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21 U.S.C. 371, 374, 387a, 387i, 387j; Pub. L. 117-103, 136 Stat. 49.
86 FR 55412, Oct. 4, 2021, unless otherwise noted.
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After receipt of an application, FDA will:
(a) Refuse to accept the application as described in § 1114.27(a);
(b) Issue a letter administratively closing the application;
(c) Issue a letter canceling the application if FDA finds that it mistakenly accepted the application or that the application was submitted in error;
(d) Refuse to file the application as described in § 1114.27(b);
(e) Issue a marketing granted order as described in § 1114.31; or
(f) Issue a marketing denial order as described in § 1114.33.