<prompt> Translate the following text to SwahiliThe 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.  <response>: Kwa mujibu wa sheria za Marekani, sheria hiyo inapaswa kuwa na athari kubwa kwa idadi kubwa ya mashirika madogo, na kwa hivyo, uchunguzi wa awali wa kubadilika kwa sheria na uchunguzi wa mwisho wa kubadilika kwa sheria zimeandaliwa na kuingizwa katika taarifa ya sheria iliyopendekezwa na taarifa ya sheria ya mwisho, kama ilivyoelezwa na sehemu 603 na 604. 