[Federal Register Volume 74, Number 204 (Friday, October 23, 2009)]
[Notices]
[Pages 54826-54827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25538]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0486]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry, FDA, and Foreign Governments: 
Fiscal Year 2010 Medical Device User Fee Small Business Qualification 
and Certification

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 Forms 3602 and FDA Form 
3602A which will allow domestic and foreign applicants to certify that 
they 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 December 22, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to: 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 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 
practicalutility; (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.

Guidance for Industry, FDA, and Foreign Governments: FY 2010 Medical 
Device User Fee Small Business Qualification and Certification FD&C Act 
Section 738 (OMB Control Number 0910-0508)--Extension

    Section 101 of the Medical Device User Fee and Modernization Act 
(MDUFMA) amends the Federal Food, Drug, and Cosmetic Act (the act) to 
provide for user fees for certain medical device applications. FDA 
published a Federal Register notice on August 3, 2009 (74 FR 38444), 
announcing fees for fiscal year (FY) 2010. To avoid harming small 
businesses, MDUFMA provides for reduced or waived fees for applicants 
who qualify as a ``small business.'' This means there are two levels of 
fees, a standard fee, and a reduced or waived small business fee.

FDA From 3602-- For Domestic Small Business Applicants

    For FY 2010, you can qualify for a small business fee discount 
under MDUFMA if you reported gross receipts or sales of no more than 
$100 million on your Federal income tax return for the most recent tax 
year. If you have any affiliates, partners, or parent firms, you must 
add their gross receipts or sales to yours and the total must be no 
more than $100 million. If your gross receipts or sales are no more 
than $30 million, including all of your affiliates, partners, and 
parent firms, you will also qualify for a waiver of the fee for your 
first (ever) premarket application, (product development protocol, 
biologics licensing application, or Premarket Report). An applicant 
must pay the full standard fee unless it provides evidence 
demonstrating to FDA that it meets the ``small business'' criteria. The 
evidence required by MDUFMA is a copy of the most recent Federal income 
tax return of the applicant, and any affiliate, partner, or parent 
firm. FDA will review these

[[Page 54827]]

materials and decide whether an applicant is a ``small business'' 
within the meaning of MDUFMA.

FDA Form 3602A-- For Foreign Small Business Applicants

    The 2007 Amendments provide an alternative 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.
    Both FDA Forms 3602 and 3602A are available in the guidance 
document, ``Guidance for Industry, FDA and Foreign Governments: FY 2010 
MDUFMA Small Business Qualification and Certification'' , available on 
the Internet at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/UCM179257.pdf. This 
guidance describes the criteria FDA will use to decide whether an 
entity qualifies as a MDUFMA small business and will help prospective 
applicants understand what they need to do to meet the small business 
criteria for FY 2010.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                        Number of         Annual Frequency        Total Annual          Hours per
                  FDA  Form No.                        Respondents          per Response            Responses            Response         Total  Hours
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3602                                                             3,000                     1                 3,000                  1              3,000
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3602A                                                              340                     1                   340                  1                340
Sections I and II
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3602A                                                               33                     7                   231                  1                231
Section III
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TOTALS                                                                                                                                             3,571
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The FDA Form 3602 burden is based on the number of applications 
received in the last 3 years. 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 3602A, FDA believes each business will require 1 hour to complete 
Sections I and II. FDA does not have any data on the time that will be 
required to complete Section III, the National Taxing Authority 
Certification, since there is a different tax verification process by 
each country's National Taxing Authority.
    The information collection for FDA Form 3602 is currently approved 
under OMB control number 0910-0508. The information collection for FDA 
Form 3602A is currently approved under OMB control number 0910-0613. 
With this request for approval, FDA is requesting to consolidate OMB 
approvals 0910-0508 and 0910-0613 into one information collection using 
the OMB control number 0910-0508.

    Dated: October 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25538 Filed 10-22-09; 8:45 am]
BILLING CODE 4160-01-S