42 U.S.C. § 287a — Cures Acceleration Network

Page 778 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 287a 1 So in original. A closing parenthesis probably should precede the comma. 2 See References in Text note below. Subsec. (c). Pub. L. 114–255, § 2042(e), substituted ‘‘Bi- ennial’’ for ‘‘Annual’’ in heading and ‘‘a report on a bi- ennial basis’’ for ‘‘an annual report’’ in introductory provisions. Subsec. (c)(6), (7). Pub. L. 114–255, § 2037(b)(1), added pars. (6) and (7). Subsecs. (d), (e). Pub. L. 114–255, § 2037(b)(2), added subsecs. (d) and (e). 2011—Pub. L. 112–74 amended section generally. Prior to amendment, text read as follows: ‘‘The general pur- pose of the National Center for Research Resources (in this subpart referred to as the ‘Center’) is to strengthen and enhance the research environments of entities en- gaged in health-related research by developing and sup- porting essential research resources.’’ 1993—Pub. L. 103–43 substituted ‘‘the National Center for Research Resources (in this subpart referred to as the ‘Center’)’’ for ‘‘the Division of Research Re- sources’’. Statutory Notes and Related Subsidiaries SHARED INSTRUMENTATION GRANT PROGRAM Pub. L. 106–505, title III, § 305, Nov. 13, 2000, 114 Stat. 2335, which was formerly set out as a note under this section, was renumbered section 404L of act July 1, 1944, ch. 373, the Public Health Service Act, by Pub. L. 112–74, div. F, title II, § 221(b)(4)(A), Dec. 23, 2011, 125 Stat. 1088, and is classified to section 283n of this title. § 287a. Cures Acceleration Network (a) Definitions In this section: (1) Biological product The term ‘‘biological product’’ has the meaning given such term in section 262 of this title. (2) Drug; device The terms ‘‘drug’’ and ‘‘device’’ have the meanings given such terms in section 321 of title 21. (3) High need cure The term ‘‘high need cure’’ means a drug (as that term is defined by section 321(g)(1) of title 21,1 biological product (as that term is defined by section 262(i) 2 of this title), or device (as that term is defined by section 321(h) of title 21) that, in the determination of the Director of the Center— (A) is a priority to diagnose, mitigate, pre- vent, or treat harm from any disease or con- dition; and (B) for which the incentives of the com- mercial 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 Net- work Subject to the appropriation of funds as de- scribed in subsection (g), there is established within the Center 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 the Center, taking into account the rec- ommendations of a CAN Review Board (re- ferred to in this section as the ‘‘Board’’), de- scribed in subsection (d); and (2) award grants and contracts to eligible en- tities, as described in subsection (e), to accel- erate the development of high need cures, in- cluding through the development of medical products and behavioral therapies. (c) Functions The functions of the CAN are to— (1) conduct and support revolutionary ad- vances in basic research, translating scientific discoveries from bench to bedside; (2) award grants and contracts to eligible en- tities to accelerate the development of high need cures; (3) provide the resources necessary for gov- ernment agencies, independent investigators, research organizations, biotechnology compa- nies, academic research institutions, and other entities to develop high need cures; (4) reduce the barriers between laboratory discoveries and clinical trials for new thera- pies; and (5) facilitate review in the Food and Drug Administration for the high need cures funded by the CAN, through activities that may in- clude— (A) the facilitation of regular and ongoing communication with the Food and Drug Ad- ministration regarding the status of activi- ties conducted under this section; (B) ensuring that such activities are co- ordinated with the approval requirements of the Food and Drug Administration, with the goal of expediting the development and ap- proval of countermeasures and products; and (C) connecting interested persons with ad- ditional technical assistance made available under section 360bbb–4 of title 21. (d) CAN Board (1) Establishment There is established a Cures Acceleration Network Review Board (referred to in this sec- tion as the ‘‘Board’’), which shall advise the Director of the Center 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 mem- bers who are appointed by the Secretary and who serve at the pleasure of the Sec- retary. (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 ‘‘Chair- person’’) and one Vice Chairperson. (B) Terms (i) In general Each member shall be appointed to serve a 4-year term, except that any member ap- Page 779 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 287a pointed 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 consecu- tively. (C) Qualifications (i) In general The Secretary shall appoint individuals to the Board based solely upon the individ- ual’s established record of distinguished service in one of the areas of expertise de- scribed in clause (ii). Each individual ap- pointed to the Board shall be of distin- guished 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 med- ical 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 indi- vidual who is eminent in such fields. (II) At least 4 individuals shall be rec- ognized leaders in professional venture capital or private equity organizations and have demonstrated experience in pri- vate equity investing. (III) At least 8 individuals shall rep- resent disease advocacy organizations. (3) Ex-officio members (A) Appointment In addition to the 24 Board members de- scribed in paragraph (2), the Secretary shall appoint as ex-officio members of the Board— (i) a representative of the National Insti- tutes of Health, recommended by the Sec- retary 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 Vet- erans Health Administration, rec- ommended 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 ini- tial ex-officio members in order to provide for a staggered term of appointment for all such members. (4) Responsibilities of the Board and the Direc- tor of the Center (A) Responsibilities of the Board (i) In general The Board shall advise, and provide rec- ommendations to, the Director of the Cen- ter with respect to— (I) policies, programs, and procedures for carrying out the duties of the Direc- tor 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 depart- ments). (ii) Report In the case that the Board identifies a significant barrier, as described in clause (i)(II), the Board shall submit to the Sec- retary a report regarding such barrier. (B) Responsibilities of the Director of the Center With respect to each recommendation pro- vided by the Board under subparagraph (A)(i), the Director of the Center shall re- spond in writing to the Board, indicating whether such Director will implement such recommendation. In the case that the Direc- tor of the Center indicates a recommenda- tion 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 representation as described in clause (iii). (ii) Chairperson or Vice Chairperson Each meeting of the Board shall be at- tended 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 orga- nization, and one representative of a pro- fessional 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 Page 780 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 287a 3 So in original. Section 5703 of title 5 does not contain a sub- sec. (b). to exceed a rate equal to the daily equiva- lent of the annual rate of basic pay pre- scribed for level IV of the Executive Sched- ule under section 5315 of title 5 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 compensa- tion 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) 3 of title 5, while away from their homes or regular places of business in the performance 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 contracts, grants, or cooperative agreements to the entities described in paragraph (2), to— (A) promote innovation in technologies supporting the advanced research and devel- opment and production of high need cures, including through the development of med- ical products and behavioral therapies. (B) accelerate the development of high need cures, including through the develop- ment of medical products, behavioral thera- pies, and biomarkers that demonstrate the safety or effectiveness of medical products; or (C) help the award recipient establish pro- tocols that comply with Food and Drug Ad- ministration standards and otherwise permit the recipient to meet regulatory require- ments at all stages of development, manu- facturing, review, approval, and safety sur- veillance 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 in- stitution, an institution of higher education, a medical center, a biotechnology company, a pharmaceutical company, a disease advo- cacy organization, a patient advocacy orga- nization, or an academic research institu- tion; (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 enti- ty’s— (aa) progress in carrying out the project; and (bb) compliance with all provisions of this section and conditions of re- ceipt of such grant or contract; and (II) a final report at the conclusion of the grant period, describing the out- comes of the project; and (iv) a description of the protocols the en- tity will follow to comply with Food and Drug Administration standards and regu- latory requirements at all stages of devel- opment, manufacturing, review, approval, and safety surveillance of a medical prod- uct; 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 pay- able 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 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 fis- cal 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 requirement in any case where the Director determines that the goals and objectives of this sec- tion cannot adequately be carried out un- less 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 pay- able 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 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 fis- cal year subsequent to the initial award under clause (i). Page 781 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 287a–1 (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 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 sub- section (g)(1) for such fiscal year. (4) Suspension of awards for defaults, non- compliance with provisions and plans, and diversion of funds; repayment of funds The Director of the Center may 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 the Center may enter into agreements with other entities to conduct periodic audits of the projects funded by grants or contracts awarded under this sub- section. (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 the Cen- ter 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 judi- cial 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 appro- priated No funds appropriated under this chapter, other than funds appropriated under para- graph (1), may be allocated to the Cures Accel- eration Network. (July 1, 1944, ch. 373, title IV, § 480, formerly § 402C, as added Pub. L. 111–148, title X, § 10409(d), Mar. 23, 2010, 124 Stat. 978; renumbered § 480 and amended Pub. L. 112–74, div. F, title II, § 221(c)(1), Dec. 23, 2011, 125 Stat. 1089.) Editorial Notes REFERENCES IN TEXT Section 262(i) of this title, referred to in subsec. (a)(3), was in the original ‘‘section 262(i)’’, and was translated as meaning section 351(i) of act July 1, 1944, ch. 373, to reflect the probable intent of Congress. CODIFICATION Section was formerly classified to section 282d of this title. PRIOR PROVISIONS A prior section 287a, July 1, 1944, ch. 373, title IV, § 480, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 864; amended Pub. L. 101–381, title I, § 102(3), Aug. 18, 1990, 104 Stat. 586; Pub. L. 102–405, title III, § 302(e)(1), Oct. 9, 1992, 106 Stat. 1985; Pub. L. 103–43, title XV, § 1501(2)(C), (D), title XX, §§ 2008(b)(12), 2010(b)(4), June 10, 1993, 107 Stat. 172, 173, 211, 214, related to the advi- sory council for the National Center for Research Re- sources, prior to repeal by Pub. L. 112–74, div. F, title II, § 221(a)(1)(B), Dec. 23, 2011, 125 Stat. 1086. AMENDMENTS 2011—Pub. L. 112–74, § 221(c)(1)(C), substituted ‘‘Direc- tor of the Center’’ for ‘‘Director of NIH’’ wherever ap- pearing. Subsec. (b). Pub. L. 112–74, § 221(c)(1)(B), substituted ‘‘within the Center’’ for ‘‘within the Office of the Direc- tor of NIH’’ in introductory provisions. Subsec. (d)(4). Pub. L. 112–74, § 221(c)(1)(D), substituted ‘‘Director of the Center’’ for ‘‘Director of NIH’’ in head- ing. Subsec. (d)(4)(B). Pub. L. 112–74, § 221(c)(1)(D), sub- stituted ‘‘Director of the Center’’ for ‘‘Director of NIH’’ in heading. § 287a–1. Office of Rare Diseases (a) Establishment There is established within the Center an of- fice to be known as the Office of Rare Diseases (in this section referred to as the ‘‘Office’’), which shall be headed by a Director (in this sec- tion referred to as the ‘‘Director’’), appointed by the Director of the Center. (b) Duties (1) In general The Director of the Office shall carry out the following: (A) The Director shall recommend an agenda for conducting and supporting re- search on rare diseases through the national research institutes and centers. The agenda shall provide for a broad range of research and education activities, including scientific workshops and symposia to identify research opportunities for rare diseases. (B) The Director shall, with respect to rare diseases, promote coordination and coopera- tion among the national research institutes and centers and entities whose research is supported by such institutes. (C) The Director, in collaboration with the directors of the other relevant institutes and centers of the National Institutes of Health, may enter into cooperative agreements with and make grants for regional centers of ex- cellence on rare diseases in accordance with section 287a–2 of this title. (D) The Director shall promote the suffi- cient allocation of the resources of the Na- tional Institutes of Health for conducting and supporting research on rare diseases. (E) The Director shall promote and en- courage the establishment of a centralized clearinghouse for rare and genetic disease