Description:
As passed by the Senate on September 17, 2014
S. 2141 would modify the review process that allows the marketing of certain new ingredients in non-prescription sunscreen based on a determination by the Food and Drug Administration (FDA) that they are generally recognized as safe and effective (GRASE). The bill would also require the agency to establish timelines for the review process that permits the marketing of other types of non-prescription drugs based on a GRASE determination. CBO estimates that implementing S. 2141 would cost $35 million for FDA expenses over the 2015-2019 period, assuming appropriation of the necessary amounts.
S. 2141 would not affect direct spending or revenues; therefore, pay-as-you-go procedures do not apply.
S. 2141 contains no intergovernmental mandates as defined in the Unfunded Mandates Reform Act (UMRA).
The bill would impose private-sector mandates, as defined in UMRA, because it would allow FDA to require that marketing applications for certain sunscreen ingredients be submitted in a new standardized format. CBO estimates that the direct cost of complying with those requirements would not exceed the annual threshold established by UMRA for private-sector mandates ($152 million in 2014, adjusted annually for inflation).
