[Federal Register Volume 72, Number 190 (Tuesday, October 2, 2007)]
[Notices]
[Pages 56077-56078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19411]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0359]


Agency Emergency Processing Under OMB Review; 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 emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information concerns a new FDA foreign small business qualification 
certification form that will allow a foreign business to qualify as a 
``small business'' and pay certain medical device user fees at reduced 
rates.

DATES: Fax written comments on the collection of information by October 
5, 2007.

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-mail to [email protected]. All comments 
should be identified with the OMB Control Number 0910-NEW and the title 
``Medical Device User Fee Amendments of 2007; Foreign Small Business 
Qualification Certification, Form FDA 3602A; (21 U.S.C. 379j); 
Emergency Request.'' 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: FDA is requesting emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA, (44 U.S.C. 3507 (j) and 5 CFR 1320.13). The Medical Device User 
Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250), which 
expires September 30, 2007, amended section 738 of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U. S.C. 379j) to provide FDA with 
new responsibilities and resources to keep up with the rapidly growing 
device industry and changing medical device technology. Congress 
recently passed an omnibus FDA bill that includes the ``Medical Device 
User Fee Amendments of 2007,'' (the 2007 Amendments), which will 
reauthorize medical device user fees for fiscal years 2008 through 2012 
and will make significant changes to the medical device user fee 
provisions of the act. The 2007 Amendments will 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. 
The user fee provisions of the 2007 Amendments provide for an October 
1, 2007, effective date, and FDA expects foreign businesses will want 
to request small business status immediately upon enactment.
    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); Emergency 
Request

    Congress recently passed an omnibus FDA bill that includes the 2007 
Amendments, which will reauthorize medical device user fees for fiscal 
years 2008 through 2012 and will makes significant changes to the 
medical device user fee provisions of the act. The 2007Amendments will 
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.
    Under existing law, 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. Since many foreign businesses have 
not, and cannot, filed 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 form, 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's gross receipts or sales for the 
most recent year, in both the local currency and in United States 
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 will allow a foreign business to qualify for the same 
small business benefits as a domestic U.S. small business. The user fee 
provisions of 2007 Amendments provide for an October 1, 2007, effective 
date, and FDA expects foreign businesses will want to request small 
business status immediately upon enactment.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 56078]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                       No. of         Annual Frequency per     Total Annual        Hours per
 FDA Form 3602A      Respondents            Response             Responses          Response       Total Hours
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Sections I and                 229                      1                 229                1              229
 II (completed
 by the
 business
 seeking
 ``small
 business''
 status)
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Section III                     33                      7                 229                1              229
 (completed by
 the foreign
 national
 taxing
 authority)
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Total Burden     ..................  .....................  ..................  ...............             458
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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 
required to collect the required information to complete the form. The 
evidence supporting each 3602A must be reviewed by a foreign national 
taxing authority to complete Section III, the National Taxing Authority 
Certification, of each 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 the Form FDA 3602, approved under OMB control 
number 0910-0508.
    FDA believes most entities that submit a Form FDA 3602A will not 
have any affiliates, and very few will have more than three or four 
affiliates. Based on our experience with Form FDA 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: September 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-19411 Filed 10-1-07; 8:45 am]
BILLING CODE 4160-01-S