Document ID: FDA-2012-N-0980-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance on Reagents for Detection of Specific Novel Influenza A Viruses
Posted Date: 2012-09-25T04:00Z

[Federal Register Volume 77, Number 186 (Tuesday, September 25, 2012)]
[Notices]
[Pages 58997-58998]
From the Federal Register Online via the Government Printing 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, 
Daniel.Gittleson@fda.hhs.gov.

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]
BILLING CODE 4160-01-P