[Federal Register Volume 73, Number 70 (Thursday, April 10, 2008)]
[Notices]
[Pages 19508-19509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-7637]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0027] (formerly Docket No. 2007N-0495)


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Device User 
Fee Amendments of 2007; Foreign Small Business Qualification 
Certification, Form FDA 3602A

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 May 12, 
2008.

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 0910-0613. Also 
include the FDA docket number found in brackets in the heading of this 
document.

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.

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.

Medical Device User Fee Amendments of 2007; Foreign Small Business 
Qualification Certification, Form FDA 3602A--(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 business 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.
    In the Federal Register of January 15, 2008 (73 FR 2503), FDA 
published a 60-day notice requesting public comment on the information 
collection

[[Page 19509]]

provisions. In response to this notice, FDA received two general 
comments on the information collection requirements which are described 
in this document along with FDA's responses.
    (Comment 1) The commenter recommended that once a firm has 
qualified for small business status, this should be good enough for 3 
to 5 years. Further, that it would be quite unlikely that a small 
business firm would move from a small business to a huge business in 3 
years, particularly for the starting business or very small business. 
The commenter concluded that the extra paperwork will cost time and 
money for the industry and FDA as well.
    (Response) FDA cannot accept this recommendation, because current 
provisions of the 2007 Amendments do not permit the recommended 
approach. Section 738(d)(2)(B) and (e)(2)(B) of the act (21 U.S.C. 
379j(d)(2)(B) and (e)(2)(B)) defines the ``Evidence of Qualification'' 
that must be provided to qualify as a small business. The provisions 
specifically require the applicant to support its claim that it 
qualifies as a small business by submitting, among other things, the 
following:
     ``a copy of the most recent Federal income tax return for 
a taxable year'' and
     A signed certification of gross receipts or sales for the 
most recent year.
    Because both requirements specify that the information must be for 
the ``most recent'' year, FDA cannot determine whether an applicant's 
status as a small business will persist for a period of more than 1 
year.
    (Comment 2) The commenter expressed concern there could be some 
problems in collecting the tax certification information required of 
Form FDA 3602A, Section III, from the national taxing authority of each 
country where an applicant has business entities. The commenter cited 
that in some countries, the national taxing authority may not agree to 
fill out this form for various reasons including: (1) The fact that it 
may not be its own official form, (2) the form is in English, and (3) 
authorities do not agree to determine the exchange rate for the U.S. 
dollar.
    As an alternative to Form FDA 3602A, Section III, the commenter 
recommends the following information be provided:
     A tax report or an income statement from each country of 
business entities,
     Translation to English could be organized by the 
applicant, and a
     Determination of exchange rate could be done by the 
applicant.
    (Response) FDA cannot accept this recommendation because the agency 
does not have authority to modify the statutory requirement for a 
signed certification form, and bearing the seal of the national taxing 
authority of the country in which the applicant, or if applicable, 
affiliate, is headquartered (see section 738(d)(2)(B)(iii) and 
738(e)(2)(B)(iii)).

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    Form FDA 3602A                         Respondents         per Response          Responses           Response         Total Hours
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Sections I and II (completed by the business seeking                  229                     1                229                  1                229
 small business status)
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Section III (completed by the foreign national taxing                  33                     7                231                  1                231
 authority)
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Total                                                                                                                                                460
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\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 Form FDA 3602A. The 
evidence supporting each Form FDA 3602A must be reviewed by a foreign 
national taxing authority to complete Section III, the National Taxing 
Authority Certification, of each Form FDA 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 Form FDA 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 Form FDA 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.

    Dated: April 7, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-7637 Filed 4-9-08; 8:45 am]
BILLING CODE 4160-01-S