Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses, 3812-3814 [2022-01369]
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Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices
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.
Exports Notification and
Recordkeeping Requirements—21 CFR
1.101
OMB Control Number 0910–0482—
Extension
Sections 801 and 802 of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 381 and 21 U.S.C. 382)
charge the Secretary of Health and
Human Services, through FDA, with the
responsibility of helping to ensure that
exports of unapproved new drugs,
biologics, devices, animal drugs, food,
cosmetics, and tobacco products that are
not to be sold in the United States meet
the requirements of the country to
which the product is to be exported.
The respondents to this information
collection are exporters who have
notified FDA of their intent to export
unapproved products that may not be
sold or offered for sale in domestic
commerce in the United States as
allowed under section 801(e) of the
FD&C Act. In general, the notification
identifies the product being exported
(e.g., name, description, and in some
cases, country of destination) and
specifies where the notifications were
sent. These notifications are sent only
for an initial export. Subsequent exports
of the same product to the same
destination or to certain countries
identified in section 802(b) of the FD&C
Act would not result in a notification to
FDA.
Respondents to the information
collection are exporters of products that
may not be sold in the United States and
are regulated by FDA’s Center for Drug
Evaluation and Research (CDER); Center
for Biologics Evaluation and Research
(CBER); Center for Devices and
Radiological Health (CDRH); Center for
Veterinary Medicine (CVM); Center for
Food Safety and Applied Nutrition
(CFSAN); and Center for Tobacco
Products. Respondents to this collection
of information maintain records
demonstrating their compliance with
the requirements in 21 CFR 1.101.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR
section
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
1.101(d) (CBER) ..................................................................
1.101(d) (CDER) ..................................................................
1.101(d) (CDRH) ..................................................................
5
5
160
92
180
1
460
900
160
15
15
15
6,900
13,500
2,400
Total ..............................................................................
........................
........................
........................
........................
22,800
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR
section
Number of
recordkeepers
Total
annual
records
Average
burden per
recordkeeping
Total hours
1.101(b), (c), and (e) (CBER, CDER, CDRH, CFSAN, and
CVM) ................................................................................
1.101(b) Office of International Programs only ...................
1.101(b) (currently regulated Tobacco Products) ................
320
1
322
3
189
3
960
189
966
22
22
22
21,120
4,158
21,252
Total ..............................................................................
........................
........................
........................
........................
46,530
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of Agency data, we
are retaining the currently approved
burden estimates associated with the
individual reporting and recordkeeping
elements.
Dated: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01372 Filed 1–24–22; 8:45 am]
BILLING CODE 4164–01–P
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Number of
records per
recordkeeper
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3662]
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.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
SUMMARY:
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17:19 Jan 24, 2022
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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 information
collection associated with the guidance
on reagents for detection of specific
novel influenza A viruses.
DATES: Submit either electronic or
written comments on the collection of
information by March 28, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
E:\FR\FM\25JAN1.SGM
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Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before March 28,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 28, 2022. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
khammond on DSKJM1Z7X2PROD with NOTICES
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–
2015–N–3662 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Guidance
on Reagents for Detection of Specific
Novel Influenza A Virus.’’ Received
comments, those filed in a timely
VerDate Sep<11>2014
17:19 Jan 24, 2022
Jkt 256001
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
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-201509-18/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:
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, PRAStaff@
fda.hhs.gov.
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.
PO 00000
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3813
‘‘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
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
E:\FR\FM\25JAN1.SGM
25JAN1
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Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices
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,’’ 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.
FDA estimates that 12 respondents
will be affected annually. The
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 360
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
part 820 have been approved under
OMB control number 0910–0073.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Recordkeeping regarding reagents for detection of specific
novel influenza A viruses .................................................
1 There
Number of
records per
recordkeeper
12
2
Average
burden per
recordkeeping
24
Total hours
15
360
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: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01369 Filed 1–24–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4042]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Establishing and
Maintaining Lists of United States
Establishments With Interest in
Exporting Center for Food Safety and
Applied Nutrition-Regulated Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Total annual
records
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17:19 Jan 24, 2022
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to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection associated with export lists
for products regulated by the Center for
Food Safety and Applied Nutrition
(CFSAN).
Submit either electronic or
written comments on the collection of
information by March 28, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before March 28,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 28, 2022. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
E:\FR\FM\25JAN1.SGM
25JAN1
]]>Agencies
[Federal Register Volume 87, Number 16 (Tuesday, January 25, 2022)]
[Notices]
[Pages 3812-3814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01369]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3662]
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 information collection
associated with the guidance on reagents for detection of specific
novel influenza A viruses.
DATES: Submit either electronic or written comments on the collection
of information by March 28, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
[[Page 3813]]
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 28, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 28, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is 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-2015-N-3662 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance on Reagents for
Detection of Specific Novel Influenza A Virus.'' 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 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: 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: 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
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
[[Page 3814]]
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,'' 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.
FDA estimates that 12 respondents will be affected annually. The
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 360 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 part 820 have been approved under OMB control
number 0910-0073.
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 12 2 24 15 360
for detection of specific novel
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: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01369 Filed 1-24-22; 8:45 am]
BILLING CODE 4164-01-P
