Document ID: FDA-2018-N-3404-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Generic Drug User
Fee Cover Sheet
Posted Date: 2019-02-07T05:00Z

[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2532-2533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01477]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3404]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Generic Drug User Fee 
Cover Sheet

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: 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.

DATES: Fax written comments on the collection of information by March 
11, 2019.

ADDRESSES: 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 oira_submission@omb.eop.gov. 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.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Generic Drug User Fee Coversheet

OMB Control Number 0910-0727--Extension

    On July 9, 2012, the President signed the Generic Drug User Fee 
Amendments (GDUFA) (Pub. L. 112-144, Title III) into law. GDUFA is 
designed to speed the delivery of safe and effective generic drugs to 
the public and reduce costs to the industry. Section 744B of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f, et seq.), as 
added by GDUFA, authorized FDA to assess and collect the fees related 
to generic drugs, beginning fiscal year (FY) 2013 and expiring at the 
close of FY 2017 on September 30, 2017. GDUFA was reauthorized on 
August 18, 2017 (GDUFA II), and is effective beginning October 1, 2017, 
through September 30, 2022. GDUFA II enables FDA to assess industry 
user fees to bring greater predictability and timeliness to the review 
of generic drug applications.
    Form FDA 3794, the Generic Drug User Fee Cover Sheet available at 
https://www.ipqpubs.com/wp-content/uploads/2012/09/GDUFA-cover-sheet.pdf, requests the minimum necessary information from applicants 
to account for and track user fees and to determine the amount of the 
fee required. Applicants complete the cover sheets to accompany 
payments. While applicants may submit payment through multiple means, 
all cover sheets are prepared using FDA's web-based electronic User Fee 
System. Upon submitting the completed cover sheet, the User Fee System 
generates a user fee identification number, which is provided to 
applicants at the bottom of the cover sheet. It also notes the correct 
FY user fee assessment that is due for the submission/program. FDA 
requests that applicants submit a copy of this completed cover sheet 
along with the abbreviated new drug application, and other GDUFA fees, 
so FDA can verify that the applicant has paid the correct user fee.
    Respondents to the collection of information are potential or 
actual generic drug application holders or related Active 
Pharmaceutical Ingredient and Finished Dosage Form manufacturers. 
Companies with multiple user fee obligations will submit a cover sheet 
for each user fee obligation.
    In the Federal Register of September 25, 2018 (83 FR 48430), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received asking whether the 
information was ``essential for FDA to conduct its duties,'' and 
whether ``there is a way to reduce burden'' on respondents. We 
appreciate this feedback. As discussed in both the 60-day notice and 
this notice, the information collection implements statutory provisions 
FDA must fulfill under GDUFA II. The information requested from 
respondents on Form FDA 3794 represents what we consider to be the 
minimum necessary for us to efficiently and electronically assess, 
collect, and track user fees associated with generic drug applications.
    We estimate the burden of the collection of information as follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               Form FDA 3794                    Number of      responses per     Total annual         Average burden per response          Total hours
                                               respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Generic Drug User Fee Cover Sheet..........             500            7.616            3,808   0.5 (30 minutes).......................           1,904
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 2533]]

    The estimated burden for the information collection reflects an 
increase since last OMB approval. This adjustment corresponds with an 
increase in submissions received by the Agency.

    Dated: February 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01477 Filed 2-6-19; 8:45 am]
 BILLING CODE 4164-01-P