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108hr4899ih
(d) Violation of agreement; liquidated penalty (1) In general The Secretary may enter into an agreement under subsection (a) regarding a drug only if— (A) the agreement specifies the amount that, as a liquidated penalty, the Secretary may require the manufacturer involved to pay to the United States for failing to ma...
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(2) Hearing; loss of effective status of agreement (A) Hearing If, after providing notice and an opportunity for a hearing, the Secretary determines that a manufacturer has failed to maintain substantial compliance with the agreement under subsection (a), the Secretary shall order the manufacturer— (i) to pay to the ...
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(B) Loss of effective status If a manufacturer fails to comply with an order under subparagraph (A), the Secretary may transmit to the Secretary of the Treasury a notice in writing that an agreement under this section is not in effect with respect to the brand-name prescription drug involved. (e) General provisions (...
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(2) Monitoring of compliance With respect to brand-name prescription drugs for which agreements under subsection (a) are in effect, the Secretary shall monitor the prices at which such drugs are being sold and determine whether the manufacturers involved are in compliance with the agreements. The Secretary may require...
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(3) Access to records The Secretary may require, as a condition of a entering into an agreement under subsection (a) with a manufacturer, that the manufacturer provide the Secretary, during negotiations and after the agreement is made, with access to financial records of the manufacturer that relate to the brand-name ...
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(4) Consideration of compliance record In determining to what extent to establish requirements under paragraphs (2) and (3) with respect to an agreement under subsection (a) with a manufacturer, the Secretary shall take into account whether the manufacturer has maintained substantial compliance with any other agreemen...
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(2) Duties The Advisory Panel shall provide advice to the Secretary on establishing prices for the sale of brand-name prescription drugs at wholesale under agreements under subsection (a). Not later than one year after the date on which the initial appointments to the Advisory Panel under paragraph (3) are completed, ...
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and (ii) a list of the 25 most commonly prescribed drugs in the United States, exclusive of drugs included on the list under clause (i); and (B) submit to the Secretary the recommendations of the Panel with respect to such prices for drugs on the lists. (3) Composition The Advisory Panel shall be composed of five memb...
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Of such members— (A) one shall be a representative of the pharmaceutical industry; (B) one shall be a representative of retail consumers generally; (C) one shall be a representative of retail consumers who are members of racial or ethnic minority groups; (D) one shall be an academic with expertise in health care econom...
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(4) Chair The Advisory Panel shall select, by recorded vote, a member of the Panel to serve as the chair of the Panel. (5) Terms (A) In general Each member of the Advisory Panel shall be appointed for a term of four years, except that the term of each of the initial members expires December 31, 2007. (B) Service aft...
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(6) Vacancies (A) Authority of advisory panel A vacancy in the membership of the Advisory Panel does not affect the power of the remaining members to carry out the duties of the Panel. (B) Appointment of successors A vacancy in the membership of the Advisory Panel shall be filled in the manner in which the original ...
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(C) Incomplete term If a member of the Advisory Panel does not serve the full term under paragraph (5)(A), the Secretary, not later than 30 days after the date on which the vacancy occurs, shall appoint an individual to serve as a member of the Advisory Panel for the remainder of such term.
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(g) Definitions For purposes of this section: (1) The term brand-name prescription drug means a drug meeting each of the following criteria: (A) An approved application under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act is in effect for the drug, or in the case of a drug that is a biological product, ...
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(C) A period of market exclusivity is in effect with respect to the drug pursuant to a patent or pursuant to section 505(j) or 505A of such Act. (2) The term drug has the meaning given such term in section 201(g)(1) of such Act. 3.
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Denial of certain tax benefits unless unless pricing agreement for brand-name prescription drugs is in effect (a) Deductions for advertising (1) In general Part IX of subchapter B of chapter 1 of subtitle A of the Internal Revenue Code of 1986 (relating to items not deductible) is amended by adding at the end the fo...
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Denial of deductions for advertising for brand-name prescription drugs unless pricing agreement is in effect (a) In general No deduction shall be allowed under this chapter for any taxable year for any expenditure relating to the advertising, promoting, or marketing (in any medium) of any brand-name prescription drug...
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(2) Special rule regarding initial commercial marketing In the case of the taxable year during which a brand-name prescription drug first enters the commercial market, subsection (a) shall not apply with respect to such drug for such taxable year if a qualified pricing agreement with respect to the drug is in effect o...
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(2) Brand-name prescription drug The term brand-name prescription drug has the meaning given such term in section 340H of the Public Health Service Act. (d) Aggregation rules For purposes of this section, all members of the same controlled group of corporations (within the meaning of section 52(a)) and all persons un...
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Denial of deductions for advertising for brand-name prescription drugs unless pricing agreement is in effect. (b) Foreign tax credit Section 901 of such Code (relating to taxes of foreign countries and of possessions of United States) is amended by redesignating subsection (l) as subsection (m) and by inserting after ...
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with respect to brand-name prescription drugs unless pricing agreement is in effect (1) In general Notwithstanding any other provision of this part, no credit shall be allowed under subsection (a) for any income, war profits, or excess profits taxes paid or accrued (or deemed paid under section 902 or 960) with respe...
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(2) Exception for qualified pricing agreement — (A) In general Paragraph (1) shall not apply with respect to any brand-name prescription drug for a taxable year if there is in effect for the entire taxable year a qualified pricing agreement with respect to such drug.
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(B) Special rule regarding initial commercial marketing In the case of the taxable year during which a brand-name prescription drug first enters the commercial market, paragraph (1) shall not apply with respect to such drug for such taxable year if a qualified pricing agreement with respect to the drug is in effect on...
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(4) Aggregation rules For purposes of this subsection, a rule similar to the rule of section 280I(d) shall apply.. (c) Effective date The amendments made by this section shall apply to taxable years beginning after December 31, 2005. 280I. Denial of deductions for advertising for brand-name prescription drugs unless ...
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(b) Exception for qualified pricing agreement (1) In general Subsection (a) shall not apply with respect to any brand-name prescription drug for a taxable year if there is in effect for the entire taxable year a qualified pricing agreement with respect to such drug.
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(2) Special rule regarding initial commercial marketing In the case of the taxable year during which a brand-name prescription drug first enters the commercial market, subsection (a) shall not apply with respect to such drug for such taxable year if a qualified pricing agreement with respect to the drug is in effect o...
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(2) Brand-name prescription drug The term brand-name prescription drug has the meaning given such term in section 340H of the Public Health Service Act. (d) Aggregation rules For purposes of this section, all members of the same controlled group of corporations (within the meaning of section 52(a)) and all persons un...
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Federal Register notice Not later than 90 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall publish in the Federal Register a notice that informs manufacturers of brand-name prescription drugs of the provisions of the amendments made by this Act, and that invites the ma...
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1. Suspension of duty on Disperse blue 281 (a) In General Subchapter II of chapter 99 of the Harmonized Tariff Schedule of the United States is amended by inserting in numerical sequence the following new heading: 9902.32.10 Disperse blue 281 (CAS Nos.
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53950-33-7, 22578-86-5, 56548-64-2, and 67674-22-0) (provided for in subheading 3204.11.50) Free No Change No Change On or before 12/31/2007 (b) Effective Date The amendment made by subsection (a) applies to goods entered, or withdrawn from warehouse for consumption, on or after the 15th day after the date of the enac...
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1. Short title This Act may be cited as the Childhood Obesity Reduction Act. 2. Findings Congress makes the following findings: (1) According to the Centers for Disease Control and Prevention, obesity may soon overtake tobacco as the leading preventable cause of death. (2) In 1999, 13 percent of children aged 6 to 11...
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(3) Risk factors for heart disease, such as high cholesterol and high blood pressure, occur with increased frequency in overweight children and adolescents compared to children with a healthy weight. (4) Type 2 diabetes, previously considered an adult disease, has increased dramatically in children and adolescents. Ove...
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(6) Overweight adolescents have a 70 percent chance of becoming overweight or obese adults. (7) The 2001 report The Surgeon General’s Call to Action to Prevent and Decrease Overweight and Obesity suggested that obesity and its complications were already costing the United States $117,000,000,000 annually. (8) Substanti...
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101. Congressional Council on Childhood Obesity (a) Establishment of Council There is established a Congressional Council on Childhood Obesity (referred to in this title as the Council ). (b) Purposes The purposes of the Council shall be— (1) to encourage every elementary school and middle school in the United State...
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Membership of the Council (a) Composition of the Council The Council shall be composed of 8 members as follows: (1) The majority leader of the Senate or the designee of the majority leader of the Senate. (2) The minority leader of the Senate or the designee of the minority leader of the Senate. (3) The Speaker of the...
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(5) 4 citizen members to be appointed in accordance with subsection (b). (b) Appointment of citizen Council members (1) Method of appointment For the purpose of subsection (a)(5), each of the 4 members described in paragraphs (1) through (4) of subsection (a) shall appoint to the Council a citizen who is an expert on...
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(c) Vacancies Any vacancy in the Council shall not affect its powers, but shall be filled in the manner in which the original appointment was made under subsection (a). (d) Chairperson The members of the Council shall elect, from among the members of the Council, a Chairperson. (e) Initial meeting The Council shall ...
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Responsibilities of the Council (a) In general The Council shall engage in the following activities: (1) Work with outside experts to develop the Congressional Challenge to Reduce and prevent Childhood Obesity, which shall include the development of model plans to reduce and prevent childhood obesity that can be adop...
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(4) Consult and coordinate with the President’s Council on Physical Fitness and other Federal Government initiatives conducting activities to reduce and prevent childhood obesity. (5) Reward elementary schools, middle schools, and local educational agencies promoting innovative, successful strategies in reducing and pr...
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(b) Congressional Challenge winners (1) In general The Council shall— (A) evaluate plans submitted by elementary schools, middle schools, and local educational agencies under paragraph (2); (B) designate the plans submitted under paragraph (2) that meet the criteria under paragraph (3) as Congressional Challenge winn...
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(2) Submission of plans Each elementary school, middle school, or local educational agency that desires to have the plan to reduce and prevent childhood obesity of such entity designated as a Congressional Challenge winner shall submit to the Council such plan at such time, in such manner, and accompanied by such info...
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(3) Selection criteria (A) In general The Council shall evaluate plans submitted by elementary schools, middle schools, and local educational agencies under paragraph (2) and shall designate as Congressional Challenge winners the plans that— (i) show promise in successfully increasing physical activity, improving nut...
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(ii) The number of children in the community in need of assistance in addressing obesity and the potential impact of the proposed plan. (iii) The involvement in the plan of the community served by the school or local educational agency. (iv) Other criteria as determined by the Council. (c) Meetings The Council shall h...
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Administrative matters (a) Pay and travel expenses (1) Prohibition of pay Members of the Council shall receive no pay, allowances, or benefits by reason of their service on the Council.
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(2) Travel expenses (A) Compensation for travel Each member of the Council shall be allowed travel expenses, including per diem in lieu of subsistence, at rates authorized for employees of agencies under subchapter I of chapter 57 of title 5, United States Code, while away from their homes or regular places of busine...
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(B) Limit on travel expenses Travel expenses under subparagraph (A) shall be appropriated from the amounts appropriated to the legislative branch and shall not exceed $1,000,000. (b) Staff The Chairperson of the Council may appoint and terminate, as may be necessary to enable the Council to perform its duties, not mo...
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Authorization of appropriations There are authorized to be appropriated to carry out this title $2,200,000 for each of fiscal years 2005 and 2006. 201. Establishment and duties of Foundation (a) In general There shall be established in accordance with this section a nonprofit private corporation to be known as the N...
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The Foundation shall not be an agency or instrumentality of the Federal Government, and officers, employees, and members of the board of the Foundation shall not be officers or employees of the Federal Government. (b) Purpose of Foundation The purpose of the Foundation shall be to support and carry out activities for ...
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(c) Endowment fund (1) In general In carrying out subsection (b), the Foundation shall establish a fund for providing endowments for positions that are associated with the Congressional Council on Childhood Obesity and the Department of Health and Human Services (referred to in this title as the Department ) and dedi...
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Subject to subsection (g)(1)(B), the fund shall consist of such donations as may be provided by non-Federal entities and such non-Federal assets of the Foundation (including earnings of the Foundation and the fund) as the Foundation may elect to transfer to the fund. (2) Authorized expenditures of fund The provision o...
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Such endowments may be expended only for the compensation of individuals holding the positions, for staff, equipment, quarters, travel, and other expenditures that are appropriate in supporting the positions, and for recruiting individuals to hold the positions endowed by the fund. (d) Certain activities of Foundation ...
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(2) Create a website to assist in the distribution of successful plans, best practices, and other information to assist elementary schools, middle schools, and the public to develop and implement efforts to reduce and prevent childhood obesity. (3) Participate in meetings, conferences, courses, and training workshops. ...
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(6) Other activities to carry out the purpose described in subsection (b). (e) Challenge awards (1) Program authorized The Foundation may provide Challenge awards to elementary schools, middle schools, and local educational agencies that submit applications under paragraph (2). (2) Application Each elementary school...
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(3) Selection criteria In the program authorized under paragraph (1), the Foundation shall provide Challenge awards based on— (A) the success of the plans of the elementary schools, middle schools, and local educational agencies in meeting the plans’ stated goals; (B) the number of children in the community served by ...
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(f) General structure of foundation; nonprofit status (1) Board of directors The Foundation shall have a board of directors (referred to in this title as the Board ), which shall be established and conducted in accordance with subsection (g). The Board shall establish the general policies of the Foundation for carryi...
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(2) Executive Director The Foundation shall have an executive director (referred to in this title as the Director ), who shall be appointed by the Board, who shall serve at the pleasure of the Board, and for whom the Board shall establish the rate of compensation. Subject to compliance with the policies and bylaws est...
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(3) Nonprofit status In carrying out subsection (b), the Board shall establish such policies and bylaws under paragraph (1), and the Director shall carry out such activities under paragraph (2), as may be necessary to ensure that the Foundation maintains status as an organization that— (A) is described in subsection (...
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(g) Board of directors (1) Certain bylaws (A) Inclusions In establishing bylaws under subsection (f)(1), the Board shall ensure that the bylaws of the Foundation include bylaws for the following: (i) Policies for the selection of the officers, employees, agents, and contractors of the Foundation. (ii) Policies, incl...
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(iv) Policies for writing, editing, printing, and publishing of books and other materials, and the acquisition of patents and licenses for devices and procedures developed by the Foundation.
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(B) Exclusions In establishing bylaws under subsection (f)(1), the Board shall ensure that the bylaws of the Foundation (and activities carried out under the bylaws) do not— (i) reflect unfavorably upon the ability of the Foundation, or the Department, to carry out its responsibilities or official duties in a fair and...
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(2) Composition (A) In general Subject to subparagraph (B), the Board shall be composed of 7 individuals, appointed in accordance with paragraph (4), who collectively possess education or experience appropriate for representing the fields of children’s health, nutrition, and physical fitness or organizations active i...
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(3) Chairperson The Board shall, from among the members of the Board, designate an individual to serve as the Chairperson of the Board (referred to in this subsection as the Chairperson ). (4) Appointments, vacancies, and terms Subject to subsection (k) (regarding the initial membership of the Board), the following s...
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Any such vacancy shall be filled not later than the expiration of the 180-day period beginning on the date on which the vacancy occurs. (B) The term of office of each member of the Board appointed under subparagraph (A) shall be 5 years. A member of the Board may continue to serve after the expiration of the term of th...
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If a member of the Board does not serve the full term applicable under subparagraph (B), the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual. (5) Compensation Members of the Board may not receive compensation for service on the Bo...
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(h) Certain responsibilities of executive Director In carrying out subsection (f)(2), the Director shall carry out the following functions: (1) Hire, promote, compensate, and discharge officers and employees of the Foundation, and define the duties of the officers and employees. (2) Accept and administer donations to ...
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(5) Take such action as may be necessary to acquire patents and licenses for devices and procedures developed by the Foundation and the employees of the Foundation. (6) Adopt, alter, and use a corporate seal, which shall be judicially noticed. (7) Commence and respond to judicial proceedings in the name of the Foundati...
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(i) General provisions (1) Authority for accepting funds The Secretary of Health and Human Services (referred to in this title as the Secretary ) may accept and utilize, on behalf of the Federal Government, any gift, donation, bequest, or devise of real or personal property from the Foundation for the purpose of aidi...
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(2) Authority for acceptance of voluntary services (A) In general The Secretary may accept, on behalf of the Federal Government, any voluntary services provided to the Department by the Foundation for the purpose of aiding or facilitating the work of the Department. In the case of an individual, the Secretary may acc...
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(B) Non-federal government employees The limitation established in subparagraph (A) regarding the period of time in which services may be accepted applies to each individual who is not an employee of the Federal Government and who serves in association with the Department pursuant to financial support from the Foundat...
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(4) Applicability of certain standards to non-federal employees In the case of any individual who is not an employee of the Federal Government and who serves in association with the Department pursuant to financial support from the Foundation, the Foundation shall negotiate a memorandum of understanding with the indiv...
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), and the Federal Technology Transfer Act of 1986 ( Public Law 99–502 ; 100 Stat. 1785); and (B) shall be subject to such ethical and procedural standards under chapter 11 of title 18, United States Code (relating to conflicts of interest), as the Secretary determines is appropriate, except such memorandum may not pro...
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(5) Financial conflicts of interest Any individual who is an officer, employee, or member of the Board may not directly or indirectly participate in the consideration or determination by the Foundation of any question affecting— (A) any direct or indirect financial interest of the individual; or (B) any direct or indi...
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(6) Audits; availability of records The Foundation shall— (A) provide for biennial audits of the financial condition of the Foundation; and (B) make such audits, and all other records, documents, and other papers of the Foundation, available to the Secretary and the Comptroller General of the United States for examina...
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Each such report shall include for the fiscal year involved a comprehensive statement of the operations, activities, financial condition, and accomplishments of the Foundation. (B) Inclusions With respect to the financial condition of the Foundation, each report under subparagraph (A) shall include the source, and a d...
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(C) Public inspection The Foundation shall make copies of each report submitted under subparagraph (A) available for public inspection, and shall upon request provide a copy of the report to any individual for a charge not exceeding the cost of providing the copy. (8) Liaisons The Secretary shall appoint liaisons to ...
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(9) Inclusion of the President’s Council The Foundation shall ensure that the President’s Council on Physical Fitness is included in the activities of the Foundation.
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(j) Federal funding (1) Authority for annual grants (A) In general The Secretary shall— (i) for fiscal year 2005, make a grant to an entity described in subsection (k)(9) (relating to the establishment of a committee to establish the Foundation); (ii) for fiscal years 2006 and 2007, make a grant to the committee est...
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(B) Rules on expenditures A grant under subparagraph (A) may be expended— (i) in the case of an entity receiving the grant under subparagraph (A)(i), only for the purpose of carrying out the duties established in subsection (k)(9) for the entity; (ii) in the case of the committee established under subsection (k)(9), o...
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(C) Restriction A grant under subparagraph (A) may not be expended to provide amounts for the fund established under subsection (c). (D) Unobligated grant funds For the purposes described in subparagraph (B)— (i) any portion of the grant made under subparagraph (A)(i) for fiscal year 2005 that remains unobligated aft...
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and (ii) any portion of a grant under subparagraph (A) made for fiscal year 2005 or 2006 that remains unobligated after such committee completes the duties established in such subsection for the committee shall be available to the Foundation. (2) Funding for grants (A) In general For the purpose of grants under parag...
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(B) Programs of the Department For the purpose of grants under paragraph (1), the Secretary may for each fiscal year make available not more than $2,200,000 from the amounts appropriated for the fiscal year for the programs of the Department. Such amounts may be made available without regard to whether amounts have be...
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(3) Certain restriction If the Foundation receives Federal funds for the purpose of serving as a fiscal intermediary between Federal agencies, the Foundation may not receive such funds for the indirect costs of carrying out such purpose in an amount exceeding 10 percent of the direct costs of carrying out such purpose...
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(k) Committee for establishment of Foundation (1) In general There shall be established, in accordance with this subsection and subsection (j)(1), a committee to carry out the functions described in paragraph (2) (referred to in this subsection as the Committee ). (2) Functions The functions referred to in paragraph...
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Such activities shall include ensuring that the articles of incorporation for the Foundation require that the Foundation be established and operated in accordance with the applicable provisions of this title (or any successor to this title), including such provisions as may be in effect pursuant to amendments enacted a...
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(D) To provide for the initial operation of the Foundation, including providing for quarters, equipment, and staff. (E) To appoint the initial members of the Board in accordance with the requirements established in subsection (g)(2)(A) for the composition of the Board, and in accordance with such other qualifications a...
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Of the members so appointed— (i) 2 shall be appointed to serve for a term of 3 years; (ii) 2 shall be appointed to serve for a term of 4 years; and (iii) 3 shall be appointed to serve for a term of 5 years. (3) Completion of functions of committee; initial meeting of Board (A) Completion of functions The Committee sh...
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The Committee shall terminate upon the expiration of the 30-day period beginning on the date on which the Secretary determines that the functions have been completed. (B) Initial meeting The initial meeting of the Board shall be held not later than November 1, 2007. (4) Composition The Committee shall be composed of ...
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Of the members of the Committee— (A) no fewer than 2 of the members shall have expertise in children’s health, nutrition, and physical activity; and (B) no fewer than 2 of the members shall have broad, general experience in nonprofit private organizations (without regard to whether the individuals have experience in ch...
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(6) Terms; vacancies The term of members of the Committee shall be for the duration of the Committee. A vacancy in the membership of the Committee shall not affect the power of the Committee to carry out the duties of the Committee. If a member of the Committee does not serve the full term, the individual appointed by...
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Members of the Committee may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the Committee. (8) Committee support The Secretary may, from amounts available to the Secretary for the general administration of the Department, provide staff and financial support t...
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(9) Grant for establishment of Committee (A) In general With respect to a grant under paragraph (1)(A)(i) of subsection (j) for fiscal year 2005, an entity described in this paragraph is a private nonprofit entity with significant experience in children’s health, nutrition, and physical activity. Not later than 180 d...
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(B) Conditions The grant referred to in subparagraph (A) may be made to an entity only if the entity agrees that— (i) the entity will establish a committee that is composed in accordance with paragraph (4); and (ii) the entity will not select an individual for membership on the Committee unless the individual agrees t...
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(C) Agreement The Secretary may make a grant referred to in subparagraph (A) only if the applicant for the grant makes an agreement that the grant will not be expended for any purpose other than carrying out subparagraph (B). Such a grant may be made only if an application for the grant is submitted to the Secretary c...
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1. Short title This Act may be cited as the Services for Ending Long-Term Homelessness Act. 2. Duties of Center for Mental Health Services Section 520(b) of the Public Health Service Act ( 42 U.S.C. 290bb–31(b) ) is amended— (1) in paragraph (14), by striking and at the end; (2) in paragraph (15), by striking the per...
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and (3) by adding at the end the following: (16) administer the program under part J in consultation with the Director of the Center for Substance Abuse Treatment; (17) provide technical assistance, in consultation with the Director of the Center for Substance Abuse Treatment, to public and private entities that are pr...
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toolkits, and registries of promising practices. 3. Duties of Administrator of Substance Abuse and Mental Health Services Administration Section 501(d) of the Public Health Service Act ( 42 U.S.C. 290aa(d) ) is amended— (1) in paragraph (17), by striking and at the end; (2) in paragraph (18), by striking the period an...
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(20) collaborate with Federal departments and programs that are part of the President’s Interagency Council on Homelessness, particularly the Department of Housing and Urban Development, the Department of Labor, and the Department of Veterans Affairs, and with other agencies within the Department of Health and Human Se...
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(22) promote collaboration between Federal, State and local agencies that are responsible for criminal justice, mental health, substance abuse treatment, medical care, employment training, and other systems of care that serve individuals who are chronically homeless to ensure that services are delivered in a coordinate...
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and recommend to the Office of Management and Budget a consistent set of performance standards for these programs consistent with the requirements of the Government Performance and Results Act. 4. Grants for services for chronically homeless individuals in supportive housing Title V of the Public Health Service Act ( ...
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Grants for services to end chronic homelessness (a) In general (1) Grants The Secretary shall make grants to entities described in paragraph (2) for the purpose of carrying out projects to provide the services described in subsection (c) to chronically homeless individuals in permanent supportive housing.
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(2) Eligible entities For purposes of paragraph (1), an entity described in this paragraph is— (A) a State or political subdivision of a State, an Indian tribe or tribal organization, or a public or nonprofit private entity, including a community-based or faith-based provider of homelessness services, health care, hou...