[Federal Register: April 10, 2008 (Volume 73, Number 70)]
[Notices]
[Page 19508-19509]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ap08-55]
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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 baguilar@omb.eop.gov. 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]
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