Notice2022-13069
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 17, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 117 (Friday, June 17, 2022)</title>
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[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36509-36510]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13069]
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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 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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#0d5d5f4c5e796c6b6b4d6b696c2365657e236a627b"><span class="__cf_email__" data-cfemail="1a4a485b496e7b7c7c5a7c7e7b34727269347d756c">[email protected]</span></a>.
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: <a href="https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm078583.htm">https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm078583.htm</a>.
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\
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Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Recordkeeping regarding reagents for detection of specific novel 12 2 24 15 360
influenza A viruses...............................................
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\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
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