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

114th CONGRESS
  1st Session
                                 H. R. 6

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 19, 2015

 Mr. Upton (for himself, Ms. DeGette, Mr. Pitts, Mr. Pallone, and Mr. 
Gene Green of Texas) introduced the following bill; which was referred 
    to the Committee on Energy and Commerce, and in addition to the 
Committee on Ways and Means, for a period to be subsequently determined 
 by the Speaker, in each case for consideration of such provisions as 
        fall within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
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.
                           TITLE I--DISCOVERY

           Subtitle A--National Institutes of Health Funding

Sec. 1001. National Institutes of Health reauthorization.
Sec. 1002. NIH Innovation Fund.
 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.
            Subtitle C--Supporting Young Emerging Scientists

Sec. 1041. Improvement of loan repayment programs of 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 National Institutes of Health Research and 
                              Data Access

Sec. 1101. Sharing of data generated through NIH-funded research.
Sec. 1102. 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 new antimicrobial 
                            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.
                          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 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 ``; and''; 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. NIH INNOVATION FUND.

    (a) Use of Innovation Fund.--Section 402(b) of the Public Health 
Service Act is amended--
            (1) in paragraph (23), by striking at the end ``and'';
            (2) in paragraph (24), by striking at the end the period 
        and inserting ``; and''; and
            (3) by inserting after paragraph (24), the following new 
        paragraph:
            ``(25) shall, with respect to funds appropriated under 
        section 402A(e) to the NIH Innovation Fund, allocate such funds 
        to the national research institutes and national centers for 
        conducting and supporting innovation fund initiatives 
        identified under paragraph (3) of such section.''.
    (b) Establishment of Innovation Fund.--Section 402A of the Public 
Health Service Act is amended--
            (1) by redesignating subsection (e) as subsection (f); and
            (2) by inserting after subsection (d) the following new 
        subsection:
    ``(e) NIH Innovation Fund.--
            ``(1) Establishment.--For the purpose of allocations under 
        section 402(b)(25), there is established a fund to be known as 
        the NIH Innovation Fund. The Director of NIH shall, with 
        respect to funds appropriated to the NIH Innovation Fund, 
        allocate such funds to support biomedical research through the 
        funding of basic, translational, and clinical research.
            ``(2) Amounts made available to fund.--
                    ``(A) In general.--Subject to subparagraph (B), 
                there is authorized to be appropriated, and 
                appropriated, to the NIH Innovation Fund out of any 
                funds in the Treasury not otherwise appropriated, 
                $2,000,000,000 for each of fiscal years 2016 through 
                2020. The amounts appropriated to the Fund by the 
                preceding sentence shall be in addition to any amounts 
                otherwise made available to the National Institutes of 
                Health.
                    ``(B) Availability subject to appropriations.--
                Amounts in the Fund shall not be available except to 
                the extent and in such amounts as are provided in 
                advance in appropriation Acts.
                    ``(C) Allocation of amounts.--Of the amounts made 
                available from the NIH Innovation Fund for allocations 
                under section 402(b)(25) for a fiscal year--
                            ``(i) not less than $500,000,000 shall be 
                        for the Accelerating Advancement Program under 
                        paragraph (5);
                            ``(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 (7);
                            ``(iii) not less than 20 percent of such 
                        amounts remaining after subtracting the 
                        allocation for the Accelerating Advancement 
                        Program shall be for high-risk, high-reward 
                        research under section 409K; and
                            ``(iv) not more than 10 percent of such 
                        amounts (without subtracting the allocation for 
                        the Accelerating Advancement Program) shall be 
                        for intramural research.
                    ``(D) Inapplicability of certain provisions.--
                Amounts in the NIH Innovation Fund shall not be subject 
                to--
                            ``(i) any transfer authority of the 
                        Secretary or the Director of NIH under section 
                        241, subsection (c), subsection (d), or any 
                        other provision of law (other than section 
                        402(b)(25) and this subsection); or
                            ``(ii) the Nonrecurring expenses fund under 
                        section 223 of division G of the Consolidated 
                        Appropriations Act, 2008 (42 U.S.C. 3514a).
            ``(3) Authorized uses.--Amounts in the NIH Innovation Fund 
        established under paragraph (1) may be used only to conduct or 
        support innovative biomedical 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 paragraph (7)).
                    ``(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 
                paragraph (5).
                    ``(F) Development and implementation of the 
                strategic plan under paragraph (6).
            ``(4) Coordination.--In funding programs and activities 
        through the NIH Innovation Fund, the Secretary, acting through 
        the Director of NIH, 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.
            ``(5) Accelerating advancement program.--The Director of 
        NIH shall establish a program, to be known as the Accelerating 
        Advancement Program, under which--
                    ``(A) the Director of NIH partners with national 
                research institutes and national centers to accomplish 
                important biomedical research objectives; and
                    ``(B) for every $1 made available by the Director 
                of NIH 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 Innovation Fund.
            ``(6) Strategic plan.--
                    ``(A) In general.--The Director of NIH 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 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 shall 
                review and, as appropriate, update the research 
                strategic plan under subparagraph (A) not less than 
                every 18 months.
            ``(7) Definition.--In this subsection, 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).''.
    (c) Supplement, Not Supplant; Prohibition Against Transfer.--Funds 
appropriated pursuant to section 402A(e) of the Public Health Service 
Act, as inserted by subsection (b)--
            (1) shall be used to supplement, not supplant, the funds 
        otherwise allocated by the National Institutes of Health for 
        biomedical research; and
            (2) notwithstanding any transfer authority in any 
        appropriation Act, shall not be used for any purpose other than 
        allocating funds for conducting and supporting innovation fund 
        initiatives as described in section 402(b)(25) of the Public 
        Health Service Act, as added by subsection (a).

 Subtitle B--National Institutes of Health Planning and Administration

SEC. 1021. NIH RESEARCH STRATEGIC PLAN.

    Section 402 of the Public Health Service Act (42 U.S.C. 282) is 
amended--
            (1) in subsection (b), by amending paragraph (5) to read as 
        follows:
            ``(5) shall ensure that scientifically based strategic 
        planning is implemented in support of research priorities as 
        determined by the agencies of the National Institutes of 
        Health, including through development, use, and updating of the 
        research strategic plan under subsection (m);''; and
            (2) by adding at the end the following:
    ``(m) Research Strategic Plan.--
            ``(1) Five-year plans for biomedical research strategy.--
                    ``(A) In general.--For each successive five-year 
                period beginning with the period of fiscal years 2016 
                through 2020, the Director of NIH, in consultation with 
                the entities described in subparagraph (B), shall 
                develop and maintain a biomedical research strategic 
                plan that--
                            ``(i) is designed to increase the efficient 
                        and effective focus of biomedical research in a 
                        manner that leverages the best scientific 
                        opportunities through a deliberative planning 
                        process;
                            ``(ii) identifies areas, to be known 
                        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.
            ``(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) Implementation of Measures To Reduce Administrative Burdens.--
The Director of the National Institutes of Health shall 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) Reports.--The Director of the National Institutes of Health 
shall submit to Congress a report on the extent to which the Director 
has implemented measures pursuant to subsection (a).

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

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

SEC. 1025. NIH TRAVEL.

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

SEC. 1026. OTHER TRANSACTIONS AUTHORITY.

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

SEC. 1027. NCATS PHASE IIB RESTRICTION.

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

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

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

``SEC. 409K. HIGH-RISK, HIGH-REWARD RESEARCH PROGRAM.

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

            Subtitle C--Supporting Young Emerging Scientists

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

    (a) In General.--Part G of title IV of the Public Health Service 
(42 U.S.C. 288 et seq.) is amended--
            (1) by redesignating the second section 487F (42 U.S.C. 
        288-6; 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) in subsection (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 487F of such Act (42 U.S.C. 288-6, as added by 
        section 1002(b) of Public Law 106-310, is amended--
                    (A) in subsection (a)(1), by striking ``$35,000'' 
                and inserting ``$50,000'';
                    (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.''; and
                    (C) by redesignating such section as section 487G.

SEC. 1042. REPORT.

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

                   Subtitle D--Capstone Grant Program

SEC. 1061. CAPSTONE AWARD.

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

``SEC. 490. CAPSTONE AWARD.

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

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

SEC. 1081. NATIONAL PEDIATRIC RESEARCH NETWORK.

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

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

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

SEC. 1083. APPROPRIATE AGE GROUPINGS IN CLINICAL RESEARCH.

    (a) Input From Experts.--Not later than 180 days after the date of 
enactment of this Act, the Director of the National Institutes of 
Health shall convene a workshop of experts on pediatrics and experts on 
geriatrics to provide input on--
            (1) appropriate age groupings to be included in research 
        studies involving human subjects; and
            (2) acceptable scientific justifications for excluding 
        participants from a range of age groups from human subjects 
        research studies.
    (b) Guidelines.--Not later than 180 days after the conclusion of 
the workshop under subsection (a), the Director of the National 
Institutes of Health shall publish guidelines--
            (1) addressing the consideration of age as an inclusion 
        variable in research involving human subjects; and
            (2) identifying criteria for justifications for any age-
        related exclusions in such research.
    (c) Public Availability of Findings and Conclusions.--The Director 
of the National Institutes of Health shall--
            (1) make the findings and conclusion 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 National Institutes of Health Research and 
                              Data Access

SEC. 1101. SHARING OF DATA GENERATED THROUGH NIH-FUNDED RESEARCH.

    Section 402 of the Public Health Service Act (42 U.S.C. 282) is 
amended by adding at the end the following:
    ``(m) Sharing of Data Generated Through NIH-funded Research.--
            ``(1) Authority.--Subject to paragraph (2), the Director of 
        NIH may require recipients of the award of an NIH grant or 
        other financial support, provided that the research is fully 
        funded through such grant or other support, to share scientific 
        data generated from research conducted through such support for 
        research purposes.
            ``(2) Limitation.--The Director of NIH shall not require 
        the sharing of data that is inconsistent with applicable law 
        and policy protecting--
                    ``(A) privacy and confidentiality;
                    ``(B) proprietary interests;
                    ``(C) business confidential information;
                    ``(D) intellectual property rights; and
                    ``(E) other relevant rights.''.

SEC. 1102. 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 shall 
                include at least--
                            ``(i) the disease or indication being 
                        studied;
                            ``(ii) inclusion criteria such as age, 
                        gender, diagnosis or diagnoses, lab values, or 
                        imaging results; and
                            ``(iii) exclusion criteria such as specific 
                        diagnosis or diagnoses, lab 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 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 in 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 Secretary shall conduct a study and 
        issue a report to the Congress, 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 
                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 a 
                description, if any, of such burden.
                    (E) An emphasis 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 subsection (g) of section 201 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 331)), a device (as defined in 
        subsection (h) of such section), 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 was--
                            (i) 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) 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 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 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 to 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 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.--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:
    ``(a) 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).
    ``(b) 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 such 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 such 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) shall 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.''.
    (b) Revision of Regulations.--Not later than 12 months after the 
date of the enactment of this Act, the Secretary of Health and Human 
Services shall revise and clarify the provisions of title 45, Code of 
Federal Regulations, for consistency with part 4 of subtitle D of the 
HITECH Act, as added by subsection (a).

               Subtitle H--Council for 21st Century Cures

SEC. 1141. COUNCIL FOR 21ST CENTURY CURES.

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

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

``SEC. 281. ESTABLISHMENT.

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

``SEC. 281A. PURPOSE.

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

``SEC. 281B. DUTIES.

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

``SEC. 281C. ORGANIZATION; ADMINISTRATION.

    ``(a) Board of Directors.--
            ``(1) Establishment.--
                    ``(A) In general.--The Council shall have a Board 
                of Directors (in this part referred to as the `Board of 
                Directors'), which shall be composed of the ex officio 
                members under subparagraph (B) and the appointed 
                members under subparagraph (C). All members of the 
                Board shall be voting members.
                    ``(B) Ex officio members.--The ex officio members 
                of the Board shall be the following individuals or 
                their designees:
                            ``(i) The Director of the National 
                        Institutes of Health.
                            ``(ii) The Commissioner of Food and Drugs.
                            ``(iii) The Administrator of the Centers 
                        for Medicare & Medicaid Services.
                            ``(iv) The heads of five other Federal 
                        agencies deemed by the Secretary to be engaged 
                        in biomedical research and development.
                    ``(C) Appointed members.--The appointed members of 
                the Board shall consist of 17 individuals, of whom--
                            ``(i) 8 shall be by the Comptroller General 
                        of the United States from a list of nominations 
                        submitted by leading trade associations--
                                    ``(I) 4 of whom shall be 
                                representatives of the 
                                biopharmaceutical industry;
                                    ``(II) 2 of whom shall be 
                                representatives of the medical device 
                                industry; and
                                    ``(III) 2 of whom shall be 
                                representatives of the information and 
                                digital technology industry; and
                            ``(ii) 9 shall be appointed by the 
                        Comptroller General of the United States, after 
                        soliciting nominations--
                                    ``(I) 2 of whom shall be 
                                representatives of academic 
                                researchers;
                                    ``(II) 3 of whom shall be 
                                representative of patients;
                                    ``(III) 2 of whom shall be 
                                representatives of health care 
                                providers; and
                                    ``(IV) 2 of whom shall be 
                                representatives of health care plans 
                                and insurers.
                    ``(D) Chair.--The Chair of the Board shall be 
                selected by the members of the Board by majority vote 
                from among the members of the Board.
            ``(2) Terms and vacancies.--
                    ``(A) In general.--The term of office of each 
                member of the Board appointed under paragraph (1)(C) 
                shall be 5 years.
                    ``(B) Vacancy.--Any vacancy in the membership of 
                the Board--
                            ``(i) shall not affect the power of the 
                        remaining members to execute the duties of the 
                        Board; and
                            ``(ii) shall be filled by appointment by 
                        the appointed members described in paragraph 
                        (1)(C) by majority vote.
                    ``(C) Partial term.--If a member of the Board does 
                not serve the full term applicable under subparagraph 
                (A), the individual appointed under subparagraph (B) to 
                fill the resulting vacancy shall be appointed for the 
                remainder of the term of the predecessor of the 
                individual.
            ``(3) Responsibilities.--Not later than 90 days after the 
        date on which the Council is incorporated and its Board of 
        Directors is fully constituted, the Board of Directors shall 
        establish bylaws and policies for the Council that--
                    ``(A) are published in the Federal Register and 
                available for public comment;
                    ``(B) establish policies for the selection and, as 
                applicable, appointment of--
                            ``(i) the officers, employees, agents, and 
                        contractors of the Council; and
                            ``(ii) the members of any committees of the 
                        Council;
                    ``(C) establish policies, including ethical 
                standards, for the conduct of programs and other 
                activities under section 281D; and
                    ``(D) establish specific duties of the Executive 
                Director.
            ``(4) Meetings.--
                    ``(A) In general.--the Board of Directors shall--
                            ``(i) meet on a quarterly basis; and
                            ``(ii) submit to Congress, and make 
                        publicly available, the minutes of such 
                        meetings.
                    ``(B) Agenda.--The Board of Directors shall, not 
                later than 3 months after the incorporation of the 
                Council--
                            ``(i) issue an agenda (in this part 
                        referred to as the `agenda') outlining how the 
                        Council will achieve the purpose described in 
                        section 281A; and
                            ``(ii) annually thereafter, in consultation 
                        with the Executive Director, review and update 
                        such agenda.
    ``(b) Appointment and Incorporation.--Not later than 6 months after 
the date of enactment of the 21st Century Cures Act--
            ``(1) the Comptroller General of the United States shall 
        appoint the appointed members of the Board of Directors under 
        subsection (a)(1)(C); and
            ``(2) the ex officio members of the Board of Directors 
        under subsection (a)(1)(B) shall serve as incorporators and 
        shall take whatever actions are necessary to incorporate the 
        Council.
    ``(c) Nonprofit Status.--In carrying out this part, the Board of 
Directors shall establish such policies and bylaws, and the Executive 
Director shall carry out such activities, as may be necessary to ensure 
that the Council maintains status as an organization that--
            ``(1) is described in subsection (c)(3) of section 501 of 
        the Internal Revenue Code of 1986; and
            ``(2) is, under subsection (a) of such section, exempt from 
        taxation.
    ``(d) Executive Director.--The Executive Director shall--
            ``(1) be the chief executive officer of the Council; and
            ``(2) subject to the oversight of the Board of Directors, 
        be responsible for the day-to-day management of the Council.

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

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

``SEC. 281E. TERMINATION; REPORT.

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

``SEC. 281F. FUNDING.

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

                         TITLE II--DEVELOPMENT

              Subtitle A--Patient-Focused Drug Development

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

    (a) In General.--Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) is amended--
            (1) in subsection (d), by striking ``The Secretary shall 
        implement'' and all that follows through ``premarket approval 
        of a drug.''; and
            (2) by adding at the end the following new subsections:
    ``(x) Structured Risk-Benefit Assessment Framework.--
            ``(1) In general.--The Secretary shall implement a 
        structured risk-benefit assessment framework in the new drug 
        approval process--
                    ``(A) to facilitate the balanced consideration of 
                benefits and risks; and
                    ``(B) to develop and implement a consistent and 
                systematic approach to the discussion of, regulatory 
                decisionmaking with respect to, and the communication 
                of, the benefits and risks of new drugs.
            ``(2) Rule of construction.--Nothing in paragraph (1) shall 
        alter the criteria for evaluating an application for premarket 
        approval of a drug.
    ``(y) Development and Use of Patient Experience Data To Enhance 
Structured Risk-Benefit Assessment Framework.--
            ``(1) In general.--Not later than two years after the date 
        of the enactment of this subsection, the Secretary shall 
        establish and implement processes under which--
                    ``(A) an entity seeking to develop patient 
                experience data may submit to the Secretary--
                            ``(i) initial research concepts for 
                        feedback from the Secretary; and
                            ``(ii) with respect to patient experience 
                        data collected by the entity, draft guidance 
                        documents, completed data, and summaries and 
                        analyses of such data;
                    ``(B) the Secretary may request such an entity to 
                submit such documents, data, and summaries and 
                analyses; and
                    ``(C) patient experience data may be developed and 
                used to enhance the structured risk-benefit assessment 
                framework under subsection (x).
            ``(2) Patient experience data.--In this subsection, the 
        term `patient experience data' means data collected by 
        patients, parents, caregivers, patient advocacy organizations, 
        disease research foundations, medical researchers, research 
        sponsors, or other parties determined appropriate by the 
        Secretary that is intended to facilitate or enhance the 
        Secretary's risk-benefit assessments, including information 
        about the impact of a disease or a therapy on patients' 
        lives.''.
    (b) Guidance.--
            (1) In general.--The Secretary of Health and Human Services 
        shall publish guidance on the implementation of subsection (y) 
        of section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355), as added by subsection (a). Such guidance shall 
        include--
                    (A) with respect to draft guidance documents, data, 
                or summaries and analyses submitted to the Secretary 
                under paragraph (1)(A) of such subsection, guidance--
                            (i) specifying the timelines for the review 
                        of such documents, data, or summaries and 
                        analyses by the Secretary; and
                            (ii) on how the Secretary will use such 
                        documents, data, or summaries and analyses to 
                        update any guidance documents published under 
                        this subsection or publish new guidance;
                    (B) with respect to the collection and analysis of 
                patient experience data (as defined in paragraph (2) of 
                such subsection (y)), guidance on--
                            (i) methodological considerations for the 
                        collection of patient experience data, which 
                        may include structured approaches to gathering 
                        information on--
                                    (I) the experience of a patient 
                                living with a particular disease;
                                    (II) the burden of living with or 
                                managing the disease;
                                    (III) the impact of the disease on 
                                daily life and long-term functioning; 
                                and
                                    (IV) the effect of current 
                                therapeutic options on different 
                                aspects of the disease; and
                            (ii) the establishment and maintenance of 
                        registries designed to increase understanding 
                        of the natural history of a disease;
                    (C) methodological approaches that may be used to 
                assess patients' beliefs with respect to the benefits 
                and risks in the management of the patient's disease; 
                and
                    (D) methodologies, standards, and potential 
                experimental designs for patient-reported outcomes.
            (2) Timing.--Not later than 3 years after the date of the 
        enactment of this Act, the Secretary of Health and Human 
        Services shall issue draft guidance on the implementation of 
        subsection (y) of section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355), as added by subsection (a). The 
        Secretary shall issue final guidance on the implementation of 
        such subsection not later than one year after the date on which 
        the comment period for the draft guidance closes.
            (3) Workshops.--
                    (A) In general.--Not later than 6 months after the 
                date of the enactment of this Act and once every 6 
                months during the following 12-month period, the 
                Secretary of Health and Human Services shall convene a 
                workshop to obtain input regarding methodologies for 
                developing the guidance under paragraph (1), including 
                the collection of patient experience data.
                    (B) Attendees.--A workshop convened under this 
                paragraph shall include--
                            (i) patients;
                            (ii) representatives from patient advocacy 
                        organizations, biopharmaceutical companies, and 
                        disease research foundations;
                            (iii) representatives of the reviewing 
                        divisions of the Food and Drug Administration; 
                        and
                            (iv) methodological experts with 
                        significant expertise in patient experience 
                        data.
            (4) Public meeting.--Not later than 90 days after the date 
        on which the draft guidance is published under this subsection, 
        the Secretary of Health and Human Services shall convene a 
        public meeting to solicit input on the guidance.

      Subtitle B--Qualification and Use of Drug Development Tools

SEC. 2021. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.

    (a) Findings.--Congress finds the following:
            (1) Development of new drugs has become increasingly 
        challenging and resource intensive.
            (2) Development of drug development tools can benefit the 
        availability of new medical therapies by helping to translate 
        scientific discoveries into clinical applications.
            (3) Biomedical research consortia (as defined in section 
        507(f) of section 507 of the Federal Food, Drug, and Cosmetic 
        Act, as added by subsection (c)) can play a valuable role in 
        helping 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 shall accept or decline to 
                accept such letter of intent;
                    ``(B)(i) if the Secretary accepts the letter of 
                intent, a requestor shall submit a qualification plan 
                to the Secretary; and
                    ``(ii) the Secretary shall accept or decline 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 shall determine whether to 
                accept such qualification package for review; and
                    ``(iii) if the Secretary accepts such qualification 
                package for review, conduct 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; non-acceptance.--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 be granted a request for 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 to 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) 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.
    ``(f) 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 
        (20 U.S.C. 1001)), 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, a statement that 
        describes 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).''.
    (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 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 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 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; and
                    (D) the number of qualification plans and full 
                qualification packages, respectively, submitted to the 
                Secretary; and
            (3) the drug development tools qualified through such 
        qualification process, specified by type of tool, such as a 
        biomarker or clinical outcome assessment (as such terms are 
        defined in subsection (f) of such section 507).

SEC. 2022. ACCELERATED APPROVAL DEVELOPMENT PLAN.

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

           Subtitle C--FDA Advancement of Precision Medicine

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

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

                   ``Subchapter J--Precision Medicine

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

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

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

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

        Subtitle D--Modern Trial Design and Evidence Development

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

    (a) Proposals for Use of Innovative Statistical Methods in Clinical 
Protocols for Drugs and Biological Products.--For purposes of assisting 
sponsors in incorporating adaptive trial design and Bayesian methods 
into proposed clinical protocols and applications for new drugs under 
section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
and biological products under section 351 of the Public Health Service 
Act (42 U.S.C. 262), the Secretary shall conduct a public meeting and 
issue guidance in accordance with subsection (b).
    (b) Guidance Addressing Use of Adaptive Trial Designs and Bayesian 
Methods.--
            (1) In general.--The Secretary of Health and Human 
        Services, acting through the Commissioner of Food and Drugs (in 
        this subsection referred to as the ``Secretary''), shall--
                    (A) update and finalize the draft guidance 
                addressing the use of adaptive trial design for drugs 
                and biological products; and
                    (B) issue draft guidance on the use of Bayesian 
                methods in the development and regulatory review and 
                approval or licensure of drugs and biological products.
            (2) Contents.--The guidances under paragraph (1) shall 
        address--
                    (A) the use of adaptive trial designs and Bayesian 
                methods in clinical trials, including clinical trials 
                proposed or submitted to help 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, as amended 
by section 2021, is further 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 support the approval of a new indication for 
        a drug approved under section 505(b); and
            ``(2) to help 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 in subsection (d), 
        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 non-specified 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 in 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) Public health exemption.--The Secretary may--
                    ``(A) deem such pilot demonstrations public health 
                activities, permitting the use and disclosure of 
                protected health information as described in section 
                164.512(b)(1)(iii) of title 45, Code of Federal 
                Regulations (or any successor regulation) and exempted 
                as a public health activity as described in section 
                46.101(b)(5) of title 46, Code of Federal Regulations 
                (or any successor regulation); and
                    ``(B) deem safety surveillance performed at the 
                request of the Food and Drug Administration or under 
                such jurisdiction by a sponsor with responsibility for 
                a drug approved under this section or section 351 of 
                the Public Health Services Act using the Sentinel 
                System surveillance infrastructure authorized under 
                section 505(k), including use of analytic tools and 
                querying capabilities developed to implement the active 
                postmarket surveillance system described in this 
                section, public health activities as described in 
                section 164.512(b)(1)(iii) of title 45, Code of Federal 
                Regulations (or any successor regulation) and exempted 
                as a public health activity as described in section 
                46.101(b)(5) of title 46, 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 of 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 analyses 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 non-misleading 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 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 with the development and 
                approval of such a drug 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 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 will 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 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) 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).''.
            (3) Recognition of interpretive criteria as device 
        standard.--Section 514(c)(1)(A) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended by inserting 
        after ``the Secretary shall, by publication in the Federal 
        Register'' the following: ``(or, with respect to susceptibility 
        test interpretive criteria or standards recognized or otherwise 
        listed under section 511, by posting on the Interpretive 
        Criteria Website in accordance with such section)''.
    (c) Report to Congress.--Not later than two years after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor and 
Pensions of the Senate a report on the progress made in implementing 
section 511 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360a), as amended by this section.
    (d) Requests for Updates to Interpretive Criteria Website.--Chapter 
35 of title 44, United States Code, shall not apply to the collection 
of information from interested parties regarding the updating of lists 
under paragraph (2) of subsection (b) section 511 of the Federal Food, 
Drug, and Cosmetic Act (as amended by subsection (a)) and posted on the 
Interpretive Criteria Website established under paragraph (1) of such 
subsection (b).
    (e) No Effect on Health Care Practice.--Nothing in this subtitle 
(including the amendments made by this subtitle) shall be construed to 
restrict, in any manner, the prescribing or administering of 
antibiotics or other products by health care practitioners, or to limit 
the practice of health care.

SEC. 2123. ENCOURAGING THE DEVELOPMENT AND USE OF NEW ANTIMICROBIAL 
              DRUGS.

    (a) Additional Payment for New Antimicrobial 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)(I) Effective for discharges beginning on or after October 
1, 2017, the Secretary shall, after notice and opportunity for public 
comment (in the publications required by subsection (e)(5) for a fiscal 
year or otherwise), provide for additional payment to be made under 
this subsection in accordance with the provisions of this subparagraph 
with respect to discharges by eligible hospitals that involve new 
antimicrobial drugs in the amount, subject to clause (vi), provided for 
under section 1847A.
    ``(II) Additional payments to be made under this subsection shall 
be with respect to discharges involving a new antimicrobial drug that 
occur during the four-fiscal-year period beginning on which an 
inpatient hospital code is issued with respect to the drug.
    ``(ii) For purposes of this subparagraph, the term `new 
antimicrobial 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--
            ``(I) either--
                    ``(aa) 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
                    ``(bb) meets the definition of a qualified 
                infectious disease product under section 505E(g) of the 
                Federal Food, Drug, and Cosmetic Act;
            ``(II) is intended to treat an infection for which there is 
        an `unmet medical need'; and
            ``(III) is intended to treat an infection associated with 
        high rates of mortality or significant patient morbidity, as 
        determined in consultation with the infectious disease 
        professional community.
    ``(iii) For purposes of this subparagraph, the term `eligible 
hospital' means a 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 reporting program 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).
    ``(iv) The Secretary may only revoke a determination of a product 
under this subparagraph as a new antimicrobial drug if the Secretary 
finds that the request for such determination contained an untrue 
statement of material fact.
    ``(v) Not later than October 1, 2017, the Secretary shall first 
publish in the Federal Register a list of the new antimicrobial drugs. 
Each fiscal year thereafter, the Secretary shall publish a list of the 
new antimicrobial drugs for such fiscal year as part of the annual 
rulemaking under this subsection.
    ``(vi)(I) The total of the additional payments made under this 
subsection pursuant to this subparagraph for discharges in a fiscal 
year (as estimated by the Secretary as part of the rulemaking under 
this subsection for the fiscal year) may not exceed the applicable 
percentage (specified in subclause (II)) of the total program payments 
estimated to be made under this subsection for all discharges in such 
fiscal year (as calculated by the Secretary as part of the rulemaking 
under this subsection for the fiscal year). For purposes of the 
preceding sentence, in the case that, with respect to a fiscal year, 
such additional payments are made only with respect to discharges 
during a portion of such fiscal year, the reference to `all discharges 
in such fiscal year' shall be considered a reference to all discharges 
during such portion of such fiscal year.
    ``(II) For purposes of subclause (I), the term `applicable 
percentage' means, for fiscal year 2018 and each fiscal year 
thereafter, 0.06807 percent.
    ``(III) If the Secretary estimates before the beginning of a 
fiscalyear that the amount of the additional payments under this 
subsection pursuant to this subparagraph for the fiscal year (or 
portion thereof) as determined under subclause (I) will exceed the 
limit established under such subclause, the Secretary shall reduce pro 
rata the amount of each of the additional payments under this 
subsection pursuant to this subparagraph for such fiscal year (or 
portion thereof) in order to ensure that the aggregate additional 
payments under this subsection pursuant to this paragraph (as so 
estimated) do not exceed such limit.''.
            (2) Conforming amendments.--
                    (A) No duplicative ntap payments.--Section 
                1886(d)(5)(K)(i) of the Social Security Act (42 U.S.C. 
                1395ww(d)(5)(K)(i)) is amended by inserting ``and with 
                respect to which an additional payment is not made 
                pursuant to subparagraph (M),'' after ``2001,''.
                    (B) Access to price information.--Section 
                1927(b)(3)(A)(iii) of the Social Security Act (42 
                U.S.C. 1396r-8(b)(3)(A)(iii)) is amended--
                            (i) in subclause (II), by inserting ``, or 
                        under section 1886(d) pursuant to paragraph 
                        (5)(M) of such section,'' after ``1847A,''; and
                            (ii) in the matter following subclause 
                        (III), by inserting ``or section 
                        1886(d)(5)(M)'' after ``1881(b)(13)(A)(ii)''.
    (b) Study and Report on Removing Barriers to Development of New 
Antimicrobial Drugs.--
            (1) Study.--The Comptroller General of the United States 
        shall conduct a study to--
                    (A) identify and examine the barriers that prevent 
                the development of new antimicrobial drugs, as defined 
                in section 1886(d)(5)(M)(iii) of the Social Security 
                Act (42 U.S.C. 1395ww(d)(5)(M)(iii)); and
                    (B) develop recommendations for actions to be taken 
                in order to overcome any barriers identified under 
                subparagraph (A).
            (2) Consideration.--In conducting such study, the 
        Comptroller General shall take into account the perspectives of 
        the Director of the National Institutes of Health, the 
        Commissioner of the Food and Drugs, and the Director of the 
        Centers for Disease Control and Prevention.
            (3) Report.--Not later than 1 year after the date of the 
        enactment of this Act, the Comptroller General shall submit to 
        Congress a report on the study conducted under paragraph (1).

         Subtitle H--Vaccine Access, Certainty, and Innovation

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

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

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

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

SEC. 2143. MEETINGS BETWEEN CDC AND VACCINE DEVELOPERS.

    Section 310 of the Public Health Service Act (42 U.S.C. 242o) is 
amended by adding at the end the following:
    ``(c)(1) In this subsection, the term `vaccine developer' means a 
nongovernmental entity engaged in--
            ``(A)(i) the development of a vaccine with the intent to 
        pursue licensing of the vaccine by the Food and Drug 
        Administration; or
            ``(ii) the production of a vaccine licensed by the Food and 
        Drug Administration; and
            ``(B) vaccine research.
    ``(2)(A) Upon the submission of a written request for a meeting by 
a vaccine developer, that includes a 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 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 120calendar 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 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 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 section 2063, is further amended by inserting after 
section 505F of such Act the following:

``SEC. 505G. 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 this subsection 
                shall not be revoked for any reason.
                    ``(B) Exception.--The Secretary may revoke a 
                designation of a drug under paragraph (1) if the 
                Secretary finds that the application or supplemental 
                application resulting in such designation contained an 
                untrue statement of material fact.
            ``(3) Notification prior to discontinuance of production 
        for solely commercial reasons.--A designation of a drug under 
        paragraph (1) shall be subject to the condition that the 
        sponsor of the drug will notify the Secretary of any 
        discontinuance of the production of the drug for solely 
        commercial reasons at least one year before such 
        discontinuance.
            ``(4) Notice to public.--Notice respecting the designation 
        of a drug under paragraph (1) shall be made available to the 
        public.
    ``(b) Extension.--If the Secretary designates a drug as a drug 
approved for a new indication for a rare disease or condition, as 
described in subsection (a)(1)--
            ``(1)(A) the 4-, 5-, and 7 \1/2\-year periods described in 
        subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 
        3-year periods described in clauses (iii) and (iv) of 
        subsection (c)(3)(E) and clauses (iii) and (iv) of subsection 
        (j)(5)(F) of section 505, and the 7-year period described in 
        section 527, as applicable, shall be extended by 6 months; or
            ``(B) the 4- and 12-year periods described in subparagraphs 
        (A) and (B) of section 351(k)(7) of the Public Health Service 
        Act and the 7-year period described in section 527, as 
        applicable, shall be extended by 6 months; and
            ``(2)(A) if the drug is the subject of a listed patent for 
        which a certification has been submitted under subsection 
        (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 or a listed 
        patent for which a certification has been submitted under 
        subsections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 
        505, the period during which an application may not be approved 
        under section 505(c)(3) or section 505(j)(5)(B) shall be 
        extended by a period of 6 months after the date the patent 
        expires (including any patent extensions); or
            ``(B) if the drug is the subject of a listed patent for 
        which a certification has been submitted under subsection 
        (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the 
        patent infringement litigation resulting from the certification 
        the court determines that the patent is valid and would be 
        infringed, the period during which an application may not be 
        approved under section 505(c)(3) or section 505(j)(5)(B) shall 
        be extended by a period of 6 months after the date the patent 
        expires (including any patent extensions).
    ``(c) Relation to Pediatric and Qualified Infectious Disease 
Product Exclusivity.--Any extension under subsection (b) of a period 
shall be in addition to any extension of the periods under sections 
505A and 505E of this Act and section 351(m) of the Public Health 
Service Act, as applicable, with respect to the drug.
    ``(d) Limitations.--The extension described in subsection (b) shall 
not apply if the drug designated under subsection (a)(1) has previously 
received an extension by operation of subsection (b).
    ``(e) Definition.--In this section, the term `rare disease or 
condition' has the meaning given to such term in section 526(a)(2).''.
    (b) Application.--Section 505G of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), applies only with respect to 
a drug for which an application or supplemental application described 
in subsection (a)(1)(B)(i) of such section 505G is first approved under 
section 505(c) of such Act (21 U.S.C. 355(c)) or section 351(a) of the 
Public Health Service Act (42 U.S.C. 262(a)) on or after the date of 
the enactment of this Act.
    (c) Conforming Amendments.--
            (1) Relation to pediatric exclusivity for drugs.--Section 
        505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355a) is amended--
                    (A) in subsection (b), by adding at the end the 
                following:
            ``(3) Relation to exclusivity for a drug approved for a new 
        indication for a rare disease or condition.--Notwithstanding 
        the references in subsection (b)(1) to the lengths of the 
        exclusivity periods after application of pediatric exclusivity, 
        the 6-month extensions described in subsection (b)(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 subsection (c)(1) to the lengths of the 
        exclusivity periods after application of pediatric exclusivity, 
        the 6-month extensions described in subsection (c)(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)(A)--
                            (i) in subparagraph (E), by striking 
                        ``and'';
                            (ii) in subparagraph (F), by striking the 
                        period 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.--The Secretary may not 
        award any priority review vouchers under paragraph (1) after 
        December 31, 2018.''.
    (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 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 priority review 
                        voucher 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 towards 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 $5,000,000 for each of fiscal years 2016 through 2020 to 
carry out this section.

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.--The Attorney General shall not promulgate nor 
enforce any regulation, subregulatory guidance, or enforcement policy 
which impedes re-exportation among European Economic Area countries (as 
provided in subsection (f)(5)), 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 (as such terms are used in subsection (f)) 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 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 (as defined in paragraph (2));
                    ``(B) under which accredited persons shall, as 
                applicable, certify that a requestor's quality system 
                meets the criteria 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 of in-scope devices subject to the 
                device-related changes involved, in lieu of compliance 
                with the following submission requirements:
                            ``(i) A thirty-day notice (as defined in 
                        paragraph (2)).
                            ``(ii) A Special PMA supplement (as defined 
                        in paragraph (2)).
            ``(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) manufacturing changes subject to a 
                        30-day notice;
                            ``(ii) changes that qualify for a Special 
                        PMA supplement; and
                            ``(iii) 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 `quality system' means a quality 
                system described in section 520(f);
                    ``(D) the term `requestor' means a device 
                manufacturer that is seeking certification under this 
                section of a quality system used by such manufacturer;
                    ``(E) 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
                    ``(F) the term `thirty-day notice' means a notice 
                described in section 515(d)(6).
            ``(3) Accreditation process; accreditation renewal.--Except 
        as inconsistent with this section, the process and 
        qualifications for accreditation of persons and renewal of such 
        accreditation under section 704(g) shall apply with respect to 
        accreditation of persons and renewal of such accreditation 
        under this section.
            ``(4) Use of accredited parties to conduct assessments.--
                    ``(A) Initiation of assessment services.--
                            ``(i) Date assessments authorized.--
                        Beginning after issuance of the final guidance 
                        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; certification 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 a waiver of and exemptions from the 
                        certification 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 as applicable shall include--
                                    ``(I) the accredited person's 
                                certification that the requestor has 
                                satisfied the criteria 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 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 manufacturers 
        for program evaluation purposes.--
                    ``(A) Periodic notification for manufacturing 
                changes otherwise subject to thirty-day notice.--A 
                requestor certified under this section that effectuates 
                device-related changes with respect to in-scope 
                devices, without prior submission of a thirty-day 
                notice, shall provide notification to the Secretary of 
                such changes in the requestor's next periodic report 
                under section 814.84(b) of title 21, Code of Federal 
                Regulations (or any successor regulation). Such 
                notification shall--
                            ``(i) describe the changes made; and
                            ``(ii) indicate the effective dates of such 
                        changes.
                    ``(B) Periodic notification for device-related 
                changes otherwise subject to special pma supplement.--A 
                requestor 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.
                    ``(C) Use of notifications for program evaluation 
                purposes.--Information submitted to the Secretary under 
                subparagraphs (A) and (B) 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 two 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 the 
        requestor's conformance with the applicable requirements of 
        this Act; and
            ``(6) shall be considered to be revoked if the Secretary 
        provides written notification to the certified requestor that 
        its quality system does not satisfy the certification criteria 
        issued under subsection (a)(5) with respect to the in-scope 
        devices at issue, such that the applicable submission 
        requirements specified in subsection (a)(1)(C) must be met for 
        changes made after receipt of such written notification, with 
        respect to such devices.
    ``(d) 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 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 include additional types of submissions and 
                additional types of changes beyond those identified in 
                subsection (a)(1)(C), including changes to devices 
                cleared under section 510(k). At the discretion of the 
                Secretary, the program may be expanded prior to January 
                31, 2021.
            ``(2) Sunset.--This section shall cease to be effective 
        October 1, 2022.
    ``(e) 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)(6)(A)(i) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 360e(d)(6)(A)(i)) is amended by inserting ``, 
        subject to section 524B,'' after ``that affects safety or 
        effectiveness''.
            (2) Requirements for thirty-day notice.--Section 
        515(d)(6)(A)(ii) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 360e(d)(6)(A)(ii)) is amended by inserting ``, 
        subject to section 524B,'' after ``the date on which the 
        Secretary receives the notice''.

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) Valid scientific evidence for purposes of 
                clause (i) may include:
                            ``(I) evidence described in well-documented 
                        case histories, including registry data, that 
                        are collected and monitored under an acceptable 
                        protocol;
                            ``(II) studies published in peer-reviewed 
                        journals; and
                            ``(III) data collected in countries other 
                        than the United States so long as such data 
                        otherwise meets 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 inserting after subsection 
(i) 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. 29 360e) is amended by adding at the end the follows:
    ``(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 subclause (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 the experience 
                with, and reliance on, a standard by other Federal 
                regulatory authorities and the device industry, and 
                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 of 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 contained in the list 
        published under subparagraph (A).'';
            (2) in paragraph (2)--
                    (A) by striking ``1 day after the date of 
                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 review by a classification panel of a 
                premarket submission for a device, the Secretary 
                shall--
                            ``(i) provide an opportunity for the person 
                        whose premarket submission is subject to panel 
                        review to provide recommendations on the 
                        expertise needed among the voting members of 
                        the panel; and
                            ``(ii) give due consideration to such 
                        recommendations and ensure that adequate 
                        expertise is represented on advisory panels to 
                        assess--
                                    ``(I) the disease or condition for 
                                which the device is intended to cure, 
                                treat, mitigate, prevent, or diagnose; 
                                and
                                    ``(II) the technology of the 
                                device.
                    ``(D) For purposes of subparagraph (B)(ii), the 
                term `adequate expertise' means that the membership of 
                the classification panel reviewing a premarket 
                submission 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 panel chairperson.''.
            (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 classification 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.) is amended by adding at the end the 
following:

``SEC. 524B. 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) is 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 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 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 12 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 facilitate the broader use of 
        single, central, or lead institutional review boards. Such 
        regulations and guidance shall include clarification of 
        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) standardization of 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 
        pursuant to 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 towards completing such harmonization.
    (d) 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'' subject to clause (ii), 
                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 the human subjects 
                        involved in research described in subparagraph 
                        (B), 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) Human subject research.--
                    (A) Except as provided in subparagraph (B), the 
                term ``human subject research'' means research, as 
                defined in subpart A of part 46 of title 45, Code of 
                Federal Regulations (or any successor regulations), 
                that involves a human subject, as defined in such 
                subpart A (or any successor regulations); and
                    (B) In the case of an investigation that is subject 
                to the provisions of part 50 of title 21, Code of 
                Federal Regulations (or any successor regulations), the 
                term ``human subject'' has the meaning given such term 
                in such part 50, and the term ``human subject 
                research'' means a clinical investigation as defined in 
                such part 50.
            (3) 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'' after ``evaluation''; 
                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), 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 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.''.

                          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 the entirety of a patient's data from any and all 
        health information technology for authorized use under 
        applicable law.
            ``(2) Complete access to health data.--The technology 
        allows access to the entirety of a patient's available data for 
        authorized use under applicable law without special effort, as 
        defined by recommendations adopted in accordance with this 
        section, by the requestor of such data unless such data is not 
        disclosable under applicable law.
            ``(3) No information blocking.--The technology is not 
        configured, set up, or implemented to engage in information 
        blocking, as defined in section 3010A(f).
    ``(b) Categories for Interoperability Standards.--The categories 
described in this subsection, with respect to standards for determining 
if health information technology is interoperable, consistent with the 
criteria described in subsection (a), include the following categories 
of standards:
            ``(1) Standards with respect to vocabulary and terminology.
            ``(2) Standards with respect to content and structure.
            ``(3) Standards with respect to transport of information.
            ``(4) Security standards.
            ``(5) Service standards.''.
            (2) Guidance.--Not later than January 1, 2017, the 
        Secretary of Health and Human Services, through 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 of 
        health information technology, as described in such section.
    (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 
                                under section 3010 are needed for the 
                                electronic 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 CONTRACT WITH 
              STANDARDS DEVELOPMENT ORGANIZATIONS.

    ``(a) Contract.--
            ``(1) In general.--For purposes of activities conducted 
        under this title, the Secretary shall enter into contracts with 
        health care standards development organizations accredited by 
        the American National Standards Institute to carry out 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 contract 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 organizations.--The Secretary shall 
        ensure the most appropriate organizations described in 
        paragraph (1) are selected for each contract under paragraph 
        (1).
    ``(b) Duties.--
            ``(1) Initial contract.--Under the initial contract under 
        subsection (a)(1), the standards development organizations--
                    ``(A) shall provide to the Secretary, in 
                consultation with the National Coordinator, for 
                adoption under section 3004, recommendations, in 
                accordance with section 3010, for interoperability 
                standards consistent with the criteria described in 
                subsection (a) of such section and with respect to the 
                categories described in subsection (b)(1) of such 
                section; and
                    ``(B) may provide to the Secretary, in consultation 
                with the National Coordinator, recommendations 
                described in paragraph (2).
            ``(2) Subsequent contracts.--Under each subsequent 
        contract, the organizations shall provide to the Secretary, in 
        consultation with the National Coordinator, for adoption under 
        section 3004 recommendations for any standards (including 
        interoperability criteria), implementation specifications, and 
        certification criteria (and modifications, including additions 
        to such standards, specifications, and criteria), which are in 
        accordance with the policies and priorities developed by the 
        Secretary, in consultation with the National Coordinator.
    ``(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 
        specification, 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, in consultation with the National 
        Coordinator, the Secretary shall, as needed, enter into 
        contracts under subsection (a) in addition to the initial 
        contract.
    ``(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 onchit.--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, 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), by striking ``and the HIT 
                Standards Committee'';
            (2) in subsection (b), by adding at the end the following 
        new paragraph:
            ``(4) Limitation.--The Secretary may not adopt any 
        standards, implementation specifications, or certification 
        criteria under this subsection or subsection (a) that are 
        inconsistent with or duplicative of an interoperability 
        standard adopted under this section, in accordance with section 
        3010. 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 that is 
        subsequently adopted under this section, such interoperability 
        standard 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 
        becomes effective.''; and
            (3) by adding at the end the following new subsections:
    ``(c) Adoption of Initial Interoperability Standards.--
Notwithstanding the previous subsections of this section, the following 
shall apply in the case of the initial set of interoperability 
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, the Secretary, in consultation with 
        the National Coordinator and representatives of other relevant 
        Federal agencies, shall jointly review such standards and shall 
        determine whether or not to propose adoption of such standards.
            ``(2) Determination to adopt.--If the Secretary 
        determines--
                    ``(A) to propose adoption of such standards, the 
                Secretary shall, by regulation under section 553 of 
                title 5, United States Code, determine whether or not 
                to adopt such standards; or
                    ``(B) not to propose adoption of such standards, 
                the Secretary shall notify the National Coordinator and 
                the standards development organizations under section 
                3003A in writing of such determination and the reasons 
                for not proposing the adoption of the recommendation 
                for such standards.
            ``(3) Publication.--The Secretary shall provide for 
        publication in the Federal Register of all determinations made 
        by the Secretary under paragraph (1).
            ``(4) Application.--Any standard adopted under this 
        subsection shall be effective 12 months after the date of 
        publication of the determination to adopt such standard.
    ``(c) Rules for Adoption.--In the case of a standard (including 
interoperability standard), implementation specification, or 
certification criteria 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 paragraph (2), any 
        such standard (including interoperability standard), 
        implementation specification, or certification criteria shall 
        be a standard, specification, or criterion that has been 
        recommended by the standards development organizations 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 is recommended under 
        paragraph (1)--
                    ``(A) in the case of interoperability 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 certification 
                criteria, 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) Effective date.--Any standard, implementation 
        specification, or certification criterion adopted under this 
        section shall be effective 12 months after the date of 
        publication of the final rule to adopt such standard, 
        implementation specification, or certification criteria.
            ``(4) Assistance to the secretary.--In complying with the 
        requirements of this subsection, the Secretary shall rely on 
        the 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.''.
    (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 of a report on the following:
                    ``(A) The initial set of interoperability standards 
                adopted under section 3004(c).
                    ``(B) The strategies for achieving widespread 
                interoperability.
                    ``(C) An overview of the extent to which electronic 
                health records and health information technology 
                offered as of such date satisfy such initial set.
                    ``(D) Any barriers that are preventing widespread 
                interoperability.
                    ``(E) The plan and milestones, including specific 
                steps, to achieve widespread interoperability.
            ``(2) Follow-up determination and report on widespread 
        interoperability.--Not later than December 31, 2019, 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 the 
        following:
                    ``(A) A determination by the Secretary whether the 
                goal of widespread interoperability has been achieved.
                    ``(B) A list identifying the vendors of, or other 
                entities offering, qualified electronic health records, 
                which categorizes such entities, with respect to such 
                records, as in compliance or not in compliance with the 
                certification criteria described in section 
                3001(c)(5)(B)(ii) and with the requirements under 
                clause (i) of section 3001(c)(5)(C) (including with the 
                terms of the attestation and other requirements under 
                such clause).
                    ``(C) Actions that may be taken by entities 
                identified under subparagraph (B) as not being in 
                compliance with such criteria and requirements in order 
                for such entities to become in compliance with such 
                criteria and requirements.
                    ``(D) Penalties described in section 3010A(d) to 
                which entities, with respect to such qualified 
                electronic health records, beginning January 1, 2019, 
                are subject if such technology and entities are not in 
                compliance with the certification criteria described in 
                section 3001(c)(5)(B)(ii) and with the requirements 
                under clause (i) of section 3001(c)(5)(C), 
                respectively.
            ``(3) 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, including by being 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) by amending subparagraph (B) of such 
                        section to read as follows:
                    ``(B) Certification criteria described.--In this 
                title, the term `certification criteria' means, with 
                respect to qualified electronic health records--
                            ``(i) for certifications made before 
                        January 1, 2018, criteria to establish that the 
                        records meet standards and implementation 
                        specifications adopted under subsections (a) 
                        and (b) of section 3004 for qualified 
                        electronic health records; and
                            ``(ii) for certifications made on or after 
                        January 1, 2018, criteria described in clause 
                        (i) and criteria to establish that the records 
                        are interoperable, in accordance with section 
                        3010, including by being in compliance with 
                        interoperability standards adopted under 
                        section 3004.''; and
                            (ii) by adding at the end the following new 
                        subparagraph:
                    ``(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 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) that the entity, 
                                        unless for a legitimate purpose 
                                        specified by the Secretary, has 
                                        not taken any action, including 
                                        through any financial, 
                                        administrative, or 
                                        technological barrier, which 
                                        the entity knows or should know 
                                        (as defined in section 
                                        1128A(i)(7) of the Social 
                                        Security Act), is to limit or 
                                        restrict the exchange of 
                                        information or to prevent or 
                                        disincentivize widespread 
                                        interoperability between any 
                                        providers using such records or 
                                        other health information 
                                        technology in connection with 
                                        such record;
                                            ``(bb) on the pricing 
                                        information described in clause 
                                        (v) for purposes of the portal 
                                        created under paragraph (9), 
                                        that such information will be 
                                        available on a public Web site 
                                        of such entity and in marketing 
                                        materials, communications 
                                        statements, and other 
                                        assertions of such entity 
                                        related to such record, and 
                                        that the entity will 
                                        voluntarily provide such 
                                        information to customers prior 
                                        to providing 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, 
                                        estimate, or other similar 
                                        marketing or promotional 
                                        material), and other persons 
                                        who request such information;
                                            ``(cc) that the software 
                                        with respect to such records 
                                        have published application 
                                        programming interfaces for 
                                        medical records data, search 
                                        and indexing, semantic 
                                        harmonization and vocabulary 
                                        translation, and user interface 
                                        applications;
                                            ``(dd) that the entity has 
                                        successfully tested the use of 
                                        the record in the type of 
                                        setting in which it would be 
                                        marketed;
                                            ``(ee) the entity has in 
                                        place implementation guidelines 
                                        for such record that support 
                                        interoperability, consistent 
                                        with section 3010; and
                                            ``(ff) that the entity has 
                                        in place data sharing programs 
                                        or capabilities based on common 
                                        data elements through 
                                        application programming 
                                        interfaces without the 
                                        requirement for vendor-specific 
                                        interfaces;
                                    ``(II) publish application 
                                programming interfaces and associated 
                                documentation, with respect to such 
                                records, for medical records data, 
                                search and indexing, semantic 
                                harmonization and vocabulary 
                                translation, and user interface 
                                applications; and
                                    ``(III) demonstrate to the 
                                satisfaction of the Secretary that data 
                                from such records is able to be 
                                exchanged through the use of 
                                application programming interfaces and 
                                used in a manner that allows for 
                                exchange and everyday use, as 
                                authorized under applicable law, of 
                                such record.
                            ``(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 section 3001(c)(5)(B)(ii) 
                        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) Annual publication.--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 vendors of or other entities offering 
                        qualified electronic health records with 
                        respect to which certification has been 
                        withdrawn under clause (ii) during such year.
                            ``(iv) Periodic review.--The Secretary 
                        shall periodically review and confirm that 
                        vendors of and other entities offering 
                        qualified electronic health records have 
                        publicly published application programming 
                        interfaces and associated documentation as 
                        required by clause (i)(II) for purposes of 
                        certification and maintaining certification 
                        under any program kept or recognized under 
                        subparagraph (A).
                            ``(v) Pricing information.--For purposes of 
                        clause (i)(I)(bb), 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 data 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 data 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 use, exchange, or portability of 
                                any data generated in the course of 
                                using any capability to which the 
                                record is to be so certified.''.
            (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 
        subsection (a)(1), 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) vendors of, or other entities offering, qualified 
        electronic health records--
                    ``(A) being in violation of an attestation made 
                under section 3001(c)(5)(C)(i)(I), with respect to the 
                use of such records by a health care provider under a 
                specified meaningful use incentive program; and
                    ``(B) having engaged in information blocking (as 
                defined in subsection (f)), unless for a legitimate 
                purpose specified by the Secretary, with respect to the 
                use of such records by a health care provider under 
                such a program;
            ``(2) health care providers, with respect to the use of 
        such records under a specified meaningful use incentive 
        program, having, unless for a legitimate purpose specified by 
        the Secretary, engaged in information blocking (as so defined);
            ``(3) health information system providers described in 
        subsection (b) having engaged in information blocking (as so 
        defined), unless for a legitimate purpose specified by the 
        Secretary, with respect to the use of such records under a 
        specified meaningful use incentive program; and
            ``(4) vendors of, or other entities offering, health 
        information technology (other than technology described in 
        paragraph (1)), health care providers, with respect to the use 
        of such technology, and health information system providers, 
        with respect to such technology, unless for a legitimate 
        purpose specified by the Secretary, having engaged in 
        information blocking (as so defined).
    ``(b) Health Information System Providers.--The Inspector General 
of the Department of Health and Human Services shall, in coordination 
with the Federal Trade Commission, ensure that health information 
system providers (such as operators of health information exchanges and 
other systems that facilitate the exchange of information) investigate 
claims of information blocking, with respect to the use of such records 
under a specified meaningful use incentive program.
    ``(c) 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) or (b) with the Inspector 
        General and Federal Trade Commission for purposes of such 
        investigations.
            ``(2) Protection from disclosure of information.--Any 
        information shared by the National Coordinator under paragraph 
        (1) shall not be subject to the provisions of section 552 of 
        title 5, United States Code (commonly referred to as the 
        Freedom of Information Act). Any information acquired pursuant 
        to paragraph (1) shall be held in confidence and shall not be 
        disclosed to any person except as may be necessary to carry out 
        the purposes of subsection (a).
            ``(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).
    ``(d) Penalty.--Any person or entity determined to have committed 
an act described in paragraph (1), (2), or (3) of subsection (a), in 
connection with a specified meaningful use incentive program, shall be 
subject to a civil monetary penalty of not more than $10,000 for each 
such act. The provisions of section 1128A (other than subsections (a) 
and (b)) 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 section 1128A(a).
    ``(e) Specified Meaningful Use Incentive Program.--For purposes of 
this section, the term `specified meaningful use incentive program' 
includes the following:
            ``(1) The incentive payments under subsection (o) of 
        section 1848 of the Social Security Act (42 U.S.C. 1395w-4) and 
        adjustments under subsection (a)(7) of such section.
            ``(2) The incentive payments under subsection (n) of 
        section 1848 of such Act (42 U.S.C. 1395ww) and adjustments 
        under subsection (b)(3)(B) of such section.
            ``(3) The incentive payments and adjustments made under 
        subsections (l) and (m) of section 1853 of such Act (42 U.S.C. 
        1395w-23).
            ``(4) The incentive payment under paragraph (3) of section 
        1814(l) of such Act (42 U.S.C. 1395f(l)) and adjustment under 
        paragraph (4) of such section.
            ``(5) The shared savings program under section 1899 of such 
        Act (42 U.S.C. 1395jjj).
            ``(6) The payments to Medicaid providers described in 
        section 1903(t) of such Act (42 U.S.C. 1396b(t)).
    ``(f) Information Blocking.--
            ``(1) In general.--For purposes of this section and section 
        3010, the term `information blocking' means, with respect to 
        the use of qualified electronic health records or other health 
        information technology under a specified meaningful use 
        incentive program, business, technical, and organizational 
        practices, including practices described in paragraph (2), 
        that--
                    ``(A) prevent or materially discourage the exchange 
                of electronic health information;
                    ``(B) the actor knows or should know (as defined in 
                section 1128A(i)(7) of the Social Security Act) is 
                likely to interfere with the exchange or use of 
                electronic health information; and
                    ``(C) do not serve to protect patient safety, 
                maintain the privacy and security of individuals' 
                health information or promote competition and consumer 
                welfare.
            ``(2) Practices described.--For purposes of paragraph (1), 
        the practices described in this paragraph are the following:
                    ``(A) Contract terms, policies, or other business 
                or organizational practices that restrict individuals' 
                access to their electronic health information or 
                restrict the exchange or use of that information for 
                treatment and other permitted purposes.
                    ``(B) Charging prices or fees (such as for data 
                exchange, portability, and interfaces) that make 
                exchanging and using electronic health information cost 
                prohibitive.
                    ``(C) Developing or implementing health information 
                technology in non-standard 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 data; lead to fraud, waste, or 
                abuse; or impede innovations and advancements in health 
                information exchange and health information technology-
                enabled care delivery.
    ``(g) 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).''.
            (3) ONCHIT.--
                    (A) Portal.--Section 3001(c) of the Public Health 
                Service Act (42 U.S.C. 300jj-11(c)) is amended by 
                adding at the end the following new paragraph:
            ``(9) Portal.--Not later than January 1, 2019, the National 
        Coordinator shall create a portal to make the information 
        described in paragraph (5)(C)(I)(i)(bb) available to the public 
        in a manner that allows for comparison of price information 
        among health information technology products and that aids in 
        making informed decisions for purchasing such a product.''.
                    (B) Information blocking.--Not later than 12 months 
                after the date of the enactment of this Act, the 
                National Coordinator shall, through rulemaking, 
                implement the provisions of this section, and 
                amendments made by this section, relating to 
                information blocking.
                    (C) HIPAA.--Not later than January 1, 2017, the 
                National Coordinator shall publish guidance to clarify 
                the relationship of the HIPAA privacy and security law, 
                as defined in section 3009(a)(2) of the Public Health 
                Service Act (42 U.S.C. 300jj-19(a)(2)) as such 
                provisions relate to information blocking (as defined 
                in section 3010A(f) of such Act, as added by paragraph 
                (2), including examples of how such provisions may 
                result in information blocking.
            (4) Demonstration required for meaningful ehr use 
        incentives under medicare.--
                    (A) Incentives for professionals.--
                            (i) In general.--Section 1848(o)(2)(C) of 
                        the Social Security Act (42 U.S.C. 1395w-
                        4(o)(2)(C)) is amended by adding at the end the 
                        following new clause:
                            ``(iii) Interoperability.--With respect to 
                        EHR reporting periods for payment years 
                        beginning with 2018, the means described in 
                        clause (i) specified by the Secretary shall 
                        include a demonstration, through means such as 
                        an attestation, that the professional has not 
                        taken any action described in subsection (a)(2) 
                        of section 3010A of the Public Health Service 
                        Act with respect to which the professional, 
                        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)(B)) 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.--
                                    ``(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 that such professional was 
                                determined to not be a meaningful EHR 
                                user because the qualified electronic 
                                health record used by such professional 
                                was 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 
                                subclause (II), during the first 
                                payment year with respect to the first 
                                EHR reporting period to which such 
                                decertification applies.
                                    ``(II) Duration.--
                                            ``(aa) In general.--In no 
                                        case shall an exemption by 
                                        reason of this clause be for a 
                                        period of less than 12 months.
                                            ``(bb) Extension.--An 
                                        exemption under this clause may 
                                        be extended for a period of an 
                                        additional 12 months subject to 
                                        the limitation described in 
                                        clause (ii).
                            ``(iii) Limitation.--Subject to clause 
                        (ii)(II)(aa), in no case may an eligible 
                        professional be granted an exemption under this 
                        subparagraph for more than 5 years.''.
                    (B) Incentives for hospitals.--
                            (i) In general.--Section 1886(o)(1) of the 
                        Social Security Act (42 U.S.C. 1395ww(o)(1)) is 
                        amended--
                                    (I) in subparagraph (A), by 
                                inserting before the period at the end 
                                the following: ``and, for performance 
                                periods for fiscal year 2018 or a 
                                subsequent fiscal year, that provide a 
                                demonstration described in subparagraph 
                                (D) to the Secretary''; and
                                    (II) by adding at the end the 
                                following new subparagraph:
                    ``(D) Demonstration described.--The demonstration 
                described in this subparagraph is a demonstration, 
                through means such as an attestation, that the hospital 
                has not taken any action described in subsection (a)(2) 
                of section 3010A of the Public Health Service Act with 
                respect to which the hospital, 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 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 such 
                                hospital was determined to not be a 
                                meaningful EHR user because the 
                                qualified electronic health record used 
                                by such hospital was 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) 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 be extended for a period of an 
                                additional 12 months subject to the 
                                limitation described in item (ee).
                                    ``(ee) Subject to item (cc), in no 
                                case may a hospital be granted an 
                                exemption under this subclause for more 
                                than 5 years.''.
                    (C) Demonstration required for meaningful ehr use 
                incentives 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 2018, 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 which the provider knows or 
                should know (as defined in section 1128A(i)(7) of the 
                Social Security Act) about, with respect to the use of 
                any certified EHR technology.''.
    (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 are 
                interoperable, in accordance with section 3010, 
                including as measured by the methods adopted under such 
                section; and
                    ``(B) such records are employed by meaningful EHR 
                users under the specified meaningful use incentive 
                programs (as defined in section 3010A(e)) and 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 adopted under section 
                3004'' after ``section 3004''.
                    (B) in subsection (b), by inserting ``including the 
                interoperability standards adopted under section 3004'' 
                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, including by being in 
                compliance with 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 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, including by 
        being in compliance with interoperability standards adopted 
        under section 3004 of such Act)''.
            (5) 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 Empowerment.--It is the sense of Congress that--
            (1) patients have the right to the entirety of the health 
        information of such patient, including such information 
        contained in an electronic health record of such patient;
            (2) such right extends to both structured and unstructured 
        data; and
            (3) to further facilitate patient ownership over health 
        information of such patient--
                    (A) health care providers should not have the 
                ability to deny a patient's request for access to the 
                entirety of such health information of such patient; 
                and
                    (B) health care providers do not need the consent 
                of their patients to share personal health information 
                of such patients 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 patient.

                         Subtitle B--Telehealth

SEC. 3021. TELEHEALTH SERVICES UNDER THE MEDICARE PROGRAM.

    (a) Provision of Information by Centers for Medicare & Medicaid 
Services.--Not later than one 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 and the Medicaid program 
        under title XIX of such Act 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 procedures codes or 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 one year 
after the date of the enactment of this Act, the Medicare Payment 
Advisory Commission established under section 1805 of the Social 
Security Act (42 U.S.C. 1395b-6) shall, using data from the Medicare 
Advantage program under part C of title XVIII of such Act, provide 
information to the committees of jurisdiction of the House of 
Representatives and the Senate that identifies--
            (1) services--
                    (A) for which payment could not be made, as of the 
                date of the enactment of this Act, under the fee-for-
                service program under parts A and B of such title by 
                reason of any limitation imposed under section 1834(m) 
                of such Act (42 U.S.C. 1395m(m)); and
                    (B) that are services that are recommended by the 
                Commission to be included as telehealth services for 
                which payment may be made under the fee-for-service 
                program under parts A and B of such title; and
            (2) barriers to furnishing telehealth services for which 
        payment may be made under such title XVIII and solutions to 
        address such barriers.
    (c) Sense of Congress.--It is the sense of Congress that--
            (1) States should collaborate, through the use of State 
        health board compacts or other mechanisms, to create common 
        licensure requirements services in order to facilitate 
        multistate practices and allow for health care providers to 
        provide such services across State lines;
            (2) health care providers should be appropriately licensed 
        in the physical location where the patient is receiving 
        services;
            (3) 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
            (4) 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) Payment for Durable Medical Items (DMI).--
            (1) In general.--Section 1861(s)(2) of the Social Security 
        Act (42 U.S.C. 1395x(s)(2)) is amended--
                    (A) in subparagraph (EE), by striking ``and'' at 
                the end;
                    (B) in subparagraph (FF), by inserting ``and'' at 
                the end; and
                    (C) by adding at the end the following new 
                subparagraph:
            ``(GG) a durable medical item that administers a drug 
        described in section 1927(k)(2)(C) that would otherwise be 
        self-administered multiple times per day and includes a 
        disposable component and at least one component that can 
        withstand repeated use, and supplies used in conjunction with 
        such item (including the drug administered by such item);''.
            (2) Payment.--
                    (A) Payment amount for dmi.--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 Methodology for Durable Medical Items (DMI).--The 
Secretary shall establish a payment methodology for a durable medical 
item described in section 1861(s)(2)(GG) and supplies used in 
conjunction with such item (other than a drug administered by such 
item) such that the estimated average total payment per individual for 
such items and supplies does not exceed the estimated average total 
payment per individual that would otherwise be made (taking into 
account the application of section 1847) for the durable medical 
equipment for which it is a substitute and for supplies used in 
conjunction with such equipment (other than such a drug) as determined 
appropriate by the Secretary.''.
                    (B) Payment for drug.--Section 1842(o)(1)(D) of the 
                Social Security Act (42 U.S.C. 1395u(o)(1)(D)) is 
                amended--
                            (i) in clause (i), by inserting ``or drugs 
                        administered by a durable medical item covered 
                        under section 1861(s)(2)(GG) on or after 
                        January 1, 2017,'' after ``after January 1, 
                        2004,''; and
                            (ii) in clause (ii), by striking 
                        ``infusion''.
                    (C) Competitive acquisition.--Section 1847(a)(2) of 
                the Social Security Act (42 U.S.C. 1395w-3(a)(2)) is 
                amended by adding at the end the following new 
                subparagraph:
                    ``(D) Durable medical item.--A durable medical item 
                and supplies used in conjunction with such item, 
                described in section 1861(s)(2)(GG).''.
            (3) Conforming amendment.--Section 1833(a)(1) of the Social 
        Security Act (42 U.S.C. 1395l(a)(1)) is amended--
                    (A) by striking ``and'' before ``(Z)''; and
                    (B) by inserting before the semicolon at the end 
                the following: ``, and (AA) with respect to durable 
                medical items described in section 1861(s)(2)(GG), the 
                amount paid shall be equal to 80 percent of the lesser 
                of the actual charge or the amount determined under 
                section 1834(r)''.
            (4) Effective date.--The amendments made by this subsection 
        shall apply to items furnished on or after January 1, 2017.
    (b) Payment for Certain Disposable Devices.--
            (1) In general.--Section 1834 of the Social Security Act 
        (42 U.S.C. 1395m), as amended by subsection (a)(2), is further 
        amended by adding at the end the following new subsection:
    ``(s) 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).''.
            (2) 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(s)(2)'' after ``durable 
        medical equipment''.
            (3) Effective date.--The amendments made by this subsection 
        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 in the 
                coverage database 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) Links 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) regard coverage, coding, or payment under 
                this title for such products.''.

        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) is 
amended by adding at the end the following new subsection:
    ``(r) 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 surgery 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 such items 
                and services 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 such an 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 existing mechanisms, 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 s(or 
                                pharmacies) elected 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 (II), 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 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), 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 drugs described in 
                                subparagraph (G), taking into account 
                                geographic location, beneficiary 
                                preference, impact on cost-sharing, and 
                                reasonable travel time; or
                                    ``(II) a PDP sponsor shall ensure 
                                such access to prescribers and 
                                pharmacies in the case of individuals 
                                with multiple residences and in the 
                                case of natural disasters and similar 
                                emergency situations.
                            ``(iii) Beneficiary preferences.--
                                    ``(I) In general.--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--
                                            ``(aa) review such 
                                        preferences;
                                            ``(bb) select or change the 
                                        selection of prescribers and 
                                        pharmacies for the beneficiary 
                                        based on such preferences; and
                                            ``(cc) inform the 
                                        beneficiary of such selection 
                                        or change of selection.
                                    ``(II) Exception.--In the case that 
                                the PDP sponsor determines that a 
                                change to the selection of prescriber 
                                or pharmacy under item (bb) 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 subclause (I).
                            ``(iv) 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); or
                                    ``(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.
                    ``(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, 
        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 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 impact 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 
                        paragraph (5) of section 1860D-4(c) of the 
                        Social Security Act (42 U.S.C. 1395w-104(c)));
                            (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).
                                 <all>