; or (ii) an investigational device exemption in effect under section 520(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j(g) ). (2) Rulemaking The Secretary of the Treasury, in consultation with the Secretary of Health and Human Services, shall issue rules to carry out this subsection. 3. Purchase of loans by fiscal agents (a) In general Fiscal agents shall purchase loans— (1) made to an eligible recipient under section 2(b) for the purpose of conducting the applicable clinical trial described in that section; and (2) with respect to which the fiscal agent determines that the borrower has the ability to repay the loan, based on collateral and financial capabilities and not on the prospects for success of the clinical trial. (b) Priority for purchase of loans The Secretary of the Treasury shall issue rules to require fiscal agents, in purchasing loans under this section, to purchase loans with respect to a diverse range of biomedical projects and not to favor one disease or disability, and to give priority to loans with potential to address unmet public health needs across the spectrum of diseases and disabilities; (c) Maximum loan amount A fiscal agent may not purchase loans in any one year with respect to a single recipient in an amount more than $25,000,000. (d) Loan terms and conditions (1) In general The Secretary of the Treasury, in consultation with the Secretary of Health and Human Services, shall issue rules— (A) to establish criteria for the terms for loans that are eligible for purchase under this section; (B) to establish criteria for the interest rate for loans that are eligible for purchase under this section, which shall be based on applicable rates for obligations of the Department of the Treasury of comparable maturity plus a rate to be determined by the Secretary of the Treasury to reflect— (i) prevailing market conditions; (ii) taxpayer protection; and (iii) the need to ensure ample funding for clinical trials described in section 2