[Federal Register Volume 77, Number 215 (Tuesday, November 6, 2012)]
[Notices]
[Pages 66620-66621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27003]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 
December 6, 2012.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Generic Drug User Fee Cover Sheet; Form FDA 3794.'' Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7726, [email protected].

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 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

[[Page 66621]]

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 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: \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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    In the Federal Register of July 26, 2012 (77 FR 43844), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received the following comment. Small 
generic manufacturers will heavily suffer from the establishment fees 
under GDUFA. FDA notes this comment is outside the scope of the 
proposed collection of information, Form FDA 3794 (Generic Drug User 
Fee Cover Sheet).
    FDA estimates the burden of this collection of information as 
follows:

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


    Dated: October 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27003 Filed 11-5-12; 8:45 am]
BILLING CODE 4160-01-P