Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification, 23267-23268 [2012-9241]
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23267
Federal Register / Vol. 77, No. 75 / Wednesday, April 18, 2012 / Notices
ANNUAL BURDEN ESTIMATES
Youth Outcome Survey ...................................................................
Data File ..........................................................................................
Estimated Total Annual Burden
Hours: 132,571.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: ACF Reports Clearance
Officer. Email address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–9337 Filed 4–17–12; 8:45 am]
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Number of
responses per
respondent
Number of
respondents
Instrument
15,334
52
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0324]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry, FDA Staff, and Foreign
Governments: Fiscal Year 2012
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.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by June 18, 2012.
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:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
DATES:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Average
burden hours
per response
1
2
0.50
1,201
Total
burden
hours
7,667
124,904
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@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.
Guidance for Industry, FDA Staff, and
Foreign Governments: Fiscal Year 2012
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) amends the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
to provide for user fees for certain
medical device applications. FDA
E:\FR\FM\18APN1.SGM
18APN1
23268
Federal Register / Vol. 77, No. 75 / Wednesday, April 18, 2012 / Notices
published a Federal Register notice on
August 1, 2011 (76 FR 45826),
announcing fees for fiscal year (FY)
2012. 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 2012 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 2012 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:
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, ‘‘Guidance for Industry,
Food and Drug Administration Staff,
and Foreign Governments: FY 2012
Medical Device User Fee Small Business
Qualification and Certification,’’
available on the Internet at: https://www.
fda.gov/downloads/MedicalDevices/
DeviceRegulationandGuidance/
Overview/MedicalDeviceUserFeeand
ModernizationActMDUFMA/
UCM267051.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 2012.
The Form FDA 3602 burden is based
on the number of applications received
in the last 3 years. FDA believes most
entities that submit Form FDA 3602A
will not have any affiliates, and very
few will have more than three or four
affiliates. Based on our experience with
Form FDA 3602A, FDA believes each
business will require 1 hour to complete
the form.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
FDA Form No.
Average
burden
per response
Total annual
responses
Total hours
3602 .................................................................
3602A ...............................................................
4,200
900
1
1
4,200
900
1
1
4,200
900
Total ..........................................................
............................
............................
............................
............................
5,100
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–9241 Filed 4–17–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–E–0310 (previously
FDA Docket No. 2005E–0245)]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; KEPIVANCE; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Notice; correction.
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The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of April 2, 2007 (72 FR 15699).
The document concerned FDA’s
determination of the regulatory review
period for KEPIVANCE. The document
cited an incorrect statute under which
the KEPIVANCE biologics license
application was submitted. This
document corrects the citation.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
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]]>Agencies
[Federal Register Volume 77, Number 75 (Wednesday, April 18, 2012)]
[Notices]
[Pages 23267-23268]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9241]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0324]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry, FDA Staff, and Foreign
Governments: Fiscal Year 2012 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 June 18, 2012.
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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@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.
Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year
2012 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) amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
to provide for user fees for certain medical device applications. FDA
[[Page 23268]]
published a Federal Register notice on August 1, 2011 (76 FR 45826),
announcing fees for fiscal year (FY) 2012. 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 2012 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 2012 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: 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, ``Guidance for Industry, Food and Drug Administration Staff,
and Foreign Governments: FY 2012 Medical Device User Fee Small Business
Qualification and Certification,'' available on the Internet at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/UCM267051.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 2012.
The Form FDA 3602 burden is based on the number of applications
received in the last 3 years. FDA believes most entities that submit
Form FDA 3602A will not have any affiliates, and very few will have
more than three or four affiliates. Based on our experience with Form
FDA 3602A, FDA believes each business will require 1 hour to complete
the form.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
3602.......................................................... 4,200 1 4,200 1 4,200
3602A......................................................... 900 1 900 1 900
-----------------------------------------------------------------------------------------
Total..................................................... ................ ................ ................ ................ 5,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-9241 Filed 4-17-12; 8:45 am]
BILLING CODE 4160-01-P
