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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601

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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 March 8, 2013.


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 All comments should be identified with the OMB control number 0910-0511. Also include the FDA docket number found in brackets in the heading of this document.

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Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156,

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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.

Medical Device User Fee Cover Sheet, Form FDA 3601—(OMB Control Number 0910-0511)—Extension

The Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), and the Medical Device User Fee Amendments of 2007 (Title II of the Food and Drug Administration Amendments Act of 2007), authorizes FDA to collect user fees for certain medical device applications. Under this authority, companies pay a fee for certain new medical device applications or supplements submitted to the Agency for review. Because the submission of user fees concurrently with applications and supplements is required, the review of an application cannot begin until the fee is submitted. Form FDA 3601, the “Medical Device 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 between the fees submitted for an application with the actual submitted application by using a unique number tracking system. The information collected is used by FDA's Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research to initiate the administrative screening of new medical device applications and supplemental applications.

The total number of annual responses is based on the number of cover sheet submissions received by FDA in fiscal years 2009 through 2011. FDA received cover sheets for the following medical device submissions (average annual): 38 premarket approval applications (premarket approval application (PMA), product development protocol (PDP), postmarketng requirement (PMR), biologics license application (BLA)), 3,561 premarket notifications, 12 panel track supplements, 180 real-time supplements, 127 180-day supplements, 749 30-day notices, 84 513(g) requests, and 463 annual fees for periodic reporting. The number of received annual responses included the cover sheets for applications that were qualified for small businesses and fee waivers or reductions. The estimated hours per response are based on past FDA experience with the various cover sheet submissions, and range from 5 to 30 minutes. The hours per response are based on the average of these estimates (18 minutes).

In the Federal Register of June 6, 2012 (77 FR 33469), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one PRA related comment.

The comment states that the cover sheet “can be obtained prior to payment of the fee and should not be available until payment of the fee has been confirmed.” It is unclear whether the comment addresses the topics on which the 60-day notice invited comment. As stated earlier in this document, 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 Start Printed Page 8544account for and track user fees. MDUFMA requires the submission of the user fees concurrently with applications (21 U.S.C. 379j(a)(2)(C)). If the required fees are not submitted, the review of the application will not begin. The User Fee Cover Sheet provides the information necessary to either initiate or defer the application review.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden

Form FDA No.No. of RespondentsNo. of Responses per RespondentTotal Annual ResponsesAverage Burden per ResponseTotal Hours
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Dated: February 1, 2013.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2013-02613 Filed 2-5-13; 8:45 am]