[Federal Register: January 15, 2008 (Volume 73, Number 10)]
[Notices]
[Page 2503-2504]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ja08-69]
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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