Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry, FDA, and Foreign Governments: Fiscal Year 2010 Medical Device User Fee Small Business Qualification and Certification, 54826-54827 [E9-25538]
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54826
Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
of Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total Hours
812.140 Original
600
0.5
300
10
3,000
812.140 Supplemental
600
7
4,200
1
4,200
812.140 Non-significant
600
1
600
6
3,600
Total
10,800
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the burden is based
on the number of IDEs received in the
last 3 years.
Dated: October 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25539 Filed 10–22–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0486]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry, FDA, and Foreign
Governments: Fiscal Year 2010
Medical Device User Fee Small
Business Qualification and
Certification
AGENCY:
Food and Drug Administration,
HHS.
CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
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
FDA Forms 3602 and FDA Form 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 written or electronic
comments on the collection of
information by December 22, 2009.
ADDRESSES: Submit electronic
comments on the collection of
VerDate Nov<24>2008
15:24 Oct 22, 2009
Jkt 220001
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:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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
practicalutility; (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
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
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, and
Foreign Governments: FY 2010 Medical
Device User Fee Small Business
Qualification and Certification FD&C
Act Section 738 (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 act) to
provide for user fees for certain medical
device applications. FDA published a
Federal Register notice on August 3,
2009 (74 FR 38444), announcing fees for
fiscal year (FY) 2010. 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.
FDA From 3602— For Domestic Small
Business Applicants
For FY 2010, 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. 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
E:\FR\FM\23OCN1.SGM
23OCN1
54827
Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Notices
• Provide the dates during which the
reported receipts or sales were
collected; and
• Bear the official seal of the national
taxing authority.
Both FDA Forms 3602 and 3602A are
available in the guidance document,
‘‘Guidance for Industry, FDA and
Foreign Governments: FY 2010
MDUFMA Small Business Qualification
and Certification’’ , available on the
Internet at https://www.fda.gov/
downloads/MedicalDevices/Device
RegulationandGuidance/Overview/
MedicalDeviceUserFeeand
ModernizationActMDUFMA/
UCM179257.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 2010.
FDA estimates the burden of this
collection of information as follows:
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;
materials and decide whether an
applicant is a ‘‘small business’’ within
the meaning of MDUFMA.
FDA Form 3602A— For Foreign Small
Business Applicants
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.
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
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
FDA
Form No.
Number of
Respondents
3602
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total
Hours
3,000
1
3,000
1
340
1
340
33
3602A
Section III
3,000
340
3602A
Sections I and II
1
7
231
1
231
TOTALS
CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
1There
3,571
are no capital costs or operating and maintenance costs associated with this collection of information.
The FDA Form 3602 burden is based
on the number of applications received
in the last 3 years. FDA believes most
entities that submit FDA Form 3602A
will not have any affiliates, and very
few will have more than three or four
affiliates. Based on our experience with
FDA Form 3602A, FDA believes each
business will require 1 hour to complete
Sections I and II. FDA does not have any
data on the time that will be required to
complete Section III, the National
Taxing Authority Certification, since
there is a different tax verification
process by each country’s National
Taxing Authority.
The information collection for FDA
Form 3602 is currently approved under
OMB control number 0910–0508. The
information collection for FDA Form
3602A is currently approved under
OMB control number 0910–0613. With
this request for approval, FDA is
requesting to consolidate OMB
approvals 0910–0508 and 0910–0613
into one information collection using
the OMB control number 0910–0508.
VerDate Nov<24>2008
15:24 Oct 22, 2009
Jkt 220001
Dated: October 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25538 Filed 10–22–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0505]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Recordkeeping
and Reporting Requirements for
Human Food and Cosmetics
Manufactured From, Processed With,
or Otherwise Containing, Material
From Cattle
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Fmt 4703
DATES: Submit written or electronic
comments on the collection of
information by December 22, 2009.
ADDRESSES: Submit electronic
comments on the collection of
Notice.
Frm 00052
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
the information collection requirements
of FDA’s regulations that require records
on FDA-regulated human food,
including dietary supplements, and
cosmetics that are manufactured from,
processed with, or otherwise contain,
material derived from cattle.
Sfmt 4703
E:\FR\FM\23OCN1.SGM
23OCN1
]]>Agencies
[Federal Register Volume 74, Number 204 (Friday, October 23, 2009)]
[Notices]
[Pages 54826-54827]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25538]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0486]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry, FDA, and Foreign Governments:
Fiscal Year 2010 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 FDA Forms 3602 and FDA Form
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 written or electronic comments on the collection of
information by December 22, 2009.
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: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
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
practicalutility; (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, and Foreign Governments: FY 2010 Medical
Device User Fee Small Business Qualification and Certification FD&C Act
Section 738 (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 act) to
provide for user fees for certain medical device applications. FDA
published a Federal Register notice on August 3, 2009 (74 FR 38444),
announcing fees for fiscal year (FY) 2010. 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.
FDA From 3602-- For Domestic Small Business Applicants
For FY 2010, 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. 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
[[Page 54827]]
materials and decide whether an applicant is a ``small business''
within the meaning of MDUFMA.
FDA Form 3602A-- For Foreign Small Business Applicants
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.
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 FDA Forms 3602 and 3602A are available in the guidance
document, ``Guidance for Industry, FDA and Foreign Governments: FY 2010
MDUFMA Small Business Qualification and Certification'' , available on
the Internet at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/UCM179257.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 2010.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Annual Frequency Total Annual Hours per
FDA Form No. Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
3602 3,000 1 3,000 1 3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
3602A 340 1 340 1 340
Sections I and II
--------------------------------------------------------------------------------------------------------------------------------------------------------
3602A 33 7 231 1 231
Section III
--------------------------------------------------------------------------------------------------------------------------------------------------------
TOTALS 3,571
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The FDA Form 3602 burden is based on the number of applications
received in the last 3 years. FDA believes most entities that submit
FDA Form 3602A will not have any affiliates, and very few will have
more than three or four affiliates. Based on our experience with FDA
Form 3602A, FDA believes each business will require 1 hour to complete
Sections I and II. FDA does not have any data on the time that will be
required to complete Section III, the National Taxing Authority
Certification, since there is a different tax verification process by
each country's National Taxing Authority.
The information collection for FDA Form 3602 is currently approved
under OMB control number 0910-0508. The information collection for FDA
Form 3602A is currently approved under OMB control number 0910-0613.
With this request for approval, FDA is requesting to consolidate OMB
approvals 0910-0508 and 0910-0613 into one information collection using
the OMB control number 0910-0508.
Dated: October 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25538 Filed 10-22-09; 8:45 am]
BILLING CODE 4160-01-S
