H.R. 4701 — what changed

changed This Act may be cited as the “Vector-Borne “Tick-Borne Disease Research Accountability and Transparency Act of 2014”.

changed Subpart 6 of part C of title IV Title III of the Public Health Service Act (42 U.S.C. 285f 241 et seq.) is amended by adding at the end the following:following new part:

changed “447D. Scientific framework for vector-borne “W Lyme disease and other tick-borne diseases

changed “(a) Development of Scientific Framework for Vector-Borne Diseases“399OO. Research

changed “(1) “(a) In General—For each vector-borne disease identified under subsection (b), the Directors general—The Secretary shall develop a scientific framework for the conduct or support of epidemiological, basic, translational, and clinical research on such vector-borne disease.regarding Lyme disease and other tick-borne diseases.

changed “(2) Contents—The scientific framework “(b) Biennial reports—The Secretary shall ensure that each biennial report under section 403 includes information on actions undertaken by the National Institutes of Health to carry out subsection (a) with respect to a vector-borne Lyme disease shall include and other tick-borne diseases, including an assessment of the following:progress made in improving the outcomes of Lyme disease and such other tick-borne diseases.

changed “(A) Current Status“399OO–1. Working Group

changed “(i) Comprehensive review of “(a) Establishment—The Secretary shall establish a permanent working group, to be known as the literature—A summary of findings from Interagency Lyme and Tick-Borne Disease Working Group (in this section and section 399OO–2 referred to as the current literature in “Working Group”), to review all efforts within the areas of—Department of Health and Human Services concerning Lyme disease and other tick-borne diseases to ensure interagency coordination, minimize overlap, and examine research priorities.

changed “(I) the prevention, diagnosis, and treatment of acute and chronic vector-borne disease;“(b) Responsibilities—The Working Group shall—

changed “(II) “(1) not later than 24 months after the fundamental environmental and biologic process that regulate acute date of enactment of this part, and chronic vector-borne disease; andevery 24 months thereafter, develop or update a summary of—

changed “(III) the epidemiology “(A) ongoing Lyme disease and other tick-borne disease research related to causes, prevention, treatment, surveillance, diagnosis, duration of acute illness, intervention, and chronic vector-borne disease.access to services and supports for individuals with Lyme disease or other tick-borne diseases;

changed “(ii) Number of incidences internationally—An assessment of the incidence of acute and chronic vector-borne disease reported internationally.“(B) advances made pursuant to such research;

changed “(iii) Scientific advances—The identification “(C) the engagement of relevant and diverse emerging scientific areas, and promising scientific advances, in basic, translational, and clinical science relating to the areas described in subclauses (I) and (II) Department of clause (i).Health and Human Services with persons that participate at the public meetings required by paragraph (5); and

changed “(iv) Researchers—A description of “(D) the availability of individuals who—comments received by the Working Group at such public meetings and the Secretary’s response to such comments;

changed “(I) conduct “(2) ensure that a broad spectrum of scientific research in the areas described viewpoints is represented in clause (i); andeach such summary;

changed “(II) represent a diversity of scientific perspectives relevant “(3) monitor Federal activities with respect to such areas.Lyme disease and other tick-borne diseases;

changed “(v) Coordinated research initiatives—The identification of the types of initiatives and partnerships for the coordination of intramural and extramural research of the National Institutes of Health and the Centers for Disease Control and Prevention in the areas described in clause (i) with research of “(4) make recommendations to the relevant national research institutes, Federal agencies, and non-Federal public and private entities in Secretary regarding any appropriate changes to such areas.activities; and

changed “(vi) Research resources—The identification of “(5) ensure public and private resources, such as patient registries, input by holding annual public meetings that are available to facilitate address scientific advances, research relating to each of the areas described questions, surveillance activities, and emerging strains in clause (i).species of pathogenic organisms.

changed “(B) Identification of Research Questions—The identification of research questions relating to basic, translational, and clinical science in the areas described in subclauses (I) and (II) of subparagraph (A)(i) that have not been adequately addressed with respect to acute or chronic vector-borne disease.“(c) Membership

changed “(C) Recommendations—Recommendations for appropriate actions that should “(1) In general—The Working Group shall be taken to advance research in the areas described in subparagraph (A)(i) and to address the research questions identified in subparagraph (B), as well composed of a total of 14 members as for appropriate benchmarks to measure progress on achieving such action, including the following:follows:

changed “(i) Researchers—Ensuring adequate availability “(A) Federal members—Seven Federal members, consisting of individuals described in subparagraph (A)(iv).one or more representatives of each of—

changed “(ii) Coordinated research initiatives—Promoting and developing initiatives and partnerships described in subparagraph (A)(v).“(i) the Office of the Assistant Secretary for Health;

changed “(iii) Research resources—Developing additional public and private resources described in subparagraph (A)(vi) “(ii) the Food and strengthening existing resources.Drug Administration;

changed “(3) Timing“(iii) the Centers for Disease Control and Prevention;

changed “(A) Initial development and subsequent update—For each vector-borne disease identified under subsection (b)(1), “(iv) the Directors shall—National Institutes of Health; and

changed “(i) develop a scientific framework under this subsection not later than 18 months after the date “(v) such other agencies and offices of the enactment Department of this section; andHealth and Human Services as the Secretary determines appropriate.

changed “(ii) review and update “(B) Non-Federal public members—Seven non-Federal public members, consisting of representatives of the scientific framework not later than 5 years after its initial development.following categories:

changed “(B) Other updates—The Directors may review “(i) Physicians and update each scientific framework developed under this subsection as necessary.other medical providers with experience in diagnosing and treating Lyme disease and other tick-borne diseases.

changed “(4) Public Notice—With respect to each scientific framework developed under this subsection, not later than 30 days after the date of completion of the framework, the Directors shall—“(ii) Scientists or researchers with expertise.

removed “(A) submit such framework to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate; and

removed “(B) make such framework publicly available on the Internet Web site of the Department of Health and Human Services.

removed “(b) Identification of vector-Borne diseases

removed “(1) In general—Not later than 6 months after the date of the enactment of this section, the Directors shall identify 2 or more bacterial or parasitic vector-borne diseases that each have a high incidence domestically.

removed “(2) Treating tick-borne diseases as a single vector-borne disease—For purposes of identifying vector-borne diseases under this subsection and developing scientific frameworks for such diseases under subsection (a), tick-borne diseases, including Lyme disease and other tick-borne diseases that are known to be transmitted by ticks to humans in the United States, shall be treated as a single vector-borne disease.

removed “(3) Additional vector-borne diseases—Subject to paragraph (2), the Directors may, at any time, identify other vector-borne diseases for purposes of this section. In identifying a vector-borne disease pursuant to the previous sentence, the Directors may consider additional metrics of progress against such type of vector-borne disease.

removed “(c) Working groups

removed “(1) In general—For each vector-borne disease identified under subsection (b), the Directors shall convene a working group in accordance with the Federal Advisory Committee Act. The Directors (or their designees) shall participate in the meetings of each such working group.

removed “(2) Members—Each working group convened under this subsection shall be comprised of the following members:

removed “(A) One or more representatives of each of the following:

removed “(i) The National Institutes of Health.

removed “(ii) The Centers for Disease Control and Prevention.

removed “(iii) Other agencies or offices of the Department of Health and Human Services, as determined appropriate by the Directors.

removed “(iv) Other Federal agencies, as determined appropriate by the Directors.

removed “(B) One or more representatives of each of the following categories:

removed “(i) Physicians with experience in diagnosing and treating stages or manifestations of the relevant vector-borne disease.

removed “(ii) Non-Federal scientists or researchers with expertise, and representing a diversity of perspectives, regarding the science pertaining to vector-borne diseases.

“(iii) Patients and their family members.

added “(iv) Nonprofit organizations that advocate for patients with respect to Lyme disease and other tick-borne diseases.

added “(v) Other individuals whose expertise is determined by the Secretary to be beneficial to the functioning of the Working Group.

added “(2) Appointment—The members of the Working Group shall be appointed by the Secretary, except that of the non-Federal public members under paragraph (1)(B)—

added “(A) one shall be appointed by the Speaker of the House of Representatives; and

added “(B) one shall be appointed by the Majority Leader of the Senate.

added “(3) Diversity of scientific perspectives—In making appointments under paragraph (2), the Secretary, the Speaker of the House of Representatives, and the Majority Leader of the Senate shall ensure that the non-Federal public members of the Working Group represent a diversity of scientific perspectives.

added “(4) Terms—The non-Federal public members of the Working Group shall each be appointed to serve a 4-year term and may be reappointed at the end of such term.

added “(d) Meetings—The Working Group shall meet as often as necessary, as determined by the Secretary, but not less than twice each year.

added “(e) Reporting—Not later than 24 months after the date of enactment of this part, and every 24 months thereafter, the Working Group—

added “(1) shall submit a report on its activities, including an up-to-date summary under subsection (b)(1) and any recommendations under subsection (b)(4), to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor and Pensions of the Senate;

added “(2) shall make each such report publicly available on the website of the Department of Health and Human Services; and

added “(3) shall allow any member of the Working Group to include in any such report minority views.

added “399OO–2. Strategic plan

added “Not later than 3 years after the date of enactment of this section, and every 5 years thereafter, the Secretary shall submit to the Congress a strategic plan, informed by the most recent summary under section 399OO–1(b)(1), for the conduct and support of Lyme disease and tick-borne disease research, including—

added “(1) proposed budgetary requirements;

added “(2) a plan for improving outcomes of Lyme disease and other tick-borne diseases, including progress related to chronic or persistent symptoms and chronic or persistent infection and co-infections;

added “(3) a plan for improving diagnosis, treatment, and prevention;

changed “(iv) Nonprofit organizations that advocate for patients by promoting education, services, or research.“(4) appropriate benchmarks to measure progress on achieving the improvements described in paragraphs (2) and (3); and

changed “(v) Other individuals whose expertise is determined “(5) a plan to disseminate each summary under section 399OO–1(b)(1) and other relevant information developed by the Directors to be beneficial Working Group to the functioning of the working group.public, including health care providers, public health departments, and other relevant medical groups.”

removed “(C) One individual appointed by the Speaker of the House of Representatives.

removed “(D) One individual appointed by the Majority Leader of the Senate.

removed “(3) FACA sunset inapplicable—Section 14(a) of the Federal Advisory Committee Act (5 U.S.C. App.; relating to termination of advisory committees) shall not apply to a working group convened under paragraph (1).

removed “(4) Other working groups—If the Directors, in addition to convening the working groups required by this subsection, choose to continue any working group on any vector-borne disease in existence on the date of enactment of the Vector-Borne Disease Research Accountability and Transparency Act of 2014, any such working group is deemed to be an advisory committee subject to the Federal Advisory Committee Act.

removed “(d) Public hearings

removed “(1) In General—The Directors shall, within 60 days after identifying a vector-borne disease under section (b), and annually thereafter, convene public forums—

removed “(A) to seek public input on the development of the scientific framework for such vector-borne disease under this section and progress in addressing related chronic conditions; and

removed “(B) to identify, and seek public input on, potential emerging strains in species of pathogenic organisms.

removed “(2) Participants—The participants at the forums convened under this subsection shall be researchers, physicians, patients, and other members of the public.

removed “(e) Reporting

removed “(1) Biennial reports—The Directors shall ensure that each biennial report under section 403 includes information on actions undertaken to carry out each scientific framework developed under subsection (a) with respect to a vector-borne disease, including the following:

removed “(A) Information on research grants awarded by the National Institutes of Health and the Centers for Disease Control and Prevention for research relating to such vector-borne disease.

removed “(B) An assessment of the progress made in improving outcomes.

removed “(2) Additional one-time reports

removed “(A) Frameworks—For each vector-borne disease identified under subsection (b)(1), the Directors shall, not later than 6 years after the initial development of a scientific framework for such disease under subsection (a), submit a report to the Congress on the effectiveness of the framework (including the update required by subsection (a)(3)(A)(ii)) in improving the prevention, detection, diagnosis, and treatment of such disease.

removed “(B) Total number of working groups—Not later than 1 year after the date of enactment of this section, the Directors shall submit a report to the Congress identifying the total number of working groups convened under this section.

removed “(f) Recommendations for exception funding—The Directors shall consider each relevant scientific framework developed under subsection (a) when making recommendations for exception funding for grant applications.

removed “(g) Definition—In this section:

removed “(1) The term Directors means the Director of NIH and the Director of the Centers for Disease Control and Prevention acting jointly.

removed “(2) The term vector-borne disease means an infection transmitted to humans or other animals by ticks, mosquitoes, or fleas, such as Lyme disease.”