§ 1473.9 Procedure for guidance documents identified as “significant”.  

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  • (a) FMCS will make an initial, preliminary determination about a guidance document's significance. Thereafter, FMCS must consult with OIRA to determine whether guidance is significant guidance, unless the guidance is otherwise exempted from such a determination by the Administrator of OIRA.

    (b) Significant guidance documents, as determined by the Administrator of OIRA, must be reviewed by OIRA under E.O. 12866 before issuance; and must demonstrate compliance with the applicable requirements for regulations or rules, including significant regulatory actions, set forth in E.O. 12866, E.O. 13563, E.O. 13609, E.O. 13771, and E.O. 13777.

    (c) Significant guidance documents must be signed by the Director.