2015年修订版1指南中删除的一段话，这是2014年定稿指南中的一段：
A. APIs with a Type II API DMF Reference
Type II API DMFs for which the required fee has been paid undergo an initial completeness assessment (CA). An ANDA that relies on a Type II API DMF for which the initial CA determination is incomplete (i.e., is not designated on FDA's available-for-reference list) at the time the ANDA is submitted will result in FDA refusing-to-receive the ANDA.
