Appendix B

Public Health Service Act, Title IV—National Institutes of Health

Part E—Other Agencies of NIH

Subpart 1 National Center for Advancing Translational Sciences

SEC. 480. CURES ACCELERATION NETWORK.

(a) Definitions- In this section:

(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 the Center--

(A) is a priority to diagnose, mitigate, prevent, or treat harm from any disease or condition; and

(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.



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Appendix B Public Health Service Act, Title IV--National Institutes of Health Part E--Other Agencies of NIH Subpart 1 National Center for Advancing Translational Sciences SEC. 480. CURES ACCELERATION NETWORK. (a) Definitions- In this section: (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 mean- ings 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 the Center-- (A) is a priority to diagnose, mitigate, prevent, or treat harm from any disease or condition; and (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. 87

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88 MAXIMIZING THE IMPACT OF THE CURES ACCELERATION NETWORK (b) Establishment of the Cures Acceleration Network.--Subject to the appropriation of funds as described in subsection (g), there is estab- lished within the Center a program to be known as the Cures Accelera- tion Network (referred to in this section as `CAN'), which shall-- (1) be under the direction of the Director of the Center, 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, includ- ing through the development of 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, inde- pendent 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 the approval requirements of the Food and Drug Administration, with the goal of expediting the development and approval of counter- measures 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 the Center on the conduct of the activities of the Cures Acceleration Network.

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APPENDIX B 89 (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 Sec- retary 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 Secretary shall appoint individu- als 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; (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 organiza- tions and have demonstrated experience in private equity investing.

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90 MAXIMIZING THE IMPACT OF THE CURES ACCELERATION NETWORK (III) At least 8 individuals shall represent disease advo- cacy 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 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 THE CENTER - (A) RESPONSIBILITIES OF THE BOARD- (i) IN GENERAL- The Board shall advise, and provide rec- ommendations to, the Director of the Center with respect to-- (I) policies, programs, and procedures for carrying out the duties of the Director of the Center under this section; and (II) significant barriers to successful translation of basic science into clinical application (including issues under the purview of other agencies and departments). (ii) REPORT- In the case that the Board identifies a signifi- cant 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 THE CENTER - With respect to each recommendation provided by the Board under subparagraph (A)(i), the Director of the Center shall respond in writing to the Board, indicating whether such Director will imple- ment such recommendation. In the case that the Director of the Center indicates a recommendation of the Board will not be imple-

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APPENDIX B 91 mented, 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 mem- bers of the Board, excluding ex-officio members, with diverse representation as described in clause (iii). (ii) CHAIRPERSON OR VICE CHAIRPERSON- Each meet- ing 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 representa- tive 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 member is engaged in the performance of the duties of the Board. All members of the Board who are officers or employees of the United 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 Gov- ernment under section 5703(b) of title 5, United States Code, while away from their homes or regular places of business in the perfor- mance of services for the Board. (e) Grant Program- (1) SUPPORTING INNOVATION- To carry out the purposes described in this section, the Director of the Center shall award con- tracts, 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.

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92 MAXIMIZING THE IMPACT OF THE CURES ACCELERATION NETWORK (B) accelerate the development of high need cures, including through the development of medical products, behavioral thera- pies, 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 per- mit the recipient to meet regulatory requirements at all stages of development, manufacturing, review, approval, and safety surveil- lance 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 com- pany, a disease advocacy organization, a patient advocacy organiza- tion, 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, manufac- turing, review, approval, and safety surveillance of a medical product; and (C) provide such additional information as the Director of the Center may require. (3) 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. (ii) FUNDING IN SUBSEQUENT FISCAL YEARS- An eli- gible entity receiving an award under clause (i) may apply for additional funding for such project by submitting to the Direc-

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APPENDIX B 93 tor of the Center the information required under subparagraphs (B) and (C) of paragraph (2). The Director 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 awarded under clauses (i) and (ii), except that the Director of the Center may waive or modify such matching require- ment 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 eli- gible 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 (2). The Director of the Center 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 the Center determines that the goals and objectives of this section cannot adequately be carried out through a contract, grant, or cooperative agreement, the Director of the Center shall have flexible research authority to use other trans- actions 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 appro- priated under subsection (g)(1) for such fiscal year. (4) SUSPENSION OF AWARDS FOR DEFAULTS, NONCOMPLI- ANCE WITH PROVISIONS AND PLANS, AND DIVERSION OF FUNDS; REPAYMENT OF FUNDS- The Director of the Center may sus- pend 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 the Center 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 sec-

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94 MAXIMIZING THE IMPACT OF THE CURES ACCELERATION NETWORK tion 74.71 of title 45, Code of Federal Regulations (or any successor regulation). (7) REVIEW- A determination by the Director of the Center as to 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 are authorized to be 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 APPROPRI- ATED- No funds appropriated under this Act, other than funds appro- priated under paragraph (1), may be allocated to the Cures Acceleration Network.