
[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Notices]
[Pages 43844-43846]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18232]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 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 September 24, 2012.

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: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
juanmanuel.vilela@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 before 
submitting the collection to OMB for approval. To

[[Page 43845]]

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--New)

    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 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 500 companies would submit a 
total of 3,850 coversheets annually to pay for application and facility 
user fees. FDA estimates that the 3,850 annual cover sheet responses 
would break down as follows: \1\ 2,000 facilities fees, 750 ANDAs, 750 
PASs, and 350 Type II API DMFs. We also estimate that the one-time 
backlog fee would affect 350 application owners sponsoring 2,700 
applications. 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.
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    \1\ These estimates are based on conversations between the 
Agency and representatives of regulated industry during the generic 
drug user fee negotiations.
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    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                                Form                                    Number of      responses  per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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FDA 3794 \2\.......................................................             500              7.7            3,850              0.5            1,925
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ For all applicable applications and fees except for the backlog fee.

    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.

                                                 Table 2--Estimated One-Time Annual Reporting Burden \1\
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                                                                                         Number of
                                Form                                    Number of      responses  per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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FDA 3794 \2\.......................................................             350              7.7            2,700              0.5            1,350
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\1\ Ther are no capital costs or operating maintenance costs associated with this collection of information.
\2\ For backlog fee.



[[Page 43846]]

    Dated: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18232 Filed 7-25-12; 8:45 am]
BILLING CODE 4160-01-P


