[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36509-36510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13069]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) 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: Submit written comments (including recommendations) on the 
collection of information by July 18, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0584. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[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 (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 [of HHS] 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

[[Page 36510]]

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 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 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. The guidance document is 
available on our website at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm078583.htm.
    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.
    In the Federal Register of January 25, 2022 (87 FR 3812), 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping regarding reagents for detection of specific novel                 12                2               24               15              360
 influenza A viruses...............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects an 
overall increase of 330 hours and a corresponding increase of 22 
records. We attribute this adjustment to an increase in the number of 
devices of this type being manufactured over the last few years.

    Dated: June 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13069 Filed 6-16-22; 8:45 am]
BILLING CODE 4164-01-P


