Laser-Assisted In Situ Keratomileusis Lasers-Patient Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period, 61335-61337 [2022-21971]
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61335
Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices
September 21, 2022
JJia M. T<iledQ. Garcia
President& Director
Laboratorio Clinico Toledo
51P.ahnast
Atecibo .PR O(X,12
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Revot:ation of EIJ:Al00207
Dear lliaM. Toledo Garcia:
'JJtlS: lmteris in resp.Qnse tQ the request fto111 Lab-Or:1¢0:tio CJinico 'l'oledp, received via email .pn
September &, 2022, thatthe US .. Food. and Drug Administration{FDA) \'.\cithdraw the EUA for
the Laboratorio Clinico Toledo SARS-CoVc2 Assay issued on July 6; :2020, and amended on
Pecembet 28, 202J):, and Septembet 23, 202:L Laboratorio Clinico Toledb indicated in their
email ®d cover letter that they are 11.p longer testing with fb,eLaborato.i:io CHnic.P Toled0: SARS
0
Cov:.2 As:i,ay ~d have none of the reagents .in stock in their faborat<>ty,
The authorization of a device tor emergency use undet section 564 oftheFede:tal Food, Drug,
and C0$11\etlc Act (the Act) {21 us.c. 360bbb·3) may, p:t)tsuantto sectiQn 564@(:2) 6ftheAct,
be revo:ked W11en circµm:stiuwes !Uake· sttcll revocation appr0:pi:iatl'l to prQtect th,e p11blic h.ealth or
safety (section 564(g)(2)(C) oftheAct). Because Laboratorio Clinico Toledo has notified FDA
that it has dedded to no longer test-using tbeLaboratorio Clinico Toledo SARScCoV4 Assay
and requested FDA withdraw the EUA f:otthe Laboratorio Cllnico Toledo SARS~CoV~2 Assay,
IDA has determined that itis appropriate iQ protect the pi,iblic health or safety to revoke this
authorization, Acc'->rdingly, FDA heret,y revokes EUA200207 forthe Labrnat.prio t:Iinico
Toledo SARS-CoV -2 Assay, pursuant to section 564(gJ(2)(C) of the Act As ofthe date ofthis
letter, the Labotatorio Clinfo.o Toledo SARS~CoV-2 Assay i:s no lortger authori1ed for
emergency use by FPA
Notice ofthis revocation will 1le pµbH$hed ln the FederatRegister, pµrs:q~t<> s~ti<>n 564(h.).(I)
oftheAct.
Isl
NamandjeN, Bimip11S.Ph.D,
ChiefScientist
Food and Drug Administration
[FR Doc. 2022–21998 Filed 10–7–22; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
BILLING CODE 4164–01–C
ACTION:
Food and Drug Administration
SUMMARY:
[Docket No. FDA–2022–D–1253]
Laser-Assisted In Situ Keratomileusis
Lasers—Patient Labeling
Recommendations; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
17:37 Oct 07, 2022
Jkt 259001
Notice of availability; extension
of comment period.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
notice of availability that appeared in
the Federal Register of July 28, 2022. In
the notice of availability, FDA requested
comments on draft guidance for
industry and FDA staff entitled ‘‘LaserAssisted In Situ Keratomileusis (LASIK)
Lasers—Patient Labeling
Recommendations.’’ The Agency is
taking this action in response to
requests for an extension to allow
E:\FR\FM\11OCN1.SGM
11OCN1
EN11OC22.000</GPH>
Dated: October 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
61336
Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices
interested persons additional time to
submit comments.
DATES: FDA is extending the comment
period on the document published July
28, 2022 (87 FR 45334). Submit either
electronic or written comments on the
draft guidance by November 25, 2022, to
ensure that the Agency considers your
comment on this draft guidance before
it begins work on the final version of the
guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
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–
2022–D–1253 for ‘‘Laser-Assisted In
Situ Keratomileusis (LASIK) Lasers—
VerDate Sep<11>2014
17:37 Oct 07, 2022
Jkt 259001
Patient Labeling Recommendations.’’
Received comments 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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Laser-Assisted In
Situ Keratomileusis (LASIK) Lasers—
Patient Labeling Recommendations’’ to
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
the Office of Policy, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Bradley Cunningham, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1414,
Silver Spring, MD 20993–0002, 301–
796–6484.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 28,
2022, FDA published a notice of
availability with a 90-day comment
period to request comments on draft
guidance for industry and FDA staff
entitled ‘‘Laser-Assisted In Situ
Keratomileusis (LASIK) Lasers—Patient
Labeling Recommendations.’’
The Agency has received requests for
an extension of the comment period.
The requests conveyed the desire for
additional time to develop meaningful
and thoughtful feedback.
FDA has considered the requests and
is extending the comment period for the
notice of availability for 30 days, until
November 25, 2022. The Agency
believes that a 30-day extension allows
adequate time for interested persons to
submit comments without significantly
delaying guidance on these important
issues.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Laser-Assisted In Situ
Keratomileusis (LASIK) Lasers—Patient
Labeling Recommendations.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This draft
guidance document is also available at
https://www.regulations.gov and at
https://www.fda.gov/regulatory-
E:\FR\FM\11OCN1.SGM
11OCN1
Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices
information/search-fda-guidancedocuments. Persons unable to download
an electronic copy of ‘‘Laser-Assisted In
Situ Keratomileusis (LASIK) Lasers—
Patient Labeling Recommendations’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 16053 and
complete title to identify the guidance
you are requesting.
Dated: October 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–21971 Filed 10–7–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2390]
Proposal To Refuse To Approve a New
Drug Application Supplement for
HETLIOZ (Tasimelteon); Opportunity
for a Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Director of the Center for
Drug Evaluation and Research (Center
Director) at the Food and Drug
Administration (FDA or Agency) is
proposing to refuse to approve a
supplemental new drug application
(sNDA) submitted by Vanda
Pharmaceuticals, Inc. (Vanda), for
HETLIOZ (tasimelteon) capsules, 20
milligrams (mg), in its present form.
This notice summarizes the grounds for
the Center Director’s proposal and offers
Vanda an opportunity to request a
hearing on the matter.
DATES: Either electronic or written
requests for a hearing must be submitted
by November 10, 2022; submit data,
information, and analyses in support of
the hearing and any other comments by
December 12, 2022.
ADDRESSES: You may submit hearing
requests, documents in support of the
hearing, and any other comments as
follows. Please note that late, untimely
filed requests and documents will not
be considered. The https://
www.regulations.gov electronic filing
system will accept hearing requests
until 11:59 p.m. Eastern Time at the end
of November 10, 2022, and will accept
documents in support of the hearing
and any other comments until 11:59
p.m. Eastern Time at the end of
December 12, 2022. Documents received
by mail/hand delivery/courier (for
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:37 Oct 07, 2022
Jkt 259001
written/paper submissions) will be
considered timely if they are received
on or before these dates.
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–
2022–N–2390 for ‘‘Proposal To Refuse
To Approve a New Drug Application
Supplement for HETLIOZ
(Tasimelteon); Opportunity for a
Hearing.’’ 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
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
61337
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:
Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6224,
Silver Spring, MD 20993, 301–796–
1546, Kaetochi.Okemgbo@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Proposal To Refuse To Approve
sNDA 205677–004
FDA approved new drug application
(NDA) 205677 for HETLIOZ
(tasimelteon) for treatment of non-24hour sleep-wake disorder on January 31,
2014. On October 16, 2018, Vanda
submitted sNDA 205677–004 for
HETLIOZ (tasimelteon) capsule, 20 mg,
as an efficacy supplement proposing to
add a new indication for the treatment
of jet lag disorder. Jet lag disorder is
recognized by the International
Classification of Sleep Disorders as a
circadian rhythm sleep-wake disorder
E:\FR\FM\11OCN1.SGM
11OCN1
]]>Agencies
[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Pages 61335-61337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21971]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-1253]
Laser-Assisted In Situ Keratomileusis Lasers--Patient Labeling
Recommendations; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice of availability that
appeared in the Federal Register of July 28, 2022. In the notice of
availability, FDA requested comments on draft guidance for industry and
FDA staff entitled ``Laser-Assisted In Situ Keratomileusis (LASIK)
Lasers--Patient Labeling Recommendations.'' The Agency is taking this
action in response to requests for an extension to allow
[[Page 61336]]
interested persons additional time to submit comments.
DATES: FDA is extending the comment period on the document published
July 28, 2022 (87 FR 45334). Submit either electronic or written
comments on the draft guidance by November 25, 2022, to ensure that the
Agency considers your comment on this draft guidance before it begins
work on the final version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
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-2022-D-1253 for ``Laser-Assisted In Situ Keratomileusis (LASIK)
Lasers--Patient Labeling Recommendations.'' Received comments 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Laser-Assisted In Situ Keratomileusis (LASIK) Lasers--Patient
Labeling Recommendations'' to the Office of Policy, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT: Bradley Cunningham, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1414, Silver Spring, MD 20993-0002, 301-
796-6484.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 28, 2022, FDA published a notice of
availability with a 90-day comment period to request comments on draft
guidance for industry and FDA staff entitled ``Laser-Assisted In Situ
Keratomileusis (LASIK) Lasers--Patient Labeling Recommendations.''
The Agency has received requests for an extension of the comment
period. The requests conveyed the desire for additional time to develop
meaningful and thoughtful feedback.
FDA has considered the requests and is extending the comment period
for the notice of availability for 30 days, until November 25, 2022.
The Agency believes that a 30-day extension allows adequate time for
interested persons to submit comments without significantly delaying
guidance on these important issues.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Laser-
Assisted In Situ Keratomileusis (LASIK) Lasers--Patient Labeling
Recommendations.'' It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.
II. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This draft guidance document
is also available at https://www.regulations.gov and at https://
www.fda.gov/regulatory-
[[Page 61337]]
information/search-fda-guidance-documents. Persons unable to download
an electronic copy of ``Laser-Assisted In Situ Keratomileusis (LASIK)
Lasers--Patient Labeling Recommendations'' may send an email request to
[email protected] to receive an electronic copy of the
document. Please use the document number 16053 and complete title to
identify the guidance you are requesting.
Dated: October 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21971 Filed 10-7-22; 8:45 am]
BILLING CODE 4164-01-P
