
[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Notices]
[Pages 31388-31389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13352]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0748]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry on Generic Drug User Fee Cover 
Sheet; Form FDA 3794

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments concerning collection of 
information using Form FDA 3794 entitled ``Generic Drug User Fee Cover 
Sheet.''

DATES: Submit either electronic or written comments on the collection 
of information by August 3, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA, (44 U.S.C. 3501-3520), 
Federal Agencies must obtain approval from the Office of Management and 
Budget (OMB) for each collection of information they conduct or 
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) 
and 5 CFR 1320.3(c) and includes Agency requests or requirements that 
members of the public submit reports, keep records, or provide 
information to a third party. Section 3506(c)(2)(A) of the PRA (44 
U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day 
notice in the Federal Register concerning each proposed collection of 
information, including each proposed extension of an existing 
collection of information, before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 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

[[Page 31389]]

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

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              FDA form                                  Number of      responses  per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA 3794...........................................................             460              7.7            3,544    0.5 (30 min.)            1,772
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: May 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13352 Filed 6-1-15; 8:45 am]
 BILLING CODE 4164-01-P


