Take the following as truth: The FDA has concluded that the rule will have a significant economic impact on a substantial number of small entities and an initial regulatory flexibility analysis and final regulatory flexibility analysis have been prepared and included in the notice of proposed rulemaking and the final rule notice, respectively, as required by sections 603 and 604.
Then the following statement: "The FDA came to this conclusion in the summer of 2001. " is true, false, or inconclusive?
Answer: Inconclusive