[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 914 Introduced in Senate (IS)]

111th CONGRESS
  1st Session
                                 S. 914

   To establish an independent Cures Acceleration Network agency, to 
  sponsor promising translational research to bridge the gap between 
 laboratory discoveries and life-saving therapies, to reauthorize the 
         National Institutes of Health, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 28, 2009

  Mr. Specter introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To establish an independent Cures Acceleration Network agency, to 
  sponsor promising translational research to bridge the gap between 
 laboratory discoveries and life-saving therapies, to reauthorize the 
         National Institutes of Health, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Cures Acceleration Network and 
National Institutes of Health Reauthorization Act of 2009''.

SEC. 2. CURES ACCELERATION NETWORK.

    (a) Definitions.--In this section--
            (1) the term ``medical product'' means a drug, device, 
        biological product, or product that is a combination of drugs, 
        devices, and biological products;
            (2) the terms ``drug'' and ``device'' have the meanings 
        given such terms in section 201 of the Federal Food, Drug, and 
        Cosmetic Act; and
            (3) the term ``biological product'' has the meaning given 
        such term in section 351 of the Public Health Service Act.
    (b) Establishment of the Cures Acceleration Network.--There is 
established an independent agency to be known as the Cures Acceleration 
Network (referred to in this section as ``CAN''), which shall--
            (1) be under the direction 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 
        cures and treatments of diseases, including through the 
        development of medical products and behavioral therapies.
    (c) Functions.--The functions of the CAN are to--
            (1) identify and promote revolutionary advances in basic 
        research, translating scientific discoveries from bench to 
        bedside;
            (2) award grants and contracts to eligible entities;
            (3) provide the resources through grants and contracts 
        necessary for independent investigators, research 
        organizations, biotechnology companies, academic research 
        institutions, and other entities to develop medical products 
        for the treatment and cure of diseases and disorders;
            (4) reduce the barriers between laboratory discoveries and 
        clinical trials for new therapies;
            (5) facilitate priority review in the Food and Drug 
        Administration for the medical products funded by the CAN; and
            (6) accept donations, bequests, and gifts to the CAN.
    (d) CAN Board.--
            (1) Establishment.--There is established a Cures 
        Acceleration Network Review Board (referred to in this section 
        as the ``Board''), which shall direct 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 President and who serve at the pleasure of 
                        the President.
                            (ii) Chairperson and vice chairperson.--The 
                        President, by and with the advice and consent 
                        of the Senate, 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.--
                            (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 President 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 President shall select 
                        individuals based upon the following 
                        requirements:
                                    (I) For each of the fields of--
                                            (aa) basic research;
                                            (bb) medicine;
                                            (cc) biopharmaceuticals;
                                            (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 President 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 President 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 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.--The Board shall--
                    (A) advise the Chairperson with respect to 
                policies, programs, and procedures for carrying out the 
                Chairperson's duties; and
                    (B) review applications for grants and contracts 
                under subsection (e) and make recommendations to the 
                Chairperson.
            (5) Authority of the chairperson.--The Chairperson may--
                    (A) prescribe regulations regarding the manner in 
                which the Chairperson's duties shall be carried out, as 
                the Chairperson determines necessary;
                    (B) appoint employees, subject to civil service 
                laws, as necessary to carry out the Chairperson's 
                functions;
                    (C) define the duties, and supervise and direct the 
                activities, of any employees appointed under 
                subparagraph (B);
                    (D) use experts and consultants, including a panel 
                of experts who may be employed as authorized by section 
                3109 of title 5, United States Code;
                    (E) accept and utilize the services of voluntary 
                and uncompensated personnel and reimburse such 
                personnel for travel expenses, as described in 
                paragraph (7)(B);
                    (F) make advance, progress, or other payments 
                without regard to section 3324 of title 31, United 
                States Code;
                    (G) rent office space in the District of Columbia 
                for use by the CAN;
                    (H) enter into agreements with other Federal 
                agencies to carry out oversight of the grant program 
                under subsection (e), which agreements may include 
                provisions for financial reimbursement for the 
                oversight provided by such agencies; and
                    (I) make other necessary expenditures.
            (6) 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 representation as 
                        described in clause (iv).
                            (ii) Chairperson or vice chairperson.--Each 
                        meeting of the Board shall be attended by 
                        either the Chairperson or the Vice Chairperson.
                            (iii) Limitation.--No member or ex-officio 
                        member of the Board may attend more than 2 
                        meetings of the Board each calendar year with 
                        the exceptions of the Chairperson and Vice 
                        Chairperson, who may attend all such meetings.
                            (iv) 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.
            (7) 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 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.--
            (1) Grants and contracts.--The Chairperson shall, through 
        the Board of the CAN, award grants and contracts to eligible 
        entities to assist such entities in carrying out projects 
        described in paragraph (3).
            (2) Award process.--The Chairperson of the Board may award 
        a grant or contract under this subsection to an eligible entity 
        only upon the approval of a majority of a quorum of the Board.
            (3) Use of funds.--Funds awarded under this subsection 
        shall be used--
                    (A) to accelerate the development of cures and 
                treatments, including through the development of 
                medical products, behavioral therapies, and biomarkers 
                that demonstrate the safety or effectiveness of medical 
                products; or
                    (B) to help the award recipient establish protocols 
                that comply with Food and Drug Administration standards 
                and otherwise permit the recipient to meet regulatory 
                requirements at all stages of development, 
                manufacturing, review, approval, and safety 
                surveillance of a medical product.
            (4) Eligible entities.--To receive a grant or contract 
        under this subsection, an entity shall--
                    (A) be--
                            (i) an individual;
                            (ii) a group of individuals; or
                            (iii) 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 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 
                Chairperson may require.
            (5) Study sections of the center for scientific review.--
                    (A) In general.--The Chairperson may enter into an 
                interagency agreement with the Center for Scientific 
                Review within the National Institutes of Health to use 
                the study sections of such Center to review 
                applications submitted under paragraphs (4)(B) and 
                additional information submitted under (4)(C) and to 
                make recommendations to the Board. The Chairperson 
                shall promulgate regulations and procedures to--
                            (i) ensure that each study section 
                        reviewing applications is composed of diverse 
                        members, as described in subparagraph (B);
                            (ii) require such study sections to create 
                        written records summarizing--
                                    (I) all meetings and discussions of 
                                the study section; and
                                    (II) the recommendations made by 
                                such study section to the Board; and
                            (iii) make the records described in clause 
                        (ii) available to the public in a manner that 
                        protects the privacy of applicants and panel 
                        members and any proprietary information from 
                        applicants.
                    (B) Membership.--The Chairperson shall ensure that 
                the study sections of the Center for Scientific Review 
                that review applications submitted under this 
                subsection are selected solely on the basis of 
                established records of distinguished service and 
                include--
                            (i) for each of the fields of--
                                    (I) basic research;
                                    (II) medicine;
                                    (III) biopharmaceuticals;
                                    (IV) discovery and delivery of 
                                medical products;
                                    (V) bioinformatics and gene 
                                therapy; and
                                    (VI) medical instrumentation,
                        at least 2 individuals with expertise in such 
                        fields;
                            (ii) at least 3 representatives of 
                        professional venture capital or private equity 
                        organizations with demonstrated experience in 
                        private equity investing; and
                            (iii) at least 3 representatives of disease 
                        advocacy organizations.
                    (C) Financial compensation.--Any agreement under 
                subparagraph (A) shall include an arrangement whereby 
                the Chairperson reimburses the Center for Scientific 
                Review for the services provided under such 
                subparagraph.
            (6) Awards.--
                    (A) The cures acceleration partnership 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, except that 
                        the Chairperson of the Board may increase the 
                        award amount for an eligible entity if the 
                        Board so determines by a majority vote.
                            (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 paragraph (4). The Chairperson 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) if the Board so determines by 
                        majority vote.
                            (iii) Matching funds.--As a condition for 
                        receiving a grant or contract under this 
                        subparagraph, an eligible entity shall 
                        contribute to the project non-Federal funds in 
                        the amount of $1 for every $3 awarded under 
                        clauses (i) and (ii), except that the 
                        Chairperson may waive or modify such matching 
                        requirement by a majority vote of the Board.
                    (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, except that 
                        the Chairperson of the Board may increase the 
                        award amount for an eligible entity if the 
                        Board so determines by a majority vote.
                            (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 paragraph (4). The Chairperson 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) if the Board so determines by 
                        majority vote.
            (7) Suspension of awards for defaults, noncompliance with 
        provisions and plans, and diversion of funds; repayment of 
        funds.--The Chairperson may suspend the award to any entity 
        upon noncompliance by such entity with provisions and plans 
        under this section or diversion of funds.
            (8) Audits.--The Chairperson may enter into agreements with 
        other entities to conduct periodic audits of the projects 
        funded by grants or contracts awarded under this subsection.
            (9) 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).
    (f) Staff.--The CAN may employ such officers and employees 
(including experts and consultants), appointed by the Chairperson, as 
may be necessary to enable the CAN to carry out its functions under 
this section, and may employ and fix the compensation of such officers 
and employees.
    (g) Gifts, Bequests, and Devises.--
            (1) In general.--The CAN may accept donations, bequests, 
        and devises, with or without conditions, and transfers for tax 
        purposes, for the purpose of aiding or facilitating the work of 
        the CAN subject to the following:
                    (A) In any case in which money or other property is 
                donated, bequeathed, or devised to the CAN without 
                designation for the benefit of which such property is 
                intended, and without condition or restriction other 
                than that such property be used for the purposes of the 
                CAN, such property shall be deemed to have been 
                donated, bequeathed, or devised to the CAN and the 
                Chairperson shall have authority to receive such 
                property.
                    (B) In any case in which any money or other 
                property is donated, bequeathed, or devised to the CAN 
                with a condition or restriction, such property shall be 
                deemed to have been donated, bequeathed, or devised to 
                the CAN whose function it is to carry out the purpose 
                or purposes described, or referred to, by the terms of 
                such condition or restriction, and the Chairperson 
                shall have authority to receive such property.
                    (C) For the purposes of subparagraph (B), if one or 
                more of the purposes of such a condition or restriction 
                is covered by the functions of the CAN, or if some of 
                the purposes of such a condition or restriction are 
                covered by the CAN, the Board shall determine an 
                equitable manner for distribution by the CAN of the 
                property so donated, bequeathed, or devised.
                    (D) For the purpose of Federal income tax, gift 
                tax, and estate tax laws, any money or other property 
                donated, bequeathed, or devised to the Chairperson 
                pursuant to authority derived under this subsection 
                shall be deemed to have been donated, bequeathed, or 
                devised to, or for the use of, the United States.
    (h) Conflicts of Interest.--
            (1) In general.--The Chairperson shall develop and enforce 
        conflict of interest policies for the CAN and shall respond in 
        a timely manner when such policies have been violated by a 
        recipient of funds provided under a grant or contract awarded 
        under this section.
            (2) Information.--
                    (A) In general.--In the case in which the principal 
                investigator for a recipient described under 
                subparagraph (B) has a conflict of interest, the 
                Chairperson shall require the recipient to provide to 
                the Chairperson the following information:
                            (i) The degree of the primary 
                        investigator's financial interest, estimated to 
                        the nearest $1,000.
                            (ii) A detailed report explaining how the 
                        recipient will manage the primary 
                        investigator's conflict of interest.
                    (B) Recipient.--A recipient described in this 
                subparagraph is a recipient--
                            (i) of a grant or contract awarded under 
                        subsection (e); and
                            (ii) that receives more than $250,000 under 
                        such grant or contract.
    (i) Authorization of Appropriations.--For purposes of carrying out 
this section, there are authorized to be appropriated--
            (1) for fiscal year 2010, $1,000,000,000 for awards 
        described under subsection (e)(6)(A), including associated 
        administrative costs;
            (2) for fiscal year 2010, $1,000,000,000 for awards 
        described under subsection (e)(6)(B), including associated 
        administrative costs; and
            (3) such sums as may be necessary for subsequent fiscal 
        years.

SEC. 3. ORGANIZATION OF NATIONAL INSTITUTES OF HEALTH.

    (a) Redesignation of Center on Minority Health and Health 
Disparities.--Title IV of the Public Health Service Act (42 U.S.C. 281 
et seq.) is amended--
            (1) by redesignating subpart 6 of part E as subpart 20;
            (2) by transferring subpart 20, as so redesignated, to part 
        C of such title IV;
            (3) by inserting subpart 20, as so redesignated, after 
        subpart 19 of such part C; and
            (4) in subpart 20, as so redesignated--
                    (A) by redesignating sections 485E through 485H as 
                sections 464z-3 through 464z-6, respectively;
                    (B) 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
                    (C) by striking ``Center'' each place such term 
                appears and inserting ``Institute''.
    (b) Purpose of Institute.--Subsection (h) of section 464z-3 of the 
Public Health Service Act, as so redesignated, is amended--
            (1) in paragraph (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.''; and
            (2) in paragraph (2)(A), by striking ``average'' and 
        inserting ``median''.
    (c) Technical Amendment.--Section 401(b)(24) of the Public Health 
Service Act (42 U.S.C. 281(b)(24)) is amended by striking ``Center'' 
and inserting ``Institute''.
    (d) Conforming Amendment.--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. 4. CONFLICTS OF INTEREST.

    Section 402 of the Public Health Service Act (42 U.S.C. 282) is 
amended by adding at the end the following:
    ``(m) Enforcement of Conflict of Interest Policies.--
            ``(1) In general.--The Director shall develop and enforce 
        the conflict of interest policies for the National Institutes 
        of Health and shall respond in a timely manner when such 
        policies have been violated by a recipient of funds provided 
        under a grant or contract awarded under this title.
            ``(2) Information.--
                    ``(A) In general.--In the case in which the 
                principal investigator for a recipient described under 
                subparagraph (B) has a conflict of interest, the 
                Director shall require the recipient to provide to the 
                Director the following information:
                            ``(i) The degree of the primary 
                        investigator's financial interest, estimated to 
                        the nearest $1,000.
                            ``(ii) A detailed report explaining how the 
                        recipient will manage the primary 
                        investigator's conflict of interest.
                    ``(B) Recipient.--A recipient described in this 
                subparagraph is a recipient--
                            ``(i) of a grant or contract awarded under 
                        this title; and
                            ``(ii) that receives more than $250,000 
                        under such grant or contract.''.

SEC. 5. AUTHORIZATION OF APPROPRIATIONS.

    (a) Authorization of Appropriations.--Section 402A of the Public 
Health Service Act (42 U.S.C. 282a) is amended by striking paragraphs 
(1) through (3) of subsection (a) and inserting the following:
            ``(1) $40,000,000,000 for fiscal year 2010; and
            ``(2) such sums as may be necessary for each of fiscal 
        years 2011 and 2012.''.
    (b) Office of the Director.--Subparagraph (b) of section 402A of 
the Public Health Service Act (42 U.S.C. 282a(b)) is amended by 
striking ``2007 through 2009'' and inserting ``2010 through 2012''.
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