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After receiving an application for a FRM or FEM determination, the Administrator will, within 120 calendar days after receipt of the application, take one or more of the following actions:
(a) Send notice to the applicant, in accordance with §53.8, that the candidate method has been determined to be a reference or equivalent method.
(b) Send notice to the applicant that the application has been rejected, including a statement of reasons for rejection.
(c) Send notice to the applicant that additional information must be submitted before a determination can be made and specify the additional information that is needed (in such cases, the 120-day period shall commence upon receipt of the additional information).
(d) Send notice to the applicant that additional test data must be submitted and specify what tests are necessary and how the tests shall be interpreted (in such cases, the 120-day period shall commence upon receipt of the additional test data).
(e) Send notice to the applicant that the application has been found to be substantially deficient or incomplete and cannot be processed until additional information is submitted to complete the application and specify the general areas of substantial deficiency.
(f) Send notice to the applicant that additional tests will be conducted by the Administrator, specifying the nature of and reasons for the additional tests and the estimated time required (in such cases, the 120-day period shall commence 1 calendar day after the additional tests have been completed).
[71 FR 61271, Oct. 17, 2006]