[Federal Register Volume 77, Number 97 (Friday, May 18, 2012)]
[Notices]
[Pages 29663-29664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-12038]


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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 Form FDA 3397, User Fee Cover 
Sheet, which 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 July 17, 2012.

[[Page 29664]]


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: 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: 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 sections 735 and 736 of the Federal Food, Drug, and Cosmetic 
Act (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 and supplements. Under this authority, pharmaceutical 
companies pay a fee for certain new human drug applications, biologics 
license applications, 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. Form FDA 3397, the user 
fee cover sheet, 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 new drug 
applications, biologics license applications, and supplemental 
applications.
    Respondents to this collection of information are new drug and 
biologics manufacturers. Based on FDA's database system for fiscal year 
(FY) 2011, there are an estimated 260 manufacturers of products subject 
to the Prescription Drug User Fee Act (Public Law 105-115). The total 
number of annual responses is based on the number of submissions 
received by FDA in FY 2011. CDER received 3,363 annual responses that 
include the following submissions: 114 new drug applications; 4 
biologics license applications; 1,900 manufacturing supplements; 1,209 
labeling supplements; and 136 efficacy supplements. CBER received 768 
annual responses that include the following submissions: 6 biologics 
license applications; 698 manufacturing supplements; 44 labeling 
supplements; and 20 efficacy supplements. The estimated hours per 
response are based on past FDA experience with the various submissions.
    FDA is revising Form FDA 3397 in the following ways: (1) By 
updating the applicable Web sites; (2) adding a Privacy Act Notice 
pursuant to the Privacy Act of 1974, 5 U.S.C. 552a(3)j; (3) by adding 
351(k) applications to the CDER and CBER lists of applications and 
supplements for which Form FDA 3397 need not be submitted; (4) by 
adding ``or proper name'' to instruction number 3; and (5) by making 
minor editorial changes.
    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 No.                                Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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Form FDA 3397......................................................             260            15.89            4,131          \2\ 0.5          2,065.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ 30 minutes.


    Dated: May 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12038 Filed 5-17-12; 8:45 am]
BILLING CODE 4160-01-P