[Federal Register: October 13, 2009 (Volume 74, Number 196)]
[Notices]
[Page 52493-52494]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13oc09-75]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0484]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance on Reagents for Detection of Specific Novel
Influenza A Viruses
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 guidance on reagents for
detection of specific novel influenza A viruses.
DATES: Submit written or electronic comments on the collection of
information by December 14, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to http://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
[[Page 52494]]
(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 on Reagents For Detection of Specific Novel Influenza A
Viruses-21 CFR 866.3332-(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 the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Section of the Federal Food, Drug, and No. of Annual Frequency Total Annual Hours per Total Operating &
Cosmetic Act Respondents per Response Responses Response Total Hours Maintenance Costs
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513 10 2 20 10 200 $5,000
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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.
Dated: October 5, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24544 Filed 10-9-09; 8:45 am]
BILLING CODE 4160-01-S