H.R. 6 — what changed

Section 402A(a)(1) of the Public Health Service Act (42 U.S.C. 282a(a)(1)) is amended—

“(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.”

“(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.”

“(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);

changed “(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 (as defined in subsection (7);paragraph (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).”

Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended—

“(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);”

“(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;

changed “(ii) identifies areas, to be known as strategic focus areas, in which the resources of the National Institutes of Health can best contribute to the goal of expanding knowledge on human health in the United States through biomedical research; and

“(iii) includes objectives for each such strategic focus area.

“(B) Entities described—The entities described in this subparagraph are the directors of the national research institutes and national centers, researchers, patient advocacy groups, and industry leaders.

“(2) Use of plan—The Director of NIH and the directors of the national research institutes and national centers shall use the strategic plan—

“(A) to identify research opportunities; and

“(B) to develop individual strategic plans for the research activities of each of the national research institutes and national centers that—

“(i) have a common template; and

“(ii) identify strategic focus areas in which the resources of the national research institutes and national centers can best contribute to the goal of expanding knowledge on human health in the United States through biomedical research.

“(3) Contents of plans

“(A) Strategic focus areas—The strategic focus areas identified pursuant to paragraph (1)(A)(ii) shall—

“(i) be identified in a manner that—

“(I) considers the return on investment to the United States public through the investments of the National Institutes of Health in biomedical research; and

“(II) contributes to expanding knowledge to improve the United States public’s health through biomedical research; and

“(ii) include overarching and trans-National Institutes of Health strategic focus areas, to be known as Mission Priority Focus Areas, which best serve the goals of preventing or eliminating the burden of a disease or condition and scientifically merit enhanced and focused research over the next 5 years.

“(B) Rare and pediatric diseases and conditions—In developing and maintaining a strategic plan under this subsection, the Director of NIH shall ensure that rare and pediatric diseases and conditions remain a priority.

added “(C) Workforce—In developing and maintaining a strategic plan under this subsection, the Director of NIH shall ensure that maintaining the biomedical workforce of the future, including the participation by scientists from groups traditionally underrepresented in the scientific workforce, remains a priority.

“(4) Initial plan—Not later than 270 days after the date of enactment of this subsection, the Director of NIH and the directors of the national research institutes and national centers shall—

“(A) complete the initial strategic plan required by paragraphs (1) and (2); and

“(B) make such initial strategic plan publicly available on the website of the National Institutes of Health.

“(5) Review; updates

“(A) Progress reviews—Not less than annually, the Director of NIH, in consultation with the directors of the national research institutes and national centers, shall conduct progress reviews for each strategic focus area identified under paragraph (1)(A)(ii).

“(B) Updates—Not later than the end of the 5-year period covered by the initial strategic plan under this subsection, and every 5 years thereafter, the Director of NIH, in consultation with the directors of the national research institutes and national centers, stakeholders in the scientific field, advocates, and the public at large, shall—

“(i) conduct a review of the plan, including each strategic focus area identified under paragraph (2)(B); and

“(ii) update such plan in accordance with this section.”

“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.”

changed Section 402 of the Public Health Service Act (42 U.S.C. 282) (as amended by section 1021(2)) is further amended by adding at the end the following:

changed “(m) “(n) 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.”

“(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;

changed “(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 includes at least—

“(i) the disease or indication being studied;

changed “(ii) inclusion criteria such as age, gender, diagnosis or diagnoses, lab laboratory values, or imaging results; and

changed “(iii) exclusion criteria such as specific diagnosis or diagnoses, lab laboratory values, or prohibited medications; and

“(D) to the extent possible, in carrying out this paragraph, make use of standard health care terminologies, such as the International Classification of Diseases or the Current Procedural Terminology, that facilitate electronic matching to data in electronic health records or other relevant health information technologies.”

“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—

changed “(1) cooperating with other entities to that sponsor or maintain disease registries, including disease registries and disease registry platforms for rare diseases;

“(2) developing or enhancing a secure information technology system that—

“(A) has the capacity to support data needs across a wide range of disease studies;

“(B) is easily modified as knowledge is gained during such studies; and

“(C) is capable of handling increasing amounts of data as more studies are carried out; and

“(3) providing advice to clinical researchers, patient advocacy groups, and other entities with respect to—

“(A) the design and conduct of disease studies;

“(B) the modification of any such ongoing studies; and

“(C) addressing associated patient privacy issues.

changed “(d) Availability of data on natural history of diseases—Data relating to the natural history of diseases obtained, aggregated, or otherwise maintained by a public-private partnership in which the Secretary participates under subsection (a) shall be made available, consistent with otherwise applicable Federal and State privacy laws, to the public (including patient advocacy groups, researchers, and drug developers) to help to facilitate and expedite medical product development programs.

“(e) Confidentiality—Notwithstanding subsection (d), nothing in this section authorizes the disclosure of any information that is a trade secret or commercial or financial information that is privileged or confidential and subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.

“(f) Authorization of appropriations—There is authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2016 through 2020.”

“4 Accessing, sharing, and using health data for research purposes

“13441. References

“In this part:

added “(1) The rule—References to “the Rule” refer to part 160 or part 164, as appropriate, of title 45, Code of Federal Regulations (or any successor regulation).

added “(2) Part 164—References to a specified section of “part 164”, refer to such specified section of part 164 of title 45, Code of Federal Regulations (or any successor section).

removed “(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).

removed “(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).

“13442. Defining health data research as part of health care operations

added “(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.

removed “(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—

added “(A) another covered entity for health care operations (as defined in section 164.501 of part 164);

removed “(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

added “(C) a business associate that has entered into a contract under section 164.504(e) of part 164 for the purpose of data aggregation (as defined in section 164.501 of part 164); and

removed “(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.

“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.

“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.

“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.”

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

“E Council for 21st Century Cures

“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.

“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.

“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.

“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—

changed “(i) 8 shall be appointed by the Comptroller General of the United States from a list of nominations submitted by leading trade associations—

“(I) 4 of whom shall be representatives of the biopharmaceutical industry;

“(II) 2 of whom shall be representatives of the medical device industry; and

“(III) 2 of whom shall be representatives of the information and digital technology industry; and

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

“(I) 2 of whom shall be representatives of academic researchers;

changed “(II) 3 of whom shall be representative representatives of patients;

“(III) 2 of whom shall be representatives of health care providers; and

“(IV) 2 of whom shall be representatives of health care plans and insurers.

“(D) Chair—The Chair of the Board shall be selected by the members of the Board by majority vote from among the members of the Board.

“(2) Terms and vacancies

“(A) In general—The term of office of each member of the Board appointed under paragraph (1)(C) shall be 5 years.

“(B) Vacancy—Any vacancy in the membership of the Board—

“(i) shall not affect the power of the remaining members to execute the duties of the Board; and

“(ii) shall be filled by appointment by the appointed members described in paragraph (1)(C) by majority vote.

“(C) Partial term—If a member of the Board does not serve the full term applicable under subparagraph (A), the individual appointed under subparagraph (B) to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.

“(3) Responsibilities—Not later than 90 days after the date on which the Council is incorporated and its Board of Directors is fully constituted, the Board of Directors shall establish bylaws and policies for the Council that—

“(A) are published in the Federal Register and available for public comment;

“(B) establish policies for the selection and, as applicable, appointment of—

“(i) the officers, employees, agents, and contractors of the Council; and

“(ii) the members of any committees of the Council;

“(C) establish policies, including ethical standards, for the conduct of programs and other activities under section 281D; and

“(D) establish specific duties of the Executive Director.

“(4) Meetings

changed “(A) In general—the 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.

“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.

“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.

“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.”

“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

changed “(iii) if the Secretary accepts such qualification package for review, the Secretary shall 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”).

changed “(B) Acceptance factors; non-acceptance—The nonacceptance—The Secretary shall determine whether to accept a qualification submission based on factors which may include the scientific merit of the submission and the available resources of the Food and Drug Administration to review the qualification submission. A determination not to accept a submission under paragraph (1) shall not be construed as a final determination by the Secretary under this section regarding the qualification of a drug development tool for its proposed context of use.

“(C) Prioritization of qualification review—The Secretary may prioritize the review of a full qualification package submitted under paragraph (1) with respect to a drug development tool, based on factors determined appropriate by the Secretary, including—

“(i) as applicable, the severity, rarity, or prevalence of the disease or condition targeted by the drug development tool and the availability or lack of alternative treatments for such disease or condition; and

“(ii) the identification, by the Secretary or by biomedical research consortia and other expert stakeholders, of such a drug development tool and its proposed context of use as a public health priority.

“(D) Engagement of external experts—The Secretary may, for purposes of the review of qualification submissions, through the use of cooperative agreements, grants, or other appropriate mechanisms, consult with biomedical research consortia and may consider the recommendations of such consortia with respect to the review of any qualification plan submitted under paragraph (1) or the review of any full qualification package under paragraph (3).

“(3) Review of full qualification package—The Secretary shall—

“(A) conduct a comprehensive review of a full qualification package accepted under paragraph (1)(C); and

“(B) determine whether the drug development tool at issue is qualified for its proposed context of use.

“(4) Qualification—The Secretary shall determine whether a drug development tool is qualified for a proposed context of use based on the scientific merit of a full qualification package reviewed under paragraph (3).

“(b) Effect of qualification

“(1) In general—A drug development tool determined to be qualified under subsection (a)(4) for a proposed context of use specified by the requestor may be used by any person in such context of use for the purposes described in paragraph (2).

“(2) Use of a drug development tool—Subject to paragraph (3), a drug development tool qualified under this section may be used for—

“(A) supporting or obtaining approval or licensure (as applicable) of a drug or biological product (including in accordance with section 506(c)) under section 505 of this Act or section 351 of the Public Health Service Act; or

“(B) supporting the investigational use of a drug or biological product under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act.

“(3) Rescission or modification

“(A) In general—The Secretary may rescind or modify a determination under this section to qualify a drug development tool if the Secretary determines that the drug development tool is not appropriate for the proposed context of use specified by the requestor. Such a determination may be based on new information that calls into question the basis for such qualification.

“(B) Meeting for review—If the Secretary rescinds or modifies under subparagraph (A) a determination to qualify a drug development tool, the requestor involved shall 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

changed “(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.

changed “(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)), 1965, patient advocacy groups, industry representatives, clinical and scientific experts, and other relevant entities and individuals.

“(3) Clinical outcome assessment

“(A) The term “clinical outcome assessment” means a measurement of a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions; and

“(B) such term includes a patient-reported outcome.

“(4) Context of use—The term “context of use” means, with respect to a drug development tool, 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).”

changed Chapter V of the Federal Food, Drug, and Cosmetic Act, as amended by section 2021, Act is further amended by inserting after section 505E of such Act (21 U.S.C. 355f) the following:

“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—

changed “(1) to help to support the approval of a new indication for a drug approved under section 505(b); and

changed “(2) to help to support or satisfy postapproval study requirements.

“(b) Evidence from clinical experience defined—In this section, the term “evidence from clinical experience” means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials, including from observational studies, registries, and therapeutic use.

“(c) Program framework

“(1) In general—Not later than 18 months after the date of enactment of this section, the Secretary shall establish a draft framework for implementation of the program under this section.

“(2) Contents of framework—The framework shall include information describing—

“(A) the current sources of data developed through clinical experience, including ongoing safety surveillance, registry, claims, and patient-centered outcomes research activities;

“(B) the gaps in current data collection activities;

“(C) the current standards and methodologies for collection and analysis of data generated through clinical experience; and

“(D) the priority areas, remaining challenges, and potential pilot opportunities that the program established under this section will address.

“(3) Consultation

“(A) In general—In developing the program framework under this subsection, the Secretary shall consult with regulated industry, academia, medical professional organizations, representatives of patient advocacy organizations, disease research foundations, and other interested parties.

“(B) Process—The consultation under subparagraph (A) may be carried out through approaches such as—

“(i) a public-private partnership with the entities described in such subparagraph in which the Secretary may participate; or

“(ii) a contract, grant, or other arrangement, as determined appropriate by the Secretary with such a partnership or an independent research organization.

“(d) Program implementation—The Secretary shall, not later than 24 months after the date of enactment of this section and in accordance with the framework established under subsection (c), implement the program to evaluate the potential use of evidence from clinical experience.

“(e) Guidance for industry—The Secretary shall—

changed “(1) utilize the program established in under subsection (d), (a), its activities, and any subsequent pilots or written reports, to inform a guidance for industry on—

“(A) the circumstances under which sponsors of drugs and the Secretary may rely on evidence from clinical experience for the purposes described in subsection (a)(1) or (a)(2); and

“(B) the appropriate standards and methodologies for collection and analysis of evidence from clinical experience submitted for such purposes;

“(2) not later than 36 months after the date of enactment of this section, issue draft guidance for industry as described in paragraph (1); and

“(3) not later than 48 months after the date of enactment of this section, after providing an opportunity for public comment on the draft guidance, issue final guidance.

“(f) Rule of construction

changed “(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 nonspecified use.

“(2) This section shall not be construed to alter—

“(A) the standards of evidence under—

“(i) subsection (c) or (d) of section 505, including the substantial evidence standard in such subsection (d); or

“(ii) section 351(a) of the Public Health Service Act; or

“(B) the Secretary’s authority to require postapproval studies or clinical trials, or the standards of evidence under which studies or trials are evaluated.

“505G. Collecting evidence from clinical experience through targeted extensions of the Sentinel System

changed “(a) In general—The Secretary shall, in parallel to implementing the program established in under section 505F and in order to build capacity for utilizing the evidence from clinical experience described in that section, identify and execute pilot demonstrations to extend existing use of the Sentinel System surveillance infrastructure authorized under section 505(k).

“(b) Pilot demonstrations

“(1) In general—The Secretary—

“(A) shall design and implement pilot demonstrations to utilize data captured through the Sentinel System surveillance infrastructure authorized under section 505(k) for purposes of, as appropriate—

“(i) generating evidence from clinical experience to improve characterization or assessment of risks or benefits of a drug approved under section 505(c);

“(ii) protecting the public health; or

“(iii) advancing patient-centered care; and

“(B) may make strategic linkages with sources of complementary public health data and infrastructure the Secretary determines appropriate and necessary.

“(2) Consultation—In developing the pilot demonstrations under this subsection, the Secretary shall—

“(A) consult with regulated industry, academia, medical professional organizations, representatives of patient advocacy organizations, disease research foundations, and other interested parties through a public process; and

“(B) develop a framework to promote appropriate transparency and dialogue about research conducted under these pilot demonstrations, including by—

“(i) providing adequate notice to a sponsor of a drug approved under section 505 or section 351 of the Public Health Service Act of the Secretary’s intent to conduct analyses of such sponsor’s drug or drugs under these pilot demonstrations;

“(ii) providing adequate notice of the findings related to analyses described in clause (i) and an opportunity for the sponsor of such drug or drugs to comment on such findings; and

“(iii) ensuring the protection from public disclosure of any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.

“(3) 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.”

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

“561A. Expanded access policy required for investigational drugs

changed “(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 or distributor’s investigational drugs.

“(b) Content of policy—A policy described in subsection (a) shall include making publicly available—

“(1) contact information for the manufacturer or distributor to facilitate communication about requests described in subsection (a);

“(2) procedures for making such requests;

“(3) the general criteria the manufacturer or distributor will consider or use to approve such requests; and

“(4) the length of time the manufacturer or distributor anticipates will be necessary to acknowledge receipt of such requests.

“(c) No guarantee of access—The posting of policies by manufacturers and distributors under subsection (a) shall not serve as a guarantee of access to any specific investigational drug by any individual patient.

“(d) Revised policy—A manufacturer or distributor that has made a policy publicly available as required by this section may revise the policy at any time.

“(e) Application—This section shall apply to a manufacturer or distributor with respect to an investigational drug beginning on the later of—

“(1) the date that is 60 days after the date of enactment of the 21st Century Cures Act; or

“(2) the first initiation of a phase 2 or phase 3 study (as such terms are defined in section 312.21(b) and (c) of title 21, Code of Federal Regulations (or any successor regulations)) with respect to such investigational new drug.”

Section 502(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(a)) is amended—

“(2)

changed “(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 analysis may be comparative to the use of another drug, to another health care intervention, or to no intervention.

“(B) Such term does not include any analysis that relates only to an indication that is not approved under section 505 or under section 351 of the Public Health Service Act for such drug.”

“(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;

changed “(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);

changed “(D) if a written agreement is reached under subparagraph (A), may approve the drug under this subsection for such use —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

changed “(A) In general—To help to expedite and facilitate the development and review of a drug for which a sponsor intends to request approval in accordance with this subsection, the Secretary may, at the request of the sponsor, conduct meetings that provide early consultation, timely advice, and sufficient opportunities to develop an agreement described in paragraph (1)(A) and help the sponsor design and conduct a drug development program as efficiently as possible, including the following types of meetings:

“(i) An early consultation meeting.

“(ii) An assessment meeting.

“(iii) A postapproval meeting.

“(B) No altering of goals—Nothing in this paragraph shall be construed to alter agreed upon goals and procedures identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012.

“(C) Breakthrough therapies—In the case of a drug designated as a breakthrough therapy under section 506(a), the sponsor of such drug may elect to utilize meetings provided under such section with respect to such drug in lieu of meetings described in subparagraph (A).

“(3) Labeling requirement—The labeling of an antibacterial or antifungal drug approved in accordance with this subsection shall contain the statement “Limited Population” in a prominent manner and adjacent to, and not more prominent than, the brand name of the product. The prescribing information for such antibacterial or antifungal drug required by section 201.57 of title 21, Code of Federal Regulations (or any successor regulation) shall also include the following statement: “This drug is indicated for use in a limited and specific population of patients.”.

“(4) Promotional materials—The provisions of section 506(c)(2)(B) shall apply with respect to approval in accordance with this subsection to the same extent and in the same manner as such provisions apply with respect to accelerated approval in accordance with section 506(c)(1).

“(5) Termination of requirements or conditions—If a drug is approved in accordance with this subsection for an indication in a limited population of patients and is subsequently approved or licensed under this section or section 351 of the Public Health Service Act, other than in accordance with this subsection, for—

“(A) the same indication and the same conditions of use, the Secretary shall remove any labeling requirements or postmarketing conditions that were made applicable to the drug under this subsection; or

“(B) a different indication or condition of use, the Secretary shall not apply the labeling requirements and postmarketing conditions that were made applicable to the drug under this subsection to the subsequent approval of the drug for such different indication or condition of use.

“(6) Relation to other provisions—Nothing in this subsection shall be construed to prohibit the approval of a drug for use in a limited population of patients in accordance with this subsection, in combination with—

“(A) an agreement on the design and size of a clinical trial pursuant to subparagraphs (B) and (C) of subsection (b)(5);

“(B) designation and treatment of the drug as a breakthrough therapy under section 506(a);

“(C) designation and treatment of the drug as a fast track product under section 506(b); or

“(D) accelerated approval of the drug in accordance with section 506(c).

“(7) Rule of construction—Nothing in this subsection shall be construed—

“(A) to alter the standards of evidence under subsection (c) or (d) (including the substantial evidence standard in subsection (d));

“(B) to waive or otherwise preclude the application of requirements under subsection (o);

“(C) to otherwise, in any way, limit the authority of the Secretary to approve products pursuant to this Act and the Public Health Service Act as authorized prior to the date of enactment of this subsection; or

“(D) to restrict in any manner, the prescribing of antibiotics or other products by health care providers, or to otherwise limit or restrict the practice of health care.

“(8) Effective immediately—The Secretary shall have the authorities vested in the Secretary by this subsection beginning on the date of enactment of this subsection, irrespective of when and whether the Secretary promulgates final regulations or guidance.

“(9) Definitions—In this subsection:

changed “(A) Early consultation meeting—The term “early consultation meeting” means a pre-investigational new drug meeting or an end-of-phase 1 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.”

“(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.”

“(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.”

“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.”

“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

changed “(1) Drugs marketed prior to establishment of Interpretive Criteria Website—With respect to an antimicrobial drug lawfully introduced or delivered for introduction into interstate commerce for commercial distribution before the establishment of the Interpretive Criteria Website, a holder of an approved application under section 505 of this Act or section 351 of the Public Health Service Act, as applicable, for each such drug—

“(A) not later than 1 year after establishment of the Interpretive Criteria Website, shall submit to the Secretary a supplemental application for purposes of changing the drug’s labeling to substitute a reference or hyperlink to such Website for any susceptibility test interpretive criteria and related information; and

“(B) may begin distribution of the drug involved upon receipt by the Secretary of the supplemental application for such change.

“(2) Drugs marketed subsequent to establishment of Interpretive Criteria Website—With respect to antimicrobial drugs lawfully introduced or delivered for introduction into interstate commerce for commercial distribution on or after the date of the establishment of the Interpretive Criteria Website, the labeling for such a drug shall include, in lieu of susceptibility test interpretive criteria and related information, a reference to such Website.

“(e) Special condition for marketing of antimicrobial susceptibility testing devices

“(1) In general—Notwithstanding sections 501, 502, 510, 513, and 515, if the conditions specified in paragraph (2) are met (in addition to other applicable provisions under this chapter) with respect to an antimicrobial susceptibility testing device described in subsection (f)(1), the Secretary may authorize the marketing of such device for a use described in such subsection.

“(2) Conditions applicable to antimicrobial susceptibility testing devices—The conditions specified in this paragraph are the following:

“(A) The device is used to make a determination of susceptibility using susceptibility test interpretive criteria that are—

“(i) included in a standard recognized by the Secretary under subsection (c); or

“(ii) otherwise listed on the Interpretive Criteria Website under subsection (b)(2).

“(B) The labeling of such device prominently and conspicuously—

“(i) includes a statement that—

“(I) the device provides information about the susceptibility of bacteria and fungi to certain drugs; and

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

“(ii) includes a statement directing health care practitioners to consult the approved labeling for drugs tested using such a device, to determine the uses for which the Food and Drug Administration has approved such drugs; and

“(iii) includes any other statement the Secretary determines appropriate to adequately convey the limitations of the data supporting the interpretive criteria described in subparagraph (A).

“(f) Definitions—In this section:

“(1) The term “antimicrobial susceptibility testing device” means a device that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug (or drugs).

“(2) The term “qualified infectious disease product” means a qualified infectious disease product designated under section 505E(d).

“(3) The term susceptibility test interpretive criteria means—

“(A) one or more specific numerical values which characterize the susceptibility of bacteria or other microorganisms to the drug tested; and

“(B) related categorizations of such susceptibility, including categorization of the drug as susceptible, intermediate, resistant, or such other term as the Secretary determines appropriate.

“(4)

“(A) The term “antimicrobial drug” means, subject to subparagraph (B), a systemic antibacterial or antifungal drug that—

“(i) is intended for human use in the treatment of a disease or condition caused by a bacterium or fungus;

“(ii) may include a qualified infectious disease product designated under section 505E(d); and

“(iii) is subject to section 503(b)(1).

“(B) If provided by the Secretary through regulations, such term may include—

“(i) drugs other than systemic antibacterial and antifungal drugs; and

“(ii) biological products (as such term is defined in section 351 of the Public Health Service Act) to the extent such products exhibit antimicrobial activity.

“(g) Rule of construction—Nothing in this section shall be construed—

“(1) to alter the standards of evidence—

“(A) under subsection (c) or (d) of section 505, including the substantial evidence standard in section 505(d), or under section 351 of the Public Health Service Act (as applicable); or

“(B) with respect to marketing authorization for devices, under section 510, 513, or 515;

“(2) to apply with respect to any drug, device, or biological product, in any context other than—

“(A) an antimicrobial drug; or

“(B) an antimicrobial susceptibility testing device that uses susceptibility test interpretive criteria to characterize and report the in vitro susceptibility of certain bacteria, fungi, or other microorganisms to antimicrobial drugs in accordance with this section; or

“(3) unless specifically stated, to have any effect on authorities provided under other sections of this Act, including any regulations issued under such sections.”

“(ee) If it is an antimicrobial drug and its labeling fails to conform with the requirements under section 511(d).”

“(M)

changed “(i)“(i) As part of the annual rulemaking under this subsection for payment for subsection (d) hospitals for each fiscal year beginning with fiscal year 2018, the Secretary shall—

changed “(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 include publication of a fiscal year or otherwise), provide for additional payment to be made under this subsection in accordance with the provisions list of this subparagraph with respect to discharges by eligible hospitals that involve the new antimicrobial drugs in the amount, subject to clause (vi), provided for under section 1847A.such fiscal year; and

changed “(II) Additional payments to be made under this subsection shall be with respect to discharges involving by eligible hospitals that involve a new antimicrobial drug that occur during the four-fiscal-year period beginning on which so published, provide for an inpatient hospital code is issued with respect additional payment to be made under this subsection in accordance with the drug.provisions of this subparagraph.

changed “(ii) For purposes of this subparagraph, the term new antimicrobial drug means a product that is approved Additional payments may not be made 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—drug under this subparagraph—

added “(I) other than during the 5-fiscal-year period beginning with the fiscal year for which the drug is first included in the publication described in clause (i)(I); and

added “(II) with respect to which payment has ever been made pursuant to subparagraph (K).

added “(iii) 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

removed “(bb) meets the definition of a qualified infectious disease product under section 505E(g) of the Federal Food, Drug, and Cosmetic Act;

removed “(II) is intended to treat an infection for which there is an “unmet medical need”; and

removed “(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.

changed “(iii) For purposes of this subparagraph, “(bb) meets the term “eligible hospital” means definition of a hospital that participates in the National Healthcare Safety Network qualified infectious disease product under section 505E(g) of the Centers for Disease Control Federal Food, Drug, 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).Cosmetic Act; and

changed “(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 “(II) is intended to treat an untrue statement of material fact.infection—

changed “(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 “(aa) for such fiscal year as part of the annual rulemaking under this subsection.which there is an unmet medical need; and

changed “(vi)“(bb) which is associated with high rates of mortality or significant patient morbidity, as determined in consultation with the Director of the Centers for Disease Control and Prevention and the infectious disease professional community.

changed “(I) The total “(iv) For purposes of the additional payments made under this subparagraph, the term “eligible hospital” means a subsection pursuant to this subparagraph for discharges (d) hospital that participates in a fiscal year (as estimated by the Secretary as part National Healthcare Safety Network of the rulemaking under this subsection Centers for the fiscal year) may not exceed the applicable percentage (specified in subclause (II)) of Disease Control and Prevention (or, to the total extent a similar surveillance system reporting program payments estimated to be made under this subsection for all discharges in such fiscal year (as calculated that includes reporting about antimicrobial drugs is determined 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 available to all discharges during such portion of hospitals, such fiscal year.similar surveillance system as the Secretary may specify).

changed “(II) For purposes of subclause (I), the term “applicable percentage” means, for fiscal year 2018 and each fiscal year thereafter, 0.06807 percent.“(v)

changed “(III) If the Secretary estimates before the beginning of a fiscalyear that “(I) Subject to the amount succeeding provisions of this clause, the additional payments payment under this subsection pursuant subparagraph, with respect 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 a drug, shall reduce pro rata be in the amount of each of the additional payments under this subsection pursuant to this subparagraph provided for such fiscal year (or portion thereof) in order to ensure that the aggregate additional payments drug under this subsection pursuant to this paragraph (as so estimated) do not exceed such limit.”section 1847A.

added “(II) The Secretary shall, as part of the rulemaking referred to in clause (i) for each fiscal year, estimate—

added “(aa) the total amount of the additional payments that will be made under this subsection pursuant to this subparagraph for discharges in such fiscal year without regard to the application of subclause (III); and

added “(bb) the total program payments to be made under this subsection for all discharges in such fiscal year.

added “(III) If the estimated total amount described in subclause (II)(aa) for a fiscal year exceeds the applicable percentage of the estimated total program payments described in subclause (II)(bb) for such fiscal year, the Secretary shall reduce in a pro rata manner the amount of each additional payment under this subsection pursuant to this subparagraph for such fiscal year in order to ensure that the total amount of the additional payments under this subsection pursuant to this subparagraph for such fiscal year do not exceed the applicable percentage of the estimated total program payments described in subclause (II)(bb) for such fiscal year.

added “(IV) For purposes of subclause (III), the term “applicable percentage” means 0.03 percent.”

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.

changed “(B) The Secretary shall provide analyses requested by a vaccine manufacturer under subparagraph (A) not later than 120calendar 120 calendar days after receipt of the request for the analyses.

“(4) The Secretary shall promptly notify a vaccine developer if—

“(A) the Secretary becomes aware of any 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

changed “(B) the change to such information may have implications for the vaccine developer’s vaccine research and development.”

changed “505G. “505I. Extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition

“(a) Designation

“(1) In general—The Secretary shall designate a drug as a drug approved for a new indication to prevent, diagnose, or treat a rare disease or condition for purposes of granting the extensions under subsection (b) if—

“(A) prior to approval of an application or supplemental application for the new indication, the drug was approved or licensed for marketing under section 505(c) of this Act or section 351(a) of the Public Health Service Act, but was not so approved or licensed for the new indication;

“(B)

“(i) the sponsor of the approved or licensed drug files an application or a supplemental application for approval of the new indication for use of the drug to prevent, diagnose, or treat the rare disease or condition; and

“(ii) the Secretary approves the application or supplemental application; and

“(C) the application or supplemental application for the new indication contains the consent of the applicant to notice being given by the Secretary under paragraph (4) respecting the designation of the drug.

“(2) Revocation of designation

changed “(A) In general—Except as provided in subparagraph (B), a designation under this subsection paragraph (1) shall not be revoked for any reason.

“(B) Exception—The Secretary may revoke a designation of a drug under paragraph (1) if the Secretary finds that the application or supplemental application resulting in such designation contained an untrue statement of material fact.

“(3) Notification prior to discontinuance of production for solely commercial reasons—A designation of a drug under paragraph (1) shall be subject to the condition that the sponsor of the drug will notify the Secretary of any discontinuance of the production of the drug for solely commercial reasons at least one year before such discontinuance.

“(4) Notice to public—Notice respecting the designation of a drug under paragraph (1) shall be made available to the public.

“(b) Extension—If the Secretary designates a drug as a drug approved for a new indication for a rare disease or condition, as described in subsection (a)(1)—

“(1)

changed “(A) the 4-, 5-, and 7 ½-year 7½-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).”

changed “(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) paragraph (1) to the lengths of the exclusivity periods after application of pediatric exclusivity, the 6-month extensions described in subsection (b)(1) paragraph (1) shall be in addition to any extensions under section 505G.”

changed “(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) paragraph (1) to the lengths of the exclusivity periods after application of pediatric exclusivity, the 6-month extensions described in subsection (c)(1) paragraph (1) shall be in addition to any extensions under section 505G.”

“(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.”

“(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.”

“(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).”

“(5) Termination of authority—The Secretary may not award any priority review vouchers under paragraph (1) after December 31, 2018.”

“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

changed “(H) assign staff to be available within a reasonable time to address questions posed by institutional review committees concerning the conditions and clinical testing requirements applicable to the investigational use of the device pursuant to an exemption under section 520(g).

“(2) Additional actions—In addition to the actions described in paragraph (1), for purposes of expediting the development and review of devices designated under subsection (c), the Secretary, in collaboration with the device sponsor, may, as appropriate—

“(A) coordinate with the sponsor regarding early agreement on a data development plan;

“(B) take steps to ensure that the design of clinical trials is as efficient as practicable, such as through adoption of shorter or smaller clinical trials, application of surrogate endpoints, and use of adaptive trial designs and Bayesian statistics, to the extent scientifically appropriate;

“(C) facilitate, to the extent scientifically appropriate, expedited and efficient development and review of the device through utilization of timely postmarket data collection, with regard to applications for approval under section 515(c); and

“(D) agree to clinical protocols that the Secretary will consider binding on the Secretary and the sponsor, subject to—

“(i) changes agreed to by the sponsor and the Secretary;

“(ii) changes that the Secretary determines are required to prevent an unreasonable risk to the public health; or

“(iii) the identification of a substantial scientific issue determined by the Secretary to be essential to the safety or effectiveness of the device involved.

“(e) Priority review guidance

“(1) Content—The Secretary shall issue guidance on the implementation of this section. Such guidance shall include the following:

“(A) The process for a person to seek a priority review designation.

“(B) A template for requests under subsection (b).

“(C) The criteria the Secretary will use in evaluating a request for priority review.

“(D) The standards the Secretary will use in assigning a team of staff, including team leaders, to review devices designated for priority review, including any training required for such personnel on effective and efficient review.

“(2) Process—Prior to finalizing the guidance under paragraph (1), the Secretary shall propose such guidance for public comment.

“(f) Construction

“(1) Purpose—This section is intended to encourage the Secretary and provide the Secretary sufficient authorities to apply efficient and flexible approaches to expedite the development of, and prioritize the agency’s review of, devices that represent breakthrough technologies.

“(2) Construction—Nothing in this section shall be construed to alter the criteria and standards for evaluating an application pursuant to section 515(c), a report and request for classification under section 513(f)(2), or a report under section 510(k), including the recognition of valid scientific evidence as described in section 513(a)(3)(B), and consideration of the least burdensome means of evaluating device effectiveness or demonstrating substantial equivalence between devices with differing technological characteristics, as applicable. Nothing in this section alters the authority of the Secretary to act on an application pursuant to section 515(d) before completion of an establishment inspection, as the Secretary deems appropriate.”

“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—

changed “(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));changes;

changed “(B) under which accredited persons shall, as applicable, shall (as applicable) certify that a requestor’s quality system meets the criteria included in the guidance issued under paragraph (5) with respect to the in-scope devices at issue; and

changed “(C) under which the Secretary shall rely on such certifications for purposes of determining the safety and effectiveness (or as applicable, substantial equivalence) of in-scope devices subject to the device-related changes involved, in lieu of compliance with the following submission requirements:

changed “(i) A thirty-day notice (as defined in paragraph (2)).premarket notification.

changed “(ii) A Special PMA supplement (as defined in paragraph (2)).thirty-day notice.

added “(iii) A Special PMA supplement.

“(2) Definitions—For purposes of this section─

“(A) the term “device-related changes” means changes made by a requestor with respect to in-scope devices, which are—

removed “(i) manufacturing changes subject to a 30-day notice;

changed “(ii) “(i) changes that qualify for to a Special PMA supplement; anddevice found to be substantially equivalent under sections 513(i) and 510(k) to a predicate device, that—

changed “(iii) such other changes relating “(I) would otherwise be subject to the devices or the device manufacturing process as the Secretary determines appropriate;a premarket notification; and

added “(II) do not alter—

added “(aa) the intended use of the changed device; or

added “(bb) the fundamental scientific technology of such device;

added “(ii) manufacturing changes subject to a 30-day notice;

added “(iii) changes that qualify for a Special PMA Supplement; and

added “(iv) such other changes relating to the devices or the device manufacturing process as the Secretary determines appropriate;

“(B) the term “in-scope device” means a device within the scope of devices agreed to by the requestor and the accredited person for purposes of a request for certification under this section;

added “(C) the term “premarket notification” means a premarket notification under section 510(k);

added “(D) the term “quality system” means the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of devices, as described in section 520(f);

added “(E) the term “requestor” means a device manufacturer that is seeking certification under this section of a quality system used by such manufacturer;

added “(F) the term “Special PMA” means a Special PMA supplement under section 814.39(d) of title 21, Code of Federal Regulations (or any successor regulations); and

added “(G) the term “thirty-day notice” means a notice described in section 515(d)(6).

removed “(C) the term “quality system” means a quality system described in section 520(f);

removed “(D) the term “requestor” means a device manufacturer that is seeking certification under this section of a quality system used by such manufacturer;

removed “(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

removed “(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

added “(i) Date assessments authorized—Beginning after the date on which the final guidance is issued under paragraph (5), an accredited person may conduct an assessment under this section.

removed “(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—

added “(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

added “(ii) criteria for accredited persons to apply for a waiver of, and exemptions from, the certification criteria under clause (i).

removed “(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

removed “(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

added “(ii) which shall include (as applicable)—

added “(I) the accredited person’s certification that the requestor has satisfied the criteria specified in the guidance issued under subsection (a)(5) for quality system certification with respect to the in-scope devices at issue; and

removed “(ii) which as applicable shall include—

removed “(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

added “(ii) the assessment summary and certification of the quality system of a requestor shall be deemed accepted by the Secretary on such 30th day.

added “(C) Actions by secretary

removed “(ii) the assessment summary and certification of the requestor shall be deemed accepted by the Secretary on such 30th day.

removed “(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.

added “(2) Notifications to Secretary by certified requestors or accredited persons for program evaluation purposes

added “(A) Annual summary report for device-related changes otherwise subject to premarket notification—A requestor whose quality system is certified under this section that effectuates device-related changes with respect to in-scope devices, without prior submission of a premarket notification, shall ensure that an annual summary report is submitted to the Secretary by the accredited person which—

added “(i) describes the changes made to the in-scope device; and

added “(ii) indicates the effective dates of such changes.

added “(B) Periodic notification for manufacturing changes otherwise subject to thirty-day notice—A requestor whose quality system is certified under this section that effectuates device-related changes with respect to in-scope devices, without prior submission of a thirty-day notice, shall provide notification to the Secretary of such changes in the requestor’s next periodic report under section 814.84(b) of title 21, Code of Federal Regulations (or any successor regulation). Such notification shall—

removed “(2) Notifications to Secretary by certified manufacturers for program evaluation purposes

removed “(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.

added “(C) Periodic notification for device-related changes otherwise subject to special pma supplement—A requestor whose quality system is certified under this section that effectuates device-related changes with respect to in-scope devices, without prior submission of a Special PMA Supplement, shall provide notification to the Secretary of such changes in the requestor’s next periodic report under section 814.84(b) of title 21, Code of Federal Regulations (or any successor regulation). Such notification shall—

removed “(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.

added “(D) Use of notifications for program evaluation purposes—Information submitted to the Secretary under subparagraphs (A) through (C) shall be used by the Secretary for purposes of the program evaluation under subsection (d).

removed “(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—

added “(1) shall remain in effect for a period of 2 years from the date such certification is accepted by the Secretary, subject to paragraph (6);

removed “(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);

added “(5) shall have no effect on the authority of the Secretary to conduct an inspection or otherwise determine whether the requestor has complied with the applicable requirements of this Act; and

added “(6) may be revoked by the Secretary upon a determination that the requestor’s quality system no longer meets the certification criteria specified in the guidance issued under subsection (a)(5) with respect to the in-scope devices at issue.

added “(d) Notice of revocation—The Secretary shall provide written notification to the requestor of a revocation pursuant to subsection (c)(6) not later than 10 business days after the determination described in such subsection. Upon receipt of the written notification, the requestor shall satisfy the applicable submission requirements specified in subsection (a)(1)(C) for any device-related changes effectuated after the date of such determination. After such revocation, such requestor is eligible to seek re-certification under this section of its quality system.

added “(e) Program evaluation; sunset

removed “(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

removed “(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.

removed “(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—

added “(i) analysis of information from a representative group of device manufacturers obtained from notifications provided by certified requestors or accredited persons under subsection (b)(2); and

removed “(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.

added “(B) Report—No later than 1 year after completing the evaluation under subparagraph (A), the Secretary shall issue a report of the evaluation’s findings on the website of the Food and Drug Administration, which shall include the Secretary’s recommendations with respect to continuation and as applicable expansion of the program under this section to encompass—

added “(i) device submissions beyond those identified in subsection (a)(1)(C); and

added “(ii) device changes beyond those described in subsection (a)(2)(A).

removed “(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.

added “(f) Rule of construction—Nothing in this section shall be construed to limit the authority of the Secretary to request and review the complete assessment of a certified requestor under this section on a for-cause basis.”

removed “(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.”

Section 513(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(a)(3)(B)) is amended—

changed “(ii) Valid scientific evidence for For purposes of clause (i) (i), valid scientific evidence may include: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

changed “(III) data collected in countries other than the United States so long as such data otherwise meets meet the criteria specified in this subparagraph.

“(iii) In the case of a study published in a peer-reviewed journal that is offered as valid scientific evidence for purposes of clause (i), the Secretary may request data underlying the study if—

“(I) the Secretary, in making such request, complies with the requirement of subparagraph (D)(ii) to consider the least burdensome appropriate means of evaluating device effectiveness or subsection (i)(1)(D) to consider the least burdensome means of determining substantial equivalence, as applicable;

“(II) the Secretary furnishes a written rationale for so requesting the underlying data together with such request; and

“(III) if the requested underlying data for such a study are unavailable, the Secretary shall consider such study to be part of the totality of the evidence with respect to the device, as the Secretary determines appropriate.”

“(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.”

“(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.”

Section 514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)) is amended—

“(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

changed “(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;determination.

“(iii) The Secretary shall make a response issued under clause (ii)(II) publicly available, in such manner as the Secretary determines appropriate.

changed “(iv) The Secretary shall take such actions as may be necessary to implement all or part of a standard recognized under subclause (I), clause (i)(I), in accordance with subparagraph (A).

“(D) The Secretary shall make publicly available, in such manner as the Secretary determines appropriate, the rationale for recognition under subparagraph (A) of part of a standard, including the scientific, technical, regulatory, or other basis for such recognition.”

“(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

changed “(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.consider—

added “(i) the experience with, and reliance on, a standard by other Federal regulatory authorities and the device industry; and

added “(ii) whether recognition of a standard will promote harmonization among regulatory authorities in the regulation of devices.

“(B) Timing—The Secretary shall publish—

“(i) draft guidance under subparagraph (A) not later than 12 months after the date of the enactment of the 21st Century Cures Act; and

added “(ii) final guidance not later than 12 months after the close of the public comment period for the draft guidance under clause (i).”

removed “(ii) final guidance not later than 12 months of the close of the public comment period for the draft guidance under clause (i).”

“(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.”

“(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

changed “(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 included in the list published under subparagraph (A).”

“(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.”

“(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.

changed “(D) For purposes of subparagraph (B)(ii), the term “adequate expertise” means that means, with respect to the membership of the classification panel reviewing a premarket submission submission, that such membership includes—

“(i) two or more voting members, with a specialty or other expertise clinically relevant to the device under review; and

“(ii) at least one voting member who is knowledgeable about the technology of the device.”

“(B)

“(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

changed “(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.”

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

changed “524B. “524C. Health software

“(a) Inapplicability of regulation to health software—Except as provided in subsection (b), health software shall not be subject to regulation under this Act.

“(b) Exception

“(1) In general—Subsection (a) shall not apply with respect to a software product—

“(A) of a type described in subparagraph (F) of section 201(ss)(1); and

“(B) that the Secretary determines poses a significant risk to patient safety.

“(2) Considerations—In making a determination under subparagraph (B) of paragraph (1) with respect to a product to which such paragraph applies, the Secretary shall consider the following:

“(A) The likelihood and severity of patient harm if the product were to not perform as intended.

“(B) The extent to which the product is intended to support the clinical judgment of a medical professional.

“(C) Whether there is a reasonable opportunity for a medical professional to review the basis of the information or treatment recommendation provided by the product.

“(D) The intended user and user environment, such as whether a medical professional will use a software product of a type described in subparagraph (F) of section 201(ss)(1).

“(c) Delegation—The Secretary shall delegate primary jurisdiction for regulating a software product determined under subsection (b) to be subject to regulation under this Act to the center at the Food and Drug Administration charged with regulating devices.

“(d) Regulation of software

“(1) In general—The Secretary shall review existing regulations and guidance regarding the regulation of software under this Act. The Secretary may implement a new framework for the regulation of software and shall, as appropriate, modify such regulations and guidance or issue new regulations or guidance.

“(2) Issuance by order—Notwithstanding subchapter II of chapter 5 of title 5, United States Code, the Secretary may modify or issue regulations for the regulation of software under this Act by administrative order published in the Federal Register following the publication of a proposed order.

“(3) Areas under review—The review of existing regulations and guidance under paragraph (1) may include review of the following areas:

“(A) Classification of software.

“(B) Standards for development of software.

“(C) Standards for validation and verification of software.

“(D) Review of software.

“(E) Modifications to software.

“(F) Manufacturing of software.

“(G) Quality systems for software.

“(H) Labeling requirements for software.

“(I) Postmarketing requirements for reporting of adverse events.

“(4) Process for issuing proposed regulations, administrative order, and guidance—Not later than 18 months after the date of enactment of this section, the Secretary shall consult with external stakeholders (including patients, industry, health care providers, academia, and government) to gather input before issuing regulations, an administrative order, and guidance under this subsection.

“(e) Rule of construction—Nothing in this section shall be construed as providing the Secretary with the authority to regulate under this Act any health software product of the type described in subparagraph (F) of section 201(ss)(1) unless and until the Secretary has made a determination described in subsection (b)(1)(B) with respect to such product.”

Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended—

changed “(4) is not health software (other than software determined to be a risk to patient safety under section 524B(b)), and”

“(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.”

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

“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.

changed “(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 for interoperability standards adopted in accordance with this section, under section 3004, 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.”

“(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.”

“(f) Termination—The HIT Standards Committee shall terminate on the date that is 90 days after the date of the enactment of this subsection.”

changed “3003A. Recommendations for standards through contract contracts with standards development organizations

changed “(a) ContractContracts

“(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).

changed “(4) Appropriate organizations—The Secretary shall ensure the most appropriate organizations described in paragraph (1) are selected for each contract under paragraph (1).such paragraph.

added “(5) Allowance for variations—Standards developed pursuant to a contract under this subsection, and the methods to test such standards, shall allow for variations on such standards as long as such variations are consistent with the standards so developed under this section.

“(b) Duties

“(1) Initial contract—Under the initial contract under subsection (a)(1), the standards development organizations—

removed “(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

changed “(B) may “(A) shall provide to the Secretary, in consultation with the National Coordinator, recommendations for adoption under section 3004, recommendations, in accordance with section 3010, for interoperability standards, and methods to test such standards, consistent with the criteria described in paragraph (2).subsection (a) of such section and with respect to the categories described in subsection (b)(1) of such section; and

changed “(2) Subsequent contracts—Under each subsequent contract, the organizations shall “(B) may provide to the Secretary, in consultation with the National Coordinator, for adoption under section 3004 Secretary 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, described in consultation with the National Coordinator.paragraph (2).

added “(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 standards and methods to test such standards), 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.

added “(3) Multiple methods to test interoperability standards—For the purposes of developing methods to test interoperability standards for adoption under section 3004, the Secretary shall ensure that contracts under this section allow for multiple methods to test such standards to account for variations in the adoption of such standards that do not conflict with section 3010(a).

“(c) Modifications and subsequent contracts

added “(1) In general—The Secretary, in consultation with the National Coordinator, shall periodically conduct hearings to evaluate and review the standards, implementation specifications, and certification criteria adopted under section 3004 for purposes of determining if modifications, including any additions, are needed with respect to such standards, specifications, and criteria.

added “(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.

removed “(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.

removed “(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.”

changed “(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. subsections (c) and (d). In the case of a standard, specification, or criterion that has been adopted under this section and is inconsistent or duplicative of such an interoperability standard 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.”

“(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

changed “(B) not to propose adoption of such standards, the Secretary shall notify the National Coordinator and the applicable standards development organizations with a contract under section 3003A in writing of such determination and the reasons for not proposing the adoption of the recommendation for such standards.

“(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.

changed “(c) “(d) 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:

changed “(1) In general—Except as provided in paragraph (2), any such standard (including interoperability standard), implementation specification, or certification criteria criterion 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.

changed “(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.criterion.

changed “(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 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.”

“(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.

changed “(2) Follow-up Followup 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.”

“(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) 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.”

“(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;

changed “(bb) on the pricing information described in clause (v) for purposes of the portal created under paragraph (9), (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, 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

changed “(III) demonstrate to the satisfaction of the Secretary that data from such records is are 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.records.

“(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.”

“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

changed “(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;

changed “(B) the actor knows or should know (as defined in section 1128A(i)(7) of the Social Security Act) is are 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.

changed “(C) Developing or implementing health information technology in non-standard nonstandard ways that are likely to substantially increase the costs, complexity, or burden of sharing electronic health information, especially in cases in which relevant interoperability standards or methods to measure interoperability have been adopted by the Secretary.

“(D) Developing or implementing health information technology in ways that are likely to lock in users or electronic health information, such as not allowing for the full export of 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).”

“(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.”

changed “(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, Act, with respect to the use of any certified EHR technology.”

“(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.”

changed “(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, Act, with respect to the use of any certified EHR technology.”

“(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.”

“(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).”

“(15) Widespread interoperability—The term “widespread interoperability” means that, on a nationwide basis—

changed “(A) health information technology are is interoperable, in accordance with section 3010, including as measured by the methods adopted under such section; 3010; and

changed “(B) such records are technology is employed by meaningful EHR users under the specified meaningful use incentive programs (as defined in section 3010A(e)) and by other clinicians and health care providers.”

added “(r) Payment for certain disposable devices

removed “(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);”

removed “(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.”

removed “(D) Durable medical item—A durable medical item and supplies used in conjunction with such item, described in section 1861(s)(2)(GG).”

removed “(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).”

“(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.

changed “(iii) Links Hyperlinks to the proposed determination and a response to comments submitted to the contractor with respect to such proposed determination.

“(iv) A summary of evidence that was considered by the contractor during the development of such determination and a list of the sources of such evidence.

“(v) An explanation of the rationale that supports such determination.”

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

changed “(B) regard are with respect to coverage, coding, or payment under this title for such products.”

changed Section 1834 of the Social Security Act (42 U.S.C. 1395m) 1395m), as amended by section 3061, is further amended by adding at the end the following new subsection:

changed “(r) Site-of-service “(s) Site-of-Service price transparency

changed “(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 surgical center under this title, the Secretary shall, for 2017 and each year thereafter, make available to the public via a searchable website, with respect to an appropriate number of such items and services—

changed “(A) the estimated payment amount for such items and services the item or service under the outpatient department fee schedule under subsection (t) of section 1833 and the ambulatory surgical center payment system under subsection (i) of such section; and

changed “(B) the estimated amount of beneficiary liability applicable to such an the item or service.

“(2) Calculation of estimated beneficiary liability—For purposes of paragraph (1)(B), the estimated amount of beneficiary liability, with respect to an item or service, is the amount for such item or service for which an individual who does not have coverage under a medicare supplemental policy certified under section 1882 or any other supplemental insurance coverage is responsible.

“(3) Implementation—In carrying out this subsection, the Secretary—

“(A) shall include in the notice described in section 1804(a) a notification of the availability of the estimated amounts made available under paragraph (1); and

changed “(B) may utilize existing mechanisms, mechanisms in existence on the date of the enactment of this subsection, such as the portion of the website of the Centers for Medicare & Medicaid Services on which information comparing physician performance is posted (commonly referred to as the Physician Compare website), to make available such estimated amounts under such paragraph.

“(4) Funding—For purposes of implementing this subsection, the Secretary shall provide for the transfer, from the Supplemental Medical Insurance Trust Fund under section 1841 to the Centers for Medicare & Medicaid Services Program Management Account, of $6,000,000 for fiscal year 2015, to remain available until expended.”

“(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;

changed “(III) of the prescriber (or prescribers) and pharmacy s(or (or pharmacies) elected selected for such individual under subparagraph (D);

“(IV) of, and information about, the beneficiary’s right to appeal such identification under subsection (h) and the option of an automatic escalation to external review;

“(V) that the beneficiary can, in the case that the beneficiary has not previously submitted to the PDP sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the PDP sponsor select under subparagraph (D), submit such preferences to the PDP sponsor; and

“(VI) that includes clear instructions that explain how the beneficiary can contact the PDP sponsor.

“(iv) Timing of notices

“(I) In general—Subject to subclause (II), a second notice described in clause (iii) shall be provided to the beneficiary on a date that is not less than 60 days after an initial notice described in clause (ii) is provided to the beneficiary.

changed “(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), (I), the PDP sponsor may provide such second notice on such earlier date.

“(C) At-risk beneficiary for prescription drug abuse

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

“(I) who is identified 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—

changed “(I) a PDP sponsor shall ensure that the beneficiary continues to have reasonable access to frequently abused drugs described (as defined in subparagraph (G), (G)), taking into account geographic location, beneficiary preference, impact on cost-sharing, costsharing, and reasonable travel time; orand

changed “(II) a PDP sponsor shall ensure such access (including access to prescribers and pharmacies with respect to frequently abused drugs) in the case of individuals with multiple residences and in the case of natural disasters and similar emergency situations.

“(iii) Beneficiary preferences

“(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—

changed “(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); orand

“(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.”

“(v) The drug management program for at-risk beneficiaries under subsection (c)(5).”

“(E) A utilization management tool to prevent drug abuse (as described in paragraph (6)(A)).”

“(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).”

“(j) Expanding Activities of Medicare Drug Integrity Contractors (MEDICs)

changed “(1) Access to information—Under contracts entered into under this section with Medicare drug integrity contractors, contractors (including any successor entity to a Medicare drug integrity contractor), the Secretary shall authorize such contractors to directly accept prescription and necessary medical records from entities such as pharmacies, prescription drug plans, MA–PD plans, and physicians with respect to an individual in order for such contractors to provide information relevant to the determination of whether such individual is an at-risk beneficiary for prescription drug abuse, as defined in section 1860D–4(c)(5)(C).

“(2) Requirement for acknowledgment of referrals—If a PDP sponsor or MA organization refers information to a contractor described in paragraph (1) in order for such contractor to assist in the determination described in such paragraph, the contractor shall—

“(A) acknowledge to the sponsor or organization receipt of the referral; and

“(B) in the case that any PDP sponsor or MA organization contacts the contractor requesting to know the determination by the contractor of whether or not an individual has been determined to be an individual described such paragraph, shall inform such sponsor or organization of such determination on a date that is not later than 15 days after the date on which the sponsor or organization contacts the contractor.

“(3) Making data available to other entities

“(A) In general—For purposes of carrying out this subsection, subject to subparagraph (B), the Secretary shall authorize MEDICs to respond to requests for information from PDP sponsors and MA organizations, State prescription drug monitoring programs, and other entities delegated by such sponsors or organizations using available programs and systems in the effort to prevent fraud, waste, and abuse.

“(B) HIPAA compliant information only—Information may only be disclosed by a MEDIC under subparagraph (A) if the disclosure of such information is permitted under the Federal regulations (concerning the privacy of individually identifiable health information) promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note).”

“(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.”