Draft guidance is due within 12 months and final guidance a year after comments close
What the document says“not later than 12 months after the date of enactment of this Act, issue draft guidance on the implementation of the amendments made by subsection (a); and”
Subsection (b) of section 6601 requires the Secretary, acting through the Commissioner of Food and Drugs, to issue draft guidance on implementing the amendments within 12 months of enactment, and to finalize it within 12 months of the close of the comment period on the draft.
What the document actually says“not later than 12 months after the date of enactment of this Act, issue draft guidance on the implementation of the amendments made by subsection (a); and”
Within 12 months of the day this law passed, put out draft guidance. It explains how the changes will work.
Draft guidance goes out for comment first. The final version comes within a year after comments close. Guidance is advice, not a rule.
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