[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Notices]
[Pages 56852-56854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24790]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 January 14, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 14, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 14, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-4206 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Medical Device User Fee Small 
Business Qualification and Certification.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the

[[Page 56853]]

docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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: 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

    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 FDA Amendments Act (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 (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 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 available in 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 56854]]



                                 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--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: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24790 Filed 11-13-18; 8:45 am]
 BILLING CODE 4164-01-P