Daily Rules, Proposed Rules, and Notices of the Federal Government
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
On July 9, 2012, the Generic Drug User Fee Act (GDUFA) (Pub. L. 112-144, Title 111) was signed into law by the President. GDUFA, designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, requires that generic drug manufacturers pay user fees to finance critical and measurable program enhancements. The user fees required by GDUFA are as follows: A one-time fee for original abbreviated new drug applications (ANDAs) pending on October 1, 2012, (also known as backlog applications); fees for type II active pharmaceutical ingredient (API) and final dosage form (FDF) facilities; fees for new ANDAs and prior approval supplements (PASs); and a one-time fee for drug master files (DMFs).
The purpose of this notice is to solicit feedback on the collection of information in an electronic form used to calculate and pay generic drug user fees. Proposed Form FDA 3794, the Generic Drug User Fee Cover Sheet, requests the minimum necessary information to determine if a person has satisfied all relevant user fee obligations. The proposed form is modeled on other FDA user fee cover sheets, including Form FDA 3397, the Prescription Drug User Fee Act Cover Sheet. The information collected would be used by the FDA to initiate the administrative screening of generic drug submissions and DMFs, support the inspection of generic drug facilities, and
Respondents to this proposed collection of information would be potential or actual generic application holders and/or related manufacturers (manufacturers of FDF and/or APIs). Companies with multiple applications will submit a cover sheet for each application and facility. Based on FDA's database of application holders and related manufacturers, we estimate that 500 companies would submit a total of 3,850 cover sheets annually to pay for application and facility user fees. FDA estimates that the 3,850 annual cover sheet responses would break down as follows:
FDA estimates the burden of this collection of information as follows:
The backlog fee is a one-time fee. The Agency expects the majority of these fees to be received in the first year only. The estimated reporting burden for the backlog fee is shown in table 2 of this document.