text: Enclosed is our assessment of the Food and Drug Administration 's compliance with the procedural steps required by sections 801 ( a ) ( 1 ) ( B ) ( i ) through ( iv ) of title 5 with respect to the rule .
  
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  In reference to the Food and Drug Administration 's compliance with the procedural steps required by sections 801 ( a ) ( 1 ) ( B ) ( i ) through ( iv ) of title 5 our assessment is enclosed along with a sample showing each of the steps .