80 FR 60394 - Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Generic Drug User Fee Cover Sheet

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 193 (October 6, 2015)

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.

[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60394-60395]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25360]


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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; 
Submission for Office of Management and Budget Review; Guidance for 
Industry on Generic Drug User Fee Cover Sheet

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 
November 5, 2015.

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 0910-0727. 
Also include the FDA 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, [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.

[[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\
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                                                                      Number of
                    FDA Form                         Number of      responses per     Total annual       Average burden per response       Total hours
                                                    respondents       respondent       responses
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3794............................................             460              7.7            3,544   0.5 (30 minutes)..................           1,772
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: September 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25360 Filed 10-5-15; 8:45 am]
 BILLING CODE 4164-01-P