[Federal Register: October 2, 2007 (Volume 72, Number 190)]
[Notices]
[Page 56077-56078]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02oc07-46]
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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 baguilar@omb.eop.gov. 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