Notice2025-16065
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
August 22, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 161 (Friday, August 22, 2025)</title>
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[Federal Register Volume 90, Number 161 (Friday, August 22, 2025)]
[Notices]
[Pages 41080-41081]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16065]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0414]
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: Submit written comments (including recommendations) on the
collection of information by September 22, 2025.
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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#8ddddfccdef9ecebebcdebe9eca3e5e5fea3eae2fb"><span class="__cf_email__" data-cfemail="f5a5a7b4a681949393b5939194db9d9d86db929a83">[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
This information collection was established as a special control
for the class II device type, Novel Influenza A Reagents. 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 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,'' (March
2006) 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/medical-
devices/guidance-documents-medical-devices-
[[Page 41081]]
and-radiation-emitting-products/reagents-detection-specific-novel-
influenza-viruses-class-ii-special-controls-guidance-industry-and.
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 May 1, 2025 (90 FR 18667), 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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Information collection Number of
activity--21 CFR part and Number of responses per Total annual Average burden per Total hours
guidance document section respondents respondent responses response
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21 CFR 866.3332 Reagents for detection of specific novel influenza A viruses and FDA Guidance Document ``Class
II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses''
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Postmarket analysis of novel 12 2 24 15 360
influenza A viral sequences--
866.3332(b)(1) and guidance
section 8, Postmarket measures
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: August 15, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16065 Filed 8-21-25; 8:45 am]
BILLING CODE 4164-01-P
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