§ 1695.4 Significance determination.

(a) Prior to issuance, the Commission shall provide OIRA with an opportunity to review a guidance document to determine if it meets the definition of “significant guidance document.”

(b) If the guidance document is determined not to be significant, the Commission shall proceed with issuance of the guidance without going through the procedures described in § 1695.5.

(c) In emergency situations, or when required by statutory deadline or court order to act more quickly than normal review procedures allow, the Chair shall notify OIRA and all Commissioners as soon as possible and, to the extent practicable, comply with the requirements of this part at the earliest opportunity.