; (B) the nature and degree of risks addressed by the rule and the countervailing risks that might be posed by agency action; and (C) to the extent practicable, the cumulative costs and benefits, and an analysis of the effects that the rule is anticipated to have on entities that purchase products or services from, sell products or services to, or otherwise conduct business with entities to which the rule will apply. (c) Notice of proposed rulemaking (1) In general If an agency determines that the objectives of the agency require the agency to issue a rule, the agency shall— (A) submit a notice of proposed rulemaking to the Administrator for review; (B) refrain from publishing the notice until the Administrator determines that review by the Administrator has concluded; and (C) at the conclusion of review by the Administrator, publish a notice of proposed rulemaking in the Federal Register, which shall include— (i) a statement of the time, place, and nature of any public rulemaking proceedings; (ii) a reference to the legal authority under which the rule is proposed, including the specific statutory provision on which the rulemaking relies; (iii) the text of the proposed rule; (iv) a summary of information known to the agency concerning the considerations described in subsection (b); and (v) where otherwise consistent with applicable law, for any major rule or high-impact rule— (I) a reasoned preliminary explanation regarding how— (aa) the proposed rule meets the objectives of the statutory provision on which the rulemaking relies; and (bb) the benefits of the proposed rule justify the costs; (II) a discussion of— (aa) the costs and benefits of alternatives considered by the agency under subsection (b)(4); (bb) whether the alternatives considered by the agency under subsection (b)(4) meet the objectives of the statutory provision on which the rulemaking relies; and (cc) the reasons why the agency did not propose an alternative considered by the agency under subsection (b)(4)