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. Our review indicates that the Administration complied with the applicable requirements.
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.