[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18667-18669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07590]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0414]
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 the information collection associated with
Agency guidance on reagents for detection of specific novel influenza A
viruses.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 30, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 30, 2025. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2025-N-0414 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance on Reagents for
Detection of Specific Novel Influenza A Viruses.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available
[[Page 18668]]
for public viewing and posted on https://www.regulations.gov. Submit
both copies to the Dockets Management Staff. If you do not wish your
name and contact information to be made publicly available, you can
provide this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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--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-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.
FDA estimates the burden of this collection of information as
follows:
[[Page 18669]]
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Total Average
Information collection activity--21 CFR Number of responses per annual burden per Total hours
part and 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 influenza 12 2 24 15 360
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: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07590 Filed 4-30-25; 8:45 am]
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