81 FR 11576 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Small Business Qualification and Certification

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 43 (March 4, 2016)

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.

[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Notices]
[Pages 11576-11577]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04704]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3287]


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 of availability.

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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 April 
4, 2016.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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

    Section 101 of the Medical Device User Fee and Modernization Act 
(MDUFMA) (Pub. L. 107-250) amends the Federal Food, Drug, and Cosmetic 
Act, to provide for user fees for certain medical device applications. 
FDA published a Federal Register notice on August 3, 2015 (80 FR 
46033), announcing fees for fiscal year (FY) 2016. 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 2016 MDUFMA 
Small Business Qualification Certification--For a Business 
Headquartered in the United

[[Page 11577]]

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 2016 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: (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 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.
    Both Forms FDA 3602 and FDA 3602A are available in the guidance 
document, ``FY 2016 Medical Device User Fee Small Business 
Qualification and Certification; Guidance for Industry, Food and Drug 
Administration Staff, and Foreign Governments'' available on the 
Internet at: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm456779.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 2016.
    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 September 17, 2015 (80 FR 55854), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
not responsive to the four collection of information topics solicited 
and therefore will not be discussed in this document.
    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
          FDA Form No.               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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FDA 3602--FY 2016 MDUFA Small              3,600               1           3,600               1           3,600
 Business Qualification and
 Certification For a Business
 Headquartered in the United
 States.........................
FDA 3602A--FY 2016 MDUFA Foreign           1,400               1           1,400               1           1,400
 Small Business Qualification
 and Certification For a
 Business Headquartered Outside
 the United States..............
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    Total.......................  ..............  ..............  ..............  ..............           5,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: February 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04704 Filed 3-3-16; 8:45 am]
 BILLING CODE 4164-01-P