Page:United States Statutes at Large Volume 107 Part 1.djvu/169

 PUBLIC LAW 103-43—JUNE 10, 1993 107 STAT. 143 are consistent with such financial interest. Such definition shall apply uniformly to each entity or individual conducting a research project under this Act. In the case of any entity or individual receiving assistance from the Secretary for a project of research described in subsection (b), the Secretary shall by regulation establish standards for responding to, including managing, reducing, or eliminating, the existence of such a financial interest. The entity may adopt individualized procedures for implementing the standards. "(b) RELEVANT PROJECTS. —^A project of research referred to in subsection (a) is a project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment and for which such entity is receiving assistance from the Secretary. "(c) IDENTIFYING AND REPORTING TO SECRETARY.—The Secretary shall by regulation require that each entity described in subsection (a) that applies for assistance under this Act for any project described in subsection (b) submit in or with its application for such assistance— "(1) assurances satisfactory to the Secretary that such entity has established and has in effect an administrative process under subsection (a) to identify financial interests (as defined under subsection (a)) that exist regarding the project; and "(2) an agreement that the entity will report to the Secretary such interests identified by the entity and how any such interests identified by the entity will be managed or eliminated in order that the project in question will be protected from bias that may stemfi*omsuch interests; and "(3) an agreement that the entity will comply with regulations issued under this section. "(d) MONITORING OF PROCESS.— The Secretary shall monitor the establishment and conduct of the administrative process established by an entity pursuant to subsection (a). "(e) RESPONSE. —In any case in which the Secretary determines that an entity has failed to comply with subsection (c) regarding a project of research described in subsection (b), the Secretary— "(1) shall require that, as a condition of receiving assistance, the entity disclose the existence of a financial interest (as defined under subsection (a)) in each public presentation of the results of such project; and "(2) may take such other actions as the Secretary determines to be appropriate. "(f) DEFINITIONS,—For purposes of this section: "(1) The term 'financial interest' includes the receipt of consulting fees or honoraria and the ownership of stock or equity. "(2) The term 'assistance', with respect to conducting a project of research, means a grant, contract, or cooperative agreement.". SEC. 165. REGULATIONS. 42 USC 289b (a) ISSUANCE OF FINAL RULES. — "°'^' (1) IN GENERAL.— Not later than 180 days after the date of the enactment of this Act, the Secretary shall, subject to paragraph (2), issue the final rule for each regulation required in section 493 or 493A of the Public Health Service Act.

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