[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6 Engrossed in House (EH)]

114th CONGRESS
  1st Session
                                 H. R. 6

_______________________________________________________________________

                                 AN ACT


 
To accelerate the discovery, development, and delivery of 21st century 
                     cures, and for other purposes.

    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.
Sec. 1002. Prize competitions.
 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.
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.
                      Subtitle R--Other Provisions

Sec. 2321. Sense of Congress.
                          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. 4062. Outreach to historically black colleges and universities.

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 409L 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 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.''.

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 nine 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-Prize Board of any 
        matter that would directly or predictably effect any financial 
        interest of--
                    ``(A) the individual or a relative (as such term is 
                defined in section 109(16) of the Ethics in Government 
                Act of 1978) of the individual; or
                    ``(B) of any business organization or other 
                entity--
                            ``(i) of which the individual is an officer 
                        or employee;
                            ``(ii) with respect to which the individual 
                        is negotiating for employment; or
                            ``(iii) in which the individual has any 
                        other financial interest.
            ``(2) No awards to competitors likely to reap financial 
        benefit from innovation.--The Director of NIH may not, with 
        respect to an innovation, award a prize under this section to 
        any individual or entity that has a vested financial interest 
        in any product or procedure that is likely to be developed or 
        marketed because of such innovation.
    ``(e) Process of Award.--The full monetary amount of any prize 
awarded under this section shall be made available to the prize winner 
not later than 90 days after the date of such award.
    ``(f) Simulation.--The Director of NIH may--
            ``(1) award one or more contracts--
                    ``(A) to perform a simulation of the prize 
                competitions to be conducted under this section, based 
                on the designs developed under subsection (b); and
                    ``(B) to use the simulation to assess the 
                effectiveness of the design; and
            ``(2) not later than 4 months after awarding such one or 
        more contracts, submit to the Congress a report on the results 
        of the simulation and assessment.
    ``(g) Implementation of Prize Competitions.--
            ``(1) In general.--The Director of NIH may enter into an 
        agreement with one or more entities described in section 
        501(c), and exempt from tax under section 501(a), of the 
        Internal Revenue Code of 1986 to implement prize competitions 
        based on the designs developed under subsection (b).
            ``(2) Minimum percentage for prizes.--If the Director of 
        NIH enters into an agreement under paragraph (1) to provide 
        funds or other assistance (including in-kind contributions and 
        testing or other technical support) to an entity to implement a 
        prize competition under this section--
                    ``(A) not more than 15 percent of such assistance 
                shall be for administration of the prize competition; 
                and
                    ``(B) not less than 85 percent of such assistance 
                shall be for activities in direct support of 
                competitors such as demonstration, testing, education, 
                and prize awards.
    ``(h) Tracking; Reporting.--The Director of NIH shall--
            ``(1) collect information on--
                    ``(A) the medical efficacy of innovations funded 
                through the prize competitions under this section; and
                    ``(B) the actual and potential effect of the 
                innovations on Federal expenditures; and
            ``(2) not later than 1 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.''.

 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 5-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.
                    ``(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 2 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.), as amended by section 1002 of this Act, is amended by adding 
at the end the following:

``SEC. 409L. 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 
Act (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 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, including 
underrepresented individuals in the sciences, such as women and other 
minorities.

                   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.
            (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 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:

   ``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) eight shall be appointed by the 
                        Comptroller General of the United States from a 
                        list of nominations submitted by leading trade 
                        associations--
                                    ``(I) four of whom shall be 
                                representatives of the 
                                biopharmaceutical industry;
                                    ``(II) two of whom shall be 
                                representatives of the medical device 
                                industry; and
                                    ``(III) two of whom shall be 
                                representatives of the information and 
                                digital technology industry; and
                            ``(ii) nine shall be appointed by the 
                        Comptroller General of the United States, after 
                        soliciting nominations--
                                    ``(I) two of whom shall be 
                                representatives of academic 
                                researchers;
                                    ``(II) three of whom shall be 
                                representatives of patients;
                                    ``(III) two of whom shall be 
                                representatives of health care 
                                providers; and
                                    ``(IV) two 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 1 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
            (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 2 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 1 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.--
            ``(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 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;
                    (D) the number of qualification plans and full 
                qualification packages, respectively, submitted to the 
                Secretary; and
                    (E) 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).

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, 
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, 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.--
            ``(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 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 2 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.--
                    (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).
    (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 3 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).

         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 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 1 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 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, 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 30-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 `30-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 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 30-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 30-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 30-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 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 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''.
    (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, 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.''.

                      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.

                          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 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:
    ``(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
            ``(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 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--
                    ``(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'';
                    (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 caretakers 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.''.
    (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 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
                            ``(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 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 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''; and
                    (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 million barrels of crude oil from the Strategic 
        Petroleum Reserve during fiscal year 2018;
            (2) 5 million barrels of crude oil from the Strategic 
        Petroleum Reserve during fiscal year 2019;
            (3) 8 million barrels of crude oil from the Strategic 
        Petroleum Reserve during fiscal year 2020;
            (4) 8 million barrels of crude oil from the Strategic 
        Petroleum Reserve during fiscal year 2021;
            (5) 10 million barrels of crude oil from the Strategic 
        Petroleum Reserve during fiscal year 2022;
            (6) 15 million barrels of crude oil from the Strategic 
        Petroleum Reserve during fiscal year 2023;
            (7) 15 million barrels of crude oil from the Strategic 
        Petroleum Reserve during fiscal year 2024; and
            (8) 15 million 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 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.

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.

            Passed the House of Representatives July 10, 2015.

            Attest:

                                                                 Clerk.
114th CONGRESS

  1st Session

                                H. R. 6

_______________________________________________________________________

                                 AN ACT

To accelerate the discovery, development, and delivery of 21st century 
                     cures, and for other purposes.