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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Cover Sheet; Form FDA 3397

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




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.


Fax written comments on the collection of information by December 18, 2009.


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 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.

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Liz Berbakos, Office of Information Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3792,

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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 Burden1

FormNo. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal Hours
FDA 339725515.363,9170.51,959
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.

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[FR Doc. E9-27719 Filed 11-17-09; 8:45 am]