Document ID: FDA-2012-N-0324-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry, FDA Staff, and Foreign Governments; FY 2012 Medical Device User Fee Small Business Qualification and Certification
Posted Date: 2013-01-31T05:00Z

[Federal Register Volume 78, Number 21 (Thursday, January 31, 2013)]
[Notices]
[Pages 6822-6823]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02093]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0324]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for 
Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 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 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 March 
4, 2013.

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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0508. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

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.

Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 
2012 Medical Device User Fee Small Business Qualification and 
Certification--(OMB Control Number 0910-0508)--Extension

    Section 101 of the Medical Device User Fee and Modernization Act 
(MDUFMA) (Pub. L. 107-250) amends the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) to provide for user fees for certain medical device 
applications. FDA published a Federal Register notice on August 1, 2011 
(76 FR 45826), announcing fees for fiscal year (FY) 2012. 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. 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 (Form FDA 3602, ``FY 2012 
MDUFMA Small Business Qualification Certification--For a Business 
Headquartered in the United States''). 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 materials and decide whether an applicant is a ``small business'' 
within the meaning of MDUFMA.
    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 (Form FDA 3602A, 
``FY 2012 MDUFMA Foreign Small Business Qualification Certification--
For a Business Headquartered Outside the United States''). 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 Forms FDA 3602 and FDA 3602A are available in the guidance 
document, ``Guidance for Industry, Food and Drug Administration Staff, 
and Foreign Governments: FY 2012 Medical Device User Fee Small Business 
Qualification and Certification,'' available on the Internet at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/UCM267051.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 2012.
    The Form FDA 3602 burden is based on the number of applications 
received in the last 3 years. 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 Form 
FDA 3602A, FDA believes each business will require 1 hour to complete 
the form.
    In the Federal Register of April 18, 2012 (77 FR 23267), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.

[[Page 6823]]

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

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
          Form FDA No.               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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3602............................           4,200               1           4,200               1           4,200
3602A...........................             900               1             900               1             900
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    Total.......................  ..............  ..............  ..............  ..............           5,100
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: January 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02093 Filed 1-30-13; 8:45 am]
BILLING CODE 4160-01-P