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Will permit comparability protocols as described in 21 CFR 514.8(b)(2)(v) to be submitted as protocols without substantial data in a JINAD file. The Agency will continue to review and act on 90 percent of JINAD submissions consisting of protocols without substantial data within 100 days after the submission date. The Agency will develop guidance for a two-phased Chemistry, Manufacturing, and Controls technical section submission and review process under the JINAD file by the end of FY 2014. The.

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