Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Draft Guidances for Industry and Food and Drug Administration Staff; Availability, 57155-57157 [2024-15337]
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57155
Federal Register / Vol. 89, No. 134 / Friday, July 12, 2024 / Notices
Comments due within 30 days of
publication. OMB must make a decision
regarding the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this information
collection by selecting ‘‘Currently under
30-day Review—Open for Public
Comments’’ or by using the search
function. You can also obtain copies of
the proposed collection of information
by emailing infocollection@acf.hhs.gov.
Identify all emailed requests by the title
of the information collection.
SUPPLEMENTARY INFORMATION:
Description: Section 676 of the CSBG
Act requires States, including the
District of Columbia and the
Commonwealth of Puerto Rico, and U.S.
territories applying for CSBG funds to
submit an application and plan (CSBG
DATES:
State Plan). The CSBG State Plan must
meet statutory requirements prior to
OCS awarding CSBG grant recipients
(States and territories) with CSBG funds.
Grant recipients have the option to
submit a detailed plan annually or
biannually. Grant recipients that submit
a biannual plan must provide an
abbreviated plan the following year if
substantial changes to the initial plan
will occur. OCS is not requesting any
changes to this form. As this will be the
11th year of submitting this form, OCS
does not anticipate any additional
burden.
OCS is also requesting to extend
approval of the following information
collections, with no changes proposed:
• CSBG Eligible Entity List. In
alignment with Federal requirements,
OCS requests that all grant recipients
continue to keep their CSBG Eligible
Entity List current, to include
maintaining an accurate listing of the
CSBG sub-grant recipients (CSBG
eligible entities) and current Unique
Entity Identifier (UEI) for each recipient
listed. This is in alignment with current
policies and processes, and therefore
OCS does not anticipate any additional
burden.
• Optional survey for the sub-grant
recipients (or CSBG-eligible entities).
The American Customer Survey Index
(ACSI) is administered biennially. OCS
uses the ACSI survey for eligible entities
as part of the CSBG performance
management framework. The survey
focuses on the customer service that the
CSBG sub-grant recipients receive from
the CSBG grant recipients. The survey is
optional, and this will be the seventh
time that CSBG sub-grant recipients
have the option to complete the survey.
There were no revisions to the survey.
OCS anticipates submitting a
subsequent revision to this information
collection, pending OMB review and
approval of a separate but related
information collection request (CSBG
Annual Report, OMB No. 0970–0492)
that is forthcoming and expected in
summer 2024 and may result in minor
updates to some of these materials.
Respondents: State governments,
including the District of Columbia and
the Commonwealth of Puerto Rico, and
U.S. territories, and local level sub-grant
recipients.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
Average
burden
hours per
response
Total
burden
hours
Annual
burden
hours
CSBG State Plan ....................................................................................................................
CSBG Eligible Entity List ........................................................................................................
56
56
3
3
28
1
4,704
168
1,568
56
Estimated Total Annual Burden Hours for CSBG Grant Recipients ...............................
CSBG ACSI Survey of CSBG Eligible Entities .......................................................................
........................
1,000
..........................
2
....................
.15
................
300
1,624
100
Estimated Total Annual Burden Hours for CSBG sub-grant recipients ..........................
........................
..........................
....................
................
100
Estimated Total Annual Burden Hours for All Respondents ...........................................
........................
..........................
....................
................
1,724
Authority: Sec. 676, Public Law 105–
285, 112 Stat. 2735 (42 U.S.C. 9908).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mary C. Jones,
ACF/OPRE Certifying Officer.
Food and Drug Administration
[FR Doc. 2024–15368 Filed 7–11–24; 8:45 am]
[Docket Nos. FDA–2024–D–2511 and FDA–
2024–D–2512]
BILLING CODE 4184–27–P
Dental Composite Resin Devices and
Dental Curing Lights—Premarket
Notification (510(k)) Submissions
Guidances; Draft Guidances for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
lotter on DSK11XQN23PROD with NOTICES1
Total
number of
responses per
respondent
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of two draft
guidances entitled ‘‘Dental Composite
Resin Devices—Premarket Notification
SUMMARY:
VerDate Sep<11>2014
16:35 Jul 11, 2024
Jkt 262001
PO 00000
Frm 00033
Fmt 4703
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(510(k)) Submissions’’ and ‘‘Dental
Curing Lights—Premarket Notification
(510(k)) Submissions.’’ These draft
guidance documents provide
recommendations for device
description, performance testing, and
labeling to include in 510(k)
submissions for dental composite resin
devices and dental curing lights. When
final, these guidances will supersede the
guidances ‘‘Dental Composite Resin
Devices—Premarket Notification
[510(k)] Submissions’’ dated October 26,
2005 and ‘‘Dental Curing Lights—
Premarket Notification [510(k)]
Submissions’’ dated March 27, 2006.
The recommendations in these draft
guidances are intended to promote
consistency and facilitate efficient
review of these submissions. These draft
guidances are not final nor are they for
implementation at this time.
E:\FR\FM\12JYN1.SGM
12JYN1
57156
Federal Register / Vol. 89, No. 134 / Friday, July 12, 2024 / Notices
Submit either electronic or
written comments on the draft guidance
by September 10, 2024 to ensure that
the Agency considers your comment on
the 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:
DATES:
lotter on DSK11XQN23PROD with NOTICES1
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–
2024–D–2511 for ‘‘Dental Composite
Resin Devices—Premarket Notification
(510(k)) Submissions’’ or the Docket No.
FDA–2024–D–2512 for ‘‘Dental Curing
Lights—Premarket Notification (510(k))
Submissions.’’ 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
VerDate Sep<11>2014
16:35 Jul 11, 2024
Jkt 262001
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 ‘‘Dental Composite
Resin Devices—Premarket Notification
(510(k)) Submissions’’ or ‘‘Dental Curing
Lights—Premarket Notification (510(k))
Submissions’’ 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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT:
Michael Adjodha, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G304, Silver Spring,
MD 20993–0002, 301–796–6276.
SUPPLEMENTARY INFORMATION:
I. Background
These draft guidance documents
provide recommendations for device
description, performance testing, and
labeling to include in 510(k)
submissions for dental composite resin
devices and dental curing lights. Dental
composite resin devices are devices
intended to fill and restore defects or
carious lesions in teeth. The device may
be supplied as a two-part base and
catalyst system that is self-cured or a
one-part system that is cured via
photoinitiation. Dental curing lights are
devices that emit non-ionizing optical
radiation intended to photopolymerize
dental restorative resins. These
guidances, when final, will supersede
‘‘Dental Composite Resin Devices—
Premarket Notification [510(k)]
Submissions’’ dated October 26, 2005
and ‘‘Dental Curing Lights—Premarket
Notification [510(k)] Submissions’’
dated March 27, 2006. The
recommendations in these draft
guidances are intended to promote
consistency and facilitate efficient
review of these submissions.
These draft guidances are being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). These draft guidances, when
finalized, will represent the current
thinking of FDA on Dental Composite
Resin Devices—Premarket Notification
(510(k)) Submissions and Dental Curing
Lights—Premarket Notification (510(k))
Submissions. They do not establish any
rights for any person and are 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 copies
of the draft guidances 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. These
guidance documents are also available
at https://www.regulations.gov and
E:\FR\FM\12JYN1.SGM
12JYN1
Federal Register / Vol. 89, No. 134 / Friday, July 12, 2024 / Notices
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download
an electronic copy of ‘‘Dental Composite
Resin Devices—Premarket Notification
(510(k)) Submissions (document
number GUI00016050)’’ or ‘‘Dental
Curing Lights—Premarket Notification
(510(k)) Submissions (document
number GUI00016017)’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number and complete title to
identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
While these guidances contain no
new collection of information, they do
OMB control
No.
Topic
807, subpart E ............................................................................
812 ..............................................................................................
‘‘Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program’’.
800, 801, 809, and 830 ..............................................................
Premarket notification ................................................................
Investigational Device Exemption ..............................................
Q-submissions and Early Payor Feedback Request Programs
for Medical Devices.
Medical Device Labeling Regulations; Unique Device Identification.
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.
Protection of Human Subjects and Institutional Review Boards
50, 56 ..........................................................................................
Dated: July 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–15337 Filed 7–11–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Investigational Agent
Accountability Record Forms and
International Investigator Statement in
the Conduct of Investigational Trials
for the Treatment of Cancer National
Cancer Institute (NCI)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide an
opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact Tali Johnson, Chief,
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
refer to previously approved FDA
collections of information. The
previously approved collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521). The collections of information in
the following table have been approved
by OMB:
21 CFR part or guidance
820 ..............................................................................................
VerDate Sep<11>2014
16:35 Jul 11, 2024
Jkt 262001
Pharmaceutical Management Branch,
Cancer Therapy Evaluation Program,
Division of Cancer Diagnosis and
Treatment, National Cancer Institute,
9609 Medical Center Drive, Bethesda,
Maryland 20892 or call non-toll-free
number (240) 276–6575 or Email your
request, including your address to:
tmjohnson@mail.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires written
comments and/or suggestions from the
public, and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’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 minimizes
the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Proposed Collection Title:
Investigational Agent Accountability
Record Forms and International
Investigator Statement in the Conduct of
Investigational Trials for the Treatment
of Cancer, 0925–0613, Expiration Date
PO 00000
Frm 00035
Fmt 4703
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57157
0910–0120
0910–0078
0910–0756
0910–0485
0910–0073
0910–0130
1/31/2025, REVISION, National Cancer
Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information
Collection: This is a request for OMB to
approve the revision of the collection
titled ‘‘Investigational Agent
Accountability Record Forms in the
Conduct of Investigational Trials for the
Treatment of Cancer National Cancer
Institute (NCI)’’ for an additional three
years of data collection. The U.S. Food
and Drug Administration (FDA) holds
the National Cancer Institute (NCI),
Division of Cancer Treatment and
Diagnosis/Cancer Therapy Evaluation
Program (NCI/DCTD/CTEP), and the
Division of Cancer Prevention (DCP)
responsible as a sponsor of
investigational drug trials, to assure the
FDA that investigators in its clinical
trials program are maintaining systems
for accountability. Data obtained from
the Investigational Agent Accountability
Record Forms (aka. Drug Accountability
Record Forms—DARF) are used to track
the dispensing of investigational
anticancer agents from receipt from the
NCI to dispensing or administration to
patients. Requirements for tracking
investigational agents under an
Investigational New Drug Application
are outlined in title 21 Code of Federal
Regulations (CFR) part 312. NCI and/or
its auditors use this information to
ensure compliance with federal
regulations and NCI policies. This
revision removes the International
Investigator Statement (IIS) form as it
was transitioned to the CTEP Branch
and Support Contracts Forms and
Surveys (OMB#0925–0753) submission.
OMB approval is requested for 3
years. There are no costs to respondents
E:\FR\FM\12JYN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 134 (Friday, July 12, 2024)]
[Notices]
[Pages 57155-57157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15337]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2024-D-2511 and FDA-2024-D-2512]
Dental Composite Resin Devices and Dental Curing Lights--
Premarket Notification (510(k)) Submissions Guidances; Draft Guidances
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 two draft guidances entitled ``Dental Composite
Resin Devices--Premarket Notification (510(k)) Submissions'' and
``Dental Curing Lights--Premarket Notification (510(k)) Submissions.''
These draft guidance documents provide recommendations for device
description, performance testing, and labeling to include in 510(k)
submissions for dental composite resin devices and dental curing
lights. When final, these guidances will supersede the guidances
``Dental Composite Resin Devices--Premarket Notification [510(k)]
Submissions'' dated October 26, 2005 and ``Dental Curing Lights--
Premarket Notification [510(k)] Submissions'' dated March 27, 2006. The
recommendations in these draft guidances are intended to promote
consistency and facilitate efficient review of these submissions. These
draft guidances are not final nor are they for implementation at this
time.
[[Page 57156]]
DATES: Submit either electronic or written comments on the draft
guidance by September 10, 2024 to ensure that the Agency considers your
comment on the 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:
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-2024-D-2511 for ``Dental Composite Resin Devices--Premarket
Notification (510(k)) Submissions'' or the Docket No. FDA-2024-D-2512
for ``Dental Curing Lights--Premarket Notification (510(k))
Submissions.'' 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
``Dental Composite Resin Devices--Premarket Notification (510(k))
Submissions'' or ``Dental Curing Lights--Premarket Notification
(510(k)) Submissions'' 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: Michael Adjodha, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G304, Silver Spring, MD 20993-0002, 301-
796-6276.
SUPPLEMENTARY INFORMATION:
I. Background
These draft guidance documents provide recommendations for device
description, performance testing, and labeling to include in 510(k)
submissions for dental composite resin devices and dental curing
lights. Dental composite resin devices are devices intended to fill and
restore defects or carious lesions in teeth. The device may be supplied
as a two-part base and catalyst system that is self-cured or a one-part
system that is cured via photoinitiation. Dental curing lights are
devices that emit non-ionizing optical radiation intended to
photopolymerize dental restorative resins. These guidances, when final,
will supersede ``Dental Composite Resin Devices--Premarket Notification
[510(k)] Submissions'' dated October 26, 2005 and ``Dental Curing
Lights--Premarket Notification [510(k)] Submissions'' dated March 27,
2006. The recommendations in these draft guidances are intended to
promote consistency and facilitate efficient review of these
submissions.
These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on Dental
Composite Resin Devices--Premarket Notification (510(k)) Submissions
and Dental Curing Lights--Premarket Notification (510(k)) Submissions.
They do not establish any rights for any person and are 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 copies of the draft guidances 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. These guidance documents are
also available at https://www.regulations.gov and
[[Page 57157]]
https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic copy of ``Dental
Composite Resin Devices--Premarket Notification (510(k)) Submissions
(document number GUI00016050)'' or ``Dental Curing Lights--Premarket
Notification (510(k)) Submissions (document number GUI00016017)'' may
send an email request to [email protected] to receive an
electronic copy of the document. Please use the document number and
complete title to identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While these guidances contain no new collection of information,
they do refer to previously approved FDA collections of information.
The previously approved collections of information are subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of
information in the following table have been approved by OMB:
------------------------------------------------------------------------
OMB control
21 CFR part or guidance Topic No.
------------------------------------------------------------------------
807, subpart E................. Premarket notification. 0910-0120
812............................ Investigational Device 0910-0078
Exemption.
``Requests for Feedback and Q-submissions and Early 0910-0756
Meetings for Medical Device Payor Feedback Request
Submissions: The Q-Submission Programs for Medical
Program''. Devices.
800, 801, 809, and 830......... Medical Device Labeling 0910-0485
Regulations; Unique
Device Identification.
820............................ Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality System
(QS) Regulation.
50, 56......................... Protection of Human 0910-0130
Subjects and
Institutional Review
Boards.
------------------------------------------------------------------------
Dated: July 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15337 Filed 7-11-24; 8:45 am]
BILLING CODE 4164-01-P
