[Federal Register Volume 84, Number 81 (Friday, April 26, 2019)]
[Notices]
[Pages 17834-17835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4206]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; 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 May 28, 
2019.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0508 and 
title ``Medical Device User Fee Small Business Qualification and 
Certification.'' Also include the FDA docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

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.

Medical Device User Fee Small Business Qualification and Certification

OMB Control Number 0910-0508--Extension

    Medical device user fees were first established in 2002 by the 
Medical Device User Fee and Modernization Act (MDUFMA) (Pub. L. 107-
250). User fees were renewed in 2007, with the Medical Device User Fee 
Amendments to the Food and Drug Administration Amendments Act of 2007 
(MDUFA II), in 2012 with the Medical Device User Fee Amendments to the 
FDA Safety and Innovation Act (MDUFA III), and in 2017 with the Medical 
Device User Fee Amendments to the FDA Reauthorization Act of 2017 
(MDUFA IV). MDUFA IV will be in place from October 1, 2017, until 
September 30, 2022.
    A business that is qualified and certified as a ``small business'' 
is eligible for a substantial reduction in most of these user fees. The 
guidance document entitled ``Medical Device User Fee Small Business 
Qualification and Certification Guidance for Industry, Food and Drug 
Administration Staff and Foreign Governments'' describes the criteria 
FDA will use to decide whether an entity is eligible for a reduction in 
user fees and the process by which a business may request certification 
as a small business.
    An applicant can qualify for a small business fee discount under 
MDUFMA if they reported gross receipts or sales of no more than $100 
million on their Federal income tax return for the most recent tax 
year. If they have any affiliates, partners, or parent firms, the 
applicant must add the gross receipts or sales of the affiliates, 
partners, or parent firms to the applicant's, and the total must be no 
more than $100 million. If the applicant's gross receipts or sales are 
no more than $30 million, including all of their affiliates, partners, 
and parent firms, they will also qualify for a waiver of the fee for 
their 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, ``MDUFA Small Business Certification Request 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.
    MDUFA II provided 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, ``MDUFA 
Foreign Small Business Certification Request for a Business 
Headquartered Outside the United States''). Before passage of MDUFA II, 
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 effectively prevented those 
businesses from qualifying for the small business fee rates. Thus, 
foreign governments, including the European Union, objected. In lieu of 
a Federal income tax return, the MDUFA II allowed 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: (1) Be in English; (2) be from the 
national taxing authority of the country in which the business is 
headquartered; (3) provide the business' gross receipts

[[Page 17835]]

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; (4) provide the dates during which the reported 
receipts or sales were collected; and (5) bear the official seal of the 
national taxing authority.
    Forms FDA 3602 and FDA 3602A are accessible through the guidance 
document entitled ``Medical Device User Fee Small Business 
Qualification and Certification Guidance for Industry, Food and Drug 
Administration Staff and Foreign Governments'' on the internet at: 
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm456779.pdf.
    The estimated burden is based on the number of applications 
received in the last 3 years and includes time required to collect the 
required information. Based on our experience with Form FDA 3602, FDA 
believes it will take each respondent 1 hour to complete the form. 
Based on our experience with Form FDA 3602A, FDA also believes that it 
will take each respondent 1 hour to complete.
    In the Federal Register of November 14, 2018 (83 FR 56852), 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 
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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FDA 3602--MDUFA Small Business             5,000               1           5,000               1           5,000
 Certification Request for a
 Business Headquartered in the
 United States..................
FDA 3602A--MDUFA Foreign Small             2,000               1           2,000               1           2,000
 Business Certification Request
 for a Business Headquartered
 Outside the United States......
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      Total.....................  ..............  ..............  ..............  ..............           7,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an 
overall increase of 2,000 hours and a corresponding increase of 2,000 
responses. We attribute this adjustment to an increase in the number of 
submissions we received over the last few years.

    Dated: April 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08471 Filed 4-25-19; 8:45 am]
 BILLING CODE 4164-01-P