21 C.F.R. § 25.43 – Records of decision.

(a) In cases requiring environmental impact statements, at the time of its decision, the agency shall prepare a concise public record of decision.
(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.