[Federal Register Volume 77, Number 186 (Tuesday, September 25, 2012)]
[Notices]
[Pages 58997-58998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23544]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0980]
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 either electronic or written comments on the collection
of information by November 26, 2012.
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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
[email protected].
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 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 FD&C 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 was codified in 21 CFR 866.3332, a regulation that
describes the new classification for reagents for detection of specific
novel influenza A viruses and sets forth the special controls that help
to provide a reasonable assurance of the safety and effectiveness of
devices classified under that regulation. The regulation refers 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
[[Page 58998]]
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; each response
is estimated to take 15 hours. This results in a total data collection
burden of 300 hours. The guidance also refers to previously approved
information collections found in FDA regulations. The collections of
information in 21 CFR 801 have been approved under OMB control number
0910-0485; the collections of information in 21 CFR part 807 subpart E
have been approved under OMB control number 0910-0120; and the
collections of information in 21 CFR part 820 have been approved under
OMB control number 0910-0073.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden 1
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Number of Average burden
FD&C Act section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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513(g)...................... 10 2 20 15 300
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: September 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23544 Filed 9-24-12; 8:45 am]
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