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Notice

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, FDA Form 3602A

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA Form 3602A, which will allow a foreign business to qualify as a “small business” and pay certain medical device user fees at reduced rates.

DATES:

Submit written or electronic comments on the collection of information by March 17, 2008.

ADDRESSES:

Submit electronic comments on the collection of information to: http://www.fda.gov/​dockets/​ecomments or http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

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FOR FURTHER INFORMATION CONTACT:

Denver Presley Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472

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SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, Form FDA 3602A—(21 U.S.C.379j) (OMB Control Number 0910-0613—Extension)

The FDA Amendments Act of 2007 includes the “Medical Device User Fee Amendments of 2007” (the 2007 Amendments), which reauthorizes medical device user fees for fiscal years (FY) 2008 through 2012 and which makes significant changes to the medical device user fee provisions of the act. The 2007 Amendments provide a new way for a foreign business to qualify as a small business eligible to pay a significantly-lower fee when a medical device user fee must be paid.

Before passage of the 2007 Amendments, the only way a business could qualify as a small business was to submit a Federal (U.S.) income tax return showing its gross receipts or sales that did not exceed a statutory threshold, currently, $100 million. If a business could not provide a Federal income tax return, it did not qualify as a small business and had to pay the standard (full) fee. Because many foreign businesses have not, and cannot, file a Federal (U.S.) income tax return, this requirement has effectively prevented those businesses from qualifying for the small business fee rates. Thus, foreign governments, including the European Union, have objected.

In lieu of a Federal income tax return, the 2007 Amendments will allow a foreign business to qualify as a small Start Printed Page 2504business by submitting a certification from its national taxing authority, the foreign equivalent of our Internal Revenue Service. This certification, referred to as a “National Taxing Authority Certification,” must:

  • Be in English;
  • Be from the national taxing authority of the country in which the business is headquartered;
  • Provide the business' gross receipts or sales for the most recent year, in both the local currency and in U.S. dollars, and the exchange rate used in converting local currency to U.S. dollars;
  • Provide the dates during which the reported receipts or sales were collected; and
  • Bear the official seal of the national taxing authority.

The new FDA Form 3602A, “FY 2008 MDUFMA Foreign Small Business Qualification Certification,” will collect the information required by the statute and allows a foreign business to qualify for the same small business benefits as a domestic U.S. business.

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

Table 1.—Estimated Annual Reporting Burden1

FDA Form 3602ANo. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal Hours
Sections I and II (completed by the business seeking small business status)22912291229
Section III (completed by the foreign national taxing authority)3372311231
Total460
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

This burden estimate is based on an examination of 510(k) premarket notifications received during FY 2006 and FDA's estimation of the time to collect the required information to complete FDA Form 3602A. The evidence supporting each FDA Form 3602A must be reviewed by a foreign national taxing authority to complete Section III, the National Taxing Authority Certification, of each FDA Form 3602A. Because this is a new activity, and neither FDA nor any foreign national taxing authority has any data that would provide an objective measure of the effort required to complete Section III, FDA is estimating that the burden will be the same as FDA experiences in reviewing FDA Form 3602, “FY 2008 MDUFMA Small Business Qualification Certification For a Business Headquartered in the United States,” approved under OMB control number 0910-0508.

FDA believes most entities that submit FDA Form 3602A will not have any affiliates, and very few will have more than three or four affiliates. Based on our experience with FDA Form 3602, FDA believes each business will require 1 hour to complete Sections I and II. Because this is a new requirement, FDA does not have any data on the time that will be required to complete Section III, the National Taxing Authority Certification.

Please note that in January 2008, the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. After the transition date, electronic submissions will be accepted by FDA through the FDMS only. When the exact date of the transition to FDMS is known, FDA will publish a Federal Register notice announcing that date.

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Dated: January 9, 2008.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E8-569 Filed 1-14-08; 8:45 am]

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