Proposed Rule and Final Rule Sample Clauses

Proposed Rule and Final Rule. On June 12, 2013, FDA published the proposed rule, ‘‘Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act’’ (78 FR 35155). In the proposed rule, the Agency set forth the factors it proposed to consider and the methodology it proposed to use in establishing the list of qualifying pathogens, as well as its interpretation of statutory language. The Agency concluded with extensive analyses of the 18 pathogens proposed for inclusion on the list of ‘‘qualifying pathogens.’’ FDA’s decisions regarding the proposed rule are described in sections III.A, III.B, III.C, and IV.
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Related to Proposed Rule and Final Rule

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