; (C) a statement of assurance that a scientifically satisfactory non-animal method of obtaining the result sought is not available; and (D) an analysis of the harms and benefits of the use of animals in the proposed research assessing whether the harms that would be caused to animals in terms of suffering, pain, and distress is justified by the expected outcomes, taking into account ethical considerations and the expected benefits to human beings, animals, or the environment. (2) Regulatory process Notwithstanding subsection (a)(2) of section 553 of title 5, United States Code, regulations under this subsection shall be promulgated in accordance with the notice and comment requirements of such section. (d) Suspension or revocation If the Director of NIH determines that— (1) the conditions of animal care, treatment, or use in an entity which is receiving a grant, contract, or cooperative agreement involving research on animals under this title do not meet applicable guidelines established under subsection (a)(5); (2) the entity has been notified by the Director of NIH of such determination and has been given a reasonable opportunity to take corrective action; and (3) no action has been taken by the entity to correct such conditions, the Director of NIH shall suspend or revoke such grant, contract, or cooperative agreement under such conditions as the Director determines appropriate. (e) Protection of certain information No guideline or regulation promulgated under subsection (a)(5) or (c) may require a research entity to disclose publicly trade secrets or commercial or financial information which is privileged or confidential. .