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tv   Book TV  CSPAN  December 19, 2009 1:00pm-2:00pm EST

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being prepared. not later than 1 year after the date of enactment of this section, and biennially thereafter, the heads of each of the agencies of the department of health and human services shall submit to the deputy assistant secretary for minority health a report summarizing the minority health activities of each of the respective agencies. (b) establishment of individual offices of minority health within the department of health and human services. (1) in general. title xvii of the public health service act (42 u.s.c. 300u et seq.) is amended by inserting after section 1707 the following section: "sec. 1707a. individual offices of minority health within the department. "(a) in general. the head of each agency specified in subsection (b)(1) shall establish within the agency an office to be known as
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the office of minority health. the head of each such office shall be appointed by the head of the agency within which the office is established, and shall report directly to the head of the agency. the head of such agency shall carry out this section (as this section relates to the agency) acting through such director. "(b) specified agencies. the agencies referred to in subsection (a) are the centers for disease control and prevention, the health resources and services administration, the substance abuse and mental health services administration, the agency for healthcare research and quality, the food and drug administration, and the centers for medicare & medicaid services. "(c) director; appointment. each office of minority health established in an agency listed in subsection (a) shall be headed by a director, with documented experience and expertise in minority health services research and health disparities elimination.
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"(d) references. except as otherwise specified, any reference in federal law to an office of minority health (in the department of health and human services) is deemed to be a reference to the office of minority health in the office of the secretary. "(e) funding. "(1) allocations. of the amounts appropriated for a specified agency for a fiscal year, the secretary must designate an appropriate amount of funds for the purpose of carrying out activities under this section through the minority health office of the agency. in reserving an amount under the preceding sentence for a minority health office for a fiscal year, the secretary shall reduce, by substantially the same percentage, the amount that otherwise would be available for each of the programs of the designated agency involved. "(2) availability of funds for staffing. the purposes for which amounts made available under paragraph may be expended by a minority health office include the costs of employing staff for such office.". (2) no new regulatory
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authority. nothing in this subsection and the amendments made by this subsection may be construed as establishing regulatory authority or modifying any existing regulatory authority. (3) limitation on termination. notwithstanding any other provision of law, a federal office of minority health or federal appointive position with primary responsibility over minority health issues that is in existence in an office of agency of the department of health and human services on the date of enactment of this section shall not be terminated, reorganized, or have any of its power or duties transferred unless such termination, reorganization, or transfer is approved by an act of congress. (c) redesignation of national center on minority health and health disparities. (1) redesignation. title iv of the public health service act (42 u.s.c. 281 et seq.) is amended- (a) by redesignating subpart 6 of part e as subpart 20; (b) by transferring subpart 20,
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as so redesignated, to part c of such title iv; (c) by inserting subpart 20, as so redesignated, after subpart 19 of such part c; and (d) in subpart 20, as so redesignated- (i) by redesignating sections 485e through 485h as sections 464z-3 through 464z-6, respectively; (ii) by striking "national center on minority health and health disparities" each place such term appears and inserting "national institute on minority health and health disparities"; and (iii) by striking "center" each place such term appears and inserting "institute". (2) purpose of institute; duties. section 464z-3 of the public health service act, as so
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redesignated, is amended- (a) in subsection (h)(1), by striking "research endowments at centers of excellence under section 736." and inserting the following: "research endowments- "(1) at centers of excellence under section 736; and "(2) at centers of excellence under section 464z-4."; (b) in subsection (h)(2)(a), by striking "average" and inserting "median"; and (c) by adding at the end the following: "(h) interagency coordination. the director of the institute, as the primary federal officials with responsibility for coordinating all research and activities conducted or supported by the national institutes of health on minority health and health disparities, shall plan, coordinate, review and evaluate research and other activities conducted or supported by the institutes and centers of the national institutes of health.". (3) technical and conforming amendments. (a) section 401(b)(24) of the public health service act (42
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u.s.c. 281(b)(24)) is amended by striking "center" and inserting "institute". (b) subsection (d)(1) of section 903 of the public health service act (42 u.s.c. 299a-1(d)(1)) is amended by striking "section 485e" and inserting "section 464z-3". sec. 10335. technical correction to the hospital value-based purchasing program. section 1886(o)(2)a) of the social security act, as added by section 3001, is amended, in the first sentence, by inserting ", other than measures of readmissions," after "shall select measures". sec. 10336. gao study and report on medicare beneficiary access to high-quality dialysis services. (a) study. (1) in general. the comptroller general of the united states shall conduct a
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study on the impact on medicare beneficiary access to high-quality dialysis services of including specified oral drugs that are furnished to such beneficiaries for the treatment of end stage renal disease in the bundled prospective payment system under section 1881(b)(14) of the social security act (42 u.s.c. 1395rr(b)(14)) (pursuant to the proposed rule published by the secretary of health and human services in the federal register on september 29, 2009 (74 fed. reg. 49922 et seq.)). such study shall include an analysis of- (a) the ability of providers of services and renal dialysis facilities to furnish specified oral drugs or arrange for the provision of such drugs; (b) the ability of providers of services and renal dialysis facilities to comply, if necessary, with applicable state laws (such as state pharmacy
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licensure requirements) in order to furnish specified oral drugs; (c) whether appropriate quality measures exist to safeguard care for medicare beneficiaries being furnished specified oral drugs by providers of services and renal dialysis facilities; and (d) other areas determined appropriate by the comptroller general. (2) specified oral drug defined. for purposes of paragraph (1), the term "specified oral drug" means a drug or biological for which there is no injectable equivalent (or other non-oral form of administration). (b) report. not later than 1 year after the date of the enactment of this act, the comptroller general of the united states shall submit to congress a report containing the results of the study conducted under subsection (a), together with recommendations for such legislation and administrative action as the comptroller general determines appropriate. subtitle d-provisions relating to title iv sec. 10401. amendments to subtitle a.
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(a) section 4001(h)(4) and (5) of this act is amended by striking "2010" each place such appears and inserting "2020". (b) section 4002(c) of this act is amended- (1) by striking "research and health screenings" and inserting "research, health screenings, and initiatives"; and (2) by striking "for preventive" and inserting "regarding preventive". (c) section 4004(a)(4) of this act is amended by striking "a gateway" and inserting "an exchange". sec. 10402. amendments to subtitle b. (a) section 399z-1(a)(1(a) of the public health service act, as added by section 4101(b) of this act, is amended by inserting "and vision" after "oral". (b) section 1861(hhh)(4)(g) of
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the social security act, as added by section 4103(b), is amended to read as follows: "(g) a beneficiary shall be eligible to receive only an initial preventive physical examination (as defined under subsection (ww)(1)) during the 12-month period after the date that the beneficiary's coverage begins under part b and shall be eligible to receive personalized prevention plan services under this subsection each year thereafter provided that the beneficiary has not received either an initial preventive physical examination or personalized prevention plan services within the preceding 12-month period.". sec. 10403. amendments to subtitle c. section 4201 of this act is amended- (1) in subsection (a), by adding before the period the following: ", with not less than 20 percent of such grants being awarded to rural and frontier areas";
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(2) in subsection (c)(2)(b)(vii), by striking "both urban and rural areas" and inserting "urban, rural, and frontier areas"; and (3) in subsection (f), by striking "each fiscal years" and inserting "each of fiscal year". sec. 10404. amendments to subtitle d. section 399mm(2) of the public health service act, as added by section 4303 of this act, is amended by striking "by ensuring" and inserting "and ensuring". sec. 10405. amendments to subtitle e. subtitle e of title iv of this act is amended by striking section 4401. sec. 10406. amendment relating to waiving coinsurance for preventive services. section 4104(b) of this act is amended to read as follows: "(b) payment and elimination of coinsurance in all settings.-section 1833(a)(1) of
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the social security act (42 u.s.c. 1395l(a)(1)), as amended by section 4103(c)(1), is amended- "(1) in subparagraph (t), by inserting '(or 100 percent if such services are recommended with a grade of a or b by the united states preventive services task force for any indication or population and are appropriate for the individual)' after '80 percent'; "(2) in subparagraph (w)- "(a) in clause (i), by inserting '(if such subparagraph were applied, by substituting '100 percent' for '80 percent')' after 'subparagraph (d)'; and "(b) in clause (ii), by striking '80 percent' and inserting '100 percent'; "(3) by striking 'and' before '(x)'; and "(4) by inserting before the semicolon at the end the following: ', and (y) with respect to preventive services
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described in subparagraphs (a) and (b) of section 1861(ddd)(3) that are appropriate for the individual and, in the case of such services described in subparagraph (a), are recommended with a grade of a or b by the united states preventive services task force for any indication or population, the amount paid shall be 100 percent of (i) except as provided in clause (ii), the lesser of the actual charge for the services or the amount determined under the fee schedule that applies to such services under this part, and (ii) in the case of such services that are covered opd services (as defined in subsection (t)(1)(b)), the amount determined under subsection (t)'.". sec. 10407. better diabetes care. (a) short title. this section may be cited as the "catalyst to better diabetes care act of 2009". (b) national diabetes report card. (1) in general.
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the secretary, in collaboration with the director of the centers for disease control and prevention (referred to in this section as the "director"), shall prepare on a biennial basis a national diabetes report card (referred to in this section as a "report card") and, to the extent possible, for each state. (2) contents. (a) in general. each report card shall include aggregate health outcomes related to individuals diagnosed with diabetes and prediabetes including- (i) preventative care practices and quality of care; (ii) risk factors; and (iii) outcomes. (b) updated reports. each report card that is prepared after the initial report card shall include trend analysis for the nation and, to the extent possible, for each state, for the purpose of- (i) tracking progress in meeting established national goals and objectives for improving diabetes care, costs, and prevalence (including healthy people 2010); and (ii) informing policy and program development.
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(3) availability. the secretary, in collaboration with the director, shall make each report card publicly available, including by posting the report card on the internet. (c) improvement of vital statistics collection. (1) in general. the secretary, acting through the director of the centers for disease control and prevention and in collaboration with appropriate agencies and states, shall- (a) promote the education and training of physicians on the importance of birth and death certificate data and how to properly complete these documents, including the collection of such data for diabetes and other chronic diseases; diseases; (b) encourage state adoption of the latest standard revisions of birth and death certificates; and (c) work with states to re-engineer their vital statistics systems in order to provide cost-effective, timely, and accurate vital systems data. (2) death certificate additional language.-in carrying out this subsection, the secretary may promote improvements to the collection of diabetes mortality
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data, including the addition of a question for the individual certifying the cause of death regarding whether the deceased had diabetes. (d) study on appropriate level of diabetes medical education.- (1) in general.-the secretary shall, in collaboration with the institute of medicine and appropriate associations and councils, conduct a study of the impact of diabetes on the practice of medicine in the united states and the appropriateness of the level of diabetes medical education that should be required prior to licensure, board certification, and board recertification. (2) report.-not later than 2 years after the date of the enactment of this act, the secretary shall submit a report on the study under paragraph (1) to the committees on ways and means and energy and commerce of the house of representatives and the committees on finance and health, education, labor, and pensions of the senate. (e) authorization of appropriations.-there are authorized to be appropriated to carry out this section such sums as may be necessary.
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sec. 10408. grants for small businesses to provide comprehensive workplace wellness programs. (a) establishment.-the secretary shall award grants to eligible employers to provide their employees with access to comprehensive workplace wellness programs (as described under subsection (c)). (b) scope.- (1) duration.-the grant program established under this section shall be conducted for a 5-year period. (2) eligible employer.-the term "eligible employer" means an employer (including a non-profit employer) that- (a) employs less than 100 employees who work 25 hours or greater per week; and (b) does not provide a workplace wellness program as of the date of enactment of this act. (c) comprehensive workplace wellness programs.- (1) criteria.-the secretary shall develop program criteria for comprehensive workplace wellness programs under this section that are based on and consistent with evidence-based research and best practices,
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including research and practices as provided in the guide to community preventive services, the guide to clinical preventive services, and the national registry for effective programs. (2) requirements.-a comprehensive workplace wellness program shall be made available by an eligible employer to all employees and include the following components: (a) health awareness initiatives (including health education, preventive screenings, and health risk assessments). (b) efforts to maximize employee engagement (including mechanisms to encourage employee participation). (c) initiatives to change unhealthy behaviors and lifestyle choices (including counseling, seminars, online programs, and self-help materials). (d) supportive environment efforts (including workplace policies to encourage healthy lifestyles, healthy eating, increased physical activity, and improved mental health). (d) application.-an eligible
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employer desiring to participate in the grant program under this section shall submit an application to the secretary, in such manner and containing such information as the secretary may require, which shall include a proposal for a comprehensive workplace wellness program that meet the criteria and requirements described under subsection (c). (e) authorization of appropriation.-for purposes of carrying out the grant program under this section, there is authorized to be appropriated $200,000,000 for the period of fiscal years 2011 through 2015. amounts appropriated pursuant to this subsection shall remain available until expended. sec. 10409. cures acceleration network. (a) short title.-this section may be cited as the "cures acceleration network act of 2009". (b) requirement for the director of nih to establish a cures acceleration network.-section 402(b) of the public health service act (42 u.s.c. 282(b))
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is amended- (1) in paragraph (22), by striking "and" at the end; (2) in paragraph (23), by striking the period and inserting "; and"; and (3) by inserting after paragraph (23), the following: "(24) implement the cures acceleration network described in section 402c.". (c) accepting gifts to support the cures acceleration network.-section 499(c)(1) of the public health service act (42 u.s.c. 290b(c)(1)) is amended by adding at the end the following: "(e) the cures acceleration network described in section 402c.". (d) establishment of the cures acceleration network.-part a of title iv of the public health service act is amended by inserting after section 402b (42 u.s.c. 282b) the following: "sec. 402c. cures acceleration network. "(a) definitions.-in this section:
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"(1) biological product.-the term 'biological product' has the meaning given such term in section 351 of the public health service act. "(2) drug; device.-the terms 'drug' and 'device' have the meanings given such terms in section 201 of the federal food, drug, and cosmetic act. "(3) high need cure.-the term 'high need cure' means a drug (as that term is defined by section 201(g)(1) of the federal food, drug, and cosmetic act, biological product (as that term is defined by section 262(i)), or device (as that term is defined by section 201(h) of the federal food, drug, and cosmetic act) that, in the determination of the director of nih- "(a) is a priority to diagnose, mitigate, prevent, or treat harm from any disease or condition; and
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"(b) for which the incentives of the commercial market are unlikely to result in its adequate or timely development. "(4) medical product.-the term 'medical product' means a drug, device, biological product, or product that is a combination of drugs, devices, and biological products. "(b) establishment of the cures acceleration network.-subject to the appropriation of funds as described in subsection (g), there is established within the office of the director of nih a program to be known as the cures acceleration network (referred to in this section as 'can'), which shall- "(1) be under the direction of the director of nih, taking into account the recommendations of a can review board (referred to in this section as the 'board'), described in subsection (d); and "(2) award grants and contracts to eligible entities, as described in subsection (e), to accelerate the development of high need cures, including through the development of
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medical products and behavioral therapies. "(c) functions.-the functions of the can are to- "(1) conduct and support revolutionary advances in basic research, translating scientific discoveries from bench to bedside; "(2) award grants and contracts to eligible entities to accelerate the development of high need cures; "(3) provide the resources necessary for government agencies, independent investigators, research organizations, biotechnology companies, academic research institutions, and other entities to develop high need cures; "(4) reduce the barriers between laboratory discoveries and clinical trials for new therapies; and "(5) facilitate review in the food and drug administration for the high need cures funded by the can, through activities that may include- "(a) the facilitation of regular and ongoing communication with the food and drug administration regarding the status of activities conducted under this section; "(b) ensuring that such activities are coordinated with
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the approval requirements of the food and drug administration, with the goal of expediting the development and approval of countermeasures and products; and "(c) connecting interested persons with additional technical assistance made available under section 565 of the federal food, drug, and cosmetic act. "(d) can board.- "(1) establishment.-there is established a cures acceleration network review board (referred to in this section as the 'board'), which shall advise the director of nih on the conduct of the activities of the cures acceleration network. "(2) membership.- "(a) in general.- "(i) appointment.-the board shall be comprised of 24 members who are appointed by the secretary and who serve at the pleasure of the secretary. "(ii) chairperson and vice chairperson.-the secretary shall designate, from among the 24 members appointed under clause (i), one chairperson of the board (referred to in this section as the 'chairperson') and one vice chairperson. "(b) terms.-
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"(i) in general.-each member shall be appointed to serve a 4-year term, except that any member appointed to fill a vacancy occurring prior to the expiration of the term for which the member's predecessor was appointed shall be appointed for the remainder of such term. "(ii) consecutive appointments; maximum terms.-a member may be appointed to serve not more than 3 terms on the board, and may not serve more than 2 such terms consecutively. "(c) qualifications.- "(i) in general.-the secretary shall appoint individuals to the board based solely upon the individual's established record of distinguished service in one of the areas of expertise described in clause (ii). each individual appointed to the board shall be of distinguished achievement and have a broad range of disciplinary interests. "(ii) expertise.-the secretary shall select individuals based upon the following requirements: "(i) for each of the fields of- "(aa) basic research; "(bb) medicine; "(cc) biopharmaceuticals;
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"(dd) discovery and delivery of medical products; "(ee) bioinformatics and gene therapy; "(ff) medical instrumentation; and "(gg) regulatory review and approval of medical products the secretary shall select at least 1 individual who is eminent in such fields. "(ii) at least 4 individuals shall be recognized leaders in professional venture capital or private equity organizations and have demonstrated experience in private equity investing. "(iii) at least 8 individuals shall represent disease advocacy organizations. "(3) ex-officio members.- "(a) appointment.-in addition to the 24 board members described in paragraph (2), the secretary shall appoint as ex-officio members of the board- "(i) a representative of the national institutes of health, recommended by the secretary of the department of health and human services; "(ii) a representative of the office of the assistant secretary of defense for health affairs, recommended by the secretary of defense; "(iii) a representative of the office of the under secretary
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for health for the veterans health administration, recommended by the secretary of veterans affairs; "(iv) a representative of the national science foundation, recommended by the chair of the national science board; and "(v) a representative of the food and drug administration, recommended by the commissioner of food and drugs. "(b) terms.-each ex-officio member shall serve a 3-year term on the board, except that the chairperson may adjust the terms of the initial ex-officio members in order to provide for a staggered term of appointment for all such members. "(4) responsibilities of the board and the director of nih.- "(a) responsibilities of the board.- "(i) in general.-the board shall advise, and provide recommendations to, the director of nih with respect to- "(i) policies, programs, and procedures for carrying out the duties of the director of nih under this section; and "(ii) significant barriers to successful translation of basic science into clinical application (including issues
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under the purview of other agencies and departments). "(ii) report.-in the case that the board identifies a significant barrier, as described in clause (i)(ii), the board shall submit to the secretary a report regarding such barrier. "(b) responsibilities of the director of nih.-with respect to each recommendation provided by the board under subparagraph (a)(i), the director of nih shall respond in writing to the board, indicating whether such director will implement such recommendation. in the case that the director of nih indicates a recommendation of the board will not be implemented, such director shall provide an explanation of the reasons for not implementing such recommendation. "(5) meetings.- "(a) in general.-the board shall meet 4 times per calendar year, at the call of the chairperson. "(b) quorum; requirements; limitations.- "(i) quorum.-a quorum shall consist of a total of 13 members of the board, excluding ex-officio members, with diverse
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representation as described in clause (iii). "(ii) chairperson or vice chairperson.-each meeting of the board shall be attended by either the chairperson or the vice chairperson. "(iii) diverse representation.-at each meeting of the board, there shall be not less than one scientist, one representative of a disease advocacy organization, and one representative of a professional venture capital or private equity organization. "(6) compensation and travel expenses.- "(a) compensation.-members shall receive compensation at a rate to be fixed by the chairperson but not to exceed a rate equal to the daily equivalent of the annual rate of basic pay prescribed for level iv of the executive schedule under section 5315 of title 5, united states code, for each day (including travel time) during which the
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member is engaged in the performance of the duties of the board. all members of the board who are officers or employees of the untied states shall serve without compensation in addition to that received for their services as officers or employees of the united states. "(b) travel expenses.-members of the board shall be allowed travel expenses, including per diem in lieu of subsistence, at rates authorized for persons employed intermittently by the federal government under section 5703(b) of title 5, united states code, while away from their homes or regular places of business in the performance of services for the board. "(e) grant program.-
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"(1) supporting innovation.-to carry out the purposes described in this section, the director of nih shall award contracts, grants, or cooperative agreements to the entities described in paragraph (2), to- "(a) promote innovation in technologies supporting the advanced research and development and production of high need cures, including through the development of medical products and behavioral therapies. "(b) accelerate the development of high need cures, including through the development of medical products, behavioral therapies, and biomarkers that demonstrate the safety or effectiveness of medical products; or "(c) help the award recipient establish protocols that comply with food and drug administration standards and otherwise permit the recipient
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to meet regulatory requirements at all stages of development, manufacturing, review, approval, and safety surveillance of a medical product. "(2) eligible entities.-to receive assistance under paragraph (1), an entity shall- "(a) be a public or private entity, which may include a private or public research institution, an institution of higher education, a medical center, a biotechnology company, a pharmaceutical company, a disease advocacy organization, a patient advocacy organization, or an academic research institution; "(b) submit an application containing- "(i) a detailed description of the project for which the entity seeks such grant or contract; "(ii) a timetable for such project; "(iii) an assurance that the entity will submit- "(i) interim reports describing
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the entity's- "(aa) progress in carrying out the project; and "(bb) compliance with all provisions of this section and conditions of receipt of such grant or contract; and "(ii) a final report at the conclusion of the grant period, describing the outcomes of the project; and "(iv) a description of the protocols the entity will follow to comply with food and drug administration standards and regulatory requirements at all stages of development, manufacturing, review, approval, and safety surveillance of a medical product; and "(c) provide such additional information as the director of nih may require. "(3) awards.- "(a) the cures acceleration partnership awards.- "(i) initial award amount.-each award under this subparagraph
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shall be not more than $15,000,000 per project for the first fiscal year for which the project is funded, which shall be payable in one payment. "(ii) funding in subsequent fiscal years.-an eligible entity receiving an award under clause (i) may apply for additional funding for such project by submitting to the director of nih the information required under subparagraphs (b) and (c) of paragraph (2). the dict may fund a project of such eligible entity in an amount not to exceed $15,000,000 for a fiscal year subsequent to the initial award under clause (i). "(iii) matching funds.-as a condition for receiving an award under this subsection, an eligible entity shall contribute to the project non-federal funds in the amount of $1 for every $3
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awarded under clauses (i) and (ii), except that the director of nih may waive or modify such matching requirement in any case where the director determines that the goals and objectives of this section cannot adequately be carried out unless such requirement is waived. "(b) the cures acceleration grant awards.- "(i) initial award amount.-each award under this subparagraph shall be not more than $15,000,000 per project for the first fiscal year for which the project is funded, which shall be payable in one payment. "(ii) funding in subsequent fiscal years.-an eligible entity receiving an award under clause (i) may apply for additional funding for such project by submitting to the board the information required under subparagraphs (b) and (c) of
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paragraph (2). the director of nih may fund a project of such eligible entity in an amount not to exceed $15,000,000 for a fiscal year subsequent to the initial award under clause (i). "(c) the cures acceleration flexible research awards.-if the director of nih determines that the goals and objectives of this section cannot adequately be carried out through a contract, grant, or cooperative agreement, the director of nih shall have flexible research authority to use other transactions to fund projects in accordance with the terms and conditions of this section. awards made under such flexible research authority for a fiscal year shall not exceed 20 percent of the total funds appropriated under subsection (g)(1) for such fiscal year. "(4) suspension of awards for defaults, noncompliance with provisions and plans, and diversion of funds; repayment of funds.-the director of nih may
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suspend the award to any entity upon noncompliance by such entity with provisions and plans under this section or diversion of funds. "(5) audits.-the director of nih may enter into agreements with other entities to conduct periodic audits of the projects funded by grants or contracts awarded under this subsection. "(6) closeout procedures.-at the end of a grant or contract period, a recipient shall follow the closeout procedures under section 74.71 of title 45, code of federal regulations (or any successor regulation). "(7) review.-a determination by the director of nih as to
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whether a drug, device, or biological product is a high need cure (for purposes of subsection (a)(3)) shall not be subject to judicial review. "(f) competitive basis of awards.-any grant, cooperative agreement, or contract awarded under this section shall be awarded on a competitive basis. "(g) authorization of appropriations.- "(1) in general.-for purposes of carrying out this section, there appropriated $500,000,000 for fiscal year 2010, and such sums as may be necessary for subsequent fiscal years. funds appropriated under this section shall be available until expended. "(2) limitation on use of funds otherwise appropriated.-no funds appropriated under this act, other than funds appropriated under paragraph (1), may be allocated to the cures
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acceleration network.". sec. 10410. centers of excellence for depression. (a) short title.-this section may be cited as the "establishing a network of health-advancing national centers of excellence for depression act of 2009" or the "enhanced act of 2009". (b) centers of excellence for depression.-subpart 3 of part b of title v of the public health service act (42 u.s.c. 290bb et seq.) is amended by inserting after section 520a the following: "sec. 520b. national centers of excellence for depression.
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"(a) depressive disorder defined.-in this section, the term 'depressive disorder' means a mental or brain disorder relating to depression, including major depression, bipolar disorder, and related mood disorders. "(b) grant program.- "(1) in general.-the secretary, acting through the administrator, shall award grants on a competitive basis to eligible entities to establish national centers of excellence for depression (referred to in this section as 'centers'), which shall engage in activities related to the treatment of depressive disorders. "(2) allocation of awards.-if the funds authorized under subsection (f) are appropriated in the amounts provided for under such subsection, the secretary shall allocate such amounts so that- "(a) not later than 1 year after the date of enactment of the enhanced act of 2009, not more than 20 centers may be established; and
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"(b) not later than september 30, 2016, not more than 30 centers may be established. "(3) grant period.- "(a) in general.-a grant awarded under this section shall be for a period of 5 years. "(b) renewal.-a grant awarded under subparagraph (a) may be renewed, on a competitive basis, for 1 additional 5-year period, at the discretion of the secretary. in determining whether to renew a grant, the secretary shall consider the report cards issued under subsection (e)(2). "(4) use of funds.-grant funds awarded under this subsection shall be used for the establishment and ongoing activities of the recipient of such funds. "(5) eligible entities.- "(a) requirements.-to be eligible to receive a grant under this section, an entity
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shall- "(i) be an institution of higher education or a public or private nonprofit research institution; and "(ii) submit an application to the secretary at such time and in such manner as the secretary may require, as described in subparagraph (b). "(b) application.-an application described in subparagraph (a)(ii) shall include- "(i) evidence that such entity- "(i) provides, or is capable of coordinating with other entities to provide, comprehensive health services with a focus on mental health services and subspecialty expertise for depressive disorders; "(ii) collaborates with other mental health providers, as necessary, to address co-occurring mental illnesses; "(iii) is capable of training health professionals about mental health; and
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"(ii) such other information, as the secretary may require. "(c) priorities.-in awarding grants under this section, the secretary shall give priority to eligible entities that meet 1 or more of the following criteria: "(i) demonstrated capacity and expertise to serve the targeted population. "(ii) existing infrastructure or expertise to provide appropriate, evidence-based and culturally and linguistically competent services. "(iii) a location in a geographic area with disproportionate numbers of underserved and at-risk populations in medically underserved areas and health professional shortage areas. "(iv) proposed innovative approaches for outreach to initiate or expand services. "(v) use of the most up-to-date science, practices, and
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interventions available. "(vi) demonstrated capacity to establish cooperative and collaborative agreements with community mental health centers and other community entities to provide mental health, social, and human services to individuals with depressive disorders. "(6) national coordinating center.- "(a) in general.-the secretary, acting through the administrator, shall designate 1 recipient of a grant under this section to be the coordinating center of excellence for depression (referred to in this section as the 'coordinating center'). the secretary shall select such coordinating center on a competitive basis, based upon the demonstrated capacity of such center to perform the duties described in subparagraph (c). "(b) application.-a center that has been awarded a grant under paragraph (1) may apply for designation as the coordinating
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center by submitting an application to the secretary at such time, in such manner, and containing such information as the secretary may require. "(c) duties.-the coordinating center shall- "(i) develop, administer, and coordinate the network of centers under this section; "(ii) oversee and coordinate the national database described in subsection (d); "(i) develop, administer, and coordinate the network of centers under this section; "(ii) oversee and coordinate the national database described in subsection (d); "(iii) lead a strategy to disseminate the findings and activities of the centers through such database; and "(iv) serve as a liaison with the administration, the national registry of evidence-based programs and practices of the administration, and any federal interagency or interagency forum on mental health. "(7) matching funds.-the secretary may not award a grant or contract under this section to an entity unless the entity agrees that it will make
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available (directly or through contributions from other public or private entities) non-federal contributions toward the activities to be carried out under the grant or contract in an amount equal to $1 for each $5 of federal funds provided under the grant or contract. such non-federal matching funds may be provided directly or through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or services. "(c) activities of the "(c) activities of the centers. each center shall carry out the following activities: "(1) general activities. each center shall- "(a) integrate basic, clinical, or health services interdisciplinary research and practice in the development,
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implementation, and dissemination of evidence-based interventions; "(b) involve a broad cross-section of stakeholders, such as researchers, clinicians, consumers, families of consumers, and voluntary health organizations, to develop a research agenda and disseminate findings, and to provide support in the implementation of evidence-based practices; "(c) provide training and technical assistance to mental health professionals, and engage in and disseminate translational research with a focus on meeting the needs of individuals with depressive disorders; and "(d) educate policy makers, employers, community leaders, and the public about depressive disorders to reduce stigma and raise awareness of treatments. "(2) improved treatment
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standards, clinical guidelines, diagnostic protocols, and care coordination practice. each center shall collaborate with other centers in the network to- "(a) develop and implement treatment standards, clinical guidelines, and protocols that emphasize primary prevention, early intervention, treatment for, and recovery from, depressive disorders; "(b) foster communication with other providers attending to co-occurring physical health conditions such as cardiovascular, diabetes, cancer, and substance abuse disorders; "(c) leverage available community resources, develop and implement improved self-management programs, and, when appropriate, involve family and other providers of social support in the development and implementation of care plans; and "(d) use electronic health
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records and telehealth technology to better coordinate and manage, and improve access to, care, as determined by the coordinating center. "(3) translational research through collaboration of centers and community-based organizations. each center shall- "(a) demonstrate effective use of a public-private partnership to foster collaborations among members of the network and community-based organizations such as community mental health centers and other social and human services providers; "(b) expand interdisciplinary, translational, and patient-oriented research and treatment; and "(c) coordinate with accredited academic programs to provide ongoing opportunities for the professional and continuing education of mental health providers.
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"(d) national database. "(1) in general. the coordinating center shall establish and maintain a national, publicly available database to improve prevention programs, evidence-based interventions, and disease management programs for depressive disorders, using data collected from the centers, as described in paragraph (2). "(2) data collection. each center shall submit data gathered at such center, as appropriate, to the coordinating center regarding- "(a) the prevalence and incidence of depressive disorders; "(b) the health and social outcomes of individuals with depressive disorders; "(c) the effectiveness of interventions designed, tested, and evaluated; "(d) other information, as the secretary may require. "(3) submission of data to the administrator. the coordinating center shall submit to the administrator the data and financial information gathered under paragraph (2).
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"(4) publication using data from the database. a center, or an individual affiliated with a center, may publish findings using the data described in paragraph (2) only if such center submits such data to the coordinating center, as required under such paragraph. "(e) establishment of standards; report cards and recommendations; third party review. "(1) establishment of "(1) establishment of standards. the secretary, acting through the administrator, shall establish performance standards for- "(a) each center; and "(b) the network of centers as a whole. "(2) report cards. the secretary, acting through the administrator, shall- "(a) for each center, not later than 3 years after the date on which such center of excellence is established and annually
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thereafter, issue a report card to the coordinating center to rate the performance of such center; and "(b) not later than 3 years after the date on which the first grant is awarded under subsection (b)(1) and annually thereafter, issue a report card to congress to rate the performance of the network of centers of excellence as a whole. "(3) recommendations. based upon the report cards described in paragraph (2), the secretary shall, not later than september 30, 2015- "(a) make recommendations to the centers regarding improvements such centers shall make; and "(b) make recommendations to congress for expanding the centers to serve individuals with other types of mental disorders. "(4) third party review.-not later than 3 years after the date on which the first grant is awarded under subsection (b)(1) and annually thereafter, the secretary shall arrange for an independent third party to
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conduct an evaluation of the network of centers to ensure that such centers are meeting the goals of this section. "(f) authorization of appropriations. "(1) in general. to carry out this section, there are authorized to be appropriated- "(a) $100,000,000 for each of the fiscal years 2011 through 2015; and "(b) $150,000,000 for each of the fiscal years 2016 through 2020. "(2) allocation of funds authorized. of the amount appropriated under paragraph (1) for a fiscal year, the secretary shall determine the allocation of each center receiving a grant under this section, but in no case may the allocation be more than $5,000,000, except that the secretary may allocate not more
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than $10,000,000 to the coordinating center.". sec. 10411. programs relating to congenital heart disease. (a) short title. this subtitle may be cited as the "congenital heart futures act". (b) programs relating to congenital heart disease. (1) national congenital heart disease surveillance disease surveillance system. part p of title iii of the public health service act (42 u.s.c. 280g et seq.), as amended by section 5405, is further amended by adding at the end the following: "sec. 399v-2. national congenital heart disease surveillance system. "(a) in general. the secretary, acting through
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the director of the centers for disease control and prevention, may- "(1) enhance and expand infrastructure to track the epidemiology of congenital heart disease and to organize such information into a nationally-representative, population-based surveillance system that compiles data concerning actual occurrences of congenital heart disease, to be known as the 'national congenital heart disease surveillance system'; or "(2) award a grant to one eligible entity to undertake the activities described in paragraph (1). "(b) purpose. the purpose of the congenital heart disease surveillance system shall be to facilitate further research into the types of health services patients use and to identify possible areas for educational outreach and prevention in accordance with standard practices of the centers for disease control and prevention.
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"(c) content. the congenital heart disease surveillance system- "(1) may include information concerning the incidence and prevalence of congenital heart disease in the united states; "(2) may be used to collect and store data on congenital heart disease, including data concerning- "(a) demographic factors associated with congenital heart disease, such as age, race, ethnicity, sex, and family history of individuals who are diagnosed with the disease; "(b) risk factors associated with the disease; "(c) causation of the disease; "(d) treatment approaches; and "(e) outcome measures, such that analysis of the outcome measures will allow derivation of evidence-based best practices and guidelines for congenital heart disease patients; and "(3) may ensure the collection and analysis of longitudinal
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data related to individuals of all ages with congenital heart disease, including infants, young children, adolescents, and adults of all ages. "(d) public access. the congenital heart disease surveillance system shall be made available to the public, as appropriate, including congenital heart disease researchers. "(e) patient privacy. the secretary shall ensure that the congenital heart disease surveillance system is maintained in a manner that complies with the regulations promulgated under section 264 of the health insurance portability and accountability act of 1996. "(f) eligibility for grant. to be eligible to receive a grant under subsection (a)(2), an entity shall- "(1) be a public or private nonprofit entity with specialized experience in congenital heart disease; and "(2) submit to the secretary an
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application at such time, in such manner, and containing such information as the secretary may require.". (2) congenital heart disease research. subpart 2 of part c of title iv of the public health service act (42 u.s.c. 285b et seq.) is amended by adding at the end the following: "sec. 425. congenital heart disease. "(a) in general. the director of the institute may expand, intensify, and coordinate research and related activities of the institute with respect to congenital heart disease, which may include congenital heart disease research with respect to- "(1) causation of congenital heart disease, including genetic causes; "(2) long-term outcomes in individuals with congenital heart disease, including infants, children, teenagers, adults, and elderly individuals;
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"(3) diagnosis, treatment, and prevention; "(4) studies using longitudinal data and retrospective analysis to identify effective treatments and outcomes for individuals with congenital heart disease; and "(5) identifying barriers to life-long care for individuals with congenital heart disease. "(b) coordination of research activities.-the director of the institute may coordinate research efforts related to congenital heart disease among multiple research institutions and may develop research networks. "(c) minority and medically underserved communities. in carrying out the activities described in this section, the director of the institute shall consider the application of such research and other activities to minority and medically underserved communities.". (c) authorization of appropriations.

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