Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Inspection by Accredited Persons Program, 6821-6822 [2013-02092]
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6821
Federal Register / Vol. 78, No. 21 / Thursday, January 31, 2013 / Notices
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
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, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@OMB.EOP.
GOV, Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013–02079 Filed 1–30–13; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
[Docket No. FDA–2012–N–0427]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Inspection by Accredited Persons
Program
Food and Drug Administration,
Inspection by Accredited Persons
Program Under the Medical Device
User Fee and Modernization Act of
2002—(OMB Control Number 0910–
0510)—Extension
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.
SUMMARY:
Fax written comments on the
collection of information by March 4,
2013.
DATES:
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 0910–0510. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
AGENCY:
ACTION:
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.
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:
HHS.
The Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
(Pub. L. 107–250) was signed into law
on October 26, 2002. Section 201 of
MDUFMA adds a new paragraph (g) to
section 704 of the Federal, Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 374), directing FDA to accredit
third parties (accredited persons) to
conduct inspections of eligible
manufacturers of class II or class III
devices. This is a voluntary program.
FDA has a guidance document that
provides information for those
interested in participating in this
program. The guidance is entitled
‘‘Implementation of the Inspection by
Accredited Persons Program Under the
Medical Device User Fee and
Modernization Act of 2002;
Accreditation Criteria.’’
FDA based these estimates on
conversations with industry, trade
association representatives, and internal
FDA estimates. Once an organization is
accredited, it will not be required to
reapply.
In the Federal Register of May 09,
2012 (77 FR 27234), 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
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Section of the FD&C Act
Activity
704(g) ..................................
Request for accreditation ...
1
1
1
80
80
Total .............................
.............................................
........................
........................
........................
........................
80
srobinson on DSK4SPTVN1PROD with
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Total hours
6822
Federal Register / Vol. 78, No. 21 / Thursday, January 31, 2013 / Notices
Dated: January 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–02092 Filed 1–30–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0324]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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
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.
SUMMARY:
Fax written comments on the
collection of information by March 4,
2013.
DATES:
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. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
srobinson on DSK4SPTVN1PROD with
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.
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:
VerDate Mar<15>2010
17:38 Jan 30, 2013
Jkt 229001
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) (Pub. L. 107–250) amends
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) to provide for user
fees for certain medical device
applications. FDA 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
PO 00000
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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.
In the Federal Register of April 18,
2012 (77 FR 23267), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
E:\FR\FM\31JAN1.SGM
31JAN1
]]>Agencies
[Federal Register Volume 78, Number 21 (Thursday, January 31, 2013)]
[Notices]
[Pages 6821-6822]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02092]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0427]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Inspection by Accredited Persons Program
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 March
4, 2013.
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 0910-0510.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Inspection by Accredited Persons Program Under the Medical Device User
Fee and Modernization Act of 2002--(OMB Control Number 0910-0510)--
Extension
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
(Pub. L. 107-250) was signed into law on October 26, 2002. Section 201
of MDUFMA adds a new paragraph (g) to section 704 of the Federal, Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 374), directing FDA to
accredit third parties (accredited persons) to conduct inspections of
eligible manufacturers of class II or class III devices. This is a
voluntary program. FDA has a guidance document that provides
information for those interested in participating in this program. The
guidance is entitled ``Implementation of the Inspection by Accredited
Persons Program Under the Medical Device User Fee and Modernization Act
of 2002; Accreditation Criteria.''
FDA based these estimates on conversations with industry, trade
association representatives, and internal FDA estimates. Once an
organization is accredited, it will not be required to reapply.
In the Federal Register of May 09, 2012 (77 FR 27234), 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 Average
Section of the FD&C Act Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
704(g).................................... Request for accreditation... 1 1 1 80 80
---------------
Total................................. ............................ .............. .............. .............. .............. 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 6822]]
Dated: January 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02092 Filed 1-30-13; 8:45 am]
BILLING CODE 4160-01-P
