compliance with interoperability standards adopted under 
     section 3004.''.
       (B) Requirements of secretary.--Section 3001(c)(5) of the 
     Public Health Service Act (42 U.S.C. 300jj-11(c)(5)) is 
     amended--
       (i) in subparagraph (B), by inserting before the period at 
     the end the following: ``and, for certifications made on or 
     after January 1, 2018, with respect to health information 
     technology, additional criteria to establish that the 
     technology is interoperable, in accordance with section 3010, 
     and in compliance with interoperability standards and 
     implementation specifications, with respect to such 
     standards, adopted under section 3004''; and
       (ii) by adding at the end the following new subparagraphs:
       ``(C) Enforcement; decertifications.--
       ``(i) Requirements.--Under any program kept or recognized 
     under subparagraph (A), the Secretary shall ensure that any 
     vendor of or other entity offering to health care providers 
     (as defined in section 3010A(g)) qualified electronic health 
     records seeking a certification of such records under such 
     program on or after January 1, 2018, shall, as a condition of 
     certification (and maintenance of certification) of such a 
     record under such program--

       ``(I) provide to the Secretary an attestation--

       ``(aa) the entity has implemented interoperability 
     standards and implementation specifications, with respect to 
     such standards, adopted under section 3004 (including through 
     application of subsection (e) of such section);
       ``(bb) that the entity, unless for a legitimate purpose 
     specified by the Secretary, has not taken and will not take 
     any action that constitutes information blocking (as defined 
     in section 3010A(d)), with respect to such qualified 
     electronic health records;
       ``(cc) that includes the pricing information described in 
     clause (iii) for purposes of inclusion under subsection (f) 
     of such information on the Internet website of the Department 
     of Health and Human Services; that such information will be 
     available on a public Internet website of such entity; and 
     that the entity will voluntarily provide such information to 
     customers prior to offering any qualified electronic health 
     records or related product or service (including subsequent 
     updates, add-ons, or additional products or services to be 
     provided during the course of an on-going contract), 
     prospective customers (such as persons who request or receive 
     a quotation or estimate), and other persons who request such 
     information;
       ``(dd) that the technology with respect to such records has 
     published application programming interfaces, with respect to 
     health information within such records, for search and 
     indexing, semantic harmonization and vocabulary translation, 
     and user interface applications;
       ``(ee) that the entity has successfully and rigorously 
     tested the real world use of the record in the type of 
     setting in which it would be marketed; and
       ``(ff) that the entity has in place data sharing programs 
     or capabilities based on common data elements through such 
     mechanisms as application programming interfaces without the 
     requirement for vendor-specific interfaces;

       ``(II) publish application programming interfaces and 
     associated documentation, with respect to health information 
     within such records, for search and indexing, semantic 
     harmonization and vocabulary translation, and user interface 
     applications; and
       ``(III) demonstrate to the satisfaction of the Secretary 
     that health information from such records are able to be 
     exchanged, accessed, and used through the use of application 
     programming interfaces without special effort, as authorized 
     under applicable law.

       ``(ii) Decertification.--Under any program kept or 
     recognized under subparagraph (A), the Secretary shall ensure 
     that beginning January 1, 2019, any qualified electronic 
     health records that do not satisfy the certification criteria 
     described in subparagraph (B) or with respect to which the 
     vendor or other entity described in clause (i) does not 
     satisfy the requirements under such clause (or is determined 
     to be in violation of the terms of the attestation or other 
     requirements under such clause) shall no longer be considered 
     as certified under such program.
       ``(iii) Pricing information.--For purposes of clause 
     (i)(I)(cc), the pricing information described in this clause, 
     with respect to a vendor of or other entity offering a 
     qualified electronic health record, is the following:

       ``(I) Additional types of costs or fees (whether fixed, 
     recurring, transaction based, or otherwise) imposed by the 
     entity (or any third-party from whom the entity purchases, 
     licenses, or obtains any technology, products, or services in 
     connection with the qualified electronic health record) to 
     purchase, license, implement, maintain, upgrade, use, or 
     otherwise enable and support the use of capabilities to which 
     such record is to be certified under this section; or in 
     connection with any health information generated in the 
     course of using any capability to which the record is to be 
     so certified.
       ``(II) Limitations, whether by contract or otherwise, on 
     the use of any capability to which the record is to be 
     certified under this section for any purpose within the scope 
     of the record's certification; or in connection with any 
     health information generated in the course of using any 
     capability to which the record is to be certified under this 
     section.
       ``(III) Limitations, including technical or practical 
     limitations of technology or its capabilities, that could 
     prevent or impair the successful implementation, 
     configuration, customization, maintenance, support, or use of 
     any capabilities to which the record is to be certified under 
     this section; or that could prevent or limit the access, use, 
     exchange, or portability of any health information generated 
     in the course of using any capability to which the record is 
     to be so certified.

       ``(D) Flexibility through compatibility.--
       ``(i) In general.--Under any program kept or recognized 
     under subparagraph (A), the Secretary shall provide for a 
     method and process by which a vendor of or other entity 
     offering to health care providers (as defined in section 
     3010A(g)) qualified electronic health records seeking a 
     certification of such records under such program on or after 
     January 1, 2018, may demonstrate, using such mechanisms as a 
     reference implementation model or other means, that the 
     standards and implementation specifications applied by such 
     entity with respect to such records are compatible with 
     baseline standards and implementation specifications, 
     including by demonstrating such records are able to transmit 
     information that is compatible with qualified electronic 
     health records that would receive such information and that 
     apply the baseline standards and implementation 
     specifications. Such a method and process shall ensure that 
     any such entity using a standard or implementation 
     specification other than a baseline standard or 
     implementation specification demonstrates, through testing, 
     compatibility with the baseline standard and implementation 
     specification with respect to receiving information.
       ``(ii) Baseline standards and implementation 
     specifications.--For purposes of clause (i), the term 
     `baseline standards and implementation specifications' means 
     the interoperability standards and implementation 
     specifications, with respect to such standards, adopted under 
     section 3004 (without application of subsection (e) of such 
     section).''.
       (2) Additional enforcement provisions under the public 
     health service act.--Subtitle A of title XXX of the Public 
     Health Service Act (42 U.S.C. 300jj-11 et seq.), as amended 
     by subsections (a)(1) and (d), is further amended by adding 
     at the end the following new section:

     ``SEC. 3010A. ENFORCEMENT MECHANISMS.

       ``(a) Inspector General Authority.--The Inspector General 
     of the Department of Health and Human Services shall have the 
     authority to investigate claims of--
       ``(1)(A) vendors of, or other entities offering to health 
     care providers (as defined in subsection (g)), qualified 
     electronic health records (as defined in section 3000(13)) 
     being in violation of an attestation (whether providing false 
     information at the time of such attestation or by act or 
     practice conducted after such attestation) made under section 
     3001(c)(5)(C)(i)(I), with respect to the use of such records 
     by a health care provider with respect to items and services 
     furnished under the Medicare program under title XVIII of the 
     Social Security Act or Medicaid program under title XIX of 
     such Act; and
       ``(B) vendors of, or other entities offering to health care 
     providers (as defined in subsection (g)), health information 
     technology having engaged in information blocking (as defined 
     in subsection (d)), unless for a legitimate purpose specified 
     by the Secretary, with respect to the use of such technology 
     by a health care provider with respect to items and services 
     furnished under such a program;
       ``(2) health care providers having engaged in information 
     blocking (as so defined), with respect to the use of health 
     information technology with respect to items and services 
     furnished under such a program, unless for a legitimate 
     purpose specified by the Secretary; and

[[Page 11308]]

       ``(3) health information system providers (such as 
     operators of health information exchanges, clinical data 
     registries, and other systems that facilitate the exchange of 
     information) having engaged in information blocking (as so 
     defined), unless for a legitimate purpose specified by the 
     Secretary, with respect to the use of health information 
     technology with respect to items and services furnished under 
     such a program.
       ``(b) Information Sharing Provisions.--
       ``(1) In general.--The National Coordinator may serve as a 
     technical consultant to the Inspector General of the 
     Department of Health and Human Services and the Federal Trade 
     Commission for purposes of carrying out this section. As such 
     technical consultant, the National Coordinator may, 
     notwithstanding any other provision of law, share information 
     related to claims or investigations under subsection (a) with 
     the Federal Trade Commission for purposes of such 
     investigations and shall share information with the Inspector 
     General, as required by law.
       ``(2) Protection from disclosure of information.--Any 
     information that is received by the National Coordinator in 
     connection with a claim or suggestion of possible information 
     blocking and that could reasonably be expected to facilitate 
     identification of the source of the information--
       ``(A) shall not be disclosed by the National Coordinator 
     except as may be necessary to carry out the purpose of this 
     section; and
       ``(B) shall be exempt from mandatory disclosure under 
     section 552 of title 5, United States Code, as provided by 
     subsection (b)(3) of such section.
     Such information may be used by the Inspector General of the 
     Department of Health and Human Services or Federal Trade 
     Commission for reporting purposes to the extent that such 
     information could not reasonably be expected to facilitate 
     identification of the source of such information.
       ``(3) Non-application of paperwork reduction act.--Chapter 
     35 of title 44, United States Code (commonly referred to as 
     the Paperwork Reduction Act of 1995) shall not apply to the 
     National Coordinator or to the Office of the National 
     Coordinator for Health Information Technology with respect to 
     the collection of complaints relating to claims described in 
     subsection (a).
       ``(4) Standardized process.--The National Coordinator shall 
     implement a standardized process for the public to submit 
     reports on claims of--
       ``(A) health information technology products of vendors (or 
     other entities offering such products to health care 
     providers (as defined in subsection (g)) not being 
     interoperable or resulting in information blocking; or
       ``(B) actions by such entities, health care providers, or 
     health information system providers that result in such 
     technology not being interoperable or in information blocking 
     with respect to such technology; and
       ``(C) any other act described in subsection (a).
     The standardized process shall provide for the collection of 
     such information as the originating institution, location, 
     type of transaction, system and version, timestamp, 
     terminating institution, locations, system and version, 
     failure notice, and other related information.
       ``(c) Penalty.--
       ``(1) In general.--Any person or entity described in 
     paragraph (1), (2), or (3) of subsection (a) determined to 
     have committed on or after January 1, 2018, an act described 
     in such respective paragraph with respect to the use of a 
     qualified electronic health record or health information 
     technology, as applicable under such respective paragraph, 
     with respect to items and services furnished under the 
     Medicare program under title XVIII of the Social Security Act 
     or the Medicaid program under title XIX of such Act, shall be 
     subject to a civil monetary penalty in such amount as 
     determined appropriate by the Secretary through rulemaking.
       ``(2) Application.--Subject to paragraph (3), the 
     provisions of section 1128A (other than subsections (a) and 
     (b)) of such Act (42 U.S.C. 1320a-7a) shall apply to a civil 
     money penalty applied under this subsection in the same 
     manner as they apply to a civil money penalty or proceeding 
     under subsection (a) of such section 1128A.
       ``(3) Recovery of funds.--Notwithstanding section 3302 of 
     title 31, United States Code, or any other provision of law 
     affecting the crediting of collections, the Inspector General 
     of the Department of Health and Human Services may receive 
     and retain for current use any amounts recovered under this 
     subsection. In addition to amounts otherwise available to the 
     Inspector General, funds received by the Inspector General 
     under this paragraph shall be deposited, as an offsetting 
     collection, to the credit of any appropriation available for 
     purposes of carrying out this subsection and subsection (a) 
     and shall be available without fiscal year limitation and 
     without further appropriation.
       ``(d) Information Blocking.--
       ``(1) In general.--For purposes of this section and section 
     3010, subject to paragraph (3), the term `information 
     blocking' means, with respect to the access, use, and 
     exchange of qualified electronic health records and other 
     health information technology, business, technical, and 
     organizational practices, including practices described in 
     paragraph (2), that--
       ``(A) prevent or materially discourage the access, 
     exchange, or use of electronic health information; and
       ``(B) the actor knows or should know (as defined in section 
     1128A(i)(7) of the Social Security Act) are likely to 
     interfere with the access, exchange, or use of electronic 
     health information.
       ``(2) Practices described.--For purposes of paragraph (1), 
     the practices described in this paragraph shall include the 
     following:
       ``(A) Contract terms, policies, or business or 
     organizational practices that restrict authorized use under 
     applicable State or Federal law of electronic health 
     information or restrict the authorized exchange under 
     applicable State or Federal law of such information for 
     treatment and other permitted purposes under such applicable 
     law, including transitions between certified EHR 
     technologies.
       ``(B) Charging unreasonable prices or fees (such as for 
     health information exchange, portability, interfaces, and 
     full export of health information) that make accessing, 
     exchanging, or using electronic health information cost 
     prohibitive.
       ``(C) Developing or implementing health information 
     technology in nonstandard ways that are likely to 
     substantially increase the costs, complexity, or burden of 
     sharing electronic health information, especially in cases in 
     which relevant interoperability standards or methods to 
     measure interoperability have been adopted by the Secretary.
       ``(D) Developing or implementing health information 
     technology in ways that are likely to lock in users or 
     electronic health information, such as not allowing for the 
     full export of health information; lead to fraud, waste, or 
     abuse; or impede innovations and advancements in health 
     information access, exchange, and use, including health 
     information technology-enabled care delivery.
       ``(3) Exceptions.--
       ``(A) In general.--The term `information blocking' shall 
     not include practices that--
       ``(i) are required by applicable law; or
       ``(ii) that the Secretary, through regulation, identifies 
     as necessary to protect patient safety, to maintain the 
     privacy or security of individuals' health information, or to 
     promote competition and consumer welfare.
       ``(B) Process.--For purposes of subparagraph (A)(ii), not 
     later than 12 months after the date of the enactment of this 
     section, the Secretary shall issue regulations following the 
     notice and comment procedures of section 553 of title 5, 
     United States Code, except that the Secretary may issue the 
     first such regulation as an interim final regulation.
       ``(C) No enforcement before exceptions identified.--The 
     term `information blocking' shall not include any practice or 
     conduct occurring before the date that is 30 days after the 
     date on which the first regulation (as described in 
     subparagraph (B)) is issued under such subparagraph.
       ``(D) Consultation.--To the extent that regulations issued 
     under this paragraph define practices that are necessary to 
     promote competition and consumer welfare, the Secretary may 
     consult with the Federal Trade Commission in issuing such 
     regulations.
       ``(E) Application.--The term `information blocking', with 
     respect to an individual or entity, shall not include an act 
     or practice other than an act or practice committed by such 
     individual or entity.
       ``(e) Treatment of Vendors With Respect to Patient Safety 
     Organizations.--In applying part C of title IX--
       ``(1) vendors shall be treated as a provider (as defined in 
     section 921) for purposes of reporting requirements under 
     such part, to the extent that such reports are related to 
     attestation requirements under section 3001(c)(5)(C)(i)(I);
       ``(2) claims of information blocking described in 
     subsection (a) shall be treated as a patient safety activity 
     under such part for purposes of reporting requirements under 
     such part; and
       ``(3) health care providers that are not members of patient 
     safety organizations shall be treated in the same manner as 
     health care providers that are such members for purposes of 
     such reporting requirements with respect to claims of 
     information blocking described in subsection (a).
       ``(f) Rulemaking and Guidance.--
       ``(1) In general.--Not later than 12 months after the date 
     of the enactment of this section, the Secretary, in 
     consultation with the National Coordinator and the Inspector 
     General of the Department of Health and Human Services, 
     shall, through rulemaking, implement the provisions of 
     section 3001 of the 21st Century Cures Act, including 
     amendments made by such section, relating to information 
     blocking.
       ``(2) Non-duplication of penalty structures.--In carrying 
     out paragraph (1), in determining the scope of penalties, 
     assessments, or exclusions under such section 3001, including 
     amendments made by such section, relating to information 
     blocking, the Secretary shall ensure to the extent possible 
     that such penalties, assessments, and exclusions do not 
     duplicate penalty, assessment, and exclusion structures that 
     would otherwise apply with respect to information blocking 
     and the type of individual or entity involved as of the day 
     before the date of the enactment of this section.
       ``(3) Clarification.--In carrying out paragraph (1), the 
     Secretary shall ensure that health care providers are not 
     penalized for actions of vendor of, and other entities 
     offering to such providers, health information technology for 
     the failure of such technology to meet requirements for such 
     technology to be certified under this title.
       ``(4) Guidance relating to hipaa.--Not later than January 
     1, 2017, the National Coordinator shall publish guidance to 
     clarify the relationship of the provisions of the HIPAA 
     privacy and

[[Page 11309]]

     security law, as defined in section 3009(a)(2) to information 
     blocking, including--
       ``(A) examples of how such provisions may result in 
     information blocking; and
       ``(B) clarifying that a health care provider (as defined in 
     subsection (g)) who discloses health information as allowed 
     under applicable State and Federal law is not liable for 
     unlawful actions, including breaches that occur in the 
     custody of the recipient unless the disclosure proximately 
     cause the breach.
       ``(g) Health Care Provider Defined.--For purposes of this 
     section, the term `health care provider' means a provider of 
     services under subsection (u) of section 1861 of the Social 
     Security Act and a supplier under subsection (d) of such 
     section.
       ``(h) Authorization of Appropriations.--In addition to 
     amounts made available under subsection (c)(3), there is 
     authorized to be appropriated $10,000,000 for fiscal year 
     2017 to carry out subsection (a), to remain available until 
     expended.''.
       (3) Postings relating to enforcement on hhs internet 
     website.--Section 3001 of the Public Health Service Act (42 
     U.S.C. 300jj-11) is amended by adding at the end the 
     following new subsection:
       ``(f) Enforcement Information Posted on HHS Internet 
     Website.--
       ``(1) Pricing information.--Not later than January 1, 2019, 
     the National Coordinator shall post the information described 
     in subsection (c)(5)(C)(I)(i)(cc) on the public Internet 
     website of the Office of the National Coordinator for Health 
     Information Technology in a manner that allows for comparison 
     of functionality, price information, and other features among 
     health information technology products that aids in making 
     informed decisions for purchasing such a product.
       ``(2) Annual posting.--For 2019 and each subsequent year, 
     the Secretary shall post on the public Internet website of 
     the Department of Health and Human Services a list of any 
     qualified electronic health records with respect to which 
     certification has been withdrawn under subsection 
     (c)(5)(C)(ii) during such year and the vendor of or other 
     entity offering to health care providers (as defined in 
     section 3010A(g)) such qualified electronic health records.
       ``(3) Periodic review.--The Secretary shall periodically 
     review and confirm that vendors of and other entities 
     offering to health care providers (as defined in section 
     3010A(g)) qualified electronic health records have publicly 
     published application programming interfaces and associated 
     documentation as required by subsection (c)(5)(C)(i)(II) for 
     purposes of certification and maintaining certification under 
     any program kept or recognized under subsection (c)(5)(A).''.
       (4) Demonstration required for meaningful ehr use under 
     medicare.--
       (A) Eligible professionals.--
       (i) In general.--Section 1848(o)(2)(A) of the Social 
     Security Act (42 U.S.C. 1395w-4(o)(2)(A)) is amended by 
     inserting after clause (iii) the following new clause:
       ``(iv) Interoperability.--With respect to EHR reporting 
     periods for payment years beginning with 2020, the eligible 
     professional demonstrates to the satisfaction of the 
     Secretary, in accordance with subparagraph (C)(i), that 
     during such period the professional has not taken any action 
     described in subsection (a)(2) of section 3010A of the Public 
     Health Service Act, with respect to the use of any certified 
     EHR technology.''.
       (ii) Hardship exemption in case of decertified ehr.--
     Subparagraph (B) of section 1848(a)(7) of the Social Security 
     Act (42 U.S.C. 1395w-4(a)(7)) is amended to read as follows:
       ``(B) Significant hardship exception.--
       ``(i) In general.--The Secretary may, on a case-by-case 
     basis, exempt an eligible professional from the application 
     of the payment adjustment under subparagraph (A) if the 
     Secretary determines, subject to annual renewal, that 
     compliance with the requirement for being a meaningful EHR 
     user would result in a significant hardship, such as in the 
     case of an eligible professional who practices in a rural 
     area without sufficient Internet access.
       ``(ii) Decertification.--The Secretary shall exempt an 
     eligible professional from the application of the payment 
     adjustment under subparagraph (A) if the Secretary determines 
     that such professional was determined to not be a meaningful 
     EHR user because the certified EHR technology used by such 
     professional is decertified under section 3001(c)(5)(C) of 
     the Public Health Service Act. An exemption under the 
     previous sentence may be applied to an eligible professional 
     only, subject to clause (iii), during the first payment year 
     with respect to the first EHR reporting period to which such 
     decertification applies.
       ``(iii) Duration of decertification.--

       ``(I) In general.--Notwithstanding clause (iv)(I), in no 
     case shall an exemption by reason of clause (ii) be for a 
     period of less than 12 months.
       ``(II) Extension.--An exemption under clause (ii) may be 
     extended, on a case-by-case basis, for a period of an 
     additional 12 months subject to the limitation described in 
     clause (iv)(I).

       ``(iv) Limitation.--

       ``(I) In general.--Subject to subclause (II), in no case 
     may an eligible professional be granted an exemption under 
     this subparagraph for more than 5 years.
       ``(II) Exception.--Subclause (I) shall not apply to an 
     exemption by reason of clause (ii) to the extent necessary to 
     satisfy clause (iii)(I).''.

       (iii) Further application.--Section 1848(o)(2) of the 
     Social Security Act (42 U.S.C. 1395w-4(o)(2)) is amended by 
     adding at the end the following new subparagraph:
       ``(E) Hardship exemption in case of decertified ehr.--In 
     the case of certified EHR technology used by an eligible 
     professional that is decertified under section 3001(c)(5)(C), 
     during the first payment year with respect to the first EHR 
     reporting period to which such decertification applies, the 
     Secretary shall not treat the professional as not being a 
     meaningful EHR user solely because the technology used by 
     such professional was so decertified. The treatment of a 
     professional under the previous sentence shall be for a 
     period of at least 12 months and may, on a case-by-case 
     basis, be for a period of an additional 12 months.''.
       (B) Eligible hospitals.--
       (i) In general.--Section 1886(n)(3)(A) of the Social 
     Security Act (42 U.S.C. 1395ww(n)(3)(A)) is amended by 
     inserting after clause (iii) the following new clause:
       ``(iv) Interoperability.--With respect to EHR reporting 
     periods for payment years beginning with 2020, the hospital 
     demonstrates to the satisfaction of the Secretary, in 
     accordance with subparagraph (C)(i), that during such period 
     the hospital has not taken any action described in subsection 
     (a)(2) of section 3010A of the Public Health Service Act, 
     with respect to the use of any certified EHR technology.''.
       (ii) Hardship exemption in case of decertified ehr.--
     Subclause (II) of section 1886(b)(3)(B)(ix) of the Social 
     Security Act (42 U.S.C. 1395ww(b)(3)(B)(ix)) is amended to 
     read as follows:
       ``(II)(aa) The Secretary may, on a case-by-case basis, 
     exempt a subsection (d) hospital from the application of 
     subclause (I) with respect to a fiscal year if the Secretary 
     determines, subject to annual renewal, that requiring such 
     hospital to be a meaningful EHR user during such fiscal year 
     would result in a significant hardship, such as in the case 
     of a hospital in a rural area without sufficient Internet 
     access.
       ``(bb) The Secretary shall exempt a subsection (d) hospital 
     from the application of subclause (I) with respect to a 
     fiscal year if the Secretary determines that such hospital 
     was determined to not be a meaningful EHR user because the 
     certified EHR technology used by such hospital is decertified 
     under section 3001(c)(5)(C) of the Public Health Service Act. 
     An exemption under the previous sentence may be applied to a 
     subsection (d) hospital only, subject to items (cc) and (dd), 
     during the first payment year with respect to the first EHR 
     reporting period to which such decertification applies.
       ``(cc) Notwithstanding item (ee), in no case shall an 
     exemption by reason of item (bb) be for a period of less than 
     12 months.
       ``(dd) An exemption under item (bb) may, on a case-by-case 
     basis, be extended for a period of an additional 12 months 
     subject to the limitation described in item (ee).
       ``(ee) Subject to item (ff), in no case may a hospital be 
     granted an exemption under this subclause for more than 5 
     years.
       ``(ff) Item (ee) shall not apply to an exemption by reason 
     of item (bb) to the extent necessary to satisfy item (cc).''.
       (C) Demonstration required for meaningful ehr use under 
     medicaid.--Section 1903(t)(2) of the Social Security Act (42 
     U.S.C. 1396b(t)(2)) is amended by adding at the end the 
     following: ``An eligible professional shall not qualify as a 
     Medicaid provider under this subsection, with respect to a 
     year beginning with 2020, unless such provider demonstrates 
     to the Secretary, through means such as an attestation, that 
     the provider has not taken any action described in subsection 
     (a)(2) of section 3010A of the Public Health Service Act, 
     with respect to the use of any certified EHR technology.''.
       (5) Guidance.--Not later than January 1, 2018, the 
     Secretary of Health and Human Services shall issue guidance 
     to further the voluntary transition of health care providers 
     between different certified EHR technology (as defined in 
     section 3000(1) of the Public Health Service Act (42 U.S.C. 
     300jj(1)) by removing disincentives to such transition, which 
     may include applying to instances of such a transition the 
     hardship exemption authority under section 1848(a)(7) of the 
     Social Security Act (42 U.S.C. 1395w-4(a)(7)), section 
     1886(b)(3)(B)(ix) of such Act (42 U.S.C. 
     1395ww(b)(3)(B)(ix)), and other provisions of law in 
     existence as of the date of the enactment of this Act. In 
     developing such guidance, the Secretary may consult with the 
     relevant Federal agencies.
       (f) Definitions.--
       (1) Certified ehr technology.--Paragraph (1) of section 
     3000 of the Public Health Service Act (42 U.S.C. 300jj) is 
     amended to read as follows:
       ``(1) Certified ehr technology.--The term `certified EHR 
     technology' means a qualified electronic health record that 
     is certified pursuant to section 3001(c)(5) as meeting the 
     certification criteria defined in subparagraph (B) of such 
     section that are applicable to the type of record involved 
     (as determined by the Secretary, such as an ambulatory 
     electronic health record for office-based physicians or an 
     inpatient hospital electronic health record for hospitals) 
     including, beginning January 1, 2018, with respect to which 
     the vendor or other entity offering such technology is in 
     compliance with the requirements under section 
     3001(c)(5)(C)(i).''.
       (2) Widespread interoperability.--Section 3000 of the 
     Public Health Service Act (42 U.S.C. 300jj) is amended by 
     adding at the end the following new paragraph:
       ``(15) Widespread interoperability.--The term `widespread 
     interoperability' means that, on a nationwide basis--

[[Page 11310]]

       ``(A) health information technology is interoperable, in 
     accordance with section 3010; and
       ``(B) such technology is employed by meaningful EHR users 
     under the Medicare program under title XVIII of the Social 
     Security Act and the Medicaid program under title XIX of such 
     Act and by other clinicians and health care providers.''.
       (g) Conforming Amendments.--
       (1) Voluntary use of standards.--Section 3006 of the Public 
     Health Service Act (42 U.S.C. 300jj-16) is amended--
       (A) in subsection (a)(1), by inserting ``, including an 
     interoperability standard or implementation specification, 
     with respect to such interoperability standard, adopted under 
     such section'' after ``section 3004''.
       (B) in subsection (b), by inserting ``, including the 
     interoperability standards and implementation specifications, 
     with respect to such interoperability standards, adopted 
     under such section'' after ``section 3004''.
       (2) HIPAA privacy and security law definition correction.--
     Section 3009(a)(2)(A) of the Public Health Service Act (42 
     U.S.C. 300jj-19(a)(2)(A)) is amended by striking ``title IV'' 
     and inserting ``title XIII''.
       (3) Coordination of federal activities.--Section 13111 of 
     the HITECH Act is amended--
       (A) in subsection (a), by inserting before the period at 
     the end the following: ``(and, beginning on January 1, 2018, 
     that are also interoperable under section 3010 of such Act 
     and in compliance with interoperability standards and 
     implementation specifications, with respect to such 
     interoperability standards, adopted under section 3004 of 
     such Act )''; and
       (B) in subsection (b), by inserting ``(and, beginning on 
     January 1, 2018, including an interoperability standard or 
     implementation specification, with respect to such 
     interoperability standard, adopted under section 3004 of such 
     Act)'' before ``the President''.
       (4) Application to private entities.--Section 13112 of the 
     HITECH Act is amended by inserting before the period at the 
     end the following: ``(and, beginning on January 1, 2018, that 
     are also interoperable under section 3010 of such Act and in 
     compliance with interoperability standards and implementation 
     specifications, with respect to such interoperability 
     standards, adopted under section 3004 of such Act)''.
       (5) NIST testing.--Section 13201 of the HITECH Act (42 
     U.S.C. 17911) is amended--
       (A) in subsection (a), by inserting ``(or, beginning 
     January 1, 2018, in coordination with the entities with 
     contracts under section 3003A, with respect to standards, and 
     implementation specifications under section 3004)'' before 
     ``, the Director''; and
       (B) in subsection (b), by inserting ``(or, beginning 
     January 1, 2018, in coordination with the entities with 
     contracts under section 3003A, with respect to standards and 
     implementation specifications under section 3004)'' before 
     ``, the Director''; and
       (C) by adding at the end the following new subsection:
       ``(c) Funding.--For purposes of carrying out this section, 
     in addition to any other funds made available to carry out 
     this section, there is authorized to be appropriated 
     $15,000,000, to remain available until expended.''.
       (6) Coordination with recommendations for achieving 
     widespread ehr interoperability.--Section 106 of the Medicare 
     Access and CHIP Reauthorization Act of 2015 (Public Law 114-
     10) is amended by striking subsection (b).''.
       (h) Patient Engagement and Empowerment.--It is the sense of 
     Congress that--
       (1) if the strategic goals that Congress set forth in the 
     HITECH Act are to be achieved, interoperability is best 
     achieved with individuals and authorized representatives 
     having equal access to the health information of such 
     individuals in electronic format;
       (2) patients have the right to the entirety of the health 
     information of such individuals, including such information 
     contained in an electronic health record of such individuals;
       (3) such right extends to both structured and unstructured 
     data;
       (4) such right extends to authorized representatives of the 
     individual involved, such as care takers of such individual, 
     family members of such individual, and guardians of such 
     individual; and
       (5) to further facilitate access of an individual to health 
     information of such individual--
       (A) health care providers should not have the ability to 
     deny a request of the individual for access to the entirety 
     of such health information of such individual;
       (B) health care providers do not need the consent of 
     individuals to share personal health information of such 
     individuals with other covered entities, in compliance with 
     the HIPAA privacy regulations promulgated pursuant to section 
     264(c) of the Health Insurance Portability and Accountability 
     Act of 1996 for the purposes of supporting patient care, 
     except in situations where consent is specifically required 
     under such regulations, such as in cases related to the 
     psychiatric records of the individual involved;
       (C) mechanisms should be utilized that allow for the 
     bidirectional exchange of information through such mechanisms 
     as web portals, appointments, and prescription refills, for 
     the purpose of patients partnering with providers to assist 
     in managing health and care;
       (D) mechanisms described in subparagraph (C) should allow 
     for connecting individuals across the continuum of care;
       (E) an individual has the right to access the health 
     information of the individual without cost to the individual;
       (F) mechanisms described in subparagraph (C) should allow 
     for data of an individual generated by the individual to be 
     integrated into such platforms as electronic health records;
       (G) such access should be timely, in accordance with the 
     HIPAA privacy regulations described in subparagraph (B), and 
     take into account communications preferences of the 
     individual involved;
       (H) an individual should have the right to be confident 
     that the data in the electronic health record of the 
     individual pertains to such individual; and
       (I) the right described in subparagraph (H) will promote 
     safety and care coordination for individuals.

                         Subtitle B--Telehealth

     SEC. 3021. TELEHEALTH SERVICES UNDER THE MEDICARE PROGRAM.

       (a) Provision of Information by Centers for Medicare & 
     Medicaid Services.--Not later than 1 year after the date of 
     the enactment of this Act, the Administrator of the Centers 
     for Medicare & Medicaid Services shall provide to the 
     committees of jurisdiction of the House of Representatives 
     and the Senate information on the following:
       (1) The populations of Medicare beneficiaries, such as 
     those who are dually eligible for the Medicare program under 
     title XVIII of the Social Security Act (42 U.S.C. 1395 et 
     seq.) and the Medicaid program under title XIX of such Act 
     (42 U.S.C. 1396 et seq.) and those with chronic conditions, 
     whose care may be improved most in terms of quality and 
     efficiency by the expansion, in a manner that meets or 
     exceeds the existing in-person standard of care under the 
     Medicare program under title XVIII of such Act, of telehealth 
     services under section 1834(m)(4) of such Act (42 U.S.C. 
     1395m(m)(4)).
       (2) Activities by the Center for Medicare and Medicaid 
     Innovation which examine the use of telehealth services in 
     models, projects, or initiatives funded through section 1115A 
     of the Social Security Act (42 U.S.C. 1315a).
       (3) The types of high volume services (and related 
     diagnoses) under such title XVIII which might be suitable to 
     the furnishing of services via telehealth.
       (4) Barriers that might prevent the expansion of telehealth 
     services under section 1834(m)(4) of the Social Security Act 
     (42 U.S.C. 1395m(m)(4)) beyond such services that are in 
     effect as of the date of the enactment of this Act.
       (b) Provision of Information by MedPAC.--Not later than 
     March 15, 2017, the Medicare Payment Advisory Commission 
     established under section 1805 of the Social Security Act (42 
     U.S.C. 1395b-6) shall, using quantitative and qualitative 
     research methods, provide information to the committees of 
     jurisdiction of the House of Representatives and the Senate 
     that identifies--
       (1) the telehealth services for which payment can be made, 
     as of the date of the enactment of this Act, under the fee-
     for-service program under parts A and B of title XVIII of 
     such Act;
       (2) the telehealth services for which payment can be made, 
     as of such date, under private health insurance plans;
       (3) with respect to services identified under paragraph (2) 
     but not under paragraph (1), ways in which payment for such 
     services might be incorporated into such fee-for-service 
     program (including any recommendations for ways to accomplish 
     this incorporation).
       (c) Sense of Congress.--It is the sense of Congress that--
       (1) eligible originating sites should be expanded beyond 
     those originating sites described in section 1834(m)(4)(C) of 
     the Social Security Act (42 U.S.C. 1395m(m)(4)(C)); and
       (2) any expansion of telehealth services under the Medicare 
     program should--
       (A) recognize that telemedicine is the delivery of safe, 
     effective, quality health care services, by a health care 
     provider, using technology as the mode of care delivery;
       (B) meet or exceed the conditions of coverage and payment 
     with respect to the Medicare program under title XVIII unless 
     specifically address in subsequent statute, of such Act if 
     the service were furnished in person, including standards of 
     care; and
       (C) involve clinically appropriate means to furnish such 
     services.

  Subtitle C--Encouraging Continuing Medical Education for Physicians

     SEC. 3041. EXEMPTING FROM MANUFACTURER TRANSPARENCY REPORTING 
                   CERTAIN TRANSFERS USED FOR EDUCATIONAL 
                   PURPOSES.

       (a) In General.--Section 1128G(e)(10)(B) of the Social 
     Security Act (42 U.S.C. 1320a-7h(e)(10)(B)) is amended--
       (1) in clause (iii), by inserting ``, including peer-
     reviewed journals, journal reprints, journal supplements, 
     medical conference reports, and medical textbooks'' after 
     ``patient use''; and
       (2) by adding at the end the following new clause:
       ``(xiii) In the case of a covered recipient who is a 
     physician, an indirect payment or transfer of value to the 
     covered recipient--

       ``(I) for speaking at, or preparing educational materials 
     for, an educational event for physicians or other health care 
     professionals that does not commercially promote a covered 
     drug, device, biological, or medical supply; or
       ``(II) that serves the sole purpose of providing the 
     covered recipient with medical education, such as by 
     providing the covered recipient with the tuition required to 
     attend an educational event or with materials provided to 
     physicians at an educational event.''.

[[Page 11311]]

       (b) Effective Date.--The amendments made by this section 
     shall apply with respect to transfers of value made on or 
     after the date of the enactment of this Act.

              Subtitle D--Disposable Medical Technologies

     SEC. 3061. TREATMENT OF CERTAIN ITEMS AND DEVICES.

       (a) In General.--Section 1834 of the Social Security Act 
     (42 U.S.C. 1395m) is amended by adding at the end the 
     following new subsection:
       ``(r) Payment for Certain Disposable Devices.--
       ``(1) In general.--The Secretary shall make separate 
     payment in the amount established under paragraph (3) to a 
     home health agency for a device described in paragraph (2) 
     when furnished to an individual who receives home health 
     services for which payment is made under section 1895(b).
       ``(2) Device described.--For purposes of paragraph (1), a 
     device described in this paragraph is a disposable device for 
     which, as of January 1, 2015, there is--
       ``(A) a Level I Healthcare Common Procedure Coding System 
     (HCPCS) code for which the description for a professional 
     service includes the furnishing of such device; and
       ``(B) a separate Level I HCPCS code for a professional 
     service that uses durable medical equipment instead of such 
     device.
       ``(3) Payment amount.--The Secretary shall establish the 
     separate payment amount for such a device such that such 
     amount does not exceed the payment that would be made for the 
     HCPCS code described in paragraph (2)(A) under section 
     1833(t) (relating to payment for covered OPD services).''.
       (b) Conforming Amendment.--Section 1861(m)(5) of the Social 
     Security Act (42 U.S.C. 1395x(m)(5)) is amended by inserting 
     ``and devices described in section 1834(r)(2)'' after 
     ``durable medical equipment''.
       (c) Effective Date.--The amendments made by this section 
     shall apply to devices furnished on or after January 1, 2017.

              Subtitle E--Local Coverage Decision Reforms

     SEC. 3081. IMPROVEMENTS IN THE MEDICARE LOCAL COVERAGE 
                   DETERMINATION (LCD) PROCESS.

       (a) In General.--Section 1862(l)(5) of the Social Security 
     Act (42 U.S.C. 1395y(l)(5)) is amended by adding at the end 
     the following new subparagraph:
       ``(D) Local coverage determinations.--The Secretary shall 
     require each medicare administrative contractor that develops 
     a local coverage determination to make available on the 
     website of such contractor and on the Medicare website, at 
     least 45 days before the effective date of such 
     determination, the following information:
       ``(i) Such determination in its entirety.
       ``(ii) Where and when the proposed determination was first 
     made public.
       ``(iii) Hyperlinks to the proposed determination and a 
     response to comments submitted to the contractor with respect 
     to such proposed determination.
       ``(iv) A summary of evidence that was considered by the 
     contractor during the development of such determination and a 
     list of the sources of such evidence.
       ``(v) An explanation of the rationale that supports such 
     determination.''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall apply with respect to local coverage determinations 
     that are proposed or revised on or after the date that is 180 
     days after the date of the enactment of this Act.

      Subtitle F--Medicare Pharmaceutical and Technology Ombudsman

     SEC. 3101. MEDICARE PHARMACEUTICAL AND TECHNOLOGY OMBUDSMAN.

       Section 1808(c) of the Social Security Act (42 U.S.C. 
     1395b-9(c)) is amended by adding at the end the following new 
     paragraph:
       ``(4) Pharmaceutical and technology ombudsman.--Not later 
     than 12 months after the date of the enactment of this 
     paragraph, the Secretary shall provide for a pharmaceutical 
     and technology ombudsman within the Centers for Medicare & 
     Medicaid Services who shall receive and respond to 
     complaints, grievances, and requests that--
       ``(A) are from entities that manufacture pharmaceutical, 
     biotechnology, medical device, or diagnostic products that 
     are covered or for which coverage is being sought under this 
     title; and
       ``(B) are with respect to coverage, coding, or payment 
     under this title for such products.
     The second sentence of paragraph (2) shall apply to this 
     paragraph in the same manner as such sentence applies to 
     paragraph (2).''.

        Subtitle G--Medicare Site-of-Service Price Transparency

     SEC. 3121. MEDICARE SITE-OF-SERVICE PRICE TRANSPARENCY.

       Section 1834 of the Social Security Act (42 U.S.C. 1395m), 
     as amended by section 3061, is further amended by adding at 
     the end the following new subsection:
       ``(s) Site-of-Service Price Transparency.--
       ``(1) In general.--In order to facilitate price 
     transparency with respect to items and services for which 
     payment may be made either to a hospital outpatient 
     department or to an ambulatory surgical center under this 
     title, the Secretary shall, for 2017 and each year 
     thereafter, make available to the public via a searchable 
     website, with respect to an appropriate number of such items 
     and services--
       ``(A) the estimated payment amount for the item or service 
     under the outpatient department fee schedule under subsection 
     (t) of section 1833 and the ambulatory surgical center 
     payment system under subsection (i) of such section; and
       ``(B) the estimated amount of beneficiary liability 
     applicable to the item or service.
       ``(2) Calculation of estimated beneficiary liability.--For 
     purposes of paragraph (1)(B), the estimated amount of 
     beneficiary liability, with respect to an item or service, is 
     the amount for such item or service for which an individual 
     who does not have coverage under a medicare supplemental 
     policy certified under section 1882 or any other supplemental 
     insurance coverage is responsible.
       ``(3) Implementation.--In carrying out this subsection, the 
     Secretary--
       ``(A) shall include in the notice described in section 
     1804(a) a notification of the availability of the estimated 
     amounts made available under paragraph (1); and
       ``(B) may utilize mechanisms in existence on the date of 
     the enactment of this subsection, such as the portion of the 
     website of the Centers for Medicare & Medicaid Services on 
     which information comparing physician performance is posted 
     (commonly referred to as the Physician Compare website), to 
     make available such estimated amounts under such paragraph.
       ``(4) Funding.--For purposes of implementing this 
     subsection, the Secretary shall provide for the transfer, 
     from the Supplemental Medical Insurance Trust Fund under 
     section 1841 to the Centers for Medicare & Medicaid Services 
     Program Management Account, of $6,000,000 for fiscal year 
     2015, to remain available until expended.''.

  Subtitle H--Medicare Part D Patient Safety and Drug Abuse Prevention

     SEC. 3141. PROGRAMS TO PREVENT PRESCRIPTION DRUG ABUSE UNDER 
                   MEDICARE PARTS C AND D.

       (a) Drug Management Program for At-Risk Beneficiaries.--
       (1) In general.--Section 1860D-4(c) of the Social Security 
     Act (42 U.S.C. 1395w-10(c)) is amended by adding at the end 
     the following:
       ``(5) Drug management program for at-risk beneficiaries.--
       ``(A) Authority to establish.--A PDP sponsor may establish 
     a drug management program for at-risk beneficiaries under 
     which, subject to subparagraph (B), the PDP sponsor may, in 
     the case of an at-risk beneficiary for prescription drug 
     abuse who is an enrollee in a prescription drug plan of such 
     PDP sponsor, limit such beneficiary's access to coverage for 
     frequently abused drugs under such plan to frequently abused 
     drugs that are prescribed for such beneficiary by one or more 
     prescribers selected under subparagraph (D), and dispensed 
     for such beneficiary by one or more pharmacies selected under 
     such subparagraph.
       ``(B) Requirement for notices.--
       ``(i) In general.--A PDP sponsor may not limit the access 
     of an at-risk beneficiary for prescription drug abuse to 
     coverage for frequently abused drugs under a prescription 
     drug plan until such sponsor--

       ``(I) provides to the beneficiary an initial notice 
     described in clause (ii) and a second notice described in 
     clause (iii); and
       ``(II) verifies with the providers of the beneficiary that 
     the beneficiary is an at-risk beneficiary for prescription 
     drug abuse.

       ``(ii) Initial notice.--An initial notice described in this 
     clause is a notice that provides to the beneficiary--

       ``(I) notice that the PDP sponsor has identified the 
     beneficiary as potentially being an at-risk beneficiary for 
     prescription drug abuse;
       ``(II) information describing all State and Federal public 
     health resources that are designed to address prescription 
     drug abuse to which the beneficiary has access, including 
     mental health services and other counseling services;
       ``(III) notice of, and information about, the right of the 
     beneficiary to appeal such identification under subsection 
     (h) and the option of an automatic escalation to external 
     review;
       ``(IV) a request for the beneficiary to submit to the PDP 
     sponsor preferences for which prescribers and pharmacies the 
     beneficiary would prefer the PDP sponsor to select under 
     subparagraph (D) in the case that the beneficiary is 
     identified as an at-risk beneficiary for prescription drug 
     abuse as described in clause (iii)(I);
       ``(V) an explanation of the meaning and consequences of the 
     identification of the beneficiary as potentially being an at-
     risk beneficiary for prescription drug abuse, including an 
     explanation of the drug management program established by the 
     PDP sponsor pursuant to subparagraph (A);
       ``(VI) clear instructions that explain how the beneficiary 
     can contact the PDP sponsor in order to submit to the PDP 
     sponsor the preferences described in subclause (IV) and any 
     other communications relating to the drug management program 
     for at-risk beneficiaries established by the PDP sponsor; and
       ``(VII) contact information for other organizations that 
     can provide the beneficiary with assistance regarding such 
     drug management program (similar to the information provided 
     by the Secretary in other standardized notices provided to 
     part D eligible individuals enrolled in prescription drug 
     plans under this part).

       ``(iii) Second notice.--A second notice described in this 
     clause is a notice that provides to the beneficiary notice--

       ``(I) that the PDP sponsor has identified the beneficiary 
     as an at-risk beneficiary for prescription drug abuse;
       ``(II) that such beneficiary is subject to the requirements 
     of the drug management program for at-risk beneficiaries 
     established by such PDP sponsor for such plan;
       ``(III) of the prescriber (or prescribers) and pharmacy (or 
     pharmacies) selected for such individual under subparagraph 
     (D);
       ``(IV) of, and information about, the beneficiary's right 
     to appeal such identification

[[Page 11312]]

     under subsection (h) and the option of an automatic 
     escalation to external review;
       ``(V) that the beneficiary can, in the case that the 
     beneficiary has not previously submitted to the PDP sponsor 
     preferences for which prescribers and pharmacies the 
     beneficiary would prefer the PDP sponsor select under 
     subparagraph (D), submit such preferences to the PDP sponsor; 
     and
       ``(VI) that includes clear instructions that explain how 
     the beneficiary can contact the PDP sponsor.

       ``(iv) Timing of notices.--

       ``(I) In general.--Subject to subclause (II), a second 
     notice described in clause (iii) shall be provided to the 
     beneficiary on a date that is not less than 60 days after an 
     initial notice described in clause (ii) is provided to the 
     beneficiary.
       ``(II) Exception.--In the case that the PDP sponsor, in 
     conjunction with the Secretary, determines that concerns 
     identified through rulemaking by the Secretary regarding the 
     health or safety of the beneficiary or regarding significant 
     drug diversion activities require the PDP sponsor to provide 
     a second notice described in clause (iii) to the beneficiary 
     on a date that is earlier than the date described in 
     subclause (I), the PDP sponsor may provide such second notice 
     on such earlier date.

       ``(C) At-risk beneficiary for prescription drug abuse.--
       ``(i) In general.--For purposes of this paragraph, the term 
     `at-risk beneficiary for prescription drug abuse' means a 
     part D eligible individual who is not an exempted individual 
     described in clause (ii) and--

       ``(I) who is identified as such an at-risk beneficiary 
     through the use of clinical guidelines developed by the 
     Secretary in consultation with PDP sponsors and other 
     stakeholders described in section 3141(f)(2)(A) of the 21st 
     Century Cures Act; or
       ``(II) with respect to whom the PDP sponsor of a 
     prescription drug plan, upon enrolling such individual in 
     such plan, received notice from the Secretary that such 
     individual was identified under this paragraph to be an at-
     risk beneficiary for prescription drug abuse under the 
     prescription drug plan in which such individual was most 
     recently previously enrolled and such identification has not 
     been terminated under subparagraph (F).

       ``(ii) Exempted individual described.--An exempted 
     individual described in this clause is an individual who--

       ``(I) receives hospice care under this title;
       ``(II) is a resident of a long-term care facility, of an 
     intermediate care facility for the mentally retarded, or of 
     another facility for which frequently abused drugs are 
     dispensed for residents through a contract with a single 
     pharmacy; or
       ``(III) the Secretary elects to treat as an exempted 
     individual for purposes of clause (i).

       ``(D) Selection of prescribers and pharmacies.--
       ``(i) In general.--With respect to each at-risk beneficiary 
     for prescription drug abuse enrolled in a prescription drug 
     plan offered by such sponsor, a PDP sponsor shall, based on 
     the preferences submitted to the PDP sponsor by the 
     beneficiary pursuant to clauses (ii)(IV) and (iii)(V) of 
     subparagraph (B) (except as otherwise provided in this 
     subparagraph), select--

       ``(I) one or more individuals who are authorized to 
     prescribe frequently abused drugs (referred to in this 
     paragraph as `prescribers') who may write prescriptions for 
     such drugs for such beneficiary; and
       ``(II) one or more pharmacies that may dispense such drugs 
     to such beneficiary.

       ``(ii) Reasonable access.--In making the selections under 
     this subparagraph--

       ``(I) a PDP sponsor shall ensure that the beneficiary 
     continues to have reasonable access to frequently abused 
     drugs (as defined in subparagraph (G)), taking into account 
     geographic location, beneficiary preference, impact on 
     costsharing, and reasonable travel time; and
       ``(II) a PDP sponsor shall ensure such access (including 
     access to prescribers and pharmacies with respect to 
     frequently abused drugs) in the case of individuals with 
     multiple residences and in the case of natural disasters and 
     similar emergency situations.

       ``(iii) Beneficiary preferences.--If an at-risk beneficiary 
     for prescription drug abuse submits preferences for which in-
     network prescribers and pharmacies the beneficiary would 
     prefer the PDP sponsor select in response to a notice under 
     subparagraph (B), the PDP sponsor shall--

       ``(I) review such preferences;
       ``(II) select or change the selection of prescribers and 
     pharmacies for the beneficiary based on such preferences; and
       ``(III) inform the beneficiary of such selection or change 
     of selection.

       ``(iv) Exception regarding beneficiary preferences.--In the 
     case that the PDP sponsor determines that a change to the 
     selection of prescriber or pharmacy under clause (iii)(II) by 
     the PDP sponsor is contributing or would contribute to 
     prescription drug abuse or drug diversion by the beneficiary, 
     the PDP sponsor may change the selection of prescriber or 
     pharmacy for the beneficiary without regard to the 
     preferences of the beneficiary described in clause (iii).
       ``(v) Confirmation.--Before selecting a prescriber (or 
     prescribers) or pharmacy (or pharmacies) under this 
     subparagraph, a PDP sponsor must request and receive 
     confirmation from such a prescriber or pharmacy acknowledging 
     and accepting that the beneficiary involved is in the drug 
     management program for at-risk beneficiaries.
       ``(E) Terminations and appeals.--The identification of an 
     individual as an at-risk beneficiary for prescription drug 
     abuse under this paragraph, a coverage determination made 
     under a drug management program for at-risk beneficiaries, 
     and the selection of prescriber or pharmacy under 
     subparagraph (D) with respect to such individual shall be 
     subject to reconsideration and appeal under subsection (h) 
     and the option of an automatic escalation to external review 
     to the extent provided by the Secretary.
       ``(F) Termination of identification.--
       ``(i) In general.--The Secretary shall develop standards 
     for the termination of identification of an individual as an 
     at-risk beneficiary for prescription drug abuse under this 
     paragraph. Under such standards such identification shall 
     terminate as of the earlier of--

       ``(I) the date the individual demonstrates that the 
     individual is no longer likely, in the absence of the 
     restrictions under this paragraph, to be an at-risk 
     beneficiary for prescription drug abuse described in 
     subparagraph (C)(i); and
       ``(II) the end of such maximum period of identification as 
     the Secretary may specify.

       ``(ii) Rule of construction.--Nothing in clause (i) shall 
     be construed as preventing a plan from identifying an 
     individual as an at-risk beneficiary for prescription drug 
     abuse under subparagraph (C)(i) after such termination on the 
     basis of additional information on drug use occurring after 
     the date of notice of such termination.
       ``(G) Frequently abused drug.--For purposes of this 
     subsection, the term `frequently abused drug' means a drug 
     that is a controlled substance that the Secretary determines 
     to be frequently abused or diverted.
       ``(H) Data disclosure.--In the case of an at-risk 
     beneficiary for prescription drug abuse whose access to 
     coverage for frequently abused drugs under a prescription 
     drug plan has been limited by a PDP sponsor under this 
     paragraph, such PDP sponsor shall disclose data, including 
     any necessary individually identifiable health information, 
     in a form and manner specified by the Secretary, about the 
     decision to impose such limitations and the limitations 
     imposed by the sponsor under this part to other PDP sponsors 
     that request such data.
       ``(I) Education.--The Secretary shall provide education to 
     enrollees in prescription drug plans of PDP sponsors and 
     providers regarding the drug management program for at-risk 
     beneficiaries described in this paragraph, including 
     education--
       ``(i) provided by medicare administrative contractors 
     through the improper payment outreach and education program 
     described in section 1874A(h); and
       ``(ii) through current education efforts (such as State 
     health insurance assistance programs described in subsection 
     (a)(1)(A) of section 119 of the Medicare Improvements for 
     Patients and Providers Act of 2008 (42 U.S.C. 1395b-3 note)) 
     and materials directed toward such enrollees.
       ``(J) Application under ma-pd plans.--Pursuant to section 
     1860D--21(c)(1), the provisions of this paragraph apply under 
     part D to MA organizations offering MA-PD plans to MA 
     eligible individuals in the same manner as such provisions 
     apply under this part to a PDP sponsor offering a 
     prescription drug plan to a part D eligible individual.''.
       (2) Information for consumers.--Section 1860D-4(a)(1)(B) of 
     the Social Security Act (42 U.S.C. 1395w-104(a)(1)(B)) is 
     amended by adding at the end the following:
       ``(v) The drug management program for at-risk beneficiaries 
     under subsection (c)(5).''.
       (b) Utilization Management Programs.--Section 1860D-4(c) of 
     the Social Security Act (42 U.S.C. 1395w-104(c)), as amended 
     by subsection (a)(1), is further amended--
       (1) in paragraph (1), by inserting after subparagraph (D) 
     the following new subparagraph:
       ``(E) A utilization management tool to prevent drug abuse 
     (as described in paragraph (6)(A)).''; and
       (2) by adding at the end the following new paragraph:
       ``(6) Utilization management tool to prevent drug abuse.--
       ``(A) In general.--A tool described in this paragraph is 
     any of the following:
       ``(i) A utilization tool designed to prevent the abuse of 
     frequently abused drugs by individuals and to prevent the 
     diversion of such drugs at pharmacies.
       ``(ii) Retrospective utilization review to identify--

       ``(I) individuals that receive frequently abused drugs at a 
     frequency or in amounts that are not clinically appropriate; 
     and
       ``(II) providers of services or suppliers that may 
     facilitate the abuse or diversion of frequently abused drugs 
     by beneficiaries.

       ``(iii) Consultation with the contractor described in 
     subparagraph (B) to verify if an individual enrolling in a 
     prescription drug plan offered by a PDP sponsor has been 
     previously identified by another PDP sponsor as an individual 
     described in clause (ii)(I).
       ``(B) Reporting.--A PDP sponsor offering a prescription 
     drug plan (and an MA organization offering an MA-PD plan) in 
     a State shall submit to the Secretary and the Medicare drug 
     integrity contractor with which the Secretary has entered 
     into a contract under section 1893 with respect to such State 
     a report, on a monthly basis, containing information on--
       ``(i) any provider of services or supplier described in 
     subparagraph (A)(ii)(II) that is identified by such plan 
     sponsor (or organization) during the 30-day period before 
     such report is submitted; and

[[Page 11313]]

       ``(ii) the name and prescription records of individuals 
     described in paragraph (5)(C).''.
       (c) Expanding Activities of Medicare Drug Integrity 
     Contractors (MEDICs).--
       (1) In general.--Section 1893 of the Social Security Act 
     (42 U.S.C. 1395ddd) is amended by adding at the end the 
     following new subsection:
       ``(j) Expanding Activities of Medicare Drug Integrity 
     Contractors (MEDICs).--
       ``(1) Access to information.--Under contracts entered into 
     under this section with Medicare drug integrity contractors 
     (including any successor entity to a Medicare drug integrity 
     contractor), the Secretary shall authorize such contractors 
     to directly accept prescription and necessary medical records 
     from entities such as pharmacies, prescription drug plans, 
     MA-PD plans, and physicians with respect to an individual in 
     order for such contractors to provide information relevant to 
     the determination of whether such individual is an at-risk 
     beneficiary for prescription drug abuse, as defined in 
     section 1860D-4(c)(5)(C).
       ``(2) Requirement for acknowledgment of referrals.--If a 
     PDP sponsor or MA organization refers information to a 
     contractor described in paragraph (1) in order for such 
     contractor to assist in the determination described in such 
     paragraph, the contractor shall--
       ``(A) acknowledge to the sponsor or organization receipt of 
     the referral; and
       ``(B) in the case that any PDP sponsor or MA organization 
     contacts the contractor requesting to know the determination 
     by the contractor of whether or not an individual has been 
     determined to be an individual described such paragraph, 
     shall inform such sponsor or organization of such 
     determination on a date that is not later than 15 days after 
     the date on which the sponsor or organization contacts the 
     contractor.
       ``(3) Making data available to other entities.--
       ``(A) In general.--For purposes of carrying out this 
     subsection, subject to subparagraph (B), the Secretary shall 
     authorize MEDICs to respond to requests for information from 
     PDP sponsors and MA organizations, State prescription drug 
     monitoring programs, and other entities delegated by such 
     sponsors or organizations using available programs and 
     systems in the effort to prevent fraud, waste, and abuse.
       ``(B) HIPAA compliant information only.--Information may 
     only be disclosed by a MEDIC under subparagraph (A) if the 
     disclosure of such information is permitted under the Federal 
     regulations (concerning the privacy of individually 
     identifiable health information) promulgated under section 
     264(c) of the Health Insurance Portability and Accountability 
     Act of 1996 (42 U.S.C. 1320d-2 note).''.
       (2) OIG study and report on effectiveness of medics.--
       (A) Study.--The Inspector General of the Department of 
     Health and Human Services shall conduct a study on the 
     effectiveness of Medicare drug integrity contractors with 
     which the Secretary of Health and Human Services has entered 
     into a contract under section 1893 of the Social Security Act 
     (42 U.S.C. 1395ddd) in identifying, combating, and preventing 
     fraud under the Medicare program, including under the 
     authority provided under section 1893(j) of the Social 
     Security Act, added by paragraph (1).
       (B) Report.--Not later than 1 year after the date of the 
     enactment of this Act, the Inspector General shall submit to 
     Congress a report on the study conducted under subparagraph 
     (A). Such report shall include such recommendations for 
     improvements in the effectiveness of such contractors as the 
     Inspector General determines appropriate.
       (d) Treatment of Certain Complaints for Purposes of Quality 
     or Performance Assessment.--Section 1860D-42 of the Social 
     Security Act (42 U.S.C. 1395w-152) is amended by adding at 
     the end the following new subsection:
       ``(d) Treatment of Certain Complaints for Purposes of 
     Quality or Performance Assessment.--In conducting a quality 
     or performance assessment of a PDP sponsor, the Secretary 
     shall develop or utilize existing screening methods for 
     reviewing and considering complaints that are received from 
     enrollees in a prescription drug plan offered by such PDP 
     sponsor and that are complaints regarding the lack of access 
     by the individual to prescription drugs due to a drug 
     management program for at-risk beneficiaries.''.
       (e) Sense of Congress Regarding Use of Technology Tools To 
     Combat Fraud.--It is the sense of Congress that MA 
     organizations and PDP sponsors should consider using e-
     prescribing and other health information technology tools to 
     support combating fraud under MA-PD plans and prescription 
     drug plans under parts C and D of the Medicare program.
       (f) Effective Date.--
       (1) In general.--The amendments made by this section shall 
     apply to prescription drug plans (and MA-PD plans) for plan 
     years beginning more than 1 year after the date of the 
     enactment of this Act.
       (2) Stakeholder meetings prior to effective date.--
       (A) In general.--Not later than January 1, 2016, the 
     Secretary of Health and Human Services shall convene 
     stakeholders, including individuals entitled to benefits 
     under part A of title XVIII of the Social Security Act or 
     enrolled under part B of such title of such Act, advocacy 
     groups representing such individuals, physicians, 
     pharmacists, and other clinicians, retail pharmacies, plan 
     sponsors, entities delegated by plan sponsors, and 
     biopharmaceutical manufacturers for input regarding the 
     topics described in subparagraph (B).
       (B) Topics described.--The topics described in this 
     subparagraph are the topics of--
       (i) the anticipated impact of drug management programs for 
     at-risk beneficiaries under paragraph (5) of section 1860D-
     4(c) of the Social Security Act (42 U.S.C. 1395w-104(c)) on 
     cost-sharing and ensuring accessibility to prescription drugs 
     for enrollees in prescription drug plans of PDP sponsors, and 
     enrollees in MA-PD plans, who are at-risk beneficiaries for 
     prescription drug abuse (as defined in subparagraph (C) of 
     such paragraph);
       (ii) the use of an expedited appeals process under which 
     such an enrollee may appeal an identification of such 
     enrollee as an at-risk beneficiary for prescription drug 
     abuse under such paragraph (similar to the processes 
     established under the Medicare Advantage program under part C 
     of title XVIII of the Social Security Act that allow an 
     automatic escalation to external review of claims submitted 
     under such part);
       (iii) the types of enrollees that should be treated as 
     exempted individuals, as described in subparagraph (C)(ii) of 
     such paragraph;
       (iv) the manner in which terms and definitions in such 
     paragraph should be applied, such as the use of clinical 
     appropriateness in determining whether an enrollee is an at-
     risk beneficiary for prescription drug abuse as defined in 
     subparagraph (C) of such paragraph;
       (v) the information to be included in the notices described 
     in subparagraph (B) of such paragraph and the standardization 
     of such notices; and
       (vi) with respect to a PDP sponsor (or Medicare Advantage 
     organization) that establishes a drug management program for 
     at-risk beneficiaries under such paragraph, the 
     responsibilities of such PDP sponsor (or organization) with 
     respect to the implementation of such program.
       (g) Rulemaking.--The Secretary of Health and Human Services 
     shall promulgate regulations based on the input gathered 
     pursuant to subsection (f)(2)(A).

            TITLE IV--MEDICAID, MEDICARE, AND OTHER REFORMS

               Subtitle A--Medicaid and Medicare Reforms

     SEC. 4001. LIMITING FEDERAL MEDICAID REIMBURSEMENT TO STATES 
                   FOR DURABLE MEDICAL EQUIPMENT (DME) TO MEDICARE 
                   PAYMENT RATES.

       (a) Medicaid Reimbursement.--
       (1) In general.--Section 1903(i) of the Social Security Act 
     (42 U.S.C. 1396b(i)) is amended--
       (A) in paragraph (25), by striking ``or'' at the end;
       (B) in paragraph (26), by striking the period at the end 
     and inserting ``; or''; and
       (C) by inserting after paragraph (26) the following new 
     paragraph:
       ``(27) with respect to any amounts expended by the State on 
     the basis of a fee schedule for items described in section 
     1861(n), as determined in the aggregate with respect to each 
     class of such items as defined by the Secretary, in excess of 
     the aggregate amount, if any, that would be paid for such 
     items within such class on a fee-for-service basis under the 
     program under part B of title XVIII, including, as 
     applicable, under a competitive acquisition program under 
     section 1847 in an area of the State.''.
       (2) Effective date.--The amendments made by this subsection 
     shall be effective with respect to payments for items 
     furnished on or after January 1, 2020.
       (b) Medicare Ombudsman.--Section 1808(c) of the Social 
     Security Act (42 U.S.C. 1395b(c)), as amended by section 
     3101, is further amended by adding at the end the following 
     new paragraph:
       ``(5) Monitoring dme reimbursement under medicaid.--The 
     ombudsmen under each of paragraphs (1) and (4) shall evaluate 
     the impact of the competitive acquisition program under 
     section 1847, including as applied under section 1903(i)(27), 
     on beneficiary health status and health outcomes.''.

     SEC. 4002. EXCLUDING AUTHORIZED GENERICS FROM CALCULATION OF 
                   AVERAGE MANUFACTURER PRICE.

       (a) In General.--Subparagraph (C) of section 1927(k)(1) of 
     the Social Security Act (42 U.S.C. 1396r-8(k)(1)) is 
     amended--
       (1) in the subparagraph heading, by striking ``Inclusion'' 
     and inserting ``Exclusion'';
       (2) by striking ``a new drug application'' and inserting 
     ``the manufacturer's new drug application''; and
       (3) by striking ``inclusive'' and inserting ``exclusive''.
       (b) Effective Date.--The amendments made by this section 
     take effect on October 1, 2015.

     SEC. 4003. MEDICARE PAYMENT INCENTIVE FOR THE TRANSITION FROM 
                   TRADITIONAL X-RAY IMAGING TO DIGITAL 
                   RADIOGRAPHY AND OTHER MEDICARE IMAGING PAYMENT 
                   PROVISION.

       (a) Physician Fee Schedule.--
       (1) Payment incentive for transition.--
       (A) In general.--Section 1848(b) of the Social Security Act 
     (42 U.S.C. 1395w-4(b)) is amended by adding at the end the 
     following new paragraph:
       ``(9) Special rule to incentivize transition from 
     traditional x-ray imaging to digital radiography.--
       ``(A) Limitation on payment for film x-ray imaging 
     services.--In the case of an imaging service (including the 
     imaging portion of a service) that is an X-ray taken using 
     film and that is furnished during 2017 or a subsequent year, 
     the payment amount for the technical component (including the 
     technical component portion of a global service) of such 
     service that would otherwise be determined under this section 
     (without application of this paragraph and before application 
     of any other adjustment under

[[Page 11314]]

     this section) for such year shall be reduced by 20 percent.
       ``(B) Phased-in limitation on payment for computed 
     radiography imaging services.--In the case of an imaging 
     service (including the imaging portion of a service) that is 
     an X-ray taken using computed radiography technology--
       ``(i) in the case of such a service furnished during 2018, 
     2019, 2020, 2021, or 2022, the payment amount for the 
     technical component (including the technical component 
     portion of a global service) of such service that would 
     otherwise be determined under this section (without 
     application of this paragraph and before application of any 
     other adjustment under this section) for such year shall be 
     reduced by 7 percent; and
       ``(ii) in the case of such a service furnished during 2023 
     or a subsequent year, the payment amount for the technical 
     component (including the technical component portion of a 
     global service) of such service that would otherwise be 
     determined under this section (without application of this 
     paragraph and before application of any other adjustment 
     under this section) for such year shall be reduced by 10 
     percent.
       ``(C) Computed radiography technology defined.--For 
     purposes of this paragraph, the term `computed radiography 
     technology' means cassette-based imaging which utilizes an 
     imaging plate to create the image involved.
       ``(D) Implementation.--In order to implement this 
     paragraph, the Secretary shall adopt appropriate mechanisms 
     which may include use of modifiers.''.
       (B) Exemption from budget neutrality.--Section 
     1848(c)(2)(B)(v) of the Social Security Act (42 U.S.C. 1395w-
     4(c)(2)(B)(v)) is amended by adding at the end the following 
     new subclause:

       ``(X) Reduced expenditures attributable to incentives to 
     transition to digital radiography.--Effective for fee 
     schedules established beginning with 2017, reduced 
     expenditures attributable to subparagraph (A) of subsection 
     (b)(9) and effective for fee schedules established beginning 
     with 2018, reduced expenditures attributable to subparagraph 
     (B) of such subsection.''.

       (2) Elimination of application of multiple procedure 
     payment reduction.--
       (A) In general.--Section 1848(b)(4) of the Social Security 
     Act (42 U.S.C. 1395w-4(b)(4)) is amended by adding at the end 
     the following new subparagraph:
       ``(E) Elimination of application of multiple procedure 
     payment reduction.--
       ``(i) In general.--For services furnished on or after 
     January 1, 2017, the Secretary shall not apply a multiple 
     procedure payment reduction to the professional component of 
     imaging services unless the Secretary has published as part 
     of a Medicare Physician Fee Schedule Proposed Rule the 
     empirical analysis described in clause (ii) with tables made 
     available on the website of the Centers for Medicare & 
     Medicaid Services.
       ``(ii) Empirical analysis described.--The empirical 
     analysis described in this clause is an analysis of the 
     Resource-Based Relative Value Scale Data Manager information 
     or other information that is used to determine what, if any, 
     efficiencies exist within the professional component of 
     imaging services when two or more studies are furnished to 
     the same individual on the same day. Such empirical analysis 
     shall include--

       ``(I) information detailing which physician work activities 
     overlap and the reductions applicable to such overlap;
       ``(II) a discussion of the clinical aspects that informed 
     the assignment of the reduction percentages described in 
     subclause (I);
       ``(III) to the extent that such reductions are used for 
     proposed payment reductions, an explanation of how the 
     percentage reductions for pre-service, intra-service, and 
     post-service work were determined and calculated;
       ``(IV) other data used to determine a reduction; and
       ``(V) a demonstration that the Secretary has consulted with 
     practicing radiologists to gain knowledge of how radiologists 
     interpret studies of multiple body parts on the same 
     individual on the same day.''.

       (B) Conforming amendment.--Section 220(i) of the Protecting 
     Access to Medicare Act of 2014 (42 U.S.C. 1395w-4 note) is 
     repealed.
       (b) Payment Incentive for Transition Under Hospital 
     Outpatient Prospective Payment System.--Section 1833(t)(16) 
     of the Social Security Act (42 U.S.C. 1395(t)(16)) is amended 
     by adding at the end the following new subparagraph:
       ``(F) Payment incentive for the transition from traditional 
     x-ray imaging to digital radiography.--Notwithstanding the 
     previous provisions of this subsection:
       ``(i) Limitation on payment for film x-ray imaging 
     services.--In the case of an imaging service that is an X-ray 
     taken using film and that is furnished during 2017 or a 
     subsequent year, the payment amount for such service 
     (including the X-ray component of a packaged service) that 
     would otherwise be determined under this section (without 
     application of this paragraph and before application of any 
     other adjustment under this subsection) for such year shall 
     be reduced by 20 percent.
       ``(ii) Phased-in limitation on payment for computed 
     radiography imaging services.--In the case of an imaging 
     service that is an X-ray taken using computed radiography 
     technology (as defined in section 1848(b)(9)(C))--

       ``(I) in the case of such a service furnished during 2018, 
     2019, 2020, 2021, or 2022, the payment amount for such 
     service (including the X-ray component of a packaged service) 
     that would otherwise be determined under this section 
     (without application of this paragraph and before application 
     of any other adjustment under this subsection) for such year 
     shall be reduced by 7 percent; and
       ``(II) in the case of such a service furnished during 2023 
     or a subsequent year, the payment amount for such service 
     (including the X-ray component of a packaged service) that 
     would otherwise be determined under this section (without 
     application of this paragraph and before application of any 
     other adjustment under this subsection) for such year shall 
     be reduced by 10 percent.

       ``(iii) Application without regard to budget neutrality.--
     The reductions made under this paragraph--

       ``(I) shall not be considered an adjustment under paragraph 
     (2)(E); and
       ``(II) shall not be implemented in a budget neutral manner.

       ``(iv) Implementation.--In order to implement this 
     subparagraph, the Secretary shall adopt appropriate 
     mechanisms which may include use of modifiers.''.

     SEC. 4004. TREATMENT OF INFUSION DRUGS FURNISHED THROUGH 
                   DURABLE MEDICAL EQUIPMENT.

       Section 1842(o)(1) of the Social Security Act (42 U.S.C. 
     1395u(o)(1)) is amended--
       (1) in subparagraph (C), by inserting ``(and including a 
     drug or biological described in subparagraph (D)(i) furnished 
     on or after January 1, 2017)'' after ``2005''; and
       (2) in subparagraph (D)--
       (A) by striking ``infusion drugs'' and inserting ``infusion 
     drugs or biologicals'' each place it appears; and
       (B) in clause (i)--
       (i) by striking ``2004'' and inserting ``2004, and before 
     January 1, 2017''; and
       (ii) by striking ``for such drug''.

     SEC. 4005. EXTENSION AND EXPANSION OF PRIOR AUTHORIZATION FOR 
                   POWER MOBILITY DEVICES (PMDS) AND ACCESSORIES 
                   AND PRIOR AUTHORIZATION AUDIT LIMITATIONS.

       Section 1834(a) of the Social Security Act (42 U.S.C. 
     1395m(a)) is amended--
       (1) in paragraph (15), by adding at the end the following 
     new subparagraph:
       ``(D) Limitation on audits after advance determination.--A 
     claim for an item that has received a provisional affirmation 
     under an advance determination under this paragraph or a 
     prior authorization under paragraph (23) shall not be subject 
     to review under section 1893(h) but may be subject to audits 
     for potential fraud, inappropriate utilization, changes in 
     billing patterns, or information that could not have been 
     considered during the advance determination (such as proof of 
     item delivery).''; and
       (2) by adding at the end the following new paragraph:
       ``(23) Prior authorization for power mobility devices 
     (pmds) and accessories.--Not later than 90 days after the 
     date of the enactment of this paragraph, the Secretary shall, 
     using funds provided under paragraph (2) of section 402(a) of 
     the Social Security Amendments of 1967 and other funds 
     available to the Secretary--
       ``(A) extend at least through August 31, 2018, the PMD 
     Prior Authorization Demonstration (being conducted under 
     paragraph (1)(J) of such section);
       ``(B) begin to expand, as appropriate, such demonstration 
     to include additional power mobility devices and accessories 
     as part of initial claims for payment under this part for 
     such devices; and
       ``(C) begin to expand such demonstration to such additional 
     States or geographic areas as may be appropriate.''.

     SEC. 4006. CIVIL MONETARY PENALTIES FOR VIOLATIONS RELATED TO 
                   GRANTS, CONTRACTS, AND OTHER AGREEMENTS.

       (a) In General.--Section 1128A of the Social Security Act 
     (42 U.S.C. 1320a-7a) is amended by adding at the end the 
     following new subsection:
       ``(o) Any person (including an organization, agency, or 
     other entity, but excluding a program beneficiary, as defined 
     in subsection (r)(4)) that, with respect to a grant, 
     contract, or other agreement for which the Secretary of 
     Health and Human Services provides funding--
       ``(1) knowingly presents or causes to be presented a 
     specified claim (as defined in subsection (r)(6)) under such 
     grant, contract, or other agreement that the person knows or 
     should know is false or fraudulent;
       ``(2) knowingly makes, uses, or causes to be made or used 
     any false statement, omission, or misrepresentation of a 
     material fact in any application, proposal, bid, progress 
     report, or other document that is required to be submitted in 
     order to directly or indirectly receive or retain funds 
     provided in whole or in part by such Secretary pursuant to 
     such grant, contract, or other agreement;
       ``(3) knowingly makes, uses, or causes to be made or used, 
     a false record or statement material to a false or fraudulent 
     specified claim under such grant, contract, or other 
     agreement;
       ``(4) knowingly makes, uses, or causes to be made or used, 
     a false record or statement material to an obligation to pay 
     or transmit funds or property to such Secretary with respect 
     to such grant, contract, or other agreement, or knowingly 
     conceals or knowingly and improperly avoids or decreases an 
     obligation to pay or transmit funds or property to such 
     Secretary with respect to such grant, contract, or other 
     agreement; or
       ``(5) fails to grant timely access, upon reasonable request 
     (as defined by such Secretary in

[[Page 11315]]

     regulations), to the Inspector General of the Department, for 
     the purpose of audits, investigations, evaluations, or other 
     statutory functions of such Inspector General in matters 
     involving such grants, contracts, or other agreements;

     shall be subject, in addition to any other penalties that may 
     be prescribed by law, to a civil money penalty in cases under 
     paragraph (1), of not more than $10,000 for each specified 
     claim; in cases under paragraph (2), not more than $50,000 
     for each false statement, omission, or misrepresentation of a 
     material fact; in cases under paragraph (3), not more than 
     $50,000 for each false record or statement; in cases under 
     paragraph (4), not more than $50,000 for each false record or 
     statement or $10,000 for each day that the person knowingly 
     conceals or knowingly and improperly avoids or decreases an 
     obligation to pay; or in cases under paragraph (5), not more 
     than $15,000 for each day of the failure described in such 
     paragraph. In addition, in cases under paragraphs (1) and 
     (3), such a person shall be subject to an assessment of not 
     more than 3 times the amount claimed in the specified claim 
     described in such paragraph in lieu of damages sustained by 
     the United States or a specified State agency because of such 
     specified claim, and in cases under paragraphs (2) and (4), 
     such a person shall be subject to an assessment of not more 
     than 3 times the total amount of the funds described in 
     paragraph (2) or (4), respectively (or, in the case of an 
     obligation to transmit property to the Secretary Health and 
     Human Services described in paragraph (4), of the value of 
     the property described in such paragraph) in lieu of damages 
     sustained by the United States or a specified State agency 
     because of such case. In addition, the Secretary of Health 
     and Human Services may make a determination in the same 
     proceeding to exclude the person from participation in the 
     Federal health care programs (as defined in section 
     1128B(f)(1)) and to direct the appropriate State agency to 
     exclude the person from participation in any State health 
     care program.
       ``(p) The provisions of subsections (c), (d), and (g) shall 
     apply to a civil money penalty or assessment under subsection 
     (o) in the same manner as such provisions apply to a penalty, 
     assessment, or proceeding under subsection (a).
       ``(q) With respect to a penalty or assessment under 
     subsection (o), the Inspector General of the Department is 
     authorized to receive, and to retain for current use, such 
     amounts of such penalty or assessment as are necessary to 
     provide reimbursement for the costs of conducting 
     investigations and audits with respect to such subsection and 
     for monitoring compliance plans with respect to such 
     subsection when such penalty or assessment is ordered by a 
     court, voluntarily agreed to by the payor, or otherwise. 
     Funds received by such Inspector General as reimbursement 
     under the preceding sentence shall be deposited to the credit 
     of the appropriations from which initially paid, or to 
     appropriations for similar purposes currently available at 
     the time of deposit, and shall remain available for 
     obligation for 1 year from the date of the deposit of such 
     funds.
       ``(r) For purposes of this subsection and subsections (o), 
     (p), and (q):
       ``(1) The term `Department' means the Department of Health 
     and Human Services.
       ``(2) The term `material' means having a natural tendency 
     to influence, or be capable of influencing, the payment or 
     receipt of money or property.
       ``(3) The term `other agreement' includes a cooperative 
     agreement, scholarship, fellowship, loan, subsidy, payment 
     for a specified use, donation agreement, award, or sub-award 
     (regardless of whether one or more of the persons entering 
     into the agreement is a contractor or sub-contractor).
       ``(4) The term `program beneficiary' means, in the case of 
     a grant, contract, or other agreement designed to accomplish 
     the objective of awarding or otherwise furnishing benefits or 
     assistance to individuals and for which the Secretary of 
     Health and Human Services provides funding, an individual who 
     applies for, or who receives, such benefits or assistance 
     from such grant, contract, or other agreement. Such term does 
     not include, with respect to such grant, contract, or other 
     agreement, an officer, employee, or agent of a person or 
     entity that receives such grant or that enters into such 
     contract or other agreement.
       ``(5) The term `recipient' includes a sub-recipient or 
     subcontractor.
       ``(6) The term `specified claim' means any application, 
     request, or demand under a grant, contract, or other 
     agreement for money or property, whether or not the United 
     States or a specified State agency has title to the money or 
     property, that is not a claim (as defined in subsection 
     (i)(2)) and that--
       ``(A) is presented or caused to be presented to an officer, 
     employee, or agent of the Department or agency thereof, or of 
     any specified State agency; or
       ``(B) is made to a contractor, grantee, or any other 
     recipient if the money or property is to be spent or used on 
     the Department's behalf or to advance a Department program or 
     interest, and if the Department--
       ``(i) provides or has provided any portion of the money or 
     property requested or demanded; or
       ``(ii) will reimburse such contractor, grantee or other 
     recipient for any portion of the money or property which is 
     requested or demanded.
       ``(7) The term `specified State agency' means an agency of 
     a State government established or designated to administer or 
     supervise the administration of a grant, contract, or other 
     agreement funded in whole or in part by the Secretary of 
     Health and Human Services.
       ``(s) For purposes of subsection (o), the term `obligation' 
     means an established duty, whether or not fixed, arising from 
     an express or implied contractual, grantor-grantee, or 
     licensor-licensee relationship, for a fee-based or similar 
     relationship, from statute or regulation, or from the 
     retention of any overpayment.''.
       (b) Conforming Amendments.--Section 1128A of the Social 
     Security Act (42 U.S.C. 1320a-7a) is amended--
       (1) in subsection (d)--
       (A) in paragraph (1), by inserting ``or specified claims'' 
     after ``claims'';
       (B) in paragraph (2), by inserting ``or specified claims'' 
     after ``claims'';
       (2) in subsection (e), by inserting ``or specified claim'' 
     after ``claim''; and
       (3) in subsection (f)--
       (A) by inserting ``or specified claim (as defined in 
     subsection (r)(6))'' after ``district where the claim'';
       (B) by inserting ``(or, with respect to a person described 
     in subsection (o), the person)'' after ``claimant'';
       (C) by inserting ``that are not received by the Inspector 
     General of the Department of Health and Human Services under 
     subsection (q) as reimbursement'' after ``amounts 
     recovered''; and
       (D) by inserting ``(or, in the case of a penalty or 
     assessment under subsection (o), by a specified State agency 
     (as defined in subsection (r)(7))'' after ``or a State 
     agency''.

                       Subtitle B--Other Reforms

     SEC. 4041. SPR DRAWDOWN.

       (a) Drawdown and Sale.--Notwithstanding section 161 of the 
     Energy Policy and Conservation Act (42 U.S.C. 6241), except 
     as provided in subsection (b) the Secretary of Energy shall 
     draw down and sell--
       (1) 4,000,000 barrels of crude oil from the Strategic 
     Petroleum Reserve during fiscal year 2018;
       (2) 5,000,000 barrels of crude oil from the Strategic 
     Petroleum Reserve during fiscal year 2019;
       (3) 8,000,000 barrels of crude oil from the Strategic 
     Petroleum Reserve during fiscal year 2020;
       (4) 8,000,000 barrels of crude oil from the Strategic 
     Petroleum Reserve during fiscal year 2021;
       (5) 10,000,000 barrels of crude oil from the Strategic 
     Petroleum Reserve during fiscal year 2022;
       (6) 15,000,000 barrels of crude oil from the Strategic 
     Petroleum Reserve during fiscal year 2023;
       (7) 15,000,000 barrels of crude oil from the Strategic 
     Petroleum Reserve during fiscal year 2024; and
       (8) 15,000,000 barrels of crude oil from the Strategic 
     Petroleum Reserve during fiscal year 2025.
     Amounts received for a sale under this subsection shall be 
     deposited in the General Fund of the Treasury during the 
     fiscal year in which the sale occurs.
       (b) Emergency Protection.--The Secretary shall not draw 
     down and sell crude oil under this section in amounts that 
     would result in a Strategic Petroleum Reserve that contains 
     an inventory of petroleum products representing less than 90 
     days of emergency reserves, based on the average daily level 
     of net imports of crude oil and petroleum products in the 
     previous calendar year.
       (c) Proceeds.--Proceeds from a sale under this section 
     shall be deposited into the general fund of the Treasury of 
     the United States.

                       Subtitle C--Miscellaneous

     SEC. 4061. LYME DISEASE AND OTHER TICK-BORNE DISEASES.

       (a) In General.--Title III of the Public Health Service Act 
     (42 U.S.C. 241 et seq.) is amended by adding at the end the 
     following new part:

          ``PART W--LYME DISEASE AND OTHER TICK-BORNE DISEASES

     ``SEC. 399OO. RESEARCH.

       ``(a) In General.--The Secretary shall conduct or support 
     epidemiological, basic, translational, and clinical research 
     regarding Lyme disease and other tick-borne diseases.
       ``(b) Biennial Reports.--The Secretary shall ensure that 
     each biennial report under section 403 includes information 
     on actions undertaken by the National Institutes of Health to 
     carry out subsection (a) with respect to Lyme disease and 
     other tick-borne diseases, including an assessment of the 
     progress made in improving the outcomes of Lyme disease and 
     such other tick-borne diseases.

     ``SEC. 399OO-1. WORKING GROUP.

       ``(a) Establishment.--The Secretary shall establish a 
     permanent working group, to be known as the Interagency Lyme 
     and Tick-Borne Disease Working Group (in this section and 
     section 399OO-2 referred to as the `Working Group'), to 
     review all efforts within the Department of Health and Human 
     Services concerning Lyme disease and other tick-borne 
     diseases to ensure interagency coordination, minimize 
     overlap, and examine research priorities.
       ``(b) Responsibilities.--The Working Group shall--
       ``(1) not later than 24 months after the date of enactment 
     of this part, and every 24 months thereafter, develop or 
     update a summary of--
       ``(A) ongoing Lyme disease and other tick-borne disease 
     research related to causes, prevention, treatment, 
     surveillance, diagnosis, diagnostics, duration of illness, 
     intervention, and access to services and supports for 
     individuals with Lyme disease or other tick-borne diseases;
       ``(B) advances made pursuant to such research;
       ``(C) the engagement of the Department of Health and Human 
     Services with persons that

[[Page 11316]]

     participate at the public meetings required by paragraph (5); 
     and
       ``(D) the comments received by the Working Group at such 
     public meetings and the Secretary's response to such 
     comments;
       ``(2) ensure that a broad spectrum of scientific viewpoints 
     is represented in each such summary;
       ``(3) monitor Federal activities with respect to Lyme 
     disease and other tick-borne diseases;
       ``(4) make recommendations to the Secretary regarding any 
     appropriate changes to such activities; and
       ``(5) ensure public input by holding annual public meetings 
     that address scientific advances, research questions, 
     surveillance activities, and emerging strains in species of 
     pathogenic organisms.
       ``(c) Membership.--
       ``(1) In general.--The Working Group shall be composed of a 
     total of 14 members as follows:
       ``(A) Federal members.--Seven Federal members, consisting 
     of one or more representatives of each of--
       ``(i) the Office of the Assistant Secretary for Health;
       ``(ii) the Food and Drug Administration;
       ``(iii) the Centers for Disease Control and Prevention;
       ``(iv) the National Institutes of Health; and
       ``(v) such other agencies and offices of the Department of 
     Health and Human Services as the Secretary determines 
     appropriate.
       ``(B) Non-federal public members.--Seven non-Federal public 
     members, consisting of representatives of the following 
     categories:
       ``(i) Physicians and other medical providers with 
     experience in diagnosing and treating Lyme disease and other 
     tick-borne diseases.
       ``(ii) Scientists or researchers with expertise.
       ``(iii) Patients and their family members.
       ``(iv) Nonprofit organizations that advocate for patients 
     with respect to Lyme disease and other tick-borne diseases.
       ``(v) Other individuals whose expertise is determined by 
     the Secretary to be beneficial to the functioning of the 
     Working Group.
       ``(2) Appointment.--The members of the Working Group shall 
     be appointed by the Secretary, except that of the non-Federal 
     public members under paragraph (1)(B)--
       ``(A) one shall be appointed by the Speaker of the House of 
     Representatives; and
       ``(B) one shall be appointed by the majority leader of the 
     Senate.
       ``(3) Diversity of scientific perspectives.--In making 
     appointments under paragraph (2), the Secretary, the Speaker 
     of the House of Representatives, and the majority leader of 
     the Senate shall ensure that the non-Federal public members 
     of the Working Group represent a diversity of scientific 
     perspectives.
       ``(4) Terms.--The non-Federal public members of the Working 
     Group shall each be appointed to serve a 4-year term and may 
     be reappointed at the end of such term.
       ``(d) Meetings.--The Working Group shall meet as often as 
     necessary, as determined by the Secretary, but not less than 
     twice each year.
       ``(e) Applicability of FACA.--The Working Group shall be 
     treated as an advisory committee subject to the Federal 
     Advisory Committee Act.
       ``(f) Reporting.--Not later than 24 months after the date 
     of enactment of this part, and every 24 months thereafter, 
     the Working Group--
       ``(1) shall submit a report on its activities, including an 
     up-to-date summary under subsection (b)(1) and any 
     recommendations under subsection (b)(4), to the Secretary, 
     the Committee on Energy and Commerce of the House of 
     Representatives, and the Committee on Health, Education, 
     Labor and Pensions of the Senate;
       ``(2) shall make each such report publicly available on the 
     website of the Department of Health and Human Services; and
       ``(3) shall allow any member of the Working Group to 
     include in any such report minority views.

     ``SEC. 399OO-2. STRATEGIC PLAN.

       ``Not later than 3 years after the date of enactment of 
     this section, and every 5 years thereafter, the Secretary 
     shall submit to the Congress a strategic plan, informed by 
     the most recent summary under section 399OO-1(b)(1), for the 
     conduct and support of Lyme disease and tick-borne disease 
     research, including--
       ``(1) proposed budgetary requirements;
       ``(2) a plan for improving outcomes of Lyme disease and 
     other tick-borne diseases, including progress related to 
     chronic or persistent symptoms and chronic or persistent 
     infection and co-infections;
       ``(3) a plan for improving diagnosis, treatment, and 
     prevention;
       ``(4) appropriate benchmarks to measure progress on 
     achieving the improvements described in paragraphs (2) and 
     (3); and
       ``(5) a plan to disseminate each summary under section 
     399OO-1(b)(1) and other relevant information developed by the 
     Working Group to the public, including health care providers, 
     public health departments, and other relevant medical 
     groups.''.
       (b) No Additional Authorization of Appropriations.--No 
     additional funds are authorized to be appropriated for the 
     purpose of carrying out this section and the amendment made 
     by this section, and this section and such amendment shall be 
     carried out using amounts otherwise available for such 
     purpose.

  The Acting CHAIR. No further amendment to the bill, as amended, shall 
be in order except those printed in House Report 114-193. Each such 
further amendment may be offered only in the order printed in the 
report, by a Member designated in the report, shall be considered read, 
shall be debatable for the time specified in the 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.


                  Amendment No. 1 Offered by Mr. Brat

  The Acting CHAIR. It is now in order to consider amendment No. 1 
printed in House Report 114-193.
  Mr. BRAT. Madam Chair, I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       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).

  The Acting CHAIR. Pursuant to House Resolution 350, the gentleman 
from Virginia (Mr. Brat) and a Member opposed each will control 5 
minutes.
  The Chair recognizes the gentleman from Virginia.
  Mr. BRAT. Madam Chair, I yield myself 2 minutes.
  I rise to support my amendment against the creation of a new 
mandatory program.
  Some on the other side have called my amendment a poison pill. I 
consider that a compliment. A poison pill was reserved for the man who 
brought human reason to Greece. I similarly would like to bring a bit 
of reason to bear on the budget process of the United States.
  We are currently $127 trillion light on mandatory spending at 
present. This means by 2027, all Federal revenues will be spent on only 
mandatory programs. This is a disaster.
  My children right now are 13 and 16. By the time they are about 30, 
we will have zero dollars for running the government because all 
dollars will be spent on these mandatory programs.
  We all want cures, and I am for the underlying bill--make no 
mistake--but in economics, rationality requires that we rank our 
preferences in order and fund the best programs. This is one of them.
  There is no issue finding $2 billion out of a $3.5 trillion budget, 
but currently, there is no discipline up here in this city. We just 
fund everything and hand the bill to the next generation.
  Every mandatory program starts off with high hopes, but go to the 
trustee reports on the major mandatory programs today, and you will 
find that they are all insolvent by around 2030 as well.
  Today, you will hear all sorts of fancy terminology about pay-fors 
and oil reserves and deficits, but don't be fooled. Our annual deficit 
spending is about $500 billion right now and on its way to a trillion 
in a few more years.
  We are off course on every front. We always talk about the children, 
but at present, we are handing our children $18 trillion in debt and 
another $127 trillion in mandatory programs.
  You want the truth? The children are the only group up here on 
Capitol Hill without a lobbyist, and that is why they are getting 
trashed.
  If you want a cure, go to a doctor; but if you want to clean up the 
U.S. economy, please consult an economist or two. The numbers in the 
story I have given are not in dispute. The only issue is whether we 
have the resolve to balance our budgets and leave our children a 
brighter day.
  I urge a ``yes'' vote on the amendment, and I reserve the balance of 
my time.
  Mr. UPTON. Madam Chair, I rise in opposition to the amendment.
  The Acting CHAIR. The gentleman from Michigan is recognized for 5 
minutes.
  Mr. UPTON. Madam Chair, I yield myself 1 minute.
  Madam Chair, I strongly oppose this amendment because making this 
funding discretionary and subject to later appropriations is critically 
shortsighted for two reasons.
  We thought that this might be a placebo amendment, but yes, it really 
is a

[[Page 11317]]

poison pill that would undermine the victories the Republicans secured 
in 21st Century Cures, including transformative regulatory reforms at 
FDA and permanent entitlement savings in both Medicare and Medicaid.
  Second, supporting the amendment means voting against the critical 
balance that we found to pay for these investments using mandatory 
savings in a way that reduces the deficit in working with the 
Appropriations Committee.
  According to the CBO, this bill will reduce the deficit by some $500-
plus million over the first 10 years, and we conservatively estimate 
that it cuts $7billion in the second decade.
  Third, more than 100 organizations have joined together to oppose 
this amendment. They represent a cross-section of organizations, 
including patient groups, universities, veterans, innovators, and 
medical providers.
  I would ask my colleagues to vote ``no'' on the Brat amendment, and I 
reserve the balance of my time.
  Mr. BRAT. Madam Chair, I yield 1 minute to the gentleman from 
California (Mr. McClintock).
  Mr. McCLINTOCK. Madam Chair, the greatest danger facing our country 
is a national debt that now exceeds our entire economy. This year, we 
spent $230 billion just to pay interest on that debt.
  The CBO warns that, on our current trajectory, interest payments will 
exceed our entire defense budget just 8 years from now. Behold the 
chaos in Greece, and consider that our Nation is not far behind.
  Congress has labored mightily to enact a budget that saves us from 
this dismal future, but having set that course, we must stay that 
course. The underlying bill makes many worthy changes in law, but it 
evades the discipline the budget requires to save our country from the 
fate of Greece.
  Mr. Brat's amendment places this bill back within the boundaries of 
the budget without budget gimmickry and can be easily accommodated by 
cutting lower priority spending. The question before us is whether we 
will fund our priorities responsibly or follow Greece to ruin.
  Mr. UPTON. Madam Chair, I yield 1 minute to the gentleman from New 
Jersey (Mr. Pallone), my friend and the ranking member of the Energy 
and Commerce Committee.
  Mr. PALLONE. Madam Chairwoman, if we want to speed the pace of 
innovation and development of new treatment and cures, we must increase 
funding to NIH.
  We all know the numbers. NIH has $8.2 billion less to spend in fiscal 
year 2015 than it had in fiscal year 2003, when adjusted for inflation. 
That funding erosion has reduced the application success rate, leaving 
promising research ideas to languish due to lack of funding. It has 
also left many young and midcareer scientists wondering whether they 
can support themselves through a career in biomedical research.
  The NIH and Cures innovation fund aims to reverse that trajectory by 
providing $8.7 in mandatory funding over a 5-year period. Providing 
mandatory funding through the innovation fund would ensure that NIH has 
increased funding to make critical investments in research that will 
help us deliver on the promise of the 21st Century Cures Act, to 
accelerate the pace of scientific advancement that leads to life-
improving and lifesaving treatments and cures.
  Madam Chairwoman, without this funding stream, H.R. 6, I think, will 
be ineffective; and I urge Members to reject the Brat amendment.
  I am in strong opposition to the Brat amendment.
  Mr. BRAT. Madam Chair, I yield 1 minute to the gentleman from 
Pennsylvania (Mr. Perry).
  Mr. PERRY. Madam Chair, I support the 21st Century Cures Act 
underlying text, and I thank the chairman. It has been masterful work.
  And who wouldn't? Who doesn't want to do something in Congress about 
these horrific, debilitating diseases that plague our families? We all 
do, but targeting additional NIH funding for cures remains critical. We 
absolutely all support it, but I don't support how we are paying for 
it--because we are not.
  Many of us who preach about the problems associated with mandatory 
spending have used the same board I use in my townhall meetings. People 
have seen this, and they know where we are headed. It is the biggest 
driver of future debt.
  We are creating more mandatory spending as we speak, and we are 
placing the burden of paying for it on people that aren't even alive 
yet. It is incredible.
  I have championed the need for providing a cure for rare diseases and 
the things that plague members of our citizenry since I have been here. 
One thing missing from this bill is the legalization of CBD. This act 
seems to forget about children with epilepsy and their desperate need 
for a cure.
  I ask for support of this amendment simply to shift the money from 
mandatory to discretionary and force us to make the tough decisions we 
came here to make.
  Mr. UPTON. Madam Chair, I yield 1 minute to the gentleman from Texas 
(Mr. Gene Green), the ranking member on the Health Subcommittee.
  Mr. GENE GREEN of Texas. Madam Chair, I thank the chair of the 
committee for yielding.
  If you like how we are doing research right now, then you need to 
support the Brat amendment because we are not funding research 
adequately. Everybody says that. That is why there are so many 
supporters in the private sector and also 230 cosponsors of this bill.
  The sponsor of the amendment called it a poison pill. I don't think 
there is anything more appropriate than that for this amendment, 
because this bill is intended to save people's lives and to make people 
have a better lifestyle. When you take a poison pill, you die. That is 
what will happen if we do not do mandatory spending in this bill.
  This bill is paid for. You can rail against mandatory spending, but 
there are cuts in other parts of the Federal budget that will pay for 
this. Don't let anybody delude themselves into thinking that this is 
increasing spending.
  We are cutting spending while we are trying to redirect it to the NIH 
and FDA to have these new therapies and also get them through the 
approval process.
  Mr. BRAT. Madam Chair, I yield 1 minute to the gentleman from 
California (Mr. Issa).
  Mr. ISSA. Madam Chair, in this short 1 minute, I will close by 
reminding people that Ronald Reagan so notably said: ``Nothing lasts 
longer than a temporary government program.''
  This is a permanent program that is only paid for in offsets at one-
quarter what it costs, and that is an estimate. If the cost goes up, it 
will spend even more.
  Understand that we are selling the strategic petroleum reserves to 
pay for the vast majority of this 5-year program, and then we are 
taking 10 years to pay for the remainder.
  This is a gimmick. It is not paid for. Do not be fooled. If you are a 
fiscal conservative, you must consider this not a permanent entitlement 
and vote for the Brat amendment because, if you don't, what you are 
doing is unfairly adding to this debt.
  I would vote for this if it was paid for. Madam Chair, it is not paid 
for. It is a fraudulent pay-for by any possible means of this body.
  Please, vote for the Brat amendment because this is not a pay-for 
entitlement.
  Mr. BRAT. I yield back the balance of my time.

                              {time}  0930


                    Announcement by the Acting Chair

  The Acting CHAIR. Members are reminded to refrain from trafficking 
the well while another Member is under recognition.
  Mr. UPTON. Madam Chair, I yield to the gentleman from Pennsylvania 
(Mr. Fattah) for a unanimous consent request.
  Mr. FATTAH. Madam Chair, I rise in favor of the underlying bill and 
in opposition to this poison-pill amendment.
  Mr. UPTON. Madam Chairman, let me just say to the gentleman from

[[Page 11318]]

California, it is paid for. CBO has certified that all of it is paid 
for.
  Madam Chair, I yield the balance of my time to the gentlewoman from 
Indiana (Mrs. Brooks), a member of the committee.
  Mrs. BROOKS of Indiana. Madam Chairman, I rise today to voice my 
unwavering support for 21st Century Cures and vehement opposition to 
the amendment before us.
  What the authors of this specific amendment fail to grasp is that 
21st Century Cures will actually advance real conservative reforms to 
the entitlement system that will reduce the deficit and save our Nation 
billions of dollars.
  There are real cuts in this bill. CBO has scored it. And since when 
are we ignoring CBO?
  These reforms didn't happen overnight. This legislation is the result 
of well over a year of thoughtful and purposeful negotiations.
  Unfortunately, the backers of this amendment cannot see the forest 
for the trees. Contrary to the misinformation that led them to craft 
it, the innovation fund is not forever on autopilot. It sunsets after 5 
years. Those are 5 solid years where we can recruit the top minds to 
investigate cures that will change and save lives, yes, the lives of 
our children and the next generation.
  I urge my colleagues to stand with me in opposition, in addition to 
the over 100 groups who are opposed to the Brat amendment, groups of 
patient groups, universities, veterans, innovators, medical providers. 
Every one of these groups urges Members to vote ``no'' on the Brat 
amendment, and I urge my colleagues to do the same.
  Mr. UPTON. Madam Chair, I yield back the balance of my time.
  The Acting CHAIR. The question is on the amendment offered by the 
gentleman from Virginia (Mr. Brat).
  The question was taken; and the Acting Chair announced that the noes 
appeared to have it.
  Mr. BRAT. Madam Chair, I demand a recorded vote.
  The Acting CHAIR. Pursuant to clause 6 of rule XVIII, further 
proceedings on the amendment offered by the gentleman from Virginia 
will be postponed.


            Amendment No. 2 Offered by Mr. Young of Indiana

  The Acting CHAIR. It is now in order to consider amendment No. 2 
printed in House Report 114-193.
  Mr. YOUNG of Indiana. Madam Chairman, I have an amendment at the 
desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       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

[[Page 11319]]

     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''.

  The Acting CHAIR. Pursuant to House Resolution 350, the gentleman 
from Indiana (Mr. Young) and a Member opposed each will control 5 
minutes.
  The Chair recognizes the gentleman from Indiana.
  Mr. YOUNG of Indiana. Madam Chair, I want to thank Mr. Upton for his 
work on the 21st Century Cures Act, finally making medical 
breakthroughs a national priority. With this bill, we will extend the 
longevity and improve the lives of millions of Americans now and in the 
future. And in the process, we will dramatically reduce the taxpayer 
money we spend to treat sick Americans.
  With all that in mind, I want to highlight an amendment that my 
thoughtful and hard-working colleague, Dr. Harris of Maryland, and I 
have worked on, and I urge my colleagues' support. This amendment would 
create within NIH a structure for a medical prize program.
  The United States is currently spending $632 billion per year through 
just one program, Medicare, to cover health services of qualified 
beneficiaries. To help lower taxpayer costs as well as improve patient 
outcomes, this amendment will offer modest monetary rewards to those 
outside of government who can develop significant medical 
breakthroughs.
  The medical prize program will encourage scientists and 
entrepreneurs, especially those that don't typically receive NIH 
grants, to develop cost-saving, life-improving cures for some of the 
most debilitating diseases that afflict our young and old.
  With those thoughts in mind, I urge your support of the amendment, 
and I reserve the balance of my time.
  Mr. PALLONE. Madam Chair, I claim time in opposition to the 
amendment.
  The Acting CHAIR. The gentleman from New Jersey is recognized for 5 
minutes.
  Mr. PALLONE. Madam Chair, while I appreciate the efforts of the 
amendment's sponsors, I cannot support the Young-Harris amendment.
  As currently drafted, the amendment threatens to undermine the 
independent peer review process that is the bedrock of NIH funding by 
injecting politics into the development and implementation of the prize 
competition.
  The amendment would create an innovation prize advisory board to 
assist the NIH Director in carrying out the prize competition that is 
composed of nine members, four of which are politically appointed. It 
would also take away resources from existing research grant programs 
and other research efforts at NIH.
  It would require NIH to put money on reserve for the prize 
competition, money that would go back into the Treasury instead of 
funding research if the prize is not won in a given fiscal year.
  While I am not opposed to the potential of setting up a prize-like 
system--in fact, NIH already has such authority--I would prefer to work 
with the sponsors on the language to find a more appropriate way to 
accomplish their goals. Therefore, I would urge my colleagues to vote 
``no.''
  Mr. UPTON. Will the gentleman yield?
  Mr. PALLONE. I yield to the gentleman from Michigan.
  Mr. UPTON. I would just like to say as chairman of the committee that 
I look forward to working with the gentleman on the language. I think 
this is an important amendment. I am going to speak in favor of it on 
Mr. Young's time in a moment.
  But I just want to pledge that we will work with you on language that 
certainly we can all accept, knowing that the goal is a very good one.
  Mr. PALLONE. I appreciate that. Thank you.
  I reserve the balance of my time.
  Mr. YOUNG of Indiana. Madam Chair, I would just add that the purpose 
of this amendment, obviously, well received on both sides of the 
aisle--perhaps there are particulars we can work on--is to catalyze 
more innovation among the thousands, tens of thousands of entrepreneurs 
and innovators around this country, really around the world.
  If we can get more minds collectively thinking about medical 
breakthroughs, about actually curing diseases, as a preventative 
measure, we can save significant amounts of money in the long term. We 
can dramatically improve lives in the shorter term.
  This is a model that opens up Federal Government funding as a reward 
for these innovations to our Nation's innovators, our entrepreneurs, 
our doers.
  Right now, the NIH grant process is suboptimal for a lot of these 
individuals. I can speak to one individual. He used to be my neighbor, 
Fazni Aziz, of Bloomington, Indiana. He is a Thomas Edison-like figure, 
and he used to have a workshop right next to his house. He developed 
medical devices on his own and sold them off to larger companies.
  Fazni Aziz would not receive an NIH grant. He will never apply for 
one. He doesn't have time to apply for one. Would he target a medical 
innovation on account of a prize that is offered? Indeed. We have 
consulted with him.
  So for the people like Fazni Aziz around the world that can help 
Americans, we have developed this prize program.
  Madam Chair, I yield 1 minute to the gentleman from Michigan (Mr. 
Upton), the chairman.
  Mr. UPTON. Madam Chair, I do rise in support of this important 
amendment that, with Mr. Young and Dr. Harris, would authorize the NIH 
to conduct a prize program. The intent of the amendment is, in fact, to 
incentivize health innovation by offering competitors the chance to win 
a prize for developing breakthroughs. We ought to be encouraging that.
  Importantly, individuals who win the prize competition would keep all 
of the intellectual property rights. I think that is very important.
  So I would ask my colleagues to support the amendment. I look forward 
to working with both sides of the aisle to make sure that we can, in 
fact, perfect it as we get to the end of the cycle and, ultimately, to 
the President's desk.
  Mr. PALLONE. Madam Chair, I yield back the balance of my time.
  Mr. YOUNG of Indiana. Madam Chair, I yield back the balance of my 
time.
  The Acting CHAIR. The question is on the amendment offered by the 
gentleman from Indiana (Mr. Young).
  The amendment was agreed to.


                   Amendment No. 3 Offered by Ms. Lee

  The Acting CHAIR. It is now in order to consider amendment No. 3 
printed in House Report 114-193.
  Ms. LEE. Madam Chair, I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

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

  The Acting CHAIR. Pursuant to House Resolution 350, the gentlewoman

[[Page 11320]]

from California (Ms. Lee) and a Member opposed each will control 5 
minutes.
  The Chair recognizes the gentlewoman from California.
  Ms. LEE. Madam Chair, I am very pleased to offer this amendment with 
my colleagues, two great women, Representative Jan Schakowsky and 
Representative Yvette Clarke.
  Our amendment is very simple. It would strike a provision in this 
bill that applies to any policy riders included in the annual Labor, 
Health and Human Services and Agricultural appropriations bills to the 
new National Institutes of Health funds and the Federal Drug 
Administration funds included in H.R. 6, the 21st Century Cures Act.
  This provision reiterates the current law restrictions on 
appropriations bills, like the Hyde amendment, which is restrictive and 
discriminatory against low-income women to make their own reproductive 
healthcare decisions. Now this would apply to this new fund created for 
the NIH in this bill.
  Let's be clear what this is really about. It is yet another attempt 
to insert abortion restrictions and other inappropriate riders into an 
unrelated bill.
  This is a bill to increase biomedical innovative research. The 21st 
Century Cures Act should have been a noncontroversial, bipartisan 
effort. But anti-choice leaders could not help but add this to the bill 
after--mind you, after--it had passed out of committee on a bipartisan 
vote. It is really outrageous and part of a larger effort to force the 
inclusion of these harmful Hyde restrictions in multiple and unrelated 
bills.
  We know that these dangerous policies disproportionately affect low-
income women and women of color. So our amendment is about removing 
these inappropriate and consistent attacks on a woman's right to make 
her own healthcare decisions.
  I urge my colleagues to vote ``yes'' to protecting a woman's right to 
choose.
  I reserve the balance of my time.
  Mr. UPTON. Madam Chair, I claim time in opposition to the amendment.
  The Acting CHAIR. The gentleman from Michigan is recognized for 5 
minutes.
  Mr. UPTON. Madam Chair, I yield 2 minutes to the gentleman from 
Pennsylvania (Mr. Pitts), the chairman of the Health Subcommittee.
  Mr. PITTS. Madam Chair, I rise in opposition to the Lee amendment. If 
passed, this amendment would allow the National Institutes of Health to 
use taxpayer dollars to conduct experiments involving abortion or to 
hone abortion techniques.
  Let me be clear. The underlying bill simply applies current Federal 
health policies that have been approved by both Republican and Democrat 
majorities for decades to new funds appropriated in the Cures bill. It 
is nothing more than the status quo applied to new funding.
  There is a reason why these policies are the status quo. Americans do 
not want their tax dollars used to destroy unborn lives. A poll 
conducted just this January showed 68 percent of Americans oppose 
taxpayer funding for abortion.
  H.R. 6, the 21st Century Cures Act, is about finding cures and 
protecting the health and well-being of Americans. It would be a 
terrible injustice if a bill designed to save lives were to become a 
conduit for the destruction of the most vulnerable, the voiceless 
unborn who are still too young to be heard crying out for help.
  I urge all Members to oppose this amendment.
  Ms. LEE. Madam Chair, I yield 1 minute to the gentlewoman from 
Illinois (Ms. Schakowsky), a cosponsor of this amendment.
  Ms. SCHAKOWSKY. Madam Chair, I am proud to join Congresswoman Lee and 
Congresswoman Clarke in offering this amendment.
  Our amendment would strike the policy riders that were added to the 
21st Century Cures Act after it passed unanimously the Energy and 
Commerce Committee, 51-0.

                              {time}  0945

  Most notably, our amendment would remove the unnecessary addition of 
the Hyde amendment. The Hyde amendment is a discriminatory policy that 
denies millions of women the full range of healthcare choices, and it 
has no business being included in this legislation.
  It is time for us to stop using these bills as a way to discriminate 
against women. Going forward, as far as I am concerned, I will not 
support any bill that adds such language.
  It is time for us to stop taking away health services from low-income 
women, from women serving in the military, from Federal employees, and 
from every woman who relies on the Federal Government for her health 
insurance. All women, regardless of their incomes and what insurance 
they have, deserve to make their own health choices.
  This harmful provision is unrelated to the goals of this otherwise 
bipartisan landmark legislation, and I ask that Members vote in favor 
of our amendment.
  Mr. UPTON. Madam Chair, I yield 2 minutes to the gentlewoman from 
Tennessee (Mrs. Blackburn), the vice chair of the Energy and Commerce 
Committee.
  Mrs. BLACKBURN. Madam Chairman, I do rise in opposition to this 
amendment. I think it is important to realize a couple of things.
  The American people have spoken out on this issue. Sixty-eight 
percent of all Americans oppose taxpayer dollars being used for 
abortions. Seventy-one percent of all millennials oppose this.
  What the Lee amendment would do is strip away bipartisan agreements 
that we use in appropriations bills. This is not something that is new. 
It is not language that is new.
  The Hyde amendment and the Hyde language has been around for a very 
long time. The Lee amendment would reverse important limitations to 
protect these taxpayer dollars.
  I have mentioned the opposition to abortion. There is also 
prohibition for the use of public funds to advocate for gun control, 
limit Federal grants from being awarded to tax cheats. Do we really 
want tax cheats being able to get Federal dollars?
  It limits extravagant conference spending for public employees. Do we 
really want them to be able to waste these dollars? Of course not. Of 
course not.
  That is why this language is in the bill. I encourage my colleagues 
to vote against the Lee amendment.
  Ms. LEE. Madam Chair, I yield 1 minute to the gentlewoman from New 
York (Ms. Clarke), another cosponsor of this amendment.
  Ms. CLARKE of New York. Madam Chair, today I rise in support of the 
Lee-Schakowsky-Clarke amendment, and I thank them for their leadership 
in advancing this amendment.
  H.R. 6, the 21st Century Cures Act, which received unanimous support 
from members of the Energy and Commerce Committee, demonstrates that 
Democrats and Republicans can work together in an effort to develop 
medicines, treatments, and cures that will save lives.
  Unfortunately, our bipartisan consensus has been undermined by a 
last-minute inclusion of an antichoice provision in this bill. This new 
provision, which is a cynical poison pill and lacks germaneness to the 
underlying bill, would place restrictions on women's ability to access 
health services.
  It fails to respect the personal dignity of women by limiting their 
healthcare options. It interferes with the private relationship between 
a woman and her doctor, and it denies women what I believe is their 
fundamental right to have control over their own bodies.
  I am deeply concerned that this new provision will only serve as 
confirmation for the skeptics, who believe that Members of Congress are 
simply unable to work with each other in the public interest.
  We have the opportunity to disprove the skeptic by voting for this 
amendment and stripping out this provision.
  Mr. UPTON. Madam Chair, could I ask how much time is remaining on 
each side?

[[Page 11321]]

  The Acting CHAIR. The gentleman from Michigan has 2 minutes 
remaining, and the gentlewoman from California has 1 minute remaining.
  Mr. UPTON. Madam Chair, I yield myself such time as I may consume.
  Madam Chair, I do rise in opposition to the Lee amendment. The Lee 
amendment would strip dozens of important limitations and restrictions 
that routinely apply to funding appropriated by Congress with 
bipartisan support and through the normal appropriation process.
  For example, this amendment would strike limitations that, as has 
been noted, would prevent taxpayer dollars from being used to destroy 
life. And, frankly, they have been in place since the seventies, going 
back to the Henry Hyde days in the House.
  The Lee amendment would also strike other commonsense protections 
that normally apply to appropriated funds. This includes restrictions 
that prevent Federal grants from being awarded to tax cheats.
  The Lee amendment would be a vote, should it pass, to allow abuse of 
taxpayer funds. So I would urge the House to reject this amendment.
  We carefully wrote provisions that the riders that are in place would 
apply to each of the years of the NIH funds. And I think that that is 
appropriate, that the Lee amendment would undermine that.
  So I would urge my colleagues to vote ``no.''
  I yield back the balance of my time.
  Ms. LEE. I yield 1 minute to the gentlewoman from Colorado (Ms. 
DeGette), a leader of this bill and sponsor.
  Ms. DeGETTE. Madam Chair, I rise in strong support of the Lee 
amendment, which removes completely unnecessary and intrusive policy 
riders attached to the funding provisions of the underlying bill after 
its unanimous passage from our committee.
  At best, these policy riders are immaterial provisions that have no 
effect on the policies and activities of the NIH or FDA. Many of them 
interfere with researchers and the scientific understanding that can 
make us all safer and healthier.
  The inclusion of the Hyde amendment, among these riders, is 
especially offensive. The last I heard, neither the NIH or the FDA ever 
performed abortions. And so Hyde's restrictions remind us that even 
bipartisan efforts are not immune from political attacks.
  Women consist of more than half the patients in America, and their 
healthcare needs should not be insulted and restricted by this 
Congress.
  I want to thank my colleagues, Congresswomen Lee, Schakowsky, and 
Clarke, for introducing this amendment. We should remove these policy 
riders and keep 21st Century Cures' focus on the great potential to do 
more for patients.
  Ms. LEE. I yield back the balance of my time.
  The Acting CHAIR. The question is on the amendment offered by the 
gentlewoman from California (Ms. Lee).
  The question was taken; and the Acting Chair announced that the ayes 
appeared to have it.
  Mr. UPTON. Madam Chair, I demand a recorded vote.
  The Acting CHAIR. Pursuant to clause 6 of rule XVIII, further 
proceedings on the amendment offered by the gentlewoman from California 
will be postponed.


             Amendment No. 4 Offered by Mr. Castro of Texas

  The Acting CHAIR. It is now in order to consider amendment No. 4 
printed in House Report 114-193.
  Mr. CASTRO of Texas. Madam Chair, I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

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

  The Acting CHAIR. Pursuant to House Resolution 350, the gentleman 
from Texas (Mr. Castro) and a Member opposed each will control 5 
minutes.
  The Chair recognizes the gentleman.
  Mr. CASTRO of Texas. Madam Chair, I thank Chairman Upton, Ranking 
Member Pallone, and also Congresswoman DeGette for their work on this 
bill.
  My amendment seeks to ensure that, when the NIH reports on its 
retention of young scientists, it includes data specifically related to 
women and other underrepresented minority populations in the scientific 
community.
  Madam Chair, I reserve the balance of my time.
  Mr. UPTON. Madam Chair, I claim time in opposition, although I do not 
oppose this amendment.
  The Acting CHAIR. Without objection, the gentleman from Michigan is 
recognized for 5 minutes.
  There was no objection.
  Mr. UPTON. Madam Chair, we support this amendment. I think that it is 
important. It would include underrepresented individuals in the 
sciences in the NIH report on efforts to attract, retain, and develop 
emerging scientists.
  It is important to ensure that the NIH is indeed focused on including 
all qualified individuals dedicated to finding cures.
  I know no one that is opposed to this amendment. We support it. I 
appreciate your hard work on this and look forward to having it be part 
of the process as it moves forward.
  I yield back the balance of my time.
  Mr. CASTRO of Texas. Madam Chair, I yield 1 minute to the gentleman 
from New Jersey (Mr. Pallone), the ranking member.
  Mr. PALLONE. Madam Chairwoman, this amendment would require the NIH 
to report on their specific efforts to attract more women and racial 
and ethnic minorities into the biomedical workforce.
  It is clear that we must reverse the harmful trend of limited 
participation by women and racial and ethnic minorities in the 
biomedical workforce.
  To remain the world's leader in research, we must encourage the best 
and brightest from all populations to pursue biomedical research 
careers.
  Without robust participation by women and ethnic minorities, we risk 
losing our position as having the best biomedical workforce in the 
world.
  So I urge my colleagues to vote ``yes'' on this amendment.
  Mr. CASTRO of Texas. Mr. Chair, I yield 1 minute to the gentlewoman 
from Texas (Ms. Jackson Lee).
  Ms. JACKSON LEE. Mr. Chair, this gives me an opportunity to not only 
thank the gentleman for his very astute amendment, but to thank the 
sponsors of this bill, Mr. Pallone, Mr. Green, Ms. DeGette, Mr. Upton, 
for all the work that has been done.
  Having served a number of years on the House Science Committee, I 
want to thank the gentleman from Texas because all we heard very often 
was the value of investing in minorities and women as the new cutting 
edge of scientific research.
  We know that this bill is expansive, but we are delighted with your 
emphasis on the recruiting of women and minorities, particularly for 
the young emerging scientists, and primarily because they begin to fuel 
the next generation of research and the next generation of the solving 
of problems, which is the American Cures Act.
  So I rise to support the gentleman's amendment and say to you that 
the documentation is long, that these individuals will then fill the 
laboratories of America and begin to do cutting-edge research to be 
able to create a better life for all of us.
  I thank the gentleman. I support his amendment.
  Mr. CASTRO of Texas. Mr. Chair, I thank Chairman Upton and the 
Republicans for their cooperation on this amendment.
  I yield back the balance of my time.
  The Acting CHAIR (Mr. Hill). The question is on the amendment offered 
by the gentleman from Texas (Mr. Castro).
  The amendment was agreed to.


                Amendment No. 5 Offered by Ms. Slaughter

  The Acting CHAIR. It is now in order to consider amendment No. 5 
printed in House Report 114-193.
  Ms. SLAUGHTER. Mr. Chair, I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:


[[Page 11322]]

       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).

  The Acting CHAIR. Pursuant to House Resolution 350, the gentlewoman 
from New York (Ms. Slaughter) and a Member opposed each will control 5 
minutes.
  The Chair recognizes the gentlewoman from New York.
  Ms. SLAUGHTER. Mr. Chair, I rise today in support of my amendment 
which directs the CDC, the Centers for Disease Control, to study 
whether incentivizing the use of new antibiotics, which the underlying 
bill does, will lead to antibiotic resistance and cause these 
lifesaving drugs to be less effective.
  Section 2123 of the 21st Century Cures Act authorizes additional 
payments to hospitals for using newly developed antibiotics.

                              {time}  1000

  Of course, the reason we need new antibiotics is that we have 
frittered away one of the greatest medical achievements of the 21st 
century by overusing the ones that we already have and hastening the 
development of bacterial resistance.
  I fear that paying hospitals more to use a new generation of 
antibiotics will just repeat the cycle of overuse and develop more 
drug-resistant superbugs. Quite simply, the taxpayers should not foot 
the bill for practices that are making antibiotics less effective.
  This amendment directs the CDC to study the effect the bill would 
have on drugs that are part of the foundation of modern medicine. I 
urge my colleagues, many of whom have expressed their alarm at the rise 
of antibiotic resistance, to support the amendment.
  I am certainly not alone in my concern about this section of the 
bill. I know there are several Members, myself included, who will feel 
safer if section 2123 was removed entirely.
  A recent report from the United Kingdom review on antimicrobial 
resistance, led by brilliant economist Jim O'Neill, noted that 
increasing reimbursements for new antibiotics risks undermining ``good 
infection control and antibiotic stewardship practices within 
hospitals.'' The study required by this amendment will provide valuable 
data on the link between efforts to incentivize development of new 
antibiotics and the development of resistance to make sure we don't 
repeat the cycle.
  Mr. Chairman, I want to be clear about what is at stake here. 
Worldwide, antibiotic-resistant infections already kill 700,000 people 
every year. If we don't act now, by the year 2050, according to Mr. 
O'Neill's study, the annual death toll will rise to 10 million a year, 
and the costs will be $100 trillion.
  The World Health Organization has told us that the very future of 
medicine is at stake. Without antibiotics, modern medical advances such 
as joint replacements and organ transplants would be impossible, and 
even the routine procedures such as dental work and caesarean sections 
would be too risky to perform.
  We have to remember that our urgent need for new antibiotics is due 
to our widespread misuse and overuse of the current antibiotics that 
led to the crisis of antibiotic resistance. We have to cure that before 
we use new antibiotics.
  Mr. Chairman, 30 to 50 percent of the antibiotics prescribed to 
humans are unnecessary, but 80 percent of the antibiotics produced in 
the United States are used on industrial farms where they are routinely 
fed to healthy animals. It is an absolute recipe for creating 
antibiotic resistance. We can't afford to keep using such precious, 
live-saving resources so thoughtlessly. The changes in how our current 
antibiotics are used are desperately needed.
  Unfortunately, my amendment doesn't do what I would really like to 
do, which would be to protect eight classes of antibiotics just for use 
in human health by not allowing their use on the farm except for sick 
animals.
  Remember, as I said before, these antibiotics, 80 percent, are fed to 
well animals every single day. However, the amendment will ensure that 
we can know whether incentives to develop new antibiotics continue the 
problem of resistance. Having effective antibiotic for humans is too 
important not to get this right.
  Mr. Chairman, I urge my colleagues to support the amendment, and I 
reserve the balance of my time.
  Mr. UPTON. Mr. Chairman, although I am not in opposition to the 
amendment, I claim the time.
  The Acting CHAIR. Without objection, the gentleman from Michigan is 
recognized for 5 minutes.
  There was no objection.
  Mr. UPTON. Mr. Chairman, we strongly support this amendment, and I 
congratulate the gentlewoman for offering it.
  Mr. Chairman, I yield 3 minutes to the gentleman from Texas (Mr. 
Barton), the former chairman, ranking member, subcommittee chair, 
ranking member, and now chairman emeritus and former deputy whip.
  Mr. BARTON. Mr. Chairman, I thank the gentleman.
  Mr. Chairman, if you look up here at the podium right behind me on 
the Republican side, what do you see? Carved into the balustrade is the 
word ``liberty.'' If you look on the Democratic side, what do you see? 
You see the word ``justice.'' If you look straight down the center 
aisle right between them, what do you see? It is ``tolerance.''
  Mr. Chairman, the bill that is before us today is a culmination of 4 
years of hard work between both political parties and both leaderships 
of the Energy and Commerce Committee on both sides of the aisle in 
which a lot of tolerance has been exhibited.
  Conservatives on the Republican side haven't gotten everything that 
we want in this bill, and liberals on the Democratic side haven't 
gotten everything they want on this bill, but the work product is a 
culmination of an open process that Chairman Upton and subcommittee 
Chairman Pitts have put together.
  Every member of the committee has been invited to numerous working 
groups--probably 10, 15, I don't know--and have been given every 
opportunity to have input into what they want and what they don't want.
  This bill would become law, and it will stay law. It will become law, 
and it will unite the medical research community. There are things in 
this bill that I have worked on for 10 years that will help find cures 
sooner rather than later.
  Mr. Chairman, I had a woman in my office in Texas 4 days ago. Her son 
has autism, and he is 11 years old. He is her only child. They 
literally don't know what to do. He speaks one word at a time. He 
becomes violent.
  She has almost given up hope, but we are doing amazing research in 
autism. This bill will facilitate and expedite that. I am tired of 
telling parents of children: I don't know. I can't help you.
  I want to say: Here is what we are doing.
  This bill does that.
  Now, Mr. Chairman, there is a $2 billion mandatory program for 5 
years called the innovation fund. Some of my conservative friends have 
said: Oh, we can't vote for the bill because of that program.
  What was Medicare part D? It was a mandatory program--$40 billion 
that was not offset. Every Republican in the House voted for that--I 
might point out every Democrat voted against it--and that was 
voluntary. The people could participate or not participate, but it was 
mandatory that the Federal Government had to spend the money.
  Last year, we voted on a program for veterans, $10 billion. Every 
Republican

[[Page 11323]]

in the House voted for that. It wasn't offset.
  Now, I would rather that we have everything discretionary. I wish the 
whole Federal budget was discretionary except for Social Security, but 
it is not.
  The Acting CHAIR. The time of the gentleman has expired.
  Mr. UPTON. Mr. Chairman, I yield the gentleman an additional 15 
seconds.
  Mr. BARTON. Mr. Chairman, let's come together. Let's vote for 
something that we can all be proud of so that we can tell the parents 
of children with autism that there is hope and there is a future.
  Vote ``yes.'' Please vote ``yes.''
  Ms. SLAUGHTER. Mr. Chairman, I very much want to thank Mr. Upton for 
his graciousness in accepting this, and I look forward to working with 
him further on this issue.
  Mr. Chairman, I yield the balance of my time to the gentleman from 
Texas, Congressman Gene Green.
  Mr. GENE GREEN of Texas. Mr. Chairman, I want to thank our ranking 
member on the Rules Committee for bringing up this amendment. I support 
the amendment.
  Mr. Chairman, this bill also includes some great provisions in there 
for the next generation of research on antibiotics. Congressman John 
Shimkus and I worked on it this session, and previously, over the last 
two sessions, Congressman Phil Gingrey and I worked on it.
  What this amendment addresses is it is not just a new generation, but 
we also need to not overuse what we have. That is a problem in our 
country. As I say, I have sinus infections, but those antibiotics won't 
help it. We need to make sure we don't overuse.
  Mr. Chairman, I am glad our colleague has come up with the amendment, 
and I support her amendment.
  Ms. SLAUGHTER. Mr. Chair, I yield back the balance of my time.
  Mr. UPTON. Mr. Chairman, I yield the balance of my time to the 
gentleman from Illinois (Mr. Roskam), a member of the important Ways 
and Means Committee.
  Mr. ROSKAM. Thank you, Chairman Upton.
  Mr. Chairman, my DISARM Act is part of this H.R. 6 Cures Act, and I 
thank Chairman Upton and his staff for including it. It is a focal 
point of a lot of discussion on both sides of the aisle as it relates 
to antibiotics.
  Mr. Chairman, there is an incredible health threat that has 
manifested itself interestingly and sadly in two important ways near my 
constituency in the Chicago area.
  Back in December of 2013, 44 patients at Lutheran General Hospital 
cultured positive for CRE, which is known as the nightmare bacteria. To 
put this in perspective, previously, only 96 cases had been reported to 
the CDC before. Nearby, in Algonquin, Illinois, two cases of an 
ostensibly drug-resistant tuberculosis were also diagnosed. Now, 
according to the CDC, 23,000 patients die annually from this.
  What the DISARM Act does--which is embedded in Cures, H.R. 6--is it 
gets researchers and scientists back in the business of antibiotic 
research and development by modernizing how Medicare views treatments 
for infections that are considered to be unmet medical needs.
  It reimburses target antibiotics at cost to ensure a functioning 
marketplace where the right treatment is used at the right time for the 
right patient helping to reinvigorate the pipeline of drugs and 
development, and it is a critical piece of the drug resistance puzzle.
  Mr. Chairman, I urge passage of Cures, H.R. 6, and I thank Chairman 
Upton.
  Mr. UPTON. Mr. Chair, I yield back the balance of my time.
  The Acting CHAIR. The question is on the amendment offered by the 
gentlewoman from New York (Ms. Slaughter).
  The amendment was agreed to.


               Amendment No. 6 Offered by Mr. Fitzpatrick

  The Acting CHAIR. It is now in order to consider amendment No. 6 
printed in House Report 114-193.
  Mr. FITZPATRICK. Mr. Chairman, I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       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.

  The Acting CHAIR. Pursuant to House Resolution 350, the gentleman 
from Pennsylvania (Mr. Fitzpatrick) and a Member opposed each will 
control 5 minutes.
  The Chair recognizes the gentleman from Pennsylvania.
  Mr. FITZPATRICK. Mr. Chairman, I yield myself such time as I may 
consume.
  Mr. Chairman, first, I want to express my deep appreciation to 
Chairman Upton and Ranking Member DeGette on this bill. The funding and 
these innovative reforms will save lives, and that is something that 
everyone in this Chamber should be proud of. There are a lot of 
wonderful provisions in this bill, and we should see those provisions 
through.
  I am a member, Mr. Chairman, of the Rare Disease Caucus. Like most of 
us here, I have met with constituents with incredible stories of 
courage and stories of their battle with diseases without treatments. 
It would be easy to fall victim to despair, but they don't.
  They remain beacons of hope, hope for a treatment and hope for a 
world where no one else has to go through what they did. They look to 
us to support them and to fight alongside them for these treatments in 
lifesaving research, and I am proud to stand with them and to fight for 
them.
  There is a part of this bill that I believe will do more harm than 
good, and that is the part that deals with easing medical device safety 
regulations. While we bring our research and treatments into the 21st 
century, I think it is equally important we bring our medical device 
safety regulations into the 21st century as well.
  As part of a 21st century approach to medical devices, the FDA has 
established a unique device identification system to adequately 
identify medical devices through their distribution and use. These 
codes can significantly improve safety and help track down dangerous 
recalled products.
  Currently, these UDIs are not incorporated into all electronic health 
records, which make it difficult to fully achieve the benefits to 
patient safety. For example, a claim form might list a procedure like a 
routine surgery to remove uterine fibroids, but not note the make or 
model of the device used, such as the laparoscopic power morcellator, a 
device that the FDA placed a black box warning on, some manufacturers 
have recalled, and some insurance companies have stopped covering as a 
result of its devastatingly adverse effects on women's health.
  It is this tragedy surrounding the power morcellator that has driven 
me to action, and it is why I offered eight amendments to the Rules 
Committee which would strengthen our safety laws.
  This week, I have heard from dozens of these individuals affected by 
complications from power morcellation. One doctor from California sent 
me a note about how her sister died 9 months after a routine surgery 
with a power morcellator. A woman from Massachusetts described her 
battle with the cancer that was spread by the morcellator. These 
constituents wrote their letters to Members of Congress and copied my 
office.
  Another constituent in New York lost her sister to cancer spread by 
the morcellator and described her sister's tragedy as ``a routine 
surgery ending with a death sentence.'' A constituent of mine, a doctor 
and a mother of six children, is courageously fighting an aggressive 
cancer that was spread by the blades of the device.
  What happened, Mr. Chairman, with the power morcellator should never 
be allowed to happen again, and I think

[[Page 11324]]

that we missed an opportunity with this bill to tackle this problem 
head-on.
  In 2011, the Institute of Medicine found the current, four-decade-old 
medical device safety process known as 510(k) inadequate, noting 
``510(k) process lacks the legal basis to be a reliable premarket 
screen of the safety and effectiveness of moderate-risk devices.''
  I wish the bill had addressed this gap that allowed the power 
morcellator to slip through and cause unnecessary harm to way too many 
families.

                              {time}  1015

  It is time we take our medical device safety regulations into the 
21st century. I ask my colleagues to join me in this effort and to 
support this amendment of mine today, which is a small but important 
step.
  I am proud to stand for patient safety. I urge my colleagues to stand 
with me and the thousands of others who have been injured or killed by 
unsafe medical devices.
  Mr. Chairman, I yield to the gentleman from Pennsylvania (Mr. Pitts).
  Mr. PITTS. Mr. Chair, I rise today in support of the amendment 
offered by Representative Fitzpatrick.
  The Fitzpatrick amendment would put forward a sense of Congress that 
our healthcare system should find ways to incorporate information from 
medical devices into the care of our Nation's patients.
  I believe that such information can prove a valuable tool advancing 
quality health care in this country, but it must be done carefully to 
ensure that the value to patients, healthcare providers, industry, and 
the government is realized.
  Mr. PALLONE. Mr. Chairman, I rise in opposition, although I do want 
to speak in favor of the amendment.
  The Acting CHAIR. Without objection, the gentleman from New Jersey is 
recognized for 5 minutes.
  There was no objection.
  Mr. PALLONE. Mr. Chairman, I yield myself such time as I may consume.
  Mr. Chairman, the amendment offered today by Congressman Fitzpatrick 
expresses a sense of Congress that recording unique device identifiers 
within electronic health records could significantly enhance the 
availability of medical device data for purposes of postmarket 
surveillance.
  I have long supported the use of UDIs. In the Food and Drug 
Administration Amendment Act of 2007, we required FDA to establish a 
unique device identification system; and in the Food and Drug 
Administration Safety and Innovation Act of 2012, we required FDA to 
promulgate final implementing regulations on how UDIs should be used.
  Better integrating the use of UDIs into our health system will lead 
to improved medical devices and care across our healthcare system that 
will modernize how FDA monitors the safety of medical devices after 
they have been approved or cleared, and it will enable FDA and 
providers to identify medical devices with a history of safety issues. 
It also will facilitate recalls and make it easier for patients to 
learn when their medical device, such as a knee implant, is subject to 
a recall.
  The unique device identifier is one more tool that can help FDA and 
our healthcare system improve their monitoring of the safety of medical 
devices. Incorporating UDIs into electronic health records will take 
time, but it is a worthy goal, and one that I support.
  I urge my colleagues to support the amendment offered by Congressman 
Fitzpatrick.
  I yield back the balance of my time.
  Mr. FITZPATRICK. Mr. Chairman, I would like to thank Ranking Member 
Pallone and Chairman Pitts for their support of this amendment.
  This amendment will, as I said, take a small step toward improving 
medical device safety in the United States.
  As I said earlier in my remarks, I have seven amendments that did not 
make it out of Rules Committee, and I hope to be able to work with the 
chairman and the ranking member on those issues as well.
  I urge my colleagues to support the amendment, and I yield back the 
balance of my time.
  Mr. PASCRELL. Mr. Chair, I rise today in support of the Fitzpatrick 
Amendment.
  The unique device identifier (UDI) is an extremely important patient-
safety tool, and can help identify safety concerns with devices more 
quickly or disprove a suspected problem. I support the inclusion of UDI 
in electronic health records, as this amendment encourages. But I have 
also been working in the Ways and Means Committee to include the UDI in 
Medicare claims.
  As is the case with any new medical technology, not all adverse 
events are detected in the product's market approval or clearance 
processes. However, we can mitigate the impact on patients with a 
robust post-market surveillance program.
  In 2013 and 2014 alone, the FDA recalled more than 120 medical 
devices, but in many cases, the recall occurs only after the devices 
have been implanted in or used by hundreds or thousands of patients. 
This can result in extensive revision surgeries, severe pain or other 
medical problems, and in some cases, even death. In a 2001 device 
recall case, Sweden's post-market surveillance program successfully 
identified the faulty device after it had been implanted in 30 
patients. By contrast, the same device was implanted into 3,000 U.S. 
patients before the gravity of the problem was recognized.
  The FDA's Sentinel Initiative, which has been very successful in 
tracking and evaluating adverse events linked to the use of 
pharmaceuticals, relies primarily on data from health insurance claims. 
Because claims currently lack information on the specific devices used 
in patients' care, Sentinel cannot be expanded to include medical 
devices as Congress has directed FDA to do. This is a missed 
opportunity.
  Patients deserve access to innovative new devices that improve their 
health and their lives. And a vote for this amendment tells patients 
that we owe it to them and to be able to quickly identify problems with 
devices when they arise.
  I urge my colleagues to support this amendment.
  The Acting CHAIR. The question is on the amendment offered by the 
gentleman from Pennsylvania (Mr. Fitzpatrick).
  The amendment was agreed to.


                  Amendment No. 7 Offered by Mr. Polis

  The Acting CHAIR. It is now in order to consider amendment No. 7 
printed in House Report 114-193.
  Mr. POLIS. Mr. Chairman, I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       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

[[Page 11325]]

       (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.).

  The Acting CHAIR. Pursuant to House Resolution 350, the gentleman 
from Colorado (Mr. Polis) and a Member opposed each will control 5 
minutes.
  The Chair recognizes the gentleman from Colorado.
  Mr. POLIS. Mr. Chairman, I would like to start by commending Chairman 
Upton, Ranking Member Pallone, Ms. DeGette, Mr. Green, and so many 
others. I am proud to join as a cosponsor for the 21st Century Cures 
Act, which is really a first step to updating our approval process to 
help countless Americans gain access to lifesaving drugs and devices.
  This bill will save lives. I am proud to support it and send a strong 
message that we need to move forward with reform.
  But at the same time we are passing this bill, we should start 
thinking about what the next step is. Passage of this bill should not 
foreclose additional opportunities in the future to improve access to 
lifesaving medical device products and lifesaving drugs.
  Most importantly, this body can move forward with the next generation 
and start the process to help people get access to medical technology 
that can help keep people healthy, independent, save lives, and save 
money.
  It is in that spirit that I put forward my amendment, which would 
look at a two-tiered approval process for medical devices, that would 
allow devices to come to market once they have demonstrated safety 
while the FDA is still reviewing them for efficacy.
  This solves a real problem in the world. In the U.S., the cost of 
bringing a medical device to market through the approval process is $30 
million to $100 million. Those are costs that are then added to 
consumers of the medical device. That makes it even more difficult for 
niche medical devices that may help rare and unusual conditions because 
they are priced prohibitively.
  In addition, there is the aspect of the timeline. In the European 
market, for instance, if somebody creates a new device to prevent blood 
clots, it reaches the market in 7 to 11 months. In the U.S. market, 
they are looking at a timeline of 2\1/2\ to 4 years. Think of how many 
sufferers might die or have additional health problems simply because 
our own government is keeping that lifesaving product off the market, 
even though it has been demonstrated as safe.
  An additional result is that some medical technology companies are 
bypassing the U.S. market altogether when they develop new devices, 
which can result in years-long delays for access to U.S. patients and, 
in some cases, companies who view the U.S. approval system as too 
expensive market their devices exclusively in other nations.
  I think it is important to talk about what comes next. I think that 
with both devices and drugs, we need to look at the potential for a 
two-tiered process that allows a provisional approval and access to the 
U.S. market. That doesn't mean that insurance will cover it. That 
doesn't mean, clearly, that they can make any health claims with regard 
to the efficacy of their product. That is in existing law. But with 
regard to the safety being demonstrated, the provisional marketing of 
the product in America can save lives and will save lives.
  I reserve the balance of my time.
  Mr. GENE GREEN of Texas. Mr. Chairman, I claim the time in 
opposition.
  The Acting CHAIR. The gentleman is recognized for 5 minutes.
  Mr. GENE GREEN of Texas. Mr. Chairman, I rise not necessarily in 
opposition to the amendment, but concerning the amendment offered by my 
colleague, Congressman Polis.
  I want to thank the Congressman for his efforts to advance medical 
device development and would like to work with him on the legislation 
to enhance patient access to therapies.
  However, I am concerned this amendment as drafted would lower the 
approval standard for medical devices and suggest that patients should 
be exposed to products that are not proven effective.
  The FDA approval is a global gold standard for safety and 
effectiveness. While I support efforts to modernize and improve the 
standard, safety cannot be evaluated in a vacuum, and patients should 
not be offered treatments that have not been studied or proven useful 
to their care.
  I have great respect for my colleague, Congressman Polis, and 
appreciate his commitment to improving our healthcare system. I would 
like to work with him forward on that because he was correct in his 
statement, this doesn't mean it will be reimbursed. So we are proving a 
device is safe but it is not effective. I think there is a way, maybe, 
we can still make sure that not only we want it to be safe, but we want 
also to solve the problem or have a cure for whatever particular 
illness.
  Mr. UPTON. Will the gentleman yield?
  Mr. GENE GREEN of Texas. I yield to the gentleman from Michigan.
  Mr. UPTON. Mr. Chairman, I would like to give my commitment, too. I 
would like to work with the gentleman from Colorado. This is an 
important issue. I believe it has got merit, but we have got to make 
sure that it is designed just the right way.
  I want to say it is probably the lateness of the timing of the 
amendment when it came forward. It is my understanding the gentleman 
may withdraw the amendment--I would appreciate that--and allow us some 
time to really get together and see if there might be another day.
  Mr. PALLONE. Will the gentleman yield?
  Mr. GENE GREEN of Texas. I yield to the gentleman from New Jersey.
  Mr. PALLONE. Mr. Chairman, I just want to join with my other 
colleagues, Mr. Green and also the chairman, that we do understand the 
purpose of the Polis amendment, but we do have problems with it at the 
same time. We would like to have a conversation with Mr. Polis about 
it. I understand he is going to withdraw it. Then we would follow up 
and have a conversation and perhaps a meeting with the FDA as well.
  Mr. GENE GREEN of Texas. Mr. Chairman, I reserve the balance of my 
time.
  Mr. POLIS. Mr. Chairman, I thank both the chair and the ranking 
member.
  This is a very important discussion to have, both with regard to 
devices and also with regard to drugs.
  We know that there are treatments that are available overseas. I 
represent a district with, by the way, one of the largest veterinary 
hospitals in our country, Colorado State University Veterinary Teaching 
Hospital, and I can tell you that there are actually treatments, 
advance treatments available today for animals with cancer, like 
horses, that are not yet approved for humans and are lifesaving.
  If we can provide access in a shortened timeframe--I understand that 
while medical devices might cost $30 million to $100 million to bring 
to market, drugs often cost over $1 billion to bring to market.
  There are additional opportunities, by the way, in making sure that, 
as part of this provisional process, at least with regard to drugs, the 
data can be gathered, too. So it can serve a dual function and might, 
at the same time complying with some of the needs or an updating of the 
needs of some of the phases of FDA efficacy trials, it can actually be 
available through a market-oriented plan where people, consumers who 
are fully informed and, of course, to whom no health claims have been 
made, can choose to purchase the product, just as they can today, by 
the way, but they have to buy it overseas and import it for their own 
personal use. I have constituents who do that. But I think we can 
facilitate that process.
  I deeply appreciate working with the chair and the ranking member of 
the committee and the subcommittee with regard to helping to bring 
access to

[[Page 11326]]

lifesaving medical devices and pharmaceutical products to our shore.
  Mr. FITZPATRICK. Will the gentleman yield?
  Mr. POLIS. I yield to the gentleman from Pennsylvania.
  Mr. FITZPATRICK. Mr. Chairman, I was actually going to rise in 
opposition to the amendment, although now it is being withdrawn I see 
an opportunity here for, perhaps, us to work together on the medical 
device safety issue.
  I was going to object and vote against the amendment because it is my 
concern that the amendment would actually loosen medical device safety 
regulations and permit safe but ineffective devices to get to the 
market. I know that this sort of came late in the process. I would have 
objected because I had seven amendments before the committee to 
strengthen medical device regulations. But since the amendment is being 
withdrawn, I would see an opportunity for us perhaps to work together, 
take a step back and look at all the FDA regulations on medical device 
safety.
  Mr. POLIS. Mr. Chairman, I ask unanimous consent to withdraw my 
amendment.
  The Acting CHAIR. Is there objection to the request of the gentleman 
from Colorado?
  There was no objection.


               Amendment No. 8 Offered by Ms. Jackson Lee

  The Acting CHAIR. It is now in order to consider amendment No. 8 
printed in House Report 114-193.
  Ms. JACKSON LEE. Mr. Chairman, I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       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.

  The Acting CHAIR. Pursuant to House Resolution 350, the gentlewoman 
from Texas (Ms. Jackson Lee) and a Member opposed each will control 5 
minutes.
  The Chair recognizes the gentlewoman from Texas.
  Ms. JACKSON LEE. Mr. Chairman, let me add my appreciation to Mr. 
Upton, Ms. DeGette, Mr. Pitts, Mr. Pallone, and Mr. Green, and I ask 
the simple question: When have we had a historic opportunity on the 
floor of the House to have such a major investment--major investment--
in the lives and health of Americans, quality investment involving a 
mandatory fund that will open America's labs and put more people in 
labs and be able to give people relief on some of the issues that we 
have heard discussed today?
  I thank Mr. Barton for raising the sadness that comes of parents that 
cannot find answers. Many of them are my constituency who have children 
with sickle cell, as we have been attempting to research this disease 
for many, many years; or the lupus that took advantage of a very active 
civic leader and caused the hospitalization for months; or this issue 
of triple negative breast cancer that many people are not aware of.
  The amendment I have today is to emphasize the importance of outreach 
to our Historically Black Colleges, Hispanic-serving, Indian, Native 
American, and rural colleges.
  Let me explain for a brief moment the importance of this particular 
message.
  Physicians are a gateway to the patient. In short, the Jackson Lee 
amendment seeks to open up the physician gateway for patients and to 
researchers. It is to emphasize STEM education. It is to talk about the 
different medical illnesses and how important it is to reach out to 
these particular institutions to produce more medical professionals.
  According to the Centers for Disease Control and Prevention, sickle 
cell trait is common among African Americans and occurs in about 1 in 
12. Additionally, race and ethnicity have also been shown to affect the 
effectiveness in response to certain drugs.
  We need these students from these colleges to be in our labs, to be 
physicians, and to welcome minorities into the clinical labs; because 
we have evidence to show of the short numbers of individuals who 
volunteer for clinicals, and minorities are at the low end.

                              {time}  1030

  I encourage my colleagues to support the Jackson Lee amendment. Open 
the doors of research and patient care through doctors, and open the 
doors of solving some of these very difficult diseases.
  I reserve the balance of my time.
  Mr. UPTON. Mr. Chairman, I claim the time in opposition, although I 
support the amendment.
  The Acting CHAIR. Without objection, the gentleman from Michigan is 
recognized for 5 minutes.
  There was no objection.
  Mr. UPTON. Mr. Chairman, I yield myself 2 minutes.
  I appreciate this amendment. It is a good amendment, and it builds on 
what a member of our committee, Bobby Rush, did in the full committee 
markup.
  It directs the Secretary of HHS to perform outreach to Historically 
Black Colleges and Universities, to Hispanic-serving institutions, 
Native American colleges, and rural colleges to ensure health 
professionals from unrepresented areas are, in fact, aware of research 
opportunities under this act. It is a real complement to what was done 
before.
  Mr. Rush, as I remember, grabbed me on the House floor literally 
during our markup process and was very supportive of a number of 
amendments through the night. In fact, we worked on those amendments 
and included them in the manager's amendment. I offered them the very 
next morning, and they were accepted on a voice vote. This is clearly a 
bipartisan amendment. It is essential that we include everyone as we 
find cures for all.
  Ms. Jackson Lee and I have worked together on a number of health-
related issues over the years, on date rape drugs and other issues that 
really strike to the heart. So I appreciate her value in adding this 
amendment, and I very strongly support it.
  Mr. Chairman, I yield 1 minute to the gentleman from Pennsylvania 
(Mr. Fattah).
  Mr. FATTAH. Mr. Chairman, this is a special day. This is probably the 
first day that I would have preferred to have been a member of the 
chairman's committee rather than of the Appropriations Committee. The 
committee should be congratulated for its great work on this bill, and 
I am happy to be an original cosponsor.
  I rise in support of the amendment. It is critically important that 
we have serious outreach to all of our universities and medical 
centers, including African American, Hispanic, Native American 
universities, and those in the most rural parts of our country.
  I thank the gentleman and Diana DeGette and all of those who worked 
on this great piece of legislation.
  Ms. JACKSON LEE. Mr. Chairman, how much time is remaining?
  The Acting CHAIR. The gentlewoman from Texas has 2\1/2\ minutes 
remaining.
  Ms. JACKSON LEE. Mr. Chairman, I am delighted to yield 30 seconds to 
the gentleman from New Jersey (Mr. Pallone), the distinguished ranking 
member of the Energy and Commerce Committee.
  Mr. PALLONE. Mr. Chairman, I just want to urge support for this 
amendment.
  We need to make sure that emerging scientists from all populations 
understand Congress' commitment to ensuring that the funding is there 
to support our biomedical workforce.
  Requiring the Secretary to do outreach to colleges and universities 
that educate large numbers of students from underrepresented groups 
will ensure that all groups know of our commitment to making sure that 
funding is not a barrier to a career in biomedical research.
  I urge my colleagues to vote ``yes'' on the Sheila Jackson Lee 
amendment.
  Ms. JACKSON LEE. In reclaiming my time, Mr. Chairman, I thank Mr.

[[Page 11327]]

Upton. I certainly thank Mr. Fattah, Mr. Pallone, and, again, my dear 
friend from Texas (Mr. Green) for his great leadership.
  Let me indicate that certain medical illnesses have been known to 
have a higher prevalence amongst certain demographic groups, including 
type 2 diabetes, lupus, sickle cell anemia, triple-negative breast 
cancer, and many other forms of diseases impacting our children, ones 
with early birth.
  So I ask my colleagues again to support this because increased 
diversity in research trials could help researchers find better, more 
precise ways to fight diseases that disproportionately impact certain 
populations and may be important for the safe and effective use of 
therapies.
  Again, I think this is a historic day, and I join with Mr. Upton to 
say that we have been friends. We started with the first bill together, 
and all of these Members have come together to put a historic mark on 
this Nation to say that we will not take a back step to any nation on 
research and on improving the quality of life for all of our citizens.
  I must say that this is a historic day as well for minorities. I 
thank Mr. Rush for his constant service, and I take note of the fact 
that increased in this is the ability to raise the FDA loans that 
people might get to $50,000, which will help many minorities. I hold 
this chart to show that minorities don't volunteer for clinicals 
without the outreach.
  Finally, I am delighted to have a letter from United Negro College 
Fund President Michael Lomax, who indicates that 25 percent of African 
American graduates with degrees in science, technology, engineering, 
and math come from our Historically Black Colleges.
  They are waiting in line to be a part of these clinicals, to be 
doctors and researchers, and we must give them that opportunity. It is 
a historic day.

                              United Negro College Fund, Inc.,

                                     Washington, DC, July 9, 2015.
     Hon. Sheila Jackson Lee,
     House of Representatives,
     Washington, DC.
       Dear Representative Jackson Lee: On behalf of UNCF (the 
     United Negro College Fund), our 37 member private 
     historically Black colleges and universities (HBCUs) and the 
     students we serve, I write to express our strong support for 
     your amendment to H.R. 6, the 21st Century Cures Act, which 
     would require the U.S. Department of Health and Human 
     Services to increase its outreach to underrepresented health 
     professionals and researchers regarding federal research 
     opportunities.
       As you know, Historically Black Colleges and Universities 
     (HBCUs) are making strong contributions to the nation's 
     scientific, technological, and research workforce. HBCUs 
     enroll 10 percent of African American undergraduates, but 
     produce 25 percent of African American graduates with degrees 
     in science, technology, engineering, and mathematics (STEM) 
     fields. According to the National Science Foundation (NSF), 
     ten of the top eleven baccalaureate institutions producing 
     African American STEM doctorate recipients are HBCUs. Four 
     HBCU medical institutions supply over 50 percent of African 
     Americans who receive doctoral degrees in medicine, 
     dentistry, and the biomedical sciences each year.
       Despite these contributions, federal efforts to tap into 
     this talent pool in the dissemination of federal research 
     grants at the National Institutes of Health, the NSF, and 
     other federal science agencies continues to lag behind. Your 
     amendment will help draw greater attention to the 
     disproportionately low representation of minority researchers 
     in U.S. Department of Health and Human Services-supported 
     biomedical and behavioral research.
       We are grateful for your recognition of the vital need to 
     diversify and strengthen the nation's scientific and research 
     workforce and thank you for your ongoing advocacy to drive 
     improvement.
           Sincerely,
                                          Michael L. Lomax, Ph.D.,
                                          President and CEO, UNCF.

  Ms. JACKSON LEE. I cannot conclude my remarks without saying that 
just a few minutes ago, by video, I witnessed the flag of South 
Carolina--the rebel flag--being taken down.
  I would only say that it is a unifying factor. This bill is a 
unifying factor, and it is going to help all of us. I ask my colleagues 
to support the Jackson Lee amendment.
  Mr. Chair, I have an amendment at the desk. It is listed in the Rule 
as Jackson Lee #8.
  I wish to thank the Chair and Ranking Member of the Committee on 
Rules for making the Jackson Lee Amendment in order.
  I thank Energy and Commerce Committee Chairman Upton and Ranking 
Member Pallone for their collaborative effort that resulted in this 
bipartisan legislation being reported favorably to the House by a vote 
of 51-0.
  I thank them all for this opportunity to explain the Jackson Lee 
Amendment, which makes a good bill even better by ensuring that the 
national goals of finding and bringing more cures and treatments to 
patients and strengthening the biomedical innovation ecosystem in the 
United States is aided by an expanding pool of diverse and talented 
medical researchers.
  Specifically, the Jackson Lee Amendment provides:
  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.
  Many racial health disparities stem from lack of access to quality 
healthcare and proper health awareness.
  Unfortunately this means that incidence of disease does not always 
match trial populations.
  For example, consider that:
  1. African-Americans represent 12% of the U.S. population but only 5% 
of clinical trial participants.
  2. Hispanics make up 16% of the population but only 1% of clinical 
trial participants.
  3. Sex distribution in cardiovascular device trials is 67% male.
  Other significant barriers to diversified clinical trials, which are 
the key to sound medical research and the foundation for medical cures 
and breakthroughs, as reported by investigators and coordinators are 
insurance status, patient inconvenience costs, availability of 
transportation, distance to the study site, and patient and family 
concerns about risk.
  But the most significant barriers limiting clinical participation are 
race, age, and sex of participants:
  1. Women and minority patients are more difficult to recruit.
  2. Women and minority physicians have less experience and are 
relatively more costly to engage.
  3. Minority patients with limited English proficiency can require 
costly translation services.
  The first step in engaging women and minorities in clinical trials is 
finding them.
  Research has shown that minority patients seek physicians of their 
own race, so bringing these doctors into trials is critical.
  ``Physicians are the gateway to the patient''.
  There are disturbing statistics on the number of African Americans, 
Hispanics and Native Americans pursuing academic qualification and 
participating in scientific research.
  Many barriers exist that account for the low rate of participation 
among diverse communities, including patient fear of experimentation 
and lack of understanding or education with regard to the importance of 
clinical trials in creating new treatments and cures.
  The Jackson Lee Amendment is intended to aid in the necessary effort 
to diversify the pool of doctors and medical researchers conducting 
clinical trials, and thereby helping to diversify the participants in 
the clinical trials.
  In short, the Jackson Lee Amendment seeks to open the ``physician 
gateway'' to the patient.
  The Journal on STEM Education reported in 2011 that only 8.34% of the 
STEM doctorates awarded in 2006 were given to URMs, despite making up 
approximately 28% of the U.S. population.
  Furthermore, GAO noted that while the percentage of underrepresented 
minorities nationwide increased from 13% to 19% from 1994 to 2003, the 
total number of STEM doctorates awarded to the same group dropped 
during this period from 8,335 to 7,310.
  In response, the National Institute of General Medical Sciences 
(NIGMS) created the Minority Opportunities in Research (MORE) Division 
and similar academic intervention programs.
  The MORE programs are comprised of four primary components: research 
experience, mentoring and advisement, supplemental instruction and 
workshops, and financial support.
  In 2007, NIGMS' annual budget was $1.9 billion, of which nearly $126 
million was spent on its MORE programs.
  This amount includes the Minority Biomedical Research Support-
Research Initiative for Scientific Enhancement (MBRS-RISE) program, the 
Minority Access to Research Careers (MARC), Post-baccalaureate Research 
Education Program (PREP), and the Bridges to the Baccalaureate and 
Bridges to the Ph.D. programs.

[[Page 11328]]

  The amount of funds dedicated to these programs reflects the 
commitment by the science and research community to the goals of the 
MORE Division in addressing this problem.
  Certain medical illnesses have been known to have higher prevalence 
in certain demographic groups, including type II diabetes, lupus, 
sickle cell anemia, and Triple Negative Breast Cancer for which African 
Americans are more than twice as likely to be diagnosed on average.
  According to the Centers for Disease Control and Prevention, sickle 
cell trait is common among African Americans and occurs in about 1 in 
12, and sickle cell disease occurs in about 1 out of every 500 African-
American births, compared to about 1 out of every 36,000 Hispanic-
American births.
  Race and ethnicity have also been shown to affect the effectiveness 
of and response to certain drugs, such as anti-hypertensive therapies 
in the treatment of hypertension in African Americans and anti-
depressants in Hispanics.
  Increased diversity in research trials could help researchers find 
better, more precise ways to fight diseases that disproportionately 
impact certain populations, and may be important for the safe and 
effective use of new therapies.
  But before we can engage more women and minorities to participate in 
clinical trials, we must be able to find them.
  And the key to finding minority patients is to find more physicians 
from their racial and ethnic groups because research has shown that 
physicians are the gateway to the patient.
  The Jackson Lee Amendment opens that gateway.
  I urge support for the Jackson Lee Amendment.
  I yield back the balance of my time.
  Mr. UPTON. Mr. Chairman, I yield back the balance of my time.
  The Acting CHAIR. The question is on the amendment offered by the 
gentlewoman from Texas (Ms. Jackson Lee).
  The amendment was agreed to.


                    Announcement by the Acting Chair

  The Acting CHAIR. Pursuant to clause 6 of rule XVIII, proceedings 
will now resume on those amendments printed in House Report 114-193 on 
which further proceedings were postponed, in the following order:
  Amendment No. 1 by Mr. Brat of Virginia.
  Amendment No. 3 by Ms. Lee of California.
  The Chair will reduce to 2 minutes the minimum time for any 
electronic vote after the first vote in this series.


                  Amendment No. 1 Offered by Mr. Brat

  The Acting CHAIR. The unfinished business is the demand for a 
recorded vote on the amendment offered by the gentleman from Virginia 
(Mr. Brat) on which further proceedings were postponed and on which the 
noes prevailed by voice vote.
  The Clerk will redesignate the amendment.
  The Clerk redesignated the amendment.


                             Recorded Vote

  The Acting CHAIR. A recorded vote has been demanded.
  A recorded vote was ordered.
  The vote was taken by electronic device, and there were--ayes 141, 
noes 281, not voting 11, as follows:

                             [Roll No. 431]

                               AYES--141

     Abraham
     Aderholt
     Amash
     Amodei
     Babin
     Barr
     Bishop (MI)
     Bishop (UT)
     Black
     Blum
     Brady (TX)
     Brat
     Bridenstine
     Brooks (AL)
     Buck
     Byrne
     Carter (GA)
     Carter (TX)
     Chabot
     Chaffetz
     Clawson (FL)
     Coffman
     Collins (GA)
     Conaway
     Cook
     Crawford
     Culberson
     DeSantis
     DesJarlais
     Duffy
     Duncan (SC)
     Duncan (TN)
     Emmer (MN)
     Farenthold
     Fincher
     Fleischmann
     Fleming
     Forbes
     Fortenberry
     Foxx
     Franks (AZ)
     Garrett
     Gibbs
     Gohmert
     Goodlatte
     Gosar
     Gowdy
     Graves (GA)
     Graves (LA)
     Grothman
     Hardy
     Harris
     Hartzler
     Heck (NV)
     Hensarling
     Hice, Jody B.
     Holding
     Huelskamp
     Huizenga (MI)
     Hultgren
     Hunter
     Hurd (TX)
     Hurt (VA)
     Issa
     Jenkins (KS)
     Johnson, Sam
     Jolly
     Jones
     Jordan
     Joyce
     King (IA)
     Labrador
     LaMalfa
     Lamborn
     Loudermilk
     Love
     Lummis
     Marchant
     Massie
     McClintock
     Meadows
     Messer
     Mica
     Miller (FL)
     Moolenaar
     Mooney (WV)
     Mulvaney
     Newhouse
     Noem
     Palazzo
     Palmer
     Paulsen
     Pearce
     Perry
     Poe (TX)
     Poliquin
     Posey
     Price, Tom
     Ratcliffe
     Renacci
     Ribble
     Rice (SC)
     Rigell
     Roby
     Rohrabacher
     Rokita
     Rooney (FL)
     Ross
     Rothfus
     Rouzer
     Royce
     Russell
     Ryan (WI)
     Sanford
     Schweikert
     Scott, Austin
     Sensenbrenner
     Sessions
     Smith (MO)
     Smith (NE)
     Smith (TX)
     Stewart
     Stutzman
     Thornberry
     Tipton
     Trott
     Walberg
     Walker
     Walorski
     Weber (TX)
     Webster (FL)
     Wenstrup
     Westerman
     Westmoreland
     Williams
     Wilson (SC)
     Wittman
     Woodall
     Yoho
     Young (IN)
     Zinke

                               NOES--281

     Adams
     Aguilar
     Allen
     Ashford
     Barletta
     Barton
     Beatty
     Becerra
     Benishek
     Bera
     Beyer
     Bilirakis
     Bishop (GA)
     Blackburn
     Blumenauer
     Bonamici
     Bost
     Boustany
     Boyle, Brendan F.
     Brady (PA)
     Brooks (IN)
     Brown (FL)
     Brownley (CA)
     Buchanan
     Bucshon
     Burgess
     Bustos
     Butterfield
     Calvert
     Capps
     Capuano
     Cardenas
     Carney
     Carson (IN)
     Cartwright
     Castor (FL)
     Castro (TX)
     Chu, Judy
     Cicilline
     Clark (MA)
     Clarke (NY)
     Clay
     Cleaver
     Clyburn
     Cohen
     Cole
     Collins (NY)
     Comstock
     Connolly
     Conyers
     Cooper
     Costa
     Costello (PA)
     Courtney
     Cramer
     Crenshaw
     Crowley
     Cuellar
     Cummings
     Curbelo (FL)
     Davis (CA)
     Davis, Danny
     Davis, Rodney
     DeFazio
     DeGette
     Delaney
     DeLauro
     DelBene
     Denham
     Dent
     Deutch
     Diaz-Balart
     Dingell
     Doggett
     Dold
     Donovan
     Doyle, Michael F.
     Duckworth
     Edwards
     Ellison
     Ellmers (NC)
     Eshoo
     Esty
     Farr
     Fattah
     Fitzpatrick
     Flores
     Foster
     Frankel (FL)
     Frelinghuysen
     Fudge
     Gabbard
     Gallego
     Garamendi
     Gibson
     Graham
     Granger
     Grayson
     Green, Al
     Green, Gene
     Griffith
     Grijalva
     Guinta
     Guthrie
     Hahn
     Hanna
     Harper
     Hastings
     Heck (WA)
     Herrera Beutler
     Higgins
     Hill
     Himes
     Hinojosa
     Honda
     Hoyer
     Hudson
     Huffman
     Israel
     Jackson Lee
     Jeffries
     Jenkins (WV)
     Johnson (GA)
     Johnson (OH)
     Johnson, E. B.
     Kaptur
     Katko
     Keating
     Kelly (IL)
     Kelly (MS)
     Kelly (PA)
     Kildee
     Kilmer
     Kind
     King (NY)
     Kinzinger (IL)
     Kirkpatrick
     Kline
     Knight
     Kuster
     Lance
     Langevin
     Larsen (WA)
     Larson (CT)
     Latta
     Lawrence
     Lee
     Levin
     Lewis
     Lieu, Ted
     Lipinski
     LoBiondo
     Loebsack
     Long
     Lowenthal
     Lowey
     Lucas
     Luetkemeyer
     Lujan Grisham (NM)
     Lujan, Ben Ray (NM)
     Lynch
     MacArthur
     Maloney, Carolyn
     Maloney, Sean
     Marino
     Matsui
     McCarthy
     McCaul
     McCollum
     McDermott
     McGovern
     McHenry
     McKinley
     McMorris Rodgers
     McNerney
     McSally
     Meehan
     Meeks
     Meng
     Miller (MI)
     Moore
     Moulton
     Mullin
     Murphy (FL)
     Murphy (PA)
     Nadler
     Napolitano
     Neal
     Nolan
     Norcross
     Nugent
     Nunes
     O'Rourke
     Olson
     Pallone
     Pascrell
     Payne
     Pelosi
     Perlmutter
     Peters
     Peterson
     Pingree
     Pittenger
     Pitts
     Pocan
     Polis
     Pompeo
     Price (NC)
     Quigley
     Rangel
     Reed
     Reichert
     Rice (NY)
     Richmond
     Rogers (AL)
     Rogers (KY)
     Ros-Lehtinen
     Roskam
     Roybal-Allard
     Ruiz
     Ruppersberger
     Rush
     Ryan (OH)
     Sanchez, Linda T.
     Sarbanes
     Scalise
     Schakowsky
     Schiff
     Schrader
     Scott (VA)
     Scott, David
     Serrano
     Sewell (AL)
     Sherman
     Shimkus
     Shuster
     Simpson
     Sinema
     Sires
     Slaughter
     Smith (NJ)
     Smith (WA)
     Speier
     Stefanik
     Stivers
     Swalwell (CA)
     Takai
     Takano
     Thompson (CA)
     Thompson (MS)
     Thompson (PA)
     Tiberi
     Titus
     Tonko
     Torres
     Tsongas
     Turner
     Upton
     Valadao
     Van Hollen
     Vargas
     Veasey
     Vela
     Velazquez
     Visclosky
     Wagner
     Walden
     Walters, Mimi
     Walz
     Wasserman Schultz
     Waters, Maxine
     Watson Coleman
     Welch
     Whitfield
     Wilson (FL)
     Womack
     Yarmuth
     Yoder
     Young (AK)
     Young (IA)
     Zeldin

                             NOT VOTING--11

     Bass
     DeSaulnier
     Engel
     Graves (MO)
     Gutierrez
     Kennedy
     Lofgren
     Neugebauer
     Roe (TN)
     Salmon
     Sanchez, Loretta

                              {time}  1107

  Messrs. RICHMOND, MARINO, KNIGHT, HUFFMAN, and RYAN of Ohio changed 
their vote from ``aye'' to ``no.''
  Mrs. WALORSKI and Mr. TROTT changed their vote from ``no'' to 
``aye.''
  So the amendment was rejected.
  The result of the vote was announced as above recorded.


                   Amendment No. 3 Offered by Ms. Lee

  The Acting CHAIR. The unfinished business is the demand for a 
recorded vote on the amendment offered by the gentlewoman from 
California (Ms. Lee) on which further proceedings were postponed and on 
which the noes prevailed by voice vote.
  The Clerk will redesignate the amendment.

[[Page 11329]]

  The Clerk redesignated the amendment.


                             Recorded Vote

  The Acting CHAIR. A recorded vote has been demanded.
  A recorded vote was ordered.
  The Acting CHAIR. This will be a 2-minute vote.
  The vote was taken by electronic device, and there were--ayes 176, 
noes 245, not voting 12, as follows:

                             [Roll No. 432]

                               AYES--176

     Adams
     Aguilar
     Ashford
     Beatty
     Becerra
     Bera
     Beyer
     Bishop (GA)
     Blumenauer
     Bonamici
     Boyle, Brendan F.
     Brady (PA)
     Brown (FL)
     Brownley (CA)
     Bustos
     Butterfield
     Capps
     Capuano
     Cardenas
     Carney
     Carson (IN)
     Castor (FL)
     Castro (TX)
     Chu, Judy
     Cicilline
     Clark (MA)
     Clarke (NY)
     Clay
     Cleaver
     Clyburn
     Cohen
     Connolly
     Conyers
     Cooper
     Costa
     Courtney
     Crowley
     Cummings
     Davis (CA)
     Davis, Danny
     DeFazio
     DeGette
     Delaney
     DeLauro
     DelBene
     Deutch
     Dingell
     Doggett
     Doyle, Michael F.
     Duckworth
     Edwards
     Ellison
     Eshoo
     Esty
     Farr
     Fattah
     Foster
     Frankel (FL)
     Fudge
     Gabbard
     Gallego
     Garamendi
     Graham
     Grayson
     Green, Al
     Green, Gene
     Grijalva
     Hahn
     Hastings
     Heck (WA)
     Higgins
     Himes
     Hinojosa
     Honda
     Hoyer
     Huffman
     Israel
     Jackson Lee
     Jeffries
     Johnson (GA)
     Johnson, E. B.
     Keating
     Kelly (IL)
     Kildee
     Kilmer
     Kind
     Kirkpatrick
     Kuster
     Langevin
     Larsen (WA)
     Larson (CT)
     Lawrence
     Lee
     Levin
     Lewis
     Lieu, Ted
     Loebsack
     Lowenthal
     Lowey
     Lujan Grisham (NM)
     Lujan, Ben Ray (NM)
     Lynch
     Maloney, Carolyn
     Maloney, Sean
     Matsui
     McCollum
     McDermott
     McGovern
     McNerney
     Meeks
     Meng
     Moore
     Moulton
     Murphy (FL)
     Nadler
     Napolitano
     Neal
     Nolan
     Norcross
     O'Rourke
     Pallone
     Pascrell
     Payne
     Pelosi
     Perlmutter
     Peters
     Pingree
     Pocan
     Polis
     Price (NC)
     Quigley
     Rangel
     Rice (NY)
     Richmond
     Roybal-Allard
     Ruiz
     Ruppersberger
     Rush
     Ryan (OH)
     Sanchez, Linda T.
     Sarbanes
     Schakowsky
     Schiff
     Schrader
     Scott (VA)
     Scott, David
     Serrano
     Sewell (AL)
     Sherman
     Sinema
     Sires
     Slaughter
     Smith (WA)
     Speier
     Swalwell (CA)
     Takai
     Takano
     Thompson (CA)
     Thompson (MS)
     Titus
     Tonko
     Torres
     Tsongas
     Van Hollen
     Vargas
     Veasey
     Vela
     Velazquez
     Visclosky
     Walz
     Wasserman Schultz
     Waters, Maxine
     Watson Coleman
     Welch
     Wilson (FL)
     Yarmuth

                               NOES--245

     Abraham
     Aderholt
     Allen
     Amash
     Amodei
     Babin
     Barletta
     Barr
     Barton
     Benishek
     Bilirakis
     Bishop (MI)
     Bishop (UT)
     Black
     Blackburn
     Blum
     Bost
     Boustany
     Brady (TX)
     Brat
     Bridenstine
     Brooks (AL)
     Brooks (IN)
     Buchanan
     Buck
     Bucshon
     Burgess
     Byrne
     Calvert
     Carter (GA)
     Carter (TX)
     Cartwright
     Chabot
     Chaffetz
     Clawson (FL)
     Coffman
     Cole
     Collins (GA)
     Collins (NY)
     Comstock
     Conaway
     Cook
     Costello (PA)
     Cramer
     Crawford
     Crenshaw
     Cuellar
     Culberson
     Curbelo (FL)
     Davis, Rodney
     Denham
     Dent
     DeSantis
     DesJarlais
     Diaz-Balart
     Dold
     Donovan
     Duffy
     Duncan (SC)
     Duncan (TN)
     Ellmers (NC)
     Emmer (MN)
     Farenthold
     Fincher
     Fitzpatrick
     Fleischmann
     Fleming
     Flores
     Forbes
     Fortenberry
     Foxx
     Franks (AZ)
     Frelinghuysen
     Garrett
     Gibbs
     Gibson
     Gohmert
     Goodlatte
     Gosar
     Gowdy
     Granger
     Graves (GA)
     Graves (LA)
     Griffith
     Grothman
     Guinta
     Guthrie
     Hanna
     Hardy
     Harper
     Harris
     Hartzler
     Heck (NV)
     Hensarling
     Herrera Beutler
     Hice, Jody B.
     Hill
     Holding
     Hudson
     Huelskamp
     Huizenga (MI)
     Hultgren
     Hunter
     Hurd (TX)
     Hurt (VA)
     Issa
     Jenkins (KS)
     Jenkins (WV)
     Johnson (OH)
     Johnson, Sam
     Jolly
     Jones
     Jordan
     Joyce
     Kaptur
     Katko
     Kelly (MS)
     Kelly (PA)
     King (IA)
     King (NY)
     Kinzinger (IL)
     Kline
     Knight
     Labrador
     LaMalfa
     Lamborn
     Lance
     Latta
     Lipinski
     LoBiondo
     Long
     Loudermilk
     Love
     Lucas
     Luetkemeyer
     Lummis
     MacArthur
     Marchant
     Marino
     Massie
     McCarthy
     McCaul
     McClintock
     McHenry
     McKinley
     McMorris Rodgers
     McSally
     Meadows
     Meehan
     Messer
     Mica
     Miller (FL)
     Miller (MI)
     Moolenaar
     Mooney (WV)
     Mullin
     Mulvaney
     Murphy (PA)
     Newhouse
     Noem
     Nugent
     Nunes
     Olson
     Palazzo
     Palmer
     Paulsen
     Pearce
     Perry
     Peterson
     Pittenger
     Pitts
     Poe (TX)
     Poliquin
     Pompeo
     Posey
     Price, Tom
     Ratcliffe
     Reed
     Reichert
     Renacci
     Ribble
     Rice (SC)
     Rigell
     Roby
     Rogers (AL)
     Rogers (KY)
     Rohrabacher
     Rokita
     Ros-Lehtinen
     Roskam
     Ross
     Rothfus
     Rouzer
     Royce
     Russell
     Ryan (WI)
     Sanford
     Scalise
     Schweikert
     Scott, Austin
     Sensenbrenner
     Sessions
     Shimkus
     Shuster
     Simpson
     Smith (MO)
     Smith (NE)
     Smith (NJ)
     Smith (TX)
     Stefanik
     Stewart
     Stivers
     Stutzman
     Thompson (PA)
     Thornberry
     Tiberi
     Tipton
     Trott
     Turner
     Upton
     Valadao
     Wagner
     Walberg
     Walden
     Walker
     Walorski
     Walters, Mimi
     Weber (TX)
     Webster (FL)
     Wenstrup
     Westerman
     Westmoreland
     Whitfield
     Williams
     Wilson (SC)
     Wittman
     Womack
     Woodall
     Yoder
     Yoho
     Young (AK)
     Young (IA)
     Young (IN)
     Zeldin
     Zinke

                             NOT VOTING--12

     Bass
     DeSaulnier
     Engel
     Graves (MO)
     Gutierrez
     Kennedy
     Lofgren
     Neugebauer
     Roe (TN)
     Rooney (FL)
     Salmon
     Sanchez, Loretta


                    Announcement by the Acting Chair

  The Acting CHAIR (during the vote). There is 1 minute remaining.

                              {time}  1115

  Mr. GRAYSON changed his vote from ``no'' to ``aye.''
  So the amendment was rejected.
  The result of the vote was announced as above recorded.
  The Acting CHAIR. There being no further amendments, the Committee 
rises.
  Accordingly, the Committee rose; and the Speaker pro tempore (Mr. 
Collins of Georgia) having assumed the chair, Mr. Hill, Acting Chair of 
the Committee of the Whole House on the state of the Union, reported 
that that Committee, having had under consideration the bill (H.R. 6) 
to accelerate the discovery, development, and delivery of 21st century 
cures, and for other purposes, and, pursuant to House Resolution 350, 
he reported the bill, as amended by that resolution, back to the House 
with sundry further amendments adopted in the Committee of the Whole.
  The SPEAKER pro tempore. Under the rule, the previous question is 
ordered.
  Is a separate vote demanded on any further amendment reported from 
the Committee of the Whole? If not, the Chair will put them en gros.
  The amendments were agreed to.
  The SPEAKER pro tempore. The question is on the engrossment and third 
reading of the bill.
  The bill was ordered to be engrossed and read a third time, and was 
read the third time.
  The SPEAKER pro tempore. The question is on passage of the bill.
  The question was taken; and the Speaker pro tempore announced that 
the ayes appeared to have it.


                             Recorded Vote

  Mr. UPTON. Mr. Speaker, I demand a recorded vote.
  A recorded vote was ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, this 5-
minute vote on passage will be followed by a 5-minute vote on approval 
of the Journal, if ordered.
  The vote was taken by electronic device, and there were--ayes 344, 
noes 77, not voting 12, as follows:

                             [Roll No. 433]

                               AYES--344

     Abraham
     Adams
     Aderholt
     Aguilar
     Allen
     Amodei
     Ashford
     Barletta
     Barr
     Barton
     Beatty
     Becerra
     Benishek
     Bera
     Beyer
     Bilirakis
     Bishop (GA)
     Bishop (MI)
     Blackburn
     Blum
     Blumenauer
     Bonamici
     Bost
     Boyle, Brendan F.
     Brady (PA)
     Brady (TX)
     Brooks (IN)
     Brown (FL)
     Brownley (CA)
     Buchanan
     Bucshon
     Burgess
     Bustos
     Butterfield
     Calvert
     Capps
     Capuano
     Cardenas
     Carney
     Carson (IN)
     Carter (GA)
     Cartwright
     Castor (FL)
     Castro (TX)
     Chabot
     Chaffetz
     Chu, Judy
     Cicilline
     Clark (MA)
     Clarke (NY)
     Clawson (FL)
     Clay
     Cleaver
     Clyburn
     Coffman
     Cohen
     Cole
     Collins (GA)
     Collins (NY)
     Comstock
     Connolly
     Conyers
     Cook
     Cooper
     Costa
     Costello (PA)
     Courtney
     Cramer
     Crenshaw
     Crowley
     Cuellar
     Cummings
     Curbelo (FL)
     Davis (CA)
     Davis, Danny
     Davis, Rodney
     DeFazio
     DeGette
     Delaney
     DelBene
     Denham
     Dent
     DeSantis
     Deutch
     Diaz-Balart
     Dingell
     Doggett
     Dold
     Donovan
     Doyle, Michael F.
     Duckworth
     Duncan (SC)
     Duncan (TN)
     Edwards
     Ellison
     Ellmers (NC)
     Emmer (MN)
     Esty
     Fattah
     Fleischmann
     Flores
     Fortenberry
     Foster
     Foxx
     Frankel (FL)
     Franks (AZ)
     Frelinghuysen
     Fudge
     Gabbard
     Gallego
     Garamendi
     Gibson

[[Page 11330]]


     Gohmert
     Gowdy
     Graham
     Granger
     Graves (LA)
     Grayson
     Green, Al
     Green, Gene
     Griffith
     Guinta
     Guthrie
     Hahn
     Hanna
     Hardy
     Harper
     Harris
     Hastings
     Heck (NV)
     Heck (WA)
     Herrera Beutler
     Higgins
     Hill
     Himes
     Hinojosa
     Honda
     Hoyer
     Hudson
     Huffman
     Huizenga (MI)
     Hultgren
     Hunter
     Hurd (TX)
     Hurt (VA)
     Israel
     Jackson Lee
     Jeffries
     Jenkins (KS)
     Jenkins (WV)
     Johnson (GA)
     Johnson (OH)
     Johnson, E. B.
     Jolly
     Joyce
     Kaptur
     Katko
     Keating
     Kelly (IL)
     Kelly (MS)
     Kelly (PA)
     Kildee
     Kilmer
     Kind
     King (IA)
     King (NY)
     Kinzinger (IL)
     Kirkpatrick
     Kline
     Knight
     Kuster
     LaMalfa
     Lance
     Langevin
     Larsen (WA)
     Larson (CT)
     Latta
     Lawrence
     Levin
     Lewis
     Lieu, Ted
     Lipinski
     LoBiondo
     Loebsack
     Long
     Lowenthal
     Lowey
     Lucas
     Luetkemeyer
     Lujan Grisham (NM)
     Lujan, Ben Ray (NM)
     Lynch
     MacArthur
     Maloney, Carolyn
     Maloney, Sean
     Marchant
     Marino
     Matsui
     McCarthy
     McCaul
     McCollum
     McDermott
     McGovern
     McHenry
     McKinley
     McMorris Rodgers
     McNerney
     McSally
     Meadows
     Meehan
     Meeks
     Meng
     Messer
     Mica
     Miller (MI)
     Moolenaar
     Moore
     Moulton
     Mullin
     Murphy (FL)
     Murphy (PA)
     Napolitano
     Neal
     Newhouse
     Noem
     Nolan
     Norcross
     Nugent
     Nunes
     O'Rourke
     Olson
     Pallone
     Pascrell
     Paulsen
     Payne
     Pelosi
     Perlmutter
     Peters
     Peterson
     Pingree
     Pittenger
     Pitts
     Pocan
     Poliquin
     Polis
     Pompeo
     Posey
     Price (NC)
     Quigley
     Rangel
     Reed
     Reichert
     Ribble
     Rice (NY)
     Richmond
     Rigell
     Roby
     Rogers (AL)
     Rogers (KY)
     Rohrabacher
     Rooney (FL)
     Ros-Lehtinen
     Roskam
     Ross
     Rothfus
     Rouzer
     Roybal-Allard
     Royce
     Ruiz
     Ruppersberger
     Rush
     Russell
     Ryan (OH)
     Ryan (WI)
     Sanchez, Linda T.
     Sarbanes
     Scalise
     Schakowsky
     Schiff
     Schrader
     Schweikert
     Scott (VA)
     Scott, Austin
     Scott, David
     Serrano
     Sessions
     Sewell (AL)
     Sherman
     Shimkus
     Shuster
     Simpson
     Sinema
     Sires
     Slaughter
     Smith (NJ)
     Smith (WA)
     Stefanik
     Stivers
     Swalwell (CA)
     Takai
     Takano
     Thompson (CA)
     Thompson (MS)
     Thompson (PA)
     Thornberry
     Tiberi
     Titus
     Tonko
     Torres
     Trott
     Tsongas
     Turner
     Upton
     Valadao
     Van Hollen
     Vargas
     Veasey
     Vela
     Velazquez
     Visclosky
     Wagner
     Walberg
     Walden
     Walorski
     Walters, Mimi
     Walz
     Wasserman Schultz
     Waters, Maxine
     Watson Coleman
     Webster (FL)
     Welch
     Whitfield
     Wilson (FL)
     Wilson (SC)
     Womack
     Woodall
     Yarmuth
     Yoder
     Yoho
     Young (AK)
     Young (IA)
     Young (IN)
     Zeldin
     Zinke

                                NOES--77

     Amash
     Babin
     Black
     Boustany
     Brat
     Bridenstine
     Brooks (AL)
     Buck
     Byrne
     Carter (TX)
     Conaway
     Crawford
     Culberson
     DeLauro
     DesJarlais
     Duffy
     Eshoo
     Farenthold
     Farr
     Fincher
     Fitzpatrick
     Fleming
     Forbes
     Garrett
     Gibbs
     Goodlatte
     Gosar
     Graves (GA)
     Grijalva
     Grothman
     Hartzler
     Hensarling
     Hice, Jody B.
     Holding
     Huelskamp
     Issa
     Johnson, Sam
     Jones
     Jordan
     Labrador
     Lamborn
     Lee
     Loudermilk
     Love
     Lummis
     Massie
     McClintock
     Miller (FL)
     Mooney (WV)
     Mulvaney
     Nadler
     Neugebauer
     Palazzo
     Palmer
     Pearce
     Perry
     Poe (TX)
     Price, Tom
     Ratcliffe
     Renacci
     Rice (SC)
     Rokita
     Sanford
     Sensenbrenner
     Smith (MO)
     Smith (NE)
     Smith (TX)
     Speier
     Stewart
     Stutzman
     Tipton
     Walker
     Weber (TX)
     Wenstrup
     Westerman
     Westmoreland
     Williams

                             NOT VOTING--12

     Bass
     Bishop (UT)
     DeSaulnier
     Engel
     Graves (MO)
     Gutierrez
     Kennedy
     Lofgren
     Roe (TN)
     Salmon
     Sanchez, Loretta
     Wittman


                Announcement by the Speaker Pro Tempore

  The SPEAKER pro tempore (during the vote). There are 2 minutes 
remaining.

                              {time}  1126

  So the bill was passed.
  The result of the vote was announced as above recorded.
  A motion to reconsider was laid on the table.


                          Personal Explanation

  Mr. DeSAULNIER. Mr. Speaker, I regret that I was unable to vote on 
Friday, July 10 as I was attending the memorial services of a dear 
friend in my congressional district. Had I been present, I would have 
cast the following votes: rollcall No. 431: ``no;'' rollcall No. 432: 
``aye;'' rollcall No. 433: ``aye.''


                          personal explanation

  Ms. LORETTA SANCHEZ of California. Mr. Speaker, I missed votes on 
H.R. 6, the 21st Century Cures Act. Specifically, I missed an amendment 
by Rep. Dave Brat (R-VA) (rollcall No. 431), amendment by Rep. Barbara 
Lee (D-CA) (rollcall No. 432), and Final Passage of H.R. 6 (rollcall 
No. 433). Had I been present, I would have voted ``nay'' on the 
amendment by Rep. Dave Brat (R-VA) (rollcall No. 431), ``yea'' on the 
amendment by Rep. Barbara Lee (D-CA) (rollcall no. 432), and ``yea'' on 
the Final Passage of H.R. 6 (rollcall No. 433).


                          personal explanation

  Mr. GUTIERREZ. Mr. Speaker, I was unavoidably absent in the House 
chamber for votes on Friday, July 10, 2015.
  Had I been present, I would have voted ``nay'' on rollcall vote 431, 
``yea'' on rollcall vote 432, and ``yea'' on rollcall vote 433 in 
support of H.R. 6--21st Century Cures Act.

                          ____________________