Code of Federal Regulations Title 45. Public Welfare § 45.2509.18 What procedures apply to guidance documents identified as “significant”?

(a) OGC review of proposed guidance documents will include a preliminary determination as to whether the proposed guidance document is significant within the meaning of § 2509.20. Unless exempt, each proposed guidance document determined to be significant must be approved by the Chief Executive Officer before issuance. In such instances, CNCS will:

(b) If the guidance document is determined to be significant under § 2509.20, CNCS may proceed with publication in the Federal Register. For each significant guidance document, the originating CNCS office should include a statement in the clearance memorandum indicating that the guidance document has been reviewed and cleared in accordance with this section.