
[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20232-20233]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08618]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0471]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; User Fee Cover Sheet; Form FDA 3397

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, 
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 on the information collection 
requirements relating to Form FDA 3397, User Fee Cover Sheet, that must 
be submitted along with certain drug and biologic product applications 
and supplements.

DATES: Submit either electronic or written comments on the collection 
of information by June 15, 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 comment 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.

User Fee Cover Sheet; Form FDA 3397 (OMB Control Number 0910-0297)--
Extension

    Under the prescription drug user fee provisions of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (sections 735 and 736 (21 
U.S.C. 379g and 379h)), as amended, FDA has the authority to assess and 
collect user fees for certain drug and biologics license applications 
(BLAs) and supplements to those applications. Under this authority, 
pharmaceutical companies pay a fee for certain new human drug 
applications (NDAs), BLAs, or supplements submitted to the Agency for 
review. Because the submission of user fees concurrently with 
applications and supplements is required, review of an application by 
FDA cannot begin until the fee is submitted. The Prescription Drug User 
Fee Cover Sheet, Form FDA 3397, is designed to provide the minimum 
necessary information to determine whether a fee is required for review 
of an application, to determine the amount of the fee required, and to 
account for and track user fees. The form provides a cross-reference of 
the fee submitted for an application by using a unique number tracking 
system. The information collected is used by FDA's Center for Drug 
Evaluation and Research (CDER) and Center for Biologics Evaluation and 
Research (CBER) to initiate the administrative screening of NDAs, BLAs, 
and/or, supplemental applications to those applications.
    Respondents to this collection of information are new drug and 
biologics manufacturers. Based on FDA's database system for fiscal year 
(FY) 2014, there are an estimated 290 manufacturers of products subject 
to the Prescription Drug User Fee Act (Pub. L. 105-115). The total 
number of annual responses is based on the number of submissions 
received by FDA in FY 2014. CDER received 3,005 annual responses that 
include the following submissions: 128 NDAs; 7 BLAs; 1,586 
manufacturing supplements; 1,081 labeling supplements; and 203 efficacy 
supplements. CBER received 705 annual responses that include the 
following submissions: 11 BLAs; 611 manufacturing supplements; 64 
labeling supplements; and 19 efficacy supplements. The estimated hours 
per response are based on past FDA experience with the various 
submissions.
    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                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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FDA 3397........................             290           12.79           3,710   0.5 (30 min.)           1,855
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



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    Dated: March 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08618 Filed 4-14-15; 8:45 am]
 BILLING CODE 4164-01-P


