on children and the regulatory analysis, a statement of the assessment by the agency of such issues, and a statement of any changes made to the proposed applicable rule as a result of such comments. (2) An estimate of the number of children whose health the final applicable rule may directly or indirectly negatively impact and the basis of such estimate or a substantiated explanation of why such estimate is unavailable. (3) A description of the demographic groups of children impacted by the final applicable rule. (4) A description of the steps the agency has taken to minimize the negative impact on children’s health, and to maximize the benefits to children, including a statement of the factual, policy, and legal reasons for selecting any alternative adopted in the final applicable rule and why any other alternative that had less negative impact on children’s health was not adopted. (5) An appendix containing the following: (A) Any draft of the proposed applicable rule submitted by the agency to the Office of Management and Budget for any interagency review process prior to proposal of any such rule and each document accompanying any such draft. (B) Each written comment to any draft described in subparagraph (A) by any other agency and each written response to such written comment by the Administrator. (C) Each draft of the final applicable rule submitted for such review process prior to promulgation and each written comment thereon and any document accompanying each such draft and any written response thereto. 4. Exception, delay, and preparation of analyses (a) Exception The requirements of sections 2 and 3 do not apply if the head of an agency— (1) certifies that an applicable rule will not have a negative impact on the health of a substantial number of children