[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Notices]
[Pages 55854-55855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23331]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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 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 November 16, 2015.

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

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.

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 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

[[Page 55855]]

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

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
          FDA form no.               Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
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..............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           5,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: September 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23331 Filed 9-16-15; 8:45 am]
BILLING CODE 4164-01-P