March 21, 2013
As reported by the Senate Committee on Health, Education, Labor, and Pensions on March 20, 2013
S. 622 would authorize the collection and spending of fees by the Food and Drug Administration (FDA) for certain activities to expedite the development and marketing approval of drugs for use in animals. Fees would supplement appropriated funds to cover FDA’s costs associated with reviewing certain applications and investigational submissions for brand and generic animal drugs. Such fees could be collected and made available for obligation only to the extent and in the amounts provided in advance in appropriation acts. The legislation would extend through fiscal year 2018, and make several technical changes to, FDA’s existing fee programs for brand and generic animal drugs, which expire at the end of fiscal year 2013.
CBO estimates that implementing S. 622 would reduce discretionary outlays, on net, by $7 million over the 2014-2018 period, assuming appropriation actions consistent with the bill.
Pay-as-you-go procedures do not apply to this legislation because it would not affect direct spending or revenues.
S. 622 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 require manufacturers of drugs for use in animals to pay specified fees to FDA. CBO estimates that the direct cost of complying with these requirements would not exceed the annual threshold established by UMRA for private-sector mandates ($148 million in 2014, adjusted annually for inflation).