Guidance documents; required elements.

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§ 313.2 Guidance documents; required elements.

Each guidance document proposed to be issued by the Agency shall:

(a) Comply with all relevant statutes and regulation;

(b) Identify or include for each guidance document:

(1) The term “guidance” or its functional equivalent;

(2) A unique identifier;

(3) The issuance date, posting date, and the issuing office within the Agency;

(4) The activity or entities to which the guidance applies;

(5) Citations to applicable statutes and regulations;

(6) A statement noting whether the guidance is intended to revise or replace any previously issued guidance and, if so, sufficient information to identify the previously issued guidance; and

(7) A summary of the subject matter covered in the guidance document at the top of the document.

(c) Avoid use of mandatory language, such as “shall,” “must,” “required,” or “requirement,” unless the language is describing an established statutory or regulatory requirement or is addressed to Agency's staff and will not foreclose the Agency's consideration of positions advanced by affected private parties;

(d) Be written in plain, understandable English; and

(e) Clearly and prominently state that the contents of the document do not have the force and effect of law and are not meant to bind the public, and the document is intended only to provide clarity to the public regarding existing requirements under the law or Agency policies.


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