[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Pages 2874-2875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-792]



Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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.


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 
February 18, 2010.

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 e-mailed 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 
the document.

Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-5156, 

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, and Foreign Governments: Fiscal Year 2010 
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) 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 
Form 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 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.
    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, because 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

[[Page 2875]]

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.
    In the Federal Register of October 23, 2009 (74 FR 54826), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 

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

    Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-792 Filed 1-15-10; 8:45 am]