Surveying, Leveling, and Alignment Laser Products; Guidance for Industry and Food and Drug Administration Staff; Availability, 6283-6284 [2023-01964]
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<![CDATA[
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
6283
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
21 CFR part; activity
226.58; requires recordkeeping for establishment of laboratory controls to ensure that adequate specifications
and test procedures for the drug components and Type
A medicated articles conform to appropriate standards
of identity, strength, quality and purity.
226.80; requires maintenance of records for packaging
and labeling of Type A medicated articles.
226.102; requires maintenance of master-formula and
batch-production records for Type A medicated articles.
226.110; requires maintenance of distribution records (2
years), for each shipment of Type A medicated articles
for recall purposes.
226.115; requires maintenance of complaint files for Type
A medicated articles for 2 years.
Total ..............................................................................
1 There
Dated: January 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–01862 Filed 1–30–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0435]
Surveying, Leveling, and Alignment
Laser Products; Guidance for Industry
and Food and Drug Administration
Staff; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Surveying, Leveling,
and Alignment Laser Products.’’ This
guidance is intended for manufacturers
of laser products and outlines FDA’s
approach regarding the applicability of
FDA’s performance standard regulations
to surveying, leveling, and alignment
(SLA) laser products.
DATES: The announcement of the
guidance is published in the Federal
Register on January 31, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Total annual
responses
Average
burden per
response
Total hours
65
260
16,900
1.75 ...............
29,575
65
260
16,900
12,675
65
260
16,900
0.75 (45 minutes).
1.75 ...............
65
260
16,900
65
10
650
........................
........................
........................
0.25 (15 minutes).
0.5 (30 minutes).
........................
29,575
4,225
325
89,050
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.
AGENCY:
Number of
responses per
respondent
VerDate Sep<11>2014
16:46 Jan 30, 2023
Jkt 259001
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
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–D–0435 for ‘‘Surveying, Leveling,
and Alignment Laser Products.’’
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
E:\FR\FM\31JAN1.SGM
31JAN1
6284
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
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 guidance
document entitled ‘‘Surveying,
Leveling, and Alignment Laser
Products’’ 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: Dina
Jerebitski, Center for Devices and
Radiological Health, Food and Drug
I. Background
This guidance is intended for
manufacturers of laser products and
outlines FDA’s approach regarding the
applicability of FDA’s performance
standard regulations to surveying,
leveling, and alignment (SLA) laser
products.
A notice of availability of the draft
guidance appeared in the Federal
Register of May 5, 2014 (79 FR 25597).
FDA considered comments received and
revised the guidance as appropriate in
response to the comments, including
requests for clarification regarding
which laser products are considered
SLA laser products and including
additional questions and answers
regarding SLA laser class limits.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on surveying, leveling,
and alignment laser products. 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 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
guidance document is also available at
https://www.regulations.gov or https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents.
Persons unable to download an
electronic copy of ‘‘Surveying, Leveling,
and Alignment Laser Products’’ may
send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1764 and
complete title to identify the guidance
you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations, guidance, and forms have
been approved by OMB as listed in the
following table:
21 CFR part, guidance, or FDA form
Topic
1002 through 1050 ............................................................................
Reporting and Recordkeeping for Electronic Products—General Requirements.
Dated: January 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
ACTION:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[OMB No. 0915–0285—Revision]
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Health Center Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
VerDate Sep<11>2014
19:38 Jan 30, 2023
Jkt 259001
Notice.
In compliance with the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
SUMMARY:
[FR Doc. 2023–01964 Filed 1–30–23; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3574, Silver Spring,
MD 20993–0002, 301–796–2411.
SUPPLEMENTARY INFORMATION:
Comments on this ICR should be
received no later than March 2, 2023.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
DATES:
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
OMB control No.
0910–0025
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call 301–594–
4394.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Health Center Program Forms OMB No.
0915–0285—Revision.
Abstract: The Health Center Program,
administered by HRSA, is authorized
under Section 330 of the Public Health
Service Act (42 U.S.C. 254b). Health
centers are community-based and
E:\FR\FM\31JAN1.SGM
31JAN1
]]>Agencies
[Federal Register Volume 88, Number 20 (Tuesday, January 31, 2023)]
[Notices]
[Pages 6283-6284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01964]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0435]
Surveying, Leveling, and Alignment Laser Products; Guidance for
Industry and Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Surveying, Leveling,
and Alignment Laser Products.'' This guidance is intended for
manufacturers of laser products and outlines FDA's approach regarding
the applicability of FDA's performance standard regulations to
surveying, leveling, and alignment (SLA) laser products.
DATES: The announcement of the guidance is published in the Federal
Register on January 31, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
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-2014-D-0435 for ``Surveying, Leveling, and Alignment Laser
Products.'' 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
[[Page 6284]]
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 guidance document entitled
``Surveying, Leveling, and Alignment Laser Products'' 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: Dina Jerebitski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3574, Silver Spring, MD 20993-0002, 301-
796-2411.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance is intended for manufacturers of laser products and
outlines FDA's approach regarding the applicability of FDA's
performance standard regulations to surveying, leveling, and alignment
(SLA) laser products.
A notice of availability of the draft guidance appeared in the
Federal Register of May 5, 2014 (79 FR 25597). FDA considered comments
received and revised the guidance as appropriate in response to the
comments, including requests for clarification regarding which laser
products are considered SLA laser products and including additional
questions and answers regarding SLA laser class limits.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on surveying, leveling, and alignment laser
products. 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 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 guidance document is also
available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Surveying, Leveling, and Alignment
Laser Products'' may send an email request to [email protected]
to receive an electronic copy of the document. Please use the document
number 1764 and complete title to identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations, guidance, and forms
have been approved by OMB as listed in the following table:
------------------------------------------------------------------------
21 CFR part, guidance, or FDA
form Topic OMB control No.
------------------------------------------------------------------------
1002 through 1050.............. Reporting and 0910-0025
Recordkeeping for
Electronic
Products--General
Requirements.
------------------------------------------------------------------------
Dated: January 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01964 Filed 1-30-23; 8:45 am]
BILLING CODE 4164-01-P
