[Federal Register Volume 73, Number 10 (Tuesday, January 15, 2008)]
[Notices]
[Pages 2503-2504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-569]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0495]


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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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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.

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: 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

[[Page 2504]]

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

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                 No. of        Annual Frequency     Total Annual        Hours per
                      FDA Form 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 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.

    Dated: January 9, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-569 Filed 1-14-08; 8:45 am]
BILLING CODE 4160-01-S