Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses, 2872-2874 [2010-794]
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Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices
334(g)), to detain during established
inspections, devices that are believed to
be adulterated or misbranded. FDA
issued a final rule that published in a
March 9, 1979, Federal Register (44 FR
13234) on administrative detention
procedures, which includes among
other things, certain reporting
requirements and recordkeeping
requirements under § 800.55(g) and (k),
(21 CFR 800.55(g) and (k)). Under
§ 800.55(g), an applicant of a detention
order must show documentation of
ownership if devices are detained at a
place other than that of the appellant.
Under § 800.55(k), the owner or other
responsible person must supply records
about how the devices may have
become adulterated or misbranded, in
addition to records of distribution of the
detained devices. These recordkeeping
requirements for administrative
detentions permits FDA to trace devices
for which the detention period expired
before a seizure is accomplished or
injunctive relief is obtained.
FDA also has the statutory authority
under section 516 of the act (21 U.S.C.
360f) to ban devices that present
substantial deception or an
unreasonable and substantial risk of
illness or injury. The final rule for
banned devices that published in the
May 18, 1979, Federal Register (44 FR
29221) contained certain reporting
requirements under 21 CFR 895.21(d)
and 895.22(a). Section 895.21(d) states
that if the Commissioner of Food and
Drugs (the Commissioner), decides to
initiate a proceeding to make a device,
‘‘a banned device,’’ a notice of proposed
rulemaking will be published in the
Federal Register and this document will
contain the finding that the device
presents a substantial deception or an
unreasonable and substantial risk of
illness or injury. The document will
also contain the reasons why the
proceeding was initiated, an evaluation
of data and information obtained under
other provisions of the act, any
consultations with the panel, and a
determination as to whether the device
could be corrected by labeling, change
of labeling, change of advertising, and if
that labeling or change of advertising
has been made. Under § 895.21(d), any
interested person may request an
informal hearing and submit written
comments. Under § 895.22, a
manufacturer, distributor, or importer of
a device may be required to submit to
FDA all relevant and available data and
information to enable the Commissioner
to determine whether the device
presents substantial deception,
unreasonable and substantial risk of
illness or injury, or unreasonable, direct,
and substantial danger to the health of
individuals.
During the past several years, there
has been an average of less than one
new administrative detention action per
year. Each administrative detention will
have varying amounts of data and
information that must be maintained.
FDA’s estimate of the burden under the
administrative detention provision is
based on FDA’s discussion with one of
three firms whose devices had been
detained.
In the Federal Register of October 16,
2009 (74 FR 53257), 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 BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
800.55(g)
Total Annual
Responses
Hours per
Response
Total Hours
1
1
25
25
26
895.21(d) and 895.22(a)
1
1
26
16
416
Totals
1 There
441
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
800.55(k)
Annual Frequency
per Recordkeeping
1
Total Annual
Records
1
Hours per
Recordkeeper
1
20
Totals
1 There
20
461
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2010–795 Filed 1–15–10; 8:45 am]
[Docket No. FDA–2009–N–0484]
BILLING CODE 4160–01–S
jlentini on DSKJ8SOYB1PROD with NOTICES
Total Hours
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Reagents for Detection of Specific
Novel Influenza A Viruses
AGENCY:
Food and Drug Administration,
HHS.
VerDate Nov<24>2008
16:28 Jan 15, 2010
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Sfmt 4703
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 February
18, 2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
E:\FR\FM\19JAN1.SGM
19JAN1
Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0584. Also
include the FDA docket number found
in brackets in the heading of the
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 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:
Guidance on Reagents for Detection of
Specific Novel Influenza A Viruses—
(OMB Control Number 0910–0584)—
Extension
In accordance with section 513 of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360c), FDA
evaluated an application for an in vitro
diagnostic device for detection of
influenza subtype H5 (Asian lineage),
commonly known as avian flu. FDA
concluded that this device is properly
classified into class II in accordance
with 21 U.S.C. 360c(a)(1)(B), because it
is a device for which the general
controls by themselves are insufficient
to provide reasonable assurance of the
safety and effectiveness of the device,
but there is sufficient information to
establish special controls to provide
such assurance. The statute permits
FDA to establish as special controls
many different things, including
postmarket surveillance, development
and dissemination of guidance
recommendations, and ‘‘other
appropriate actions as the Secretary
deems necessary’’ (21 U.S.C.
360c(a)(1)(B)). This information
collection is a measure that FDA
determined to be necessary to provide
reasonable assurance of safety and
effectiveness of reagents for detection of
specific novel influenza A viruses. FDA
issued an order classifying the H5
(Asian lineage) diagnostic device into
class II on February 3, 2006, establishing
the special controls necessary to provide
reasonable assurance of the safety and
effectiveness of that device and similar
future devices. The new classification
will be codified in 21 CFR 866.3332, a
regulation that will describe the new
classification for reagents for detection
of specific novel influenza A viruses
and set forth the special controls that
help to provide a reasonable assurance
of the safety and effectiveness of devices
classified under that regulation. The
regulation will refer to the special
controls guidance document entitled
‘‘Class II Special Controls Guidance
Document: Reagents for Detection of
Specific Novel Influenza A Viruses,’’
which provides recommendations for
measures to help provide a reasonable
assurance of safety and effectiveness for
these reagents. The guidance document
recommends that sponsors obtain and
analyze postmarket data to ensure the
continued reliability of their device in
detecting the specific novel influenza A
virus that it is intended to detect,
particularly given the propensity for
influenza viruses to mutate and the
potential for changes in disease
2873
prevalence over time. As updated
sequences for novel influenza A viruses
become available from the World Health
Organization, National Institutes of
Health, and other public health entities,
sponsors of reagents for detection of
specific novel influenza A viruses will
collect this information, compare them
with the primer/probe sequences in
their devices, and incorporate the result
of these analyses into their quality
management system, as required by 21
CFR 820.100(a)(1). These analyses will
be evaluated against the device design
validation and risk analysis required by
21 CFR 820.30(g), to determine if any
design changes may be necessary.
FDA estimates that 10 respondents
will be affected annually. Each
respondent will collect this information
twice per year, estimated to take 10
hours. This results in a total data
collection burden of 200 hours (10 x 20
= 200). FDA estimates that cost of
developing standard operating
procedures for each data collection is
$500 (10 hours of work at $50/hour).
This results in a total cost to industry of
$5,000 ($500 x 10 respondents). The
guidance also refers to previously
approved information collections found
in FDA regulations. The information
collections in 21 CFR part 820 have
been approved under OMB control
number 0910–0073.
In the Federal Register of October 13,
2009 (74 FR 52493), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was
received, however it was not PRA
related.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Section of the Act
No. of
Respondents
513(g)
jlentini on DSKJ8SOYB1PROD with NOTICES
1 There
Annual Frequency
per Response
10
Total Annual
Responses
2
Hours per
Response
20
15
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Nov<24>2008
16:28 Jan 15, 2010
Jkt 220001
PO 00000
Frm 00030
Fmt 4703
Sfmt 9990
E:\FR\FM\19JAN1.SGM
Total Hours
19JAN1
300
2874
Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices
Due to a clerical error, capital costs
and operating and maintenance costs
that appeared in a notice published in
the Federal Register of October 20, 2009
(74 FR 53749) were incorrect. There are
actually no capital and maintenance
costs; additionally, the hours per
response which were reported as 10 are
actually 15. Table 1 of this document
contains the correct hour burden.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–794 Filed 1–15–10; 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; Submission for Office of
Management and Budget Review;
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.
jlentini on DSKJ8SOYB1PROD with NOTICES
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 February
18, 2010.
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 e-mailed 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 the
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–5156,
Daniel.Gittleson@fda.hhs.gov.
VerDate Nov<24>2008
16:28 Jan 15, 2010
Jkt 220001
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:
Guidance for Industry, FDA, and
Foreign Governments: Fiscal Year 2010
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 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 Form 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
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
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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/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.
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, because
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
E:\FR\FM\19JAN1.SGM
19JAN1
]]>Agencies
[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2872-2874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-794]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0484]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance on Reagents
for Detection of Specific Novel Influenza A Viruses
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
February 18, 2010.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of
[[Page 2873]]
Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:
202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0584. Also
include the FDA docket number found in brackets in the heading of the
document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 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.
Guidance on Reagents for Detection of Specific Novel Influenza A
Viruses--(OMB Control Number 0910-0584)--Extension
In accordance with section 513 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360c), FDA evaluated an application
for an in vitro diagnostic device for detection of influenza subtype H5
(Asian lineage), commonly known as avian flu. FDA concluded that this
device is properly classified into class II in accordance with 21
U.S.C. 360c(a)(1)(B), because it is a device for which the general
controls by themselves are insufficient to provide reasonable assurance
of the safety and effectiveness of the device, but there is sufficient
information to establish special controls to provide such assurance.
The statute permits FDA to establish as special controls many different
things, including postmarket surveillance, development and
dissemination of guidance recommendations, and ``other appropriate
actions as the Secretary deems necessary'' (21 U.S.C. 360c(a)(1)(B)).
This information collection is a measure that FDA determined to be
necessary to provide reasonable assurance of safety and effectiveness
of reagents for detection of specific novel influenza A viruses. FDA
issued an order classifying the H5 (Asian lineage) diagnostic device
into class II on February 3, 2006, establishing the special controls
necessary to provide reasonable assurance of the safety and
effectiveness of that device and similar future devices. The new
classification will be codified in 21 CFR 866.3332, a regulation that
will describe the new classification for reagents for detection of
specific novel influenza A viruses and set forth the special controls
that help to provide a reasonable assurance of the safety and
effectiveness of devices classified under that regulation. The
regulation will refer to the special controls guidance document
entitled ``Class II Special Controls Guidance Document: Reagents for
Detection of Specific Novel Influenza A Viruses,'' which provides
recommendations for measures to help provide a reasonable assurance of
safety and effectiveness for these reagents. The guidance document
recommends that sponsors obtain and analyze postmarket data to ensure
the continued reliability of their device in detecting the specific
novel influenza A virus that it is intended to detect, particularly
given the propensity for influenza viruses to mutate and the potential
for changes in disease prevalence over time. As updated sequences for
novel influenza A viruses become available from the World Health
Organization, National Institutes of Health, and other public health
entities, sponsors of reagents for detection of specific novel
influenza A viruses will collect this information, compare them with
the primer/probe sequences in their devices, and incorporate the result
of these analyses into their quality management system, as required by
21 CFR 820.100(a)(1). These analyses will be evaluated against the
device design validation and risk analysis required by 21 CFR
820.30(g), to determine if any design changes may be necessary.
FDA estimates that 10 respondents will be affected annually. Each
respondent will collect this information twice per year, estimated to
take 10 hours. This results in a total data collection burden of 200
hours (10 x 20 = 200). FDA estimates that cost of developing standard
operating procedures for each data collection is $500 (10 hours of work
at $50/hour). This results in a total cost to industry of $5,000 ($500
x 10 respondents). The guidance also refers to previously approved
information collections found in FDA regulations. The information
collections in 21 CFR part 820 have been approved under OMB control
number 0910-0073.
In the Federal Register of October 13, 2009 (74 FR 52493), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received, however it was not
PRA related.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual
Section of the Act No. of Respondents per Response Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
513(g) 10 2 20 15 300
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 2874]]
Due to a clerical error, capital costs and operating and
maintenance costs that appeared in a notice published in the Federal
Register of October 20, 2009 (74 FR 53749) were incorrect. There are
actually no capital and maintenance costs; additionally, the hours per
response which were reported as 10 are actually 15. Table 1 of this
document contains the correct hour burden.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-794 Filed 1-15-10; 8:45 am]
BILLING CODE 4160-01-S
