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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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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 February 18, 2010.


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 e-mailed 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 (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 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 (Public Law 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 Start Printed Page 2867submitted 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 (CDRH) and the Center for Biologics Evaluation and Research (CBER) 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 year (FY) 2008. CDRH received approximately 5,095 annual responses that included the following submissions: 16 premarket approval applications (PMAs) (PDP, PMR, and BLA),1 3,625 premarket notifications, 8 modular premarket applications, 9 panel track supplements, 201 real-time supplements, 173 180-day supplements, 633 30-day notices, 93 513(g) requests, and 337 annual fees for periodic reporting.

CBER received approximately 97 annual responses that included the following submissions: 2 PMAs, 1 BLA efficacy supplement, 50 premarket notifications, 3 180-day supplements, 2 real-time supplements, 20 30-day notices, 3 513(g) requests, and 16 annual fees for periodic reporting. The number of received annual responses in FY 2008 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.

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

Table 1.—Estimated Annual Reporting Burden1

ActivityFDA Form No.No. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal Hours
Medical Device Manufacturers36015,19215,19218/601,558
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

In the Federal Register of October 15, 2009 (74 FR 52965), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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Dated: January 12, 2010.

David Dorsey,

Acting Deputy Commissioner for Policy, Planning and Budget.

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1.  PDP means product development protocol, PMR means postmarketing requirements, and BLA means biologics license applications.

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[FR Doc. 2010-790 Filed 1-15-10; 8:45 am]