Document ID: FDA-2012-N-0471-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Prescription Drug User Fee Cover Sheet
Posted Date: 2012-10-22T04:00Z

[Federal Register Volume 77, Number 204 (Monday, October 22, 2012)]
[Notices]
[Pages 64523-64524]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25898]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Prescription Drug 
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 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 21, 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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0297. 
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, Ila.Mizrachi@fda.hhs.gov.

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.

Prescription Drug 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 
and supplements to those applications. Under this authority, 
pharmaceutical companies pay a fee for certain new drug applications 
(NDAs), biologics license applications (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) 2011, there are an estimated 260 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 2011. CDER received 3,363 annual responses that 
include the following submissions: 114 NDAs; 4 BLAs; 1,900 
manufacturing supplements; 1,209 labeling supplements; and 136 efficacy 
supplements. CBER received 768 annual responses that include the 
following submissions: 6 BLAs; 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) by 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.
    In the Federal Register of May 18, 2012 (77 FR 29663), 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:

[[Page 64524]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                     Number of
                  FDA Form No.                      Number of      responses per     Total annual      Average  burden per  response       Total hours
                                                   respondents       respondent       responses
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Form FDA 3397..................................             260            15.89            4,131   0.5 (30 min.)                               2,065.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: October 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-25898 Filed 10-19-12; 8:45 am]
BILLING CODE 4160-01-P