Document ID: FDA-2012-N-0324-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals; Guidance for Industry, Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification
Posted Date: 2012-04-18T04:00Z

[Federal Register Volume 77, Number 75 (Wednesday, April 18, 2012)]
[Notices]
[Pages 23267-23268]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9241]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
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 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 Form FDA 3602 and Form FDA 
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 either electronic or written comments on the collection 
of information by June 18, 2012.

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: 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: 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.

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) amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
to provide for user fees for certain medical device applications. FDA

[[Page 23268]]

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

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Number of
                         FDA Form No.                               Number of       responses per     Total annual     Average burden      Total hours
                                                                   respondents       respondent         responses       per 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: April 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-9241 Filed 4-17-12; 8:45 am]
BILLING CODE 4160-01-P