Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Small Business Qualification and Certification, 17834-17835 [2019-08471]
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17834
Federal Register / Vol. 84, No. 81 / Friday, April 26, 2019 / Notices
21 CFR part; guidance; or FDA form
Topic
807, subpart E ..............................................................................................................
814, subparts A through E ...........................................................................................
814, subpart H ..............................................................................................................
812 ................................................................................................................................
820 ................................................................................................................................
‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’ ...
‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’.
Premarket notification ...............................
Premarket approval ..................................
Humanitarian Device Exemption ..............
Investigational Device Exemption .............
Quality System Regulation .......................
De Novo classification process ................
Q-submissions ..........................................
Dated: April 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–08465 Filed 4–25–19; 8:45 am]
BILLING CODE 4164–01–P
Medical Device User Fee Small
Business Qualification and Certification
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.
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 oira_
submission@omb.eop.gov. 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, PRAStaff@
fda.hhs.gov.
amozie on DSK9F9SC42PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:28 Apr 25, 2019
Jkt 247001
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
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OMB control
No.
0910–0120
0910–0231
0910–0332
0910–0078
0910–0073
0910–0844
0910–0756
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
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17835
Federal Register / Vol. 84, No. 81 / Friday, April 26, 2019 / Notices
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,
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:
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
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FDA form No.
Total
annual
responses
Average
burden per
response
Total hours
FDA 3602—MDUFA Small Business Certification Request
for a Business Headquartered in the United States ........
FDA 3602A—MDUFA Foreign Small Business Certification
Request for a Business Headquartered Outside the
United States ....................................................................
5,000
1
5,000
1
5,000
2,000
1
2,000
1
2,000
Total ..........................................................................
........................
........................
........................
........................
7,000
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–4048]
Unique Device Identification:
Convenience Kits; Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Unique Device
Identification: Convenience Kits;
Guidance for Industry and Food and
Drug Administration Staff.’’ The unique
device identification system regulations
require that the label and device
package of a device must bear a unique
SUMMARY:
amozie on DSK9F9SC42PROD with NOTICES
Number of
responses per
respondent
VerDate Sep<11>2014
17:28 Apr 25, 2019
Jkt 247001
device identifier (UDI), unless an
exception or alternative applies. An
exception is provided for devices
packaged within the immediate
container of a convenience kit, if the
label of the convenience kit bears a UDI.
This guidance document describes
FDA’s interpretation of the definition of
‘‘convenience kit.’’ This guidance does
not apply to in vitro diagnostic (IVD)
devices that are subject to IVD labeling
requirements nor does it apply to
combination products.
DATES: The announcement of the
guidance is published in the Federal
Register on April 26, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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
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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–
2015–D–4048 for ‘‘Unique Device
Identification: Convenience Kits:
Guidance for Industry and Food and
Drug Administration Staff;
Availability.’’ Received comments 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
E:\FR\FM\26APN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of
FDA form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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......
-------------------------------------------------------------------------------
Total..................... .............. .............. .............. .............. 7,000
----------------------------------------------------------------------------------------------------------------
\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
