Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Small Business Qualification and Certification, 55854-55855 [2015-23331]
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55854
Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Notices
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
ACF Reports Clearance Officer.
[FR Doc. 2015–23353 Filed 9–16–15; 8:45 am]
BILLING CODE 4184–07–P
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.
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 https://
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
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:30 Sep 16, 2015
Jkt 235001
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, PRAStaff@
fda.hhs.gov.
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
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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
E:\FR\FM\17SEN1.SGM
17SEN1
55855
Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Notices
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: https://www.fda.gov/ucm/
groups/fdagov-public/@fdagov-meddevgen/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
respondents
FDA form no.
Number of
responses per
respondent
Total annual
responses
Average burden per response
Total hours
FDA 3602—FY 2016 MDUFA Small Business Qualification
and Certification For a Business Headquartered in the
United States ....................................................................
FDA 3602A—FY 2016 MDUFA Foreign Small Business
Qualification and Certification For a Business
Headquartered Outside the United States .......................
3,600
1
3,600
1
3,600
1,400
1
1,400
1
1,400
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0429]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance on
Meetings With Industry and
Investigators on the Research and
Development of Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:30 Sep 16, 2015
Jkt 235001
public comment in response to the
notice. This notice solicits comments on
FDA’s meetings with tobacco
manufacturers, importers, researchers,
and/or investigators relating to their
plans to conduct research to inform the
regulation of tobacco products, or
support the development or marketing
of tobacco products.
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 https://
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, PRAStaff@
fda.hhs.gov.
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
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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
E:\FR\FM\17SEN1.SGM
17SEN1
]]>Agencies
[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 https://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, PRAStaff@fda.hhs.gov.
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: https://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
