Skip to Content


Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Generic Drug User Fee Cover Sheet

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Enhanced Content

Relevant information about this document from provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.


Fax written comments on the collection of information by November 5, 2015.


To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to All comments should be identified with the OMB control number 0910-0727. Also include the FDA docket number found in brackets in the heading of this document.

Start Further Info


FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,

End Further Info End Preamble Start Supplemental Information


In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.Start Printed Page 60395

Generic Drug User Fee Cover Sheet; Form FDA 3794 OMB Control Number 0910-0727—Extension

On July 9, 2012, the Generic Drug User Fee Act (GDUFA) (Pub. L. 112-144, Title III) 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: (1) A one-time fee for original abbreviated new drug applications (ANDAs) pending on October 1, 2012 (also known as backlog applications); (2) fees for type II active pharmaceutical ingredient (API) and final dosage form (FDF) facilities; (3) fees for new ANDAs and prior approval supplements (PASs); and (4) 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 FDA to initiate the administrative screening of generic drug submissions and DMFs, support the inspection of generic drug facilities, and otherwise support the generic drug program. A copy of the proposed form will be available in the docket for this notice.

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 approximately 460 companies would submit a total of 3,544 cover sheets annually to pay for application and facility user fees. FDA estimates that the 3,544 annual cover sheet responses would break down as follows: 1,439 facilities fees, 942 ANDAs, 502 PASs, and 661 Type II API DMFs. The estimated hours per response are based on FDA's past experience with other submissions and range from approximately 0.1 to 0.5 hours. The hours per response are estimated at the upper end of the range to be conservative.

In the Federal Register of June 2, 2015 (80 FR 31388), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden 1

FDA FormNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
37944607.73,5440.5 (30 minutes)1,772
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Start Signature

Dated: September 30, 2015.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2015-25360 Filed 10-5-15; 8:45 am]