21 CFR §25.43

1. (a)In cases requiring environmental impact statements, at the time of its decision, the agency shall prepare a concise public record of decision.
2. (b)The record of decision shall:
   1. (1)State what the decision was;
   2. (2)Identify and discuss alternatives considered by the agency in reaching its decision;
   3. (3)State whether all practicable means to avoid or minimize environmental harm have been adopted, and if not, why not; and
   4. (4)Summarize the program for monitoring and enforcing the practicable means adopted to avoid or minimize the environmental harm.