Policy Clarification and Premarket Notification Submissions for Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug Administration Staff; Availability, 16364-16365 [2018-07824]
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Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Number of
respondents
Instrument
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
SOAR Specialized T/TA Feedback Form ........................................................
Webinar Participant Feedback Form ...............................................................
Survivor Impact Consultant Application ...........................................................
Expert T/TA Consultant Application .................................................................
Organizational Scholarship Application ...........................................................
Professional Development Survivor Scholarship Application ..........................
200
1000
20
20
10
30
1
1
1
1
1
1
.150
.067
.283
.267
.317
.333
30.00
67.00
5.66
5.34
3.17
9.99
Total Annual Burden .................................................................................
5,908
........................
........................
689.15
Estimated Total Annual Burden
Hours: 689 Hours.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. Chap 35), the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
Reports Clearance Officer.
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
srobinson on DSK3G9T082PROD with NOTICES
[FR Doc. 2018–07843 Filed 4–13–18; 8:45 am]
BILLING CODE 4184–47–P
VerDate Sep<11>2014
19:42 Apr 13, 2018
Jkt 244001
Food and Drug Administration
[Docket No. FDA–2017–D–4764]
Policy Clarification and Premarket
Notification Submissions for
Ultrasonic Diathermy Devices;
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the
guidance entitled ‘‘Policy Clarification
and Premarket Notification [510(k)]
Submissions for Ultrasonic Diathermy
Devices; Guidance for Industry and
Food and Drug Administration Staff.’’
This guidance clarifies FDA’s policy
related to compliance with applicable
performance standards and
conformance to International
Electrotechnical Commission (IEC)
consensus standards for ultrasonic
diathermy devices. This guidance
provides recommendations for
information to provide in 510(k)
submissions for ultrasonic diathermy
devices.
DATES: The announcement of the
guidance is published in the Federal
Register on April 16, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
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–
2017–D–4764 for ‘‘Policy Clarification
and Premarket Notification [510(k)]
Submissions for Ultrasonic Diathermy
Devices; Guidance for Industry and
Food and Drug Administration Staff.’’
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 office
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
E:\FR\FM\16APN1.SGM
16APN1
srobinson on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
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 ‘‘Policy Clarification
and Premarket Notification [510(k)]
Submissions for Ultrasonic Diathermy
Devices; Guidance for Industry and
Food and Drug Administration Staff ’’ to
the Office of the Center Director,
Guidance and Policy Development,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5431, Silver Spring, MD 20993–
VerDate Sep<11>2014
19:42 Apr 13, 2018
Jkt 244001
0002. Send one self-addressed adhesive
label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT:
Jismi Johnson, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1524, Silver Spring,
MD 20993–0002, 301–796–6424.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry and FDA staff
entitled ‘‘Policy Clarification and
Premarket Notification [510(k)]
Submissions for Ultrasonic Diathermy
Devices; Guidance for Industry and
Food and Drug Administration Staff.’’
Ultrasonic diathermy devices are class II
medical devices regulated under 21 CFR
890.5300(a), Ultrasonic diathermy.
Ultrasonic therapy devices must also
comply with FDA radiation safety
performance standards in 21 CFR part
1010, Performance standards for
electronic products: General, and 21
CFR 1050.10, Ultrasonic therapy
products. FDA recognizes that there are
several IEC standards with which other
countries require conformance or
recognize for ultrasonic therapy
products. This means that
manufacturers who distribute these
products in the United States and other
countries might have to ensure
conformance of their products to IEC
standards and comply with FDA
performance standards. This may cause
manufacturers to duplicate their efforts.
This guidance clarifies FDA’s policy
related to compliance with applicable
performance standards and
conformance to IEC consensus
standards for ultrasonic diathermy
devices. If firms provide a declaration of
conformity with the relevant provisions
of the current FDA recognized versions
of the IEC 60601–2–5 and IEC 61689
standards, FDA does not intend to
consider whether firms comply with
certain requirements of 21 CFR 1050.10.
This guidance also provides
recommendations for information to
provide in 510(k) submissions for
ultrasonic diathermy devices.
No comments were received on the
draft guidance that was published in the
August 31, 2017, Federal Register
notice (82 FR 41417).
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
16365
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on policy clarification
and premarket notification (510(k))
submissions for ultrasonic diathermy
devices. 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. This guidance is not
subject to Executive Order 12866.
III. 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/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
guidance document is also available at
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Policy Clarification and Premarket
Notification [510(k)] Submissions for
Ultrasonic Diathermy Devices; Guidance
for Industry and Food and Drug
Administration Staff’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 1500003 to identify
the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E have been
approved under OMB control number
0910–0120; 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 820 have
been approved under OMB control
number 0910–0073; and the collections
of information in 21 CFR parts 1002
through 1050 are approved under OMB
control number 0910–0025.
Dated: April 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07824 Filed 4–13–18; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16364-16365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07824]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-4764]
Policy Clarification and Premarket Notification Submissions for
Ultrasonic Diathermy Devices; 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 the guidance entitled ``Policy Clarification and
Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy
Devices; Guidance for Industry and Food and Drug Administration
Staff.'' This guidance clarifies FDA's policy related to compliance
with applicable performance standards and conformance to International
Electrotechnical Commission (IEC) consensus standards for ultrasonic
diathermy devices. This guidance provides recommendations for
information to provide in 510(k) submissions for ultrasonic diathermy
devices.
DATES: The announcement of the guidance is published in the Federal
Register on April 16, 2018.
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-2017-D-4764 for ``Policy Clarification and Premarket Notification
[510(k)] Submissions for Ultrasonic Diathermy Devices; Guidance for
Industry and Food and Drug Administration Staff.'' 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 office between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be
[[Page 16365]]
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.gpo.gov/fdsys/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.
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
``Policy Clarification and Premarket Notification [510(k)] Submissions
for Ultrasonic Diathermy Devices; Guidance for Industry and Food and
Drug Administration Staff '' to the Office of the Center Director,
Guidance and Policy Development, 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: Jismi Johnson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993-0002, 301-796-6424.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Policy Clarification and Premarket Notification
[510(k)] Submissions for Ultrasonic Diathermy Devices; Guidance for
Industry and Food and Drug Administration Staff.'' Ultrasonic diathermy
devices are class II medical devices regulated under 21 CFR
890.5300(a), Ultrasonic diathermy. Ultrasonic therapy devices must also
comply with FDA radiation safety performance standards in 21 CFR part
1010, Performance standards for electronic products: General, and 21
CFR 1050.10, Ultrasonic therapy products. FDA recognizes that there are
several IEC standards with which other countries require conformance or
recognize for ultrasonic therapy products. This means that
manufacturers who distribute these products in the United States and
other countries might have to ensure conformance of their products to
IEC standards and comply with FDA performance standards. This may cause
manufacturers to duplicate their efforts.
This guidance clarifies FDA's policy related to compliance with
applicable performance standards and conformance to IEC consensus
standards for ultrasonic diathermy devices. If firms provide a
declaration of conformity with the relevant provisions of the current
FDA recognized versions of the IEC 60601-2-5 and IEC 61689 standards,
FDA does not intend to consider whether firms comply with certain
requirements of 21 CFR 1050.10. This guidance also provides
recommendations for information to provide in 510(k) submissions for
ultrasonic diathermy devices.
No comments were received on the draft guidance that was published
in the August 31, 2017, Federal Register notice (82 FR 41417).
II. Significance of Guidance
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 policy clarification and premarket
notification (510(k)) submissions for ultrasonic diathermy devices. 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. This guidance
is not subject to Executive Order 12866.
III. 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Policy Clarification
and Premarket Notification [510(k)] Submissions for Ultrasonic
Diathermy Devices; Guidance for Industry and Food and Drug
Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 1500003 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120; 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 820
have been approved under OMB control number 0910-0073; and the
collections of information in 21 CFR parts 1002 through 1050 are
approved under OMB control number 0910-0025.
Dated: April 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07824 Filed 4-13-18; 8:45 am]
BILLING CODE 4164-01-P
