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 .
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 .