[Federal Register Volume 74, Number 221 (Wednesday, November 18, 2009)]
[Notices]
[Pages 59555-59556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-27719]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0251]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 18, 2009.

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: 202-395-6974, or e-mailed to [email protected]. 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: Liz Berbakos, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3792, [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.

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 (the act) (21 U.S.C. 379g and 379h), the Prescription Drug User Fee 
Act of 1992 (PDUFA) (Public Law 102-571), as amended by the Food and 
Drug Administration Modernization Act of 1997 (Public Law 105-115), the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002, which includes the Prescription Drug User Fee Amendments of 
2002 (Public Law 107-188), and most recently by the Food and Drug 
Administration Amendments Act of 2007 (Public Law 110-85), 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) 2008, there are an estimated 255 manufacturers of products subject 
to the user fee provisions of PDUFA. However, not all manufacturers 
will have any submissions, and some may have multiple submissions in a 
given year. The total number of annual responses is based on the number 
of submissions received by FDA in FY 2008. CDER received 3,107 annual 
responses that include the following submissions: 147 new drug 
applications; 13 biologics license applications; 1,813 manufacturing 
supplements; 987 labeling supplements; and 147 efficacy supplements. 
CBER received 810 annual responses that include the following 
submissions: 9 biologics license applications; 743 manufacturing 
supplements; 48 labeling supplements; and 10 efficacy supplements. 
Based on the previous submissions that were received, the rate of these 
submissions is not expected to change significantly in the next few 
years. The estimated hours per response are based on past FDA 
experience with the various submissions, and the average is 30 minutes.
    FDA is revising Form FDA 3397 in the following ways: (1) By 
including an additional question regarding redemption of a priority 
review voucher; (2) by deleting the exclusion for certain applications 
submitted under section 505(b)(2) of the act (21 U.S.C. 355(b)(2)); and 
(3) by making several minor editorial changes.
    In the Federal Register of June 8, 2009 (74 FR 27145), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received on the information 
collection.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                      No. of         Annual Frequency       Total Annual        Hours per
     Form          Respondents         per Response          Responses           Response         Total Hours
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FDA 3397                      255                 15.36              3,917                0.5              1,959
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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: November 12, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27719 Filed 11-17-09; 8:45 am]
BILLING CODE 4160-01-S