USDA Publishes Final Rule on Review and Issuance of Agency Guidance Documents

Hogan Lovells

The United States Department of Agriculture (USDA) has published a Final Rule codifying internal procedures that must be followed when issuing agency guidance documents. The Final Rule amends USDA’s administrative regulations by adding procedural regulations for the review an issuance of USDA guidance documents. The Final Rule adds a new Subpart Q, “Review and Issuance of Agency Guidance Documents,” to 7 CFR Part 1. The new procedures are in some ways similar to the Food and Drug Administration’s (FDA) “Good Guidance Practices” regulations which for two decades have governed the procedural steps FDA follows when developing guidance documents. Although the Final Rule is positioned as an internal agency procedural requirement not conferring rights on third parties, regulated companies may wish to consider whether the agency properly followed these procedures when commenting on future agency guidance.

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