[Federal Register Volume 81, Number 57 (Thursday, March 24, 2016)]
[Notices]
[Pages 15727-15728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06710]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3662]


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.

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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 April 
25, 2016.

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 [email protected]. 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 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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--21 CFR Part 866 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 section 513(a)(1)(B) of the FD&C Act, 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'' (section 513(a)(1)(B) of the FD&C Act). 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 March 22, 2006 (71 FR 14377), 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 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 part 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

[[Page 15728]]

part 820 have been approved under OMB control number 0910-0073.
    In the Federal Register of October 19, 2015 (80 FR 63230), 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 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: March 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06710 Filed 3-23-16; 8:45 am]
 BILLING CODE 4164-01-P