date:Nov 23, 2015
he Paperwork Reduction Act of 1995
This guidance contains collections of information that are exempt from the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). Section 586D(a)(1)(C) of the FD&C Act (21 U.S.C. 360fff-4(a)(1)(C)) as amended by the SIA states that the PRA shall not apply to collections of information made for purposes of guidance under that subsection.